FDA WARNING_LETTER - Dr. Garber’s Natural Solutions - February 19, 2021

The FDA reviewed Dr. Garber's website, www.drgarbers.com, in January and February 2021 and determined that the "Dr. Garber's Depression Relief" product is marketed as a drug intended for the cure, mitigation, treatment, or prevention of disease, based on website claims. This product is considered a "new drug" under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) because it is not generally recognized as safe and effective for its intended uses. Introducing or delivering this product into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act.

Furthermore, the product is deemed misbranded under section 502(f)(1) of the Act because it fails to bear adequate directions for its intended use. As a product intended for diseases not amenable to self-diagnosis or treatment, it requires supervision by a licensed practitioner, making it impossible to provide adequate directions for layperson use. The introduction or delivery of this misbranded drug into interstate commerce violates section 301(a) of the Act.

The letter states that these are not the only violations and that the firm is responsible for investigating and preventing recurrence. Prompt action is required to address these violations, as failure to do so may result in legal action, including seizure and injunction. Dr. Garber must notify the FDA in writing