Almost all ingredients used in food must be disclosed in ingredient lists, but federal regulations require manufacturers to use vague catch-all terms such as “artificial flavors,” “natural flavors,” or “spices.” It is allowed to hide some ingredients behind it. A report released Thursday by the nonprofit Center for Science in the Public Interest examines the problems that arise when companies hide ingredients behind these conditions, and examines the problems that arise when companies hide ingredients behind these terms. calls for reforms to protect consumers from harmful chemicals, allergens, or unwanted animal products.
Flavors may be derived from natural ingredients or may be synthesized in a factory. For example, vanilla flavor can be extracted from vanilla beans or derived from artificially produced vanillin and other chemicals found in vanilla beans. When flavors (but not all ingredients) are included in the ingredient list, there is no need to specify exactly the chemicals that make them up. Rather, they are sometimes blandly described as “natural flavors” or “artificial flavors.” Consumers have no way of knowing how many flavors are in a product.
A loophole allowing the use of “natural flavors” and “artificial flavors” is built into the Federal Food, Drug, and Cosmetic Act of 1938, which would otherwise require ingredients to be listed on food labels. Masu. Federal law also requires that substances added to food (including flavoring substances) be deemed safe before companies can begin using them.
But who decides when a flavor substance is safe? The short answer is that food manufacturers have two paths to choose from. The first route available is for a company to submit a formal food additive application to the Food and Drug Administration that includes information demonstrating the safety of the substance prior to marketing. FDA will then conduct a safety assessment, provide an opportunity for public comment, and decide whether to approve or deny the petition.
However, when Congress amended the Food, Drug, and Cosmetic Act in 1958, it created an exception for “Generally Recognized as Safe” substances (GRAS), which include traditionally used substances such as vinegar and baking powder. You can now also use raw materials that are Bypass formal approval processes. Food and chemical companies currently exploit this “GRAS loophole” in one of two ways to circumvent FDA approval and make safety decisions with little or no FDA oversight. . First, you can submit a voluntary notification to the FDA confirming that the ingredient is GRAS based on your company's evaluation. This is a much less rigorous process than a formal food additive application, but it at least informs the FDA of impending marketing and gives you an opportunity to ask questions. Second, companies can decide for themselves that an ingredient is “generally recognized as safe” and begin using it in food without notifying the FDA. CSPI calls this the “secret his GRAS” loophole.
Of the approximately 10,000 chemicals that are used in our food or that can end up in our food through contact with its packaging, more than 3,000 have undergone substantive review by the FDA. not. It is estimated that 1,000 of these 3,000 substances enter the food supply through secret GRAS pathways, meaning the FDA has no information about them at all. The rest were given the green light not through formal GRAS notifications, but by panels convened by industry groups purporting to provide information to the FDA.
“U.S. consumers are likely under the mistaken impression that the FDA reviews and affirms the safety of flavor additives used in food products,” says CSPI Food Additives and Supplements. said lead scientist Thomas Galligan. “In fact, the FDA has all but abandoned its role in approving new flavor chemicals and delegated that authority to food companies. This is a clear conflict of interest, and consumers should be aware of what is in their food. I can't tell what's going on.”
Companies can determine for themselves whether an ingredient is GRAS, or they can turn to one of the industry groups, the Flavor and Extract Manufacturers Association (FEMA). FEMA, which describes itself as “the authoritative voice promoting the safe and responsible use of fragrances,” pays a panel of scientists to conduct the safety assessments that lead to the GRAS designation. Although FEMA claims to limit conflicts of interest by its experts, the organization itself is compensated by its members and therefore has a vested interest in providing positive reviews to ensure repeat business. , the process can be biased in ways that are difficult to document. to the report.
Manufacturers of dietary supplements can also take advantage of the GRAS loophole. For example, the makers of the dietary supplement Prevagen took advantage of a secret loophole in GRAS to make its ingredient, apoaequorin, available to the public even though it had twice failed the FDA's premarket approval process for supplements. Designated as recognized as safe.
CSPI's report includes several recommendations for federal and state policymakers. At the federal level, CSPI recommends requiring full disclosure of all ingredients, including spices and flavorings, on the labels of packaged foods, meat and poultry. Federal policymakers should close the GRAS loophole by requiring all flavoring substances and other food chemicals to be marketed through food additive petitions.
At the state level, CSPI supports efforts by state legislatures to ban unsafe and unnecessary food additives. California recently enacted a law banning four food additives: Red 3, brominated vegetable oil, potassium bromate, and propylparaben. This will come into effect in 2027. The New York state legislature has proposed a bill that would ban these four additives, as well as azodicarbonamide, butylated hydroxyanisole (BHA), and titanium dioxide. If adopted this year, it will go into effect next year. Another bill in New York would require food manufacturers to notify the state if they use chemicals that have not been reviewed by the FDA.
Finally, CSPI recommends that the food industry begin full disclosure of flavors and spices on its own and completely stop exploiting GRAS loopholes, or at least secret GRAS pathways.
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