FDA is postponing routine domestic facility inspections as it strives to protect its staff and contract workers amid a disease (COVID-19) that has already claimed more than 100 lives in the United States.
The agency will move forward with “for-cause inspection assignments” if they are deemed “mission-critical,” FDA commissioner Stephen Hahn, M.D., announced Wednesday in a statement.
“We will continue to respond to natural disasters, outbreaks and other public health emergencies involving FDA-regulated products,” Hahn said.
The news came on the heels of FDA’s earlier announcement that it was postponing most foreign facility inspections through April, though it would evaluate “inspections outside the U.S. deemed mission-critical.”
FDA also is evaluating other ways to conduct its inspection work in a manner that would protect FDA staff and firms and not threaten public safety, the commissioner said.
Marian Boardley, an independent consultant in Moab, Utah who advises companies on compliance with cGMPs (current good manufacturing practices)—the FDA regulations applicable to the dietary supplement industry—outlined measures she anticipated FDA would adopt to address the lack of routine inspections.
“FDA will increase the use of alternative and remote activities, such as online regulatory meetings, in lieu of follow-up on-site inspections at dietary supplement firms," she said in an email.
The onus to “reliably produce quality products,” Hahn said, is chiefly on firms.
But companies aren’t operating at the same capacity and are under stress, which likely increases the chance of noncompliance with GMPs, said former FDA official Bob Durkin, of counsel in Washington, D.C., with the law firm Arnall Golden Gregory LLP (AGG), in an interview.
Durkin said FDA revealed what activities it is not going to conduct, but he questioned what actions FDA will take to ensure the safety of the food supply, such as whether it would enhance its oversight of products imported into the U.S.
Bill Marler, an attorney in Seattle who sues companies culpable for foodborne illness, said FDA only routinely inspects 1 to 2% of food being imported annually into the U.S.
FDA’s announcements, perhaps, don’t “make that much difference because they weren’t inspecting enough to begin with,” Marler, of the law firm Marler Clark LLP PS, said in an interview. “But obviously the idea behind inspections is to not only just catch things coming in that are problematic, but to make sure that companies are paying attention to the details because they in fact might get inspected.”
While Marler showed appreciation for the need of the government to devote resources to COVID-19, he stated, “You don’t want to put your eyes on one ball and watch another ball go out of bounds.”
“It’s hard to say they’re doing the wrong thing under these circumstances, but I think importantly it sort of underscores the fact that we’ve never had enough FDA inspectors to begin with,” he added.
Betsy Booren, executive vice president of regulatory and technical affairs with the Arlington, Virginia-based Consumer Brands Association, previously known as the Grocery Manufacturers Association, said FDA's "decisions were not made lightly" and were done in consultation with public health agencies, including the Centers for Disease Control and Prevention (CDC).
"FDA is balancing its public health mission with public health risk, and industry appreciates the temporary, risk-based approach FDA is taking," she said in an email.
The Food Marketing Institute (FMI), an organization representing food retailers, wholesalers and suppliers, did not immediately respond to a request for comment.
Brandon Hernandez is co-owner of Whole Brain Consulting, a food and beverage consulting firm with offices in Chicago and Loveland, Colorado, whose areas of expertise include food safety and regulatory compliance. Hernandez said he was on an FDA call in which the agency said it would only visit facilities if there was a Class I recall.
“It’s really going to have to be something major to trigger investigators to go out," said Larisa Pavlick, a former FDA investigator who is vice president of global regulatory and compliance with the United Natural Products Alliance (UNPA), a trade group in Salt Lake City, Utah for natural health products companies.
Hernandez said he appreciated FDA's reasons for scaling back inspections: to prevent the spread of COVID-19. If the entire Denver field office were to fall ill, the food safety consultant noted, FDA wouldn't be conducting any inspections in that region.
FDA's actions signal the agency is being "proactive" and doesn't "want to be a vector for the disease," he said in an interview.
Hernandez and others emphasized it's incumbent on the food industry to meet its obligations regardless of whether FDA is auditing facilities.
“Just because the FDA says they’ve backed off, my duty and obligation doesn’t begin and end with whether the FDA is going to catch me or not," he said.
FDA each year only inspects a fraction of the firms that produce conventional food and dietary supplements.
“It really is, and has always been, the responsibility of the industry and of the individual companies to be compliant and to provide safe products," Pavlick said in an interview. “FDA can’t and has never been … Big Brother overseeing food production."
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), a trade organization in Washington, D.C. representing the dietary supplement industry, said it’s crucial that companies validate their suppliers and the ingredients in their plant “because FDA is basically telling the industry, ‘We’re not out there looking over your shoulder.’”
With the dietary supplement industry expected to face shortages obtaining quality material in the supply chain due to disruptions caused by COVID-19 worldwide, companies may face greater temptations to adulterate substances with inferior material.
“Between the fact that you have this added temptation because it’s harder to get good material and the fact that FDA is not going to be looking as closely, it’s very important that everybody step up and recognize that we have a role for our consumers and we got to honor that,” Mister said.
Kevin Bell, a partner with AGG, suggested responsible industry might go the extra mile to ensure compliance amid a lack of FDA oversight. However, the lawyer expressed concern about the behavior of “bad actors,” including those in China.
“If they were cutting corners or using manufacturing methods that were skeptical or controversial before, essentially we’re giving them a license to keep doing that without looking over their shoulder out of concern that it might stopped,” he said in an interview.
By scaling back foreign inspections, Bell reiterated FDA is sending a message to facilities that “already use highly-questionable manufacturing practices and methods” that they need not worry about the U.S. government stepping in to check on them.
“That is a dangerous message if FDA is not going to protect the borders through import alerts and seizures,” he said in a follow-up email.
In response to FDA’s announcement, the Washington, D.C.-based Natural Products Association (NPA) recommended FDA issue import alerts to ensure products coming into the U.S. are compliant with FDA regulations and applicable laws. It also recommended increasing the number of companies who agree to meet industry specific quality assurance standards in an industry-driven initiative known as SSCI (Supplement Safety and Compliance Initiative).
“We want to work with government officials and all stakeholders to fill gaps where necessary and ensure we maintain the safest food and supplement supply in the world,” Daniel Fabricant, Ph.D., president and CEO of NPA, said in a statement.
Hahn said his agency “remains committed to using all available tools to oversee the safety and quality of FDA-regulated products for American patients and consumers.”
“As this remains a dynamic situation, we will continue to assess and calibrate our approach as needed and we stand ready to resume any postponed inspections as soon as feasible,” he concluded.