In the United States, consumers spend tens of billions of dollars a year on dietary supplements, according to Nutrition Business Journal.
But FDA’s responsibility to police a vast array of commodities—including conventional food, pharmaceutical drugs and tobacco products—may seemingly overshadow its oversight of supplements. The agency’s Office of Dietary Supplement Programs (ODSP) is staffed with two dozen employees, a tiny fraction of its total headcount—more than 17,000 workers.
However, a recent announcement to modernize FDA’s regulation of dietary supplements highlighted the agency’s focus on an industry with an estimated 50,000 to 80,000 products on the market. The widely reported statement was made by Scott Gottlieb, a physician who was sworn in as FDA’s 23rd Commissioner in 2017.
Steven Tave, director of ODSP, weighed in on the significance of Gottlieb’s statement.
“Maybe the most significant thing is we have an FDA commissioner for the first time in recent history, and probably longer, addressing dietary supplements and saying, ‘This is an agency priority and an area where we want to do more,’” Tave said in an interview with Natural Products INSIDER. “Even though the statement itself doesn’t say that, to me, that’s one of the most powerful parts of it.”
ODSP is charged with policing an industry that has grown more than 10-fold over the last quarter century. In 2018, U.S. sales of supplements generated an estimated US$45.8 billion, reflecting 5.7 growth over the previous year, according to Nutrition Business Journal.
In revealing his plans to strengthen FDA’s regulation of dietary supplements, Gottlieb expressed concern that “changes in the supplement market may have outpaced the evolution of our own policies and our capacity to manage emerging risks."
Tave said his office has met with Gottlieb, whom he observed has been “very receptive to learning about what’s going on in different parts of the agency.”
Despite Gottlieb’s recent announcement, Tave suggested ODSP isn’t planning to move in a radically new direction when it comes to oversight of supplements.
“It’s not the case that it’s going to continue to be business as usual,” Tave said, commenting on enforcement and policy changes. “But I also don’t think that you are going to see a significant change in direction from what we’ve been doing over the past year or two or three. This [statement by Gottlieb] was really an agency articulation of the direction our program has been moving.”
But Tave added he anticipated “more coordination from an agency-wide perspective.”
“Instead of just hearing from ODSP, it’s going to become an FDA priority [and] FDA initiative,” he explained.
‘Twin pillars’ of DSHEA
ODSP continues to be focused on three priorities: ensuring safety; maintaining product integrity; and informed decision-making. In the coming months and beyond, Tave predicted his office would drive “novel approaches” to promote those priorities.
Tave recognized the balance struck in the law 25 years ago when Congress passed the Dietary Supplement Health and Education Act of 1994 (DSHEA).
“We have this framework established by DSHEA, which has these twin pillars of consumer access to safe, well manufactured, accurately labeled products combined with an agency responsibility to protect the public from dangerous or illegal products,” he said. “We’re going to look for ways that we can protect and promote the public health while we stay within those two boundaries.”
As an example of preserving the “twin pillars” in DSHEA, Tave referenced FDA guidance adopted last year regarding pure or highly concentrated caffeine in powder or liquid forms. FDA asserted such products are considered unlawful when sold in bulk amounts to consumers, due to the significant health risks they pose.
“We don’t want to sweep with an overly broad brush,” Tave noted. “It would have been foolish to say, ‘Caffeine is all dangerous.’ That wouldn’t pass the laugh test. It also wouldn’t really help anybody.”
Instead, FDA developed “a narrowly targeted approach” that promoted access to safe products while protecting consumers from harms the agency identified, he said.