Supplement makers may get temporary reprieve from FDA inspections

Some manufacturers of dietary supplements are likely getting a reprieve from FDA inspections in the first part of 2022.

“Temporary changes” implemented Dec. 29 by FDA likely mean the agency has halted non-mission-critical inspections of facilities producing conventional food and beverages, dietary supplements and other regulated commodities through at least Jan. 19.

FDA recently paused certain inspectional activities amid a spike in COVID-19. On Monday, The Wall Street Journal reported the seven-day average of newly reported COVID-19 infections in the U.S. is on pace to triple the pre-omicron record set a year ago.

In a Jan. 4 roundup, FDA noted its plans to “continue mission-critical work,” but temporarily postpone “certain inspectional activities with the hopes of restarting these activities as soon as possible.”

Also, while FDA planned to commence “prioritized surveillance foreign inspection assignments” in February, those activities also have been postponed.

“FDA is also continuing to conduct mission-critical domestic inspections,” the agency added in the roundup. “State inspections under FDA contract have the discretion to make inspection decisions based on their local information.”

FDA cGMP (current good manufacturing practice) inspections of dietary supplement facilities have been down significantly over the last few years.

In the fiscal year ending Sept. 30, 2021, FDA conducted 278 cGMP inspections, with the majority (275) focused on U.S. facilities. That compares to 289 inspections the previous year, when the COVID-19 pandemic emerged, FDA data show.

Some people have criticized FDA for conducting even fewer cGMP inspections in FY21 than in FY20. But the leader of the Council for Responsible Nutrition (CRN), Steve Mister, observed the U.S. wasn’t in lockdown until the third week of March 2020.

“FDA had 2 ½ months of full-steam ahead inspections before they had to start pulling their inspectors out of the field, and that might very well explain the number of inspections being more in 2020 than in 2021,” he said in an interview.

Throughout the COVID-19 pandemic, FDA has continued to perform “mission-critical inspections” across all the commodities it regulates, regardless of the physical location in the U.S. or outside the country, an FDA spokesperson said.

The FDA spokesperson said the agency determines the need for a mission-critical inspection based on the following factors:

o             Product that received breakthrough therapy or regenerative medicine advanced therapy designation.

o             Product is used to treat a serious disease or medical condition and there is no substitute.

o             Product requires follow-up due to a recall, or there is evidence of serious adverse events or outbreaks of a foodborne illness.

o             Product is related to FDA’s COVID-19 response (e.g., drug shortages).

“While the majority of mission-critical inspections have been domestic, we have successfully conducted mission-critical inspections in nearly 30 countries,” the FDA spokesperson added via email.

K Srinivasa Reddy, Ph.D., former assistant general manager of corporate quality at Sami-Sabinsa Group Ltd., is in favor of such foreign inspections, given adulteration issues that occurred amid a surge in demand for immune support supplements during the pandemic. But as Natural Products Insider previously reported, FDA only conducted three cGMP inspections of foreign facilities in FY21.

Reddy suggested FDA investigators consider performing virtual audits of foreign dietary supplement facilities using state-of-the-art technology like those performed by the agency’s Center for Drug Evaluation and Research (CDER).

“This same technology is being used by Canadian health regulatory authorities for drugs and biologics in these pandemic times,” Reddy noted in an email.

FDA’s Jan. 4 roundup stated the agency is continuing remote foreign supplier verification program activities for human and animal foods and using other remote tools to continue to oversee foods, drugs, medical products and tobacco.

Larisa Pavlick, vice president of regulatory and compliance with the United Natural Products Alliance (UNPA), said in a Jan. 7 memo that most of her members will likely not be inspected in the next month or two unless they are connected to an outbreak or emergency.

“Within the UNPA family, we understand that most responsible and reputable companies will remain on course, and we will continue to be vigilant with appropriate GMP practices,” Pavlick wrote in the memo to her members. “Let’s use this time, free of audits and inspections, to focus and get better.”

Even in normal times, FDA only inspects a fraction of dietary supplement facilities, Pavlick observed in an interview. Nearly 81,000 U.S. food facilities are registered with FDA, as well as over 101,000 foreign registrations, though FDA does not disclose the total number of facilities producing dietary supplements.

Even with the further-reduced number of cGMP inspections during the pandemic, Pavlick doesn’t believe the risk to consumers is high since she said the number of outbreaks and emergencies tied to dietary supplements is low compared to other commodities.

“Is it dangerous now that the FDA is not in the field?” asked Pavlick, a former FDA investigator with the Denver District office. “Is it more dangerous than it was before? No, in my opinion, because reputable and responsible companies have always focused on compliance and quality as part of the values of the organization and commitment to consumers.”

She added, “Nobody’s going to stay in business if they have poor-quality products that are hurting people.”