November 8, 2018

CMS Case # 567536

WARNING LETTER

VIA UPS OVERNIGHT

Mark Kang, Owner
Guardian Pet Products
231 Lafayette Cir.
Tallahassee, FL 32304

Mr. Kang:

This letter concerns your firm’s marketing of veterinary products under the Guardian Pet Products and PetStar Product name for the “treatment” of disease in dogs and cats, including all dosage forms of: Guardian with Nitenpyram and PetStar Nitenpyram. The U.S. Food and Drug Administration (FDA) has reviewed your websites at: www.theguardianpets.com and www.petstarpets.com, where you promote and sell these products, as well as your product labeling. We have determined that your products are intended for use in the mitigation, treatment, or prevention of diseases in animals, which makes them drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B)].  Further, as discussed below, these products are unapproved new animal drugs and your marketing of them violates the FD&C Act.

Statements and testimonials on your website and product labeling show these intended uses of your products include, but are not limited to, the following:

Testimonials from Guardian Pet Products Website: Guardian with Nitenpyram

The following testimonials were located through the “Product Reviews and Testimonials” link on same page as “Web Store” link. The testimonials were displayed amongst screen shots of consumer product reviews with terms redacted.

• “…We had flea infestation nightmares This resolved it.”
• “…all four of my dogs had [text blurred] infestations…after bathing one dog to kill [text blurred], they’d get reinfected from the other dogs.  I needed an internal [text blurred] and Nitenpyram to the rescue, I could now treat all four dogs simultaneously…Within 30 minutes after treatment, the dead [text blurred] fell off each dog!”

The claims quoted above are supplemented by the metatags used to bring consumers to your website through Internet searches. Examples of metatags targeted to consumers who are looking for products to prevent or treat parasitic infections include: “flea” and “wormer.”

Because your products are intended to prevent, mitigate or treat diseases in animals, they are drugs within the meaning of section 201(g)(1)(B) of the FD&C Act, [21 U.S.C. § 321 (g)(1)(B)]. Moreover, these products are new animal drugs, as defined by section 201(v) of the FD&C Act, [21 U.S.C. § 321(v)], because they are not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.  They are not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. Therefore, the products are unsafe within the meaning of section 512(a) of the FD&C Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)]. 

This letter is not intended to be an all-inclusive review of your products.  It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products. 

You should notify this office, in writing, within fifteen (15) working days of the receipt of this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include any documentation necessary to show that correction has been achieved. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made. 

Electronically mail your written response to John W. Diehl, Director, Compliance Branch, Office of Pharmaceutical Quality Operations, Division 2, at [email protected] and [email protected]. Please identify your response with CMS Case # 567536.

If you have questions regarding any issues in this letter, please contact Mr. Diehl at (214) 253-5288. 

Sincerely,
/S/
Monica R. Maxwell
Program Division Director
Office of Pharmaceutical Quality Operations,
Division II