First Strike Pet Products – FDA Warning Letter, Aug 30, 2022

The FDA issued a Warning Letter to (b)(6) on August 15, 2022, following a May 2022 review of their website (https://www.petdefenderproducts.com/) and eBay store (https://www.ebay.com/sch/first_strike_pet_supply/m.html?_nkw=&_armrs=1&_ipg=&_from=), where products like "Strike-pyram," "Strike-nuron," "Strike 30," "Bulk Combo-Package," "First Strike - Strike-pyram Bulk Powder," "Strike-nuron Bulk Powder," "First Strike Nitenpyram capsules," "First Strike De-wormer," and "Super Pack 30 day Flea killer and De-wormer" are sold.

The FDA determined these products are unapproved new animal drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), due to claims on their website, eBay store, and product labeling indicating intended use for diagnosis, cure, mitigation, treatment, or prevention of disease in animals. These products are considered "new animal drugs" under section 201(v) of the FD&C Act, 21 U.S.C. 321(v), as they are not generally