Health Law Advisor

Whether a consumer is taking calcium carbonate for strong bones, magnesium to fall asleep, or high-dose caffeine to stay awake, the U.S. Food and Drug Administration (FDA) does not approve dietary supplements for safety and effectiveness. So how do consumers know if a product is safe, and how can manufacturers protect themselves in the case of a problem?

In response to stakeholder feedback, the FDA on February 21, 2024, released its updated directory of FDA actions and communications with respect to “Information on Select Dietary Supplement Ingredients and Other Substances.”

In this episode of the Diagnosing Health Care Podcast: The U.S. Food and Drug Administration’s (FDA’s) broad definition of “misbranding” has created some industry confusion, while the Federal Trade Commission’s (FTC’s) updates to its Health Products Compliance Guidance have done the same.

In light of these recent actions, what challenges are dietary supplement manufacturers now facing?

On this episode, Epstein Becker Green attorneys Jack Wenik, Teddy McCormick, Zach Taylor, and Tracey Gonzalez discuss recent updates to the FDA and FTC guidelines as they apply to ...

On February 22, 2023, the U.S. Food and Drug Administration (“FDA”) announced a much-anticipated draft guidance regarding the naming and labeling of plant-based milk alternatives.[1] Significantly, under the draft guidance, FDA will not prohibit the use of the identifier “milk” in plant-based milk alternatives but does recommend the product be labeled with “voluntary nutrient statements” to help consumers understand the nutritional differences in the products.

Over the past decade, plant-based milk alternatives have dramatically increased in both availability and consumption. During this time, industry stakeholders have disagreed over the use of the term “milk” for plant-based alternatives that do not contain milk from cows. The dairy industry has lobbied both federal and state governments to restrict the use of “milk” to only fluid “obtained by the complete milking of one or more healthy cows.”[2] To address this debate and to acknowledge the exponential increase in the sale of plant-based milk products, FDA issued a notice for public comment in September 2018 on the “Use of Name of Dairy Foods in the Labeling of Plant-Based Products” that amassed over 13,000 comments. The recently issued draft guidance indicates that the agency did in fact rely on the findings from this notice in developing its recommendations.

The Food and Drug Administration (FDA) recently issued both draft and final guidance regarding food allergen labeling requirements.  The draft guidance document, Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5), updates the previous (fourth) edition with new and revised guidance concerning food allergen labeling. FDA also issued a final guidance document with the same title in order to preserve questions and answers that were unchanged from the previous (fourth) edition, which was published in 2004 and last updated in 2006.