FDA Posts Proposed Rule on GRAS: What We Know So Far

"The FDA has posted an outline of a proposed rule to require the mandatory submission of Generally Recognized as Safe (GRAS) notices. If finalized, the rule would effectively eliminate self-affirmed GRAS without notification-long criticized for its lack of transparency-by requiring companies to notify the FDA and be listed in a public-facing register. Substances already listed as GRAS by regulation or that have received a "no questions" letter would be exempt."

"It will be critical for ANH to participate in the FDA rulemaking to ensure that foods, dietary ingredients, and dietary supplements long used safely are not encumbered with new regulatory strictures that rob consumers of freedom of choice. We are all for FDA reliance on the peer reviewed scientific literature to identify specific food additives that are provably unsafe (and, thus, adulterated) for removal from the market."

FDA posted a proposed rule outline that would require mandatory submission of Generally Recognized as Safe (GRAS) notices and public listing of those submissions. The proposal would effectively eliminate self-affirmed GRAS determinations made without FDA notification by requiring companies to notify FDA and appear in a public-facing register. Substances already established as GRAS by regulation or that received a "no questions" letter would be exempted. ANH signaled intent to participate in the rulemaking, supporting removal of provably unsafe additives while opposing a broad pre-market FDA authorization system that would restrict consumer choice. The proposal may mirror recent legislative initiatives requiring wider review.

Read at Natural Health News