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FDA Import Testing Trial Reveals Presence of Pharmaceutical Drugs in ‘Supplements’

The use of portable screening devices in an FDA pilot study revealed the presence of pharmaceutical drugs in products marketed as dietary supplements.

The use of portable screening devices in an FDA pilot study revealed the presence of pharmaceutical drugs in products marketed as dietary supplements.

The location of the screening devices: international mail facilities (IMFs) where FDA monitors importations of products coming from more than 180 countries.

“The pilot study focused on dietary supplements that had label claims for weight loss and sexual enhancement,” Jeremy Kahn, an FDA spokesman, explained in an emailed statement.

Of approximately 240 samples collected and screened in the field, a staggering 65 percent tested positive for undeclared pharmaceutical ingredients, FDA revealed. The agency was looking for such pharmaceutical ingredients as sibutramine, sildenafil and phenolphthalein.

FDA didn’t disclose where the packages originated.

“The study was designed to focus on the use of the instrument and for our purposes did not record/focus on the origin of the packages,” Kahn explained.

FDA conducted a six-month pilot program at two IMFs to examine portable screening devices, ion mobility spectrometers. The devices enable FDA to rapidly test for ingredients originating from overseas, offering an alternative to laboratory testing whose results may not come in for days or even weeks.

Commenting on the screening process in a video, Connie Ruzicka, Ph.D., a research chemist in FDA’s Division of Pharmaceutical Analysis, said, “We’re able to do a quick extraction method on the products of interest and then analyze them within 30 seconds with the instrumentation.”

In a blog Wednesday, FDA officials revealed findings from the pilot study and plans to eventually install portable devices at nine IMFs throughout the United States, Puerto Rico and the U.S. Virgin Islands.

FDA Commissioner Scott Gottlieb, M.D., authored the blog, 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 use of the technology compliments FDA’s other efforts to more effectively screen for illegal products entering the United States. FDA last year increased the number of investigators working at IMFs from eight to 22 full-time employees, Gottlieb and his colleagues said.

The augmented workforce enables FDA to screen 40,000 packages annually; that’s up from 10,000 packages each year, they added.

“These are packages that our partners at CBP [U.S. Customers and Border Protection] have flagged for additional screening in order to intercept and detail what are believed to be nefarious products prior to refusal of admission and possible destruction,” FDA officials wrote in the blog.

It’s challenging work. Before refusing a product’s admission to the United States or possibly destroying it, FDA must establish it’s a drug, necessitating what FDA officials described as a “labor-intensive process” to document the product’s contents.

“Some of the packages may contain loose pills without any packaging or contain hundreds of small internal packages,” Gottlieb and his colleagues wrote. “Screening a single package can take about 20 minutes, while packages that contain multiple products or large quantities can take much longer.”

FDA officials said the portable screening devices have similar accuracy and reliability as laboratory methods. Airport security uses the same technology to swipe luggage for explosives, as well as prisons to screen visitors who possess illegal narcotics, they said.

Results from the pilot study confirmed what FDA already knew: that products marketed as supplements may be laced with undeclared pharmaceutical ingredients. Notorious for drug spiking: products marketed for weight loss, muscle building and sexual enhancement.

“[H]owever, we were not aware of the extent of the problem until we completed our pilot study,” Kahn, the FDA spokesman, said.

At a National Institutes of Health (NIH) workshop on liver injury and dietary supplements held in 2015, an FDA official explained the agency’s use of ion mobility spectrometry at various ports and in the field found high rates of adulterated weight loss and sex supplements: Ninety one percent of 168 weight-loss products screened since 2011 were flagged for possibly containing the drug sibutramine, and 79 percent of male sex/erectile dysfunction products tested showed adulteration with sildenafil.

Such tainted products can adversely interact with prescription medicines and cause harm to consumers, FDA officials and other medical experts maintain.

Even when FDA finds undeclared pharmaceutical drugs and other unlawful products in packages originating from outside the United States, the agency is only scratching the surface.

“It’s estimated that FDA is able to physically inspect less than 0.06 percent of the packages that are presumed to contain drug products that are shipped through the IMFs,” FDA officials revealed, noting the IMFs combined receive more than 275 million packages annually.

 

 

 

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