You could burn 50 calories just by reading this blog post. Or not. But if you sell a weight loss product with false, deceptive, and misleading claims, you’ll burn a lot more calories when the Federal Trade Commission (FTC) comes after you, or if you get sued by a consumer plaintiff’s lawyer.
Recently, the Federal Trade Commission mailed out 477,083 refund checks totaling $26,023,329 to consumers who bought the sprinkle-on weight-loss supplement Sensa. FTC says:
The refunds stem from a January 2014 settlement with the marketers of Sensa, who claimed that consumers could “sprinkle, eat, and lose weight” by using the product. According to the FTC’s complaint, the California-based company, its parent company, and two individuals, including the product’s inventor, deceptively advertised that the powder enhances food’s smell and taste, making users feel full faster, so they eat less and lose weight without changing their diet or exercise routine. The FTC’s complaint alleged, among other things, that the defendants did not have competent and reliable scientific evidence to support the weight-loss claims. The defendants charged $59 for a one-month supply of Sensa.
The FTC’s complaint also charged the defendants with failing to disclose that they paid some consumer endorsers for promoting the product, and controlled a purportedly independent study. The complaint also alleged that Sensa’s inventor deceptively endorsed the product and provided others with the tools for deception. In addition to requiring consumer refunds, the settlement with the FTC prohibits such practices.
First of all, when dealing with weight loss products, beware of making claims that are unsubstantiated. FDA and FTC vigorously enforce their rules against false and misleading claims.
With weight loss products FTC penalties can be heavy.
On the FDA side, of course, the product (if a dietary supplement, and not a drug), should assert a proper structure/function claim; and then, have substantiation by “competent and reliable scientific evidence.”
FDA and FTC enforcement scrutiny is common in weight loss products, because aggressive advertising claims can easily mislead customers, and weight loss is an area rife with unrealistic consumer expectations. See, for example, Weight Loss Advertisements Found Deceptive and Misleading – Conspiracy & Health Fraud Violations.
Here, the manufacturers did several things that triggered a huge enforcement penalty:
- The weight loss product manufacturer claimed that consumers could lose weight without changing their diet or exercise.
- The weight loss product manufacturer did not have substantiation for their weight loss claims.
- The weight loss product manufacturer failed to follow FTC rules concerning disclosure of consuming endorsements
- The weight loss product manufacturer misrepresented a study of the weight loss products
What are the lessons?
- Substantiation is critical. Even if you have a compliant claim, the claim still must be substantiated.
- Following FTC legal rules is just as important as dotting and crossing the FDA i’s and t’s.
- Be sure to have your healthcare product reviewed for FTC weight loss red flags, FTC substantiation issues, FTC endorsement issues, and other FTC advertising rules.
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Our FDA and FTC attorneys and healthcare lawyers track FDA and FTC regulatory developments involving weight loss and other health care products so we can counsel our clients on their FDA and FTC product compliance legal obligations. Contact our FDA and FTC legal team for laws and updates relevant to your healthcare products, whether they involve dietary supplements, cosmetics, medical devices, OTC or homeopathic drugs, or other consumer health products.