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FDA Rule Exploited: New Food Chemicals Unvetted
7 Mar
Summary
- Over 100 food substances lack FDA safety review.
- Companies exploit GRAS rule for unscrutinized chemicals.
- Tara flour incident caused over 300 illnesses and hospitalizations.
A review of FDA records by the Environmental Working Group (EWG) reveals that over 100 substances widely used in US foods, supplements, and beverages have not undergone any health and safety review by the agency. Companies are leveraging the 1958 'generally recognized as safe' (GRAS) rule, designed for simple ingredients, to introduce new chemicals into the food system without adequate scrutiny.
This exploitation of the GRAS rule has led to potentially dangerous substances entering the market. For instance, food made with tara flour in 2022 was linked to over 300 illnesses and 113 hospitalizations. Popular brands such as Trader Joe's, Whole Foods, and PepsiCo are among those using ingredients with unknown safety profiles, undermining public trust in food regulation.
The GRAS process allows companies to self-determine safety based on publicly available scientific evidence, but notification to the FDA is voluntary. Some firms push this by providing limited data or relying on company-convened scientists. This lack of mandatory review means substances like aloe vera extract, linked to cancer, and purified green tea extracts, associated with various health defects, are used in hundreds of products without thorough safety vetting.
