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A new stance on supplement regulation emerges

A new stance on supplement regulation emerges
Is product notification the way forward?

A new regulatory scheme involving product registration or notification—but decidedly not pre-market approval by the FDA—has gained widespread acceptance among CEOs of leading supplements manufacturers. 

In private, and not-so-private, discussions, including conversations at NBJ Summit in July, a consensus appears to be emerging that product registration would strengthen the industry against a crisis of plummeting consumer trust. As part of a multi-faceted strategy to strengthen public faith in supplements, product registration has moved from taboo status to widely supported idea.

Increasing support for the idea is a notable departure from past resistance to change. “One year ago, we wouldn’t have talked publicly about the need for product  notification, but we, as leaders of the responsible sector of the industry need to actively address the issue of eroding consumer trust,’ said Tom Aarts, principal at Nutrition Capital Network and co-chair of the NBJ Summit. “That’s why the notion of product notification is gaining so much support.”

How we got here

Issues around product integrity and consumer trust were highlighted by a February investigation by the New York attorney general’s office, and reported as front-page news in The New York Times, alleging widespread ingredient adulteration and contamination among leading retailers of dietary supplements.

Although many in the industry criticized the testing used by the attorney general’s office as being “not fit for purpose,” neither the Times nor most other media outlets have seized on this fact. The Times reporter Anahad O’Connor, speaking at the NBJ Summit, described quibbling over DNA barcode testing as “inside baseball.”

Although the industry remains opposed to a pharmaceutical-style pre-market approval from the FDA, a number of additional ideas are on the table in an attempt to address issues around ingredient adulteration, contamination and product quality—all matters that lie at the heart of consumer distrust. Among the ideas gaining general acceptance with many industry executives are:

Pre-market product registration: As noted, the first priority is to work on establishing a registry of new products that would be affixed to product labels. This pre-market notification could be similar to the system used for OTC products and would result in a number or “NDS Code.” The code would tie into a database accessible to the public and health authorities with essential data to assure transparency of production, traceability and confidence. Products that are in commerce without this code would be deemed illegal per se and could easily be withdrawn without a protracted legal fight. “I’m in favor of product registration,” said Robert Craven, CEO of supplement manufacturer FoodState, makers of the MegaFood and Innate Response brands.

Extending GMPs to ingredient suppliers: Executives also proposed pushing Good Manufacturing Practices (GMPs) down the value chain to ingredient suppliers. Currently, the onus for GMPs falls to brand holders, which had been expected to push manufacturers to demand quality control from suppliers. While this has worked to some extent, and branded ingredient suppliers are already up to par, this requirement would specifically target roughly 25 percent of ingredients on the market. “This would shine a light on non-compliant categories,” said Steve Peirce, president of ingredient supplier Ribus.

Support a third-party product seal or certification: Seals and certifications are clear ways for vouchsafing product integrity and quality, and there is no shortage of existing logos brand holders can select from in an effort to inform consumers of product quality – GMP certified, NSF, USP, even branded ingredient logos. That makes this effort to unify behind a single logo somewhat of a political minefield, though an overarching, mandatory logo would likely lead to improved consumer confidence. After all, as part of DSHEA, the industry accepted the uniform black-box warning about how the FDA has not evaluated the product, and it’s “not intended to diagnose, treat, cure, or prevent any disease.” A positive uniform logo is seen as a simple and direct appeal to consumer trust.

Create a higher-profile Office or Division of Dietary Supplements within the FDA: Currently, non-compliant companies receive 483s, then Warning Letters, from FDA. Rarely, and after years of effort, do such cases merit enough attention from the U.S. Department of Justice that would force scofflaw companies to cease illegitimate practices. “This would result in a line item in the budget, so the department would be empowered to enforce the laws on the books and not have to resort to the Department of Justice to bring cases,” said Mark LeDoux, chairman and CEO of Natural Alternatives International, Inc.

The impetus for change

Consumer surveys from Nutrition Business Journal suggest consumer confidence in dietary supplements has dropped 11 percent in the last year. The up-and-coming Millennial generation is demanding transparency and traceability to gain trust of the entire product category. Some of this distrust is undoubtedly heightened the New York attorney general-led scandal around ingredient quality, as well as groups such as issuing regular reports that show products not meeting label claims.

“We’re feeling a significant shift in consumer attitudes. Consumers want more clarity and transparency,” said Loren Israelsen, president of trade group United Natural Products Alliance. “We are at a point where change is not just a good idea, it’s imperative.”

Trading ideas

Other trade groups are cautiously getting on board the general idea of meaningful reform.

“I do think the industry is ripe for some disruption,” said Steve Mister, president of the trade group NCouncil for Responsible Nutritoin. “But [reformers] need to be careful that we’re not so far ahead of the industry that they push us over a cliff.”

The industry’s newest group, the
Organic & Natural Health Association, has been most aggressive in advocating for GMPs that apply to suppliers. 

“Ensuring supply chain integrity must start at the earliest possible point,” said Todd Harrison, president of Organic & Natural Health Association and an attorney at Venable LLP. “It would make sense to apply the FDA’s current cGMPs—Code 21 CFR Part 111—to raw material manufacturers. Not only does it provide flexibility but it would also be welcomed by branded ingredient manufacturers that are already following cGMPs but are forced to compete with lower-quality ingredient manufacturers that have minimal, if any, cGMPs.”

The modern supplement industry’s liberating document, the 1994 Dietary Supplement Health and Education Act (DSHEA), served the industry well as a bulwark against excessive rules and regulations from the FDA—an antagonistic relationship that goes back decades. The law provided for increased accessibility of safe and healthful products, and it paved the way for two decades of product innovation that has pushed the U.S. market to the forefront of the global self-help movement.

The industry has always said that self-regulation is appropriate for a relatively safe class of consumer products. But The New York Times’ coverage of the New York attorney general’s much-publicized investigation, targeting the country’s largest supplement retailers, has shifted media attention to one of derision and scorn.

“Self-regulation is difficult at best,” said Craven. “If we don’t have trustworthy brands, we won’t have a trustworthy industry.”

How to get it done

The industry’s Congressional champions who authored DSHEA are retiring one by one. While new representatives are being informed about industry issues, the tug-of-war is thrown off balance by critics such as Senators Richard Durbin (D-IL) and Richard Blumenthal (D-CT).

These senators and their allies are demanding improved product quality, enhanced scientific evidence for product efficacy, and a greater focus on traceability to ensure product quality. Certain market segments appear to be listening.

“Millennials’ confidence has been shaken by the recent reports in the media regarding dietary supplements,” said LeDoux. “The media continues to postulate that the industry is bereft of regulation and oversight and, notwithstanding multiple FDA officials being on the legislative record as contradicting that assertion, this mantra continues. So what do we do?”

Embracing measures to enhance consumer confidence, build in transparency and offer scientific support of products is now seen as paramount. Nor is it enough to continue to defend DSHEA—not that anyone is talking about abolishing it. Clearly changes must be made.

Educating industry manufacturers about the problems—and solutions to problems such as ingredient adulteration—is one method. To that end, some educational efforts are already in place. The Amerian Botanical Council has teamed with the American herbal Pharmacopoeia and the National Center for Natural Products Research at the University of Mississippi  to launch a program to inform the botanicals industry of commonly adulterated herbs in commerce.

“As the managing organization for the ABC-AHP-NCNPR Botanical Adulterants Program, ABC has been educating and promoting the proposition for over four years that industry members and others must become more aware of the level of adulteration of raw materials and extracts in the botanicals supply chain,” noted ABC Executive Director Mark Blumenthal.

ABC in August released a detailed report on appropriate testing methodologies around bilberry—an expensive botanical known to be adulterated. Black cohosh, another commonly adulterated herb, is also on the docket.

But simple education efforts, noble and helpful though they may be, are clearly not getting the job done. And previous trade group suggestions—that the regulatory structure as it currently exists is adequate and the problem lies with enforcement—are now falling on deaf ears.

So industry leaders are hoping to engage hitherto congressional opponents of the supplements industry to push forward this slate of new rules and sharper enforcement actions against scofflaws. As part of efforts to increase regulatory power over the industry, some are advocating an industry-contributed funding mechanism that would provide the regulatory power to go after companies giving the industry a bad name.

“In order to get anything through this Congress, it has to be a user-supported scenario,” said LeDoux. “This delivers one side of the equation, which is that the industry is willing to pay user fees that are appropriate to help safeguard the credibility of the industry.”

These positions could be expected to conduct GMP reviews and analytical work, prosecute products that are failing to meet GMPs, and be granted rights to search and seizure if it’s warranted under certain constitutional protections.

Providing for some sort of NDS Code on product labels should also resonate with congressional critics because it provides for increased transparency and traceability of products.

“It’s a mechanism by which, if there’s a problem, the regulators can step in efficiently and go back to the sourcing and identify the root cause of a problem,” said LeDoux. “It doesn’t magically make your product better, but it makes it eminently more traceable. In a case of consumer confidence, that’s a very important component.”

Action and urgency

The FDA has said that it is focused on four primary categories where concerns about ingredient integrity lie: sports, weight loss, sexual aids and diabetes products. Despite high-profile cases, such as the removal of DMAA from military base store shelves, the problem of unsafe—or at the very least, adulterated or contaminated products—remains rife.

“We are only as trustworthy as our suppliers,” said Craven. “Transparency is the mechanism for building trust.”

MegaFood is renowned for its transparency efforts, including live webcams set up inside its manufacturing facility, but that’s just one company responding to an increasingly skeptical market, hence the push for increased rules and regulations.

“The best defense here may very much be a good offense,” Aarts said. “If we make a proposal to Congress, we’re taking the high road. I’m not sure we’re going to get all the companies, but I think we’ll get enough companies that resonate with this idea behind it that we’re going to get some traction and momentum.”

As the conventional wisdom goes with legislation in Washington, D.C., you’re either at the table or you’re on the menu. Today, the supplements industry is on the menu. The hope is to change that calculus with these proposals to clean up product quality, restore trust, and give the supplements a place at the table—and in consumers’ cabinets.

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