Marketing Dietary Supplements
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In July 2011, FDA published a draft guidance for industry intended to assist in the determination of when premarket notification for a dietary supplement containing a new dietary ingredient was necessary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Following the issuance of this draft guidance (July 2011), concern was expressed by the trade associations representing dietary supplement manufacturers, as well as consumers, that FDA appeared to be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 In this draft guidance FDA also attempted to bring the notification requirements to the same status as food additives, a point that was specifically excluded in DSHEA, as dietary supplements were given separate status. The trade associations worked in concert to develop comments to submit to FDA on the NDI draft guidance. In June 2012, following a meeting with Senators Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa), FDA agreed that it needed to substantially revise the guidance to address the concerns voiced by industry.
More recently, the dietary supplement trade associations have requested that the FDA issue revised guidance on new dietary ingredient (NDI) notifications, with a specific focus on the information to be included to identify the new dietary ingredient.