Nation’s dietary supplement chief among furloughed employees during gov’t shutdownNation’s dietary supplement chief among furloughed employees during gov’t shutdown
The government shutdown, which is in day 19, has affected many operations at the Food and Drug Administration, including its Office of Dietary Supplement Programs. The longer the government shutdown lasts, the greater the impacts on industry, several sources said.
January 9, 2019
The leading government official responsible for overseeing dietary supplements in the United States is among the FDA employees on furlough status during a government shutdown that has stretched 19 days.
Steven Tave is director of FDA’s Office of Dietary Supplement Programs (ODSP), which is responsible for regulating a subset of the food industry with more than US$46 billion in annual sales.
In an automatic email reply Tuesday, Tave disclosed he was out of the office on furlough status.
He’s hardly alone.
At the beginning of the period in the funding lapse, 59 percent of FDA employees remained working, according to the Alliance for a Stronger FDA. That left 41 percent, or more than 7,000 employees, on furlough, the not-for-profit organization wrote in a report, “FDA shutdown toolkit.”
Impact on food safety
“We know that food safety will be particularly hit-hard,” the Alliance for a Stronger FDA in Silver Spring, Maryland, reported, “including the furloughing of workers in charge of routine inspections, guidance development and, also, we assume, those staffing training and technical assistance programs (e.g., assistance to industry in complying with FSMA [Food Safety Modernization Act] requirements).”
In an interview Wednesday with the Washington Post, FDA's commissioner, Scott Gottlieb, M.D., confirmed his agency has suspended all routine inspections of domestic food-processing facilities. But the newspaper said he was working on a plan to redeploy FDA personnel as early as next week to inspect facilities considered high-risk.
Sarah Sorscher is deputy director of regulatory affairs with the Center for Science in the Public Interest (CSPI), a consumer advocacy and watchdog group in Washington.
The halt in customary food inspections has put the nation’s “food supply at risk,” Sorscher said Tuesday in a statement. “Regular inspections, which help stop foodborne illness before people get sick, are vital.”
The government shutdown probably affects FDA’s food center more than any other part of the agency since it is mostly reliant on federal funding and not user fees, Sorscher suggested.
“We urge the FDA to publish more information about the impact of the shutdown on the safety of the food supply, including more about which types of inspection, import screening, and enforcement activities are considered ‘critical’ and which have been suspended,” she added.
Former FDA investigator Larisa Pavlick inspected dietary supplement facilities for compliance with cGMPs (current good manufacturing practices) and is familiar with the impact of a government furlough.
In her experience while working at the FDA Denver District, a 2013 furlough affected nearly all investigators, she wrote in an email.
“During the current shutdown, many of my friends and former colleagues are out of work and pay while they are waiting for this to be resolved,” said Pavlick, vice president of global regulatory and compliance with the United Natural Products Alliance (UNPA), a Salt Lake City-based trade association representing the natural products industry.
It’s unclear when Congress and President Donald Trump will reach an agreement to fund the federal government. The president wants billions of dollars in funding to build a wall along the southern U.S. border with Mexico, which Democratic leaders oppose.
“How much American blood must we shed before Congress does its job,” Trump asked in a nationally televised address Tuesday evening from the Oval Office. “For those who refuse to compromise in the name of border security, I would ask, ‘Imagine if it was your child, your husband or your wife whose life was so cruelly shattered and totally broken.’”
‘Routine regulatory functions’
One might argue the government shutdown has broken the routine operations of the federal government. Industries who regularly deal with FDA are already feeling the impact of the second-longest government shutdown in the history of the nation. The longest one, USA Today reported, was during the Clinton administration in a battle over taxes, and it lasted for 21 days in 1995 and 1996.
“None of the routine regulatory functions are being handled,” said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), a trade association in Washington representing the dietary supplement and functional food industry, in an interview.
FDA, for example, is not reviewing safety-related notifications for food and dietary supplement ingredients or holding meetings with companies to discuss such documentation before it’s submitted to the agency.
Marc Sanchez is an attorney specializing in FDA regulatory matters. He has several GRAS (generally recognized as safe) notifications pending for clients.
“We can’t do anything with those,” he said in an interview. “Those are completely stalled.”
The reason? FDA has no one assigned to review the submissions during the government shutdown. As a former FDA employee told INSIDER, the FDA scientists who review new dietary ingredient (NDI) notifications, for example, are not deemed “essential.”
The longer FDA employees sit home, the more likely the agency will be unable to complete reviews of myriad submissions within regulatory or statutory deadlines.
Sanchez said he anticipated a “serious backlog” on such regulatory matters as responses to GRAS notices and FDA technical desk assistance with issues related to FSMA.
“I’m still sending in things [to FDA] even though I know the document control center is just going to put them in a pile,” he said.
If a matter such as an NDI notification requires an evaluation and staff is unable to work, FDA may eventually write to companies advising them the agency needs more time to respond, said Daniel Fabricant, Ph.D., a former FDA official who leads the Natural Products Association (NPA) in Washington, a trade organization representing retailers and manufacturers of the natural products industry.
In 2013, during a lapse in government funding, Fabricant was the director of the then-Division of Dietary Supplement Programs. On the first day of the shutdown, he was sent home.
But Fabricant was soon called back into the office as part of a crisis team to examine adverse event reports (AERs) in the United States tied to dietary supplements containing aegeline and distributed by USPlabs, a company in Texas that has been under criminal indictment since 2015.
At the time, everyone else in FDA’s dietary supplement division was on furlough. Even Fabricant’s boss—Barbara Schneeman, who ran the Office of Nutrition, Labeling, and Dietary Supplements—wasn’t working, he recalled.
Dietary supplement operations
During the current government shutdown, FDA’s routine dietary supplement operations are among those that have essentially ground to a halt.
“Most people [who] would be touching dietary supplements are furloughed,” Mister said.
Three FDA spokespeople were contacted via email for this article asking how the shutdown was impacting the agency’s dietary supplement operations. One of them didn’t respond, and the other two sent automatic replies saying they were on furlough and unable to respond to messages.
Mister didn’t know whether FDA’s entire supplement office of around two dozen employees in College Park, Maryland, was closed. However, he said it was a logical presumption since “unless there’s a public health crisis that would call them in, they would be deemed nonessential, and FDA is closed.”
And outside Washington throughout the nation, FDA investigators aren’t conducting routine dietary supplement inspections, sources said. Former FDA investigator Pavlick and her colleagues faced a similar situation several years ago.
“In the 2013 furlough, the Denver District office was staffed by existing investigators who were also members of the Public Health Service,” she said. “Although they reported to the office, they were not working on routine GMP food or supplement audits.”
Impacts at the U.S. border
Among the work that FDA said continues during the current shutdown: screening food and medical products imported into the United States.
“I’ve now had a couple of conversations with [FDA] import divisions where it’s pretty clear that a lot of folks were sent home,” said Ricardo Carvajal, a director in Washington with the law firm Hyman Phelps & McNamara PC. “Exactly how they’re prioritizing their work is not entirely clear to me. They’re obviously focusing on whatever they perceive to be the higher-risk imports.”
Meanwhile, conventional food, dietary supplements and other FDA-regulated articles may be languishing at the border.
Typically, when imported articles are stopped at the border because FDA identifies a problem, the agency gives an importer an opportunity to rectify the issue, Carvajal explained. Usually, an FDA center with “subject matter expertise” will review what the lawyer described as a “request for reconditioning,” such as a proposal routed to the Center for Food Safety and Applied Nutrition (CFSAN) to make changes to a food label.
“Guess what?” the lawyer asked rhetorically. “There’s nobody that will look at it” during the current government shutdown.
Exporters’ products are stopped routinely at the border if they are subject to an FDA import alert, which concerns products that appear to be in violation of FDA laws and regulations. Although an exporter may have acted to address the problem identified by regulators, it can’t get the products released into the United States unless FDA removes it from an import alert. FDA personnel, Carvajal suggested, are likely unavailable during the government shutdown to review requests for removal from an import alert.
“For some folks, there’s going to be less scrutiny and less engagement with regulators, and they’re probably fine with that,” said the lawyer, who counsels, among other clients, manufacturers and marketers of food and dietary supplements on federal regulatory issues. “For other folks who were counting on being able to engage the regulator to solve a problem, they’ve got nobody to talk to.”
Attorney Claudia Lewis is a partner in Washington with Venable LLP. She said FDA may want to test a product imported into the United States as a routine matter to ensure the actual potency is consistent with what’s declared on the label.
“And the testing takes time because the labs are backed up or what have you,” the lawyer observed.
The testing results may have landed in the inbox of an FDA employee presently on furlough. That could result in significant delays in releasing a product into commerce—an acute problem for food with expiration dates.
The government shutdown also may adversely affect startup companies with no or limited experience dealing with FDA.
For example, Lewis raised the hypothetical of a new company that hasn’t yet set up an account with FDA to notify the agency of serious adverse events potentially tied to its products.
Suppose the company must now submit an AER to FDA through the agency’s electronic portal. Although FDA must approve such new accounts, “that is not functioning right now,” Lewis said.
The government shutdown hasn’t led to a “crisis yet, but let’s say we go to day 25” with government employees remaining out of work, the FDA specialist said. “A lot of our clients are going to be in a crisis mode.”
The longer the government shutdown lasts, the greater the impacts on industry. Among the consequences: FDA recommendations and decisions on sweeping policy-related issues will get pushed back. For instance, Mister highlighted a recent announcement by FDA’s commissioner that his agency had formed a working group to improve oversight of the dietary supplement industry.
Any recommendations from the working group, Mister said, will be delayed.
Gottlieb also recently suggested his agency is willing to consider pursuit of a legal pathway to market for CBD [cannabidiol] in conventional food and dietary supplements.
“Any of those discussions that might have been going on have just been put on hold,” Mister remarked. “And I think the industry appreciates the need for speed when it comes to this CBD issue because less reputable players will ignore the FDA’s comments and go to market anyway. We’re already seeing that.”
A prolonged shutdown, sources said, also has the potential to endanger public health.
“While the FDA claims that it will continue to conduct ‘for cause’ inspections and pursue criminal and civil investigations related to ‘imminent threats to human health or life,’ the agency has posted no new warning letters since the shutdown began more than two weeks ago,” Sorscher of CSPI said in her statement. “That raises concerns that enforcement activities effectively may have stopped.”
An extended shutdown is “bound to have an impact on enforcement, and whenever you have less enforcement, effectively there is a pull toward the lowest common denominator for lack of a better term,” Carvajal said. “For companies that are trying to abide by the law, they’re at a very significant competitive disadvantage when you have companies that are violating the law and doing so with impunity.”
Employees at FDA and other agencies who continue to work during the shutdown face a looming hardship: no pay. They are expected to miss their first paycheck this week. That equates to an estimated $2.2 billion in lost pay, according to the Center for American Progress, a policy institute in Washington.
“What motivation do employees have to come into work to do enforcement if they’re not being paid?” Sanchez asked.
Federal employees may seek employment in the private sector as a matter of necessity if the shutdown endures for several more weeks or longer. That could deprive the government of seasoned workers who are hard to replace, including those who have achieved expertise over a period of many years in nuanced areas like FDA regulations.
“It’s one thing to miss one paycheck,” Carvajal said. “What if it’s two or three or four? At some point, that becomes unsustainable.”
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