In Washington D.C., you will always find that there is an elephant (or donkey) in the room that no one wants to talk about. One that has been hanging around the dietary supplements industry is the New Dietary Ingredient (NDI) draft guidance. While this topic is brought up every so often, the conversation often gets pushed to the side for one reason or another—until it is brought up yet again.
Recently, this has happened and there has been much conversation regarding the redraft of the NDI guidance and when the U.S. Food and Drug Administration (FDA) will actually publish it.
NDI Guidance Recap
As a quick recap, any ingredient that was not listed as an article of food prior to October 15, 1994, must be listed as a NDI and a notification must be made to the FDA. When the NDI guidance was originally posted to the Federal Register on July 5, 2011, the concern from the dietary supplement industry was immediately apparent. The draft guidance outlined a regulatory scheme that imposes burdensome regulatory oversight by the FDA, and it was also apparent that the document strays from the intent of the authors of the Dietary Supplement Health and Education Act of 1994 (DSHEA). This first draft guidance generated over 7,000 unique entries totaling 146,000 pages of comments.
In 2012, after the original draft guidance was published, Senator Orrin Hatch (R-UT) and former Senator Tom Harkin (D-IA) met with former FDA Commissioner Margaret Hamburg to address concerns from both Congress and the industry and to ask for a redraft. When no new draft guidance had been introduced in 2013, industry champion, Frank Pallone (D-NJ) and 24 other members of the House sent a letter to Hamburg asking for an expedited process on the introduction of the new draft guidance.
While it is believed that there will not be any changes to the toxicology section of the re-draft, FDA is likely to consider six points of clarification to be responsive to industry concern.
- Master file. Akin to a drug master file, this system would eliminate the need for unnecessary duplicate filings of the same NDI and also include clarification on allowance for easy, follow-on notifications involving previously submitted evidence.
- A “grandfathered” list of old dietary ingredients. Such a list of dietary ingredients would provide a safe harbor for firms and eliminate any unnecessary submissions.
- Clarification on 201(ff)(1)(E) of the Federal Food Drug and Cosmetic Act. These are defined as dietary substances for use by man to supplement the diet by increasing total dietary intake. 201(ff)(1)(E) dietary ingredients could encompass a large or small ingredient deck depending on the FDA’s interpretation of the statute.
- Synthetic copies of naturally-occurring constituents. Naturally occurring constituents of an extract of a botanical or metabolite are dietary ingredients, but industry is not clear on FDA’s position regarding synthetic copies of those dietary ingredient constituents.
- IP protection. The new draft guidance will hopefully cover the protection of intellectual property (IP) to discourage copy-cat ingredients entering the marketplace without an active NDI on file.
- “Chemically altered.” Industry hopes the new re-draft will include a listing of chemical processes that would and would not lead to a “chemically altered” ingredient and clarification over what is meant by “present in the food supply in a form not chemically altered.”
The current (from 2011) NDI guidance can be found on the FDA’s website (http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/dietarysupplements/ucm257563.htm). The re-draft was supposed to be introduced by the end of 2014. We are now nearing the end of the 3rd quarter in 2015, leaving everyone in the industry wondering when exactly we will see the re-draft of the NDI guidance. As the FDA continues to take actions over ingredients they determine not to be dietary ingredients pursuant to 201(ff)(1) of the Act, it is imperative that industry push to see the updated draft. Attacks are coming in from Attorneys General around the country and they may soon attempt to invade federal jurisdiction over what they believe to be dietary ingredients. Until a draft guidance is reissued, firms are vulnerable to industry detractors casting unsubstantiated aspersions and launching invalid investigations on an industry that is already regulated by FDA.
The Natural Products Association (NPA) will keep the industry abreast to any updates to the guidance. We were the first to break the news of the original draft and plan on doing the same again. Within 72 hours of the introduction of the re-draft introduction by the FDA, NPA will hold a two-hour webinar highlighting the most important and pressing aspects of the guidance and its regulatory and scientific impact. The webinar will detail how the re-draft differs from the 2011 version, if and how the re-draft addresses industry’s original concerns, when you must file an NDI submission, what changes to an ingredient would require a NDA submission, different responses that you can expect to receive from the FDA (and what they mean) as well as what happens if you do not file an NDI.
We urge the FDA to release the new NDI draft guidance sooner rather than later and are hopeful that the concerns of the industry were taken into account during its compilation. NPA strives to be your go-to source when it comes to industry regulation and advocacy information and advice. If you have any questions, please do not hesitate to reach out to me directly at email@example.com. WF
Emily Dowsett joined the Natural Products Association (NPA) in January of 2015 as the Manager of Government Affairs. Since joining NPA, Emily has made a significant impact, leading some of the largest industry grassroots campaigns in years, holding multiple fundraisers for industry champions, and fostering and maintaining meaningful and impactful relationships with many Congressional offices. Prior to joining NPA, Emily worked at the Food Processing Suppliers Association (FPSA) where she managed many aspects of the Annual Conference and one of the country’s largest trade shows PROCESS EXPO, as well as many other projects that garnered national attention for the association.
Published in WholeFoods Magazine, October 2015