In a letter sent to Good Morning America, Fabricant clarified safety standards set by FDA regarding dietary supplements, including good manufacturing practices (GMPs) put in place by the agency. Fabricant also stressed the standards supplement companies must comply to regarding product claims, stating, “Products with claims to treat diseases are regulated as unapproved drugs."
Wrapping up the letter, Fabricant wrote, “NPA fully supports FDA enforcement against manufacturers of products that do not follow the federal standards that have been set forth for dietary supplements. Consumers should stay vigilant for any products that do not adhere to these requirements."
Read Fabricant’s full letter below:
While the Natural Products Association (NPA), the oldest and largest trade association representing the dietary supplement industry, encourages stories surrounding consumer safety, we found several points in your Good Morning America Health Alert on dietary supplements that require clarification.
A dietary supplement is a commodity of food regulated by the Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN). Dietary supplements are designed to supplement the diet for healthy populations, and to enhance a healthy lifestyle in which nutrition and exercise are also critically important. Dietary supplements are finished products containing at least one dietary ingredient, as well as a packaging label that includes a dietary supplement statement of identity. In addition, nutrition information is displayed in an enclosed box with the title “Supplement Facts." It is also the only food commodity with a requirement to display a full domestic address or domestic telephone number through which the responsible party can be contacted for reporting a serious adverse event. It is crucial to stress that if products or ingredients do not have this mandatory information, they are not dietary supplements.
The manufacturing of finished dietary supplement products are heavily regulated by the FDA’s good manufacturing practices (GMP) for dietary supplements. The agency has performed more than 2,700 domestic GMP inspections for dietary supplements since 2008, and this represents a significant investment of time and resources. The FDA is an enforcement agency responsible for protecting public health. If a company manufactures a dietary supplement and is inspected by the agency and their products are pulled for contaminant testing, the agency has the right to enforce the law where a firm has failed to meet GMPs.
The Good Morning America segment suggests that “Chinese herbal supplements" were prescribed by an acupuncturist to help treat recurring eczema. Dietary supplements do not require a prescription nor are they permitted to treat diseases like eczema. Products with claims to treat diseases are regulated as unapproved drugs. During the discussion of “Chinese herbal supplements," the camera panned several bins of raw botanical ingredients. If the product was a raw herbal ingredient for use in a tea, as many traditional Chinese medicines are, then it would not be a finished product, and also not a dietary supplement. The label of the product and the intent conveyed in product labeling determines whether it is a dietary supplement or not.
Consumer Labs, who was interviewed for this segment, suggested that 20 to 25 percent of the products it tests do not pass its review process, which is not peer-reviewed, and that products may not contain all the ingredients they claim or are not as pure as promised. We see several issues here. First, what are the criteria Consumer Labs uses in its review of products? Does passing its review include GMP requirements under the federal statute of the Food Drug and Cosmetic Act? All dietary supplement manufacturers must comply with the dietary supplement GMPs for quality, identity, strength, purity and composition. Firms must set limits on the levels of contamination that are within the agency’s provisional total tolerable intake levels (PTTILs) established for a particular known contaminant.
NPA fully supports FDA enforcement against manufacturers of products that do not follow the federal standards that have been set forth for dietary supplements. Consumers should stay vigilant for any products that do not adhere to these requirements.
We hope that you will take this information into account for future stories related to dietary supplements to ensure consumers have all the tools they need to make informed decisions in the marketplace.
Daniel Fabricant, Ph.D.
CEO and Executive Director
Natural Products Association