Steves Distributing, LLC
Volume 171 · 171 F.T.C. 555
deceptive advertisinghealth claimsonline internet
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Steves Distributing, LLC, 171 F.T.C. 555 (2021). Consumer Law Library, https://consumerlawlibrary.org/decisions/v171-0012
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Cites
- 81 F.T.C. 23, pin 62 — L - FADERAL; TRADE COMMISSION AND, THE FUR. PRODUCTS LABELING ACTS cited_neutral
- 104 F.T.C. 648, pin 813 — MATTEL, INC. and CARSON-ROBERTS, INC resolved_page_range
- 155 F.T.C. 1, pin 6 — POM WONDERFUL LLC, ROLL GLOBAL LLC, STEWART A. RESNICK, LYNDA RAE RESNICK AND MATTHEW TUPPER followed
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IN THE MATTER OF STEVES DISTRIBUTING, LLC D/B/A STEVE’S GOODS, AND STEVEN TAYLOR SCHULTHEIS CONSENT ORDER, ETC. IN REGARD TO ALLEGED VIOLATIONS OF SECTIONS 5 AND 12 OF THE FEDERAL TRADE COMMISSION ACT Docket No. C-4739; File No. 202 3065 Complaint, March 2, 2021 – Decision, March 2, 2021 This consent order addresses Steves Distributing, LLC’s advertising of cannabidiol (“CBD”) and cannabigerol (“CBG”), cannabinoid compounds found in hemp and cannabis. The complaint alleges that Respondents violated Sections 5(a) and 12 of the FTC Act by disseminating false and unsubstantiated advertisements claiming that: (1) CBD and CBG products can effectively prevent, treat, or mitigate multiple diseases and other health conditions; and (2) studies or scientific research prove that CBD and CBG products effectively prevent, treat, or mitigate multiple diseases and other health conditions. The consent order requires randomized, double-blind, placebo-controlled clinical testing for the challenged claims or any disease treatment, mitigation, or cure claim for any dietary supplement, food, or drug including but not limited to CBD products or CBG products. The consent order also prohibits other misleading or unsubstantiated representations about the health benefits, performance, efficacy, safety, or side effects of any Covered Product or essentially equivalent product. Participants For the Commission: Laura Fremont and Ronnie Solomon.
For the Respondents: David Bush, Donni Emmie, and Larry Mishkin, Hoban Law Group. COMPLAINT The Federal Trade Commission, having reason to believe that Steves Distributing, LLC, a limited liability company, and Steven Taylor Schultheis, individually and as an officer and owner of Steves Distributing, LLC (collectively, “Respondents”), have violated the provisions of the Federal Trade Commission Act, and it appearing to the Commission that this proceeding is in the public interest, alleges:
1. Respondent Steves Distributing, LLC (“Steves”), also doing business as “Steve’s Goods,” is a limited liability company registered in Colorado, with its principal office or place of business at 1500 Kansas Avenue, Suite 2C, Longmont, Colorado 80501. 2. Respondent Steven Taylor Schultheis (“Schultheis”) is the Chief Executive Officer, President, and principal shareholder of Steves. Schultheis currently holds a 95% equity interest in the Company. As founder and CEO, Schultheis has control over the operations and decisions of the Company. Individually or in concert with others, he controlled or had the VOLUME 171 Complaint authority to control, or participated in the acts and practices of Steves, including the acts and practices alleged in this complaint. His principal office or place of business is the same as that of Steves.
3. The acts and 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.
Respondents’ Marketing of CBD and CBG Products 4. Cannabidiol (“CBD”) and cannabigerol (“CBG”) are non-psychoactive cannabinoids, naturally occurring in, and that can be extracted from, the hemp plant, cannabis sativa. CBG is a minor cannabinoid and precursor molecule of CBD and THC. Respondents have manufactured, labeled, advertised, promoted, offered for sale, sold, and distributed products containing CBD (“CBD Products”) and products containing CBG (“CBG Products”) that are intended for human use. These CBD Products and CBG Products are “food” and/or “drugs,” within the meaning of Sections 12 and 15 of the Federal Trade Commission Act. 5. Steves sells a variety of CBD Products and CBG Products, including but not limited to tinctures, gummies, capsules, topical balms, suppositories, and coffee. Consumers can purchase Steves’ CBD Products and CBG Products from Respondents by ordering them through Respondents’ website at stevesgoods.com, by telephone, or at a brick and mortar retail store located at 1264 S. Hover Street, Longmont, Colorado 80501. 6. According to the product labels and Steves’ website, dosages vary. For example, Steves’ website advertises edible CBD gummies containing 10 mg of CBD. One dosage could range from 10 mg to 50 mg, depending on a variety of factors, including the user’s weight. 7. Respondents promoted CBD Products and CBG Products through a variety of means, including through their website, stevesgoods.com, and through social media platforms such as Twitter.
8. Schultheis has been directly involved in the promotion and advertising of the Company’s CBD and CBG Products. Schultheis appears in the Company’s promotional and social media content relating to CBD and/or CBG, and is frequently quoted in press articles about the Company and the CBD and/or CBG industries.
Claims about CBD Products 9. Respondents have disseminated or have caused to be disseminated advertisements for CBD Products, including but not necessarily limited to the attached Exhibits A through F. These advertisements have or had the following statements: STEVES DISTRIBUTING, LLC 557 Complaint a. Steve’s Goods (@stevesgoods) Endocannabinoid System The human endocannabinoid system (ECS) is a network of receptors spread through-out our entire body that control some of our most vital life functions, including our immune system, memory, appetite, sleep pattern, mood, and pain sensation.
Disorders CBD assists with:
CTE Alzheimer’s Glioblastoma Parkinson’s Amyotrophic Lateral Sclerosis (ALS) PTSD Asthma Hypertension Crohn’s Disease Irritable Bowel Syndrome Testicular Cancer Prostate Cancer Osteoporosis Migraines Multiple Sclerosis Fibromyalgia Depression Epilepsy Breast Cancer Diabetes . . .
Rheumatoid Arthritis . . .
CBD (Hemp Extract) – Key benefits Anti-bacterial Inhibits cancer cell growth Neuro-protective Promotes bone growth Reduces seizures and convulsions Reduces blood sugar levels . . .
Reduces risk of artery blockage VOLUME 171 Complaint . . .
Slows bacterial growth . . .
Treats psoriasis Vasorelaxant [Exhibit A, @stevesgoods, Twitter, posted on Aug. 16, 2018, retrieved on July 7, 2020.] b. Steve’s Goods (@stevesgoods) CBD Reduces blood sugar levels Helps control seizures Reduces risk of nerve damage Decreases pressure in blood vessels #StevesGoodies . . .
[Exhibit B, @stevesgoods, Twitter, posted Apr. 17, 2018, retrieved on July 7, 2020.] c. Steve’s Goods (@stevesgoods) The Endocannabinoid System is where our cannabinoid receptors reside in our body! Project CBD provides a great introductory insight into what the Endocannabinoid System is with references to support their findings. . . .
Endocannabinoid System DISORDERS CBD ASSISTS WITH:
PTSD Alzheimers [sic] Glioblastoma Parkinson’s Amyotrophic Lateral Sclerosis (ALS) Asthma Hypertension Crohn’s Disease Irritable Bowel Syndrome Testicular Cancer Prostate Cancer Osteoporosis STEVES DISTRIBUTING, LLC 559 Complaint Migraines Multiple Sclerosis Fibromyalgia Depression Epilepsy Breast Cancer Diabetes Rheumatoid Arthritis . . .
#StevesGoodies Stevesgoods.com [Exhibit C, @stevesgoods, Twitter, posted Aug. 23, 2018, retrieved on July 7, 2020.] d. Why CBD Edibles Are A Hot Commodity in 2019 │ Steve’s Goods . . .
Explaining Commonly Misunderstood Facts About CBD Products and Edibles . . .
Essentially, store-bought CBD has roughly similar effects to most over the-counter medications with a far more holistic approach to personal care. Plus, this hemp-derived cannabinoid is available in many different forms including CBD oil, wax, dietary supplement, in addition to edibles. As such, the familiarity combined with finding the method for delivering effective CBD a [sic] the form that most users are comfortable with makes it easy for everyone to try as an alternative to prescription medications. [Exhibit D, https://stevesgoods.com/why-cbd-edibles-are-a-hot commodity, retrieved on Feb. 6, 2020.] e. CBD Edibles vs CBD Suppositories: Exploring CBD From Both Ends . . .
Plumbing the Depths of CBD Suppository Benefits . . .
CBD suppositories have been purported to be invaluable for sufferers of digestive-related maladies including Crohn’s disease, anal fissures, VOLUME 171 Complaint irritable bowel syndrome and recurring hemorrhoids due to their specific application to the regions of the body most affected by those ailments. . . .
CBD is ideal for users with digestive, nausea, or dietary issues . . .
In addition, suppository CBD is ideal for users with digestive issues, nausea, or dietary issues including diabetes.
[Exhibit E, https://stevesgoods.com/cbd-edibles-vs-cbd-suppositories, retrieved on Feb. 6, 2020.] f. CBD HEMP OIL TINCTURES . . .
CBD Oil by Steve’s Goods . . .
As far as benefits, studies have shown that CBD may be useful in helping with pain, inflammation, anxiety, cancer, neuro-disorders, and other health issues all with few if any side effects. It’s an exciting time in cannabinoid research.
. . .
CBD Oil Dosage for Anti-Inflammation When you suffer from day-to-day inflammation, you know it can sneak up on you. . . . If you have inflammation on a regular basis, you may want to supplement with CBD daily.
. . .
There is nothing sweeter than relief from pain, chronic or acute. . . .
If you have pain on a regular basis, you may want to supplement with CBD daily.
[Exhibit F, https://stevesgoods.com/cbd-oil/, retrieved on Aug. 5, 2020.] STEVES DISTRIBUTING, LLC 561 Complaint Claims about CBG Products 10. Respondents have disseminated or have caused to be disseminated advertisements for CBG Products, including but not necessarily limited to the attached Exhibits G through I. These advertisements contain the following statements:
a. What is CBG, How Does it Work, & What Are the Potential Benefits? . . .
Benefits of CBG Oil . . .
It’s been found in research [hyperlink], by the US National Institute [sic] of Health, to inhibit the growth of colon cancer, and has positive effects on glaucoma and irritable bowel syndrome known as IBS.
. . .
[Exhibit G, https://stevesgoods.com/blog/what-is-cbg-oil/, retrieved on Feb. 6, 2020.] b. Stevesgoods.com:
Studies on CBG have revealed a wide range of possible benefits: Stimulates bone formation and healing Slows tumor growth Antifungal and antibacterial treatment Relieves pain Reduces Inflammation Overactive bladder treatment Psoriasis and skin treatment Glaucoma treatment Depression and anxiety treatment Neuroprotective effects [Exhibit H, excerpt from live chat on stevesgoods.com recorded on Jan. 21, 2020.] c. The ABCs of CBG - Steves Goods . . .
How is cannabigerol used? . . .
VOLUME 171 Complaint Various scientific studies have revealed use cases for ailments ranging from ocular diseases to inflammatory bowel conditions. Other studies have shown CBG to carry antibacterial and anti-inflammatory effects on the body.
[Exhibit I, https://stevesgoods.com/abcs-of-cbg/, retrieved on Feb. 6, 2020.] Count I False or Unsubstantiated Efficacy Claims Regarding CBD Products 11. In connection with the advertising, promotion, offering for sale, sale, or distribution of CBD Products, Respondents have represented, directly or indirectly, expressly or by implication, that CBD Products:
a. have antibacterial properties;
b. prevent or reduce the risk of artery blockage, heart attacks, heart disease, and stroke;
c. reduce blood sugar levels;
d. promote bone growth;
e. prevent or reduce the risk of nerve damage;
f. prevent or reduce the risk of seizures and convulsions; g. effectively treat or mitigate Alzheimer’s disease, amyotrophic lateral sclerosis, anal fissures, asthma, cancer, chronic inflammation, chronic pain, chronic traumatic encephalopathy, Crohn’s disease, depression, diabetes, epilepsy, fibromyalgia, glioblastoma, hemorrhoids, hypertension, irritable bowel syndrome (“IBS”), migraines, multiple sclerosis, neurological disorders, osteoporosis, Parkinson’s disease, post-traumatic stress disorder (“PTSD”), psoriasis, rheumatoid arthritis, and seizures; and h. treat or mitigate diseases and health conditions as effectively as most over the-counter medications and are effective alternatives to prescription medications.
12. The representations set forth in Paragraph 11 are false or misleading, or were not substantiated at the time the representations were made. STEVES DISTRIBUTING, LLC 563 Complaint Count II False or Unsubstantiated Efficacy Claims Regarding CBG Products 13. In connection with the advertising, promotion, offering for sale, sale, or distribution of CBG Products, Respondents have represented, directly or indirectly, expressly or by implication, that CBG Products:
a. have antibacterial properties;
b. stimulate bone formation and healing;
c. have neuroprotective effects; and d. effectively treat or mitigate cancer, depression, glaucoma, inflammatory bowel conditions, IBS, ocular diseases, overactive bladder, and psoriasis. 14. The representations set forth in Paragraph 13 are false or misleading, or were not substantiated at the time the representations were made. Count III False Establishment Claims Regarding CBD Products 15. In connection with the advertising, promotion, offering for sale, sale, or distribution of CBD Products, Respondents have represented, directly or indirectly, expressly or by implication, that studies or scientific research prove that CBD Products effectively treat or mitigate anxiety, cancer, inflammation, neurological disorders, and pain. 16. In fact, studies or scientific research do not prove that CBD Products effectively treat or mitigate anxiety, cancer, inflammation, neurological disorders, and pain. Therefore, the representations set forth in Paragraph 15 are false or misleading. Count IV False Establishment Claims Regarding CBG Products 17. In connection with the advertising, promotion, offering for sale, sale, or distribution of CBG Products, Respondents have represented, directly or indirectly, expressly or by implication, that studies or scientific research prove that CBG Products: a. have antibacterial properties;
b. stimulate bone formation and healing;
c. have neuroprotective effects; and d. effectively treat or mitigate anxiety, cancer, depression, glaucoma, inflammation, inflammatory bowel conditions, IBS, ocular diseases, overactive bladder, pain, and psoriasis.
VOLUME 171 Complaint 18. In fact, studies or scientific research do not prove that CBG Products: a. have antibacterial properties;
b. stimulate bone formation and healing;
c. have neuroprotective effects; and d. effectively treat or mitigate anxiety, cancer, depression, glaucoma, inflammation, inflammatory bowel conditions, IBS, ocular diseases, overactive bladder, pain, and psoriasis.
Therefore, the representations set forth in Paragraph 17 are false or misleading. Violations of Sections 5 and 12 19. The acts and practices of Respondents as alleged in this complaint constitute unfair or deceptive acts or practices, and the making of false advertisements, in or affecting commerce in violation of Sections 5(a) and 12 of the Federal Trade Commission Act. THEREFORE, the Federal Trade Commission this second day of March, 2021, has issued this Complaint against Respondents.
By the Commission.
STEVES DISTRIBUTING, LLC Complaint Exhibit A Endocannabinoid System The Harner wrocermetsren! ) emer (PCS 6 e meTort of receptor! igreee rrvegh A Gul CONE DOGS Rat COMMA bom Of Ger Most Veta Ife tencune inciabeg cur FremEne Wye Temery, anpsete Weep gatOnE rence Ind Bwn LemEEeT CRD (rfeemp Latert! ep @eneser S\ ectercen sell tavetine contem tions EXHIBIT A Page 1 of 1 VOLUME 171 Complaint Exhibit B STEVES DISTRIBUTING, LLC 567 Complaint Exhibit C 8 Deets wr Tet xO S > SF Ow Mabther corm stevens rset MIRAI 4S + (elaine ~~) Sz - Dwes tome ° nwo Mew to Tovitter? 2p at Sa pp ae pr ae Dh The Endocannabineic System is where our cannabinaid recente wilde wax voay Prec ced pons: 2 gproat inroctuctary aeght nto what the Endocannatineid System (9 mth referees tr suppert Redevant pecrie their findings. —— mes Conus 9) meweyen = Read More Here anes Sob & a Leer CED terns cureesraccen poet) As orarry tet indocennabinoid System eauri tapeling — a Ce et re we Mae ire tratee reer Sop ene vepaewy te FS from w99 EXHIBIT C Page 1 of 2 VOLUME 171 Complaint STEVES DISTRIBUTING, LLC 569 Complaint Exhibit D Why CBD Edibles Are A Hot Commodity m 2019 | Steve's Goods lof3 Why CBD Edibles Are A Hot Commodity in 2019 | Steve's Goods Eli Mann Get the Supplements Without the Stigma: Why CBD Edibles are Having A Moment As scientific developments discover new ways to help people live fuller, happier lives, CBD edibles have become a popular item found in pockets, purses, and bags all over the world. Offering an unexplored wealth of benefits that may help society address evervthing from pain relief to anxiety without a doctor's prescription. 2019 seems to be a milestone year in popularity for people taking CBD edibles and supplements for a broad range of purposes — without the stigma of smoking cannabis. One of the most popular methods for ingesting the daily supplements required for the desired results is by taking CBD edibles. However, with all the purported claims regarding how full spectrum CBD products may improve your quality of life, it was important to discover why exactly 2019 seemed to bea renaissance for the popularity of edible CBD. Initially, the boost in visibility came from the quantifiable conclusion of government studies proving that CBD could be used to treat chronic seizures caused by a Tange of genetic conditions.
Tracing the Popularity of CBD Edibles Through Policy Change After years of openly advocating the use of hemp-derived supplements, activists were presented with a measure of legitimacy following governmental approval of CBD based product Epidiolex. Though the FDA only approved a single laboratory engineered, synthetic CED medication, the measurable results of the sta were proof that quality CBD paericn cepa ee be used as a supplement to address other chronic health issues.
Since CED has no psychotropic effects, it is more easily attainable and sold everywhere from the local health food store to Amazon, an online retailer famously restrictive for the products they allow to be sold through their website. In fact, because it can not be used as a recreational drug and has a low probability for abuse, the DEA reclassified a range of hemp-derived CBD products from Schedule I to Schedule V, clearly separating it from the rest of the cannabis family. With trusted backing from the medical, scientific and governmental communities, people from every comer of society were empowered to sample potable products like CBD summies, CBD Capsules, and full spectrum CBD coffee. These tasty edibles with CBD incorporated in their creation have been celebrated for their use against chronic pain and social anxiety. Essentially, anyone can have direct access to effective, potent Sethi china that may help them achieve alevel ar ein and normalcy they hadn't imagined possible from over-the-counter medications previously. EXHIBITD Page 1 of 3 ittps:/steveszoods.com/why-cbhd-edibles-are-a-hot-commndity! 2/6/2020, 3:26 PM VOLUME 171 Complaint STEVES DISTRIBUTING, LLC 571 Complaint Why CBD Edibles Are A Hot Commodity in 2019 | Steve's Goods 3 of 3 , rat “e — pe aw Pd » 2 Are CBD Edibles A Passing Fad? Consistency Is the Key to Results Over the last decade, fad diets, exercise regimens, and other health crazes have become common fixtures in our daily lives. In fact, considering the naturally at aig tr Sphembne poi to interpret how they can complement the natural compounds and attributes of foods we eat every day. Creating a healthy feat lina can can require discipline and dedication to fully iccciicani tas pamela ds sw aac” Soar addition to paying for expensive meal prep. Adding CBD edibles products to your daily routine can be unbelievably easy to adhere to and a accessible to everyone — without prior knowledge or experience to try out.
This is truly valuable when you explore the benefits of CBD gummies for anxiety and the way in which they put users at ease or allow them to interact more freely can help them live fuller more robust social lives. Beyond the most common benefits of taking CBD as an edible, the unstudied riches yet to be uncovered for making full use of the human body's endocannabinoid system may be delivering unexpected enrichment that will be revealed by future scientific discoveries. Since the approval of a CBD-based treatment by the FDA and the reclassification of hemp-derived products, there has never been a more advantageous moment in time to get the relief you need to livea healthy, normal life. Experience CBD for all its benefits in the present and find out why CBD edibles may be the best tool to start living your best life today.
EXHIBIT D Page 3of3 https://steveszoods.comwhy-cbd-edibles-are-a-hot-commodity’ 2/6/2020, 3:26 PM VOLUME 171 Complaint Exhibit E STEVES DISTRIBUTING, LLC 573 Complaint CBD Edibles vs CBD Suppozitones: Explonng CBD From Both Ends 2 of 3 orally. Even CBD oils, which is a simple form to process CBD, but still requires processing in the gut to break down, and allocate to the bloodstream before being circulated throughout the body. Reflexively, CED suppositories for hemorrhoids, menstrual pain or lower back pain and other ailments closely affecting that region of the body are applied directly to a point of dispersal where it can be directly absorbed and allocated.
Phunbing the Depths of CBD Suppository Benefits There has been a great deal of publicized theory relating the relationship of the hip region to the storing of emotional pain, but what if that baggage could be unloaded through physical action or therapeutic application of certain cannabinoids? Even without scientific study, it at least helps to understand the tangible uses for CBD as it relates to physical pain and relief created using the interactivity and connections of the human body.
CBD can be applied to desensitize pain receptors; research has shown that it helps to decrease active nerve pain by plugging into the CB1 endocannabinoid receptors, In addition, methods which introduce cannabinoids directly into the bloodstream which aren't broken down or diffused by digestion and processing have a more focused intensity. In other words, the CBD suppository retains more of its original intensity and has more intrinsic value regardless of dosage compared to edible CBD of the same amount. Where a user may not experience the effects of CBD edibles quickly, suppositories can become active and valuable almost immediately, not unlike tinctures but without the detrimental addition of alcohol which many Coa Sietanees crs Ens dea ts the distillates pecoeee One of the most popular uses for CBD suppositories relates to menstrual health and the typical symptoms associated with the onset of a period. Essentially, administering CBD directly to the region most affected by menstrual chicas Can bis bo amelie the inflammation and intensity. Likewise, CBD suppositories have been purported to be invaluable for sufferers of pontiee clined me maladies including Crobn’s disease, sel fiaveares, ievteabin homed syndrome and recurring hemorrhoids due to their specific application to the regions of the body most affected by those ailments. CBD is ideal for users with digestive, nausea, or dietary issues An Unobstructed View of CBD Suppositories vs CBD Edibles Suppositories have helped users experience incredible results by directing the flow of cannabinoids to their pelvic region, while edible CBD methods provide them with cumulative relief in a full-body effect that disseminates the intensity where it is needed. That said, there are other peripheral effects produced by using CBD suppositories vs CBD edibles because the rectal cavity is so close to the spinal column and may have positive effects on sexual arousal and stimulation as well. In addition, suppository CBD is ideal for users with digestive issues, nausea, or dietary issues including diabetes. Administering CBD this way allows users to control their diet with the knowledge that they are still getting an effective dosage of cannabinoids. Plus, it is possibly the most discreet way of taking CBD without anyone knowing that continues to take effect long after it is initially used. In all, there are endless benefits to taking CBD suppositories for intensity localized to the pelvic region. Bear in mind, the drawbacks are relatively intense, the most obvious being the invasive nature of inserting a foreign object into your body cavity. Another is the inconvenience of finding a private place to insert them, though any restroom will do.
EXHIBIT E Page 2 of 3 https://steveszoods.com/chd-edibles-vs-cbd-suppositones/ 2/6/2020, 3:29 PM VOLUME 171 Complaint STEVES DISTRIBUTING, LLC 575 Complaint Exhibit F 07ers of TP 40) Suppae ievetincdcom Oxy Accnet STEVES ih A Naka RRR: ARS, ARN ee sane a 8 coonps id CR VOU THRONES ARE T Ulol TO Give THE OL IT v Dlve Ss Favor C80 PecOuCTS Wuncul das CBO CONCENTRAIES COO Worhies Can Comeau aun Tomes « ") Ee OP = MHOLEMALE «= AEGLUT + MEMONSUrArION <contact cUMCETNS KEW CONN OG CBG PROOUCTS as & | = pe 88 CONCENTRATED cho breeues COD Ctbasts AND TOPCmS CBO BLAUTY PROOLCTS CED POR PETS tee ceo BOLATE peer:
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HESOURCES 7 GET i TOUCH MARE CHEE FOR DEALS - EXHIBIT F Page 3 of 4 VOLUME 171 Complaint STEVES DISTRIBUTING, LLC 579 Complaint Exhibit G What is CBG, How Does it Work, d& What Ave the Potential Benefits? lot4 What is CBG, How Does it Work, & What Are the Potential Benefits? Amy Glin What is Steve’s Goods CBG Oil? CBG, short for cannabigerol, is at the forefront of cannabinoid research. It’s an important cannabinoid to learn about and add to your daily routine. Here's why...
It's been known since the early 1990's that humans and animals have an endocannabinoid system regulating all body functions including digestion, sleep, and nerves. It’s the body's largest receptor system and maintains homeostasis. There are two main types; CBi and CB2.
CBi receptors are mostly in the brain and organs. CB2 receptors live on cells. This system needs Omega Fatty acids, in the proper ratio, to produce and uptake its own cannabinoids. Unfortunately, today’ y's diet is severely a tions in Omega-3’s, and that can lead to an endocannabinoid deficiency, causing unrest, imbalance, and disease. Once that happens it’s easy to feel helpless and ook traditional pharmaceutical medicine paths with all the nasty effects besides the one you're looking for. But it doesn’t have to go that way. Fortunately, the hemp plant's important medicinal pre rties and multipurpose uses are becoming more known and accepted, And the nology is well-developed for extracting both isolates and full-spectrum pear for human il animal use. You can feed your endocannabinoid system with 7 gue from the hemp plant and return your body to balance. jah! How it Works CBGa is considered the stem cell molecule of cannabinoids, where it all began! It’s the precursor to three different cannabinoids, THCa, CBDa, CBNa, acid forms a the compounds found when in raw states. Ingenious as nature is, the cannabis/hemp plant has a natural enzyme, called synthase, that uses heat or UV light to break the CBGa down into one of the three paths, making it bioavailable. EXHIBIT G Page 1 of 4 https:/steveszoods.com blog what-is-cbg-oil!’ 2/6/2020, 3:43 PM VOLUME 171 Complaint STEVES DISTRIBUTING, LLC 581 Complaint What is CBG, How Does rt Work, & What Are the Potential Benefits? 3 of 4 What Sets us Apart? Steve's Goods formulates award winning full spectrum CBG oil, the strongest and best-tasting on the market. In addition to the purest ingredients seuble it’s made with intention, love, and passion. Purity and soul in one sweet package. CBG oil is currently available in two terpene profiles, our name for flavor. Terpenes are unique compounds found in a large variety of plants and even in some insects. Botanists refer to them as a plant’s essential oils, the building blocks of plant resin. They're responsible for the color, scents, and flavors of plants and each fa distinguishing values.
The terms terpene and terpenoids are often used interchangeably but there is a slight difference between the two. Raw terpenes are hydrocarbons and terpenoids have been denatured by drying and curing the flowers.
Blueberry Blast is made with our Blueberry OG Flavor profile/CBG Distillate Wax This terpene profile features limonene, known for being anti-fungal, antibacterial and anti-carcinogenic. It relieves pain and is known for its mood elevating and stressreducing qualities. It also helps ease insommia, fatigue, and lack of appetite. NEW! Watermelon Kush is made with Watermelon OG Flavor profile/CBG Distillate Wax. It offers the active terpene compounds Alpha and Beta-Pinene, known for their antibacterial and anti-inflammatory qualities. These terpenes also aid in memory and work as a bronchodilator. This compound has been used in traditional medicine for centuries.
Steve's Goods CBG oil comes in 30 mil. bottles. We offer three strengths, 500 mg. 10 9 mg. or 2500 mg. We're haces to discuss the best strength for your personal ne Coming Soon!!! Keep on the lookout for our soon-to-be-released new terpene profiles Pineapple Express, Terpene Gorilla, and Girl Scout Cookies. We pride ourselves on having something for everyone! The Entourage Effect When you begin using CBG, CBD and hemp-based products, and as you become more in balance and begin to exude joy and an pe se gather around you and follow you everywhere. This is known as The Entourage Effect. Okay, not really. But it could happen! Silliness aside, when you combine CBD with CBG it enhances the CBD’s performance. When you add terpenes to that combo, benefits are amplified. The i sie alsin synergy between compounds is known as The Entourage Effect and explains why some compounds are better for individuals than others, and why aise CBG to your CBD por increases its efficacy.
The facts:
Our distillate oil is 4% — 8% CBG, we have the lab rts. Others weigh in at much less. Our epaioaas are simple, in addition to the oil we add monk fruit and agave for sweetness, and the terpene profile based its name, giving each tincture its unique EXHIBIT G Page 3 of 4 https:!/steveszoods.com blog'what-is-chz-oil!’ 2/6/2020, 3:43 PM VOLUME 171 Complaint STEVES DISTRIBUTING, LLC 583 Complaint Exhibit H CBD Fresh From The Farm (Sas ee ane sick Seated Rann, — = leew are ~ <' .
EXHIBIT H_ Page 1 of 1 VOLUME 171 Complaint Exhibit I STEVES DISTRIBUTING, LLC 585 Complaint The ABCs of CBG - Steves Goods 2 of 3 with it.
What are the best ways to buy CBG? Though we anticipate a wave of high-CBG flower strains emerging to satisfy demand from the market, there are few to no such strands in circulation presently. Again, cannabigerol is almost always biosynthesized into another cannabinoid while plants grow and flower, meaning someone would have to interrupt such biosynthesis to retain the maximum levels of CBG produced by a particular strain or plant. That is not to say CBG cannot be attained in bulk volume. Steve's Goods deals in three major bulk forms of CBG: CBG isolate powder, CBG distillate, and CBG oils and tinctures. Steve's Goods CBG Isolate Slab CBG Isolate Explained CBG isolate powder is utilized in the manufacturing of other concentrate products, Including including CBG isolate slab. It looks and feels similar to powdered sugar, and comes in a concentration of 99% purity. CBG isolate powder could theoretically be utilized to make gummies, capsules, topicals, and vier forms of say including shatter, and any other product for which CBD isolate powder is a base product. This powder is coumencinly ienkaked Sevek Cha other cannabinoids among the lave spectrum through refinement from hemp or marijuana.
CBG Super Distillate CBG super distillate is utilized in the formulation of oils and tinctures. This distillate is the key ingredient in Steve’s Goods CBG oils, and could theoretically be used in the formation of several other products, including wax concentrates, similar to the products Steve’s Goods offers among their CBD wax concentrates. CBG super distillate is made via chromatography. This process passes anaes hemp distillate into a medium in which all the different cannabinoids (CBG, THC, =p pte Ae separated manually with no error. This is one of the most advanced methods for generating pure cannabinoid concentrates and is certainly one of the cleanest methods. CBG Oils & Tinctures If you enjoy a tasty, smoke-free means of getting your controlled dose of CBG daily, Steve’s Goods CBG oils are a fantastic option. They are available in Watermelon, Blueberry. and OG Hemp flavors, achieved by blending our CBG super distillate with the appropriate terpene p' rofile to offer the ideal formula to satisfy just about any taste pallet. Every flavor is sold in 15mL bottles with 250mg, 500mg, and 1250mg concentrations, and in 3oml bottles with 500mg, 1000mg, and 2,500mg concentrations, ensuring Steve's Goods is also ready with every size and strength refill one could possibly need for home use. These tinctures are also available for private labeling. CBG Slab?! If you enjoy Steve's Goods CBD concentrates, you will love their state-of-the-art CBG isolate slab. Made from CBG isolate powder, and via Steve's proprietary process, Steve's is offering a terpene-free, 99°%- EXHIBIT! Page 2 of 3 https://steveszoods.com/abes-of-cbz! 2/6/2020, 3:12 PM VOLUME 171 Complaint STEVES DISTRIBUTING, LLC 587 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 Section 2.34 of its Rules, 16 C.F.R. § 2.34. Now, in further conformity with the procedure prescribed in Rule 2.34, the Commission issues its Complaint, makes the following Findings, and issues the following Order: Findings 1. The Respondents are:
a. Respondent Steves Distributing, LLC, also doing business as Steve’s Goods, is a Colorado corporation, with its principal office or place of business at 1500 Kansas Avenue, Suite 2C, Longmont, CO 80501. b. Respondent Steven Taylor Schultheis is Chief Executive Officer, President, and principal shareholder of Steves Distributing, LLC. Individually or in concert with others, he formulates, directs, or controls the policies, acts, or practices of Steves Distributing, LLC. His principal office or place of business is the same as that of Steves Distributing, LLC. 2. The Commission has jurisdiction over the subject matter of this proceeding and over the Respondents, and the proceeding is in the public interest. VOLUME 171 Decision and Order ORDER Definitions For purposes of this Order, the following definitions apply: A. “CBD Product” means any Dietary Supplement, Food, or Drug containing cannabidiol.
B. “CBG Product” means any Dietary Supplement, Food, or Drug containing cannabigerol.
C. “Covered Product” means any Dietary Supplement, Food, or Drug, including but not limited to CBD Products or CBG Products.
D. “Dietary Supplement” means: (1) any product labeled as a dietary supplement or otherwise represented as a dietary supplement; or (2) any pill, tablet, capsule, powder, softgel, gelcap, liquid, or other similar form containing one or more ingredients that are a vitamin, mineral, herb or other botanical, amino acid, probiotic, or other dietary substance for use by humans to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any ingredient described above, that is intended to be ingested, and is not represented to be used as a conventional Food or as a sole item of a meal or the diet.
E. “Drug” means: (1) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans; (3) articles (other than Food) intended to affect the structure or any function of the body of humans; and (4) articles intended for use as a component of any article specified in (1), (2), or (3); but does not include devices or their components, parts, or accessories.
F. “Essentially Equivalent Product” means a product that contains the identical ingredients, except for inactive ingredients (e.g., binders, colors, fillers, excipients), in the same form and dosage, and with the same route of administration (e.g., orally, sublingually), 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. G. “Food” means: (1) any article used for food or drink for humans; (2) chewing gum; and (3) any article used for components of any such article. STEVES DISTRIBUTING, LLC 589 Decision and Order H. “Respondents” means the Corporate Respondent and the Individual Respondent, individually, collectively, or in any combination.
1. “Corporate Respondent” means Steves Distributing, LLC, a limited liability company, also doing business as Steve’s Goods, and its successors and assigns.
2. “Individual Respondent” means Steven Taylor Schultheis. Provisions I. PROHIBITED REPRESENTATIONS: REGARDING HEALTH-RELATED CLAIMS REQUIRING HUMAN CLINICAL TESTING FOR SUBSTANTIATION IT IS ORDERED that Respondents, Respondents’ officers, agents, and employees, 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 manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any Covered Product, must not make, or assist others in making, expressly or by implication, any representation that such product:
A. treats, alleviates, or cures overactive bladder; B. reduces blood sugar levels;
C. stimulates bone formation and healing;
D. treats, alleviates, or cures any disease, including but not limited to Alzheimer’s disease, amyotrophic lateral sclerosis, anal fissures, asthma, cancer, chronic inflammation, chronic traumatic encephalopathy, Crohn’s disease, depression, diabetes, epilepsy, fibromyalgia, glaucoma, glioblastoma, heart disease, hemorrhoids, hypertension, inflammatory bowel conditions, inflammatory bowel syndrome (“IBS”), migraines, multiple sclerosis, neurological disorders, ocular diseases, osteoporosis, pain, Parkinson’s disease, post-traumatic stress disorder, psoriasis, rheumatoid arthritis, or seizures; or E. treats, alleviates, or cures diseases and other health conditions as effectively as most over-the-counter medications, or is an effective alternative to prescription medications, unless the representation is non-misleading, and, at the time of making such representation, they possess and rely upon competent and reliable scientific evidence substantiating that the representation is true. For purposes of this Provision, competent and reliable scientific evidence must consist of 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 VOLUME 171 Decision and Order considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true. Such testing must be: (1) randomized, double-blind, and placebocontrolled; and (2) 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 field as relevant to an assessment of such testing as described in the Provision entitled Preservation of Records Relating to Competent and Reliable Human Clinical Tests or Studies must be available for inspection and production to the Commission. Persons covered by this Provision have the burden of proving that a product satisfies the definition of Essentially Equivalent Product.
II. PROHIBITED REPRESENTATIONS: OTHER HEALTH-RELATED CLAIMS IT IS FURTHER ORDERED that Respondents, Respondents’ officers, agents, and employees, 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 manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any Covered Product must not make, or assist others in making, expressly or by implication, any representation, other than representations covered under the Provision of this Order entitled Prohibited Representations: Regarding Health-Related Claims Requiring Human Clinical Testing For Substantiation, about the health benefits, performance, efficacy, safety, or side effects of any Covered Product, unless the representation is non-misleading, and, at the time of making such representation, they possess and rely upon competent and reliable scientific evidence 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.
For purposes of this Provision, competent and reliable scientific evidence means tests, analyses, research, or studies (1) that 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 set forth in the Provision entitled Preservation of Records Relating to Competent and Reliable Human Clinical Tests or Studies must be available for inspection and production to the Commission. Persons covered by this Provision have the burden of proving that a product satisfies the definition of Essentially Equivalent Product.
STEVES DISTRIBUTING, LLC 591 Decision and Order III. 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. 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 Corporate Respondents’ size and complexity, the nature and VOLUME 171 Decision and Order scope of Respondents’ activities, and the sensitivity of the personal information collected from or about the participants.
IV. PROHIBITED MISREPRESENTATIONS REGARDING TESTS, STUDIES, OR OTHER RESEARCH IT IS FURTHER ORDERED that Respondents, Respondents’ officers, agents, and employees, 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 manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any product must not misrepresent, in any manner, expressly or by implication: A. That any Covered Product is scientifically proven to have antibacterial properties, stimulate bone formation or healing, have neuroprotective effects, or cure, mitigate, or treat anxiety, cancer, depression, glaucoma, inflammation, inflammatory bowel conditions, IBS, neurological disorders, ocular diseases, overactive bladder, pain, or psoriasis;
B. That the performance or benefits of any product are scientifically or clinically proven or otherwise established; or C. The existence, contents, validity, results, conclusions, or interpretations of any test, study, or other research.
V. FDA-APPROVED CLAIMS IT IS FURTHER ORDERED that nothing in this Order prohibits Respondents, Respondents’ officers, agents, and employees, and all other persons in active concert or participation with any of them from:
A. For any Drug, making a representation 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 Food and Drug Administration; and B. For any product, making a representation that is specifically authorized for use in labeling for such product by regulations promulgated by the Food and Drug Administration pursuant to the Nutrition Labeling and Education Act of 1990 or permitted under Sections 303-304 of the Food and Drug Administration Modernization Act of 1997.
STEVES DISTRIBUTING, LLC 593 Decision and Order VI. MONETARY RELIEF IT IS FURTHER ORDERED that:
A. Respondents must pay to the Commission $75,000, which Respondents stipulate their undersigned counsel holds in escrow for no purpose other than payment to the Commission.
B. Such payment must be made within 8 days of the effective date of this Order by electronic fund transfer in accordance with instructions provided by a representative of the Commission.
VII. ADDITIONAL MONETARY PROVISIONS IT IS FURTHER ORDERED that:
A. Respondents relinquish dominion and all legal and equitable right, title, and interest in all assets transferred pursuant to this Order and may not seek the return of any assets.
B. The facts alleged in the Complaint will be taken as true, without further proof, in any subsequent civil litigation by or on behalf of the Commission to enforce its rights to any payment pursuant to this Order, such as a nondischargeability complaint in any bankruptcy case.
C. The facts alleged in the Complaint establish all elements necessary to sustain an action by or on behalf of the Commission pursuant to Section 523(a)(2)(A) of the Bankruptcy Code, 11 U.S.C. § 523(a)(2)(A), and this Order will have collateral estoppel effect for such purposes.
D. All money paid to the Commission pursuant to this Order may be deposited into a fund administered by the Commission or its designee to be used for relief, including consumer redress and any attendant expenses for the administration of any redress fund. If a representative of the Commission decides that direct redress to consumers is wholly or partially impracticable or money remains after redress is completed, the Commission may apply any remaining money for such other relief (including consumer information remedies) as it determines to be reasonably related to Respondents’ practices alleged in the Complaint. Any money not used is to be deposited to the U.S. Treasury. Respondents have no right to challenge any activities pursuant to this Provision. E. In the event of default on any obligation to make payment under this Order, interest, computed as if pursuant to 28 U.S.C. § 1961(a), shall accrue from the date of default to the date of payment. In the event such default continues for 10 days beyond the date that payment is due, the entire amount will immediately become due and payable.
VOLUME 171 Decision and Order F. Each day of nonpayment is a violation through continuing failure to obey or neglect to obey a final order of the Commission and thus will be deemed a separate offense and violation for which a civil penalty shall accrue. G. Respondents acknowledge that their Taxpayer Identification Numbers (Social Security or Employer Identification Numbers), which Respondents have previously submitted to the Commission, may be used for collecting and reporting on any delinquent amount arising out of this Order, in accordance with 31 U.S.C. § 7701.
VIII. CUSTOMER INFORMATION IT IS FURTHER ORDERED that Respondents must directly or indirectly provide sufficient customer information, including sufficient identification of all resellers, to enable the Commission to efficiently administer consumer redress to all purchasers of Respondents’ CBD Products and CBG Products. If a representative of the Commission requests in writing any information related to redress, Respondents must provide it, in the form prescribed by the Commission representative, within 14 days.
IX. NOTICES TO CUSTOMERS IT IS FURTHER ORDERED that Respondents must notify customers as follows: A. Respondents must identify all consumers who purchased CBD Products or CBG Products on or after January 1, 2018 (“eligible customers”). 1. Such eligible customers, and their contact information, must be identified to the extent such information is in Respondents’ possession, custody or control, including from third parties such as resellers; 2. Eligible customers include those identified at any time, including after Respondents’ execution of the Agreement through the eligibility period, which runs for 1 year after the issuance date of the Order. B. Respondents must send a notice via electronic mail to all identified eligible customers:
1. The notice must be in the form shown in Attachment A. 2. The subject line of the email must state: “About Your Purchase of Steve’s Goods’ CBD or CBG Products.”
3. The email of the notice must not include any other enclosures. C. Respondents must notify all eligible customers within 180 days after the issuance date of this Order and any eligible customers identified thereafter within 30 days of their identification.
STEVES DISTRIBUTING, LLC 595 Decision and Order D. Respondents must provide a notice on all of their social media accounts (including any Facebook, Twitter, Instagram, or YouTube accounts) and on the first page of their websites. Such notice must link to a copy of the Order, along with a toll-free telephone number and an email address for the redress administrator. The notice must be posted not later than 3 days after the effective date of the Order and for at least 1 year after the redress period ends. E. Respondents must report on their notification program under penalty of perjury: 1. Respondents must submit a report annually and at the conclusion of the program summarizing their compliance to date, including the total number of eligible customers identified and notified.
2. If a representative of the Commission requests any information regarding the program, including any of the underlying customer data, Respondents must submit it within 10 days of the request.
3. Failure to provide required notices or any requested information will be treated as a continuing failure to obey this Order.
X. NOTICE TO AFFILIATES AND OTHER RESELLERS IT IS FURTHER ORDERED that within 30 days of the effective date of this Order, Respondents must notify all affiliates and other resellers by sending each via electronic mail the notification letter attached as Attachment A. Respondents must include a copy of this Order, but no other document or enclosure.
XI. 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 5 years after the issuance date of this Order, the 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 each 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 labeling, manufacturing, advertising, marketing, promotion, distribution, offering for sale, or sale of CBD or CBG Products; 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 VOLUME 171 Decision and Order 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.
XII. COMPLIANCE REPORTS AND NOTICES IT IS FURTHER ORDERED that Respondents make timely submissions to the Commission:
A. Sixty days 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 the Individual Respondent 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, including a discussion of all of the changes the Respondent made to comply with the 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 such Respondent performs services whether as an employee or otherwise and any entity in which such Respondent has any ownership interest; and (c) describe in detail such Respondent’s involvement in each such business activity, including title, role, responsibilities, participation, authority, control, and any ownership. B. 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 any Corporate Respondent or any entity that Respondent has any ownership interest in or controls directly or STEVES DISTRIBUTING, LLC 597 Decision and Order 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 such Respondent performs services whether as an employee or otherwise and (ii) any entity in which such 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.
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 Steves Distributing, LLC, FTC File No. 202 3065.
XIII. RECORDKEEPING IT IS FURTHER ORDERED that Respondents must create certain records for 7 years after the issuance date of the Order, and retain each such record for 5 years, unless otherwise specified below. Specifically, the 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; VOLUME 171 Decision and Order 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. All records necessary to demonstrate full compliance with each provision of this Order, including all submissions to the Commission;
E. A copy of each unique advertisement or other marketing material making a representation subject to this Order;
F. 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 2. All tests, studies, analysis, other research, or other such evidence in Respondents’ possession, custody, or control that contradicts, qualifies, or otherwise calls into question the representation, or the basis relied upon for the representation, including complaints and other communications with consumers or with governmental or consumer protection organizations.
XIV. 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.
STEVES DISTRIBUTING, LLC 599 Decision and Order D. Upon written request from a representative of the Commission, any consumer reporting agency must furnish consumer reports concerning the Individual Respondent, pursuant to Section 604(2) of the Fair Credit Reporting Act, 15 U.S.C. § 1681b(a)(2).
XV. 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 20 years from the date of its issuance (which date may be stated at the end of this Order, near the Commission’s seal), 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; 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.
VOLUME 171 Decision and Order ATTACHMENT A TO THE ORDER CLAIMS ABOUT PRODUCTS CONTAINING CBD/CBG In the Matter of Steves Distributing, LLC et al Dear <Name of customer>:
We are writing to you because our records show that you bought CBD and/or CBG products from our company, Steve’s Goods. The Federal Trade Commission (FTC) has settled claims against us relating to certain advertising practices. While we deny that we violated the law, we have agreed to stop making certain claims about our products as follows: • Unless we have scientific proof, we will not say that our CBD and CBG products can effectively treat or ease serious diseases and health conditions, such as Alzheimer’s disease, cancer, Crohn’s disease, diabetes, and irritable bowel syndrome (IBS);
• Unless we have scientific proof, we will not say that we have studies or scientific research that prove that our CBD or CBG products have antibacterial properties, stimulate bone formation or healing, have neuroprotective effects, or cure, mitigate, or treat anxiety, cancer, depression, glaucoma, inflammation, inflammatory bowel conditions, IBS, neurological disorders, ocular diseases, overactive bladder, pain, or psoriasis.
For a full list of the health claims covered by the settlement, and to learn more about the settlement, please visit [add URL].
Talk to your doctor before you stop any prescriptions or take CBD, CBG, or any other treatments to treat health conditions. For more information about health product claims, visit ftc.gov/health.
Sincerely, [signature] [identify Respondent or other person responsible for signing the notification letter] STEVES DISTRIBUTING, LLC 601 Concurring Statement STATEMENT OF COMMISSIONER ROHIT CHOPRA Summary • When companies lie about the effectiveness of their treatments for serious conditions, this harms patients and diverts sales away from firms that tell the truth. • Congress gave the FTC a new authority to crack down on abuses in the opioid treatment industry, but the agency has not prioritized this issue. This should change. • The FTC can increase its effectiveness when it comes to health claims by shifting resources away from small businesses and by deploying the unused Penalty Offense Authority.
Today, the Federal Trade Commission is taking action against several outfits regarding their outlandish – and unlawful – claims about cannabidiol (CBD). While CBD is currently the subject of considerable scientific research, there is no evidence yet that CBD can treat or cure cancer, Alzheimer’s, or other serious diseases. Baseless claims give patients false hope, improperly increase or divert their medical spending, and undermine “a competitor’s ability to compete” on honest attributes.1 I support these actions and congratulate those who made them a reality. Going forward, however, the FTC will need to refocus its efforts on health claims by targeting abuses in the substance use disorder treatment industry, shifting attention toward large businesses, and making more effective use of the FTC’s Penalty Offense Authority. First, COVID-19 and the resulting economic and social distress are fueling new concerns about substance use disorders. In particular, there are signs that the pandemic is leading to greater dependence on opioids.2 It is critical that the FTC take steps to prevent exploitation of patients seeking treatment for substance use disorders.
I am particularly concerned about abusive practices in the for-profit opioid treatment industry, and believe this should be a high priority. This industry has grown exponentially by profiting off those suffering from addiction. Many of these outfits use lead generators to steer 1 In re Pfizer, Inc., 81 F.T.C. 23, 62 (1972).
2 See, e.g., Jon Kamp & Arian Campo-Flores, The Opioid Crisis, Already Serious, Has Intensified During Coronavirus Pandemic, WALL STREET J. (Sept. 8, 2020), https://www.wsj.com/articles/the-opioid-crisis-already serious-has-intensified-during-coronavirus-pandemic-11599557401; Issue brief: Reports of increases in opioid- and other drug-related overdose and other concerns during COVID pandemic, AMERICAN MEDICAL ASSOCIATION (last updated on Oct. 31, 2020), https://www.ama-assn.org/delivering-care/opioids/covid-19-may-be-worsening-opioid crisis-states-can-take-action.
VOLUME 171 Concurring Statement Americans into high-cost, subpar treatment centers, and some even hire intermediaries – socalled “body brokers” – who collect kickbacks from this harmful practice.3 More than two years ago, Congress passed the SUPPORT for Patients and Communities Act. Among other provisions, the Act authorized the Commission to seek civil penalties, restitution, damages, and other relief against outfits that engage in misconduct related to substance use disorder treatment.4 The Commission is well positioned to help shut down these abuses, ensure they are not profitable, and hold predatory actors and their enablers to account.5 Unfortunately, the Commission has brought zero cases under this new authority. While I have supported actions like this one that challenge baseless CBD claims, as well as previous actions charging that pain relief devices and similar products were sold deceptively,6 I am concerned that we have largely ignored Congressional concerns about unlawful opioid treatment practices. I urge my fellow Commissioners to change course on our enforcement priorities, especially given our limited resources.
Second, the FTC should focus more of its enforcement efforts on larger firms rather than small businesses. Today’s actions focus on very small players, some of which are defunct. While I appreciate that small businesses can also harm honest competitors and families, they are often judgment-proof, making it unlikely victims will see any relief.7 I am confident that FTC staff can successfully challenge powerful, well-financed defendants that break the law. Finally, the Commission should reduce the prevalence of unlawful health claims by triggering civil penalties under the FTC’s Penalty Offense Authority.8 Under the Penalty Offense 3 For example, recent reporting describes the “Florida Shuffle,” where treatment facilities pay brokers to recruit patients through 12-step meetings, conferences, hotlines, and online groups, leading to serious harm. See German Lopez, She wanted addiction treatment. She ended up in the relapse capital of America, VOX (Mar. 2, 2020), https://www.vox.com/policy-and-politics/2020/3/2/21156327/florida-shuffle-drug-rehab-addiction-treatment-bri jayne. See also Letter from Commissioner Chopra to Congress on Deceptive Marketing Practices in the Opioid Addiction Treatment Industry (July 28, 2018), https://www ftc.gov/public-statements/2018/07/letter-commissioner chopra-congress-deceptive-marketing-practices-opioid (calling on the FTC to do more to tackle this problem). 4 Pub. L. No. 115-271 §§ 8021-8023 (codified in 15 U.S.C. § 45d). The Act also allows the Commission to prosecute deceptive marketing of opioid treatment products. Notably, a number of respondents in this sweep are alleged to have made claims that CBD could replace OxyContin. 5 Given public reports regarding private equity rollups of smaller opioid treatment facilities, the Commission can also examine whether anticompetitive M&A strategies are leading to further patient harm. See Statement of Commissioner Rohit Chopra Regarding Private Equity Roll-ups and the Hart-Scott-Rodino Annual Report to Congress, Commu File No. P110014 (July 8, 2020), https://www.ftc.gov/public-statements/2020/07/statement commissioner-rohit-chopra-regarding-private-equity-roll-ups-hart. 6 Press Release, Fed. Trade Commu, Marketers of Pain Relief Device Settle FTC False Advertising Complaint (Mar. 4, 2020), https://www.ftc.gov/news-events/press-releases/2020/03/marketers-pain-relief-device-settle-ftc false-advertising.
7 In one of these matters, the respondents are paying nothing. 8 15 U.S.C. § 45(m)(1)(b).
STEVES DISTRIBUTING, LLC 603 Concurring Statement Authority, firms that engage in conduct they know has been previously condemned by the Commission can face civil penalties, in addition to the relief that we typically seek.9 For example, the Commission routinely issues warning letters to businesses regarding unsubstantiated health claims. Future warning letters can be more effective if they include penalty offense notifications.
The Commission has repeatedly found that objective claims require a reasonable basis,10 and apprising firms of these findings – along with a warning that noncompliance can result in penalties – makes it significantly more likely they will come into compliance voluntarily. In fact, when the Commission employed this strategy four decades ago, it reportedly resulted in a “high level of voluntary compliance achieved quickly and at a low cost.”11 Going forward, we should pursue this strategy.12 I thank everyone who made today’s actions possible, and look forward to future efforts that address emerging harms using the full range of our tools and authorities. 9 See Rohit Chopra & Samuel A.A. Levine, The Case for Resurrecting the FTC Act’s Penalty Offense Authority (Oct. 29, 2020), https://papers.ssrn.com/sole/papers.cfm?abstract id=3721256. Particularly given challenges to the FTC’s 13(b) authority, incorporating a penalty offense strategy can safeguard the Commission’s ability to seek strong remedies against lawbreakers.
10 This requirement was first established in the Commission’s 1972 Pfizer decision, and it has been affirmed repeatedly. Pfizer, Inc., supra note 2 (finding that “[f]airness to the consumer, as well as fairness to competitors” compels the conclusion that affirmative claims require a reasonable basis); In re Thompson Medical Co., 104 F.T.C. 648, 813 (1984) (collecting cases), aff’d, 791 F.2d 189 (D.C. Cir. 1986). Appended to Thompson Medical was the Commission’s Policy Statement Regarding Advertising Substantiation, which states that “a firm’s failure to possess and rely upon a reasonable basis for objective claims constitutes an unfair and deceptive act or practice in violation of Section 5 of the Federal Trade Commission Act.” Id. at 839. This standard continues to govern the Commission’s approach to substantiation, as recently reaffirmed in the Commission’s final order against POM Wonderful. In re POM Wonderful LLC et al., 155 F.T.C. 1, 6 (2013).
11 Commissioner Bailey made this observation in the context of opposing industry efforts to repeal this authority, an authority she described as an “extremely effective and efficient way to enforce the law.” Testimony of Commissioner Patricia P. Bailey Before the Subcomm. on Com., Tourism and Transp. of the Comm. on Energy and Com. of the H.R. Concerning the 1982 Reauthorization of the Fed. Trade Commu, at 11 (Apr. 1, 1982), https://www.ftc.gov/system/files/documents/public statements/693551/19820401 bailey testimony before the sub corrmittee on commerce subcommittee on commerce touri.pdf. 12 My colleague, Commissioner Christine S. Wilson, has issued a statement in this matter. I agree that the Commission should not prioritize close-call substantiation cases, especially those involving small businesses. VOLUME 171 Concurring Statement CONCURRING STATEMENT OF COMMISSIONER CHRISTINE S. WILSON Today the Commission announces six settlements with marketers of cannabidiol (CBD) products resolving allegations that they made false, misleading, and/or unsubstantiated express disease claims for their products. I support these cases because accurate and complete information about products contributes to the efficient functioning of the market and facilitates informed consumer decision-making. In contrast, deceptive or false claims inhibit informed decision-making and may cause economic injury to consumers. The Commission’s complaints in these matters allege that the marketers claimed their products could treat, prevent, or cure diseases or serious medical conditions, including cancer, heart disease, Alzheimer’s, diabetes, and Parkinson’s disease, and that scientific research or clinical studies supported these claims. In fact, according to the Commission’s complaints, the proposed respondents did not conduct scientific research on the efficacy of their products to treat these diseases or conditions. In addition, the complaints allege that some of the proposed respondents claimed that their products could be taken in lieu of prescription medication. The Commission has been working with the FDA, and on its own, to combat false and unsubstantiated claims for CBD products, including through warning letters1 and a law enforcement action.2 Here, where consumers may have foregone proven measures to address serious diseases and the marketers have made virtually no effort to possess and rely on scientific evidence to support their strong, express disease claims, as we allege in our complaint, I agree that law enforcement is appropriate.
The Commission’s proposed consent orders in these matters require respondents to possess and rely on competent and reliable evidence, defined as randomized, double-blind, placebo- controlled human clinical trials to support disease and other serious health claims for these types of products in the future.3 Although I support this requirement in these cases, for these types of claims, I caution that the Commission should impose this stringent substantiation requirement sparingly. Credible science supports the use of CBD products to treat certain conditions – specifically, the FDA has approved a drug containing CBD as an active ingredient 1 Press Release, FTC and FDA Warn Florida Company Marketing CBD Products about Claims Related to Treating Autism, ADHD, Parkinson’s, Alzheimer’s, and Other Medical Conditions, Oct. 22, 2019, available at https://www.ftc.gov/news-events/press-releases/2019/10/ftc-fda-warn-florida-company-marketing-cbd productsabout-claims; Press Release, FTC Sends Warning Letters to Companies Advertising Their CBD-Infused Products as Treatmentsfor Serious Diseases, Including Cancer, Alzheimer’s, and Multiple Sclerosis, Sept. 10, 2019, available at https://www.ftc.gov/news-events/press-releases/2019/09/ftc-sends-warning-letters-companies advertising-their-cbdinfused; Press Release, FTC Joins FDA in Sending Warning Letters to Companies Advertising and Selling Products Containing Cannabidiol (CBD) Claiming to Treat Alzheimer’s, Cancer, and Other Diseases, Apr. 2, 2019, available at https://www.ftc.gov/news-events/press-releases/2019/04/ftc-joins-fda-sending-warning letters-companiesadvertising.
2 Press Release, FTC Order Stops the Marketer of “Thrive” Supplement from Making Baseless Claims It Can Treat, Prevent, or Reduce the Risks from COVID-19, July 10, 2020, available at https://www.ftc.gov/newsevents/press releases/2020/07/ftc-order-stops-marketer-thrive-supplement-making-baseless-claims. 3 See, e.g., Part I of Proposed Order, In the Matter of Bionatrol Health, LLC, et. al. (Dec. 2020). STEVES DISTRIBUTING, LLC 605 Concurring Statement to treat rare, severe forms of epilepsy.4 And I understand that many research studies are currently seeking to determine whether there are other scientifically valid and safe uses of this ingredient. I agree with my predecessors who have stated that the Commission should be careful to avoid imposing an unduly high standard of substantiation that risks denying consumers truthful, useful information, may diminish incentives to conduct research, and could chill manufacturer incentives to introduce new products to the market.5 And I agree with the observation of my colleague Commissioner Chopra in his statement that “[b]aseless claims give patients false hope, improperly increase or divert their medical spending, and undermine ‘a competitor’s ability to compete’ on honest attributes.”6 Although I support these cases, I hope that the Commission’s actions here, which challenge wholly unsubstantiated disease claims, do not discourage research into the potential legitimate benefits of CBD and a wide array of other products. In addition, going forward, I urge the Commission to focus our scarce resources on marketers that make strong, express claims about diseases and serious health issues with little to no scientific support and engage in deceptive practices that cause substantial consumer injury. 4 See FDA Press Release, FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy (June 25, 2018), available at: https://www.fda.gov/news-events/press announcements/fda-approves-first-drug-comprised-active-ingredient-derived-marijuana-treat-rare-severe-forms. 5 See, e.g., Statement of Commissioner Maureen K. Ohlhausen, In the Matter of Health Discovery Corporation and FTC v. Avrom Boris Lasarow, et al. (Feb. 2015), https://www ftc.gov/public-statements/2015/02/dissenting statement-commissioner-maureen-k-ohlhausen-matter-health; Statement of Commissioner Joshua D. Wright, FTC v. Kevin Wright; HCG Platinum, LLC; and Right Way Nutrition, LLC (Dec. 2014), https://www.ftc.gov/public statements/2014/12/statement-commissioner-joshua-d-wright-federal-trade-commission-v-kevin; Statement of Commissioner Joshua D. Wright, In the Matter of Genelink, Inc., and foru International Corporation (January 2014), https://www ftc.gov/public-statements/2014/01/statement-commissioner-joshua-d-wright-matter-genelink inc-foru; Statement of Commissioner Maureen K. Ohlhausen Dissenting in Part and Concurring in Part, In the Matter of Genelink, Inc. and foru International Corporation (January 2014), https://www.ftc.gov/public statements/2014/01/statement-commissioner-maureen-k-ohlhausen-dissenting-part-concurring-part; Dissenting Statement of Commissioner Maureen K. Ohlhausen, FTC v. Springtech 77376, et al. (July 2013), https://www.ftc.gov/public-statements/2013/07/dissenting-statement-commissioner-maureen-k-ohlhausen; see also J. Howard Beales, III and Timothy J. Muris, In Defense of the Pfizer Factors, George Mason Law & Economics Research Paper No. 12-49 (May 2012), available at: https://papers.ssrn.com/sole/papers.cfm?abstract id=2087776. 6 See Statement of Commissioner Rohit Chopra Regarding the Cannabidiol (CBD) Enforcement Actions (Dec. 17, 2020).
VOLUME 171 Analysis to Aid Public Comment 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 with Steves Distributing, LLC, a limited liability company doing business as “Steves Goods,” and Steven Taylor Schultheis, individually and as an officer and owner of Steves Distributing, LLC (collectively, “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 Order and the comments received, and will decide whether it should withdraw the Order or make it final.
This matter involves the Respondents’ advertising of cannabidiol (“CBD”) and cannabigerol (“CBG”), cannabinoid compounds found in hemp and cannabis. The complaint alleges that Respondents violated Sections 5(a) and 12 of the FTC Act by disseminating false and unsubstantiated advertisements claiming that: (1) CBD and CBG products can effectively prevent, treat, or mitigate multiple diseases and other health conditions; and (2) studies or scientific research prove that CBD and CBG products effectively prevent, treat, or mitigate multiple diseases and other health conditions.
The Order includes injunctive relief that prohibits these alleged violations and fences in similar and related conduct. The product coverage would apply to any dietary supplement, drug, or food the respondent sells, markets, promotes, or advertises. Provision I requires randomized, double-blind, placebo-controlled clinical testing for the challenged claims or any disease treatment, mitigation, or cure claim for a Covered Product. The Order defines “Covered Product” as any dietary supplement, food, or drug including but not limited to CBD products or CBG products.
Provision II prohibits other misleading or unsubstantiated representations about the health benefits, performance, efficacy, safety, or side effects of any Covered Product or essentially equivalent product. It also covers prevention claims not specifically included in Provision I.
Provision III requires the preservation of certain records for any testing Respondents rely upon as competent and reliable scientific evidence. Provision IV addresses Respondents’ false establishment claims and generally prohibits misrepresentations regarding the scientifically or clinically proven benefits of any product. Provision V provides a safe harbor for FDA-approved claims. Provisions VI and VII contain monetary payment provisions. STEVES DISTRIBUTING, LLC 607 Analysis to Aid Public Comment Provisions VIII, IX, and X require Respondents to provide customer information to the Commission and to provide notice of the Order to customers, affiliates and other resellers. Provision XI requires an acknowledgement of receipt of the Order. It also requires the individual Respondents to deliver a copy of the Order to certain individuals in any business for which they are the majority owner or which they control directly or indirectly. Provisions XII, XIII, and XIV provide the required reporting, recordkeeping, and compliance monitoring programs that must be put in place. Provision XV explains when the Order is final and effective. The purpose of this analysis is to facilitate public comment on the Order, and it is not intended to constitute an official interpretation of the complaint or order, or to modify the order’s terms in any way.
VOLUME 171 Complaint