What’s next for FDA dietary supplement inspections in 2021 amidst COVID-19?

Have routine inspections resumed in any capacity? If not, what can industry members expect in 2021?

At the onset of the COVID-19 pandemic in 2020, FDA announced 1 a temporary halt to on-site facility inspections. With few exceptions, the agency made clear it would remove itself from this aspect of its usual operations in order to prioritize the health of its own employees and those of inspected firms. That was back in March 2020. Since then, much time has passed, and at the time of this writing COVID-19 vaccines are in their early stages of U.S. deployment.

Have routine inspections resumed in any capacity? If not, what can industry members expect in 2021?

Mission-Critical Inspections

In summer 2020, FDA announced2 it had resumed inspections for “mission-critical situations and other activities,” while the vast majority of routine inspections laid in waiting. Mission-critical situations can apply to food and dietary supplement facilities and may include situations of consumer complaints with reports of injury as well as follow-up inspections if required.

We can only speculate as to how many inspections FDA is taking part in, even when it comes to what the agency defines as “mission-critical.” It’s reasonable to assume that FDA is still proceeding with caution. Michael McGuffin, president of the American Herbal Products Association (AHPA; Silver Spring, MD), says he has heard that FDA is utilizing data to identify U.S. counties designed as “red” (i.e., a high portion of reports of COVID-19) and that FDA may not be conducting regular on-site inspections in those counties. At this stage in the virus’s spread throughout the country, that could be a majority of all U.S. counties.

Virtual Inspections

FDA has alluded to the use of remote tools for conducting facility inspections during COVID as part of a risk-based approach, but such work is likely be limited and cursory in nature, such as for basic recordingkeeping, sharing of documents, and to ascertain that manufacturers have food-defense plans in place. Virtual inspections would likely increase the agency’s ability to perform a large number of inspections even after the current health threats diminish, but there are security issues to consider.

“I don’t know if a company will let [FDA] in with cameras,” says Daniel Fabricant, PhD, CEO and president of the Natural Products Association (NPA; Washington, DC). “That’s not for public consumption. I think it’s happening between business to business, say, if a brand has a contract manufacturer.” Such virtual inspections would have to be federally noticed with rules and guidelines.

Self-Regulation

In lieu of government inspections, remote or in person, industry members are advised to continue with their own due diligence and recordkeeping, using the various resources available to them. Projects like the Supplement Safety & Compliance Initiative (SSCI) aim to streamline industry regulations and best practices so that product manufacturers can guarantee quality assurance of products in ways outside of FDA’s current scope of enforcement.

“People are still interested in making sure they’ve got the right product on the shelves,” says Fabricant. “[FDA] isn’t interested in that, but they should be. It’s part and parcel of compliance.”

Industry members are encouraged to reach out to organizations like AHPA and NPA for guidance on how best to self-regulate their businesses during COVID and after.

What’s Next?

It’s reasonable to assume that FDA will eventually try to make up for its backlog of inspections, but industry members should expect the same rigor of pre-COVID inspections when they recommence for everyone, whether virtual or otherwise.

Many questions remain as to how inspections will start up again: When will FDA report on these inspections? Will they be inspecting the same firms as last year? Will the focus be on manufacturers of one product or 5,000? And if a problem surfaces in the inspection, what are the plans for remediations?

Unfortunately, questions such as these will likely remain unanswered for a bit longer, says Larisa Pavlick, global regulatory and compliance vice president at the United Natural Products Alliance (UNPA; Salt Lake City), noting that “Much of the FDA approach will be based on the appointments of the next HHS Secretary and the FDA commissioner.” Maybe in the upcoming weeks or months we will understand more.

References

  1. FDA website. “Coronavirus Disease 2019 (COVID-19) Update: Foreign Inspections.” Published March 10, 2020. Accessed here.
  2. FDA website. “Coronavirus (COVID-19) Update: FDA Prepares for Resumption of Domestic Inspections with New Risk Assessment System.” Published July 10, 2020. Accessed here.