FDA Releases Draft Guidance for NDI Notification
The U.S. Food and Drug Administration issued a long-awaited revised draft guidance on Aug. 11 seeking to clarify new dietary ingredient (NDI) notifications for industry.
Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, manufacturers and distributors must notify FDA at least 75 days prior to marketing a dietary supplement that contains an NDI, a dietary ingredient that had not been marketed in the United States prior to October 15, 1994, unless used in the food supply without chemical alteration. However, according to FDA, while 55,600 dietary supplements exist on the market, with 5,560 being released each year, the agency has received fewer than 1,000 NDI notifications since DSHEA was passed in 1994.
The current draft guidance is revised from an initial draft guidance released by FDA in 2011. Based on feedback received, the agency chose to clarify important points of misunderstanding and is once again accepting additional comments. Among the topics addressed, are: What qualifies as an NDI, when NDI notification is required, the procedures for submitting an NDI notification and the types of data and info FDA recommend for evaluating the safety of NDIs and dietary supplements containing NDIs.
Trade groups such as the Natural Products Association (NPA) are concerned about the economic impact of NDI notifications which, based on research from its member companies, typically costs between $178,000–$328,000 for toxicology studies, $162,500 for FTE & consultants for preparing the NDI submission and $27,500 for analytical & physical properties. This conflicts with what FDA reported was the burden of reporting NDIs. According to the agency, the burden amounted to 20 hours per notification or 1,100 hours based on the average of 55 notifications per year.
“The numbers speak for themselves. It is critical for FDA to conduct a fair and accurate economic impact analysis for the cost of an NDI submission,” said Daniel Fabricant, Ph.D., CEO and executive director of NPA, in a press release issued prior to the release of the draft guidance. NPA also seeks clarification on a number of other topics, including: the expectation that each manufacturer must submit a notification for identical products, the definition of what does not constitute chemical alteration, exceptions to notification requirements for NDIs with an established history of use in conventional foods and protection of intellectual property, among other things.
Take-home points. The United Natural Products Alliance (UNPA) communicated several key take-home points from the draft guidance to its members in emails and during UNPA’s “NDI Guidance II & Substances Generally Recognized as Safe” September workshop in Salt Lake City. According to UNPA, important points from the draft included:
* Companies will be required to submit an NDI notification if there are certain changes to an existing manufacturing process such as new solvents used, new particle sizes used or a new fermentation process.
* Any old or new dietary supplement that use nano-sized particles (1 nm to 100 nm [particle size]), requires a separate NDI notification.
* If companies start using a new solvent (other than water) for botanical extraction, an NDI notification is needed.
* UNPA says the draft guidance proposes making an NDI Master File about NDIs and manufacturing data.
* FDA is proposing to develop an official “grandfathered in” list of old dietary ingredients that do not require a notification.
* A combination of two NDI ingredients create an NDI that requires a third NDI notification.
Comment period. In late August, the Natural Products Association (NPA) submitted a request to FDA for an extension of the comment period on the newly revised guidance. The draft guidance currently has a 60-day comment period; however NPA believes a 30-day extension will allow the opportunity for stakeholders to make a sufficient response.
“NPA believes that no harm will result from FDA extending the comment period due to the interest, significance, and complexities generated by the topics included in this re-draft,” said Fabricant. “NPA looks forward to working with its member companies to engage this important public notice and comment period to make changes in helping to bring novel, innovative dietary ingredients to the market safely.”
Fabricant also added that although the “re-draft, which includes points of clarification over the earlier draft, was no Magna Carta par excellence,” there were still, in some cases, wins for the industry. However, the trade group found “inconsistencies and errors in the guidance” which they plan to address during the comment period.
Further education. Several groups held webinars and meetings following the release of the draft guidance to discuss its contents with members. Contact these groups for information about what was discussed and whether access to webinar recordings is available: NPA, Council for Responsible Nutrition, UNPA, American Herbal Products Association and Nutrition Capital Network.
Published in WholeFoods Magazine, October 2016, Online 8/11/16, updated 9/1/16