FDA WARNING_LETTER - www.peacefulmeds.com

On May 5, 2025, the FDA issued a Warning Letter to www.peacefulmeds.com for unlawfully selling unapproved and misbranded drugs to U.S. consumers via their website. The FDA's review found the website introduces unapproved and misbranded opioid (Tramadol), benzodiazepine (Diazepam), and injectable semaglutide (Ozempic) drug products into interstate commerce.

These products are considered "new drugs" under the FD&C Act because they lack FDA approval for safety and effectiveness, violating sections 301(d) and 505(a). The FDA cited specific product descriptions as evidence of intended use. The letter highlights the public health risks associated with unapproved opioids and benzodiazepines, including addiction, abuse, and severe adverse effects, especially when co-used with other substances. Injectable products pose additional risks of contamination and life-threatening conditions.

Furthermore, the drugs are misbranded under section 502(f)(1) because their labeling lacks adequate directions for layperson use, as they are prescription-only drugs requiring professional supervision. The website also offers these prescription drugs, including semaglutide, without requiring a prescription, violating sections 301(a) and 301(k) and misbranding them under section 503(b)(1).

www.peacefulmeds.com must cease offering all unapproved and misbranded