FDA WARNING_LETTER - hoof health llc - December 11, 2014

The FDA issued a Warning Letter to Hoof Health LLC dba Hoof Effects following a December 2014 inspection. The letter concerns their product, Hoof Effects, a footbath solution for lactating dairy cattle containing tetracycline hydrochloride and formaldehyde.

The FDA determined Hoof Effects is an unapproved new animal drug, violating sections 201(g)(1) and 201(v) of the FD&C Act. Labeling and promotional materials indicate intended uses for disease mitigation, treatment, or prevention, and affecting animal body structure/function (e.g., "Prevents warts," "Cleans up hoof rot"). Although tetracycline hydrochloride is an approved drug, its use in Hoof Effects is not covered by an approved application, rendering the product unsafe (section 512(a)) and adulterated (section 501(a)(5)).

Furthermore, Hoof Effects is misbranded under multiple sections of the FD&C Act: - Section 502(f)(1): Inadequate directions for use regarding footbath replenishment, potency maintenance, and disposal of used solution/residual product. - Section 502(e)(1)(A)(ii): Label fails to include the established name and strength/concentration of each active ingredient (e.g., listing oxytetracycline instead of tetracycline hydrochloride). - Section 502(o): Drug not listed as required by