Recently a physician called me, raving about HCG for weight loss, letting me know he recommends HCG to all his obese patients, because he lost over 150 pounds on HCG. “The scientific evidence is there,” the medical doctor insisted. His own personal (anecdotal) testimony was a major piece of his belief in the evidence – and possibly, the revenue he generated from physician in-office sales of dietary supplements and/or participation in a multi-level marketing (MLM) weight loss system.
FTC has now cracked down on marketers of HCG products.
FTC writes:
Marketers who pitched homeopathic HCG drops as a quick and easy way to lose substantial weight have agreed to pay $1 million to settle Federal Trade Commission charges that their weight-loss claims were deceptive and not supported by scientific evidence. The defendants have stopped selling HCG Platinum drops, and under the settlement, Kevin Wright and his Utah-based companies, HCG Platinum, LLC and Right Way Nutrition, LLC, are banned from making similar weight-loss claims in the future.
The settlement marks the second time this year the FTC has taken legal action against marketers of HCG weight-loss products. In January, a company called HCG Diet Direct settled similar charges brought by the FTC.
“Fad weight-loss products like HCG drops come and go, but consumers shouldn’t be fooled by their empty promises,” said Jessica Rich, Director of the FTC’s Bureau of Consumer Protection. “The foundation of successful weight loss is to eat a healthy diet and to increase physical activity.”
HCG, or human chorionic gonadotropin, is a hormone produced by the human placenta that for decades has been falsely promoted for weight loss. In November 2011, Wright and six other HCG marketers received warning letters issued jointly by FDA and FTC staff, advising them that their products are mislabeled drugs under the Federal Food, Drug, and Cosmetic Act, and warning that it is illegal to make weight-loss claims that are not supported by competent and reliable scientific evidence.
Selling the products at GNC, Rite Aid, Walgreens, and on their own websites, Wright and his companies promised consumers that HCG Platinum drops would cause rapid and substantial weight loss, and that consumers likely would lose as much as 43 and even 50 pounds, as claimed in product testimonials.
The defendants, who also made claims on Facebook, on product packaging, and in Internet pop-up ads and magazines, directed consumers to place the HCG drops under their tongues before meals and stick to a very low calorie diet. The defendants marketed two of their three formulations as “homeopathic,” meaning the listed ingredients were diluted to the point they were undetectable. They typically charged between $60 and $85 for a 30-day supply of all three formulations, and sold approximately $10 million of the products from 2010 to earlier this year, when they were sued.
The settlement bans the defendants from making a number of specific weight-loss claims about any over-the-counter drug, patch, cream, wrap, or any other product. It also requires the defendants to substantiate any future claims that using a product causes weight loss, rapid weight loss, or a specific amount of weight loss or that consumers can expect to lose as much weight as the product’s endorser, unless they have at least two adequate and well-controlled human clinical studies. Claims regarding the health benefits, safety, performance, or efficacy cannot be made unless they are not misleading and are substantiated by competent and reliable scientific evidence. The defendants also are barred from misrepresenting the results of any scientific study.
The order also imposes a $10 million judgment, representing all net sales of HCG Platinum drops, which will be suspended, provided the defendants pay the FTC $1 million. If it is determined that the financial information the defendants gave the FTC was untruthful, the full amount of the judgment will become due.
Note that the company’s promotion of HCG included claims on Facebook and Internet marketing, as well as product packaging.
Under the FTC advertising standard, all advertising must be supported by competent and reliable scientific evidence. If you’re not sure whether you have enough evidence to meet this legal standard, ask an FTC lawyer to evaluate your labeling and online marketing for FTC as well as FDA compliance.
Legal review of dietary supplements should review of:
- claims: in most cases, are they proper structure/function claims
- labeling: is the labeling technically correct, under FDA guidance and relevant regulations
- substantiation: is the claim supported by competent and reliable evidence
- FTC advertising standards: is the advertising content reasonably supported under FTC as well as FDA legal rules.
Weight loss claims or claims for fad diets or products are particularly suspect and vulnerable to enforcement.
FDA has previously indicated its skepticism regarding HCG claims:
HCG weight-loss products that promise dramatic results and claim to be homeopathic are sold as drops, pellets and sprays on the Web, in drugstores and at General Nutrition Centers. They are supposed to be used in combination with a very low-calorie diet of 500 calories a day.
Many of the labels indicate the products contain HCG, or human chorionic gonadotropin, a hormone made by the placenta during pregnancy. The hormone itself is approved as a prescription treatment for infertility and other conditions.
There is no evidence the oral over-the-counter products are effective for weight loss, says Elizabeth Miller, FDA’s leader for the Internet and health fraud team.
FTC warns consumers:
Consumers should carefully evaluate advertising claims for weight-loss products. For more information, see the FTC’s guidance for consumers of products and services advertised for Weight Loss & Fitness. Consumers also should be skeptical of advertisements that tout HCG in any form as a weight-loss treatment. For more information see the FDA video, Being Fooled by Empty Diet Promises.
Beware as well of consumer protection statutes such as those regulating products to prevent health fraud.
See our other related posts:
- HCG – FDA drug approval / legal issues for weight loss
- Legal issues in use of HCG for weight loss
- Weight loss products raise legal issues
- Fire therapy treatment for weight loss
- Medical spas face fee splitting issues
- Off-Label Promotion and Marketing – Misbranding (FDA Issues, Part 1)
- Off-Label Promotion & Marketing Creates FDA Penalties (Part 2)
- New Report Outlines Key Legal Issues for Medical Spas and Aesthetic Medical Practices
- FTC Charges on Fake Acai Berry Claims
Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.
Contact Us
