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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Amber Technology, LLC 1/30/14

  

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

Public Health Service
Food and Drug Administration
 Denver District Office
Building 20 -Denver Federal Center
P.O. Box 25087
Denver, Colorado 80225-0087
TELEPHONE: 303-236-3000 

 

January 30, 2014
 
WARNING LETTER
 
 
VIA UPS Overnight Mail
 
Mr. Richard J. Van Komen, Co-Owner
Amber Technology, LLC
1963 Pebble Circle
Lake Point, UT 84074
 
Ref: # DEN-14-03-WL
 
Dear Mr. Komen:
 
This letter concerns your firm’s marketing of numerous veterinary products as “nutraceuticals for pets.” The U.S. Food and Drug Administration (FDA) reviewed your website at the internet address www.ambertech.com, and product labeling obtained during the inspection of your facility at Amber Technology, LLC 1963 Pebble Circle Lake Point, UT 84074 from May 14-16, 2013.
 
We have determined that several of your products marketed as “nutraceuticals for pets” 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)]. Further, 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 your drugs are not generally recognized as safe and effective and therefore your marketing of them without an approved new animal drug application violates the law. 
 
Statements on your website reviewed on December 13, 2013 and January 14, 2014, product catalog and product labeling that show these intended uses of your products include, but are not limited to, the following:
 
Parvaid
  • “Parvaid is most commonly used to help puppies overcome the Parvo virus.” 
  • “Aids in the Fight Against PARVO,”
  • “An herbal supplement formulated to promote normalization of the digestive tract functions in the face of diarrhea, vomiting, gas, cramps, and other intestinal dysfunctions"
 
Vibactra
  • “Plays a key role in attenuating a variety of infections.” 
  • “VIBACTRA An HERBAL, ORGANIC, NATURAL ANTIBIOTIC Alternative WITH ANTIOXIDANTS That May Help Your Pet Overcome VIRAL, FUNGAL AND BACTERIAL INFFECTIONS!***
  • “Vibactra has been known to help: 1. Clear upper respiratory infections 2. Aid in viral infections 3. Aid in bacterial infections 4. Strengthen the immune system Disorders of the immune system cancer of the immune system”
 
 
Vibactra Plus
  • “…an herbal supplement formulated for bacterial, viral and parasitcal [sic] infections.” 
  • "A special combination of herbs demonstrated to enhance immunity through natural antibiotic antioxidant and microscopic parasitical activities".
  • "Vibactra Plus is an herbal supplement for bacterial, viral, and micro-parasitical infections (such as Coccidia and Giardia)"
 
 
Kitty Distempaid
  • “Is safe and effective when used in associating [sic] with the gastrointestinal tract (i.e. quell nausea and emesis (vomiting), affect a calming of the stomach, which facilitates healing of the mucosal lining, elimination of mucosal toxins and normalization of upper gastrointestinal tract function in an accelerated fashion…” 
  • “…can also help: ease travel discomfort, gas, vomiting, diarrhea, corona [virus], distemper, e-coli, giardia, …”
  • “Kitty Distempaid An all-natural dietary supplement. Promotes normalization of abnormal digestive tract function to include diarrhea (in some cases bloody diarrhea), vomiting, gas and more, Feline Distemper (panleukopenia) is a viral DISEASE affecting domestic cats & all other felids”
  • “Kitty Distempaid is safe and effective when used in associating with the gastrointestinal tract*** which facilitates healing of the mucosal lining, elimination of mucosal toxins***and its anti-viral, anti-bacterial, astringent immune-augmentation effects, cardiovascular effects”
 
HWF or Heartworm Free
  • "An aid to help animals fight heartworms".
  • “Helps rid the body of Heart Worms,”
  • “HWF Helps:
  • Reduce the symptoms of heartworms
  • Support Heartworm affected organs
  • Cleanse the vessels of microfilaria and heartworms
  • Relax dilating arteries
  • Diuretic”
 
Canine Distempaid
  • “We highly suggest the following products if your dog has CDV (Canine Distemper Virus) or has been exposed to CDV.”
  • Canine Distempaid™ – Administer 2 times daily to support neurological symptoms of tremors, hard pad, and seizures.
  • Derma NERV™ – Administer 3 times daily as an important part of recovery due to the fact that the virus attacks the nervous system.
  • Vibactra Plus™ – Administer 3 times daily…”
  • “Administer 2 times daily to support neurological symptoms of tremors, hard pad, and seizures.”
     
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 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)]. 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. It is your responsibility to ensure that all of your products are in compliance with the FD&C 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 Matthew R. Dionne, Compliance Officer, U.S. Food and Drug Administration, 6th Avenue & Kipling Street – Building 20 DFC, P.O. Box 25087, Denver, Colorado 80225-0087. If you have any questions about this letter, please contact Compliance Officer Matthew R. Dionne at (303) 236-3064 or email at Matthew.Dionne@fda.hhs.gov.
 
 
Sincerely yours,
/S/
LaTonya M. Mitchell
District Director
Denver District
 
 
cc:      
Ms. Cynthia A. Van Komen, Co-Owner
Amber Technology, LLC
1963 Pebble Circle
Lake Point, UT 84074
 
Mr. Eldon E. Griffiths, Co-Owner
Amber Technology, LLC
1963 Pebble Circle
Lake Point, UT 84074
 
 Ms. Patricia A. Griffiths, Co-Owner
 Amber Technology, LLC
1963 Pebble Circle
Lake Point, UT 84074