FDA WARNING_LETTER - JCM Dropship - September 06, 2019

The FDA and DEA issued a Warning Letter to JCM Dropship on September 6, 2019, for unlawfully selling opioids and unapproved/misbranded drugs to U.S. consumers via the internet.

The DEA determined JCM Dropship violates the Ryan Haight Online Pharmacy Consumer Protection Act (RHA) by offering and advertising controlled substances, including opioids, without a modified DEA registration. JCM Dropship operates as an "online pharmacy" and an agent bringing together buyers and sellers of controlled substances without proper authorization, violating 21 U.S.C. §§ 841(h) and 843(c).

The FDA determined JCM Dropship introduces unapproved new drugs and misbranded drugs into interstate commerce, violating sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, products like "Top-Tram" (tramadol) are unapproved new drugs lacking FDA approval and are misbranded because they lack adequate directions for use by a layperson and are sold without a prescription, despite being prescription-only drugs with significant risks (e.g., addiction, respiratory depression, neonatal opioid withdrawal syndrome).

JCM Dropship is directed to immediately cease offering violative drugs for sale and notify DEA and FDA within