Jason Sapsin was quoted in the NutraIngredients-USA article, "Is FDA Doing Enough To Stem Tide of Tainted Products? Probably Not." Full text can be found in the August 28, 2014, issue, but a synopsis is below.
A review of recent FDA enforcement actions against tainted products marketed as dietary supplements helps to highlight the problem facing regulators and the limitations they operate under in dealing with it.
The period before an enforcement action is taken by the FDA against a tainted product can range from months to more than a year or even multiple years.
Jason Sapsin, former associate chief counsel of the FDA and current Fox Rothschild partner, offered insight from his time with the agency, saying that the FDA's response to tainted products is complicated by resource limitations and an institutional aversion to risk.
"There are so many resource limitations and then there is the question of the agency's will to enforce," Sapsin said. "The resource limitations come in the form of a limited number of inspectors to go out and do inspections and take samples. Then, are there enough compliance officers to evaluate the cases, enough lab capacity to run the tests and so forth."
"Then there is the issue that the agency is extremely reluctant to lose cases, so it works extremely hard to gather all the facts it can to be very procedurally exacting both in the policy it imposes on itself and in fulfilling the legal requirements for filing a complaint," Sapsin added. "It all results in significant under-enforcement."
Sapsin noted that in years past, the FDA had a culture that downplayed enforcement and emphasized the agency's role as an industry partner and teacher. While that has changed in recent years and enforcement is now a priority, Sapsin said the shift in culture could take time.
"We are fortunate here in the U.S.," he said. "By the global standards of public health disaster, with high morbidity, the U.S. has not had one of these events. We do have bad events, but there has not been that level of death that would make either the political system or industry or the public sit up and say, things have got to change."
"The relative ease with which companies can move into and out of this marketplace means there is a huge upside for companies that want to game the system," Sapsin said. "There are more targets for enforcement and the agency is more willing to pursue these companies and enforce the law. But the real question is, is it enough? The answer is, probably not."
"The question of whether to give a regulatory agency like FDA more resources is unfortunately a highly political question and from a public health standpoint it ought not to be," he said.
Originally published by NutraIngredients-USA
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