A recent analysis by the Environmental Working Group (EWG) sheds light on a concerning practice in the food and chemical industry – the exploitation of a legal loophole that enables companies to self-approve new food chemicals. The analysis reveals that nearly 99 percent of food chemicals introduced since 2000 were greenlit for use by the food and chemical industry itself, rather than being subject to the oversight of the Food and Drug Administration (FDA), the regulatory agency responsible for ensuring the safety of the food supply.
The loophole, which has been leveraged by food and chemical companies, allows them to decide whether a chemical is safe for consumption, bypassing the rigorous safety review that the FDA is designed to conduct. The analysis exposes a departure from the intent of Congress when it enacted food chemical laws in 1958.
This practice has been particularly concerning as it means that most new chemicals, including those such as EGCG, propyl paraben, and theobromine, are being allowed in foods without undergoing FDA's pre-market safety reviews. Instead, companies are exploiting the "generally recognized as safe" (GRAS) designation to make their own determinations of safety.
Since 2000, a mere 10 petitions for new substances have been submitted to the FDA by food and chemical companies for approval. In stark contrast, a staggering 756 out of 766 new food chemicals added to the food supply since then, or 98.7 percent, have entered the market through the GRAS loophole. This loophole allows companies to decide their products' safety without FDA intervention.
The original intent behind the 1958 Food Additives Amendment was to subject new food chemicals to rigorous FDA review before their introduction. However, over time, this loophole has been stretched to allow food and chemical companies to self-determine safety based on their own standards.
Under the GRAS loophole, a company can determine that a substance is generally recognized as safe among qualified experts and then voluntarily submit a notice to the FDA. The FDA can review these notices but does not have the authority to approve or disapprove them. If questions arise, companies can withdraw their notices, and the ingredient can continue to be used without further FDA scrutiny.
This practice has raised significant concerns, particularly when harmful ingredients make their way into the food supply. For instance, carcinogenic flavor ingredients classified as GRAS by industry trade groups were later banned due to their harmful effects. Substances like BHA and BHT, both of which raise health concerns, have also exploited this loophole.
The EWG's analysis emphasizes the need to close the GRAS loophole and prevent unsafe chemicals from entering the food supply without proper oversight. The Toxic Free Food Act, introduced by Rep. Rosa DeLauro, aims to make the GRAS process more transparent, with public input and stricter data requirements. Additionally, the Food Chemical Reassessment Act of 2021, introduced by Rep. Jan Schakowsky, seeks to address inadequacies in food additive regulations by mandating regular reviews and reassessments of food chemicals.
Ultimately, the analysis underscores the importance of congressional action to protect the integrity of the food supply and ensure that public health remains a top priority.