WASHINGTON—During a three-year period, federal inspectors have cited seven out of 10 facilities that make dietary supplements for violating regulations intended to ensure products are safe and contain the ingredients that are listed on the labels.
A total 444 out of 626 inspections for cGMPs (current Good Manufacturing Practices) resulted in the issuance of a "Form 483," according to data Natural Products INSIDER obtained through a Freedom of Information Act (FOIA) request.
Those firms that received Form 483s from fiscal year 2010 to 2012 were cited for an average of seven "observations," such as failure to keep a facility sanitary, possess the equivalent of a recipe (known as a master manufacturing record [MMR]), or verify the identity of ingredients.
Some firms received as few as two observations, while one company was cited in fiscal year 2012 for 58 violations. A portion of the observations may reflect infractions other than cGMP violations, such as failure to comply with food cGMPs and neglect to report to FDA "serious adverse events" as required under federal law.
In fiscal year 2012—the 12-month period ending Sept. 30, 2012—253 of the 361 firms FDA inspected received Form 483s. One hundred and eight firms, or roughly 30 percent of the companies inspected, did not receive this document, reflecting the agency's view that they were following the regulations.
One Third of Cases Result in "Official Action"
FDA expects firms that receive a Form 483 to make the necessary changes in order to comply with the cGMPs. But in fiscal year 2012, FDA classified 116 firms as "official action," initiating such actions as sending them a warning letter, according to a presentation from the agency.
Such an "official action" classification following an inspection "occurs when significant objectionable conditions or practices were found and regulatory action is warranted to address the establishment's lack of compliance with statute(s) or regulation(s)," according to a separate FDA document posted online.
In fiscal year 2012, roughly the same number of dietary supplement firms (116) were classified "voluntary action", making voluntary corrections in response to an FDA inspection. FDA also classified 92 inspections in which it took "no action."
In total, 62 percent of the firms inspected received a classification indicating the companies made the necessary corrections and/or FDA did not consider the observations listed on the Form 483 serious enough to warrant regulatory action. FDA classified roughly one-third of firms as "official action."
"When you look at the numbers of warning letters issued a year and compare it with the numbers of supplements currently on the market, it's safe to conclude that most companies comply with FDA regulations," said Tamara Ward, a spokeswoman with FDA.
Some Firms Fail Basic Requirements
While that may be the agency's broad perspective, the observations listed on the Form 483 reflect its more narrow view that most supplement firms it inspects are initially violating at least some cGMPs that a top-ranking FDA official referred to as "minimum" standards.
"Unlike traditional foods, when it's rotten, the consumer will often know by taste or smell, [but] with supplements we're swallowing them based on blind faith in the manufacturer," noted Pieter Cohen, M.D., a general internist at Cambridge Health Alliance and assistant professor of medicine at Harvard Medical School, who has studied supplement safety and reviewed the FDA data. "But FDA inspections appear to reveal a different story: when we take a look behind closed doors, less than a third of companies are doing everything they can to ensure top-notch products."
Drawing broad conclusions from the data is potentially misleading, the leader of a trade organization representing the supplement industry warned.
"Having 10 observations that are insignificant is not as big a deal as one company having one observation where they were failing to do any identity testing," observed Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), the Washington, D.C.-based trade organization representing dietary supplement manufacturers and ingredients suppliers.
"Look at the nature of the 483," he said. "Just looking at the sheer number of 483s … that doesn't really tell you what's the impact of the 483 … on the quality of the finished product the consumer is actually going to have in his hand."
Marc Ullman, a New York-based supplement lawyer who works with his clients to comply with cGMPs, finds the reported infractions disconcerting.
"We're talking basic failures here," said Ullman, who reviewed the FDA data. "[FDA inspectors] are telling us there are a significant number of players in the industry who are unwilling, unable or don't care what they are required to do to implement the most fundamental operations designed to ensure they are making what they claim they are making because that's what the GMPs are all about."
Shelly Maifarth, principal of the Broomfield, CO-based FDA Compliance Group LLC, which helps companies adhere to FDA requirements, said the cGMPs for dietary supplements reflect a significant change from the former rules. Supplement firms previously were inspected under food cGMPs.
The government inspections are not lackadaisical reviews of a firm's manufacturing operations. FDA shows up at a facility unannounced to conduct an inspection, which usually last several days, said Maifarth, who served as an FDA compliance officer in Denver for 22 years.
"The majority of firms receiving the 483 items have been hit hard by the new requirements," she told INSIDER. "They often do not have the quality personnel in place to implement the requirements, are not prepared for the complexity, and documentation and testing requirements, … and have not budgeted for the new expenses of quality and testing. FDA did a large educational campaign, but many firms were not listening."
In a previous analysis of publicly available FDA data, independent consultant Marian Boardley Consulting found the most common cGMP violations in fiscal year 2012 included a lack of identity testing of dietary ingredients, failing to have written procedures for quality control (QC) operations, and an absence of written procedures concerning customer complaints.
"It's baffling to me," Marian Boardley, the principal of the consulting firm, said earlier this year when asked to explain the reasons for the violations she found, "because some of these items are so easy to correct."
A select number of firms were cited for committing dozens of violations. In fiscal year 2012, one company received 58 "observations": Create-A-Pack Foods Inc. of Ixonia, WI, a manufacturer of food and dietary supplements.
In a Sept. 19, 2012, warning letter, an FDA official advised Create-A-Pack Foods owner Glen M. Cochrane that his company was in violation of the Federal Food, Drug and Cosmetic Act and a number of regulations ranging from food-labeling rules to preventative controls for juice to cGMPs for food. The letter didn't specifically mention cGMP violations for supplements, although Create-A-Pack was cited for "misbranding" supplements. Cochrane did not respond to phone messages seeking comment.