FDA WARNING_LETTER - Firsttrustchemicals.com - March 20, 2019

On March 20, 2019, the FDA issued a Warning Letter to Firsttrustchemicals.com for unlawfully selling unapproved and misbranded opioids to U.S. consumers via the internet. The FDA determined that the website introduces opioids, specifically "fentanyl powder," into interstate commerce in violation of sections 301(a), 301(d), 503(b), and 505(a) of the FD&C Act [21 U.S.C. §§ 331(a), 331(d), 353(b), and 355(a)].

The products are deemed "unapproved new drugs" because they are intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect body structure/function, and are not generally recognized as safe and effective for their labeled uses. No FDA-approved applications under section 505 of the FD&C Act are in effect for these products. The sale of unapproved opioids is particularly concerning due to their potential for abuse and dependency amidst the U.S. opioid epidemic.

Furthermore, the drugs are "misbranded" under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] because they lack adequate directions for use. As prescription drugs