HHS Aims to End Rule Letting Food Companies Skip FDA Ingredient Approval


The Department of Health and Human Services (HHS) is taking action to tighten regulations on food additives. They announced plans to put an end to a rule that allows food companies to use certain ingredients without getting formal approval.

This rule, known as Generally Recognized As Safe (GRAS), lets companies self-approve additives, bypassing the Food and Drug Administration (FDA).

Secretary Robert F. Kennedy Jr. is leading this effort, aiming to eliminate the “self-affirmed GRAS pathway.” The goal is to enhance transparency and ensure the FDA has more oversight on these ingredients.

Currently, companies can submit notices to the FDA about new additives, but they aren’t required to do so.

By removing this option, companies would need to notify the FDA publicly before introducing new ingredients. They would have to provide safety data and explain how they intend to use these ingredients.

The Environmental Working Group (EWG) highlighted how the GRAS rule has let nearly all new food chemicals since 2000 bypass FDA approval.

Of the 766 new chemicals added since 2000, only 10 were formally petitioned for approval. Most of these petitions happened before 2010, with only one occurring in 2018. Kennedy pointed out the loophole that has allowed unknown ingredients into the food supply without proper checks.

This move is seen as a step toward regaining consumer trust by ensuring the safety of food ingredients. The EWG’s 2022 analysis showed that some additives classified as GRAS, like butylated hydroxyanisole (BHA), are actually potential carcinogens. BHA is commonly used as a preservative in meats.

Another concerning additive is the green tea extract EGCG, which has been linked to cancer risks. Mona Calvo, from the Icahn School of Medicine, noted that many GRAS-listed additives were approved decades ago when food consumption habits were different. Back then, people relied more on home-cooked meals with natural ingredients.

Dr. Jaime Uribarri pointed out that once an additive is on the market, the FDA doesn’t routinely test its safety. This regulatory gap has raised concerns about the long-term health impacts of such additives. The crackdown aligns with President Donald Trump’s initiative to form the Make America Healthy Again Commission.

This commission aims to assess how certain food chemicals affect children’s health. Kennedy has been in talks with major food companies like Kraft Heinz and Pepsi to push for better food safety and transparency. He emphasized the importance of removing toxins from the food supply.

Kennedy’s discussions with food industry leaders focused on protecting the health of Americans, especially children.

The commitment to “radical transparency” aims to rebuild trust in the food industry. This move is part of a broader effort to make America’s food supply safer and healthier for everyone.

Flora Zhao contributed to this report, highlighting the ongoing changes in food safety regulations. The focus remains on ensuring that food additives are safe and properly vetted.

By closing the GRAS loophole, the HHS hopes to prevent potential health risks associated with untested food ingredients.

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