By Wes Siegner –
In response to a history of FDA illegal restriction of the marketing of dietary supplements in the 1980s and early 1990s, Congress amended the Federal Food, Drug, and Cosmetic Act (“FDC Act”), passing by unanimous consent the Dietary Supplement Health and Education Act of 1994 (“DSHEA”). In simple terms, DSHEA clarified that FDA does not have premarket approval authority over dietary supplements or the dietary ingredients in such products, put the onus for the safety of such products on industry, and established a new dietary ingredient (“NDI”) notification process in section 413 of the FDC Act, 21 U.S.C. § 350b, for certain ingredients that had not been marketed in the United States prior to 1994 to provide notice to FDA of the basis for safety of new ingredients.
In July 2011, FDA published a controversial draft guidance that attempted to return the industry to pre-DSHEA restrictions by narrowly interpreting the NDI notification provision of the FDC Act. This firm and many others filed comments critical of the guidance and pointing out that FDA was once again exceeding its legal authority (see here and here).
The guidance has effectively been rejected, though not officially withdrawn, causing further speculation as to what the law requires. FDA for its part has claimed that too few companies are filing prior to marketing, implying that companies are violating the NDI notification requirements. Some industry consultants have suggested that the answer to when an NDI notification is needed, and whether the filing of an NDI notification opens the door to “me too” ingredients, will remain unclear until FDA’s draft guidance is revised and reissued (see here). However, guidance documents are not legally binding on either industry or FDA, and given the distance between FDA and industry on even the basics of the NDI notification process, there is considerable uncertainty as to when – if ever – any guidance will be finalized.
So where to look for answers? The answer is the statutory provision in question, 21 U.S.C. § 350b. Our prior comments on FDA’s draft NDI guidance, referenced herein, analyze the statutory provision in detail. However, here are the basic principles:
- No notification is required for any dietary ingredient marketed in the United States before the date of passage of DSHEA, October 15, 1994. These are commonly referred to as “old” or “grandfathered” ingredients. One challenge to industry is the lack of any authoritative list of such ingredients.
- No notification is required if the dietary ingredient is “present in the food supply” anywhere in the world. Therefore, the FDC Act does not require notification if the ingredient is present in food, including dietary supplements, in the United States or any other country either because the ingredient is added to food or because it is a natural constituent of food.
- “Me too” ingredients are generally not required to file an additional NDI notification if the ingredient has already been notified. The focus of the notification provision is on the ingredient, not the process by which it is made or the amount in the dietary supplement, issues on which the provision is silent. Therefore, an herbal extract from the same plant and with the same constituents as a notified extract is not subject to the NDI notification process for two reasons: 1) the notification requirement for the ingredient has been satisfied by the prior filing; and 2) the ingredient is now in food, since by law dietary supplements are also “food,” and is therefore “present in the food supply.”
DSHEA granted much greater marketing freedom to industry, and curtailed FDA’s illegal efforts to block market access. However, even for ingredients that do not require notification, the FDC Act still requires manufacturers to assure the safety of their products by appropriate means – by consulting with food safety experts, compiling supporting data, or conducting necessary studies – and the penalties for ignoring this safety requirement are severe, including criminal prosecution.