Healthylife Sciences, LLC

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IN THE MATTER OF HEALTHYLIFE SCIENCES, LLC CONSENT ORDER, ETC. IN REGARD TO ALLEGED VIOLATIONS OF SECTIONS 5 AND 12 OF THE FEDERAL TRADE COMMISSION ACT Docket No. C-4493; File No. 122 3287 Complaint, October 22, 2014 – Decision, October 22, 2014 This consent order addresses Healthylife Sciences, LLC’s (“HLS”) advertising for its Healthe Trim line of weight-loss dietary supplements (“Healthe Trim”). The complaint alleges that the company violated Sections 5(a) and 12 of the Federal Trade Commission Act by making false or unsubstantiated representations that Healthe Trim would cause rapid and substantial weight loss, including as much as 35, 130, and 165 pounds. The consent order bans HLS from making any of the seven “gut check” weight loss claims that the Commission has publicly advised are always false, specifically that any dietary supplement, over-the-counter drug, or patch, cream, wrap, or other product worn on the body or rubbed into the skin: 1) causes weight loss of two pounds or more a week for a month or more without dieting or exercise; 2) causes substantial weight loss no matter what or how much the user eats; 3) causes permanent weight loss; 4) blocks the absorption of fat or calories to enable users to lose substantial weight; 5) safely enables users to lose more than three pounds per week for more than four weeks; 6) causes substantial weight loss for all users; or 7) causes substantial weight loss by wearing a product on the body or rubbing it into the skin.

Participants For the Commission: Christine DeLorme and Elizabeth Nach. For the Respondent: Curt Friedberg, Partner. COMPLAINT The Federal Trade Commission, having reason to believe Healthylife Sciences, LLC, a limited liability company (“Respondent”), has 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 Healthylife Sciences, LLC (“Healthylife Sciences”), is a Georgia limited liability company with its HEALTHYLIFE SCIENCES, LLC 869 Complaint principal office or place of business at 8601 Dunwoody Place, Suite 418, Atlanta, Georgia 30350.

2. Respondent has advertised, offered for sale, sold, and distributed the Healthe Trim line of weight-loss dietary supplements to consumers, including Healthe Trim Original Formula, Healthe Trim Powered by Raspberry Ketone, Healthe Trim Powered by Green Coffee Bean, and Healthe Trim Garcinia Cambogia (collectively, “the Healthe Trim Products”). These products are “foods” and/or “drugs,” within the meaning of Sections 12 and 15 of the Federal Trade Commission Act. 3. The acts and practices of Respondent alleged in this complaint have been in or affecting commerce, as “commerce” is defined in Section 4 of the Federal Trade Commission Act. Healthe Trim Weight-Loss Products 4. Respondent has marketed Healthe Trim Original Formula since 2009, introducing Healthe Trim Powered by Raspberry Ketone in September 2012, Healthe Trim Powered by Green Coffee Bean in February 2013, and Healthe Trim Garcinia Cambogia in June 2013. The Healthe Trim Products were sold by Respondent primarily through its website www.healthytrim.com, and Original Formula was also available in retail stores including CVS, GNC, and Walgreens. The price for a one-month supply of the Healthe Trim Products ranged from approximately $49.95 to $64.95. Through the end of 2013, gross sales minus refunds of the Healthe Trim Products exceeded $76 million. 5. Respondent participated in the dissemination of or caused to be disseminated advertising, packaging, and promotional materials for the Healthe Trim Products, including, but not necessarily limited to, the attached Exhibits A through E. These materials contain the following statements: a. MATTHEW DWYER: Fall is here. So it’s time for your weight to start falling off. Healthe Trim is the answer to your weight loss struggles. It’s a natural supplement that actually works.

VOLUME 158 Complaint Hi, it’s Matthew, founder of Healthe Trim, and we’ve sold over 1.5 million bottles. That should tell you right there that Healthe Trim works. Lose weight easily and quickly today . . . .

If you’ve tried diets, meal plans, clinics, meetings and nothing’s worked for you, it doesn’t surprise me. You got to give Healthe Trim a try.

Healthe Trim is so easy. Just a couple of capsules in the morning right when you wake up, drink water and go about your day. We guarantee it or your money back.

Make today the day you stop struggling with your weight and give Healthe Trim a try . . . . (Exhibit A, 60-second radio ad).

b. MATTHEW DWYER: Are you ready for this? We’ve got something new for you. It’s Matthew, founder of Healthe Trim. We’ve now added Healthe Trim raspberry ketone to our unique proprietary blend of Healthe Trim.

It’s a breakthrough. It is awesome. I feel fantastic. Healthe Trim raspberry ketone will change your life. You’ll lose weight without dieting. You won’t believe how fast the fat will start burning off. I guarantee it. 30-day, no questions asked money back guarantee. You will be as excited as I am with Healthe Trim, now powered by raspberry ketone. It burns the fat, suppresses your appetite, and will boost your energy. It’s natural, it’s safe and it is so easy. With our 30-day money back guarantee, you have nothing to lose but the weight. . . .

(Exhibit B, 60-second radio ad).

HEALTHYLIFE SCIENCES, LLC 871 Complaint c. ELVIS DURAN: Hi, it’s Elvis. You guys have heard about Healthe Trim and their excellent website Healthytrim.com. Well, the founder of Healthe Trim and our weight loss expert is back with a 30-day money back guarantee. You have nothing to lose but the weight. Go to Healthytrim.com, start losing weight today. Healthytrim.com.

SKEERY JONES: How’s it going? It’s Skeery Jones. A lot of people have been asking me over the past year about this all-natural supplement I’ve been taking, which has allowed me to lose a whole bunch of weight and still eat the foods I like when I want them. It’s called Healthe Trim at Healthytrim.com. Well, I figured to clear a whole lot of rumors up and to answer everyone’s question [sic], we’d bring in Matthew Dwyer, the founder of Healthe Trim. Good morning, Matthew.

MATTHEW DWYER: Skeery, how are you buddy? SKEERY JONES: The past year has just been amazing for me.

MATTHEW DWYER: Yeah, see, listen, here’s the thing. Healthe Trim’s not a diet, you know. It’s just an all-natural supplement that you take in the morning and it works. It’s not a lifestyle change, and I think that’s why we’re having so much success with it, because research shows that 95 percent of diets fail because you have to give up the foods that you love. So, you end up gaining the weight back. And that’s not the case with Healthe Trim.

SKEERY JONES: Right.

MATTHEW DWYER: Listen, I was a guy that was just desperately trying to lose the weight. So, I started trying all different dietary supplements and they all gave me the crazy jittery feeling until I stumbled upon VOLUME 158 Complaint Healthe Trim. I lost five pounds the first week; I lost 16 pounds in three weeks; I lost 47 pounds in 100 days.

SKEERY JONES: Oh, my God.

MATTHEW DWYER: It’s not important what we weigh, Skeery, but it’s the visceral fat around our organs, the belly fat, that causes all the health issues. SKEERY JONES: And, you know, when I started taking Healthe Trim, I realized I was given more energy in the morning when I started taking the Healthe Trim. And then, throughout the day, the energy was sustained. I can eat what I want, but I don’t find myself as hungry as I used to be. MATTHEW DWYER: I think it’s important to know there’s 17 all-natural ingredients. I couldn’t do the meal plans, I couldn’t do the shake plans. What I can do is I can wake up in the morning, take two allnatural supplements, drink water and go about my day. I’m now a 32-inch waist. After three years, I haven’t gained a pound back. I feel great. I don’t have the crazy jittery feeling.

Dr. Oz does specials all the time about how over twothirds of the supplements out there are scams because they don’t have authentic hoodia in here. Hoodia is the cactus plant that the Africans used to live off way back in the day to go five or six days to hunt their prey without food. We have authentic hoodia in Healthe Trim.

SKEERY JONES: And I know that because I’ve checked your website and I’ve looked into it and you guys have the documents to back it up, that this is the real deal hoodia.

MATTHEW DWYER: And by no means is Dr. Oz endorsing Healthe Trim, but he says that all 17 HEALTHYLIFE SCIENCES, LLC 873 Complaint ingredients in Healthe Trim are not only safe, they’re very, very healthy for you.

SKEERY JONES: What about this Resveratrol I’ve been reading about? MATTHEW DWYER: Yeah, Resveratrol is the grape red wine extract, okay? I encourage your listeners to Google the Harvard study on Resveratrol. There’s just so many anti-aging benefits and healthy benefits to Resveratrol. Listen, everything that’s in one capsule of Healthe Trim, it’s just 17 fruits and vegetables. You get great energy from the green tea. There’s 175 milligrams from green tea in one capsule, which is equivalent to about a 16-ounce Dunkin Donuts or Starbucks cup of coffee.

SKEERY JONES: Mm-hmm.

MATTHEW DWYER: Do I know that Healthe Trim is the best all-natural supplement in the world? No, I do not. But here’s what I do know, Healthe Trim absolutely works and we have a 30-day no questions asked money back guarantee… (Exhibit C, radio ad).

d. Healthe Trim GET HIGH SCHOOL SKINNY! […] A REVOLUTIONARY THERMO-ENERGY BOOSTER LOSE WEIGHT! FEEL GREAT! Our powerful diet supplements are made of only the finest natural ingredients available. They are formulated to provide energy boosts, surpass[sic] cravings and burn fat. Most importantly, they’re EASY to add to your day – just take two in the morning! VOLUME 158 Complaint [...] Real People, Incredible Results! […] Emily York Phoenix, AZ Lost 137 pounds! My name is Emily. I’m a twenty-nine-year-old mother of three. After my first daughter, I gained 60 pounds in a year and learned I had thyroid disease, a condition that not only meant I would gain weight it also meant it would be difficult to lose weight. As the years went by, pounds piled on, and as I tried all the diet plans and pills and shakes with no success, my frustration grew. Then I heard about healthé trim on the radio and the DJ had thyroid disease like me! I decided it would be my last try and if this didn’t work maybe I was meant to stay that way. September 13, 2009, the day after my 29th birthday, I started healthé trim and I have since lost 121 pounds! I lost 19 pounds the first week and felt amazing. I have the energy to exercise that I didn't have before and there were no side effects with my thyroid meds.

Thanks to healthé trim I am high school skinny again. I have myself back, my husband has his wife back, and my kids have the mom they deserve! Thank you healthé trim!! * The weight loss experienced by these individuals actually occurred. We do not have many facts about the circumstances about how this weight loss was achieved, other than the consuming of HealtheTrim, for either us or you to conclude that this should be a generally expected outcome from the use of HealtheTrim. We encourage a reasonable exercise and healthy diet as an important part of your weight loss HEALTHYLIFE SCIENCES, LLC 875 Complaint and maintenance program. A clinical study of 60 participants in 2009 reflected an average weight loss of 2.43 pounds in 30 days when those individuals took HealtheTrim exclusive of a diet and exercise program. […] How to Lose Weight Fast […] Natural Weight Loss Supplements There are a lot of weight loss supplements out there, but not all of them are effective at producing real results. Healthé Trim is clinically proven to help you lose weight. Our weight loss supplement is made from natural ingredients that curb your appetite, boost energy, and increase your metabolism for rapid weight loss.

Fad diets that promise fast results may be dangerous to your health if they require you to consume too few calories. Healthé Trim lets you continue eating the food you enjoy in smaller portions while giving you extra energy for a more active lifestyle. Our natural weight loss supplement has everything your body needs to achieve quick weight loss and better overall health.

[…] Fat Burner People who want to lose body fat without sacrificing muscle need an effective fat burner as part of their weight loss strategy. Healthe Trim has developed a successful weight loss trio consisting of appetite suppressants, metabolism boosters and fat burners which work together to keep you healthy and help you burn fat without losing muscle.

VOLUME 158 Complaint Burning Fat and Preserving Muscle Muscles keep us healthy and strong; they can also help both men and women feel more attractive and confident. We use them every day for a number of different tasks, so it is important to ensure they are not diminished by dieting. When trying out a new diet or weight loss plan, it is easy to neglect the nutrients you need to preserve your muscles. Fortunately, Healthe Trim provides a safe and natural solution for losing body fat while minimizing the loss of muscle. Healthe Trim’s Successful Weight Loss Trio Appetite Suppressants A major ingredient in Healthe Trim is Hoodia gordonii. This supplement acts as an appetite suppressant, keeping you focused and reducing the temptation to overeat. The combination of hoodia and our fat burner can result in losing up to 50 pounds by simply adding our weight loss pill to your diet. Metabolism Boosters Healthe Trim gives your body a metabolism boost which causes an increased amount of calories to be burned more quickly. Less food plus a faster metabolism means your body eats away at the fat reserves in order to keep going at its normal pace, resulting in a slimmer you.

Fat Burners Healthe Trim includes a fat burner ingredient that targets stores of fat without weakening your muscles. Our balance of natural ingredients will ensure that your body uses stored fat reserves as fuel rather than preventing your muscles from getting the nutrition they need to stay strong and continue building. HEALTHYLIFE SCIENCES, LLC 877 Complaint Muscles burn more energy than other parts of the body, so losing muscle mass actually slows down your overall metabolism. Maintaining or building muscle is an important part of any weight loss plan. To ensure minimal muscle loss, you need a weight loss supplement to manage the energy that fuels your muscles. Healthe Trim’s winning combination of fat burners, appetite suppressants and metabolism boosters will allow you to meet your weight loss goals using time-tested, all natural ingredients. (Exhibit D, Healthytrim.com website).

e. […] DR. WENDY WALSH: …But it all begins with one man, who’s worked tirelessly to help hundreds of thousands of people lose millions of pounds. He desperately wanted to lose weight himself, but nothing he tried worked. Then he discovered the formula for Healthe Trim and it changed his life forever. I’m happy to introduce Mr. Matthew Dwyer! Hi, Matthew.

MATTHEW DWYER: Hey, how are you? Thanks so much for having me.

DR. WENDY WALSH: People are losing weight. Matthew, I need to know what’s going on. MATTHEW DWYER: Hundreds of thousands of people have lost millions of pounds on Healthe Trim and they’re keeping it off because Healthe Trim is just so darn easy.

DR. WENDY WALSH: Why do they stick to Healthe Trim? MATTHEW DWYER: Because all you do is wake up in the morning, take two natural supplements, drink VOLUME 158 Complaint water and go about your day, and it is just that simple. You’ll be less hungry and you’ll be less tired. [On Screen Depiction: Before and after photos of Matthew Dwyer, labeled “Lost 47 pounds”] You’ll have great energy. It will motivate you to move around. It will curb your cravings and you’ll lose the weight easy and naturally.

[…] DR. WENDY WALSH: I’d like to introduce now Ann Hudson. Ann is a popular radio disc jockey and TV host in Austin, Texas. Welcome, Ann.

[On Screen Depiction: “Before” photo of Ann labeled “189 pounds” – subscript, “Lost 54 pounds”] […] ANN HUDSON: Everyone around the office when I came back from maternity leave was taking Healthe Trim. It was all the rage. And I was like, what the heck is this? What’s going on? When I started taking it, I felt better. I had a lot more energy. I wanted to do stuff. And after six weeks, the weight just started falling off. It was like five pounds, six pounds, eight pounds. It was a huge transition.

DR. WENDY WALSH: How much did you lose total? ANN HUDSON: Fifty-four.

DR. WENDY WALSH: Fifty-four pounds.

ANN HUDSON: Yeah.

MATTHEW DWYER: So, you went from a 12 in a dress to a two in a dress.

ANN HUDSON: Now I’m a 2.

HEALTHYLIFE SCIENCES, LLC 879 Complaint MATTHEW DWYER: In five months, six months? ANN HUDSON: Yes.

DR. WENDY WALSH: Five sizes, five months! […] DR. WENDY WALSH: Welcome back. Well, everybody’s talking about Healthe Trim and I’m finally beginning to understand why. It’s quite simple. It’s because Healthe Trim works. There’s no extreme dieting, no extreme exercising, no costly meal delivery programs. Just two capsules in the morning and Healthe Trim goes right to work, making you feel less hungry while simultaneously giving you an alert, focused energy. So, you burn more calories than you take in. The result, you lose weight naturally. MATTHEW DWYER: Most people are out there like me. They’re stressed. Jobs, kids, it’s difficult to eat a well-balanced meal and it’s difficult to watch what you’re eating and exercise all the time on a regular basis. It’s not very difficult, though, to wake up in the morning, take two natural supplements, drink water and go about your day.

[…] DR. WENDY WALSH: You’ve seen and heard great stories about real people just like you who have lost 10 to 20, 40 to 60, even 100 pounds or more with the number one natural weight loss supplement, Healthe Trim. Isn’t it finally time for you to take control with Healthe Trim?. . . Just take two capsules a day and you’re on your way to a better, healthier, happier life….

(Exhibit E, Healthe Trim infomercial). VOLUME 158 Complaint Count I False or Unsubstantiated Efficacy Claims for the Healthe Trim Products 6. In connection with the advertising, promotion, offering for sale, or sale of the Healthe Trim Products, Respondent has represented, directly or indirectly, expressly or by implication, that:

a. The Healthe Trim Products cause substantial weight loss, including as much as 35, 50, 130, and 165 pounds;

b. The Healthe Trim Products cause rapid weight loss, including as much as 19 pounds in the first week, 47 pounds in 100 days, and 54 pounds in five months; c. The Healthe Trim Products cause weight loss without the need to diet, give up any foods, or make any changes in lifestyle;

d. The Healthe Trim Products burn fat and cause fat loss; e. The Healthe Trim Products boost metabolism; and f. The Healthe Trim Products suppress appetite. 7. The representations set forth in Paragraph 6 are false or misleading, or were not substantiated at the time the representations were made.

Count II False Establishment Claims for the Healthe Trim Products 8. In connection with the advertising, promotion, offering for sale, or sale of the Healthe Trim Products, Respondent has represented, directly or indirectly, expressly or by implication, that scientific studies prove that the Healthe Trim Products cause weight loss.

9. In fact, scientific studies do not prove that the Healthe Trim Products cause weight loss. Among other reasons, two HEALTHYLIFE SCIENCES, LLC 881 Complaint clinical trials showed no statistically significant differences in weight loss between the test groups taking Healthe Trim Original Formula and test groups taking a placebo. Therefore, the representation set forth in Paragraph 8 is false or misleading. Violations of Sections 5 and 12 11. The acts and practices of Respondent 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 twentysecond day of October, 2014, has issued this Complaint against Respondent.

By the Commission.

VOLUME 158 Complaint Exhibit A

VOLUME 158 Complaint Exhibit C

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Drink Lots of Water Exergy] MIPOWES SMENgy, TES POU SIkep, DUIS CHIONES, an DUI Muscle Miss. even boosts your metabolism, helping you io lose weght more quickly. A baknoe of caging and exercise is healhier than dissing alana and can aise help youio ince more atiractive: Natural Weight Loss Supplements There area lot of megol fase suppleness aul lene, but eet allof ther are effective al producing real nesulls, Heald Trin is dinically proven te help yau lose weigh Our wegiy oss suppfenoal is made fom nelurwl GREEN COFFEE BEAN ingredents that carb your apoetite, boost anand, and increase your matabolsm for raoat weagh ross. aK Fed diets that promise fast results may be dangerous to your health if hey require you to Consume wo Tew calonss. Hesliné fom isis you contnue eating the food you enjoy in smaber portions while gning you emia ancy for a more active lifesty¥e. Our natural weigh! less supplement hes eveything your body needs tn achiowe quick Weialt Ince and hatter averal heel.

LEARN MORE (http: / vee. healthytrim.comyartches!inse-wetght: fast[ty MyM. 9230-9 Ale HEALTHYLIFE SCIENCES, LLC 905 Complaint pa EXHIBIT D —— SEES SSS SSS SSS SSS SSS See healthe’ GET HIGH SCHOOL Custemes Senice | 30 Day Guarentee | Free Caching bem SKINNY! — driginal Dery inia ule Fat Burner People who wantio lose body fat without sacmiong muscle nee! an effective fat luneras. pert of thea weit foes strateay. Heelthe Trim hes developed a Successiul weaht bss tric consisting of apeatita suppressants, Mitaboksm boosiers and fal buries which work Legellvar le kien you Fiealthy aire Inelgr yond Lr fal without: since muscle, Burning Fat and Preserving Muscle Muscles heap us healiiq and strony, they can aise hep bet me and woren feel more atireacivs and confedern, We use them every day for a numter of different tases, soit is iportart to ensure they arg nod diminishes! by dheting. When nang oul anew dolor waht ints alin, is oem fo noghect the ruitents you need to penserve yout Muscies. Ferlunaialy, Kealthe Tim provides @ sage and natural solution for fosing body fat while minimizing the joss. of muscde, Healthe Trim’s Successful Weight Loss Trio Appetite Suppressants A mane ingrediert in Heallhe Trim is Moodie gorda. This suppemen acs as an appoile suopressant, keeping you fecumed and reducing the fempiation to covered. The combanation of hoodia and ourfat bumer can resi im losing up ta 50 peunds by sinply agding aur weight bss pa‘ to your diet Metabolism Boosters Healhe Trin gives your body a metabolism boos! which ciusesan incedsed amamt of calones to be burned more quickly. (Less food plusa aster metabolism means your bedy eas away atthe fatreeares in ordario keep Qoing at its nonmel pace, resMiiiIng m2 slimmer you. Fat Burners Healiie Trin inchedes a fal bumer ngrodbent that targets stores of Fal without weakening your muschs Chr balires of nalurad ingredionts ull ermures that your bady wees eleed Gb pacarvec se fuel rather thar prmcentiray your MUSCKS from gating the nutrion they mead to stay strong and continue buiking. MUSCeS DUN money energy than other parts of Me Oody, $0 losing MUSCe mass acuity Slows down your averel Matatolism. Maintaining oF bubding musde isan important part of any weight loss plan. To ensure minimal muscle lest, pom trond ae samagh! Ines eappkmond ia mime the anorsgy hat fusle year muscles Hewltho Trim's winning COmbngaon of fa! bivnars, sapette suppressants and matiboksn boosters will allow you to meet your weight loss goals using Gneesied, all natural ingredients: (http: //veew. healthytrim,comyartches\St-bumes["y Mh a4 92342 AM] VOLUME 158 Complaint Exhibit E

HEALTHYLIFE SCIENCES, LLC 955 Decision and Order DECISION AND ORDER The Federal Trade Commission (“Commission”) having initiated an investigation of certain acts and practices of the respondent named in the caption hereof, and the respondent having been furnished thereafter with a copy of a draft complaint that the Bureau of Consumer Protection proposed to present to the Commission for its consideration and which, if issued by the Commission, would charge the respondent with violation of the Federal Trade Commission Act, 15 U.S.C. § 45 et seq.; and The respondent and counsel for the Commission having thereafter executed an agreement containing a consent order (“consent agreement”) that includes: a statement that the agreement is for settlement purposes only and does not constitute an admission that the law has been violated as alleged in the draft complaint, or that the facts as alleged in the draft complaint, other than the jurisdictional facts, are true; and waivers and other provisions as required by the Commission’s Rules; and The Commission having thereafter considered the matter and having determined that it has reason to believe that the respondent has violated the Federal Trade Commission Act, and that a complaint should issue stating its charges in that respect, and having thereupon accepted the executed consent agreement and placed such consent agreement on the public record for a period of thirty (30) days for the receipt and consideration of public comments, 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 hereby issues its complaint, makes the following jurisdictional findings, and enters the following order:

1. Respondent Healthylife Sciences, LLC is a Georgia limited liability company with its principal office or place of business at 8601 Dunwoody Place, Suite 418, Atlanta, Georgia 30350.

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

VOLUME 158 Decision and Order ORDER DEFINITIONS For purposes of this Order, the following definitions shall apply:

A. Unless otherwise specified, “respondent” shall mean Healthylife Sciences, LLC, its successors and assigns, and officers, and their agents, representatives, and employees.

B. “Commerce” shall mean as defined in Section 4 of the Federal Trade Commission Act, 15 U.S.C. § 44. C. “Covered Product” shall mean any Dietary Supplement, Food, or Drug.

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 is 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. “Essentially Equivalent Product” shall mean 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 HEALTHYLIFE SCIENCES, LLC 957 Decision and Order ingredients if reliable scientific evidence generally accepted by experts in the relevant field indicates that the amount and combination of additional ingredients is unlikely to impede or inhibit the effectiveness of the ingredients in the Essentially Equivalent Product. F. “Food” and “Drug” mean as defined in Section 15 of the FTC Act, 15 U.S.C. § 55.

G. “Reliably Reported,” for a human clinical test or study (“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.

H. The term “including” in this Order shall mean “without limitation.”

I. The terms “and” and “or” in this Order shall be construed conjunctively or disjunctively as necessary, to make the applicable phrase or sentence inclusive rather than exclusive.

I.

IT IS ORDERED that respondent, directly or through any corporation, partnership, subsidiary, division, or other device, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any Dietary Supplement, over-the-counter Drug, or patch, cream, wrap, or other product worn on the body or rubbed into the skin, in or affecting commerce, shall not make any representation, in any manner, expressly or by implication, including through the use of product name, endorsement, illustration, trademark, or trade name, that such product:

A. Causes weight loss of two pounds or more a week for a month or more without dieting or exercise; B. Causes substantial weight loss no matter what or how much the user eats;

VOLUME 158 Decision and Order C. Causes permanent weight loss;

D. Blocks the absorption of fat or calories to enable users to lose substantial weight;

E. Safely enables users to lose more than three pounds per week for more than four weeks;

F. Causes substantial weight loss for all users; or G. Causes substantial weight loss by wearing a product on the body or rubbing it into the skin.

II.

IT IS FURTHER ORDERED that respondent, directly or through any corporation, partnership, subsidiary, division, or other device, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any Covered Product, in or affecting commerce, shall not make any representation, other than representations banned under Part I of this Order, in any manner, expressly or by implication, including through the use of product name, endorsement, illustration, trademark, or trade name, that such product: A. Causes weight loss;

B. Cause substantial weight loss;

C. Causes rapid weight loss;

D. Causes weight loss without the need to diet, give up any foods, or make any changes in lifestyle; E. Causes users to burn fat or lose fat; F. Increases users’ metabolism; or G. Causes suppression of appetite;

unless the representation is non-misleading and, at the time of making such representation, respondent possesses and relies upon HEALTHYLIFE SCIENCES, LLC 959 Decision and Order competent and reliable scientific evidence that substantiates that the representation is true.

For purposes of this Part, competent and reliable scientific evidence shall consist of at least two adequate and well-controlled human clinical studies of the Covered Product, or of an Essentially Equivalent Product, conducted by different researchers, independently of each other, that conform to acceptable designs and protocols and whose results, when considered in light of the entire body of relevant and reliable scientific evidence, are sufficient to substantiate that the representation is true. Respondent shall have the burden of proving that a product satisfies the definition of an Essentially Equivalent Product.

For purposes of this Part, “adequate and well-controlled human clinical study” means a human clinical study (1) that is randomized, double-blind, and placebo-controlled; (2) that is conducted by persons qualified by training and experience to conduct such a study; and (3) as to which, all underlying or supporting data and documents generally accepted by experts in weight loss research as relevant to an assessment of such testing as described in Part VI must be available for inspection and production to the Commission.

III.

IT IS FURTHER ORDERED that respondent, directly or through any corporation, partnership, subsidiary, division, or other device, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any Covered Product, in or affecting commerce, shall not make any representation, other than representations covered under Parts I and II of this Order, in any manner, expressly or by implication, including through the use of product name, endorsement, illustration, trademark, or trade name, about the health benefits, performance, or efficacy of any Covered Product, unless the representation is non-misleading, and, at the time of making such representation, respondent possesses and relies upon competent and reliable scientific evidence that is sufficient in quality and quantity based on standards generally accepted in the relevant scientific fields, when considered in light of the entire body of VOLUME 158 Decision and Order relevant and reliable scientific evidence, to substantiate that the representation is true.

For purposes of this Part, competent and reliable scientific evidence means tests, analyses, research, or studies (1) that have been conducted and evaluated in an objective manner by qualified persons; (2) that are generally accepted in the profession to yield accurate and reliable results; and (3) as to which, when they 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 Part VI must be available for inspection and production to the Commission.

IV.

IT IS FURTHER ORDERED that respondent, directly or through any corporation, partnership, subsidiary, division, or other device, in connection with the manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any Covered Product, in or affecting commerce, shall not misrepresent, in any manner, expressly or by implication: A. The existence, contents, validity, results, conclusions, or interpretations of any test, study, or research; or B. That the efficacy of such product has been clinically or scientifically proven.

V.

IT IS FURTHER ORDERED that:

A. Nothing in this Order shall prohibit respondent from making any representation for any drug that is permitted in labeling for such drug under any tentative final or final standard promulgated by the Food and Drug Administration, or under any new drug application approved by the Food and Drug Administration; and HEALTHYLIFE SCIENCES, LLC 961 Decision and Order B. Nothing in this Order shall prohibit respondent from making any representation for any product specifically permitted 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.

VI.

IT IS FURTHER ORDERED that, with regard to any human clinical test or study (“test”) upon which respondent relies to substantiate any claim covered by this Order, respondent shall 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, but not necessarily limited to: 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, but not limited to, any pretest analysis, intent-to-treat analysis, or VOLUME 158 Decision and Order 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 shall not apply to a Reliably Reported test, unless the test was conducted, controlled, or sponsored, in whole or in part (1) by respondent, or by any person or entity affiliated with or acting on behalf of respondent, including officers, agents, representatives, and employees, or by any other person or entity in active concert or participation with respondent (“respondent’s affiliates”), (2) by the supplier or manufacturer of the product at issue, or (3) by a supplier to respondent, to respondent’s affiliates, or to the product’s manufacturer of any ingredient contained in such product.

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

IT IS FURTHER ORDERED that respondent and its successors and assigns, for five (5) years after the last date of dissemination of any representation covered by this Order, maintain and upon reasonable notice make available to the Federal Trade Commission for inspection and copying: A. All advertisements and promotional materials containing the representation;

B. All materials that were relied upon in disseminating the representation; and HEALTHYLIFE SCIENCES, LLC 963 Decision and Order C. All tests, reports, studies, surveys, demonstrations, or other evidence in their possession or control that contradict, qualify, or call 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.

VIII.

IT IS FURTHER ORDERED that respondent and its successors and assigns shall deliver a copy of this Order to all current and future principals, officers, directors, and other employees having responsibilities with respect to the subject matter of this Order, and shall secure from each such person a signed and dated statement acknowledging receipt of the Order. Respondent shall deliver this Order to current personnel within thirty (30) days after date of service of this Order, and to future personnel within thirty (30) days after the person assumes such position or responsibilities.

IX.

IT IS FURTHER ORDERED that respondent and its successors and assigns shall notify the Commission at least thirty (30) days prior to any change in the company, that may affect compliance obligations arising under this Order, including, but not limited to, dissolution, assignment, sale, merger, or other action that would result in the emergence of a successor corporation; the creation or dissolution of a subsidiary, parent, or affiliate that engages in any acts or practices subject to this Order; the proposed filing of a bankruptcy petition; or a change in the corporate name or address. Provided, however, that, with respect to any proposed change in the corporation about which respondent learns fewer than thirty (30) days prior to the date such action is to take place, respondent shall notify the Commission as soon as is practicable after obtaining such knowledge. Unless otherwise directed by a representative of the Commission in writing, all notices required by this Part shall be emailed to [email protected] or sent by overnight courier to: Associate Director for Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC VOLUME 158 Decision and Order 20580. The subject line must begin: Healthylife Sciences, LLC, FTC File No. 122-3287.

X.

IT IS FURTHER ORDERED that respondent and its successors and assigns, within sixty (60) days after the date of service of this Order, shall file with the Commission a true and accurate report, in writing, setting forth in detail the manner and form of their own compliance with this Order. Within ten (10) days of receipt of written notice from a representative of the Commission, respondent shall submit additional true and accurate reports.

XI.

This Order will terminate on October 22, 2034, or twenty (20) years from the most recent date that the United States or the Commission files a complaint (with or without an accompanying consent decree) in federal court alleging any violation of the Order, whichever comes later; provided, however, that the filing of such a complaint will not affect the duration of: A. Any Part in this Order that terminates in less than twenty (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 Part.

Provided, further, that if such complaint is dismissed or a federal court rules that 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 Part 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.

HEALTHYLIFE SCIENCES, LLC 965 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 from Healthylife Sciences, LLC (“Healthylife Sciences”).

The proposed consent order (“proposed order”) has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement or make final the agreement’s proposed order.

This matter involves Healthylife Science’s advertising for its Healthe Trim line of weight-loss dietary supplements (“Healthe Trim”). The complaint alleges that the company violated Sections 5(a) and 12 of the Federal Trade Commission Act by making false or unsubstantiated representations that Healthe Trim would cause rapid and substantial weight loss, including as much as 35, 130, and 165 pounds. It also claimed that users would lose weight without dieting, and that Healthe Trim would burn fat, increase metabolism, and suppress appetite. The complaint also alleges that Healthylife Sciences violated Sections 5(a) and 12 by falsely representing that Healthe Trim is clinically proven to cause weight loss. The proposed order includes injunctive relief that prohibits these alleged violations and fences in similar and related violations. For purposes of the order, “Covered Product” means any dietary supplement, food, or drug. Part I of the proposed order bans HLS from making any of the seven “gut check” weight loss claims that the Commission has publicly advised are always false, specifically that any dietary supplement, over-the-counter drug, or patch, cream, wrap, or other product worn on the body or rubbed into the skin: 1) causes weight loss of two pounds or more a week for a month or more without dieting or exercise; 2) causes substantial weight VOLUME 158 Analysis to Aid Public Comment loss no matter what or how much the user eats; 3) causes permanent weight loss; 4) blocks the absorption of fat or calories to enable users to lose substantial weight; 5) safely enables users to lose more than three pounds per week for more than four weeks; 6) causes substantial weight loss for all users; or 7) causes substantial weight loss by wearing a product on the body or rubbing it into the skin.

Part II of the proposed order prohibits HLS from making claims that any Covered Product causes weight loss, causes substantial or rapid weight loss, causes weight loss without the need to diet or make lifestyle changes, burns fat or causes fat loss, boosts metabolism, or suppresses appetite, unless it possesses and relies upon competent and reliable scientific evidence, defined as at least two adequate and well-controlled human clinical studies. The studies must have been conducted by qualified persons, and have been randomized, double-blinded, and placebo-controlled. In addition, the company must maintain all underlying or supporting data that experts in weight-loss research generally would accept as relevant to an assessment of such testing.

Part III of the proposed order prohibits any representation about the health benefits, performance, or efficacy of any Covered Product, unless it is non-misleading and supported by competent and reliable scientific evidence that is sufficient in quality and quantity based on standards generally accepted in the relevant scientific fields, 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 Part, competent and reliable scientific evidence is defined as tests, analyses, research, or studies that have been conducted by qualified persons in an objective manner and are generally accepted in the profession to yield accurate and reliable results. When that evidence consists of human clinical tests or studies, HLS must maintain all underlying or supporting data and documents that experts in the field generally would accept as relevant to an assessment of such testing. Part IV of the proposed order prohibits HLS from misrepresenting the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research in HEALTHYLIFE SCIENCES, LLC 967 Analysis to Aid Public Comment connection with the manufacturing, labeling, advertising, promotion, offering for sale, and sale or distribution of any Covered Product.

Part V provides a safe harbor for representations permitted under any tentative final or final standard promulgated by the Food and Drug Administration (“FDA”), any new drug application approved by the FDA, or FDA regulations pursuant to the Nutrition Labeling and Education Act of 1990 or the FDA Modernization Act of 1997.

Triggered when the human clinical testing requirement in Part II or III applies, Part VI of the proposed order requires HLS to secure and preserve all underlying or supporting data and documents generally accepted by experts in the field as relevant to an assessment of the human clinical test or study, such as protocols, instructions, participant-specific data, statistical analyses, and contracts with the test’s researchers. There is an exception for a “Reliably Reported” test, defined as a test published in a peer-reviewed journal that was not conducted, controlled, or sponsored by HLS, its affiliates, or others in the manufacturing and supply chain. Also, the published report must provide sufficient information about the test for experts in the relevant field to assess the reliability of the results. Parts VII through X of the proposed order require HLS to: deliver a copy of the order to principals, officers, directors and other employees having responsibilities with respect to the subject matter of the order; notify the Commission of changes in corporate structure that might affect compliance obligations under the order; and file compliance reports with the Commission.

Part XI provides that the order will terminate after twenty (20) years, with certain exceptions.

The purpose of this analysis is to facilitate public comment on the proposed order, and it is not intended to constitute an official interpretation of the complaint or proposed order, or to modify the proposed order’s terms in any way. VOLUME 158 Complaint