FDA WARNING_LETTER - CanAmerica Global

The FDA issued a Warning Letter to CanAmerica Global for offering unapproved new drugs and misbranded drugs for sale on numerous websites, including locuspharma.com and canamerica.com. The FDA determined these products violate sections 301(a), 301(d), 503(b), and 505(a) of the FD&C Act.

Specifically, the company is selling "Allerject," an injectable epinephrine product, which is an unapproved new drug under section 201(p) of the FD&C Act because it lacks FDA approval and is not generally recognized as safe and effective for its labeled uses. No approved applications under section 505 of the FD&C Act are in effect for "Allerject." This is particularly concerning as "Allerject" devices were subject to a 2015 recall in Canada due to a drug delivery malfunction.

Furthermore, "Allerject" is a misbranded drug under section 502(f)(1) of the FD&C Act because, as a prescription product for conditions not amenable to self-diagnosis, it lacks adequate directions for layperson use. Its unapproved status means it is not exempt from this requirement under 21 CFR 201.115.

The FDA emphasizes the inherent risk to consumers from unapproved and misbranded drugs, which may be contaminated, counterfeit, or have inconsistent