For the fiscal year that ended Sept. 30, 2016, FDA’s Office of Dietary Supplement Programs (ODSP) had a budget of US$4.6 million to police an industry with tens of billions of dollars in sales and tens of thousands of products on the U.S. market.
The Council for Responsible Nutrition (CRN), a trade organization in Washington representing the dietary supplement industry, is seeking $5 million above current funding and has been in talks with lawmakers who hold the government’s purse strings.
Mike Greene, senior vice president of government relations with CRN, said his organization has met with more than 50 appropriators on Capitol Hill.
“Generally, everyone we meet with—Republican or Democrat—is supportive of the idea," he said. “They understand this a growing industry."
Explained Greene in the first of two interviews on the subject: “We’re hopeful we get funding now, but if we don’t or if we get less funding, we’ll be focused on this over the long haul, probably the next three years, working to ensure that adequate funding is given to the Office of Dietary Supplement Programs."
ODSP’s director, Steven Tave, and his staff of 25 in College Park, Maryland, face a daunting task: policing a $41 billion industry.
In 1994, the year Congress passed the Dietary Supplement Health and Education Act (DSHEA), there were an estimated 4,000 products on the market, according to FDA. Twenty years later, the number of dietary supplements on the market exceeded 85,000, according to FDA estimates in 2014.
In late 2015, FDA’s Division of Dietary Supplement Programs was elevated to an office. As FDA explained in its FY18 budget report to Congress, the move “further enhances the effectiveness of dietary supplement regulation by allowing ODSP to better compete for government resources and capabilities to regulate this rapidly expanding industry."
However, Greene said to some extent, there was no immediate follow-up to ensure FDA supplement officials received additional resources.
In FY16, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) provided ODSP $4.6 million, the agency disclosed to the Senate Committee on Appropriations. Michael Felberbaum, an FDA spokesman, said in an email to INSIDER that ODSP’s FY17 budget is $6.5 million.
FY16 FDA Dietary Supplement Activities
678 domestic inspections
99 foreign inspections
83 warning letters
6 untitled letters
Source: FDA FY18 budget request to Congress
Appropriators on Capitol Hill with whom CRN has met “believe that an office should be funded appropriately because these are products that we put into our bodies," Greene said. “We have to be very concerned with public health."
While FDA’s FY18 budget request to Congress doesn’t specify a requested funding level for ODSP, CFSAN may have an incentive to boost FY18 funding for dietary supplement activities if it receives such direction from Congress in House and Senate appropriations committee reports.
Nonetheless, Steven Grossman, deputy executive director of the Alliance for a Stronger FDA, cautioned, “Technically, FDA doesn’t have to follow the report language—just be prepared to explain what it did or didn’t do in response to it. As a practical matter, they are not going to say that they didn’t follow Congress’ direction."
On June 20, FDA Commissioner Scott Gottlieb, M.D., appeared before the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies.
During the hearing to discuss President Trump’s FY18 request and the budget justification for FDA, lawmakers discussed with Gottlieb a range of issues from the opioid epidemic to prescription drugs to regulations impacting premium cigars.
Dietary supplements weren’t mentioned. On a broader level, lawmakers expressed concerns about FDA’s ability to carry out its duties under Trump’s proposed budget.
Excluding a proposal to increase user fees and the mandatory funding through the 21st Century Cures Act of 2016, FDA’s FY18 budget features a 34 percent cut, according to Sen. Patrick Leahy, a Democrat from Vermont.
“The cuts include $119 million from monitoring food safety and a $55 million reduction in medical product safety," Leahy said in a statement. “In my many years in the Senate, I have heard repeatedly that the FDA needs more, not less, resources to adequately fulfill the agency’s mission."
In response to a question from Sen. Jon Tester (D-Montana) regarding expedited review of generic drugs under Trump’s budget proposal, Gottlieb conceded, “These are challenging budgetary times, and we’re going to have to figure out ways to do more with less."
While Greene of CRN acknowledged the budgetary constraints under the Trump administration, he described a $5 million increase in ODSP’s budget as “a drop in the bucket" relative to FDA’s overall budget ($5.1 billion in requested appropriations for FY18).
CRN is seeking additional funds for ODSP to increase dietary supplement inspections and bolster enforcement activities to target companies that violate the law, such as dietary supplement firms that spike products with pharmaceutical ingredients. ODSP has faced criticisms on occasion for moving too slowly against “bad actors" in the industry, while the agency has cited limited resources and its focus on safety in prioritizing its work.
Concluded Greene: “We are a growing and robust industry, and therefore, we should have an office that matches the industry growth and is able to inspect and enforce all the things that they [FDA officials] need to fully implement the Dietary Supplement Health and Education Act."
The following members of Congress did not respond to requests for comment for this article: Sens. John Hoeven (R-North Dakota) and Jeff Merkley (D-Oregon), the chairman and ranking member of the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration; Reps. Robert Aderholt (R-Alabama) and Sanford Bishop (D-Georgia), the chairman and ranking member of the corresponding appropriations subcommittee in the House; and Sen. Dick Durbin (D-Illinois), who has introduced dietary supplement legislation in previous years and cited shortcomings with the current regulatory framework at FDA.