As we previously reported, in June 2025, Texas enacted a labeling law requiring a warning statement on any food and beverage containing one of 44 specified substances. We indicated that such state law initiatives might well be challenged by industry. So it did not come as …
As we previously reported, HHS Secretary Robert F. Kennedy, Jr. and FDA have highlighted the removal of petroleum-based synthetic dyes which remain approved for use in food as a focus of the MAHA campaign. These dyes include FD&C Green No. 3, FD&C Red No. 40, …
On December 18, 2025, the U.S. Food and Drug Administration (FDA or the Agency) published clarification on its enforcement approach under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) with the release of a draft guidance titled “Questions and Answers Regarding Mandatory Cosmetics Recalls: …
As we previously reported, nearly four years ago, the Natural Grocers, Citizens for GMO Labeling, Label GMOs, Rural Vermont, Good Earth Natural Foods, Puget Consumers Co-op, and the Center for Food Safety (Plaintiffs) filed a complaint against AMS challenging the final rule implementing the National …
One familiar with homeopathy might reasonably think that the practice would have a place in the Make America Healthy Again movement as an alternative to conventional pharmaceutical treatment. But after a recent court decision issued on July 15, 2025, the regulatory path for homeopathic medicine …
On July 14, 2025, the U.S. Food and Drug Administration (FDA) approved Gardenia Blue, a plant-based color additive, while simultaneously making clear to industry that the Agency encourages food manufacturers to accelerate their phasing out of the use of the synthetic dye FD&C Red No. …
Two southern states are taking bold steps to change the way they approach food labeling—and they’re not mincing words. In a growing movement aligned with the “Make America Healthy Again” (MAHA) agenda, Texas and Louisiana have each passed sweeping new laws requiring clearer warnings and …
On June 5, 2025, FDA announced two proposed monograph orders: 1) Proposed order OTC000038 proposes to make it easier to make (minor) changes to solid oral dosage forms not currently permitted under the specific order, and 2) proposed order OTC000037 proposes to require that certain …
Readers of this blog likely are familiar with the ongoing, often contentious battle over the labeling of plant-based foods (see, e.g., here, here, and here). Nearly two years after FDA issued draft guidance on Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements, on January 6, …
A little over two years ago, the Modernization of Cosmetic Regulation Act (MoCRA) was (at long last) enacted. The passing of the law which, among other things, amended the Federal Food, Drug, and Cosmetic Act to include requirements for facility registration and product listing, safety …
On January 6, 2025, FDA released two final guidance documents on food allergens: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5), and Evaluating the Public Health Importance of Food Allergens Other …
As we previously reported in 2022, FDA published a proposed rule defining the nutrient content claim “healthy.” The proposed revised rule constituted a radical change from the original definition of healthy, which focused on the presence of individual (beneficial) nutrients. In contrast, the 2022 proposed …
The dietary supplement exclusionary clause is, as its name suggests, a clause in the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of dietary supplement. That clause excludes those ingredients that were first marketed as drug ingredients. Specifically, FDC Act 201(ff)(3)(B) provides that a …
On Thursday, the 27th of June, the Supreme Court issued its decision in Securities and Exchange Commission v. Jarkesy. The court ruled that the Securities and Exchange Commission (SEC) may not impose fines to penalize securities in its administrative proceedings because that practice violates the …
As readers of this blog know, there is a lot of contention about the naming of alternative protein products (APPs), including both plant-based and cell-cultured alternatives for (traditional) animal products. The animal product industry, particularly the beef industry and the dairy industry, has challenged naming …
