Dietary Supplement Industry, FDA Reflect on Decade-Old Regulations

In June 2007—13 years after the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA)—FDA published final regulations to ensure dietary supplements are manufactured to meet quality standards.

In interviews and statements, FDA and others reflected on the 10-year anniversary, the benefits of the regulations, and why some firms continue to fall short of meeting the requirements.

FDA’s cGMPs (current good manufacturing practices) require that dietary supplements produced in the United States consistently meet established specifications for certain traits, including composition, identity, purity and strength. Companies also must establish limits on the types of contamination that may “adulterate" a finished batch of a dietary supplement.

The cGMPs “help to ensure consumers are receiving quality, consistent, safe products, that also contain the ingredients they are paying for and that those ingredients are appropriately labeled," FDA said in an emailed statement Monday. “Since 2007, the FDA has worked to enforce the cGMP regulations, giving priority to cases in which cGMP violations potentially compromise product safety or result in consumer deception, when, for example, manufacturers do not verify the identity of their raw materials.

“Still, we continue to see a number of issues with dietary supplements including companies not adhering to cGMPs or with controls that are so weak they aren’t even testing their ingredients, as they are required to do, to know what’s really in them," FDA disclosed. “The agency has and will continue to inspect facilities and pursue enforcement actions based on the dietary supplement cGMPs, taking into account our resources and priorities based on risk."

Loren Israelsen, president of the United Natural Products Alliance (UNPA) in Salt Lake City, Utah, described the cGMPs as “exceptionally important for self-evident reasons.

“Consumers do want quality products made to reliable standards, especially if you eat them," he said in a phone interview.

Israelsen acknowledged there is room for improvement with cGMP compliance.

“Tens years on, we should be doing better as an industry, and that is a disappointment to myself and I think to FDA as well," he observed. “The question is why. What needs to be done?"

Commenting on FDA inspection data, Israelsen remarked, “The problems are persistent. It’s the same things that seem to crop up, beginning with inability to identify the raw material ingredients. That is, I think, the most important challenge."

FDA exempted manufacturers of dietary ingredients from its cGMPs.

“We do not agree, as some comments suggested, that we need to issue a separate or modified set of cGMP requirements for dietary ingredients," FDA said in its 2007 Federal Register notice, publishing the final regulations. “That is because there are adequate controls established in this final rule for the use of dietary ingredients used by the manufacturer of a dietary supplement."

However, with a vast number of dietary ingredients being sourced from outside the United States, the industry has faced challenges over the years confirming the identity of raw materials.

“Trying to get boots on the ground, whether it’s FDA’s or the manufacturer here that is using the material, that’s a problem," Israelsen said. “That’s just time and expense."

Dietary ingredients coming from overseas often have been sold into the United States through brokers, and the middlemen have been prone to conceal the identity of the actual supplier of raw materials or ingredients, according to industry sources. The lack of transparency has created problems for manufacturers of dietary supplements, whose obligations under the cGMPs include verifying the identity of dietary ingredients through appropriate tests or examinations.

Said Israelsen: “You’d like to pick up the phone [to] call customer service to say, ‘Hey, this isn’t working. We’re testing it. We can’t figure out why it doesn’t match our spec. Walk us through your process here. How did you do this or that?’ If you call the broker … they’re normally not in a position to answer those sorts of questions."

However, FDA’s implementation of the Food Safety Modernization Act (FSMA)—and its accompanying regulations, including a human food preventative controls rule that takes effect for many companies in September 2017 and applies to dietary ingredient manufacturers, among others—is expected to help improve quality and safety.

“We believe the real solution to the GMP compliance challenge is, ‘Look at the root cause,’" Israelsen said.

“The problem resides at the ingredient level," he explained. “Getting the supplier and the manufacturer to talk to each other, to verify their quality systems, to have joint training that creates a standardized approach to managing safety is the primary issue, and if you solve safety issues by identifying hazards or weaknesses in your system, you will improve quality."

Meanwhile, large manufacturers of dietary supplements in the United States have invested over the years in sophisticated systems, processes and personnel to meet the cGMPs, according to industry sources.

“The responsible companies have a strong track record of compliance with cGMPs and often go above and beyond what is required," said Gisele Atkinson, vice president of quality and technical affairs with the Washington-based Council for Responsible Nutrition (CRN), in an emailed statement.

“However, like many growing industries, there are less experienced companies that get cGMP warning letters," she said, and as FDA enforces FSMA, Atkinson noted there may be an increase in warning letters.

Others in the dietary supplement industry—including dietary supplement manufacturers that tend to be relatively small—have a record of repeated, egregious violations of the cGMPs. For instance, as INSIDER learned through a Freedom of Information Act request, half of the dietary supplement companies reinspected in fiscal year 2015 (FY15) by FDA were flagged for significant noncompliance with cGMPs following a previous inspection.

“Unfortunately, there are also outliers that ignore the law," Atkinson acknowledged, “and CRN supports FDA enforcement actions so FDA can get these bad actors to come into compliance or face consequences."

Laura MacCleery, director of regulatory affairs with the Center for Science in the Public Interest (CSPI) in Washington, said FDA doesn’t have sufficient funding to conduct an appropriate number of inspections for compliance with cGMPs.

As INSIDER reported Monday, CRN has lobbied on Capitol Hill for additional funds for FDA’s 26-person Office of Dietary Supplement Programs (ODSP). MacCleery is supportive of CRN’s efforts.

“FDA needs adequate funding to conduct a much greater number of inspections and to keep an active watch on this industry," said MacCleery, who added industry has had several years to come into compliance with the cGMPs.

MacCleery described the cGMPs as “really basic standards for sound practice in the dietary supplement area.

“And the industry is obviously still struggling," she said in a phone interview. “They need to have that oversight."

But “industry" can’t be painted with one brush. As industry consultant Marian Boardley observed, larger companies and contract manufacturers have shown cGMP improvements.

“Some sectors are still lagging, partly just because … companies come and go," she said in a phone interview.

FDA FY16 data obtained by Boardley indicates there are fewer cases today of egregious violations of the cGMPs, based on the number of firms that have been designated “official action indicated."

FDA investigators report violations or “observations" of cGMPs following an inspection of a dietary supplement manufacturing facility, but their observations are not immune from critique. The investigators have a range of experience, and FDA has faced criticism for being inconsistent in its audits.

That may change. Michael McGuffin, president of the American Herbal Products Association (AHPA), said a program realignment within FDA’s Office of Regulatory Affairs represents an opportunity to maximize the benefits of the cGMPs, hopefully resulting in “more consistent facility inspections by FDA staff with specific product category experience.

“In addition, continued efforts to better educate the media, consumers and policymakers about cGMP requirements will help increase consumer confidence in these products and dispel persistent misinformation about how the industry is regulated," McGuffin added in an emailed statement.

Vasilios “Bill" Frankos, Ph.D., who worked on drafting of the cGMPs as a former FDA official, told INSIDER the regulations have “contributed to an increase in consumer trust, by ensuring that what is on the label is in the supplement.

“That trust has directly translated to increased supplement industry sales," said Frankos, senior corporate advisor of product science, safety and compliance at Herbalife Nutrition, in an emailed statement.

Israelsen said the overall quality of dietary supplements has improved over the years, and he pointed out the number of experts and analytical capabilities available to help companies with cGMPs has increased dramatically as well over the last decade.

“Consumers … are certainly better off than they were 10 years ago," he concluded.