Grandfathered Dietary Ingredients, DSHEA, and the New Draft Guidance

Dietary ingredients having a “history of use” in accordance with the “Dietary Supplement Health and Education Act of 1994” (DSHEA) are not new dietary ingredients (NDIs) and hence do not require the filing of a 75-day premarket notification with the Food and Drug Administration (FDA):

“…[T]the term ‘‘new dietary ingredient’’ [NDI] means a dietary ingredient that was not marketed in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15, 1994” [Section 413 (c) of the Federal Food, Drug and Cosmetic Act (FDC Act); 21 USC §350(b)].

In essence, DSHEA established different regulatory requirements for dietary ingredients based simply on whether an ingredient was first marketed before or after the statute’s effective date of passage.  “Old” dietary ingredients (ODIs) marketed in the U.S. before October 15, 1994 are “grandfathered” in under DSHEA, are considered to be safe for continued consumer use, and can be sold without prior notification to FDA. In the case of ODIs, a presumption of safety, based on documented historical use of the ODI, remains with the manufacturer. To remove a “grandfathered” ingredient from commerce, FDA is required to demonstrate (i.e., FDA has the burden of proof) that the product holds “an unreasonable or significant risk of injury or illness”. (So far, ephedra is the most well-known example of an ODI found to hold “unreasonable or significant risk” and removed from commerce.) For ingredients entering commerce after DSHEA’s passage, no presumption of safety exists; the burden shifts to the manufacturer to submit evidence demonstrating a “reasonable expectation of safety”; however, it is up to FDA to determine if the ingredient is unsafe. Products containing NDIs that have not been notified may be subject to recall as being “adulterated.”