Warning Letter — Beaute Bounty
The FDA issued a warning letter to Beaute Bounty following a review by the Center for Biologics Evaluation and Research (CBER) regarding the regulatory status of their products.
This affects Beaute Bounty and regulatory professionals involved in the marketing and distribution of biological products.
The involvement of CBER suggests the products in question are being regulated as biological drugs rather than cosmetics or supplements. Failure to maintain an approved Biologics License Application (BLA) for products making therapeutic claims typically results in the products being classified as unapproved new drugs and misbranded biologics, which carries significant enforcement risk including potential seizure or injunction.
Review all product labeling and promotional materials to ensure health-related claims do not inadvertently classify a biological product as a drug. Ensure that any biological product intended for therapeutic use has a valid Biologics License Application (BLA) or Investigational New Drug (IND) application in effect before distribution.
FDA Warning Letter issued to: Beaute Bounty. 09/25/2026 — Center for Biologics Evaluation and Research (CBER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/beaute-bounty-729163-09252026
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