FDA WARNING_LETTER - Everything Aquatic - September 30, 2020

The FDA issued a Warning Letter to Ms. Edwards of Everything Aquatic on October 6, 2020, following a review of their website in August and September 2020. The FDA identified that the company offers unapproved new animal drug products for aquarium species, including Chloroquine Phosphate products and various other veterinary products.

The claims on the website establish these products as drugs under Section 201(g) of the FD&C Act due to their intended use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals, or to affect animal body structure/function. Since these products are for minor species (ornamental aquarium fish), they are classified as "new animal drugs" under Section 201(v) of the FD&C Act.

The identified violations include marketing new animal drugs without required FDA approval, conditional approval, or index listing, rendering them "unsafe" under Section 512(a) and "adulterated" under Section 501(a)(5) of the FD&C Act. Introducing adulterated drugs into interstate commerce violates Section 301(a).

Furthermore, certain pellet and flake products are intended as animal feed containing unsafe new animal drugs, making them "unsafe animal feeds" under Section 512(a)(2) and "adulterated drugs" under Section 501(a)(6). If considered "food," they