For the second year in a row, FDA performed fewer than 300 inspections of dietary supplement facilities to assess their compliance with manufacturing rules, Natural Products Insider has learned.
In the fiscal year ending Sept. 30, 2021, FDA conducted 278 cGMP (current good manufacturing practice) 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.
In FY21, 143 inspections received a Form 483 from FDA investigators for alleged “observations,” or violations of the manufacturing rules. About 47% of inspections—131 facilities—were not cited for any observations.
Forty three facilities, or 15%, were reinspected last fiscal year based on a previous designation of official action indicated (OAI), which means FDA recommended administrative or regulatory action against a firm.
Natural Products Insider obtained the FDA inspection data via Freedom of Information Act (FOIA) requests. The data from FDA’s inspection database has certain limitations and may not reflect Form 483s manually prepared by officials.
cGMPs are the rules FDA adopted in 2007 to ensure dietary supplements are made to quality standards, or as stated in the code of federal regulations, “manufactured, packaged, held and labeled in a consistent and reproducible manner.”
By the numbers: FDA dietary supplement cGMP inspections
Source: FDA inspection database, obtained via FOIA requests
FDA each year likely inspects only a fraction of the U.S. facilities producing dietary supplements, which are considered a subset of food products. Nearly 81,000 U.S. food facilities are registered with FDA, as well as over 101,000 foreign registrations.
But it’s unclear how many facilities manufacture dietary supplements because FDA does not disclose such information in reliance on Section 415(a)(5) of the Federal Food, Drug & Cosmetic Act (FDCA). Under this section pertaining to registered food facilities, the list of registered facilities and registration documents are not subject to public disclosure under FOIA.
COVID-19 last year led to a drastic reduction of FDA inspections of dietary supplement facilities. The number of inspections in FY20 was down 52% from 598 in the prior fiscal year.
In a foreword to a May 2021 report, “Resiliency Roadmap for FDA Inspectional Oversight,” FDA Commissioner Janet Woodcock explained her agency decided to pause inspections “in response to federal guidelines to mitigate the spread of the COVID-19 virus.”
When the pandemic emerged in March 2020, FDA temporarily paused most domestic and foreign inspections with the exception of those deemed “mission-critical,” according to Woodcock.
FDA in July 2020 “resumed prioritized domestic inspections while continuing to conduct mission-critical foreign inspections across commodities, while keeping the safety of our workforce, the workforce at the facilities we inspect and public health top of mind,” Lindsay Haake, an FDA spokeswoman, said.
A year later, FDA started to focus on domestic inspections that it could not conduct during the pandemic based on “a risk-based approach to help ensure the continued safety of our nation’s food and medical product supply,” she added.
Reactions to inspectional data
Dr. Pieter Cohen, an associate professor of medicine at Harvard Medical School, said FDA’s inspections were insufficient before the pandemic “to keep up with the size and complexity” of manufacturing of dietary supplements.
“The problem has now grown exponentially,” added the physician, whose peer-reviewed research on dietary supplements has attracted the attention of industry, lawmakers, regulators and others. “While consumers are turning to supplements more than ever during the pandemic, the FDA has scaled back their inspections by more than half.”
He concluded, “Consumers can now be certain of one thing: when purchasing a supplement to improve their health, they are relying solely on the manufacturer to ensure quality and safety because the FDA has taken a pass on their most basic responsibilities.”
Annual sales of dietary supplements in 2020 reached $55.7 billion, representing 14.5% growth, according to Nutrition Business Journal. Four in five Americans use supplements, according to a survey released in October by the Council for Responsible Nutrition (CRN).
With the U.S. market estimated to contain as many as 80,000 dietary supplement products, FDA has advocated for new authorities to effectively police the industry. FDA and some industry trade groups are in favor of a proposal requiring that manufacturers list their dietary supplement products with the agency, providing such information as a copy of the label.
CONSUMERS “ARE RELYING SOLELY ON THE MANUFACTURER TO ENSURE QUALITY AND SAFETY BECAUSE THE FDA HAS TAKEN A PASS ON THEIR MOST BASIC RESPONSIBILITIES.”
- Dr. Pieter Cohen, Harvard Medical School
But at least one trade group has strongly objected to the proposal for mandatory product listing, arguing FDA isn’t effectively using its current tools, such as its authority to inspect facilities producing supplements.
“It’s inexcusable that FDA was able to inspect more facilities in 2020—during the height of COVID—than in 2021,” said Kyle Turk, director of government affairs with the Natural Products Association (NPA). “How can they justify to NPA members and the rest of the industry that they need additional authorities like mandatory product listing when they aren’t doing the basics? Congress has consistently provided FDA with new resources, yet [the agency] did less with more.”
Daniel Gastelu, a long-time consultant in the dietary supplement industry, said FDA should be auditing dietary supplement firms far more often than it does.
"Considering dietary supplement companies are required to spend a fortune to comply with 21 C.F.R. Part 111 cGMP regulations, the FDA should be required to conduct establishment inspections at least once a year, on-site and/or remotely of all companies,” he said.
He also is in favor of rewarding dietary supplement firms for demonstrating compliance with FDA’s cGMP regulations by mandating the agency issue certificates of compliance. This would give firms the chance to share such certificates with their customers and others.
“Dietary supplement companies should be rewarded for their significant investment and quality management work, and supplement takers would appreciate seeing such FDA cGMP certifications,” Gastelu, president of Health Product Business Success LLC, said. The compliance certificates, he added, “would also help eliminate the misinformation about the industry not being regulated.”
It remains to be seen whether FDA’s FY22 inspections of dietary supplement facilities will increase over the previous two years and start to resemble its auditing activity before the pandemic emerged.
“FDA will use a risk-based approach to consider surveillance inspections postponed due to the pandemic, along with surveillance inspections scheduled to be conducted in FY22,” Haake, the FDA spokeswoman, said. “We will generate a new prioritized list of firms to be inspected in 2022 based on this risk analysis.”
She added her agency is “actively planning to resume prioritized foreign inspections, including surveillance and application-related inspections, starting in February 2022 for all commodities.”
Of the 289 dietary supplement inspections FDA performed in FY20, 46 inspections were of foreign facilities, including 22 in Canada and nine in Poland, Natural Products Insider previously reported. But FDA only conducted three foreign inspections in FY21, FDA data show.
FDA also will continue to use surveillance tools in FY22 to expand its oversight of facilities, Haake shared.
“These tools include remote interactive evaluations, record requests and leveraging information from trusted regulatory partners at the local, state, tribal and international levels,” she said.