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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Process Managers LLC 5/18/12

  

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

Public Health Service
Food and Drug Administration
 
Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761 

 

May 18, 2012
 
Via United Postal Service
 
WARNING LETTER
CIN-12-269380-17
 
James G. Criggall, Owner
Process Managers, LLC
485 Gawthrope Drive
Winchester, KY 40391
 
 
Dear Mr. Criggall:
 
This letter concerns your firm’s marketing of your “CalDensity®” and “Want A Snack™” products.  An inspection of your facility located at 485 Gawthrope Dr., Winchester, Kentucky was conducted on December 12-16, 19, 21, and 27, 2011. The inspection found that your firm manufactures and distributes products for animal consumption. Our review of your products’ labeling, including your websites at the internet addresses www.caldensity.com and www.wantasnack.com, where the products are available for sale, reveals that, “CalDensity®” and “Want A Snack™,” are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (“the Act”) [21 U.S.C. § 321(g)(1)(B)], as they are intended for use in the mitigation, treatment, or prevention of disease in animals. We consider these products to be unapproved new animal drugs and your marketing of them violates the Act. 
 
We received your January 10, 2012, response to the Form FDA 483, List of Inspectional Observations that was issued to your firm at the conclusion of the inspection. Your response stated, among other things, that you have removed all questionable language from your CalDensity® and Want A Snack™ websites. However, your websites continue to contain claims that establish that the intended use of your products is to mitigate, treat, or prevent disease in animals.  
 
Some examples of statements on your websites that establish these intended uses of your products include, but are not limited to the following:
 
From your website http://www.caldensity.com:
 
  • “I have been using CalDensity® extensively for over three years now. In that time, I have seen superior clinical results in healing and prevention of bone disease using this product in conjunction with my medical and surgical treatments. CalDensity® is the primary product I recommend to help prevent Developmental Orthopedic Disease and to help improve bone healing and density post surgically.”
  • “In addition, Want A Snack™ products have been recognized by vets for the benefits they provide to growing and aging pets in helping maintain healthy mobility and joints and defense against developmental orthopedic disease.”
 
From your website, http://wantasnack.com:
 
In the product description under “WAS® Refresher” (5 lb, 10 lb, 25 lb, and 50 lb Pail):
 
  • “Helps alleviate acidosis-dehydration and tying up syndrome, which can occur after long and heavy training or exercise.”
 
In the product listing for “Snacks for Household Dogs 2 lb Pail”:,
 
  • “Provide this snack as a daily supplement to your dogs regular nutrition to aid in arthritis, mobility, healthy coat, healthy skin, cardiovascular health as well as strengthen bones, heal paws, and maintain energy”

Because “CalDensity®” and “Want A Snack™” are intended to prevent, mitigate or treat disease in animals, they are drugs within the meaning of section 201(g)(1)(B) of the Act, [21 U.S.C. § 321 (g)(1)(B)].  The products are also new animal drugs under 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.   Neither product is 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 Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1].  Therefore, the products are unsafe within the meaning of section 512(a) of the Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)].  Introduction of an adulterated drug into interstate commerce is prohibited under section 301(a) of the Act [21 U.S.C. § 331(a)]. 
 
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 correct the violations specified above may result in enforcement action without further notice.  Enforcement action may include, but is not limited to: seizure of violative products and/or injunction against the manufacturers and distributors of violative products. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that the claims you make for your products do not cause them to violate the Act.
 
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.  If you no longer manufacture or market the aforementioned products, your response should so indicate, including the reasons that, and the date on which, you ceased production. 
 
Please direct your response to the U.S. Food and Drug Administration, 6751 Steger Dr., Cincinnati, Ohio 45237-3097, Attention: Mark E. Parmon, Compliance Officer.
 
 
Sincerely,
/S/ 
Paul J. Teitell
District Director
Cincinnati District
 
 
Cc: 
Dr. William Thom
University of Kentucky
Division of Regulatory Service
103 Regulatory Service Building
Lexington, KY 40546-0275