Inspections, Compliance, Enforcement, and Criminal Investigations
Bio Health Solutions 8/1/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Francisco District
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Our Reference: 3009682914
August 1, 2012
Mark Garrison, DC
101 Convention Center Drive, Ste. 700
Las Vegas, NV 89109
Dear Mr. Garrison:
This letter concerns your firm’s marketing of the product RenAvast. The U.S. Food and Drug Administration (FDA) reviewed your website at the internet address www.renavast.com, where you promote and sell this product. We have determined that RenAvast is intended for use in the mitigation, treatment, or prevention of disease in animals, which makes it a drug 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, this product is an unapproved new animal drug as defined by the FD&C Act and your marketing of it therefore violates the law.
Statements on your website that show these intended uses of your product include, but are not limited to, the following:
• RenAvast™ can halt the progression of chronic renal failure
• RenAvast™ may reverse the effects of chronic renal failure
• RenAvast™ may help prevent kidney disease in healthy cats
• RenAvast™ is a new, highly effective compound that has been proven through a two-year clinical study to halt the progression of Chronic Renal Failure (CRF) in cats and improve overall kidney function
• Unlike other products and drugs, RenAvast™ does not treat the symptoms of renal failure, it treats the cause
• RenAvast™ was highly successful in halting the progression of Chronic Renal Failure and in most cases improved kidney function.
• Finally a solution for cats with Chronic Renal Failure
• A two-year open ended clinical study proves that RenAvast can halt the decline in kidney function
• Until now, veterinary medicine could only manage symptoms in an attempt to maintain quality of life while the disease progressed relentlessly onward. All of that has now changed
• Chronic Renal Failure is no longer a death sentence
Because RenAvast is intended to mitigate, treat, or prevent disease in animals, it is a drug within the meaning of section 201(g)(1)(B) of the FD&C Act. Further, this product is a new animal drug, as defined by section 201(v) of the FD&C Act, [21 U.S.C. § 321(v)], because it is 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]. RenAvast is not approved or listed by the FDA, and therefore the product is considered unsafe under 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)]. 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)].
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 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.
Your written response should be sent to Lawton W. Lum, Director, Compliance Branch, U.S. Food and Drug Administration, San Francisco District, at 1431 Harbor Bay Parkway, Alameda, California 94502. If you have any questions about this letter, please contact Compliance Officer Karen L. Robles at (916) 930-3674 extension 1114 or via e-mail at Karen.Robles@fda.hhs.gov.
Barbara J. Cassens
San Francisco District
U. S. Food and Drug Administration