Advisory Letter to Dietary Supplement Manufacturers about Unsubstantiated Weight Loss Claims

Dear Dietary Supplement Manufacturer:

In August 2003, the Food and Drug Administration (FDA) announced its Strategic Action Plan, Protecting and Advancing America's Health. A major element of the Plan is to focus agency resources to increase the amount and quality of available information to enable consumers to make better food choices. One means of achieving this goal is for FDA to use its enforcement authority to promote the use of accurate information by manufacturers in the marketing of their products. FDA's efforts include increasing our enforcement activities against companies that market products with false or misleading claims. Consumers rely on labeling information in forming their dietary choices, and this enforcement effort is expected to result in labeling information for food and dietary supplement products that is sciencebased. FDA is taking this opportunity to make clear its concerns about these products and to seek your assistance in this important public health initiative.

As part of its continuing efforts to that end, FDA is paying close attention to the types of claims being made in the labeling of dietary supplements promoted for weight loss. We are increasingly concerned that claims for such products are misleading to consumers and that the purported benefits of many products are not supported by sound scientific evidence, making the claims unsubstantiated.

In 1994, the Federal Food, Drug, and Cosmetic Act (the Act) was amended by the Dietary Supplement Health and Education Act (DSHEA). One provision of DSHEA provides that manufacturers may describe, in the labeling of their products, certain benefits attributed to the use of the dietary supplement. Manufacturers may, among other things, describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body in humans, characterize the documented mechanism by which a nutrient or a dietary ingredient acts to maintain such structure or function, or describe the general well-being resulting from consumption of a nutrient or dietary ingredient. In order to make such claims, however, the dietary supplement manufacturer must have substantiation that the claim is truthful and not misleading. In addition, the label with such a claim must contain the following statement prominently displayed, and in boldface type: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease."

In December 2003, the Federal Trade Commission (FTC) released a staff report identifying eight claims about a product's ability to promote weight loss that a scientific panel convened by the Commission staff had concluded are not "scientifically feasible" for nonprescription weight-loss products. The FTC published the claims as a means to assist industry, the media, and consumers in identifytng weight-loss claims that FTC has generally agreed to be false.

The eight claims identified in the FTC report are:

• "Consumers who use the advertised product can lose two pounds or more per week (over four or more weeks) without reducing caloric intake and/or increasing their physical activity.
• Consumers who use the advertised product can lose substantial weight while still enjoying unlimited amounts of high calorie foods.
• The advertised product will cause permanent weight loss (even when the user stops using the product).
• The advertised product will cause substantial weight loss through the blockage of absorption of fat or calories.
• Consumers who use the advertised product (without medical supervision) can safely lose more than three pounds per week for a period of more than four weeks.
• Users can lose substantial weight through the use of the advertised product that is worn on the body or rubbed into the skin.
• The advertised product will cause substantial weight loss for all users. Consumers who use the advertised product can lose weight only fiom those parts of the body where they wish to lose weight."

FDA intends to evaluate weight loss dietary supplement products, will consider for regulatory action products that make claims similar to those above, and will ensure that the claimed effects on weight-loss being made for specific ingredients and products are substantiated by sound science.

If you are a manufacturer or own-label distributor, it is your responsibility to ensure that claims you make about your products are substantiated. If a claim is made in the labeling for a dietary supplement and the claim is not substantiated, the product is misbranded under the Act. Whether you manufacture or distribute dietary supplements, you risk enforcement action against misbranded products in your possession.

As part of its enforcement efforts, the Agency may inspect a broad range of establishments and identify products with unsubstantiated weight loss claims. FDA is taking this opportunity to make clear its concerns about these products and to seek your cooperation in this important public health initiative.

We appreciate your attention to the matters discussed above.

List of Distributers Receiving Warning Letters for Unsubstantiated Weight Loss Claims November 2004