In 2007, the FDA issued regulations to ensure that dietary supplements are produced consistently and to quality standards.
Over the years, manufacturers have made significant progress adhering to cGMP (current good manufacturing practices), some industry experts have said. The regulations came into effect for the biggest brands in 2008, medium-sized businesses in 2009 and small businesses in 2010.
“The industry has absolutely moved on,” said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN). “They took over. They are GMP compliant for the most part.
The industry’s “big brands” have taken regulation “seriously”, he added in an interview, putting processes in place over the past decade to meet the requirements.
Mister and others recognized that there was still room for improvement. In FY21, 147 FDA inspections, or 53%, received a Form 483 for alleged cGMP violations.
Former FDA investigator Larisa Pavlick noted that the FDA has been citing supplement companies for the same observations for more than a decade. Of the companies that received a Form 483 in FY21 for violating federal rules, 59 inspections—or about 40%—were cited for failing to establish product specifications for identity, purity, the strength and composition of the finished batch of the supplement.
“At this point in our evolution as an industry…we need to be able to get past the point of having deficient specs and not checking specs and understanding what elements of a manufacturing record are needed,” said Pavlick, vice president of Global Regulatory and Compliance with United Natural Products Alliance (UNPA), in an interview. “There are easy improvements we can make in understanding…the communication gap between industry and agency.”
Many supplement manufacturers don’t take rudimentary steps to ensure the quality of their products, according to Pieter Cohen, MD, assistant professor of medicine at Harvard Medical School. For several years, Cohen researched potentially dangerous ingredients marketed in “dietary supplements,” including active pharmaceutical ingredients that would make the products illegal or “tampered with.”
“Consumers and their physicians should expect access to safe, high-quality health products when purchasing dietary supplements. Unfortunately, FDA inspections reveal, year after year, that a large percentage of manufacturers don’t take the most basic steps to ensure supplements contain what they say on the label,” the Massachusetts doctor said in an email.
Cohen added: “Until manufacturers take responsibility for ensuring that basic cGMPs are in place, it will be difficult to convince consumers that they can trust that the ingredients listed on the label are actually inside the supplement bottle.”
In an email to Natural Products Insider in December 2021, an FDA spokeswoman, Lindsay Haake, described cGMPs as “an integral part of a market for safe, high-quality dietary supplements.”
“That said, despite the efforts of a number of companies that take compliance very seriously, the fundamental deficiencies identified remain of concern,” she said. “For example, establishing finished product specifications and written procedures for quality control [QC] personnel remain the two most cited violation observations again this year, both of which are integral to an effective cGMP system.
Sir suspects that many smaller companies continue to struggle with cGMPs, including own-brand distributors who outsource the manufacture of their products and fail to understand that they are ultimately responsible for meeting the requirements.
Based, in part, on his review of an FDA spreadsheet of dietary supplement facilities audited by the FDA in FY21, Mister concluded: “[We] have a problem with very small companies in the sector still not 100% on board with GMP 11 years later. »
“We still have a lot of small businesses that don’t understand their obligation to set their own specifications and make sure they’re met,” he said. “They can’t rely on a subcontractor to do it for them. But if they don’t come to trade shows and they don’t belong to professional associations, where are they going to get that education? »