Washington, D.C. — A U.S. Food and Drug Administration (FDA) pilot study using portable screening devices has revealed the presence of pharmaceutical drugs in products marketed as dietary supplements.
The FDA recently concluded a six-month pilot at two international mail facilities (IMFs) where the FDA monitors the import of products coming from more than 180 countries. The FDA currently has staff working at nine IMFs throughout the U.S., Puerto Rico and the U.S. Virgin Islands. Investigators are responsible for monitoring mail importations of FDA regulated products by conducting comprehensive examinations of suspect packages.
According to a blog posted on the U.S Food and Drug Administration website, and authored by FDA Commissioner Scott Gottlieb, M.D., along with two colleagues: Melinda Plaisier, M.S.W., FDA’s associate commissioner for Regulatory Affairs; and Michael Kopcha, Ph.D., director of the Office of Pharmaceutical Quality at FDA’s Center for Drug Evaluation and Research (CDER), the study was done to test whether the agency could increase the number of packages screened by making use of the portable screening devices, or ion mobility spectrometers. This is the same technology used by airport security to swipe luggage for explosives and by prisons to screen visitors for illegal narcotics.
The device works by comparing the chemical signature of the unknown substance against the chemical signatures of known compounds in a process that takes less than 30 seconds.
For the pilot, the devices tested whether products marketed for weight loss and sexual enhancement contained undeclared drug compounds such as sibutramine, phenolphthalein and sildenafil.
These compounds have significant safety concerns and are often counterfeited; and are commonly found within packages coming into the IMFs. When criminals secretly spike products with these compounds, consumers do not know that they are at higher risk of harm from the products.
Sixty-five percent of the samples screened tested positive for the presence of undeclared pharmaceutical ingredients, results that were confirmed in a FDA laboratory.
Based on these results, the agency plans to expand the use of the technology and add them to two additional IMFs, with the intention of using them in all nine IMFs.
The agency eventually plans to develop an opioid screening method for the device.