FDA's plans to increase prosecutions of noncompliant food and drug industry officials, as recommended by an internal committee, should include the dietary supplement market, stakeholders say.

Commissioner Margaret Hamburg stated the agency's plans in a March 4 ¹ letter to Sen. Charles Grassley, R-Iowa, following the same-day release of a Government Accountability Office ² report critical of FDA's criminal investigations activity.

Hamburg said an internal committee recommended the agency's Office of Criminal Investigations "increase the appropriate use of misdemeanor prosecutions, which allows responsible corporate officials to be held accountable and is a valuable enforcement tool."

Supplement industry stakeholders have criticized FDA's lack of prosecution activity against firms that market adulterated products. They point out the Dietary Supplement Health and Education Act gives FDA authority to criminally prosecute businesses and individuals marketing products that contain drug ingredients or that should have filed new dietary ingredient notifications.

Food and drug attorney Marc Ullman, a frequent critic of FDA's supplement regulation enforcement, said there is reason to expect some enforcement activity from FDA based on the GAO report and on Hamburg's letter to Grassley.

"I imagine [the report] could have some positive effects. We'd welcome some criminal cases," Ullman said.

He said the industry "is aware that there is an ongoing problem" with weight-loss, sexual-enhancement and sports-training supplements adulterated with Rx ingredients, and with "economic adulteration" by manufactures using lower-quality and less-expensive ingredients than listed on their product labels.

However, given FDA's enforcement history in the supplement arena, Ullman said he does not expect prompt action. "Institutional change comes very slow," he observed.

Meanwhile, FDA's practice of sending warning letters to firms marketing adulterated supplements will continue to have little effect on slowing the availability of such products, he added.

"There's no fear of a warning letter. I've heard it many times, 'What's the worst that's going to happen to me, a warning letter?'"

The prevalence of supplements spiked with steroids or steroid-like ingredients prompted the New York Police Department to prohibit officers from using supplements found by FDA and other regulators to be adulterated.

According to the December 2009 NYPD Personnel Bureau memo stating the ban, demand for steroids "creates an illegal market" for spiked supplements "that is supported through organized crime."

Monitoring OCI

Following the review requested by Grassley, GAO recommended FDA regularly monitor OCI and establish a process to monitor the Office of Internal Affairs' compliance with the agency's investigative policies. The report also recommends FDA establish performance measures to assess whether OCI achieves results.

"Although OCI and OIA have policies that govern how they conduct investigations, FDA's oversight of these investigations has been limited. FDA has established a process to ensure compliance with OCI's policies, but it does not routinely carry out this process as only about 30 percent of the OCI field office assessments have been completed," according to the report.

Hamburg said FDA agrees with the findings. The internal committee of senior FDA leadership also recommended the agency improve procedures for information-sharing between OCI and other components with the goal of enhanced alignment of criminal/regulatory priorities and activities.

According to Hamburg's letter, the committee recommended FDA strengthen its mechanisms to "ensure that senior leaders share information and coordinate strategic priorities to align criminal enforcement and regulatory activities" and "enhance its debarment and disqualification procedures."

- Malcolm Spicer ( ³ m.spicer@elsevier.com )

FDA Agrees With GAO Recommendations To Give Prosecutions Higher Priority

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