FDA WARNING_LETTER - Royer Animal Health, LLC

On January 13, 2010, the FDA issued a Warning Letter to Royer Animal Health, LLC, regarding violations concerning their "R-Gel Antibiotic Wound Dressing" for horses, dogs, and cats. The FDA's review of the product label and the firm's website, www.royerah.com, revealed that R-Gel is an unapproved new animal drug and is misbranded.

R-Gel is deemed an unapproved new animal drug under section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)] because it is unsafe within the meaning of section 512 of the Act [21 U.S.C. § 360(b)]. The product's label and website statements, such as "Proven effective against numerous localized infections" and "Contains Amikacin and Clindamycin to treat traumatic wounds and local infections," establish its intended use as a drug. However, it is not "generally recognized...as safe and effective" for these uses, making it a "new animal drug" without an approved new animal drug application (NADA), violating section 512(a)(1) of the Act [21 U.S.C. § 360b(a)(1)].

Furthermore, R-Gel is misbranded under section 502(o) of