Jan 19, 2022
Under the Dietary Supplements Health and Education Act (DSHEA), the manufacturer of a dietary supplement or dietary ingredient is responsible for ensuring that the product is safe before marketing. Once a product has reached the U.S. market, the U.S. Food and Drug Administration (FDA) is responsible for monitoring safety and has the authority to remove any unsafe dietary supplement product. Products marketed in the U.S. prior to the passage of DSHEA (1994) are assumed to have a history of safe use (i.e., “grandfathered”).
Supplement manufacturers introducing a new dietary ingredient to the U.S. market, defined as "a dietary ingredient that was not marketed in the United States before October 15, 1994" must notify the FDA of its intent 75 days before doing so. This pre-market review period allows FDA to examine the available safety data for the new ingredient and, if necessary, to request more information or to deny marketing of the dietary supplement containing the new ingredient. “Old” dietary ingredients (those marketed as a dietary supplement prior to October 15, 1994) are presumed to be safe and no notification is required. Manufacturers including claims on the label of a dietary supplement must have substantiation to ensure that the claim is truthful and not misleading. FDA has published guidance detailing the amount and nature of the substantiation manufacturers should have.
In July 2011, FDA published a draft guidance for industry intended to assist in the determination of when premarket notification for a dietary supplement containing a new dietary ingredient was necessary in preparing a New Dietary Ingredient (NDI) notification.
Following the issuance of this draft guidance (July 2011), concern was expressed by the trade associations representing dietary supplement manufacturers, as well as consumers, that FDA appeared to be attempting to shift the enforcement burden from the agency to the manufacturers, creating significant bureaucratic hurdles to new product innovations and market availability. In June 2012, FDA agreed that it needed to substantially revise the guidance to address the concerns voiced by industry.
In August 2016, FDA released a revised draft of the NDI Guidance. CHPA submitted comments to FDA noting a number of proposals in the Guidance that could impede product/ingredient innovation by responsible companies and make it difficult to introduce new products.
As for all products on the market, advertising for dietary supplements must be truthful and substantiated. The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) work together in regulating dietary supplement advertising. FDA is primarily responsible for claims on product labeling, while FTC has primary responsibility for claims in advertising, including print and broadcast ads, infomercials, catalogs, and similar direct marketing materials. These two agencies collaborate to ensure consistency in dietary supplement advertising regulation.
Claims describing the role of a dietary supplement in supporting wellness are allowed on dietary supplement labels provided the manufacturer has evidence substantiating these claims and notifies FDA of the claim within 30 days of marketing the product. In some instances, the dietary supplement must contain the following disclaimer on the label: “This statement has not been evaluated by the U.S. Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
There are three types of permissible claims for dietary supplements: health claims, structure/function claims, and nutrient content claims.