FDA WARNING_LETTER - Center for Wellness and Integrative Medicine - June 25, 2020

On June 30, 2020, the FDA and FTC issued a Warning Letter to Dr. Tomy Arema regarding the sale of unapproved and misbranded products related to COVID-19 on their website, drtomyarema.com. The FDA reviewed the website on June 17 and June 25, 2020, identifying products like "COVID Supplement Protection Pack," Thymosin-Alpha, and Methylene Blue Capsules marketed with claims to mitigate, prevent, treat, diagnose, or cure COVID-19.

These products are deemed unapproved new drugs, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and misbranded drugs under section 502 (21 U.S.C. § 352). Their introduction into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The letter emphasizes the ongoing public health emergency declared for COVID-19.

The FDA requires immediate action to cease the sale of these products and demands an email within 48 hours to COVID-19-Task-Force-CDER@fda.hhs.gov detailing corrective steps, recurrence prevention, and supporting documentation. Failure to comply may result in legal action, including