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FDA Warns Emu Products & Management

WASHINGTON — Emu Products & Management, Inc. last year found itself having to answer to FDA over marketing claims on its website,

"The claims on your website indicate establish that these products are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the human body, rendering them drugs under the [Federal Food, Drug, and Cosmetic] Act," FDA stated in a Nov. 19, 2012 warning letter addressed to Tony Anderson, president of Emu Products & Management. "The marketing of these products with these claims evidencing these intended uses violates the Act."

FDA declared the following products are promoted for uses that cause them to be drugs: ARP Gel Caps, Extreme Cryo Gel, F.A.C.E. Doctor, Multi-Omega Gel Caps, Pure Emu Oil, Recover Gel Caps and Skin Doctor.

FDA also said certain products — including Multi-Omega Gel Caps, Recovery Gel Caps and Skin Doctor — are "misbranded" since they fail to include adequate directions for use.

"Multi-Omega Gel Caps, Recovery Gel Caps, and Skin Doctor products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes," the agency wrote.

Emu Products & Management, which was given 15 days to address FDA's letter, did not respond immediately Tuesday to an emailed request for comment.

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