Inspections, Compliance, Enforcement, and Criminal Investigations

Abler Inc 10/29/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Rockville, MD  20855 

October 29, 2014
 

WARNING LETTER

Via UPS

Mr. Lindsay Kotthoff
Abler, Inc.
P.O. Box 158
Corowa 2645 NSW Australia
 

Dear Mr. Kotthoff:
 

This letter concerns the marketing of several products including, but not limited to, AbGard, Abprazole, Abprazole Plus, Abler Omeprazole, AbButazone, AblerQuant, and AbFen by your firm, Abler, Inc. The U.S. Food and Drug Administration (FDA) reviewed your website at the internet address abler.com, where you promote and sell this product, and obtained and tested samples of your AbGard product.

We have determined that the above referenced products are intended for use in the mitigation, treatment, or prevention of disease 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)]. Under the FD&C Act, drugs intended for use in animals require an approved new animal drug application unless they are generally recognized as safe and effective. As discussed below, we have determined that these drugs are not generally recognized as safe and effective, and are therefore unsafe under section 512(a)(1) 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)], because you are marketing them without approved new animal drug applications. In addition, the drug AbGard is adulterated under section 501(c) of the FD&C Act [21 U.S.C. § 351 (c)], as testing of the drug revealed that its strength differs from the strength stated on the label.

Statements on your website and product labeling that show these products are intended for use in the mitigation, treatment or prevention of disease in animals include, but are not limited to, the following:
 

AbGard
• " ... for treatment and prevention of equine ulcers ... "

Abprazole
• " ... for treatment and prevention of equine ulcers ... "

Abprazole Plus
• " ... for treatment and prevention of equine ulcers ... "

Abler Omeprazole
• " ... for prevention and treatment of Equine Gastric Ulcers Syndrome ... "

AbButazone
• " ... for the alleviation of inflammation and pain associated with musculoskeletal disorders in adult horses"

AblerOuant
• " ... for treatment and prevention of equine worms and parasites . .. "

AbFen
• " ... to treat parasites that can damage a horse's gastro-intestinal and respiratory tracts."

The above referenced products are only a sampling of the violative products you are currently marketing. Similarly, the above referenced claims are only a sampling of statements that demonstrate the intended uses of your products.

Because the above referenced products are intended to mitigate, treat, or prevent disease 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)]. Further, 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.

To be legally marketed, a new animal drug must have 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]. The above referenced products are not approved or index listed by the FDA, and therefore the products are considered unsafe under section 512(a)(1) 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)]. Introduction of an adulterated drug into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].

In addition, testing by FDA of samples of the drug AbGard revealed that the amount of active ingredient (omeprazole) in the drug did not correspond with the amount represented on the labeling. Specifically, the drug was found to be super-potent at 111.3% of the label claim for potency. The drug is therefore adulterated under section 501 (c) of the FD&C Act [21 U.S.C. § 351(c)], in that its strength differs from that which it purports or is represented to possess.

This letter is not intended to be an all-inclusive review of your products and their promotion. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations. Failure to promptly connect 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.

Please direct your response to Dillard H. Woody Jr., Supervisor, Post Market Compliance Team at the U.S. Food and Drug Administration with the Center for Veterinary Medicine, 7519 Standish Place, Rockville, MD 20855-2773. If you have any questions about this letter, please contact Dillard Woody at 240-276-9237.
 

Sincerely,
/S/

Eric Nelson, Director
Division of Compliance (HFV-230)
Office of Surveillance & Compliance
Center for Veterinary Medicine

Page Last Updated: 11/10/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English