Published: Monday, August 22, 2016
Herbal products industry experts provide analysis of the 2016 Draft Guidance for New Dietary Ingredients (NDIs) during a webinar presented August 30 by the American Herbal Products Association (AHPA).
The webinar is free for AHPA members ($99 for non-members) and explores the Food and Drug Administration's (FDA's) latest revision of the draft guidance. The webinar features insights from:
Tony Young, Partner at Kleinfeld, Kaplan and Becker LLP and AHPA's General Counsel, will discuss key takeaways from the latest revision of the NDI Draft Guidance and NDI-related legal realities of the Federal Food, Drug and Cosmetics Act.
Wes Siegner, Director at Hyman, Phelps & McNamara PC, will explore next steps for the industry with respect to the revised Draft NDI Guidance.
Michael McGuffin, President of AHPA, will look at how FDA did (and did not) address key concerns raised by AHPA about the 2011 draft, including where:
- The 2011 draft guidance improperly narrowed the range of "pre-DSHEA dietary ingredients"
- The 2011 draft guidance placed a burden on companies that market only pre-DSHEA ingredients where the Act places no such burden
- FDA failed to acknowledge the value of published and industry-submitted ingredient lists of pre-DSHEA dietary ingredients
- The 2011 draft guidance was inaccurate in its discussion of when separate NDI notifications are needed, and did not clarify that a generally-described dietary supplement is acceptable in a NDI notification
- FDA overstated the amount of data required by the law
"The dietary supplement industry and FDA share the goal of ensuring that NDI notifications, when required, are clearly presented and thorough in providing safety information to FDA as required by law," said Michael McGuffin, AHPA's president. "It is important for the herbal products industry to have a clear understanding of the latest draft guidance and the next steps in the process so it can be actively engaged in improving this important guidance."
The latest revision of the draft guidance is subject to a 60-day comment period. AHPA is convening a working group of the Government Relations Committee to prepare comments to the revised draft. AHPA is also cooperating with other trade associations to identify and address issues in the revised draft.
AHPA has several existing resources to help the industry file NDI notifications, including:
A recording of the webinar and all webinar handouts are now available for download.