WASHINGTONThe Natural Products Association (NPA) will host a two-hour webinar highlighting key aspects of FDA’s re-draft of NDI guidance (Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues) within 72 hours of publication.
FDA is releasing the revised guidance after immediate and overwhelmingly negative reactions came in response to the initial draft in July 2011, with the main criticism involving an apparent departure from the intention of the Dietary Supplement Health and Education Act of 1994 (DSHEA), FDA’s definition of “chemical alteration," the agency’s stance on synthetic botanical ingredients, grandfathered ingredients and the potential for duplicate filings. The redraft can be released from anytime between now and the end of the year.
The webinar will feature industry professionals, doctors and lawyers. Speakers include Daniel Fabricant, Ph.D., NPA’s CEO/executive director; Scott Bass, Esq.; William McConagha, Esq.; Corey Hilmas, M.D., Ph.D., NPA’s senior VP of scientific and regulatory affairs; and a to-be-announced FDA speaker.
The exclusive webinar will feature discussion on the new draft’s variation from the current one, if and how the re-draft addresses concerns raised in NPA’s previous comments, FDA’s thinking on when companies must file and what changes to an ingredient would require them to file an NDI submission, and more.
For more on NDIs, read Marc Ullman’s article “Negotiating the New Dietary Ingredient Notification Process."