The general rule is that no type of “health claim” or “disease claim” can be made on a dietary supplement unless that claim has been authorized by the Federal Food and Drug Administration (“FDA”). There are several options for obtaining this authorization if a health claim is desired. There are also some strategies for avoiding health claims.
What are “health claims,” and how to avoid them?
As the FDA defines it here, a “health claim” on a dietary supplement explicitly links two essential things a substance (like a food, component, or ingredient) and a disease or health-related condition. For a more detailed and legalistic definition, see FDA regulations at 21 CFR § 101.14.
Avoiding a “health claim” is a matter of eliminating one of those essential elements. If either is missing or there is no linkage asserted, then there is no “health claim.” Note that a health claim can be explicit or implicit. For example, using symbols to make an unauthorized health claim is not allowed. An example might be using a symbol or picture recognized as a heart and linking it to a symbol of your supplement.
Methods of obtaining FDA authorizations for “health claims”
There are several methods of finding or obtaining FDA authorization for “health claims.”
The first is to do sufficient research on the FDA regulations to locate an already-issued regulation. Over the years, the FDA has issued extensive regulations under the Nutrition Labeling and Education Act (“NLEA”) and other authorizing legislation. For example, the linkage between calcium supplements and bone density has been well established. As such, the FDA has a regulation that authorizes a health claim for foods containing calcium and calcium supplements. If an FDA regulation already exists related to your supplement and a health claim, then that health claim can safely be made.
Note, however, that the claim made on the label and in advertising/marketing MUST comply with the regulations. As can be seen in the regulation linked above, certain words must be contained on the label, and any limiting or qualifying language related to the health claim must be prominently displayed.
Alternatively, a petition can be filed asking for authorization pursuant to the NLEA. This can be done by providing scientific evidence that substantiates the linkage between the substance/ingredient and the medical condition.
Depending on the scientific substantiation, another option for obtaining FDA authorization is to file a notification with the FDA pursuant to the Food and Drug Administration Modernization Act. The scientific substantiation must come in the form of an “authoritative statement” from the National Academy of Sciences or a scientific body of the U.S. government. If an authoritative statement of this sort is available, then — instead of a petition — a health claim notification can be submitted to the FDA. This can be used for making a health claim on labels and in marketing 120 days after the notification is submitted unless the FDA issues a denial/refusal.
Finally, there is also the possibility of obtaining authorization for what is called a “qualified health claim.” As described in the link above, petitions can be filed with the FDA to authorize health claims where the scientific evidence falls below what is required for issuing a regulation or for notifications allowed under the Modernization Act. Generally, the FDA will allow a “qualified health claim” if the evidence supporting the proposed claim is credible and the claim can be qualified to prevent it from misleading consumers.
Contact The FDA Health Claim Attorneys at Revision Legal
For more information, contact the experienced FDA Health Claim Lawyers at Revision Legal. You can contact us through the form on this page or call (855) 473-8474.
