# FDA WARNING_LETTER - Body Good Studio - August 01, 2025

Source: https://www.keypedia.com/records/warning_letter/body-good-studio/30953943-d94c-4fbc-8f45-8f57e5c7101a

> FDA WARNING_LETTER for Body Good Studio on August 01, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Body Good Studio
- Inspection Date: 2025-08-01
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On September 9, 2025, the FDA issued a warning letter to Body Good Studio following an August 2025 review of the company"s website. The agency found that the firm was marketing compounded semaglutide products using false and misleading claims. Specifically, the website stated that its compounded semaglutide contains the same active ingredients as the FDA-approved medications Ozempic and Wegovy. The FDA clarified that because compounded drugs are not FDA-approved, implying they are identical to approved products is misleading and constitutes misbranding under the Federal Food, Drug, and Cosmetic Act (FDCA). These violations fall under sections 502(a) and 502(bb) of the FDCA, which prohibit false labeling and advertising. The FDA warned that introducing misbranded products into interstate commerce is illegal. To resolve these issues, Body Good Studio must immediately cease using the misleading language and ensure all operations comply with federal law. The company was directed to provide a written response within fifteen working days detailing the specific corrective actions taken to address the violations and prevent their recurrence. Failure to comply could lead to legal enforcement, including product seizure or injunctions.

## Related Documents

- [WARNING_LETTER - 2025-08-31](https://www.keypedia.com/records/warning_letter/body-good-studio/ae20f5fe-c9d0-4b31-8a28-059e93d85773)

## Related Officers

- [Director](https://www.keypedia.com/people/george-tidmarsh/b9977f2c-595d-429e-abb0-8e302a2133b6)

Company: https://www.keypedia.com/companies/body-good-studio/c06bb83c-e422-495d-b73f-20625646ea8c

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c