The Food and Drug Administration’s (FDA) re-draft of the NDI Guidance (Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues) for industry is imminent. It is set to be published in calendar 2014, so it could be released at any time between now and the end of the year. Within 72 hours of the FDA’s publication of the re-draft of the NDI Guidance, the Natural Products Association (NPA) will hold a two-hour webinar highlighting the most important and pressing aspects of the guidance and its regulatory and scientific impact.
The FDA published the draft NDI Guidance for industry in July 2011, and it quickly became apparent that the supplement industry had significant problems with this document and the direction of the FDA. The draft guidance outlined a regulatory scheme that imposes burdensome regulatory oversight by the FDA, and it was also apparent that the document strays from the intent of the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).
The response from industry associations and stakeholders was immediate and overwhelmingly negative. NPA submitted comments to the draft guidance, focusing on industry concerns regarding the food additive level of testing; the FDA’s definition of “chemical alteration;” and the agency’s stance on synthetic botanical ingredients, grandfathered ingredients and the potential for duplicate filings. In June 2012, FDA Commissioner Margaret Hamburg met with staff members from the offices of Sens. Tom Harkin, D-Iowa, and Orrin Hatch, R-Utah, to discuss the Draft NDI Guidance Document. During the meeting the Commissioner said that the FDA would redraft the document to address concern raised by Congress and the industry. We are still waiting for the publication of the re-draft.
Featured speakers for this webinar include:
- Daniel Fabricant, Ph.D., NPA’s CEO/executive director: Dr. Fabricant has helped businesses navigate the complex regulatory world of natural products, including dietary supplements, for more than a decade, and he recently served as director of the FDA's division of dietary supplement programs. Dr. Fabricant oversaw all of the FDA’s dietary supplement programs including NDI notifications.
- Scott Bass, Esq., partner at Sidley Austin: Mr. Bass heads his firm’s Global Life Sciences team, ranks internationally among the top authorities on FDA-related enforcement and regulatory issues, is a principal architect of DSHEA and is considered a pre-eminent authority on dietary supplement law.
- William McConagha, Esq., partner at Sidley Austin: Mr. McConagha, who has worked with firms to develop successful NDI notifications, has developed a deep knowledge of FDA regulatory and enforcement matters during his more than 17 years in high-level positions with the FDA. Mr. McConagha was an attorney in the FDA’s Office of Compliance.
- Corey Hilmas, M.D., Ph.D., NPA’s senior vice president of scientific and regulatory affairs: Dr. Hilmas, former chief of the FDA’s Dietary Supplement Regulation Implementation Branch, was the senior toxicologist for New Dietary Ingredient notifications (NDINs). He reviewed both animal toxicology and clinical trial data submitted as part of NDI notifications at the agency.
- To-be-announced FDA speaker: FDA will be invited to participate in this exclusive event.
There is no better team of experts to review the re-draft guidance and provide useful insight regarding its potential effect on the industry. During this two-hour webinar they will share their thoughts about the re-draft and answer questions about the following:
- How the re-draft differs from the earlier draft published in July 2011
- If and how the re-draft addresses the concerns raised in the NPA comments to the July 2011 draft, i.e., the agency’s stance on synthetic botanical ingredients, the definition of “chemical alteration,” etc.
- The FDA’s thinking on when you must file an NDI submission
- The FDA’s thinking on what changes to an ingredient would require you to file an NDI submission
- Whether the recommendations for toxicology studies is based upon “reasonable expectation of safety” or based upon a more stringent standard (i.e., Redbook food additives)
- The different responses you can expect to receive from the FDA and what they each mean
- What filing an NDI submission will get you
You can’t afford to miss this crucial educational opportunity on the re-draft of the NDI Guidance. Register before Sept. 15 and receive $100 off the registration fee.