New York S8615/A9295 GRAS Transparency Bill

Companies can identify new food chemicals as safe (GRAS) without FDA review. NY S8615/A9295 would require companies to publish those safety assessments.


FDA does not know what chemicals are in our food 

While the US Food and Drug Administration (FDA) does approve a small fraction of new food chemicals, the agency does not require premarket approval, notice, or its own safety review for the vast majority of chemicals before they are first used in foods. Companies can secretly determine that a new chemical is “generally recognized as safe“ (GRAS) and add it to foods without informing or submitting evidence to FDA. They can even use paid “experts” or their own employees to secretly determine that a chemical is GRAS. As a result, FDA and the public do not know when food chemicals come to market with inadequate, biased, or no safety assessments. Companies can abuse this “secret GRAS” pathway to introduce new chemicals that are not actually generally recognized as safe by experts.

S8615/A9295 takes the 'secret' out of food chemical safety 

New York’s S08615/A9295, takes the secret out of GRAS. Introduced by Senator Kavanagh and Assemblymember Dr. Kelles, the bill requires that industry notify the state of NY if they make a secret GRAS determination and market that secret GRAS chemical in New York without notifying FDA. This notification would include a summary of the company’s evidence and assessment establishing the chemical’s safety. These notices would then be published in a publicly available database funded by reporting fees and maintained by the state. In effect, this bill prevents industry from secretly self-determining the safety of food chemicals and will enable public scrutiny of food chemical safety –allowing regulators and consumer advocates to spot any instances where no safety review was conducted at all! FDA and state regulators can utilize this database to better regulate food chemical safety. When companies are required to provide their evidence establishing safety, unsafe chemicals can be more easily identified before they are widely consumed.

For more information, see the PDF resource at the top of this page.

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