Seems there is a bit of confusion in the air regarding the extensive number of dietary supplements on the market and how the U.S. Food and Drug Administration (FDA) communicates safety regulations, and when in fact developers need to alert the FDA of new additions to their formulas. The law requires manufacturers to file a safety notification with the FDA before marketing dietary ingredients that were not on the market when the 1994 law passed.

In 16 years, the FDA received only about 700 notifications of new dietary ingredients. The agency believes there are more than 55,000 dietary supplement products in the general public.

This new guidance answers frequently asked questions about NDI notifications and related issues. It also makes recommendations to industry for preparing better NDI notifications that the agency will be able to review more efficiently, which should result in quicker response times.

Cara Welch, vice president of science and regulatory affairs at the Natural Products Association, said some companies had to submit notifications multiple times while Ivan Wasserman of law firm Manatt, Phelps & Phillips said in a statement:

“Once everyone understands what it means and how to comply with it, you’ll see compliance increasing. If (the FDA) doesn’t see an increased number of new dietary ingredient notification (NDI) submissions… I wouldn’t be surprised to see some type of uptick in enforcement.”

Welch said the Natural Products Association plans to ask the FDA to ease up on some guidelines, such as the documentation to show an ingredient was on the market before 1994.

A food safety reform law passed in January included a requirement that gave the FDA six months to issue draft guidelines for when to file a new dietary ingredient notification, or NDI, and what evidence is required to show product safety.

The agency recommends that the data and information that are submitted should include (1) a full description of the identity and composition of the NDI and the dietary supplement in which it will be marketed, (2) a discussion of the basis for the notifier’s conclusion that the substance is a NDI, (3) a description of the conditions of use recommended or suggested in the labeling of the dietary supplement, or, if no conditions of use are recommended or suggested in the labeling, the ordinary conditions of use of the supplement, and (4) an explanation of how the history of use or other evidence of safety in the notification justifies the notifier’s conclusion that the dietary supplement containing the NDI will reasonably be expected to be safe.

This draft guidance focuses on interpreting the FD&C Act’s requirements relating to NDIs and dietary supplements that contain a NDI. It does not discuss other parts of the FD&C Act that may affect the regulatory status of a particular ingredient or product, such as provisions of the recently enacted FSMA that may apply to dietary ingredients and/or dietary supplements.

The mere presence of a substance as a component of a conventional food that was marketed before October 15, 1994 does not establish that the substance was marketed as a dietary ingredient before that date. Similarly, the fact that the component may have been isolated as part of an analytical chemical procedure to examine the composition of the previously marketed food before October 15, 1994, is not sufficient to establish that the component is a pre-DSHEA dietary ingredient or even that it is a dietary ingredient at all. If it is not a dietary ingredient, it is ineligible to be a NDI.

Sources: The U.S. Food and Drug Adminstration and The Natural Products Association

Written by Sy Kraft