NDI Draft Guidance

• Read the proposed NDI Draft Guidance
• Read the current NDI Rule here: Premarket Notification for a New Dietary Ingredient  
• Two-page Summary of NDI Draft Guidance
• Read NPA's September 4, 2012, Comments to the FDA
• Read NPA's November 30, 2011, Comments to the FDA
• Letter from Sen. Tom Harkin and Sen. Orrin Hatch to the FDA regarding the NDI Draft Guidance 
• Natural Products Day Position Paper: For Your Information: FDA New Dietary Ingredients Draft Guidance 

• NPA believes the draft guidance does not match Congress’s clear intent that products made from ingredients on the market prior to DSHEA should remain on the market.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• The draft guidance requires NDI notifications for: components of food marketed before 1994; a change in solvent when processing an ingredient; a change in manufacturing that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.