FDA WARNING_LETTER - Fishman Chemical of North Carolina, LLC - June 30, 2020

On July 21, 2020, the FDA issued a Warning Letter to Dr. Fishman regarding the sale of unapproved new animal drug products for aquarium fish via the firm's website, fishchemical.com. A June 2020 review of the website revealed products like doxycycline hyclate, enrofloxacin, erythromycin, and others, marketed with claims indicating their use for disease treatment in animals, thus classifying them as drugs under the FD&C Act.

These products are considered unapproved new animal drugs because they are intended for minor species, lack FDA approval (new animal drug application, conditional approval, or index listing), and are not generally recognized as safe and effective. This renders them unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act, respectively.

The letter also noted the continued sale of chloroquine phosphate, an adulterated new animal drug for which a previous Warning Letter was issued on April 15, 2020, with no response received to date. The FDA requires a written response within fifteen working days detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction, against all adulterated new animal drugs.