FDA Makes Its Case for Mandatory GRAS: ‘We Lack a Complete Understanding’ of What’s in Food
In a webinar on its proposed rule, FDA said voluntary GRAS leaves it without a full picture of the food supply. Comments close December 9.
The Food and Drug Administration (FDA) is making its public case for ending voluntary GRAS. Officials explained the proposed rule in a webinar and asked for comments before December 9.
TLDR
- The proposed rule, published August 11, would make GRAS notification mandatory.
- FDA says it would not create a new premarket review program.
- Ingredients already on the market would get a one-year streamlined pathway.
- Comments on the proposal close December 9.
The Gap FDA Describes
Today, companies can decide on their own that an ingredient is “generally recognized as safe” and never tell FDA. In the webinar, reported by NutraIngredients, officials pointed to a changing food supply with thousands of additives and said a “fair portion” lack adequate safety data. They also described notifiers who asked FDA to stop reviewing a substance, then marketed it anyway based on their own GRAS conclusion.
“GRAS is not a general or inherent property of a substance,” said Kristi Muldoon Jacobs, director of FDA’s Office of Premarket Additive Safety. She described the agency’s “lack of a complete understanding of what substances are being used in the food supply.”
What the Proposal Would Do
- Require GRAS notification unless an exception applies. FDA could consider whether a substance was notified when it prioritizes post-market reviews.
- Offer a one-year streamlined pathway for substances already on the market, with results published in a public list. FDA said being listed would not mean it had reviewed or endorsed a substance.
- Set compliance at 18 months after the final rule takes effect.
- Revise the threshold-of-regulation process, with a 0.5 parts per billion dietary threshold. Carcinogenic uses would remain excluded.
Supplements Are in the Frame
Cara Welch, director of FDA’s Office of Dietary Supplement Programs, raised concerns about companies using self-affirmed GRAS to avoid FDA review of new dietary ingredients. Attorney Rend Al-Mondhiri of Amin Wasserman Gurnani said that exemption is “not a blanket exemption for ingredients that have GRAS status.”
Some lawyers want more. On the one-year streamlined pathway, attorney Ashish Talati asked, “Why not make it permanent?”
Why It Matters
Self-affirmed GRAS is how many newer ingredients, from novel proteins to fibers and colors, reach the market. Whether this rule becomes a real safety check or a paperwork exercise depends on the details, and on whether FDA has the staff to handle the submissions.
Source: NutraIngredients. Read the report.