FDA, FTC, and Weight Loss Claims (Part 1 of 2)

There probably have been more enforcement actions brought by FDA and FTC against dietary supplements making weight loss claims than any other category of products.    

As stated by FTC in its "Red Flag Bogus Weight Claim" brochure: 

If the claim looks too good to be true, it probably is.

Despite claims to the contrary, there are no magic bullets or effortless ways to burn off fat. The only way to lose weight is to lower caloric intake and/or increase physical activity. Claims for diet products or programs that promise weight loss without sacrifice or effort are bogus. And some can even be dangerous.

These facts do not keep fraudulent advertisers from preying on consumers and reaping billions of dollars each year. While the scams may vary (for example, pills, patches, clips, body wraps, insoles or "diet teas"), the claims are almost always the same - dramatic, effortless weight loss without diet or exercise. 

Despite these obvious facts, because people want to keep eating too much, and do not want to bother exercising, their search for the next magic bullet that will "really work" continues. So companies will continue marketing such products and the FTC and FDA enforcement actions will continue. 

How can a company avoid or be able to defend against an enforcement action?  The only way that I know is to have a safe and effective product advertised and marketed with truthful, non-misleading, and adequately substantiated claims.

FTC is the government agency that regulates most advertising, including that for weight loss products. While FDA tends to focus on product composition and safety and structure/function claims vs. drug claims, FTC is focused solely on advertising -- Is it truthful? Is it misleading? Is it adequately substantiated?

I think the reason there may be so much FTC enforcement against weight loss products, as opposed to other product claims, is that the adequacy of substantiation for weight loss claims is so much easier to determine than the substantiation for most other structure/function claims made for dietary supplements.

Experts in the field may not agree on exactly what constitutes or how to quantify adequate substantiation for a "healthy joint function" or a "healthy heart" structure/function claim, but we can all agree on precisely what constitutes substantiation for a weight loss claim: did people actually lose weight and, if so, how much?  It is so easy to quantify the result.

As far as FTC is concerned, I would imagine enforcement is relatively easy.  People lose "X" pounds per week using the product. FTC merely needs to ask, "show us the study."You do not have to diet or exercise and still lose weight. "Show us the study."  If you are advertising a product for weight loss and you cannot supply FTC with actual results to back up the claims should they come knocking at your door, you are finished. FTC will demand that you "disgorge" all of your "ill-gotten gains." This means all of the money that you have taken from consumers, not just your net profits. This is an enormous financial penalty that comes along with a 20-year decree with even greater financial penalties if violated.

What does FTC consider obvious weight loss "red flags"?  

1.) Cause weight loss of two pounds or more a week for a month or more without dieting or exercise

2.) Cause substantial weight loss no matter what or how much the consumer eats

3.) Cause permanent weight loss (even when the consumer stops using product)

4.) Block the absorption of fat or calories to enable consumers to lose substantial weight

5.) Safely enable consumers to lose more than three pounds per week for more than four weeks

6.) Cause substantial weight loss for all users

7.) Cause substantial weight loss by wearing it on the body or rubbing it into the skin

Tomorrow, Ill examine what grabs the attention of FDA.

STEVEN SHAPIRO is a partner in the New York based firm of Ullman, Shapiro & Ullman, LLP and has over 25 years of experience in food and drug regulatory matters and regularly counsels clients in the areas of food and drug law relating to the manufacture and marketing of foods, dietary supplements, drugs, and cosmetics. He concentrates on areas of interest to the natural products industry and spends much of his time advising companies on the intricacies of the Dietary Supplement Health and Education Act of 1994 ("DSHEA"), as they concern the marketing of dietary supplements. In addition, Mr. Shapiro has extensive experience in the review of product labels, advertising and marketing materials. Mr. Shapiro also assists clients in matters relating to enforcement by the Food and Drug Administration, including the handling of FDA inspections and responding to 483's and Warning Letters, as well as defending companies in litigation brought by FDA and FTC. He can be reached through the companys Website,  www.usulaw.com .