Warning Letter — Ray’s Vitamins
The FDA issued a warning letter to Ray’s Vitamins following a review by the Center for Drug Evaluation and Research (CDER).
This action affects Ray’s Vitamins and potentially other manufacturers or distributors of dietary supplements making drug-like claims.
The involvement of CDER suggests the FDA may have identified claims that cause the products to be classified as unapproved new drugs rather than dietary supplements. Regulatory teams should interpret this as a signal that the agency continues to monitor supplement marketing for claims that overstep the boundaries of the Dietary Supplement Health and Education Act (DSHEA).
Review all product labeling and digital marketing materials to ensure no claims suggest the product can diagnose, treat, cure, or prevent a disease. Conduct a gap analysis between supplement labeling and drug claim regulations to prevent unintended classification as an unapproved new drug.
FDA Warning Letter issued to: Ray’s Vitamins. 04/24/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rays-vitamins-726694-04242026
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