- On December 11, 2025, the U.S. Food and Drug Administration (FDA) issued a letter to the dietary supplement industry which clarifies the placement of the Dietary Supplement Health and Education
DIETARY SUPPLEMENTS
FDA Issues Warning Letters for Products Containing 7-Hydroxymitragynine
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- On July 15, 2025, FDA sent warning letters to seven different companies for the illegal marketing of products containing 7-Hydroxymitagynine (7-OH). 7-OH is a naturally occurring chemical component of Kratom
FDA Releases Educational Materials on the NDIN Process
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- Yesterday, the U.S. Food and Drug Administration (FDA) unveiled two educational videos and a supplemental fact sheet to help the dietary supplement industry with the New Dietary Ingredient Notification (NDIN)
Two Class Actions Target Supplement Promoted for Increasing GLP-1
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- A plaintiff has filed two class actions targeting a dietary supplement promoted as increasing GLP-1. One case is in federal court in New York, while the other is in California
Supreme Court Declines to Review FDA Labeling Preemption for State Claims
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- The Supreme Court declined to review (Law360 subscription required) a First Circuit decision affirming dismissal of false advertising and consumer protection claims alleging that McNeil Nutritionals LLC misbranded Lactaid drug
FDA Publishes Draft Guidance on NDIN Master Files
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- On April 3, 2024, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary
Reintroduced Bill Seeks Legal Pathway for CBD in Food
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- On July 20, U.S. Senators Ron Wyden, D-Ore., Rand Paul, R-Ky., and Jeff Merkley, D-Ore., and U.S. Representative Earl Blumenauer, D-Ore., reintroduced legislation, called the “Hemp Access and Consumer
FDA Webinar Reiterates a New Regulatory Pathway Created by Federal Legislation is Required for CBD
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- A high-level internal working group that FDA convened to explore potential regulatory pathways for cannabidiol (CBD) products announced by way of a January 26, 2023 statement that existing regulatory pathways
FDA Launches Dietary Supplement Ingredient Directory
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- Yesterday, FDA launched its new Dietary Supplement Ingredient Directory which contains a list of ingredients used in dietary supplements along with links to FDA’s actions and communications regarding the ingredients.
FDA Publishes List of 2023 Priority Guidance Topics
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- FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) routinely publish a list of possible new topics for guidance documents or revisions