Inspections, Compliance, Enforcement, and Criminal Investigations

Advantage Biosciences 12/17/15

  

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

Public Health Service
Food and Drug Administration
 Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-4415 

 

WARNING LETTER
 
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
 
December 17, 2015
WL # 12-16
Mr. Peter Brandt
Owner, Advantage Biosciences, Inc.
1580 Monrovia Ave   
Newport Beach, CA 92663
 
Dear Mr. Brandt:
 
This letter concerns your firm’s marketing of numerous products as “nutritional supplements” for animals, including Resvantage Canine, Resvantage Feline, and Resvantage Equine. The U.S. Food and Drug Administration (FDA) reviewed your product labeling and your website at the internet address www.resvantage.com, where you promote and sell these products. We have determined that these 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 on your website and product labeling that show these intended uses of your products include, but are not limited to, the following:
 
RESVANTAGE CANINE®
 
    “Resveratrol can be used as a cancer therapy by itself or combined with other therapies.”
 
    “Anti-Cancer Activity”
 
    “Recent evidence from animal studies has shown resveratrol to be an effective chemo preventive/curative agent in three stages of the cancer process; initiation, promotion and progression.”
 
    “Tumors shown to be sensitized by resveratrol include lung carcinoma, acute myeloid leukemia, promyelocytic leukemia, multiple myeloma, prostate cancer, oral epidermoid carcinoma, and pancreatic cancer.”
 
    “A number of preclinical findings suggest resveratrol having high therapeutic potential for cancer prevention and treatment.”
 
RESVANTAGE FELINE®
 
           “Resveratrol is one of a group of antioxidant compounds called polyphenols found in numerous plants that has anti-inflammatory, cardiovascular protective and cancer chemopreventive properties.”
 
           “It helps support the immune system and has been shown to curb insulin resistance. A powerful antioxidant, resveratrol provides protection from the damaging effects of free radicals and inflammatory chronic health problems.”
 
           “The combined activities of these pharmacological effects provide an effective a new therapy for treating type II diabetes. Resvantage Feline® is being used clinically to manage diabetes and reduce the incidence and severity of glycemic seizures.”
 
“Resveratrol has demonstrated high therapeutic potentials for the treatment of cardiovascular diseases.”
 
RESVANTAGE EQUINE®
 
    “Just as in humans, supplements may be the best tool for maintaining health and preventing disease for your pets and horses. Research has proven that resveratrol is the first compound to consistently prolong the life of several different animal groups.”
 
    “A precise blend from natural sources that promotes enhanced performance along with potent anti-inflammatory, cardioprotective, antioxidant, anti-cancer, and neuroprotective properties.”
 
    “And Resveratrol has proven anti-viral properties that help increase immunity to diseases.”
 
    “Dietary supplementation of resveratrol has been shown in studies to attenuate chronic intestinal inflammation”
 
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. 
 
Your response should be sent to:
 
Daniel Cline
Acting Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612
 
If you have any questions about the content of this letter, please contact Jessica Mu, Compliance Officer, at 949-608-4477. Please include Special Identifier CMS ID: Case # 481488 on all correspondence.
 
 
Sincerely,
/S/
LCDR Steven Porter, Acting Director
Los Angeles District

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