Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm384594.htm
Timestamp: 2019-04-26 03:46:53+00:00

Document:
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.
“An herbal supplement formulated to promote normalization of the digestive tract functions in the face of diarrhea, vomiting, gas, cramps, and other intestinal dysfunctions"
"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)"
"An aid to help animals fight heartworms".
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.
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.

References: § 321
 § 321
 § 321
 § 360
 § 351
 § 331