{"id":813514,"date":"2026-08-14T15:56:16","date_gmt":"2026-08-14T15:56:16","guid":{"rendered":"https:\/\/www.newsbeep.com\/us\/813514\/"},"modified":"2026-08-14T15:56:16","modified_gmt":"2026-08-14T15:56:16","slug":"nutracast-fdas-gras-shake-up-likely-to-face-major-legal-hurdles","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/us\/813514\/","title":{"rendered":"NutraCast: FDA\u2019s GRAS shake-up likely to face \u2018major\u2019 legal hurdles"},"content":{"rendered":"

The FDA\u2019s proposal to make GRAS notifications mandatory<\/a> could have a significant impact on the food, beverage and dietary supplement industries, but the agency faces substantial legal and policy hurdles, according to Todd Harrison, partner and co-chair of the FDA group at Venable LLP.<\/p>\n

Harrison said the proposal could be \u201cvery significant\u201d if it survives judicial scrutiny, noting that the Federal Food, Drug and Cosmetic Act (FD&C Act) does not explicitly require companies to submit GRAS notifications.<\/p>\n

\u201cThe law says that you have to, if you\u2019re a food additive, unless you\u2019re GRAS,\u201d Harrison said. \u201cIt doesn\u2019t say unless you\u2019re GRAS and you file a notification.\u201d<\/p>\n

He questioned why FDA has changed its position after previously stating it lacked the authority to mandate notifications and said the agency would need to provide a stronger rationale for the shift.<\/p>\n

Harrison also warned that the proposal could have an outsized impact on ingredient suppliers and the growing functional food and beverage market, where dietary ingredients are increasingly appearing in consumer packaged goods. <\/p>\n

\u201cIf it was [to withstand] judicial scrutiny, it may very well end the functional beverage space,\u201d he said.<\/p>\n

A key concern is what happens when FDA disagrees with a company\u2019s GRAS determination after a notification has been submitted. Harrison argued that the proposal does not provide companies with a clear remedy or final agency decision, potentially leaving businesses exposed to commercial consequences even without formal FDA enforcement.<\/p>\n

He also questioned whether FDA has the resources to review the potentially large number of ingredients and botanical extracts that could fall under the proposed system.<\/p>\n

Harrison suggested the agency instead create a database requiring companies to identify ingredients being used in the food supply, allowing FDA to focus its resources on potential safety concerns.<\/p>\n

The proposal\u2019s legal vulnerability is heightened by the Supreme Court\u2019s 2024 Loper Bright decision<\/a>, which ended Chevron deference and requires courts to independently determine the best interpretation of a statute.<\/p>\n

\u201cI think they\u2019re going to have a hard time in court,\u201d Harrison said.<\/p>\n

To hear more on the FDA\u2019s proposed GRAS changes, the legal hurdles facing the agency and what the proposal could mean for the supplement and functional food industries, listen to the NutraCast above or on your preferred podcast platform. <\/p>\n

If you enjoy listening to the NutraCast, feel free to leave a review. You can subscribe on Apple<\/a>, iHeart<\/a>, Spotify<\/a> or wherever you get your podcasts. <\/p>\n","protected":false},"excerpt":{"rendered":"The FDA\u2019s proposal to make GRAS notifications mandatory could have a significant impact on the food, beverage and…\n","protected":false},"author":2,"featured_media":631816,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[61],"tags":[97,269],"class_list":["post-813514","post","type-post","status-publish","format-standard","has-post-thumbnail","category-nutrition","tag-health","tag-nutrition"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/813514","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/comments?post=813514"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/813514\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media\/631816"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media?parent=813514"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/categories?post=813514"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/tags?post=813514"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}