FDA Ends 'Generally Recognized As Safe' Loophole, Mandates Safety Review for All Food Ingredients

The Grocery Reform And Safety Act, or the GRAS Act, is looking to end one of the biggest shortcuts in the food industry: the 'Generally Recognized As Safe' (GRAS) exemption. For decades, companies could simply declare an ingredient safe based on their own expert review, bypassing the formal FDA approval process for food additives. This bill slams the door on that practice.

Under Section 2, the GRAS exemption is removed from the definition of a food additive. This means that all substances added to food must now go through a formal safety check. If a company wants to use a new ingredient or a new use for an old ingredient, Section 3 requires them to submit a comprehensive notice to the FDA. This isn't a quick email; the notice must include extensive scientific data proving safety, specifically covering cancer risks, reproductive and developmental harm, and even effects related to hormone disruption (endocrine mode of action). Crucially, the company cannot start using the ingredient until the FDA issues a written statement saying they have no objection to the determination. This shifts the burden of proof and the risk of waiting time squarely onto the manufacturer.

The End of Self-Policing: Mandatory Safety Check-Ups

For consumers, this is a major win for transparency and safety. Section 4 mandates that the FDA must systematically re-evaluate the safety of at least 10 existing food additives and GRAS substances every three years, starting within three years of the bill passing. Think of it as a mandatory safety recall process for chemicals already in your pantry. If the FDA finds new information that raises safety flags during these reassessments, they gain the power to revoke any previous 'no objection' letters, pulling the ingredient out of circulation. This is a huge deal because it means ingredients that were approved decades ago under less rigorous standards will finally get reviewed using modern science.

What This Means for Your Grocery Bill and the Industry

While consumers benefit from tighter controls, the bill introduces significant new costs and hurdles for the food industry. Section 6 authorizes the FDA to charge fees to manufacturers that cover 100% of the costs for reviewing GRAS notices and conducting those mandatory triennial reassessments. For a large corporation, this is the cost of doing business. But for smaller food manufacturers or ingredient suppliers, these new compliance costs and fees could be a serious barrier to innovation or market entry. If those costs get passed down, we might see a slight bump in prices for certain processed foods.

Another major change is transparency (Section 3). Once a company submits a GRAS notice, the FDA must post the notice and all the supporting safety data online for at least 60 days of public comment. This means advocacy groups, independent scientists, and even concerned citizens will get a look at the data before the ingredient hits the market. You get to see the homework before the test. This switch from a closed-door, industry-driven process to a public, FDA-vetted one is the core of the GRAS Act’s overhaul.