Which Way to Quality Assurance?

The New York Attorney General wants better quality assurance for dietary supplements. So does the supplements industry. So how does it get there?

FDA’s Good Manufacturing Practices (GMPs) for dietary supplements are meant to ensure industry-wide quality, but does the system actually work? Now is a good time to ask, because whether through public scrutiny or regulatory pressure, the dietary supplement industry is being forced to take a deeper look.

Spurred by New York Attorney General Eric Schneiderman’s (NY AG) recent dietary supplement industry investigation, Schneiderman and 13 other state attorneys general (AG) asked Congress in April to consider a more “robust” role for FDA in regulating the dietary supplements industry. The AGs asked Congress to address “the extent to which Congress should mandate, or direct the FDA to develop, enhanced, uniform, industry-wide quality-assurance and verification regimes” to ensure ingredient identity and product safety and efficacy.

At the core, the AGs and the supplements industry share a desire: to ensure safe, effective, high-quality products for customers. What the industry and the AGs do not agree on is the best way of getting there.

Different Paths to Quality Assurance

Dietary supplement industry leaders say that FDA’s GMP regulations are appropriate and sufficient. In a letter documenting GNC’s March agreement with AG Schneiderman-an agreement that subsequently ceased the AG’s investigation of GNC products- GNC said it disagreed with the AG’s opinions about “the sufficiency of federal rules and testing requirements”-the implication being that GNC feels federal laws are fitting, while AG Schneiderman does not.

FDA’s GMPs are the bare minimum-“the floor”-of what FDA believes a company must do in order to ensure quality. The GMPs, however, leave it to companies to decide how best to meet the minimum, and companies can-and should-do what they can to rise above that floor.

“Where the regulations say you must conduct at least one appropriate test, you have to do that. But if you’re a company that really has a commitment to quality, you’re probably doing more than just one test,” and you’re personally auditing your key vendors, etc., said Steve Mister, president and CEO of the Council for Responsible Nutrition (Washington, DC), at an Ingredient Marketplace trade show panel in April. GNC CEO Mike Archbold said via open letter that his company has “always gone above and beyond to assure compliance with FDA cGMPs.”

But, of course, whether through human error or human deceit, not all companies engage in best practices. Cases of economic adulteration and mislabeling in recent years are enough to confirm that bad practices are indeed happening with dietary supplements. The same is true of any industry. Dietary supplement leaders refer to these lawbreakers as “industry outliers.”

These outliers are what keep the public, regulators, and law-abiding industry members up at night asking themselves whether the dietary supplement industry has the proper framework in place to achieve industry-wide compliance and self-policing. Depending on whom you ask, the rules either are sufficient (and would be even more effective if FDA had the resources to pull more lawbreakers off the market), or new rules are needed (such as premarket regulation).

Answers to these questions don’t come easily. But as the fire grows hotter, the industry needs a concrete response-“a grand gesture,” Mister said-to reassure the public at large whether existing dietary supplement regulations can protect consumers.

Prescribing Specific Tests Isn’t the Answer

By using DNA testing as the sole test method in his investigation, and by furthermore requiring GNC to adopt DNA testing per their agreement, AG Schneiderman seems to believe that DNA testing should be an integral part of the “uniform, industry-wide quality-assurance regime” the AGs asked Congress to consider. Today, companies are able to chart their own course for how best to meet FDA’s GMPs, but AG Schneiderman now aims to make that course more specific-at least from what can be inferred from the GNC settlement. “The GNC settlement tries to articulate a specific set of testing standards, whereas FDA’s GMPs just focus on the general concept of what needs to be done in order to come into compliance with FDA’s concept of GMP,” said another Ingredient Marketplace panelist, attorney Dan Dwyer.  

FDA’s GMPs decline to dictate the exact quality-assurance tests a company must perform, only requiring that the test be valid and fit for purpose. There’s a good reason for this, and that is that the testing needs of supplement manufacturers will range broadly depending on what type of ingredient or product a company is dealing with. When you take a minute to consider the scope of the supplements industry, this makes sense.

“The breadth of the industry is so broad” that an ingredient like fish oil requires a completely different set of quality-assurance procedures than does, say, an ingredient like chondroitin sulfate, said CRN’s Mister. Even a market sub-segment like botanicals comprises “a huge spectrum” of products, different plant parts, and different formulations, added fellow panelist Mark Blumenthal, founder and executive director of the American Botanical Council (Austin, TX). This makes finding a singular test method that works “very challenging,” he said. “I have no indication as to how certifying organizations would propose [a single solution] because it’s not simple.”

“We’re not just one industry; we’re a group of different industries,” Blumenthal said.

Take DNA testing. Blumenthal outlined real-world examples of when DNA testing alone would fail to catch some of the most common cases of herbal product adulteration. (Blumenthal isn’t anti-DNA testing, either. He called DNA barcode technology “a perfectly reasonable tool in the analyst’s toolbox.”)

In the cases of known ginseng adulteration, DNA tests will not detect adulteration of ginseng root extract with ginseng leaf extract (done to raise ginsenoside levels). This is because DNA testing does not differentiate plant parts. This kind of differentiation “can only be done through proper chemical analysis by looking at different ratios of the different ginsenosides,” Blumenthal said. The same is true for ashwagandha, whose root extracts are often adulterated with leaf extract. In these cases, DNA testing as a sole solution would certainly not meet FDA’s GMP requirement for fit-for-purpose testing.

“There is no ‘one size fits all’ testing methodology when it comes to analyzing dietary supplement ingredients and finished products,” says Lisa Thomas, general manager, dietary supplement programs, NSF International (Ann Arbor, MI), which provides third-party GMP testing for dietary supplement companies based on standards of the American National Standards Institute (ANSI). “Methods vary depending on the ingredients of interest and the product matrix or form.”

Is There an Industry-Wide Solution?

Amending the GMPs to dictate specific test methods may not be the right way to better quality assurance, but the dietary supplement industry still can and should endeavor to improve industry-wide quality assurance in other ways. With adulteration, pharmaceutical spiking, and general safety issues still happening, even dietary supplement industry leaders acknowledge that. “I think there’s enough going on in this industry that warrants improvement,” Blumenthal said. “We have problems here.”

Existing tools-such as U.S. Pharmacopeia public standards-are available for many ingredients, and if everyone in the industry were to abide by publicly created, broadly accepted testing standards, quality assurance would find an even playing field. “We have real tools that can deal with these issues,” said Steven Lukawski, whose company Fruit d’Or Nutraceuticals (Notre-Dame-de-Lourdes, QC, Canada) sponsored the Ingredient Marketplace panel session. Lukawski pointed out that industry advances, including technology, means the industry has greater means of product testing than it did 20 years ago.

“The correct test methods are certainly available; the problem is that many dietary supplement companies do not have the in-house expertise or instrumentation necessary to perform all proper purity and identity testing in compliance with GMPs,” NSF’s Thomas adds. Third-party certification is one solution, and Thomas says that NSF International is seeing “more manufacturers…stepping up to fulfill this expectation” of product quality by increasingly using third-party verification. (Read Nutritional Outlook’s take on how standards are created here.)

Good tools do exist, but the challenge is in getting everyone in the industry to use them. To that end, increased criticism and scrutiny of industry will have one positive effect: dietary supplement manufacturers have no choice now but to improve.

Scrutiny Down the Line

If public confidence in dietary supplements erodes, the impact will hit all members of industry where it hurts the most-the bottom line. As such, “What I’ve heard is that people are having a very serious conversation internally,” said Mister. “This has taken the [conversation] out of the QA/QC departments, and it’s going all the way to the executive suites of the companies. They are now asking, ‘What are we doing to assure the identity of our products? What are we doing to assure that we’re providing a pure and quality product?’”

Scrutiny will work its way through the supply chain. Already, Mister said, recent conversations he’s had with marketers and retailers lead him to this conclusion: “I think the retailers may start to put pressure on the industry. They are going to want to know more about the products they put on their shelves, both their store brands and even the national brands. They, as much as the end-consumer, may be what puts the pressure on industry.”

At least that’s the hope, industry leaders say. “I don’t think you will get an industry initiative that has 100% buy-in, no matter what you have,” said Mister. “But I think what you get is an agreement among the majority of companies as to where they should go, and then what happens is the companies who don’t agree get left by the wayside-either that, or consumers move away from them.”

The industry might see more proposals for industry solutions in the coming months. Mister said industry leaders are definitely discussing strategies internally. But with quality assurance at the heart of the publicity storm supplements face today, taking a look at one’s own QA procedures is a smart place to start.

Also read:

Why Won’t NY Attorney General Schneiderman Release the Report? (Editorial)

Sidebar: Should FDA Provide More GMP Guidance?

By law, quality assurance for dietary supplements means meeting or surpassing FDA’s GMP requirements. While 21 CFR 111 only instructs that manufacturers “conduct at least one appropriate test or examination” that are “appropriate, scientifically valid methods” (21 CFR 111.75), in certain scenarios, it may behoove FDA to in fact be more specific, said Steve Mister, president and CEO of the Council for Responsible Nutrition.

Mister suggested that perhaps FDA can take a heavier hand in guiding companies operating in some supplement categories that are known to be at high risk of adulteration (sports nutrition, weight loss, and erectile dysfunction). FDA could, for instance, suggest that these companies go beyond the GMP “floor” of one test; perhaps companies in those high-risk markets need to do more than a few tests to ensure they are testing for known adulterants, if they aren’t doing so already. “I think they could provide more clarity to the industry for certain kinds of products what is appropriate and what is sufficient,” he said.

Sidebar: Does the Food Industry’s Smart Choices Story Hold a Lesson for the Supplement Market?

When the food industry created its front-of-package labeling program Smart Choices in 2009, the program was met with widespread derision, including from numerous state attorneys general. How the food industry handled the Smart Choices fallout following that may serve as a good model for the dietary supplements industry now, said attorney Dan Dwyer.

In the case of Smart Choices, public outcry eventually led to a number of attorneys general, and eventually FDA, investigating the program itself. The industry eventually dropped the program, but what it did next was interesting, and "I think might be instructive for the herbal supplement industry as well,” Dwyer said.

Through its trade associations, the food industry subsequently adopted a voluntary set of standards for front-of-package labeling. Those standards were created to assuage the concerns of regulators, and it also enabled to industry to carry forth with a front-of-package labeling program. Additionally, companies individually bolstered their own in-house procedures for GMP compliance and documentation.

By revising its framework to exclude the most-criticized elements of the Smart Choices program, the food industry was able to keep what it wanted-a front-of-package labeling system-while ensuring it forestalled further enforcement action or rulemaking, Dwyer said.

“Although one can pick and poke and critique the food industry’s front-of-package labeling program-and it hasn’t been formally accepted as far as I know by FDA or any attorneys general-it’s still out there and it’s working and it’s a useful paradigm,” Dwyer said.

Jennifer Grebow
Editor-in-Chief
Nutritional Outlook magazine
jennifer.grebow@ubm.com

Also read:

Why Won’t NY Attorney General Schneiderman Release the Report? (Editorial)

NY AG Takes Dietary Supplements Fight to Congress

NY Attorney General Forms Coalition in Case against Herbal Supplements

Editor: New York Attorney General Case Requires Strong Response, Supplement Leaders Say

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