A & O Enterprises Inc

Volume 167 · 167 F.T.C. 209

Citation: 167 F.T.C. 209
Docket: C-4670
Complaint: 2019-02-13
Decision: 2019-02-13
Document type: consent order
Case type: consumer protection
Statutes: FTC Act (section 5)
Industry: intravenous vitamin therapy services
Outcome: consent order entered
Relief: cease_and_desist; compliance_reporting; recordkeeping
Order term (years): 20
Source: Original volume PDF
Original PDF: This decision as a PDF

Cite this decision

A & O Enterprises Inc, 167 F.T.C. 209 (2019). Consumer Law Library, https://consumerlawlibrary.org/decisions/v167-0005

Report an error in this record (decision id v167-0005)

Order status: active_until:2039-02-13. Sunset may be extended by the latest qualifying federal-court complaint alleging an order violation; complaints, dismissal/appeal outcomes, and respondent-specific extensions are not fully tracked.

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A & O ENTERPRISES INC

Complaint

IN THE MATTER OF

A & O ENTERPRISES INC D/B/A IV BARS INCORPORATED AND IV BARS, AND AARON K. ROBERTS, A/K/A AARON KEITH

CONSENT ORDER, ETC. IN REGARD TO ALLEGED VIOLATIONS OF SECTIONS 5 AND 12 OF THE FEDERAL TRADE COMMISSION ACT

Docket No. C-4670; File No. 172 3016 Complaint, February 13, 2019 – Decision, February 13, 2019

This consent order addresses A & O Enterprises Inc.’s advertising, promotion and sale of intravenous drip cocktails (“iV Cocktails”), including the Myers Cocktail, which contain a mixture of water, vitamins, minerals and amino acids. The complaint alleges that the respondents violated Sections 5(a) and 12 of the Federal Trade Commission Act by representing that their iV Cocktails are effective treatments for cancer, angina, cardiovascular disease, congestive heart failure, myocardial infarction, multiple sclerosis, diabetes, fibromyalgia and neurodegenerative disorders, and that their cocktails produce fast, lasting results, are safe for all ages and cause no side effects. The complaint also alleges that respondents falsely represented that their iV Cocktails are clinically or scientifically proven to effectively treat the enumerated diseases and produce fast, lasting results. The consent order prohibits express or implied health benefit, efficacy, safety, or side effects claims for any covered product, unless the representation is non-misleading, and, at the time the representation is made, proposed respondents possess and rely upon competent and reliable scientific evidence that is sufficient in quality and quantity to support the claim, based on standards generally accepted by experts in the area.

Participants

For the Commission: Thomas B. Carter and James R. Golder.

For the Respondents: Ryan J. Meyer and Barrett R. Howell, Bracewell LLP.

COMPLAINT

The Federal Trade Commission, having reason to believe that A & O Enterprises Inc, a corporation, and Aaron K. Roberts, individually and as owner and operating manager of A & O Enterprises Inc. (collectively, “Respondents”), have violated provisions of the Federal Trade Commission Act, and it appearing to the Commission that this proceeding is in the public interest, alleges:

1. Respondent A & O Enterprises Inc (“iV Bars”), also doing business as iV Bars Incorporated and iV Bars, is a Wyoming corporation with its principal office or place of business at 4101 Centurion Way, Addison, Texas 75001.

2. Respondent Aaron K. Roberts, also known as Aaron Keith, is the owner and operating manager of iV Bars. Individually or in concert with others, he controlled or had the authority to control, or participated in the acts and practices of iV Bars, including the acts and

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practices alleged in this Complaint. His principal office or place of business is the same as that of iV Bars.

3. Respondents have advertised, offered for sale, sold, and administered at least 10 different intravenous cocktails (“iV Cocktails”) to consumers, including the Myers Cocktail and Immune Booster. Respondents’ iV Cocktails or “bags” contain mixtures of water, vitamins, minerals, and amino acids infused directly into the bloodstream through an intravenous drip, typically through a vein in the arm. These iV Cocktails cost $100.00 or more per session. Respondents refer to these treatments, among other things, as “Intravenous Micro-Nutrient Therapy,” “Intravenous Vitamin Therapy,” “Hydration Therapy,” or simply “iV Therapy.” Respondents claimed that their iV Cocktails could be used to treat consumers suffering from serious diseases, including cancer, congestive heart failure, multiple sclerosis, diabetes, fibromyalgia, and neurodegenerative disorders. Respondents further claimed that their iV Cocktails produced fast, lasting results and, in many instances, were more effective and better tolerated than conventional medical therapies. Respondents also touted their iV Cocktails as hangover cures and a way to replenish fluids and essential vitamins and minerals. In addition, Respondents offered several intramuscular treatments that directly inject mixtures into human muscle. Respondents’ iV Cocktails and intramuscular treatments are “drugs,” within the meaning of Sections 12 and 15 of the Federal Trade Commission Act.

4. Respondents’ first and primary iV Bars location is housed in a NextGen Wellness Center, an upscale gym and clinic that independently offers chiropractic care, pain management therapy, physical therapy, medical massages, and counseling. New iV Bars customers create an online account and complete a short health assessment questionnaire when making their first appointment. Respondents have an arrangement with a doctor who does a quick, online review of all health assessment questionnaires that customers submit to iV Bars. Respondents pay the doctor a flat fee of $250 per month for this service. Shortly before the customer arrives, an iV Bars employee takes about five minutes to mix ingredients obtained from a local compounding pharmacy into the customer’s requested iV Cocktail. Once at iV Bars, the customer is asked to sign a release form that discloses risks and releases Respondents from liability. Thereafter an iV Bars nurse seats the customer in one of five oversized reclining chairs and administers the iV Cocktail to them over a 25-45 minute period. Respondents also maintain a “full service mobile vehicle” that allows them to “come right to your door to deliver the treatment of your needs.”

5. The acts or practices of Respondents alleged in this Complaint have been in or affecting commerce, as “commerce” is defined in Section 4 of the Federal Trade Commission Act.

iV Bars Efficacy Claims

6. Beginning at least as early as August 2015, Respondents have disseminated, or caused to be disseminated, advertisements for their iV Cocktails, including through company Facebook, Twitter, and Instagram accounts and company websites, including the ivbars.com website (imaged on January 27, 2017), attached as Exhibit A (“iV Bars Website” or “Website”). As described below, the iV Bars Website contained the following statements and depictions, among others:

A & O ENTERPRISES INC

Complaint

a. On the top section of the Website homepage, Respondents prominently offered "MEDICAL iV TREATMENTS" for, among other things, "CANCER." They also stated, "If you are new to the concept of Intravenous vitamin Therapy, you might be wondering why you're suddenly hearing so much about it. Why [it is] being relied upon by . . . patients suffering from a very serious illness. [It] represents an exciting new paradigm in integrative and functional medicine, allowing us to both prevent and help treat a wide variety of conditions safely and effectively":

MY ACCOUNT iV BARS INCORPORATED ATHLETIC MEDICAL HANGOVER AGE & BEAUTY MOBILE SCIENCE CONTACT Book Now!

MEDICAL iV TREATMENTS SPORTS RECOVERY ANXIETY ATTACKS NEUROPATHY HYDRATION WEDDING DISASTERS FLU / COLD RECOVERY CANCER MIGRAINES BELL'S PALSY HANGOVERS AND MORE

TAKING VITAMINS ORALLY? IT SIMPLY DOES NOT WORK! BE EFFECTIVE.

ONLY 15% OF THE ACTIVE NUTRIENTS CONSUMED ORALLY FIND THEIR WAY INTO YOUR BLOODSTREAM Our iV Therapy delivers replenishing fluids, vitamins, minerals & amino acids into the bloodstream with 100% absorption, where they are immediately available for your cells to use. Resulting in quicker recovery time and improved overall performance. 100% TRUE VITAMIN RETENTION

If you are new to the concept of Intravenous vitamin Therapy, you might be wondering why you're suddenly hearing so much about it. Why is it being relied upon by professional athletes to CEO's and most importantly by patients suffering from a very serious illness. Intravenous Vitamin Therapy represents an exciting new paradigm in integrative and functional medicine, allowing us to both prevent and help treat a wide variety of conditions safely and effectively. Learn more about us, click the button below! ! ABOUT iV BARS: THE COMPANY

(Exhibit A-1)

b. The middle section of the Website homepage titled "The Science Behind iV Bars" stated, "Vitamins, minerals and amino acids enter your bloodstream directly and immediately to help the body to begin healing itself" and claimed that iV Bars treatments were, "Developed by a team of leading medical doctors, naturopathic doctors, biochemists, nutritionists and exercise physiologists":

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The Science Behind iV Bars Vitamins, minerals and amino acids enter your bloodstream directly and immediately to help the body to begin healing itself. Developed by a team of leading medical doctors, naturopathic doctors, biochemists, nutritionists and exercise physiologists. iV Bars profiling is a technique employed by our medical staff to assist in identifying a person's specific nutrient requirements. LEARN MORE ABOUT THE LAB VISIT VITAMINDRIP Dehydrated iV BARS DNA Vita-Panel Your Life, Just Better!

(Exhibit A-1)

c. The bottom section of the Website homepage titled "Our Success Stories" contained brief endorsements of iV Bars by two sports figures and an international model and a link titled "READ MORE STORIES":

Our Success Stories "Since using iV Bars, I find I don't get down and out with the cold and flu." Kellen Winslow Jr., NFL Player "I am absolutely hooked on iV Bars. I am able to keep up with my busy lifestyle." Kamila Drotlef, International Model READ MORE STORIES "Since starting iV Bars, I find my aches and pains have gone down dramatically." Zenon Konopka, NHL player

(Exhibit A-1)

Clicking the "READ MORE STORIES" link took consumers to pages titled "SUCCESS STORIES" that described "case studies about different disorders and the effects that iV therapy has had on these conditions":

A & O ENTERPRISES INC

Complaint

MY ACCOUNT iV BARS INCORPORATED ATHLETIC MEDICAL HANGOVER AGE & BEAUTY MOBILE SCIENCE CONTACT Book Now! SUCCESS STORIES A majority of ill patients have significant underlying nutritional deficiencies. Food intolerances, allergies, and sensitivities can lead to gastrointestinal absorption problems. Additionally, oral supplementation can be incomplete or minimally absorbed. The use of intravenous (IV) therapy has the ability to work instantaneously. The following are case studies about different disorders and the effects that IV therapy has had on these conditions.

(Exhibit A-3)

These case study success stories included the following purported results:

Case #3: Multiple Sclerosis

* * *

Case#4: Diabetic peripheral neuropathy/Restless leg syndrome

A 65 year-old male presents to the clinic with a ten plus year history of rheumatoid arthritis, diabetes, high blood pressure, neuropathy and restless leg syndrome . . . . The patient was started on intravenous vitamin C and glutathione therapy. After the fourth treatment, the patient's restless symptoms and joint pain was [sic] completely resolved . . . . Although the symptoms have returned, they were not of the same intensity.

* * *

More Success Stories

Asthma

EXHIBIT A - 3

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Case #1: A five-year-old boy presented with a two-year history of asthma. During the previous 12 months he had suffered 20 asthma attacks severe enough to require a visit to the hospital emergency department. His symptoms appeared to be exacerbated by several foods, and skin tests had been positive for 23 of 26 inhalants tested. His initial treatment consisted of identification and avoidance of allergenic foods, as well as daily oral supplementation with pyridoxine (50 mg), vitamin C (1,000 mg), calcium (200 mg), magnesium (100 mg), and pantothenic acid (100 mg), in two divided doses with meals. On this regimen, he experienced marked improvement, and had no asthma attacks requiring medical care until nearly 11 months after his initial visit. At that time the child, now six years old, presented for an emergency visit with mild but persistent wheezing and difficulty breathing. He was given a slow IV infusion containing 8 mL vitamin C, 1.4 mL magnesium, and 0.5 mL each of calcium, B12, B6, B5, and B complex. The symptoms resolved within two minutes and did not recur. Over the ensuing eight years and three months, he received a total of 53 IV treatments for acute exacerbations of asthma. In most instances, a single injection resulted in marked improvement or complete relief within two minutes, and the acute symptoms did not recur. Occasionally, a second injection was needed after a period of 12 hours to two days, and during one episode three treatments were required over a four-day period. As the patient grew, the nutrient doses were gradually increased: by age 10 he was receiving 10 mL vitamin C, 3 mL magnesium, 1.5 mL calcium, and 1 mL each of B12, B6, B5, and B complex. The treatment was unsuccessful only once, on that occasion the patient presented with generalized urticaria, angioedema, and unusually severe asthma, after the inadvertent ingestion of an artificial food coloring (FD&C red #40) and other potential allergens. Three separate injections given over a 60-minute period produced transient improvement each time. However, the symptoms returned, and he was taken to the emergency room and hospitalized. Despite that single treatment failure, the patient and his parents reported that IV nutrient therapy worked faster, produced a more sustained improvement, and caused considerably fewer side effects than the conventional therapies he had received previously in the emergency room. The author has treated approximately a dozen asthmatics (mainly adults) with the Myers' for acute asthma attacks. In most instances, marked improvement or complete relief occurred within minutes. A few patients received maintenance injections once weekly or every other week during difficult times and reported the treatments kept their asthma under better control. Intravenous magnesium is now well documented as an effective treatment for acute asthma. In one study, 38 patients with an acute exacerbation of moderate-to-severe asthma that had failed to respond to conventional beta-agonist therapy were randomly assigned to receive, in double-blind fashion, IV infusions of either magnesium sulfate (1.2 g over a 20-minute period) or placebo (saline). 13 Peak expiratory flow rate improved to a significantly greater extent in the magnesium group (225 to 297 L/min) than the placebo group (238 to 216 L/min). In addition, the hospitalization rate was significantly lower in the magnesium group than in the placebo group (37% vs. 79%; p < 0.01). No patient had a significant drop in blood pressure or change in heart rate after receiving magnesium. In a second double-blind study, 149 patients with acute asthma who were being treated with inhaled beta-agonists and IV steroids were randomly assigned to receive an IV infusion of magnesium sulfate (2 g over 20 minutes) or saline placebo, beginning 30 minutes after presentation. 14 Among patients with severe asthma (defined as forced expiratory volume in 1 second [FEV1] less than 25 percent of predicted value) compared with placebo, magnesium significantly reduced the hospitalization rate (33.3% vs. 78.9%; p < 0.01) and significantly improved FEV1. However, magnesium treatment was of no benefit to patients with moderate asthma (defined as baseline FEV1 between 25 and 75 percent of predicted value). In two placebo-controlled studies of asthmatic children, IV magnesium sulfate significantly improved pulmonary function and significantly reduced hospitalization rates during acute exacerbation's that has failed to respond to conventional therapy. 15,16 A dose of 40 mg per kg body weight (maximum dose, 2 g) given over a 20-minute period appeared to be more effective than 25 mg per kg. Higher doses of IV magnesium sulfate (10-25 g over 1 hour, followed by 2.4 g per hour for 24 hours) have been used successfully in the treatment of life-threatening status asthmaticus. In a few studies, IV magnesium failed to improve pulmonary function or to reduce the need for hospitalization. 17,18 However, a meta-analysis of seven randomized trials concluded that IV magnesium reduced the need for hospitalization by 90 percent among patients with severe asthma, although the treatment was not beneficial for patients with moderate asthma. Calcium is the only other component of the Myers' that has been studied as a treatment for acute exacerbation's of asthma. In an early report, a series of IV infusions of calcium chloride relieved asthma symptoms in three consecutive patients, with relief occurring almost immediately after some injections. 20 Intravenous and IM administration of an unspecified calcium salt temporarily inhibited severe anaphylactic reactions in two other patients. Nutrients other than magnesium and calcium may have contributed to the beneficial effect observed in asthma patients. Oral vitamins C22 and B6 23,24 and IM vitamin B12 25 have each been used with some success against asthma, although none of these nutrients has been tested as a treatment for acute attacks. Intramuscular administration of niacinamide has been shown to reduce the severity of experimentally induced asthma in guinea pigs. 26 and pantothenic acid appears to have an anti-allergy effect in humans. 27 On one occasion, a patient's asthma attack was treated with IV magnesium alone. Although the symptoms resolved rapidly, they returned within 10-15 minutes. The remaining constituents of the Myers' (without additional magnesium) were then administered, and the symptoms disappeared almost immediately and did not return. Thus, it seems the Myers' is more effective than magnesium alone in the treatment of asthma attacks.

Migraine Case #2: A [illegible]-old female suffered from frequent migraines, which appeared to be triggered in many instances by exposure to environmental chemicals or, occasionally, to ingestion of foods to which she was allergic. Allergy desensitization therapy had provided little benefit. Over a six-year period, the patient was given IV therapy on approximately 70 occasions for migraines. Nearly all of these injections resulted in considerable improvement or complete relief within several minutes, although a few treatments were ineffective. Through trial and error, it was determined her most effective regimen was 18 mL vitamin C, 8 mL magnesium, 4 mL calcium, 2 mL B6, and 1 mL each of B12, B5, and B complex. The 4-mL dose of calcium was found to provide better relief than lower calcium doses. Over the years, a half dozen other patients have presented one or more times with an acute migraine. In almost every instance, the Myers' produced a gratifying response within a few minutes. The beneficial effect of IV magnesium as a treatment for migraines has been demonstrated in recent clinical trials. In one study, 40 patients with an acute migraine received 1 g magnesium sulfate over a five-minute period. 28 Fifteen minutes after the infusion, 35 patients (87.5%) reported at least a 50-percent reduction of pain, and nine patients (22.5%) experienced complete relief. In 21 of 35 patients who benefited, the improvement persisted for 24 hours or more. Patients with an initially low serum ionized magnesium concentration (less than 0.54 mmol/L) were significantly more likely to experience long-lasting improvement than were patients with initially higher serum ionized magnesium levels. In a single-blind trial that included 30 patients with an acute migraine, IV administration of magnesium sulfate (1 g over 15 minutes) completely and permanently relieved pain in 13 of 15 patients (86.6%), whereas no patients in the placebo group became pain free (p < 0.001 for difference between groups). 29 In addition, magnesium treatment resulted in rapid disappearance of nausea, vomiting, and photophobia in all 14 patients who had experienced those symptoms. A single 1-g dose of magnesium sulfate has also been reported to abort an episode of cluster headaches in seven of 22 patients (32%), and a series of three to five injections provided sustained relief in an additional two patients (9%). It is not clear whether the Myers' is more effective than magnesium alone for migraines; however, one patient did experience noticeable benefit from IV calcium.

Fatigue Many patie[illegible] unexplained fatigue have responded to the Myers', with results lasting only a few days or as long as several months. Patients who benefited often returned at their own discretion for another treatment when the

EXHIBIT A - 4

A & O ENTERPRISES INC

Complaint

effect had worn off. One patient with fatigue associated with chronic hepatitis B experienced marked and progressive improvement in energy levels with weekly or twice-monthly injections. Approximately 10 patients with chronic fatigue syndrome (CFS) received a minimum of four treatments (usually once weekly for four weeks), with more than half showing clear improvement. One patient experienced dramatic benefit after the first injection, whereas in other cases three or four injections were given before improvement was evident. A few patients became progressively healthier with continued injections and were eventually able to stop treatment. Several others did not overcome their illness, but periodic injections helped them function better. There is some research support for the use of parenteral magnesium in patients with fatigue. One study found magnesium deficiency, demonstrated by an IV magnesium-load test, in 47 percent of 93 patients with unexplained chronic fatigue, including 50 with CFS. In a second study, the mean erythrocyte magnesium concentration was significantly lower in 20 patients with CFS than in healthy controls. One arm of the second study, 32 patients with CFS were randomly assigned to receive, in double-blind fashion, 1 g magnesium sulfate IM or placebo, once weekly for six weeks. Twelve (80%) of 15 patients given magnesium reported improvement (e.g., more energy, a better emotional state, and less pain) and fatigue was eliminated completely in seven cases. In contrast, only three (18%) of 17 placebo-treated patients improved (p<0.0015 for difference between groups), and in no case was the fatigue completely eliminated. According to one report, at least half of CFS patients with magnesium deficiency benefited from oral magnesium supplementation; however, some patients needed IM injections. Other investigators, using the IV magnesium-load test, found no evidence of magnesium deficiency in patients with CFS, and observed no improvement in symptoms following a single infusion of magnesium sulfate (5 g in one hour). Vitamin B12, given IM, has been reported to be helpful for patients with unexplained fatigue, 35 as well as those with CFS. While the results obtained with the Myers' may be attributable in part to vitamin B12, many patients who responded to IV therapy obtained little or no benefit from IM vitamin B12 alone.

Fibromyalgia

Case #3: A 40-year-old woman presented with a six-year history of fairly constant myalgias and arthralgias, with pain in the neck, back, and hip, and tightness in the left arm. Six months previously she was found to have an elevated sedimentation rate (50 mm/hr). She was diagnosed by a rheumatologist as possibly having polymyalgia rheumatica, although the diagnosis of fibromyalgia was also considered. Her history was also significant for migraines about eight times per year and chronic nasal congestion. Physical examination revealed extremely stiff muscles, with decreased range of motion in many areas of her body. The patient was given a therapeutic trial consisting of 6 mL vitamin C, 4 mL magnesium, 2.5 mL calcium and 1 mL each of B12, B6, B5, and B complex. At the end of the injection, she got off the table and, with a look of amazement, announced her muscle aches and joint pains were gone for the first time in six years. This treatment was repeated after a week (at which time her symptoms had not returned), followed by every other week for several months, then once monthly for three years. Her initial regimen also included the identification and avoidance of allergenic foods and treatment with low-dose desiccated thyroid (eventually stabilized at 60 mg per day). She discovered that eating refined sugar caused myalgias and arthralgias, and that thyroid hormone improved her energy level, mood, and overall well being. During the three years of monthly maintenance injections she reported symptoms would begin to recur if she went much longer than a month between treatments. However, they were never as severe as they were before she began receiving IV therapy. The author has given the Myers' to approximately 30 patients with fibromyalgia; half have experienced significant improvement, in a few cases after the first injection, but more often after three or four treatments. The beneficial effect of parenteral nutrient therapy has been confirmed by one study published only as an abstract. Eighty-six patients with chronic muscular complaints, including myofascial pain, relapsing soft tissue injuries, and fibromyalgia, received IM or IV injections of magnesium, either alone or in combination with calcium, B vitamins, and vitamin C. 37 Improvement occurred in 74 percent of the patients; of those, 64 percent required four or fewer injections for optimal results. A minority of patients required long-term oral or parenteral magnesium to maintain improvement. The positive response to parenteral magnesium is consistent with the observation that nearly half of patients with fibromyalgia have intracellular magnesium deficiency, despite having normal serum levels of the mineral. 38

Depression

Case #4: A 46-year [illegible] presented with a history of depression and anxiety since childhood. He had been in psychoanalysis for the past eight years. A therapeutic trial with IV nutrients was considered because the patient reported that consumption of alcohol (known to deplete magnesium) aggravated his symptoms, and because he was taking a magnesium-depleting thiazide diuretic for hypertension. He was initially given 1 mL each of magnesium, B12, B6, B5, and B complex, which resulted in a 70-80 percent reduction in his symptoms for one week. A second injection produced a similar response that lasted two weeks. Through trial and error it was determined the most effective treatment was 5 mL magnesium, 3 mL B complex, and 1 mL each of B12, B6, and B5. The addition of calcium to the injection appeared to block some of the benefit. Both oral and IM administration of the same nutrients were tried but found to be ineffective. Weekly injections provided almost complete relief from symptoms and allowed him to discontinue psychotherapy. The patient noted that rapidly administered injections provided longer-lasting relief than did slower injections. The infusion rate was therefore carefully and progressively increased, without causing any adverse side effects or changes in blood pressure or heart rate. The patient reported that when the treatment was given over a one-minute period, the effect would last approximately two weeks, whereas a slower injection (such as five minutes) would last only a week. Approximately four years after initial treatment, he was able to reduce the frequency of injections to once monthly or less. Many other patients with depression and/or anxiety have shown a positive response to the Myers'. However, this treatment should not be considered first-line therapy for major depression. It seems to be helpful only for certain subsets of depressed individuals, such as those who also suffer from fibromyalgia, migraines, excessive stress, or alcohol-induced exacerbations. Shealy et al have observed an antidepressant effect of IV magnesium in some patients with chronic pain. 39

Cardiovascular Disease

Case #5: A 70-year-old man was seen [illegible] in end-stage heart failure, after having suffered four myocardial infarctions. During the previous 12 months, spent mostly in the hospital, he had become progressively worse; his ejection fraction had fallen to 19 percent and his body weight had declined from 171 pounds to a severely cachectic 113 pounds. He was confined to bed and required supplemental oxygen much of the time. He also had severe peripheral occlusive arterial disease, which had resulted in the development of gangrene of six toes. A peripheral angiogram revealed complete occlusion of both femoropopliteal arteries, with no detectable blood flow to the distal extremities. Two independent vascular surgeons had recommended bilateral above-the-knee amputations to prevent development of septicemia. However, the cardiologist advised the patient that his heart would not last more than another month, so the patient declined the amputations. He was treated with weekly IM injections of magnesium sulfate (1 g) for eight weeks, and prescribed oral supplementation with vitamins C and E, B complex, folic acid, and zinc. The magnesium injections appeared to reduce the pain in his gangrenous toes considerably, with the benefit lasting about five days each time. Six weeks after the first injection, his ejection fraction had increased from 19 percent to 39 percent and he no longer required supplemental oxygen. After eight weeks, the IM injections were replaced by weekly IV injections, consisting of 5 mL magnesium, 1 mL each of B12, B6, B5, and B complex, and a low-dose (0.2 mL) trace mineral preparation (MTE-5 containing: zinc, copper, chromium, selenium,

EXHIBIT A -5

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and manganese). After a total of 18 months, his weight had increased from 113 to 147 pounds, which was remarkable as cardiac cachexia is generally considered to be irreversible. In addition, the gangrenous areas on his toes had sloughed and been replaced almost entirely by healthy tissue. Intravenous therapy was continued and eventually reduced to every other week. The patient lived for eight years and died at age 87 from multiple organ failure. Of the handful of other patients with angina or heart failure who received IV or IM injections of magnesium (with or without B vitamins), all showed significant improvement. The results with angina are consistent with those reported by others using parenteral magnesium therapy. 40-42

Upper Respiratory Tract Infections

Case #6: A 40-year-old male presented with a cold and a one-day history of fatigue, nasal congestion, and rhinorrhea. He was given an IV infusion of 18 mL vitamin C, 3 mL magnesium, 1.5 mL calcium, and 1 mL each of B12, B6, B5, and B complex. By the end of the 10-minute treatment he was symptom-free. The cold symptoms did return the next day but were only 10 percent as severe as before the injection. One-quarter to one-third of patients who received the Myers' for an acute respiratory infection experienced marked improvement, either immediately or by the next morning. Approximately half of patients given this treatment reported that it shortened the duration of their illness. Patients who benefited tended to have a similar response if treated for a subsequent infection, whereas non-responders tended to remain non-responders.

Case #7: A 32-year-old female had a long history of chronic sinusitis. Avoidance of allergenic foods and oral supplementation with vitamin C and other nutrients had provided only minimal benefit. She was given an IV infusion of 20 mL vitamin C, 4 mL magnesium, 2 mL calcium, and 1 mL each of B12, B6, B5, and B complex; this protocol was repeated the next day. At the time these injections were given she had been experiencing persistent sinus problems for a year. Her symptoms resolved rapidly after the injections and she remained relatively symptom-free for more than six months. The same treatment given at a later date was also helpful, although the benefit was not as pronounced as the first time. One other patient with chronic sinusitis had a similar response to back-to-back injections, while a few others showed no improvement.

Seasonal Allergic Rhinitis

Case #8: A 39-year-old man had a long history of seasonal allergic rhinitis, occurring each spring and lasting about a month. Symptoms included nasal congestion, itchy eyes, and fatigue. During a symptomatic period, an IV infusion of 12 mL vitamin C, 3 mL magnesium, and 1 mL each of B12, B5, B6, and B complex provided rapid relief. This treatment was repeated as needed during the hay fever season (once weekly or less) and successfully controlled his symptoms. In subsequent years he began the IVs shortly before, and repeated them periodically during, the hay fever season; this approach prevented the development of symptoms.

Narcotic Withdrawal

Case #9: A 36-year-old man addicted to morphine came to the office in the early stages of withdrawal, with diaphoresis and extreme agitation. He was given an IV infusion of 16 mL vitamin C, 5 mL magnesium, 2.5 mL calcium, and 1 mL each of B12, B6, B5, and B complex. In his agitated state he was unable to sit still on the exam table, so we walked up and down the hall with a butterfly needle in his arm. Halfway through the injection, he was able to sit still, and by the end of the injection his withdrawal symptoms were alleviated. The symptoms returned 36 hours later; he therefore came for another treatment, which again relieved the symptoms within minutes. He returned the next day, still symptom free, for a third injection, which carried him uneventfully through the remainder of the withdrawal period.

Chronic Urticaria

Case #10: A 71-year-old woman had chronic urticaria with hives present somewhere on her body nearly every day for 10 years. An allergy-elimination diet and oral supplementation with vitamin C and other nutrients provided little or no relief. She was given an IV infusion of 12 mL vitamin C, 3 mL magnesium, 1.5 mL calcium, and 1 mL each of B12, B6, B5, and B complex. The same treatment was repeated the following day. After these injections the hives resolved rapidly and did not recur for more than a year. When the lesions did recur, the IV treatment was repeated but was ineffective.

Athletic Performance

Case #11: An 18-year-old, 235-[illegible] high school wrestler developed a flu-like illness four days before a major tournament. Two days before the three-day tournament, when he appeared he might have to miss the event, he was given an IV injection of 16 mL vitamin C, 5 mL magnesium, 2.5 mL calcium, and 1 mL each of B12, B6, B5, and B complex. The next morning he remarked that he had more energy than he had ever had in his life. This energy boost persisted for the duration of the tournament, at which he took second place, a better performance than at any other time in his career. In this era in which many athletes are using performance-enhancing drugs, it is not the author's intention to encourage athletes to seek another "boost" with IV nutrients. However, this case does demonstrate that nutritional factors can play an important role in athletic performance.

Hyperthyroidism

Two patients with hyperthyroidism were treated with the Myers' once or twice weekly for several weeks. In one case, the treatment controlled the symptoms of hyperthyroidism although there was no reduction in thyroidhormone levels. The injections were discontinued after medical therapy had restored the hormone levels to normal. In the other case, symptoms improved markedly after the first injection and thyroid-function tests, measured two weeks later, returned to normal. The potential value of IV nutrient therapy for patients with hyperthyroidism is supported by several studies. Serum and erythrocyte magnesium levels have been found to be low in patients with Graves' disease. 43 In addition, daily IM injections of magnesium chloride (20 mL of a 14-percent solution) for 3-7 weeks reduced the size of the thyroid gland and improved the clinical condition of three patients with hyperthyroidism. 44 Intravenous vitamin B6 (50 mg per day) was reported to relieve muscle weakness in three patients with hyperthyroidism, 45 and animal studies indicate vitamin B12 can counteract some of the adverse effects of experimentally induced hyperthyroidism.

FDA DISCLAIMER: THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THESE PRODUCTS ARE NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

EXHIBIT A - 6

A & O ENTERPRISES INC

Complaint

[illegible] iv BARS ATHLETIC MEDICAL HANGOVER AGE & BEAUTY MOBILE SCIENCE CONTACT Book Now!

BOOK APPOINTMENT

Why Drip? [illegible] [illegible]

Benefits Conditions

Adrenal fatigue Cancer Asthma Colds & flu Celiac disease Gluten sensitivity Chronic fatigue syndrome Chronic pain Congestive heart failure Dehydration Depression & anxiety

Diabetes Effects of Aging Infertility & Pregnancy Fibromyalgia Gastrointestinal conditions General wellness Hangovers Heavy metal toxicity High blood pressure Immune health Aids in Weight Loss

Injuries Low energy Poor memory Migraine & tension headaches Neurodegenerative disorders Nutrient deficiencies Post surgical healing Preventative care Skin conditions Stress Revitalize hair & nails

RECHARGE. REPAIR.

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[illegible] HANGOVERS [illegible]

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Complaint

IV BARS ATHLETIC MEDICAL HANGOVER AGE & BEAUTY MOBILE SCIENCE CONTACT BOOK NOW

Age and Beauty

Why Drip? [illegible]

Mood Support Aches & Pains Diet & Detox Immune Support

[illegible]

RECHARGE. REPAIR.

[illegible]

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Complaint

[illegible] iV BARS ATHLETIC MEDICAL HANGOVER AGE & BEAUTY MOBILE SCIENCE CONTACT [illegible] Book Now!

WE COME TO YOU

PRIVATE

We Are Mobile. We Come To You!

[illegible]

Benefits Conditions

[illegible] [illegible] [illegible] [illegible]

[illegible]

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Complaint

BOOK APPOINTMENT

iV BARS ATHLETIC MEDICAL HANGOVER AGE & BEAUTY MOBILE SCIENCE CONTACT [illegible] Book Now!

THE SCIENCE BEHIND IV Bars KNOWLEDGE DID YOU KNOW IV Bars IS MUCH MORE EFFECTIVE THAN TAKING VITAMINS ORALLY? [illegible]

INTRAVENOUS (IV) THERAPY [illegible]

WHAT CAN IVMT BE USED FOR? [illegible]

IS IT SAFE? [illegible]

IV Bars PROFILING PROCESS [illegible]

IV Bars PROFILE [illegible]

[illegible] THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION [illegible] TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE [illegible]

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IV BARS ATHLETIC MEDICAL HANGOVER AGE & BEAUTY MOBILE SCIENCE CONTACT

ARE YOU GETTING THE NUTRIENTS YOU NEED?

WHY IS NUTRIENT STATUS SO IMPORTANT? [illegible] confirms that vitamin deficiencies are associated with disease processes and the overall condition of one's health. Vitamin, mineral and antioxidant deficiencies has been shown to suppress immune function and contribute to chronic degenerative processes such as arthritis, cancer, Alzheimer's, cardiovascular disease and diabetes. This body of research has been reviewed by the journal of the American Medical Association (June 19, 2002 Vol 287, no 23)

Nutrient deficiencies are common.

University research shows that 90% of people are deficient, and 50% of those people are already taking a multivitamin.

But I eat a balanced diet, exercise and take a multivitamin...

IF THIS DESCRIBES ALL OR PART OF YOUR LIFESTYLE, READ ON.

Many people lead healthy lifestyles, yet some individuals still have deficiencies. But Why? ABSORPTION Although you may eat a balanced diet, if you do not absorb vitamins, minerals, antioxidants and/or other essential micronutrients properly, you can have deficiencies. LIFESTYLE Excessive physical activity, prescription drugs, smoking, alcohol and sedentary habits, all impact micronutrient demands. CHRONIC ILLNESS Health conditions such as arthritis, cancer, cardiovascular disease, diabetes, fatigue and multiple sclerosis, to name a few, can be affected, directly or indirectly, by micronutrient deficiencies. AGING Our micronutrient requirements at age 30 are quite different from our requirements at age 40, 50 and beyond. Absorption difficulties, especially of vitamin B12, quite commonly occur as we age. BIOCHEMICAL INDIVIDUALITY Because each of us is metabolically and biochemically unique, the micronutrient requirements for one person may be quite different than the requirements of another.

[illegible]

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iV BARS ATHLETIC MEDICAL HANGOVER AGE & BEAUTY MOBILE SCIENCE CONTACT

BOOK APPOINTMENT

Nutrition is at the core of integrative health and IV Bars' Micronutrient Testing is the most advanced diagnostic tool available.

Micronutrient testing measures how micronutrients are actually functioning within your white blood cells. These tests allow nutritional assessment for a broad variety of clinical conditions, general wellness and the prevention of chronic diseases including arthritis, cancer, cardiovascular risk, diabetes, various immunological disorders and metabolic disorders.

Micronutrient Testing gives a functional cellular analysis of nutrient deficiencies and provides a 4-6 month window of nutritional history. For those people living in Dallas or Addison [illegible] testing might be able to provide information to best optimize your vitamin supplementation.

TEST COMPONENTS:

VITAMINS VITAMIN A, VITAMIN B1, VITAMIN B2, VITAMIN B3, VITAMIN B6, VITAMIN B12, VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN K, BIOTIN, FOLATE, PANTOTHENATE MINERALS CALCIUM, MAGNESIUM, ZINC, COPPER, MANGANESE AMINO ACIDS ASPARAGINE, GLUTAMINE, SERINE FATTY ACIDS OLEIC ACID METABOLITES CHOLINE, INOSITOL, CARNITINE ANTIOXIDANTS GLUTATHIONE, SELENIUM, VITAMIN E, ALPHA LIPOIC ACID, COENZYME Q10, CYSTEINE CARBOHYDRATE METABOLISM CHROMIUM, FRUCTOSE SENSITIVITY, GLUCOSE-INSULIN METABOLISM

Talk to a IV Bars® doctor today about Micronutrient Testing to determine your nutritional status.

BOOK APPOINTMENT NOW

EXHIBIT A - 13

VOLUME 167 Complaint BOOK APPOINTMENT iV BARS | ATHLETIC MEDICAL HANGOVER AGE & BEAUTY MOBILE SCIENCE CONTACT | Book Now! SCIENTIFIC EVIDENCE FACTS Intravenous Nutrient Therapy " The Myers' Cocktail "

By Alan R. Gaby, M.D.

[illegible] Introduction [illegible] Theoretical Basis For IV Therapy [illegible] The Modified Myers Cocktail [illegible] Nutrients in the Myers Cocktail Magnesium chloride hexahydrate 20% (magnesium) Calcium gluconate 10% (calcium) Hydroxocobalamin 1,000 mcg/mL (B12) Pyridoxine hydrochloride 100 mg/mL (B6) Dexpanthenol 250 mg/mL (B5) B complex 100 (B complex) Vitamin C 222 mg/mL (C) [illegible] EXHIBIT A - 14

A & O ENTERPRISES INC

Complaint

[illegible]

Cost Considerations

[illegible]

Conclusion

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References

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BOOK APPOINTMENT

iV BARS ATHLETIC MEDICAL HANGOVER AGE & BEAUTY MOBILE SCIENCE CONTACT CONTACT US

At the IV Bars, we are ready to help you get on the right track for better health Conveniently located in the heart of Addison Texas, we are easily accessible to most residents of greater Dallas area.

PHONE (800) 272-9900 or (469) 480-7447 for Mobile Assistance ADDRESS 4101 Centurion Way, Addison, Texas 75001 HOURS Friday - Monday (10 am - 2 pm) Schedule Your Consultation Today There are two easy ways to get started:

1) Call us at (800) 272-9900 today to speak with our IV specialists. They will arrange a consultation for you with a IV Consultant, who will supervise and direct your intravenous nutrient therapy. If you have any questions or concerns, our helpful and caring staff is available to address all your needs.

2) Fill in the form on this page and we will contact you promptly. Rest assured that your personal information will be held in the strictest confidence. The IV Bars of Addison will never disclose or sell such information to any third party.

Name * First Last Email * Phone * Comments / Questions: *

[illegible]

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Complaint

BOOK APPOINTMENT

IV BARS ATHLETIC MEDICAL HANGOVER AGE & BEAUTY MOBILE SCIENCE CONTACT

[illegible]

PHONE:

[illegible] or [illegible] for Mobile Assistance ADDRESS:

8965 Davis Blvd Southlake (Keller), Texas 76092 HOURS Friday - Monday (10 am - 2 pm) Schedule Your Consultation Today [illegible]

Name * First Last Email * Phone * Comments / Questions: *

Submit

[illegible]

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Complaint

iV BARS ATHLETIC MEDICAL HANGOVER AGE & BEAUTY MOBILE SCIENCE CONTACT ENHANCE IMMUNITY & ENERGIZE HOW IT WORKS [illegible] TREATMENT [illegible] Disclaimer: [illegible]

EXHIBIT A - 20

A & O ENTERPRISES INC

Complaint

iV BARS ATHLETIC MEDICAL HANGOVER AGE & BEAUTY MOBILE SCIENCE CONTACT [illegible] ATHLETICISM AT ITS FINEST HOW IT WORKS IV Bars The Performance is a functional IV injection providing replenishing fluids, vitamins, minerals and amino acids before, during and after all extreme activities. TREATMENT Extreme Sports - Running, Cycling, Swimming, Soccer, Football, Hockey, Motorsports, Surfing, Sky Diving, Snow Boarding, Climbing, Tennis, Boxing, MMA, Flying, Adventure and much more Disclaimer: You should consult your physician before taking vitamins, minerals, nutritional supplements or herbal products. Our vitamins and nutritional supplement products on this site are not intended to diagnose, treat, cure or prevent any disease. Final product ingredients and dosages may vary depending on personal requirements and availability. Statements made here have not been evaluated by FDA.

FDA DISCLAIMER: THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THESE PRODUCTS ARE NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

BOOK APPOINTMENT

EXHIBIT A - 21

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[illegible] IV BARS ATHLETIC MEDICAL HANGOVER AGE & BEAUTY MOBILE SCIENCE CONTACT [illegible]

HOW IT WORKS IV Bars Re-hydrate is a functional IV injection providing replenishing fluids, vitamins, minerals to restore hydration TREATMENT Exercise Fatigue, General Exhaustion, Hangover, Skin Complexion, Seasonal Illness, Jet Lag and much more.

EXHIBIT A - 22

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Complaint

IV BARS ATHLETIC MEDICAL HANGOVER AGE & BEAUTY MOBILE SCIENCE CONTACT RE-JUVENATE HOW IT WORKS IV Bars Re-juvenate is a functional IV injection providing replenishing fluids, vitamins, minerals and amino acids to restore youthful radiance TREATMENT Reduce fine lines and wrinkles, suppress formation of acne and blemishes, produce collagen to enhance elasticity, cleaner skin and much more.

Disclaimer: You should consult your physician before taking vitamins, minerals, nutritional supplements or herbal products. Our vitamins and nutritional supplement products on this site are not intended to diagnose, treat, cure or prevent any disease. Final product ingredients and dosages may vary depending on personal requirements and availability. Statements made here have not been evaluated by FDA FDA DISCLAIMER THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION THESE PRODUCTS ARE NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE BOOK APPOINTMENT

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[illegible] iV BARS ATHLETIC MEDICAL HANGOVER AGE & BEAUTY MOBILE SCIENCE CONTACT [illegible] Diet & Detox BOOK APPOINTMENT HOW IT WORKS [illegible] TREATMENT [illegible] Disclaimer: [illegible] [illegible]

EXHIBIT A - 24

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Complaint

[illegible] iV BARS ATHLETIC MEDICAL HANGOVER AGE & BEAUTY MOBILE SCIENCE CONTACT SICK & TIRED OF BEING...

SICK & TIRED? HOW IT WORKS [illegible] TREATMENT [illegible] Disclaimer [illegible]

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[illegible] iV BARS ATHLETIC MEDICAL HANGOVER AGE & BEAUTY MOBILE SCIENCE CONTACT [illegible] INCREASED AROUSAL HOW IT WORKS iV Bars Libido Enhancer is a fast-acting IV injection providing replenishing fluids Vitamins, minerals and amino acids to relax blood vessels and increase blood flow TREATMENT Increased sex drive, stamina, energy, youthful vitality, boost testosterone in a natural way and much more

[illegible]

EXHIBIT A - 26

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Complaint

BOOK APPOINTMENT

iV BARS ATHLETIC MEDICAL HANGOVER AGE & BEAUTY MOBILE SCIENCE CONTACT

FOR LIVES BIGGER THAN PAIN.

HOW IT WORKS [illegible]

TREATMENT [illegible]

Disclaimer [illegible]

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BOOK APPOINTMENT iV BARS ATHLETIC MEDICAL HANGOVER AGE & BEAUTY MOBILE SCIENCE CONTACT STAY FOCUSED & DETERMINED HOW IT WORKS IV Bars The Focus is a functional IV injection providing replenishing fluids, vitamins, minerals and amino acids to improve brain performance. TREATMENT Cognitive enhancement - focus, quicker thinking, problem solving, memory, attention, sharpness, determination and much more. Disclaimer: You should consult your physician before taking vitamins, minerals, nutritional supplements or herbal products. Our vitamins and nutritional supplement products on this site are not intended to diagnose, treat, cure or prevent any disease. Final product ingredients and dosages may vary depending on personal requirements and availability. Statements made here have not been evaluated by FDA. FDA DISCLAIMER THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION THESE PRODUCTS ARE NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

EXHIBIT A - 28

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Complaint

iV BARS ATHLETIC MEDICAL HANGOVER AGE & BEAUTY MOBILE SCIENCE CONTACT Book Now! BOOK APPOINTMENT FIND YOUR NIRVANA HOW IT WORKS IV Bars Nirvana is a functional IV hydration providing replenishing fluids, vitamins, minerals and amino acids to boost the body's natural serotonin levels and help promote calmness. TREATMENT Ideal for when - under stress, anxious, or exhausted to relax muscles, chill, rest, restore, improve mood and much more. Disclaimer: You should consult your physician before taking vitamins, minerals, nutritional supplements or herbal products. Our vitamins and nutritional supplement products on this site are not intended to diagnose, treat, cure or prevent any disease. Final product ingredients and dosages may vary depending on personal requirements and availability. Statements made here have not been evaluated by FDA. FDA DISCLAIMER THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION THESE PRODUCTS ARE NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

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iVBARS ATHLETIC MEDICAL HANGOVER AGE & BEAUTY MOBILE SCIENCE CONTACT

PURE ENERGY

HOW IT WORKS iVBars Pure Energy is a functional IM injection providing vitamins and active ingredients to keep you energized for days. TREATMENT Working or playing long hours, preparing big race or competition studying or use to regulate sleep, mood, appetite and much more

BOOK APPOINTMENT

EXHIBIT A - 30

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Complaint

iV BARS ATHLETIC MEDICAL HANGOVER AGE & BEAUTY MOBILE SCIENCE CONTACT ANTI-OXIDIZE HOW IT WORKS IV Bars Anti-Oxidize is a functional IV injection providing pure L-Glutathione to prevent damage to important cellular components in your body. TREATMENT Protect against free radicals, reduce oxidative stress, boost immune system, [illegible] reduce cellular inflammation and much more Disclaimer: You should consult your physician before taking vitamins, minerals, nutritional supplements or herbal products. Our vitamins and nutritional supplement products on this site are not intended to diagnose, treat, cure or prevent any disease. Final product ingredients and dosages may vary depending on personal requirements and availability. Statements made here have not been evaluated by FDA. BOOK APPOINTMENT

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iV BARS ATHLETIC MEDICAL HANGOVER AGE & BEAUTY MOBILE SCIENCE CONTACT Work Hard, Play Harder, Recover Faster HOW IT WORKS A Myers' Cocktail is an Intra Venous Vitamin Infusion which will enhance your Immune System, Reduce Fatigue, help with Allergies, reduce symptoms of Fibromyalgia and Asthma TREATMENT An alternative treatment for a broad range of conditions including asthma, fibromyalgia, chronic fatigue syndrome and even some of those hangover cures Disclaimer You should consult your physician before taking vitamins, minerals, nutritional supplements or herbal products. Our vitamins and nutritional supplement products on the [illegible] are not intended to diagnose, treat, cure or prevent any disease. Final product ingredients and dosages may vary depending on personal requirements and availability. Statements made here have not been evaluated by FDA

EXHIBIT A - 32

A & O ENTERPRISES INC

Complaint

[illegible] IV BARS ATHLETIC MEDICAL HANGOVER AGE & BEAUTY MOBILE SCIENCE CONTACT PRIVACY POLICY The Effective Date of this Privacy Policy is June 1, 2015.

SUMMARY AND GENERAL CONTACT INFORMATION [illegible] COLLECTION AND USE OF INFORMATION [illegible] THIRD PARTY SITES [illegible] OPT OUT PROCEDURES [illegible] INFORMATION ACCESS [illegible] SECURITY [illegible] CHANGES TO THIS POLICY [illegible]

EXHIBIT A - 33

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[illegible] iv BARS ATHLETIC MEDICAL HANGOVER AGE & BEAUTY MOBILE SCIENCE CONTACT [illegible]

Terms & Conditions

Privacy

[illegible]

Use of the IV Bars Web Site

[illegible]

Limited Scope

[illegible]

Not a Substitute for Medical Advice

[illegible]

Disclaimer of Warranties Limitation of Liability

[illegible]

Governing Law and Jurisdiction

[illegible]

BOOK APPOINTMENT

EXHIBIT A - 34

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Complaint

Exhibit B

iV BARS IN THE VALLEY 27 Main Street Suite C 104E Edwards, Colorado Website: iVBarsVail.com email: [email protected]

Consent and Authorization for Intravenous Therapy Procedures

Client's name Date____________________

Vitamins are vital for our body's normal function and are absolutely necessary for our growth, general well-being, and vitality. Except for a few exceptions, vitamins cannot be manufactured or synthesized by the body and their absence or improper absorption results in specific deficiency diseases. Therefore it is important for our body to obtain vitamins from outside sources to battle against the chance for a deficiency. Latest researches indicate that many vitamins taken in large doses can have miraculous healing effects in a wide range of common complaints and illnesses. Proper vitamin injections can supply the much needed nutrients your body needs to maintain and enhance normal bodily functions.

Vitamin Injections are better absorbed by the body since they go directly into the blood stream. Alternatives to these injections are Oral Vitamins, Capsules, Liquid drinks, Lotions, Topical Creams, and Mouth Sprays.

Vitamin Injections common side effects include but are not limited to:

1. Risks: I understand there is risk of mild diarrhea, upset stomach, nausea, a feeling of pain and a warm sensation at the site of the injection, a feeling, or a sense, of being swollen over the entire body, headache and joint pain.

2. If any of these side effects become severe or troublesome I will contact my physician immediately.

3. I understand that although rare Vitamin injections can result in serious side effects. Although this is a relatively rare occurrence, anyone taking Vitamin injections should be aware of the possibility. Uncommon side effects are much more serious than the common side effects of Vitamin injections, and such side effects should be reported to a physician to be evaluated for seriousness. Uncommon and dangerous side effects include:

4. I understand the possibility of having an allergic reaction to any of the ingredients found within the Vitamin injection is quite plausible and that I should communicate with my Physician if I have any known allergic reactions to foods, dyes, preservatives, or any other substances. If I experience any of these following signs of allergic reactions I should immediately consult my primary health care Physician and discontinue further use of the product. Signs of allergic reactions include, but not limited to:

• Itching of skin • Hives • Rashes • Wheezing • Difficulty breathing • Swelling of mouth or throat

FOIA CONFIDENTIAL TREATMENT REQUESTED BY BRACEWELL LLP EXHIBIT B - 1 IVB-FTC-000171

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5. When medications are taken in conjunction with the Vitamin Injection, drug interactions could occur. These interactions can either increase your risk of bleeding or block the absorption of the Vitamins into the body. These medications at the time of your injection should either be discontinued or be consulted with by a Physician. Some of the medications that may cause drug interactions include, but are not limited to:

• Heparin (Fragmin, Lovenox, Innohep...ect.) • Antithrombin (A Tryn, Thrombate III) • Argatroban • Aspirin • Ibuprofen • Dipyridamole (Persantine) • Bivalirudin (Angiomax) • Clopidogrel (Plavix) • Warfarin (Coumadin, Jantoven) • Nonsteroidal anti-inflammatory drugs (Ibuprofen, etc.)

6. Before starting the Vitamin injections I will make sure to tell my Physician if I am pregnant, lactating or have any of the following conditions.

• Leber's Disease • Kidney disease • History of Kidney stones • Liver disease • Hormonal disease • Cardiovascular disease • History of ulcers • History of gastrointestinal problems • Bipolar disorder (manic depression) • Attention Deficit Hyperactivity Disorder (ADHD) • Muscular Dystrophy • Elliptic seizures • Hypoglycemia • Schizophrenia • Benign prostatic hypertrophy (BPH) • Acetaminophen poisoning • Hypertension (high blood pressure) • History of seizures • Under-active thyroid (hypothyroidism) • Osteoporosis • Receiving treatment or taking any medication that might "thin" the blood • Receiving treatment or taking medication that has an effect on bone marrow • An infection • Iron deficiency • Folic acid deficiency • Dependent on intravenous nutrition (TPN) or liquid nutrition products for food • Diabetes, mellitus, or high blood sugar levels • An unusual or allergic reaction other medicines, foods, dyes, or preservatives

7. I understand that certain herbal products, vitamins, minerals, nutritional supplements, prescription and non-prescription medications may result in side effects when they interact with the Vitamin Injection.

8. Treatments: Will be determined by the provider. I understand and agree that all services rendered to me are charged directly to me and that I am personally responsible for payment. I further agree in the event of nonpayment, to bear the cost of collection, and/or Court cost and reasonable legal fees, should this be required. By signing below, I acknowledge that I have read the foregoing informed consent and agree to the treatment with its associated risks. I hereby give consent to perform this and all subsequent Vitamin Injections with the above understood. I hereby release the doctor, the person injecting the Vitamin Injection, and the facility from liability associated with this procedure.

Print Name: ________________________ Nurse/EMT Print Name: ______________ Contact No: ________________________ Signature: __________________________ Date: ______________ Time: __________ Date: ______________ Time: __________ Patient Signature: ___________________ Nurse/EMT Signature: ________________

FOIA CONFIDENTIAL TREATMENT REQUESTED BY BRACEWELL LLP

EXHIBIT B - 2

IVB-FTC-000172

A & O ENTERPRISES INC

Decision and Order

DECISION

The Federal Trade Commission (“Commission”) initiated an investigation of certain acts and practices of the Respondents named in the caption. The Commission’s Bureau of Consumer Protection (“BCP”) prepared and furnished to Respondents a draft Complaint. BCP proposed to present the draft Complaint to the Commission for its consideration. If issued by the Commission, the draft Complaint would charge the Respondents with violations of the Federal Trade Commission Act.

Respondents and BCP thereafter executed an Agreement Containing Consent Order (“Consent Agreement”). The Consent Agreement includes: 1) statements by Respondents that they neither admit nor deny any of the allegations in the Complaint, except as specifically stated in this Decision and Order, and that only for purposes of this action, they admit the facts necessary to establish jurisdiction; and 2) waivers and other provisions as required by the Commission’s Rules.

The Commission considered the matter and determined that it had reason to believe that Respondents have violated the Federal Trade Commission Act, and that a Complaint should issue stating its charges in that respect. The Commission accepted the executed Consent Agreement and placed it on the public record for a period of 30 days for the receipt and consideration of public comments. The Commission duly considered any comments received from interested persons pursuant to Commission Rule 2.34, 16 C.F.R. § 2.34. Now, in further conformity with the procedure prescribed in Commission Rule 2.34, the Commission issues its Complaint, makes the following Findings, and issues the following Order:

Findings

1. The Respondents are:

a. Respondent A & O Enterprises Inc, a Wyoming corporation, also doing business as iV Bars Incorporated and iV Bars, with its principal office or place of business at 4101 Centurion Way, Addison, Texas 75001.

b. Respondent Aaron K. Roberts, also known as Aaron Keith, the owner and operating manager of A & O Enterprises Inc. Individually or in concert with others, he formulates, directs, or controls the policies, acts, or practices of A & O Enterprises Inc. His principal office or place of business is the same as that of A & O Enterprises Inc.

2. The Commission has jurisdiction over the subject matter of this proceeding and over the Respondents, and the proceeding is in the public interest.

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ORDER

Definitions

For purposes of this Order, the following definitions apply:

A. “Covered product” means any intravenous therapy, including Respondents’ iV Cocktails, and any intramuscular injection.

B. “Essentially equivalent product” means a product that contains the identical ingredients, except for inactive ingredients (e.g., inactive binders, colors, fillers, excipients), in the same form and dosage, and with the same route of administration (e.g., intravenous), as the covered product; provided that the covered product may contain additional ingredients if reliable scientific evidence generally accepted by experts in the field indicates that the amount and combination of additional ingredients are unlikely to impede or inhibit the effectiveness of the ingredients in the essentially equivalent product.

C. “Intramuscular injection” means the injection of substances, including mixtures of water, vitamins, minerals, amino acids, or other active ingredients, directly into human muscle.

D. “Intravenous therapy” means the infusion of substances, including mixtures of water, vitamins, minerals, amino acids, or other ingredients, directly into the human bloodstream.

E. “iV Cocktail” means any intravenous therapy, advertised, promoted, offered for sale, or sold by Respondents, including the Myers Cocktail and the Immune Booster.

F. “Respondents” means the Corporate Respondent and the Individual Respondent, individually, collectively, or in any combination.

1. “Corporate Respondent” means A & O Enterprises Inc, also doing business as iV Bars Incorporated and iV Bars, and its successors and assigns.

2. “Individual Respondent” means Aaron K. Roberts, also known as Aaron Keith.

Provisions

I. Prohibited Disease Claims

IT IS ORDERED that Respondents, and Respondents’ officers, agents, employees, and attorneys, and all other persons in active concert or participation with any of them, who receive actual notice of this Order, whether acting directly or indirectly, in connection with the advertising, promotion, offering for sale, or sale of any covered product must not make any

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Decision and Order

representation, or assist others in making any representation, expressly or by implication, that such product:

A. Is an effective treatment for cancer;

B. Is an effective treatment for angina, cardiovascular disease, congestive heart failure, or myocardial infarction;

C. Is an effective treatment for multiple sclerosis;

D. Is an effective treatment for diabetes;

E. Is an effective treatment for fibromyalgia;

F. Is an effective treatment for neurodegenerative disorders;

G. Produces fast, lasting results; or

H. Cures, mitigates, or treats any disease;

unless the representation is non-misleading, including that, at the time such representation is made, they possess and rely upon competent and reliable scientific evidence that substantiates that the representation is true. For purposes of this Provision, “competent and reliable scientific evidence” means human clinical testing of the covered product or of an essentially equivalent product that is sufficient in quality and quantity, based on standards generally accepted by experts in the relevant disease, condition, or function to which the representation relates, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true. Such testing must (1) be randomized, double-blind, and placebo-controlled; and (2) be conducted by researchers qualified by training and experience to conduct such testing. In addition, all underlying or supporting data and documents generally accepted by experts in the relevant field as relevant to an assessment of such testing as described in the Provision titled Preservation of Records Relating to Competent and Reliable Human Clinical Tests or Studies must be available for inspection and production to the Commission. Respondents will have the burden of proving that a product satisfies the definition of an essentially equivalent product.

II. Prohibited Health Benefit and Safety Claims

IT IS FURTHER ORDERED that Respondents, and Respondents’ officers, agents, employees, and attorneys, and all other persons in active concert or participation with any of them, who receive actual notice of this Order, whether acting directly or indirectly, in connection with the advertising, promotion, offering for sale, or sale of any covered product must not make any representation, or assist others in making any representation, other than representations covered under the Provision titled Prohibited Disease Claims, expressly or by implication, about the health benefits, efficacy, safety, or side effects of such product, unless the representation is non-misleading, including that, at the time such representation is made, they possess and rely upon competent and reliable scientific evidence that is sufficient in quality and quantity based on

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standards generally accepted by experts in the relevant disease, condition, or function to which the representation relates, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true. For purposes of this Provision, “competent and reliable scientific evidence” means tests, analyses, research, or studies that (1) have been conducted and evaluated in an objective manner by experts in the relevant disease, condition, or function to which the representation relates; (2) that are generally accepted by such experts to yield accurate and reliable results; and (3) that are randomized, double-blind, and placebo-controlled human clinical testing of the covered product, or of an essentially equivalent product, when such experts would generally require such human clinical testing to substantiate that the representation is true. In addition, when such tests or studies are human clinical tests or studies, all underlying or supporting data and documents generally accepted by experts in the field as relevant to an assessment of such testing as described in the Provision of this Order titled Preservation of Records Relating to Competent and Reliable Human Clinical Tests or Studies must be available for inspection and production to the Commission. Respondents will have the burden of proving that a product satisfies the definition of an essentially equivalent product.

III. Prohibited Misrepresentations Regarding an iV Bars Research Lab

A. Assembled physicians, biochemists, or physiologists to create the formulas for their products;

B. Employ biologists, chemists, pharmacists, medical doctors, naturopathic doctors, or exercise physiologists to test or approve their products; or

C. Maintain a research facility, including an iV Bars Research Lab.

IV. Prohibited Misrepresentations Regarding Tests, Studies, or Other Research

A. About the existence, contents, validity, results, conclusions, or interpretations of any test, study, or other research, including that studies, research, or trials prove that such product or service is an effective treatment for cancer, angina, cardiovascular disease, congestive heart failure, myocardial infarction, multiple

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Decision and Order

sclerosis, diabetes, fibromyalgia, or neurodegenerative disorders or produces fast, lasting results; or

B. That any benefit of such product or service is scientifically or clinically proven or otherwise established.

V. Preservation of Records Relating to Competent and Reliable Human Clinical Tests or Studies

IT IS FURTHER ORDERED that, with regard to any human clinical test or study ("test") upon which Respondents rely to substantiate any claim covered by this Order, Respondents must secure and preserve all underlying or supporting data and documents generally accepted by experts in the field as relevant to an assessment of the test, including:

A. All protocols and protocol amendments, reports, articles, write-ups, or other accounts of the results of the test, and drafts of such documents reviewed by the test sponsor or any other person not employed by the research entity;

B. All documents referring or relating to recruitment; randomization; instructions, including oral instructions, to participants; and participant compliance;

C. Documents sufficient to identify all test participants, including any participants who did not complete the test, and all communications with any participants relating to the test; all raw data collected from participants enrolled in the test, including any participants who did not complete the test; source documents for such data; any data dictionaries; and any case report forms;

D. All documents referring or relating to any statistical analysis of any test data, including any pretest analysis, intent-to-treat analysis, or between-group analysis performed on any test data; and

E. All documents referring or relating to the sponsorship of the test, including all communications and contracts between any sponsor and the test's researchers.

Provided, however, the preceding preservation requirement does not apply to a reliably reported test, unless the test was conducted, controlled, or sponsored, in whole or in part by (1) any Respondent; (2) any Respondent's officers, agents, representatives, or employees; (3) any other person or entity in active concert or participation with any Respondent; (4) any person or entity affiliated with or acting on behalf of any Respondent; (5) any supplier of any ingredient contained in the product at issue to any of the foregoing or to the product's manufacturer; or (6) the supplier or manufacturer of such product.

For purposes of this Provision, "reliably reported test" means a report of the test has been published in a peer-reviewed journal, and such published report provides sufficient information about the test for experts in the relevant field to assess the reliability of the results.

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For any test conducted, controlled, or sponsored, in whole or in part, by Respondents, Respondents must establish and maintain reasonable procedures to protect the confidentiality, security, and integrity of any personal information collected from or about participants. These procedures must be documented in writing and must contain administrative, technical, and physical safeguards appropriate to Respondents' size and complexity, the nature and scope of Respondents' activities, and the sensitivity of the personal information collected from or about the participants.

VI. FDA Approved Claims

IT IS FURTHER ORDERED that nothing in this Order prohibits Respondents, or Respondents' officers, agents, employees, and attorneys, or all other persons in active concert or participation with any of them, from making a representation for any drug that is approved in labeling for such drug under any tentative final or final monograph promulgated by the Food and Drug Administration ("FDA"), or under any new drug application approved by the FDA.

VII. Acknowledgments of the Order

IT IS FURTHER ORDERED that Respondents obtain acknowledgments of receipt of this Order:

A. Each Respondent, within 10 days after the effective date of this Order, must submit to the Commission an acknowledgment of receipt of this Order sworn under penalty of perjury.

B. For 10 years after the issuance date of this Order, Individual Respondent for any business that such Respondent, individually or collectively with any other Respondents, is the majority owner or controls directly or indirectly, and Corporate Respondent, must deliver a copy of this Order to: (1) all principals, officers, directors, and LLC managers and members; (2) all employees having managerial responsibilities for conduct related to the subject matter of the Order and all agents and representatives who participate in conduct related to the subject matter of the Order; and (3) any business entity resulting from any change in structure as set forth in the Provision titled Compliance Reports and Notices. Delivery must occur within 10 days after the effective date of this Order for current personnel. For all others, delivery must occur before they assume their responsibilities.

C. From each individual or entity to which a Respondent delivered a copy of this Order, that Respondent must obtain, within 30 days, a signed and dated acknowledgment of receipt of this Order.

VIII. Compliance Report and Notices

IT IS FURTHER ORDERED that Respondents make timely submissions to the Commission:

A & O ENTERPRISES INC

Decision and Order

A. One year after the issuance date of this Order, each Respondent must submit a compliance report, sworn under penalty of perjury, in which:

1. Each Respondent must: (a) identify the primary physical, postal, and email address and telephone number, as designated points of contact, which representatives of the Commission, may use to communicate with Respondent; (b) identify all of that Respondent's businesses by all of their names, telephone numbers, and physical, postal, email, and Internet addresses; (c) describe the activities of each business, including the goods and services offered, the means of advertising, marketing, and sales, and the involvement of any other Respondent (which Individual Respondents must describe if they know or should know due to their own involvement); (d) describe in detail whether and how that Respondent is in compliance with each Provision of this Order; and (e) provide a copy of each Acknowledgment of the Order obtained pursuant to this Order, unless previously submitted to the Commission.

2. Additionally, the Individual Respondent must: (a) identify all his telephone numbers and all his physical, postal, email and Internet addresses, including all residences; (b) identify all his business activities, including any business for which the Respondent performs services whether as an employee or otherwise and any entity in which the Respondent has any ownership interest; and (c) describe in detail the Respondent's involvement in each the business activity, including title, role, responsibilities, participation, authority, control, and any ownership.

B. For 10 years after the issuance date of this Order, each Respondent must submit a compliance notice, sworn under penalty of perjury, within 14 days of any change in the following:

1. Each Respondent must submit notice of any change in: (a) any designated point of contact; or (b) the structure of Corporate Respondent or any entity that Respondent has any ownership interest in or controls directly or indirectly that may affect compliance obligations arising under this Order, including: creation, merger, sale, or dissolution of the entity or any subsidiary, parent, or affiliate that engages in any acts or practices subject to this Order.

2. Additionally, the Individual Respondent must submit notice of any change in: (a) name, including alias or fictitious name, or residence address; or (b) title or role in any business activity, including (i) any business for which the Respondent performs services whether as an employee or otherwise and (ii) any entity in which the Respondent has any ownership interest and over which Respondents have direct or indirect control. For each such business activity, also identify its name, physical address, and any Internet address.

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C. Each Respondent must submit notice of the filing of any bankruptcy petition, insolvency proceeding, or similar proceeding by or against such Respondent within 14 days of its filing.

D. Any submission to the Commission required by this Order to be sworn under penalty of perjury must be true and accurate and comply with 28 U.S.C. § 1746, such as by concluding: “I declare under penalty of perjury under the laws of the United States of America that the foregoing is true and correct. Executed on: ______” and supplying the date, signatory’s full name, title (if applicable), and signature.

E. Unless otherwise directed by a Commission representative in writing, all submissions to the Commission pursuant to this Order must be emailed to [email protected] or sent by overnight courier (not the U.S. Postal Service) to: Associate Director for Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580. The subject line must begin: In re A & O Enterprises Inc.

IX. Recordkeeping

IT IS FURTHER ORDERED that Respondents must create certain records for 10 years after the issuance date of this Order, and retain each such record for 5 years, unless otherwise specified below. Specifically, Corporate Respondent and the Individual Respondent for any business that such Respondent, individually or collectively with any other Respondents, is a majority owner or controls directly or indirectly, must create and retain the following records:

A. accounting records showing the revenues from all goods or services sold, the costs incurred in generating those revenues, and resulting net profit or loss;

B. personnel records showing, for each person providing services in relation to any aspect of the Order, whether as an employee or otherwise, that person’s: name; addresses; telephone numbers; job title or position; dates of service; and (if applicable) the reason for termination;

C. copies or records of all consumer complaints and refund requests, whether received directly or indirectly, such as through a third party, and any response;

D. a copy of each unique advertisement or other marketing material making a representation subject to this Order;

E. for 5 years from the date of the last dissemination of any representation covered by this Order:

1. all materials that were relied upon in making the representation; and

A & O ENTERPRISES INC

Decision and Order

2. all tests, studies, analysis, other research or other such evidence in Respondent's possession, custody, or control that contradicts, qualifies, or otherwise calls into question the representation, or the basis relied upon for the representation; and

F. all records necessary to demonstrate full compliance with each provision of this Order, including all submissions to the Commission.

X. Compliance Monitoring

IT IS FURTHER ORDERED that, for the purpose of monitoring Respondents' compliance with this Order:

A. Within 10 days of receipt of a written request from a representative of the Commission, each Respondent must: submit additional compliance reports or other requested information, which must be sworn under penalty of perjury, and produce records for inspection and copying.

B. For matters concerning this Order, representatives of the Commission are authorized to communicate directly with each Respondent. Respondents must permit representatives of the Commission to interview anyone affiliated with any Respondent who has agreed to such an interview. The interviewee may have counsel present.

C. The Commission may use all other lawful means, including posing through its representatives as consumers, suppliers, or other individuals or entities, to Respondents or any individual or entity affiliated with Respondents, without the necessity of identification or prior notice. Nothing in this Order limits the Commission's lawful use of compulsory process, pursuant to Sections 9 and 20 of the FTC Act, 15 U.S.C. §§ 49, 57b-1.

D. Upon written request from a representative of the Commission, any consumer reporting agency must furnish consumer reports concerning Individual Respondent, pursuant to Section 604(2) of the Fair Credit Reporting Act, 15 U.S.C. § 1681b(a)(2).

XI. Order Effective Dates

IT IS FURTHER ORDERED that this Order is final and effective upon the date of its publication on the Commission's website (ftc.gov) as a final order. This Order will terminate on February 13, 2039, or 20 years from the most recent date that the United States or the Commission files a complaint (with or without an accompanying settlement) in federal court alleging any violation of this Order, whichever comes later; provided, however, that the filing of such a complaint will not affect the duration of:

A. Any Provision in this Order that terminates in less than 20 years;

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B. This Order's application to any Respondent that is not named as a defendant in such complaint; and

C. This Order if such complaint is filed after the Order has terminated pursuant to this Provision.

Provided, further, that if such complaint is dismissed or a federal court rules that the Respondent did not violate any provision of the Order, and the dismissal or ruling is either not appealed or upheld on appeal, then the Order will terminate according to this Provision as though the complaint had never been filed, except that the Order will not terminate between the date such complaint is filed and the later of the deadline for appealing such dismissal or ruling and the date such dismissal or ruling is upheld on appeal.

By the Commission, Commissioner Wilson not participating.

ANALYSIS OF CONSENT ORDER TO AID PUBLIC COMMENT

The Federal Trade Commission ("FTC" or "Commission") has accepted, subject to final approval, an agreement containing a consent order from A & O Enterprises Inc, a corporation, doing business as iV Bars Incorporated and iV Bars, and Aaron K. Roberts, also known as Aaron Keith ("respondents"). The proposed consent order ("order") has been placed on the public record for 30 days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After 30 days, the Commission will again review the agreement, and the comments received, and will decide whether it should withdraw from the agreement and take appropriate action or make final the agreement's proposed order.

This matter involves respondents' advertising, promotion and sale of intravenous drip cocktails ("iV Cocktails"), including the Myers Cocktail, which contain a mixture of water, vitamins, minerals and amino acids. According to the FTC complaint, respondents made false or unsubstantiated representations that their iV Cocktails are effective treatments for cancer, angina, cardiovascular disease, congestive heart failure, myocardial infarction, multiple sclerosis, diabetes, fibromyalgia and neurodegenerative disorders, and that their cocktails produce fast, lasting results, are safe for all ages and cause no side effects. The FTC also alleges that respondents falsely represented that their iV Cocktails are clinically or scientifically proven to effectively treat the enumerated diseases and produce fast, lasting results. The complaint alleges that respondents' actions constitute unfair or deceptive acts or practices and the making of false advertisements, in violation of Sections 5(a) and 12 of the Federal Trade Commission Act.

A & O ENTERPRISES INC

Analysis to Aid Public Comment

The order is designed to prevent respondents from engaging in similar acts or practices in the future. It includes injunctive relief to address these alleged violations and to prohibit similar and related conduct.

• The order defines “covered product” to mean any intravenous therapy, including all of respondents’ iV Cocktails, and any intramuscular injection.

• Part I of the order prohibits express or implied claims that any covered product: (1) is an effective treatment for cancer, angina, cardiovascular disease, congestive heart failure, myocardial infarction, multiple sclerosis, diabetes, fibromyalgia, or neurodegenerative disorders, (2) produces fast, lasting results, or (3) cures, mitigates, or treats any disease, unless the claim is supported by competent and reliable scientific evidence that is sufficient in quality and quantity, based on standards generally accepted by experts in the relevant area. It further requires that such substantiation include a randomized, double-blind, and placebo-controlled human clinical trial.

• Part II of the order prohibits express or implied health benefit, efficacy, safety, or side effects claims for any covered product, unless the representation is non-misleading, and, at the time the representation is made, proposed respondents possess and rely upon competent and reliable scientific evidence that is sufficient in quality and quantity to support the claim, based on standards generally accepted by experts in the area. It further provides that such substantiation must include a randomized, double-blind, and placebo-controlled human clinical trial, when experts generally require such human clinical testing to substantiate the representation.

• Part III of the order prohibits respondents, in connection with the advertising, promotion, offering for sale, or sale of any covered product, from misrepresenting, expressly or by implication, that they assembled physicians, biochemists, or physiologists to create, test or approve the products, or that they maintain a research facility, including an iV Bars Research Lab.

• Part IV of the order prohibits respondents, in connection with the advertising, promotion, offering for sale, or sale of any product or service, from making any misrepresentation about the existence, contents, validity, results, conclusions, or interpretations of any test, study, or other research, or that any product or service is scientifically or clinically proven to produce any benefit.

• Part V of the order requires that respondents, with regard to any human clinical test or study upon which they rely to substantiate any claim covered by the order, must preserve all underlying data and documents generally accepted by experts in the field as relevant to an assessment of the test.

• Part VI of the order provides that nothing in the order prohibits respondents from making a representation for any drug that is approved in labeling for such drug under any tentative final or final monograph promulgated by the Food and Drug Administration, or under any new drug application approved by the FDA.

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Analysis to Aid Public Comment

Parts VII through XI are reporting and compliance provisions. Part VII mandates that respondents acknowledge receipt of the order and, for 10 years, distribute the order to certain employees and agents and secure acknowledgments from recipients of the order. Part VIII requires that respondents submit compliance reports to the FTC one year after the order’s issuance and submit additional reports when certain events occur. Part IX requires that, for 10 years, respondents create certain records and retain them for at least 5 years. Part X provides for the FTC’s continued compliance monitoring of respondents’ activity during the order’s effective dates. Part XI is a provision “sunsetting” the order after 20 years, with certain exceptions.

The purpose of this analysis is to facilitate public comment on the proposed order. It is not intended to constitute an official interpretation of the complaint or order, or to modify in any way the order’s terms.

CORPUS CHRISTI POLYMERS LLC

Complaint

IN THE MATTER OF

CORPUS CHRISTI POLYMERS LLC, ALFA S.A.B. DE C.V., INDORAMA VENTURES PLC, FAR EASTERN NEW CENTURY CORPORATION, ALOKE LOHIA AND SUCHITRA LOHIA

CONSENT ORDER, ETC. IN REGARD TO ALLEGED VIOLATIONS OF SECTION 5 OF THE FEDERAL TRADE COMMISSION ACT AND SECTION 7 OF THE CLAYTON ACT

Docket No. C-4672; File No. 181 0030 Complaint, February 20, 2019 – Decision, February 20, 2019

This consent order addresses the $1.1 billion acquisition by Corpus Christi Polymers LLC of certain assets of M&G Chemicals S.A. The complaint alleges that the joint venture of Alfa, S.A.B. de C.V. (DAK), Indorama Ventures Plc (Indorama), and Far Eastern New Century Corporation (FENC) would violate Section 7 of the Clayton Act and Section 5 of the Federal Trade Commission Act by lessening competition in the production of polyethylene terephthalate resin (PET). The consent order prohibits each joint venture member from owning more than a one-third equity interest in CCP and from owning tolling rights to more than one-third of the Corpus Christi plant’s PET and PTA capacity, without prior approval from the Commission.

Participants

For the Commission: Michael E. Blaisdell, Nicholas Bush, Mary Casale, Keitha Clopper, Clarke Edwards, Eric Olson, Marc Schneider, and Julia Zhang.

For the Respondents: Jeff L. White, Weil, Gotshal & Manges LLP; Michael Perry and Stephen Weissman, Baker Botts LLP; Edward Biester, Duane Morris LLP.

COMPLAINT

Pursuant to the provisions of the Federal Trade Commission Act (“FTC Act”), and by virtue of the authority vested in it by said Act, the Federal Trade Commission (“Commission”), having reason to believe that Respondent Corpus Christi Polymers LLC (“CCP”), a joint venture between corporate entities under the control of Respondents Alfa S.A.B. de C.V. (“DAK”), Indorama Ventures Plc (“Indorama”), controlled by Aloke and Suchitra Lohia, and Far Eastern New Century Corporation (“FENC”), intends to acquire certain assets from M&G Resins USA LLC and its affiliates (“M&G”) in bankruptcy, in violation of Section 5 of the FTC Act, as amended, 15 U.S.C. § 45, and which, if the acquisition is consummated, may substantially lessen competition in violation of Section 7 of the Clayton Act, 15 U.S.C. § 18, and Section 5 of the FTC Act, and it appearing to the Commission that a proceeding by it in respect thereof would be in the public interest, hereby issues its complaint pursuant to Section 5(b) of the FTC Act, 15

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