FDA WARNING_LETTER - Guna Inc.

On January 11, 2018, the FDA and FTC issued a Warning Letter to GUNA, Inc. regarding their product GUNA-ADDICT 1, sold via gunainc.com. The FDA determined GUNA-ADDICT 1 is an unapproved new drug and a misbranded drug, violating the Federal Food, Drug, and Cosmetic Act (the Act).

GUNA-ADDICT 1 is considered a drug under section 201(g)(1) of the Act due to claims like "For the temporary relief of cravings, irritability, and inability to concentrate related to the use and over-use of: . . . Alcohol, Narcotics." It is an unapproved new drug (section 201(p) and 505(a)) because it lacks FDA approval and is not generally recognized as safe and effective for its intended use.

Furthermore, GUNA-ADDICT 1 is a prescription drug (section 503(b)(1)(A)) as it's not safe for use without professional supervision, yet its label lacks the "Rx only" symbol, making it misbranded under section 503(b)(4). It is also misbranded under section 502(f)(1) because adequate directions for layperson use cannot be provided for conditions requiring professional supervision.

Despite being labeled homeopathic, the product is not exempt from regulatory requirements, especially given the