{"id":24327,"date":"2025-02-10T09:00:41","date_gmt":"2025-02-10T14:00:41","guid":{"rendered":"https:\/\/www.vrg.org\/blog\/?p=24327"},"modified":"2025-01-31T13:42:31","modified_gmt":"2025-01-31T18:42:31","slug":"fdas-newly-released-guidance-for-industry-on-allergen-labeling-includes-guidance-for-genetically-engineered-foods","status":"publish","type":"post","link":"https:\/\/www.vrg.org\/blog\/2025\/02\/10\/fdas-newly-released-guidance-for-industry-on-allergen-labeling-includes-guidance-for-genetically-engineered-foods\/","title":{"rendered":"FDA\u2019s Newly Released Guidance for Industry on Allergen Labeling Includes Guidance for Genetically Engineered Foods"},"content":{"rendered":"

\"\"<\/a><\/p>\n

By Reed Mangels, PhD, RD<\/p>\n

In January 2025 the U.S. Food and Drug Administration (FDA) released a 27-page document<\/a> that provides updated guidance for industry on labeling of allergens.<\/p>\n

One question which this document addresses is \u201cAre proteins from major food allergens, produced from other sources through the use of genetic engineering and other technologies, subject to the food allergen labeling requirements of the FD&C Act?\u201d The FDA states that \u201cfood ingredients that include proteins derived from a major food allergen (e.g. , through chemical, biochemical, mechanical, fermentation, or bioengineering processes) may be capable of eliciting an allergic reaction, and their presence is not obvious without declaration of the allergen.\u201d They provide an example of using a genetically engineered strain of yeast to produce a protein identical (or very similar) to the protein in cow\u2019s milk. A product with this protein in it would have to be labeled to indicate that it contains \u201cmilk\u201d (FDA\u2019s word for milk from cows, goats, sheep, or other ruminants). The FDA also says that \u201cadditional information may be helpful in some cases to make the source ingredient clear, such as \u2018Contains milk-derived protein,\u2019\u2026\u201d<\/p>\n

The FDA recognizes milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame as the major food allergens.<\/p>\n

Another question that this document addresses is whether a product or ingredient that is derived from a major food allergen but that does not contain the allergenic protein must have a food allergen label. For example, ghee which has been processed so that it does not contain milk protein or lactose (milk sugar) which does not contain milk protein. If an ingredient is derived from a major food allergen and does not contain protein, it is not subject to allergen labeling requirements. The ingredient, such as ghee, or lactose would still have to be listed on the label but would not need to be identified as \u201c(milk)\u201d or \u201ccontains milk.\u201d The FDA notes that residual protein is often present in milk-derived ingredients, so manufacturers would need to demonstrate that an ingredient does not contain milk protein in order to avoid having to comply with allergen labeling requirements.<\/p>\n

Spice blends that contain additives derived from a major food allergen must declare the allergen on the label. For example, a product label might say \u201cspices (wheat)\u201d or \u201cContains: Wheat.\u201d<\/p>\n

Allergen labeling requirements apply to human food and dietary supplements but not to pet foods, animal feeds, prescription or over-the-counter drugs, cosmetics, or cleaning products.<\/p>\n

The FDA states that a guidance document, such as the one discussed here, does not \u201cestablish legally enforceable responsibilities\u201d and \u201cshould be viewed only as recommendations unless specific regulatory or statutory requirements are cited.\u201d<\/p>\n

This post contains my personal understanding of the FDA\u2019s guidance and should not be construed, viewed, or used as legal advice on product labeling to comply with this guidance.<\/p>\n

Reference<\/em><\/p>\n

U.S. Food and Drug Administration. Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry. https:\/\/www.fda.gov\/media\/117410\/download<\/a>. 2025.<\/p>\n","protected":false},"excerpt":{"rendered":"

By Reed Mangels, PhD, RD In January 2025 the U.S. Food and Drug Administration (FDA) released a 27-page document that provides updated guidance for industry on labeling of allergens. One question which this document addresses is \u201cAre proteins from major food allergens, produced from other sources through the use of genetic engineering and other technologies, […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-24327","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/www.vrg.org\/blog\/wp-json\/wp\/v2\/posts\/24327","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.vrg.org\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.vrg.org\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.vrg.org\/blog\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.vrg.org\/blog\/wp-json\/wp\/v2\/comments?post=24327"}],"version-history":[{"count":1,"href":"https:\/\/www.vrg.org\/blog\/wp-json\/wp\/v2\/posts\/24327\/revisions"}],"predecessor-version":[{"id":24329,"href":"https:\/\/www.vrg.org\/blog\/wp-json\/wp\/v2\/posts\/24327\/revisions\/24329"}],"wp:attachment":[{"href":"https:\/\/www.vrg.org\/blog\/wp-json\/wp\/v2\/media?parent=24327"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.vrg.org\/blog\/wp-json\/wp\/v2\/categories?post=24327"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.vrg.org\/blog\/wp-json\/wp\/v2\/tags?post=24327"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}