By Steve Myers
Editor's Note: This article was orginally published on Natural Products Insider, an Informa Exhibitions media outlet covering the dietary supplement industry.
In a March 4 House Appropriations Agriculture subcommittee hearing on the 2016 FDA budget, outgoing FDA commissioner Margaret Hamburg, M.D., defended her agency’s request for a significant increase in funding and touched upon issues such as food safety, GMO labeling and dietary supplement regulation.
Hamburg, who ends her six-year run as FDA Commissioner at the end of this month, talked mostly about food safety and FSMA, the Food Safety Modernization Act. Of the agency’s largest ever budget request of $4.9 billion, which is $400 million more than the current year budget, nearly $150 million would go to food safety, up $109 million from current funding. Rep. Hal Rogers (R-KY), chairman of the full Appropriations committee, said he was concerned about the size of the overall budget request and the huge amount for FSMA would be “hard to swallow."
Rep. Robert Aderholt, chairman of the Agriculture subcommittee, said while FDA reportedly regulates 20 percent of each U.S. consumer dollar spent on products, “the size of FDA’s fiscal year 2016 request includes increases for budget authority that disregard the debt crisis facing our nation." He said FDA must prove the funds needed cannot come from base resources and must look for potential savings and efficiencies—no overlap with other agencies. “The subcommittee funding level will stay flat, at best," he warned.
While most committee members speaking during the hearing praised the work Hamburg has done, many asked for and sometimes demanded more.
There were questions about inspecting foreign food suppliers. “I am concerned about the obstacles created by the Chinese got to our inspection of foreign food and drug products," Rogers said, noting he would like to see an even playing field. “If domestic manufacturers are subjected to extensive regulations, so should foreign suppliers."
Hamburg noted there are eight FDA staff stationed in China, with five more pending. She said they use the FDA office there as a hub for inspections throughout the large country. “There are many manufacturers in China we want to know about," she said, referring to efforts to ensure Chinese suppliers meet quality standards. “Yet, it is much more costly to conduct inspections overseas. One effort that may help, she noted, is the potential sharing of inspection data amongst the big buyers of Chinese foods, such as the European Union, Brazil, Canada and Australia.
Dietary supplement regulation only came up when Rep. Nita Lowey (D-NY), ranking member of the full committee, brought up the New York Attorney General’s recent investigation of herbal supplements sold at major retailers in the state. The investigation—the testing for which has been challenged by herbal experts both in and out of the supplement industry—found many herbal extract supplements did not contain what was on the label and, in some cases, contained contaminants.
“I’m really concerned about what that means for those with allergies, who may not know that supplements they consume may be contaminated by other substances which could cause the individual great harm," Lowey said. She asked Hamburg if dietary supplements should be evaluated at a higher standard and how should labeling standards be improved to make sure that allergens are properly disclosed?
“Many Americans are surprised to learn that dietary supplements are not subject to the same premarket review and approval process that drugs are," Hamburg said, adding the agency does have responsibilities with respect to claims and oversight of GMPs (good manufacturing practices) and companies are required to report serious adverse event reports to FDA. “We do monitor dietary supplements, and we are sadly called to action, in terms of enforcement, periodically because of findings dietary supplements contain unapproved drugs, various kinds of contaminants or are making claims that are false or misleading."
Hamburg noted the regulatory challenge is heightened by the increase in supplements coming in from all over the world via complex supply chains. “It’s an area I think we are concerned about, and we continue to act within in the responsibilities we’ve been given for oversight of dietary supplements," she said. “Certainly when we hear of concerns, we respond."
Hamburg reported there are many reputable manufacturers in the supplement industry. “We want to work closely with industry and the responsible players in the industry to see how we can ensure a higher level of quality," she said. “But we do not have the authority for premarket review nor the resources." She suggested Congress could undertake a discussion on premarket review in light of some of its concerns.
When Lowey asked if it would take an act of Congress to change the standards and expand FDA’ authority over dietary supplements, Hamburg said yes, but “it would b e a very large task for us."
Labeling of genetically modified organisms (GMOs) in foods was brought up by Rep. Sam Farr, ranking member of the subcommittee. “I think the public distrust is born out by all these local initiatives to require labeling of GMOs," he stated. “We have not had the scientific evidence to show that genetically modified does any kind of harm, yet people are…freaked out about it." He said despite recent failures of voter initiatives mandating GMO labeling of foods, it will eventually pass. He asked for statements or studies from FDA, because “there is a lot of confusion out there."
Unfortunately he also added a request for a statement from Hamburg on medical marijuana research, which she addressed, leaving the GMO question unanswered.
Farr suggested Congress might have fallen short in either setting FDA’s role or allocating money for the agency to meet its oversight obligations. “It seems that Congress, in our lawmaking, has given you … tons of authorities, but we never give you the money to carry it out," he said. “Maybe we’ve overstretched your role. Yet, if you polled the public, you are the most trusted part of the federal government."
Hamburg recognized FDA will never get everything it needs, but the big “ask" for FSMA implementation is required to undertake an historic transformation from a reactive system to a preventive system. She noted FSMA won wide support from stakeholders and saw bipartisan passage in Congress. “By strengthening food safety and reducing foodborne illness, we will save the healthcare system an estimated $78 billion a year," she noted. “This is a critical time for implementation… there is a terrific return on investment if we invest now."
See Hamburg’s submitted written testimony at the House website.
The Senate Appropriations Agriculture subcommittee will hold its own hearing on FDA’s 2016 budget request this Thursday, March 12, 10 am EDT. Hamburg will testify, along with FDA CFO Jay Tyler and Health Department Deputy Assistant Secretary Norris Cochran.