9 Keys to Managing Risk of FTC enforcement (especially with anti-aging and weight loss claims)

If you market your healthcare products, FTC enforcement can stop your sales in their tracks. All it takes is a search – yes, good old keywords – and you’re in line for significant penalties for false, deceptive and misleading advertising. Healthcare products marketed for weight loss are particularly vulnerable to FTC legal enforcement action. In Weight Loss Advertising Basics, FTC warns that companies need “scientific proof to support objective claims their ads make:”

False or misleading claims can be conveyed in words and in images. Some brazen scammers just flat-out lie. Others use eye-catching before-and-after pictures. A word about consumer endorsements (sometimes called testimonials): Endorsements from supposedly satisfied customers – “D.G. lost 38 pounds in just 3 weeks” or “Jane from Springfield dropped 4 dress sizes in 30 days!” – are a staple of weight loss ads. Too often, advertisers cherry-pick their best cases or even make up bogus endorsements, deceptively conveying to consumers that they’ll get similar results. Under the law, advertisers that choose to use endorsements have two choices: Either the results in the ad must be typical of what other consumers can expect to achieve or the ad must clearly and conspicuously disclose what the typical results are. Even for the most effective products, services, or programs, weight loss of more than a pound a week over a long period is unusual. As a rule, endorsements from people who claim to have lost an average of two pounds or more per week for a month or more – or endorsements from people who say they lost more than 15 pounds overall – should be accompanied by a disclosure of how much weight consumers typically can expect to lose. What makes a disclosure “clear and conspicuous”? Simply put, it stands out in an ad. It finds you; you don’t have to look for it. In general, disclosures should be:

• close to the claims they relate to – for example, consumer testimonials – and not buried in footnotes or blocks of text people aren’t likely to read;
• in a font that’s easy to read;
• in a shade that stands out against the background;
• for video ads, on the screen long enough to be noticed, read, and understood;
• for video or radio ads, read at a cadence that’s easy for consumers to follow; and
• in words consumers will understand.

If disclosures are hard to find, tough to understand, obscured by other elements in the ad, or buried in unrelated details, they don’t meet the “clear and conspicuous” standard. Furthermore, it’s not enough to say “results not typical” or “your results will vary.”

FTC red-flags 7 “gut check” claims–those referring to substantial weight loss:

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 consumer eats;
3. causes permanent weight loss even after the consumer stops using product;
4. blocks the absorption of fat or calories to enable consumers to lose substantial weight;
5. safely enables consumers 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.

Recently FTC slammed two companies that market skin care and weight-loss products for making false or unsubstantiated deceptive claims about their products:

In one case, the FTC challenged ads for DermaTend, a skin cream that was promoted for do-it-yourself removal of moles, skin tags, and warts, as well as Lipidryl, a supplement promoted for weight loss. In the second case, the agency challenged claims for Photodynamic Therapy anti-aging lotions, as well Shrinking Beauty, a supposed body-slimming lotion. The FTC settlements in both cases prohibit the defendants from misleading consumers about the efficacy of their products and about whether their claims are backed by scientific evidence.

In addition, the marketers of DermaTend and Lipidryl are required to disclose when people promoting the products are paid for their endorsement. “These companies made outrageous claims that their products could provide a range of benefits – from removing warts to decreasing the appearance of cellulite to providing substantial weight loss,” said Jessica Rich, Director of the Bureau of Consumer Protection. “The common thread for all of these claims was the fundamental lack of scientific evidence. Consumers deserve better.”

The settlement order for the wart removal product requires that weight-loss products must be supported by at least two well-done human clinical studies.

9 Keys to Manage Risk of FTC Enforcement When you market healthcare and wellness products online:

• Be sure your products are substantiated.
• Have all website pages and marketing materials reviewed for potential false advertising exposure under FTC, FDA and state laws.
• Use caution regarding claims of “clinical” proof.
• Before and After pictures create implied claims and will trigger FTC scrutiny.
• Claims of safety and efficacy are particularly vulnerable.
• Know that weight loss claims are red flagged.
• Health claims need appropriate scientific support, including high-quality human clinical testing.
• Materials connections between the advertiser and the endorser must be disclosed, according to FTC legal rules.
• “Natural” must be backed with proof.

Our FDA and FTC attorneys and healthcare lawyers track regulatory developments so we can counsel our clients on their FDA and FTC compliance legal obligations.