Options for Food Substance without Regulatory Status . Any substance that is intentionally added to food is a “food additive” that is subject to pre-market review and approval unless it is GRAS - PowerPoint PPT Presentation
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Options for Food Substance without Regulatory Status
Any substance that is intentionally added to food is a “food additive” that is subject to pre-market review and approval unless it is GRAS
If substance is not listed as approved food additive at 21 CFR Part 172 or GRAS listed or affirmed at 21 CFR Parts 182, 184, and 186, then an appropriate regulatory status must be sought
FDA started the GRAS Notification program because the prior GRAS Affirmation process was “broken”! • Over 100 pending GRAS Affirmation Petitions• FDA had insufficient resources to do a
Practical demands may dictate whether one takes self-determined or notification approach• What’s really happening!?• Are there really thousands of substances
being directly added to food based simply on “self-determined” GRAS?
GAO recommends FDA• Finalize 1997 proposal*• Develop strategy to conduct reconsiderations• Monitor appropriateness of GRAS determinations
(e.g., random audits)• Develop way to avoid conflicts of interest* • Collect information on self-GRAS positions • Ensure nanomaterials not reviewed or approved for
use are safe and disclose if GRAS substance includes engineered nanomaterials*
CFS Lawsuit to Vacate FDA’s GRAS Notification Program
At issue, FDA’s failure to finalize 1997 proposal to establish GRAS notification program and operation of GRAS program under proposal
Asks FDA to reinstate GRAS Affirmation Petition Process• Didn’t work pre-1997; why would it work now?• What happens to GRAS Notices that FDA has responded to?
NRDC’s 2014 “Generally Recognized as Secret” report claims that chemical additives should not be GRAS if identity, chemical composition, and safety determination are not made public
Recommendations: • Congress get involved • Adopt recommendations in 2010 GAO, including:
– limit conflicts of interests – FDA be informed of all GRAS determinations– Make public FDA concerns with all notices it reviews,
On November 8, 2013, FDA announced it has tentatively determined that partially hydrogenated oils (PHOs) are not GRAS under any conditions of use in food (See 78 Fed. Reg. 67169)
PHOs will be considered food additives that require pre-market approval
Issue: PHOs primary dietary source of trans fats, which are linked to health risks such as coronary heart disease
FDA position on PHOs is unique In our view, strengthens integrity of the
GRAS program and demonstrates that the GRAS program works
If scientific information materializes after GRAS conclusion reached conclusion should be reassessed and GRAS position reversed, where necessary, but here, some would argue that data challenging GRAS position is weak