Warning Letter — Happy Farm Botanicals, Inc.
The FDA issued a Warning Letter to Happy Farm Botanicals, Inc. following an inspection by the Center for Drug Evaluation and Research (CDER). The source indicates enforcement action related to the firm's manufacturing and marketing practices.
This affects Happy Farm Botanicals, Inc., as well as regulatory and quality departments involved in the production and labeling of botanical or topical products marketed with drug claims.
The issuance of a Warning Letter by CDER typically signifies that the FDA has identified significant violations of the Federal Food, Drug, and Cosmetic Act, such as the sale of unapproved new drugs or failure to adhere to Current Good Manufacturing Practice (CGMP). This action suggests that the firm's products may be positioned in a manner that subjects them to drug regulations without the required safety and efficacy approvals.
Ensure all products marketed with therapeutic claims are supported by an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Review all labeling, websites, and marketing collateral to identify and remove language that implies a product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
FDA Warning Letter issued to: Happy Farm Botanicals, Inc.. 09/01/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/happy-farm-botanicals-inc-731926-09012026
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