"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.