The Food and Drug Administration (FDA) today released revised draft guidance for new dietary ingredients (NDIs) to be published in the Federal Register on Friday, Aug. 12. The revised draft replaces FDA’s 2011 draft.
The guidance, “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,” is subject to a 60-day comment period. AHPA (American Herbal Products Association) will be convening a working group of the Government Relations Committee to prepare comments to the revised draft. AHPA will also be cooperating with other trade associations in addressing the revised draft.
AHPA identified several keys points of concern with FDA’s 2011 draft that AHPA requested be completely withdrawn. Key points of concern in the 2011 draft identified by AHPA, included:
- The draft guidance improperly narrowed the range of “pre-DSHEA dietary ingredients”
- The draft guidance placed a burden on companies that market only pre-DSHEA ingredients, where the Act places no such burden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- The draft guidance was inaccurate in its discussion of when separate NDI notifications are needed, and did not clarify that a generally-described dietary supplement is acceptable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
AHPA staff is reviewing the revised draft guidance to assess FDA’s responsiveness to these issues and to determine the extent of changes and whether FDA has brought the revised draft into alignment with the law. AHPA will be providing members with additional analysis in the near future.
“The dietary supplement industry and FDA should have a shared goal to ensure that NDI notifications, when they are required, are clearly presented and thorough in providing to FDA the safety information that is required under the law,” said Michael McGuffin, AHPA’s president. “This system is in need of improvement, so it is AHPA’s sincere hope that FDA has not missed another opportunity in this draft guidance to assist industry in meeting this goal.”
AHPA has several resources to help the industry file NDI notifications, including:
- The AHPA NDI Database is a searchable online resource that documents more than 800 NDI notifications that have been submitted to FDA.
AHPA’s Guidance for New Dietary Ingredient Notifications for Manufacturers and Distributors of New Dietary Ingredients (rev. September 2011) explains the NDI regulations, details what information to include–and exclude–in a notification, and provides three hands-on worksheets.