In this blog, I often rail about how unapproved drugs and illegal dietary supplements find their way into the U.S. market through the internet or mail outlets. I’ve wondered why the FDA is not doing more to stop the game of whack-a-mole where, as soon as the FDA makes an enforcement action against one supplier, another one pops up to fill the void and take over the illicit supply. Well, a new article I read this morning, titled “FDA Scientists Working in Satellite Laboratories Across U.S. Help Prevent Harmful Drugs from Reaching Americans” (here), gave me a glimpse into how the FDA is working to enforce U.S. regulatory and statutory requirements regarding the interception and interdiction of illicit materials entering the United States.

The article states, “Satellite laboratories stationed inside high-volume international mail facilities at airports in Chicago, New York, Los Angeles, Miami—and now Honolulu—are one of the U.S. Food and Drug Administration’s numerous weapons in combating counterfeit and other potentially harmful drugs.” This was news to me, and I’m glad to have a better view of how the FDA is using its various resources to fight the battle and whack those moles down once and for all.

The FDA works “side-by-side with our Office of Inspections and Investigations Office of Import Operations (OIO) colleagues, as well as our U.S. Customs and Border Protection partners, who refer to us any suspicious FDA-regulated drugs or other medical products requiring further analysis.” The lab’s work clearly pays off as evidenced by the fact that “[s]ince 2021, the FDA’s Satellite Laboratory Branch has analyzed and helped block two million lot units (capsules and tablets) of illegal, counterfeit and other unsafe drug and medical products from reaching U.S. consumers and patients.”

The labs use a variety of sophisticated analytical tools to detect illicit and counterfeit substances. While there are many products coming into the U.S. that slip through detection, the FDA satellite laboratories across the United States are part of the good fight that continues to better tighten the borders against illicit drugs, drug substances, and other dangerous novel compounds.

The article points out a few of the many intercepted products that the FDA counts amongst its wins:

  • Tablets containing a novel synthetic opioid with a potency estimated to be twenty-five times greater than fentanyl.
  • Single capsules containing multiple drugs (some of which are controlled substances) including sibutramine, diazepam, fluoxetine, hydrochlorothiazide, furosemide, cimetidine, bupropion, and bisacodyl.
  • Tablets containing 2C-B-FLY, a psychedelic designer drug from the phenethylamine and FLY families (so named for its chemical structure’s resemblance to a flying insect).

The article provided me with greater assurance that the Agency is meeting its mandate of protecting U.S. consumers from dangerous illicit products entering the country and trying to keep one step ahead of the bad guys. Good work, FDA! You just made my day!