FDA in 2007 published regulations to ensure dietary supplements are produced consistently and to quality standards.
Manufacturers over the years have made significant progress meeting the cGMPs (current good manufacturing practices), some industry experts said. The regulations took effect for the largest brands in 2008, medium-sized companies in 2009 and small firms in 2010.
“The industry absolutely has evolved,” said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN). “They’ve stepped up to the plate. They are compliant with GMPs for the most part.”
The sector’s “major brands” took “seriously” the regulations, he added in an interview, by implementing processes over the last decade to meet the requirements.
Mister and others acknowledged room for improvement remains. In FY21, 147 FDA inspections—or 53%—received a Form 483 for purported violations of the cGMPs.
Former FDA investigator Larisa Pavlick noted FDA has been citing supplement firms for the same observations for over a decade. Of the firms that received a Form 483 in FY21 for violations of the federal rules, 59 inspections—or about 40%—were cited for failing to establish product specifications for identity, purity, strength and composition of the supplement’s finished batch.
“At this point in our evolution as an industry…we have to be able to get beyond the point of having specifications that are deficient and not verifying specifications and understanding what elements of a manufacturing record are required,” said Pavlick, vice president of global regulatory and compliance with the United Natural Products Alliance (UNPA), in an interview. “There’s some easy improvements that we can make in understanding ... the communication gap between the industry and the agency.”
Many manufacturers of supplements are not taking rudimentary steps to ensure the quality of their products, according to Pieter Cohen, M.D., an associate professor of medicine at Harvard Medical School. For several years, Cohen has researched potentially dangerous ingredients marketed in “dietary supplements,” including active pharmaceutical ingredients that would render the products unlawful or “adulterated.”
“Consumers and their doctors should expect to have access to safe, high-quality health products when they purchase dietary supplements. Unfortunately, FDA inspections find, year after year, that a large percentage of manufacturers are not taking the most basic steps to ensure that supplements contain what they list on the label,” the Massachusetts-based physician said in an email.
Cohen added, “Until manufacturers take responsibility for ensuring that basic cGMPs are in place, it's going to 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 the cGMPs as “integral to a safe and high-quality dietary supplement marketplace.”
“That said, notwithstanding the efforts of a number of firms who take compliance very seriously, the fundamental deficiencies being identified remain concerning,” she said. “For example, establishing finished product specifications and written procedures for quality control [QC] personnel remain the two most-cited violations observations again this year, both of which are integral to an effective cGMP system.”
Mister suspects many small companies are continuing to struggle with the cGMPs, including own-label distributors who outsource the manufacturing of their products and don’t understand they are ultimately responsible for meeting the requirements.
Based, in part, on his review of an FDA spreadsheet of dietary supplement facilities audited by FDA in FY21, Mister concluded, “[We] have a problem with very small companies in the industry that still are not 100% on board with GMPs 11 years later.”
“We still have a lot of small companies who do not understand their obligation to set their own specs and make sure they are being met,” he said. “They cannot rely on a contract manufacturer to do that for them. But if they’re not coming to trade shows and they’re not part of trade associations, where are they going to get that education?”