FDA Names Individuals Barred From Importing Drugs or Controlled Substances for 5 Years
The FDA has named several individuals barred for importing drugs or certain controlled substances for five years because of convictions involving past imports, according to recent Federal Register notices.
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Michael Dominic Diaz, who was affiliated with Proximo Research and Gulf Coast Chems, was found to be misbranding prescription drugs. The drugs, Clonazolam, Flubromazolam, Fluclotizolam, O-Desmethyl-cis-tramadol (ODSMT) and 2-Methyl-AP-237 (2MAP), were not approved by the FDA for use in the U.S., but they were available for sale and sold to sellers located outside the U.S. and primarily from China. Once the orders were placed, the drugs were repackaged into consumer-size containers and shipped to customers throughout the U.S. The drugs were packaged with disclaimers that they were “for research purposes only” and “not for human consumption” in an attempt to evade FDA's regulatory oversight and authority, the FDA said.
As the operator of Proximo Research, Evan Asher Field was found to be misbranding prescription drugs under the same conditions as Diaz.
Justin Cole Henry was convicted of a felony under federal law for possession with intent to distribute a Schedule III controlled substance, the FDA said. Henry had purchased large volumes of anabolic steroids, including testosterone (17β-hydroxyandrost-4-en-3-one), a Schedule III controlled substance, from mostly overseas wholesale vendors, and he repackaged the drugs and sold them to customers under his own label, American Muscle Labs.
Carlton Reico Mallard Jr. was owner of Golden Royal Honey USA, where he marketed and sold misbranded drugs, specifically male enhancement products, that were unlawfully imported into the U.S. Three products sent for laboratory analyses -- Leopard Miracle Honey, Vitamax Double Shot Honey and Golden Royal Honey VIP -- at the FDA Forensic Chemistry Center were confirmed to have sildenafil present in the Leopard Miracle Honey, and tadalafil present in both Vitamax Double Shot Honey and Golden Royal Honey VIP. These substances violate the Federal Food, Drug and Cosmetic Act.