The FDA issued a warning letter to Best Chinese Medicines LLC on October 23, 2026, stating that five products promoted on its website are unapproved new drugs. The FDA determined that these products lack effective marketing applications under section 505 and that introducing them into interstate commerce violates sections 301(d) and 505(a). The company must promptly correct the violations and prevent recurrence or may face regulatory or legal action such as seizure and injunction.
Why it matters
FDA warning letter declares five website-promoted products unapproved new drugs under the FD&C Act.
