Around 1,000 ingredients found in grocery store foods have never undergone safety checks by the Food and Drug Administration (FDA). This has raised significant safety concerns among experts. So, how did the FDA allow this to happen?
The answer seems to stem from a somewhat flexible understanding of lesser-known regulatory bodies. Companies can often decide for themselves whether their ingredients are safe.
There are, fortunately, actions that can be taken to prevent unsafe ingredients from entering the food supply. As detailed in a recent letter from the Environmental Defense Fund, it’s worth examining how we got to this point.
The term “Generally Recognized as Safe” (GRAS) was established by Congress in 1958, letting commonly used food ingredients skip the FDA’s pre-market safety reviews. It applies to common items like vinegar, oils, and baking soda—considered safe due to their long history of use.
However, over time, this designation has expanded far beyond its original aim. Current FDA rules state that a chemical can receive GRAS status if there’s wide agreement among experts about its safety. But GRAS was not meant for new ingredients, and Congress permitted these materials to bypass the FDA’s review process, despite needing similar evidence for other additives.
Under the present interpretation by government agencies, businesses can declare substances as safe and market products containing them without FDA oversight. While companies can voluntarily notify the FDA with safety data, it’s not mandatory, and often, they don’t do it. Reports suggest that less than half of the ingredients deemed safe by the FDA even originate from these GRAS standards.
Moreover, companies that do choose to file notifications can withdraw those filings at any time if they cite safety evidence. However, this “evidence” is frequently not independent. Companies might use their own staff or selected consultants to conduct these safety assessments, which raises potential conflicts of interest, allowing unsafe foods into American households.
An analysis revealed that out of 1,163 GRAS notifications submitted between 1997 and April 2024, a notable number were withdrawn, and several raised safety concerns. Furthermore, 31 ingredients that companies claimed were safe lacked necessary scientific validation to support those claims.
While revamping the GRAS system would require Congressional action, the FDA can take immediate steps to enhance safety decision-making. Starting now, the FDA could utilize its authority to revoke safety designations from substances identified as unsafe and force their removal from the market. They could also inform manufacturers and retailers when a substance is no longer considered safe.
Additionally, the FDA could require that companies provide safety data that is publicly accessible. This wouldn’t prevent companies from declaring substances as safe but would demand transparency regarding the supporting evidence.
Thirdly, it could mandate that safety evaluations consider crucial health information, like the sources of the substances and their potential cancer risks. Finally, the FDA should modify any GRAS notifications that don’t meet current standards before they can be fully processed.
The GRAS designation system isn’t perfect, but with better interpretation and enforcement, it could be more effective. If the FDA truly cares about public health, it should start leveraging the tools that it already has at its disposal.
