NDI Draft Guidance
Recent NPA News and Actions
September 4, 2012: NPA Files Supplemental Comments for NDI Draft Guidance
Comments "Intended to Ensure the Safety of Consumers and Provide Clarity to the Industry." Read more...
June 20, 2012: NPA Praises FDA’s Decision to Rewrite the NDI Draft Guidance
“NPA is pleased that the FDA will rewrite the NDI draft guidance to provide greater clarity and address concerns that the document is not in line with the intent of DSHEA. This action by the FDA shows that they are committed to an open dialogue with industry on these issues.” Read more...
Basic Points to Know:
- NPA believes the draft guidance does not match Congress’s clear intent that products made from ingredients on the market prior to DSHEA should remain on the market.
- The FDA is asking for far more from the industry to prove that an ingredient was on the market before 1994 than most makers can probably produce.
- These requirements will reduce ingredients meeting the established grandfathered status to a regrettably small number.
- The draft guidance requires NDI notifications for: components of food marketed before 1994; a change in solvent when processing an ingredient; a change in manufacturing that produces nanoscale particles; and each manufacturer of each supplement containing an NDI.
- Synthetic versions of dietary ingredients require an NDI notification, with the exception of synthetic botanical constituents that FDA has declared are not considered dietary ingredients.
- The safety testing requirements for NDIs are raised to a level well above what was contemplated in DSHEA. These requirements will be harder for manufacturers to meet, inevitably leading to fewer new products in the marketplace.
Missed NPA's NDI Draft Guidance webinar? Order it on CD-ROM!
NPA held the dietary supplement industry’s first education session about the recently released New Dietary Ingredients (NDI) Draft Guidance by the FDA. The NPA webinar, “NDI Guidance: What You Need to Know,” was attended by nearly 150 manufacturers, trade media and industry stakeholders on July 11, 2011. A CD-ROM of the webinar, PowerPoint slides and text of the NDI guidance is available for sale.
To purchase the CD-ROM, complete the order form or contact natural@NPAinfo.org. Expect 7-10 business days for delivery. Prices include:
- NPA members: $99
- Non-members: $149