The United States Food and Drug Administration (FDA) sent a letter to dietary supplement companies, announcing that they plan to exercise enforcement discretion relating to the Dietary Supplement Health and Education Act of 1994 (DSHEA) disclaimer placement requirements.
21 CFR 101.93(d) currently requires the DSHEA disclaimer (i.e., “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease”) to be placed on each panel of a dietary supplement where there is a
structure / function claim.
The FDA has received requests to change the placement requirement in the regulations. Based on the FDA’s initial review, they will probably propose changes to the regulation to remove the requirement for the DSHEA disclaimer to appear on each panel where there is a claim. However, since rulemaking is not a fast process, the FDA announced that they intend to take enforcement discretion regarding the requirement for the DSHEA disclaimer to appear on each panel of a product label where there is a structure / function claim.
Link: https://www.fda.gov/food/information-industry-dietary-supplements/letter-dietary-supplement-industry-dshea-disclaimer
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