FDA Issues Letter to Industry on the DSHEA Disclaimer
Constituent Update
December 11, 2025
Today, the U.S. Food and Drug Administration (FDA) published a letter to the dietary supplement industry regarding the agency’s labeling regulations that govern the placement of the disclaimer on dietary supplement labels required under the Federal Food, Drug, and Cosmetic Act, as amended by the Dietary Supplement Health and Education Act of 1994 (DSHEA). The letter is being issued in response to several deregulatory requests received by the agency.
As outlined in the letter, the agency is considering a regulatory amendment regarding the requirement for the DSHEA disclaimer to appear on each panel of a dietary supplement product label where an applicable claim is made. In the meantime, FDA intends to exercise enforcement discretion on this topic.
For further information, please refer to our letter to industry.
Additional Information: