FDA WARNING_LETTER - the camel milk co. llc - September 22, 2021

The FDA issued a Warning Letter to Camel Culture on September 22, 2021, following a review of their website and social media in July and August 2021. The FDA determined that Camel Culture's products, Camel Milk (pint and liter) and Dry Camel Milk Powder, are marketed with claims that establish them as unapproved new drugs intended to mitigate, prevent, treat, diagnose, or cure COVID-19.

The violations include introducing or delivering unapproved new drugs into interstate commerce, which violates sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. 331(d), 355(a)]. The products are considered "new drugs" under section 201(p) [21 U.S.C. 321(p)] because they are not generally recognized as safe and effective for their claimed uses.

Furthermore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] because they lack adequate directions for use. As they are intended for conditions not amenable to self-diagnosis or treatment, adequate directions for a layperson cannot be provided, making their introduction into interstate commerce a violation of section 301(a) [21 U.S.C