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

Public Health Service
Food and Drug Administration
 
Southwest Region
Kansas City District
8050 Marshall Drive
Suite 205
Lenexa, Kansas 66214-1524
913-495-5100 

October 7, 2016

WARNING LETTER
Ref. CMS Case: 495135
FEI: 3004400178
 
DELIVERY VIA UPS
 
Ms. Kay M. Fox, Owner
Buck Mountain Botanicals, Inc.
HC 30
Miles City, Montana 59301
 
Dear Ms. Fox:
 
This letter concerns your firm’s marketing of numerous unapproved drugs for animals, including but not limited to, Neoplasene Oral, Neoplasene Topical, NeoplaseneX with methyl sulfoxide, NeoplaseneX with saline solution, Hawthorn for the Heart, Thyrolyte, Lepsilyte, Parasite Dust for Animals, Uva Ursi for Animals, and Bugleweed. The U.S. Food and Drug Administration (FDA) reviewed your website at the internet address www.buckmountainbotanicals.net, where you promote 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 that establish the intended uses of your products include, but are not limited to, the following:
 
Neoplasene Oral, Neoplasene Topical, NeoplaseneX with methyl sulfoxide, and NeoplaseneX with saline solution:
Hawthorn for the Heart
Thyrolyte
Lepsilyte
Parasite Dust for Animals
Uva Ursi for Animals
Bugleweed
Because your products are intended to prevent, mitigate or treat disease 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, the 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 and their promotion. The above referenced products are only a sampling of the violative products you are currently marketing. 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 directed to: Eric Mueller, Compliance Officer, U.S. Food and Drug Administration, Omaha Resident Post, 10918 John Galt Blvd., Omaha, NE 68137. If you have any questions, please do not hesitate to call CO Mueller at: 402-331-8536 ext. 101 or send him an email at eric.mueler@fda.hhs.gov.
 
Sincerely,
/S/
Cheryl A. Bigham
District Director
FDA Kansas City District Office

This page was posted on March 28, 2019.

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