Inspections, Compliance, Enforcement, and Criminal Investigations

NuVet Labs 7/29/16

  

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
 
 
July 29, 2016
 WL # 37-16
Mr. Blake G. Kirschbaum
NuVet Laboratories
5717 Corsa Avenue
Westlake Village, CA 91362
 
Dear Mr. Kirschbaum:
 
This letter concerns your firm’s marketing of numerous products as “nutritional supplements” for animals, including but not limited to, NuVet Plus Canine Wafers, NuVet Plus Canine Powder, and NuVet Plus Feline, NuJoint Plus, NuJoint DS, NuVet Labs Ear Cleaner. The U.S. Food and Drug Administration (FDA) reviewed your product labeling and your websites at various internet addresses where you promote and sell these products. These internet addresses include, but are not limited to: www.nuvet.com, www.nuvetonline.com, www.nuvetlabs.com, www.mydogshealthnow.com, www.nujointplus.com, www.k9allergies.com, www.nuvetplus.com, www.nuvet.net, www.felinesupplement.com, www.nuvetplusreviews.com, www.nuvetreviews.com, www.petprohealth.com,   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 websites and product labeling that show these intended uses of your products include, but are not limited to, the following:
 
NuVet Plus® Canine Wafers, NuVet Plus® Canine Powder, and NuVet Plus® Feline
  • “NuVet Plus® contains those ingredients and can help strengthen the immune system to help prevent the development of tumor growth.”
  • ‘Not only will NuVet Plus® support an animal suffering from kidney problems by creating a strong immune system, but it is a complete formula that will support all your pet’s internal systems.”
  • “Many dogs and cats with kidney problems have benefited from the addition of NuVet Plus® to their diet.”
  • “Not only will NuVet Plus® help to manage diabetes by strengthening your pet’s natural defenses, it is also a very complete formula that will support all your pet’s internal functions.”
  • “NuVet® helps to minimizes inflammation and skin damage from a flea bite-mediated itching and scratching response.”
  • “NuVet Plus® contains those ingredients and can help strengthen the immune system to help prevent the development of infections.”
  • “I was hesitant to have another surgery or chemo, & I found NUVET labs!!!! His tumor never came back, I started him on one tablet a day, then decided to give him 2 a day, well...Brando is cancer free...& looking so healthy!!!”
  • “Not only will NuVet Plus® fight infections by creating a strong immune system, it is also a very complete formula that will support all your pet’s internal functions.”
  • After intense research I found NuVet Plus, so I ordered the wafers, the 1st week the new mass was almost gone, 2nd week it had disappeared our Vet was amazed!”
NuJoint Plus®
  • “We’ve designed NuJoint Plus® to be a premium natural anti-inflammatory hip and joint therapy supplement. We use only the highest quality pharmaceutical, human-grade ingredients that are specifically compounded in a FDA-registered laboratory for maximum potency and effectiveness.”
  • “NuJoint Plus® has designed a cutting edge formula that we believe will help increase your pets longevity and quality of life. Our scientists performed extensive research and experiments with the ingredients in NuJoint Plus®, finding the most powerful synergistic defense against the harm caused by osteoarthritis.” 
NuJoint DS®
  • “Introducing the newest addition to the NuVet line of natural products: NuJoint Double-Strength (DS)! This hip and joint therapy supplement can help dogs of all ages by accelerating the healing process and reducing pain quickly – now with increased anti-inflammatory properties!”
  • “NuJoint DS can be used as a preventative measure to help reduce the risk of osteoarthritis and cartilage deterioration.” 
NuVet Labs® Ear Cleaner (also promoted as “NuVet Theraputic [sic] Ear Treatment”)
  • “This is the perfect solution for irritated and infected canine or feline ears.”
  • “Reduces inflammation caused by ear mite infestation” 
Because your productsare 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:
 
CAPT Larry Howell
Acting Director, Compliance Branch
Food and Drug Administration
19701 Fairchild
Irvine, CA   92612-2506
 
If you have any questions about the content of this letter, please contact Marco Esteves, at 949-608-4439, or via e-mail to Marco.Esteves@fda.hhs.gov.
 
 
Sincerely,
/S/ 
CDR Steven E. Porter, Jr.
Los Angeles District Director
 
 
Cc:     
David M. Mazzera, Ph.D.
Chief, Food and Drug Branch
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
Sacramento, CA   95899-7413

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