SupplySide West 2015 Coverage

Seven esteemed experts on dietary supplements regulations kicked off the Wednesday morning SupplySide West program with a panel discussion about the state of the dietary supplements industry and which issues might surface in the near future.

The discussion began with some analysis of the events surrounding the attacks launched by the NY Attorney General (NYAG), which most recently included the mailing of cease-and-desist letters to 13 companies selling supposedly misbranded devil’s claw supplements. The main damage, said Michael McGuffin, president of the American Herbal Products Association, sprouted from negative media reports, which could lead to lack of consumer confidence in supplements. While the issue of negative media attention has long plagued the supplements industry, the NYAG attacks have been especially long lasting.

“There’s so much more public attention on quality issues,” he stated.

As Karen Howard, CEO and executive director of the Organic & Natural Health Association, stressed, “Industry suffers from a credibility problem.”

Marc Ullman, Esq., of counsel at Rivkin Radler, pointed out that there’s been an exponential increase in class lawsuits overall, including multiple lawsuits filed immediately following the NYAG attacks. He called the lawsuits (when frivolous) “expensive and time consuming” for industry companies.

Despite the class actions and negative press surrounding the NYAG reports, Steve M. Mister, Esq., CEO and president of the Council for Responsible Nutrition (CRN), added some good news: Based on soon-to-be released results from a CRN consumer survey, “We’re not seeing a dip in consumer confidence.”

Mister did admit, however, that the NYAG’s attacks have put a bull’s eye on the industry’s back, and has placed it on the radars of many states’ attorney generals. “We need to be more active at the state level,” Mister stated, to combat these threats.

This is key because, as Daniel Fabricant, Ph.D., CEO and executive director of the Natural Products Association, noted, there has been bigger regulatory creep lately, including on the state level. “We don’t know where the next hit is going to be from,” he said.

Loren Israelsen, president of the United Natural Products Alliance, said that the most recent attacks on devil’s claw represent some evolution on the part of the NYAG. In comparison to the original attacks on herbal supplements, the September assault was a “more informed and competent attack on the industry.”

But Ullman pointed out that even though the attack may have been better thought-out this time, consumers received little benefit from the NYAG making a distinction between the various species of the herb (both of which are widely recognized). “Consumers still got efficacious products. Adding more text to the label isn’t going to help consumers,” he believes.

While industry has said that the NYAG’s method of using DNA barcoding was inappropriate, Israelsen said it would be a mistake to discount this method completely. “DNA bardcoding has a place,” he stated, perhaps for identity testing of proteins, probiotics, algae, mushroom supplements and more.

He believes industry cannot turn its back on new analytical testing methods. “We can’t be seen as anti-science,” he said. “We need to speed up our understanding of DNA we know where to stand our ground.”

But, Fabricant disagreed somewhat on this point: “There are official testing methods...Why waste time on DNA barcoding of supplements?”

Mark LeDoux, founder, chairman and CEO of Natural Alternatives International, then raised an important issue. He felt in light of the attacks on the industry, now is the time for premarket registration of products. He called this a “seminal point for the industry…to lead.”  He believes if industry takes this step, it should get something in return such as “bona fide health claims.”

McGuffin agreed: “It’s time to have a dialogue on preregistration.” But, he made it clear that the first steps should be an industry-led database, and then be agressive in what it gets in return, like drug claims. “We want something back for consumers,” he said.

He also believes industry could use as models similar systems that exist in Canada or Australia for product registration.

Mister was also in favor of some sort of industry-lead preregistration system, and then once it is up and running and working well, try to make it mandatory. “We need to do that grand effort…step up and be responsible,” he said.

But Fabricant said proceeding with such an effort could inadvertently bring additional problems to the industry. He felt that most consumers probably believe that such a system is already in place at FDA. So trying to create it for the first time may spur additional questions about the regulatory status of the industry.

Additional points raised by the panel included some analysis of the FTC–Bayer court case and the idea to negotiate a revision of the third-party literature section of the Dietary Supplements Health and Education Act.


Published in WholeFoods Magazine, December 2015 (online 10/17/15)