Latest news with #Recognized
Yahoo
15 hours ago
- Health
- Yahoo
Opinion - How thousands of unreviewed ingredients got into our food — and what FDA can do about it
At least 1,000 ingredients in food products on our grocery store shelves have never been checked for safety by the Food and Drug Administration. Dozens have raised serious safety concerns among experts. How did the FDA allow this? The answer can be found in the agency's lax interpretation of a little-known legal designation that lets companies decide for themselves if ingredients in their products are safe. Fortunately, there are steps the agency can take right now to stem the flow of potentially unsafe ingredients into our food supply. Environmental Defense Fund outlined these steps in a letter we recently sent to the agency, but first let's take a closer look at how we got here. 'Generally Recognized as Safe' is a designation Congress created in 1958 to allow commonly used food ingredients to bypass the FDA's pre-market safety review process. It was meant for food substances — such as oils, vinegar, baking soda and common spices — that were widely considered safe due to their long history of everyday use. Since 1958, this status has been coopted to cover a universe of foods that extends far beyond its original intent. According to FDA regulations, a chemical can receive the designation if experts widely agree that scientific evidence shows its use to be safe. But because 'Generally Recognized as Safe' wasn't meant for newer ingredients, Congress allowed ingredients so designated to skip the FDA's premarket approval process — despite requiring similar evidence for other additives. Under the agency's current interpretation, companies can designate the use of a substance as safe and take products with that substance to market without informing the FDA or the public of its decision. While companies may voluntarily submit a notice to FDA offering safety evidence, they are not required to — and often don't. Our organization estimated that manufacturers have notified FDA of fewer than half of the ingredients they market as safe under the 'Generally Recognized' standard. Companies that do bother to submit a notice to the FDA are free to withdraw it at any point and take their product to market, provided they can cite evidence of its safe use. But this 'evidence' is often far from independent. Companies can, and often do, enlist their own employees or handpicked consultants to conduct their safety assessments. The result is a process riddled with conflicts of interest that lets unsafe foods into Americans' homes. We analyzed 'Generally Recognized as Safe' notices received by the FDA, obtained via a Freedom of Information request, and found that of the 1,163 submitted by companies between 1997 and April 2024, 192 were later withdrawn, with safety concerns cited in at least a dozen cases. We also identified 31 ingredients that companies have advertised to be recognized as safe, such as in press releases, trade publications and on their own websites (see the Appendix of our letter). However, we were unable to find the scientific evidence required under this standard to demonstrate these ingredients are commonly regarded as safe among experts. This raises red flags that FDA should be taking seriously. Although a comprehensive fix to the 'Generally Recognized' standard will require legislation from Congress, there are significant steps the FDA can take right away to ensure a more rigorous determination process that better protects Americans' health. Starting today, the FDA can use existing authority to remove safe designations from ingredients it deems unsafe and take them off the market. It can also notify manufacturers, importers, distributors and retailers that the substance is no longer recognized as safe. In addition, the FDA can enforce the requirement that companies base safety designations on publicly available data. Although this won't curtail companies' ability to self-declare substances as safe, it will require those who do to be transparent in citing their evidence. Third, the FDA can enforce the requirement that safety assessments consider vital health information such as a substance's dietary sources, potential cancer risks and the cumulative health effects of similar substances. Finally, the FDA can make companies revise and resubmit their data for review when they submit 'Generally Recognized as Safe' notices that fail to comply with the criteria. The 'Generally Recognized as Safe' designation is far from a perfect system, but it can work better if it is interpreted and enforced more comprehensively. If the FDA is serious about protecting public health, it should start by fully exercising the tools already at its disposal. Maria Doa is senior director at the Chemicals Policy at Environmental Defense Fund. Maricel Maffini is an independent consultant focused on human and environmental health and chemical safety. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
The Hill
17 hours ago
- Health
- The Hill
How thousands of unreviewed ingredients got into our food — and what FDA can do about it
At least 1,000 ingredients in food products on our grocery store shelves have never been checked for safety by the Food and Drug Administration. Dozens have raised serious safety concerns among experts. How did the FDA allow this? The answer can be found in the agency's lax interpretation of a little-known legal designation that lets companies decide for themselves if ingredients in their products are safe. Fortunately, there are steps the agency can take right now to stem the flow of potentially unsafe ingredients into our food supply. Environmental Defense Fund outlined these steps in a letter we recently sent to the agency, but first let's take a closer look at how we got here. 'Generally Recognized as Safe' is a designation Congress created in 1958 to allow commonly used food ingredients to bypass the FDA's pre-market safety review process. It was meant for food substances — such as oils, vinegar, baking soda and common spices — that were widely considered safe due to their long history of everyday use. Since 1958, this status has been coopted to cover a universe of foods that extends far beyond its original intent. According to FDA regulations, a chemical can receive the designation if experts widely agree that scientific evidence shows its use to be safe. But because 'Generally Recognized as Safe' wasn't meant for newer ingredients, Congress allowed ingredients so designated to skip the FDA's premarket approval process — despite requiring similar evidence for other additives. Under the agency's current interpretation, companies can designate the use of a substance as safe and take products with that substance to market without informing the FDA or the public of its decision. While companies may voluntarily submit a notice to FDA offering safety evidence, they are not required to — and often don't. Our organization estimated that manufacturers have notified FDA of fewer than half of the ingredients they market as safe under the 'Generally Recognized' standard. Companies that do bother to submit a notice to the FDA are free to withdraw it at any point and take their product to market, provided they can cite evidence of its safe use. But this 'evidence' is often far from independent. Companies can, and often do, enlist their own employees or handpicked consultants to conduct their safety assessments. The result is a process riddled with conflicts of interest that lets unsafe foods into Americans' homes. We analyzed 'Generally Recognized as Safe' notices received by the FDA, obtained via a Freedom of Information request, and found that of the 1,163 submitted by companies between 1997 and April 2024, 192 were later withdrawn, with safety concerns cited in at least a dozen cases. We also identified 31 ingredients that companies have advertised to be recognized as safe, such as in press releases, trade publications and on their own websites (see the Appendix of our letter). However, we were unable to find the scientific evidence required under this standard to demonstrate these ingredients are commonly regarded as safe among experts. This raises red flags that FDA should be taking seriously. Although a comprehensive fix to the 'Generally Recognized' standard will require legislation from Congress, there are significant steps the FDA can take right away to ensure a more rigorous determination process that better protects Americans' health. Starting today, the FDA can use existing authority to remove safe designations from ingredients it deems unsafe and take them off the market. It can also notify manufacturers, importers, distributors and retailers that the substance is no longer recognized as safe. In addition, the FDA can enforce the requirement that companies base safety designations on publicly available data. Although this won't curtail companies' ability to self-declare substances as safe, it will require those who do to be transparent in citing their evidence. Third, the FDA can enforce the requirement that safety assessments consider vital health information such as a substance's dietary sources, potential cancer risks and the cumulative health effects of similar substances. Finally, the FDA can make companies revise and resubmit their data for review when they submit 'Generally Recognized as Safe' notices that fail to comply with the criteria. The 'Generally Recognized as Safe' designation is far from a perfect system, but it can work better if it is interpreted and enforced more comprehensively. If the FDA is serious about protecting public health, it should start by fully exercising the tools already at its disposal. Maria Doa is senior director at the Chemicals Policy at Environmental Defense Fund. Maricel Maffini is an independent consultant focused on human and environmental health and chemical safety.
Yahoo
20-03-2025
- Health
- Yahoo
Food safety legislation would require warning labels for some dyes and chemicals
HARRISBURG, Pa. (WHTM) – New bipartisan legislation would increase awareness about what's in food. Products that contain certain dyes and chemicals would be required to have warning labels. Currently, companies can add new 'Generally Recognized as Safe' chemicals to food without any type of FDA approval or independent review through an FDA loophole. If this legislation passes, companies that manufacture, distribute, or sell food products in the Commonwealth will have to disclose the use of those substances and document that they're safe. 'People need to understand what's in their food,' says Rep. Justin Fleming. 'They need to understand what they're eating.' Rep. Fleming says there are students who get most of their meals at school, so those meals need to be safer. 'There are all these dyes in food and it's no secret, we as Americans are getting sicker, unfortunately, and it's it's due in large part to what we're eating. Levels of diabetes have gone up with more high fructose corn syrup,' Fleming says. Under the legislation, products with Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2 and Green 3 could no longer be served in any Pennsylvania public school and those items would need labels warning consumers that the product may affect children's behavior and health. 'If this is something we can really look at and see if it's going to correct those behavior issues, it's going to be great in the long run for educators also,' says Dennis Michaels with Metz Culinary Management. Michaels oversees schools in the central Pennsylvania region, including Carlisle, Fulton and Mifflin school districts. 'We have a captured audience for those two meals a day, so it's something that we can really influence at any age, but especially at a young age, introducing very healthy, fresh food to them, chemical free dye free, that could really help guide their eating habits in the future,' Michaels says. Both Fleming and Michaels say manufacturers are already making improvements and this legislation would offer more guidance for food production. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
