FDA Warns Against Unapproved Animal Drugs Intended For Dogs

The U.S. Food and Drug Administration has issued two warning letters to BullyKamp Products LLC as well as Top Dog Pet Store LLC dba The Bulldog Cartel, for marketing unapproved animal drugs intended f...

Written by: RTT Staff Writer • Thursday, August 15, 2024 • 2 min read

• Last updated: Thursday, August 15, 2024

FDA Warns Against Unapproved Animal Drugs Intended For Dogs

The U.S. Food and Drug Administration has issued two warning letters to BullyKamp Products LLC as well as Top Dog Pet Store LLC dba The Bulldog Cartel, for marketing unapproved animal drugs intended for dogs, in violation of federal law.

According to the agency, the unapproved animal drugs have not been submitted for review, due to which it is unable to confirm whether they are safe, effective, and properly manufactured. The FDA is also not able to confirm whether the drugs contain the ingredients stated on the labels, in the stated quantities.

In the letter to BullyKamp Products, the FDA revealed concerns about the unapproved new animal drugs The Antidote (Parvo Killer), Steroid Shot 5ML, Increase Litter Shot, Clavamox 5ML, and Bulldog Sauce.

The warning was issued after reviewing the company website in May and June 2024 and determining that these products for offered for sale there.

In the letter to The Bulldog Cartel, the FDA noted concerns about unapproved new animal drugs, Green Magic and Bulldog Cartel Parvo Combat, to treat diseases in animals in violation of the Federal law. The company’s website have been reviewed in May 2024 and found that these products were for sale.

Based on the review of the respective websites, it was found that these products are drugs under the Federal Food Drug and Cosmetic Act, because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and/or intended to affect the structure or any function of the body of an animal.

Also, these animal drugs are misbranded as they have not been drug listed with FDA.

The FDA noted that a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing to be legally marketed.

These warned products are not approved or index listed by FDA, and therefore, the products are unsafe and adulterated. The introduction or delivery for introduction into interstate commerce of an adulterated drug is prohibited.

Both BullyKamp and Bulldog Cartel are required to respond to the warning letter within 15 working days of receipt of the letter with the specific steps taken to address any violations.

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