Pursuant to the Food Safety Modernization Act (FSMA), enacted at the beginning of this year, the FDA recently issued a draft Guidance document clarifying its expectations on new dietary ingredients (NDI). The 1994 Dietary Supplement Health and Education Act (DSHEA) required dietary supplement manufacturers to notify the FDA in advance when they intend to add a new dietary ingredient to their products, except when the ingredient has been part of the food supply and has not been chemically altered for use in supplements. The notifications must identify the new dietary ingredient and be accompanied by evidence on its safety. The FDA states that the draft Guidance is intended to inform and assist manufacturers, distributors, and others in deciding when a premarket safety notification for a dietary supplement containing a new dietary ingredient is necessary and in preparing premarket safety notifications.
A section titled “Scope of the Guidance” states that there are over 55,000 dietary supplements on the market, yet FDA has only received 700 premarket notifications in the 17 years since DSHEA was enacted. Further, FDA’s Institute of Medicine estimates that 1,000 new dietary supplements are brought to market every year, making the 700 number for notifications seemingly even more difficult to explain.
As noted above, under DSHEA it is not necessary to submit a NDI notification to FDA for ingredients that were in the food supply before Oct. 15, 1994. The Guidance makes clear that “in the food supply” means the ingredient must have been on the market as a dietary supplement before that date and not “in the food supply” as an ingredient of conventional foods. If dietary supplement manufacturers have not been filing NDI notifications on the theory that their ingredient was a component of conventional food before Oct. 15, 1994, the draft Guidance rejects their premise. The result could be that many notifications will have to be filed.
Per the draft Guidance, if there is a change to the manufacturing process of an ingredient that was marketed as a dietary supplement before Oct. 15, 1994, and the change may affect the chemical composition or structure of the ingredient, a NDI notification is “most likely” required. The draft Guidance also states that a dietary supplement which contains a NDI is adulterated under the Food, Drug and Cosmetic Act, even if the supplement contains only dietary ingredients that have been present in the food supply as articles used for food in a form in which the food has not been chemically altered.
The draft Guidance also establishes requirements to prove that an ingredient was marketed as a dietary supplement in the U.S. before Oct. 15, 1994, and therefore is not a NDI. According to the draft Guidance: Documentation to show that a dietary ingredient is not a NDI should consist of written business records, promotional materials, or press reports with a contemporaneous date prior to Oct. 15, 1994. Examples include sales records, manufacturing records, commercial invoices, magazine advertisements, mail order catalogues, or sales brochures. Documentation should include adequate information to establish that marketing took place in the U.S., the identity (e.g., chemical or botanical name) and form (e.g., ground herb, water extract, oil) of the marketed ingredient, and whether the ingredient was marketed as a dietary ingredient or for some other purpose.
The draft Guidance expressly states that affidavits alone, i.e., unaccompanied by such records, are insufficient to show that an ingredient is not an NDI.
In light of these understandings of what it means for an ingredient to have been “in the food supply” before the relevant date, the draft Guidance includes this summary chart showing when a NDI notification is required and when the adulteration standard applies. To view the entire chart, please click here:
Appendix A to the Guidance includes a decision tree to assist manufacturers and others in deciding whether a NDI notification is necessary.
The draft Guidance addresses many other questions about when a NDI may be marketed, such as in relation to the timing of its testing or approval as a drug. The Guidance also contains detailed instructions on the contents of a NDI notification when one is required and of the evidence of safety that will be required depending on the evidence of historical use and proposed use of the
It is important to remember that FDA Guidance documents are not “law,” like a statute or regulation. Rather, they are non-binding statements of FDA’s current thinking on a topic.
This Barnes & Thornburg LLP publication should not be construed as legal advice or legal opinion on any specific facts or circumstances. The contents are intended for general informational purposes only, and you are urged to consult your own lawyer on any specific legal questions you may have concerning your situation.© 2013 BARNES & THORNBURG LLP