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FDA GMP Inspections

Harvard Medical School professor criticizes FDA drop in dietary supplement inspections

Physician Pieter Cohen of Harvard Medical School and several industry sources weighed in on a decrease in FDA cGMP inspections in fiscal year 2018.

In reviewing annual data on FDA inspections of dietary supplement facilities for compliance with FDA regulations, Physician Pieter Cohen of Harvard Medical School said he was struck by two observations.

“Number one, FDA is not doing its job,” he proclaimed in a recent interview. “And the second thing is the firms are not holding up to their part of the bargain.”

FDA data shows the agency conducted 591 inspections in fiscal year 2018 (FY18) for compliance with cGMPs (current good manufacturing practices), regulations FDA adopted more than a decade ago. That’s down from 656 inspections the previous year.

Of the total inspections in FY18, 317—or 54 percent—received a document (Form 483) alleging violations of the cGMPs, according to FDA data INSIDER obtained through a Freedom of Information Act request. In the previous year, 379 inspections—or 58 percent—were cited for alleged infractions or “observations,” FDA data shows.

Dietary supplement cGMPs: By the numbers

FY18 inspections: 591

Firms issued Form 483: 317

Average number of inspections per 483: 5.12

Most common “observation”: You did not establish product specifications for identity, purity, strength and composition of finished dietary supplement (75 inspections/23.66 percent of inspections issued 483).

Source: FDA based on response to Freedom of Information Act request.

“The dietary supplement cGMP regulation has been in effect for about 10 years, and the overall level of industry-wide compliance that we observe during inspections is still well below where it needs to be,” Steven Tave, director of FDA’s Office of Dietary Supplement Programs, said in an emailed statement. “We continue to see fundamental deficiencies, and our compliance and enforcement activity, including recalls, warning letters and judicial actions, reflects that reality. This is a state of affairs that has to improve.”

Nonetheless, Tave recognized “many firms are, for the most part, getting it right.”

“They are making the investments and showing a true commitment to doing what is necessary to deliver a quality product to their customers,” the FDA official added. “That’s exactly what we want to see, and it’s attributable in part to industry-led efforts to promote compliance, including through education and training.”

Cohen is an associate professor of medicine at Harvard Medical School whose research on dietary supplements has been widely publicized. He criticized the decrease in FDA inspections.

“If industry is so out of compliance with the law that more than half of the firms … are being issued a 483 … it becomes essential that the agency steps up the inspections, not decreases” them, he said.

Daniel Fabricant, Ph.D., is president and CEO of the Natural Products Association (NPA), a trade association for dietary supplements, natural health and sports nutrition, and other products.

“It’s never good if the [inspection] numbers go down,” he said in an interview.

But he wondered how quickly FDA is re-inspecting firms with problems, such as those that received a warning letter for failing to sufficiently address cGMP violations following an FDA inspection.

“If FDA knows by collecting data there are firms out there that aren’t making the grade, how quickly are they getting back in?” asked Fabricant, former director of FDA’s then-Division of Dietary Supplement Programs. “To us, that’s really the critical thing in terms of the numbers.”

Fabricant highlighted another important inspection figure: the number of annual random inspections. Is there a point at which an increased number of random cGMP inspections results in a decrease in the percentage of firms with significant issues of noncompliance?

At what point is the “threat of [a] random inspection going to be top of mind to firms that are reasonable firms?” Fabricant asked.

Corey Hilmas, M.D., Ph.D., previously worked with Fabricant at FDA and presently serves as NPA’s senior vice president of scientific and regulatory affairs. He and Fabricant also wondered whether the agency has diverted resources from supplements to support other food initiatives, such as inspections under the Food Safety Modernization Act (FSMA).

Hilmas also asked about the number of “for-cause” inspections in FY18 in which FDA inspected a facility based on, perhaps, a complaint from a whistleblower providing evidence of wrongdoing, or a review of dietary supplement labels.

“It’s not an iron-clad assumption, but if someone is struggling with labels, maybe they’re struggling with GMPs too,” Fabricant said.

Steve Mister is president and CEO of the Council for Responsible Nutrition (CRN), a trade group representing dietary supplement and functional food manufacturers and ingredient suppliers.

He questioned why FDA’s annual cGMP inspections had dropped by 10 percent.

“I would be concerned if they are doing fewer and fewer dietary supplement inspections if they’re putting all of their resources into food,” Mister said in an interview. “That is not what’s supposed to happen.”

Corinne Newhart, an FDA spokeswoman, said “annual comparisons do not provide an accurate picture of inspection rates” due to the way in which the agency inspects dietary supplement facilities.

“Generally speaking, dietary supplement firms are inspected every three years or five years, depending on whether they are considered to be high risk,” she explained in an email. “A number of factors can influence a firm’s classification, and firms can move from high risk to non-high risk during the course of an inspectional cycle.”

Under FSMA, high-risk facilities must be inspected every three years. But each year, FDA only inspects a fraction of the total number of registered facilities. According to a presentation from an FDA official, there were 9,300 registered dietary supplement facilities in FY17.

Potentially complicating matters for FDA, new entrants regularly venture into the dietary supplement market, while others merge or go out of business.

“There’s a lot of new companies,” Marian Boardley, an independent cGMP consultant, said in an interview. “Companies get bought. Companies get sold. They get merged. They go bankrupt.”

Larisa Pavlick is a former FDA investigator who inspected dietary supplement facilities for compliance with cGMPs in the Denver District. She has firsthand experience dealing with the agency’s competing priorities and limited resources.

“Just from a management perspective, when you only have one handful of investigators to apply to the entire food industry, the resources are not being placed in the supplement area, especially when there’s outbreaks,” said Pavlick, vice president of global regulatory and compliance with the United Natural Products Alliance (UNPA). “Everyone gets pulled into whatever the emergency or outbreak is and managing those versus the routine work that might [be devoted to] the supplement GMPs.”

 

 

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