Mr Frags, LLC – FDA Warning Letter, Oct 27, 2020

The FDA issued a Warning Letter to Jason Weage regarding the sale of unapproved chloroquine phosphate products on the website https://mrfrags.com/. An FDA review in October 2020 found that the website offered chloroquine phosphate for sale in the United States, with product labels and descriptions indicating intended use for treating disease in fish.

The FDA determined these products are "drugs" intended for use in "minor species" (fish) and are therefore "new animal drugs" under the FD&C Act. To be legally marketed, new animal drugs require an approved new animal drug application, conditional approval, or an index listing. The chloroquine phosphate products offered by MrFrags.com lack any such approval or listing.

Consequently, these products are deemed "unsafe" and "adulterated" under sections 512(a) and 501(a)(5) of the FD&C Act, making their introduction into interstate commerce a prohibited act under section 301(a). The letter requires a written response within 48 hours detailing specific corrective actions taken, an explanation of steps to prevent recurrence, and supporting documentation. Failure to address these violations may result in legal action, including seizure and injunction.