FDA WARNING_LETTER - Chronic Lyme Treatments - May 05, 2020

On May 7, 2020, the FDA and FTC issued a Warning Letter to Chronic Lyme Treatments after reviewing their website, www.chroniclymetreatments.com, on April 28 and May 5, 2020. The letter states that the company offers herbal products for sale in the U.S. that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19.

The FDA determined these products are unapproved new drugs, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and are misbranded drugs under section 502 (21 U.S.C. § 352). The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The letter cites the public health emergency and national emergency declarations for COVID-19 as context for urgent protective measures.

The company is required to immediately cease selling these unapproved and unauthorized products for COVID-19 related uses. Within 48 hours, Chronic Lyme Treatments must email COVID-19-Task-Force-CDER@fda.hhs.gov detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action