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Re: RocketMan14 post# 16308

Friday, 11/20/2015 3:29:48 PM

Friday, November 20, 2015 3:29:48 PM

Post# of 38250
"We have determined that your products are drugs as defined by 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)], as the products are intended for use in the mitigation, treatment, or prevention of disease in animals. As discussed below, the products are unapproved new animal drugs and your marketing of them violates the FD&C Act."

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