“Hidden ingredients are increasingly becoming a problem in products promoted for bodybuilding, weight loss and sexual enhancement,” the agency notes on a new web page that details all the drug spiking enforcement actions it has taken.
These include recalls, warning letters and consumer alerts. The FDA page can be found here.
Serious risk
In an excerpt from the latest American Herbal Product Association (AHPA) Report, AHPA president Michael McGuffin and the group’s general counsel, Anthony L Young, write that the FDA action is no surprise given recent statements from the agency.
They note that Dr Joshua Sharfstein, the FDA Principal Deputy Commissioner, gave testimony at a late-May Senate Special Committee on Aging, where Sharfstein said of all its dietary supplement regulation concerns the greatest was, “without question … the pharmaceutical spiking of dietary supplements because we’re talking about very serious risk and injuries that can happen to people.”
McGuffin and Young note that the FDA spiking actions should serve as a warning to the whole industry.
“These cases are felony indictments and it appears from the allegations that these individuals knew that they were distributing spiked products,” they write.
“But they are a warning as well to companies that may inadvertently market products in these categories that contain drugs due to illegal actions by a remote manufacturer.”
They add that the agency could employ criminal liability powers if the problem is not curtailed.
“And because this is an international problem, do not be surprised if Interpol and other international law enforcement agencies begin to move in concert against those who are perpetrating it.”
FDA spiking enforcement page
On its enforcement page the FDA states: “Consumer may unknowingly take products laced with varying quantities of approved prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients.”
Whilst the page contains more than 60 actions dating to at least 2006, the agency notes that it cannot test all products on the market.
“Enforcement actions and consumer advisories for tainted products only cover a small fraction of the tainted over-the-counter products on the market,” it observes.
The AHPA is presenting a two-day seminar on “Microscopic Identification of Popular Botanical Materials” on November 13-14 at the University of Southern California’s School of Pharmacy in Los Angeles.
It aims to help manufacturers and suppliers meet Good Manufacturing Practices (GMPs).