The FDA office responsible for overseeing the dietary supplement industry has traditionally been handed a relatively modest budget to carry out its myriad duties.
In the fiscal year that ended Sept. 30, 2019, the Office of Dietary Supplement Programs (ODSP) had a final budget of $7.8 million, which included operating and personnel expenses, Lindsay Haake, an FDA spokesperson, said via email.
That may seem fairly small considering ODSP is responsible for policing an industry with annual sales of $46 billion, according to Nutrition Business Journal. The supplement office, however, received a substantial boost in fiscal year 2020 funding through an omnibus appropriations bill signed by President Donald Trump. Report language in the bill allocated an additional $3 million to ODSP.
That will leave the supplement office with an FY2020 budget exceeding $10 million, Haake said.
“The [Senate Appropriations] Committee applauds the FDA’s inspection of and enforcement actions against manufacturers of dietary supplement products but recognizes that more resources are needed to oversee products that are contaminated, either intentionally or unintentionally, with unsafe ingredients,” the report language stated.
Congress directed ODSP to use the additional funds “towards enforcement of DSHEA [Dietary Supplement Health and Education Act of 1994], including inspection and enforcement activities.”
“The FDA appreciates Congress’s investments in our efforts to effectively regulate the dietary supplement marketplace,” Haake said in an email. “This additional funding is a meaningful increase for an office with the mission to oversee the dietary supplement marketplace in the U.S., which is worth more than $40 billion today, up from $4 billion in 1994, when there were only 4,000 products on the market. Today, current estimates range from 50,000 to 80,000 different products produced through a global supply chain that includes more than 10,000 facilities.”
FDA Office of Dietary Supplement Programs (ODSP): By The Numbers
FY19 final budget: $7.8 million
Increase in FY2020 budget (via congressional appropriations): $3 million
Current number of full-time employees: 25
Steve Mister is president and CEO of the Counsel for Responsible Nutrition (CRN), one of the trade organizations that had lobbied for more funding for ODSP.
He said he anticipates FDA’s supplement office will hire more full-time employees and devote additional staff to review of new dietary ingredient notifications (NDINs) as well as enforcement, coordinating the activities of FDA inspectors in the field.
Ricardo Carvajal, a former FDA lawyer, questioned whether FDA would use additional funds toward such matters as review of NDINs, since Congress expressly directed the agency to allocate the money towards inspection and enforcement activities.
“Nonetheless, the increase in funding should be a welcome shot in the arm for ODSP,” said Carvajal, a director in Washington with the law firm Hyman, Phelps & McNamara P.C., in an email. “It will be interesting to see how FDA puts that funding to use, and whether there is a meaningful increase in judicial proceedings” since the U.S. Department of Justice must bring actions in court on behalf of FDA.
Stuart Pape, another former FDA lawyer, noted the funding increase for ODSP is a sizeable one based on “absolute dollars” and a percentage of the office’s overall budget.
“While there are countless things the office could do with additional funding,” it will need to hire additional personnel to usefully spend the money, said Pape, a shareholder in Washington with the law firm Polsinelli, in an email. That hiring process, the former FDA lawyer added, will take time.
“Obviously, there is a long list of deferred priorities for the office to address,” Pape said in an email.
With the additional funding in FY2020 from Congress, ODSP “intends to enhance its efforts in support of the FDA’s three strategic priorities for implementing and enforcing” DSHEA: “consumer safety, product integrity and informed decision-making,” Haake said. “The FDA is still finalizing specific financial operating plans for FY2020.”
Daniel Gastelu is president of Health Product Business Success LLC, a dietary supplement consulting firm in Sparta, New Jersey. He said he’s been working in the field since the 1970s.
Gastelu recommended ODSP allocate resources in 2020 to develop an official list of old grandfathered ingredients exempt in the law from new dietary ingredient notifications, as well as NDINs and GRAS (generally recognized as safe) notifications to FDA that the agency has not opposed.
“Such a list can be very involved when we consider all the versions of dietary ingredients,” such as botanicals, enzymes and probiotics, he said in an email.
In a 2016 NDI draft guidance, FDA expressed a willingness to develop a list of grandfathered ingredients.
In a follow-up phone interview, Gastelu said compiling a list that he envisioned would be a public process involving publication in the Federal Register, the U.S. government’s official journal.
Asked about the benefits of such a list for consumers and industry, he responded: “It takes the question marks out of the category because now it just reassures people that it is a regulated product category, and here’s the list of ingredients that the FDA considers can be used in dietary supplements.”
FDA Staffing Changes
ODSP has a little over two dozen full-time employees, though it has lost some key officials in recent months, including former deputy director Robert Durkin and former associate director for research and strategy, Sibyl Swift, who earned her Ph.D. in nutrition and M.S. in physiology at Texas A&M University.
The Natural Products Association (NPA) announced this week that Swift had joined the trade organization to serve as senior vice president for scientific and regulatory affairs.
“Dr. Swift played a critical role in nearly every major ODSP initiative over the past several years, and for at least the last year in particular, I relied on her to help ensure the quality of our work product,” Steve Tave, director of ODSP, said in an emailed statement. “We congratulate her on her new role and wish her all the best.”
Tave mentioned his office has lost four employees in less than three months following a long duration of no attrition in its workforce. However, a veteran official, Cara Welch, Ph.D., recently rejoined ODSP as deputy director after serving a detail as special assistant to FDA’s deputy commissioner for policy, legislation and international affairs.
“Fortunately, Dr. Cara Welch’s return last month, along with some new hires last year, will help ease the transition,” Tave said. “[N]evertheless, in an office as small as ours, every person is significant. We look forward to continuing to work collaboratively with all of our stakeholders to pursue our shared goals in furtherance of protecting the public health.”
Haake, the FDA spokesperson, said ODSP is working to fill additional positions but hasn’t finalized the specific number while awaiting completion of its 2020 financial operating plan.