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

Click here to read part 1.

As to FDA, the agency arguably does have the authority to request to see substantiation for weight loss claims and requires 30-day notices for structure/function claims that include a certification that the notifier has "substantiation that the statements are truthful and not misleading." Enforcement rarely focuses on substantiation.

In its regulation of structure/function claims, while FDA allows claims for weight loss, it will object if a claim implies or expressly states that a product will treat obesity, which is a disease. Most companies know not to make obesity claims, and FDA has had little enforcement in this area.

What we are increasingly seeing from FDA, however, is enforcement against products making weight loss claims that are "spiked" with active pharmaceutical ingredients.  There are far too many products masquerading as weight loss dietary supplements that contain undisclosed active ingredients such as sibutramine, which is a prescription drug pulled from the market due to increased risk of heart attack and stroke.

Legitimate dietary supplements usually work slowly and over time. And they definitely require that they be used in conjunction with a reduced calorie diet and exercise.  If a dietary supplement promises much more than that (see yesterdays post) it is probably either a false claim or the product is spiked with something that is not listed on the label.

On the FDA website, there is a page called "Tainted Weight Loss Products.  As of my writing this post, here are 57 notification and 17 recalls listed. Almost all are for undeclared, spiked pharmaceutical ingredients in products claiming to be dietary supplements. The page, it should be noted, has not been updated for months.

As recently as August 23, the American Herbal Products (AHPA) issued a "Legal Alert" to its members notifying that in August 2013, FDA had performed four voluntary recalls advising consumers not to purchase or use products because FDA laboratory analysis confirmed that these products contain undeclared ingredients.  AHPA further reported that "International health agencies issued 10 consumer warnings in three countries concerning 27 products that 'contain hidden drug ingredients.'"

AHPA maintains a webpage in which it monitors FDA's activities relative to spiked weight loss and other categories of spiked dietary supplements called www.keepsupplementsclean.org

The number of spiked products being illegally sold has reached epidemic proportions. Legitimate industry needs to demand further and stronger FDA action. Recalls and Warning letters are simply not enoughfor the industry and the safety of millions of consumers.

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.