This warning letter addresses regulatory violations identified at Herbsens Botanicals during an FDA inspection. The inspection revealed significant issues regarding the labeling and marketing practices of the company’s herbal products, including unsubstantiated health claims that mislead consumers and contravene federal regulations. Specific violations included the absence of required disclaimers and misleading representations regarding the efficacy of certain products, raising concerns about consumer safety and product integrity. The FDA outlined necessary corrective actions, including the revision of product labels and a commitment to adhere to Good Manufacturing Practices (GMP). Failure to address these violations may result in legal actions, including product seizures or injunctions. The letter emphasizes the importance of compliance to ensure the safety and efficacy of herbal products and protect consumer interests.
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