alternative health experts llc – FDA Warning Letter, Mar 24, 2020

On April 6, 2020, the FDA issued a Warning Letter to Immunization Alternatives and Homeopathic Remedies Online after reviewing their websites and social media on March 24, 2020. The FDA observed that the firm was offering homeopathic drugs and dietary supplement products for sale in the U.S. with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. These products are deemed unapproved new drugs under section 505(a) of the FD&C Act (21 U.S.C. § 355(a)) and misbranded drugs under section 502 of the FD&C Act (21 U.S.C. § 352). Their introduction into interstate commerce is prohibited by sections 301(a) and (d) of the FD&C Act (21 U.S.C. § 331(a) and (d)). Given the public health emergency declared for COVID-19, the FDA is taking urgent measures against such unauthorized products. The firm was instructed to immediately cease the sale of these unapproved and unauthorized products for COVID-19 related uses. They must email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction, and the firm will be added to FDA's public list of fraudulent COVID-19 product sellers. Products offered for importation may also face detention and refusal of admission.