Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm455249.htm
Timestamp: 2019-02-17 04:06:10
Document Index: 294342722

Matched Legal Cases: ['§ 321', '§ 321', '§ 321', '§ 360', '§ 360', '§ 360', '§ 351', '§ 352', '§ 352', '§ 352']

Hoof Health LLC dba Hoof Effects 7/9/15
Refer to MIN 15 - 13
Jeremy J. Kastner
Hoof Health LLC dba Hoof Effects
W330 S3794 Honeysuckle Drive
Dousman, Wisconsin 53118-9779
This letter concerns your firm’s marketing of the product Hoof Effects, a footbath solution for lactating dairy cattle containing tetracycline hydrochloride, an antibiotic, and formaldehyde, among other ingredients. The U.S. Food and Drug Administration (FDA) inspected your facility, Hoof Health LLC dba Hoof Effects, located at N4525 County Road D, Door #12, Helenville, Wisconsin, on December 1, 5, and 11, 2014. The FDA also reviewed your product labeling.
We have determined that Hoof Effects is a drug as defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (“the FD&C Act”), 21 U.S.C. § 321(g)(1), as it is intended for use in the mitigation, treatment, or prevention of disease in animals, and/or to affect the structure or function of the body of animals. As discussed below, this product is an unapproved new animal drug and your marketing of it violates the FD&C Act. Statements on your product labeling and promotional material that establish the intended uses of your product include, but are not limited to, the following:
• “Hoof Effects Foot Solutions is a foot bath designed to maintain foot health”
• “... the most efficient and effective hoof health”
• “Prevents warts”
• “Cleans up hoof rot, heel cracks, and ulcers”
Because Hoof Effects is intended to mitigate, treat, or prevent disease in animals, and/or to affect the structure or function of the body of animals, the product is a drug within the meaning of section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1). Furthermore, the product is a new animal drug, as defined by section 201(v) of the FD&C Act, 21 U.S.C. § 321(v), because it is 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. To be legally marketed, a new animal drug must have an approved new animal drug application (NADA), 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.
You are using tetracycline hydrochloride soluble powder as an ingredient in the formulation of your product. Although tetracycline hydrochloride soluble powder is an approved drug, your use of tetracycline hydrochloride soluble powder in your product is not a use covered by its approved application, and your product is 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 product is unsafe under 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).
Misbranded New Animal Drug
Your Hoof Effects product is misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. § 352(f)(1), in that its labeling fails to bear adequate directions for use. The product label provides inadequate directions to determine appropriate footbath replenishment in order to maintain potency of the solution. The label also lacks adequate directions on the proper disposal of the used solution and any residual undiluted product.
In addition, your Hoof Effects products is misbranded under section 502(e)(1)(A)(ii) of the FD&C Act, 21 U.S.C. § 352(e)(1)(A)(ii), in that its label fails to include the established name for each active ingredient and the strength or concentration of each active ingredient. The product label indicates the product contains oxytetracycline when it, in fact, contains tetracycline hydrochloride soluble powder and the label fails to include the strength or concentration of any of the active ingredients.
Furthermore, your Hoof Effects product is misbranded under section 502(o) of the FD&C Act, 21 U.S.C. § 352(o), because the drug has not been listed as required by section 510(j) of the Act, 21 U.S.C. 360(j). Although following the inspection you registered your facility as a drug establishment, you have not provided a list of drugs being manufactured for commercial distribution.
FDA reviewed your January 6, 2015, letter responding to the form FDA-483, Inspectional Observations, issued at the close of the inspection. FDA remains concerned that you continue to market this product containing tetracycline hydrochloride and formaldehyde without an approval. In addition, although you claimed you would amend your label “to comply with animal drug labeling requirements,” you did not specifically address the labeling issues discussed above or submit a copy of your revised label.
This letter is not intended to be an all-inclusive review of all 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 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 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 Brian D. Garthwaite, Ph.D., Compliance Officer, U.S. Food and Drug Administration, at the address listed on this letterhead. If you have any questions about this letter, please contact
Dr. Garthwaite at (612) 758-7132.
Hoof Health LLC dba Hoof Effects - Close Out Letter 3/7/16