All talk, no action—certainly no consensus—was the theme of a seven-member panel discussion at SupplySide West last week regarding the supplement industry’s current challenges around product quality that emerged after a February sting operation by the New York attorney general’s office. Resembling a political debate forum, heads of five trade organizations, an attorney and a manufacturer sat on a stage to discuss the industry response going forward.
Sanguine comments suggesting consumers have not lost confidence in supplements are at clear odds with the hundreds of comments on the New York Times web page all saying otherwise. Nutrition Business Journal consumer research says there’s been an 11 percent decline in consumer confidence about supplements over the last year.
And only a minority of the panel seemed to truly grasp how DNA barcode testing—not ready for prime time though it may be—will nonetheless crush the botanical industry as well as the larger supplements industry if the industry does not come to terms with its adulteration and contamination issues. Stat.
Karen Howard, executive director of the nascent Organic and Natural Health Association, said the attendant media attention from the New York attorney general’s campaign against botanicals is a “drip, drip, drip” credibility issue that will drive away mainstream consumers.
Attorney Marc Ullman, partner at the New York law firm of Rivkin Radler, noted that an immediate threat is the class-action lawsuits that have arisen from the attorney general’s campaign. From that, something needs to be done. “We need help to impose transparency and quality throughout the supply chain,” he said. “Don’t let the perfect be the enemy of the good.”
Michael McGuffin, president of the American Herbal Products Association, cautioned that any industry response may lead to “self-inflicted” damage, that small-time botanical operations would be killed by costs from any additional regulations, plus the new, as-yet-implemented regulations in the Food Safety Modernization Act should shore up deficiencies in the supply pipeline over the next three years.
Steve Mister, president and CEO of the Council for Responsible Nutrition, suggested the responsible industry should take the lead in implementing voluntary measures “that says accountability to consumers,” and then take that test case and make it mandatory throughout the industry in a couple years.
"Rhymes with cohosh"
While most panelists professed to not know where the next hits to the industry will come after the September New York attorney general’s latest hit, against the obscure botanical devil’s claw, LeDoux said he knows.
“It rhymes with cohosh,” he said.
Loren Israelsen, president of the United Natural Products Alliance, has dug deeper into the issue of DNA barcode testing than perhaps anyone in the industry. From his vantage point, the campaign has only just begun.
“The worst is probably yet to come,” he said. “DNA barcoding is a disruptive technology. It’s not going away. If we reject DNA, we’ll be seen as anti-science Luddites. We need to know where it fits in so we know where to hold our ground.”
He said botanicals like black cohosh—a plant with well-known adulteration issues—are only the beginning. Probiotics, protein powders, mushrooms and algae are other categories that could see under investigations.
“This is just the beginning of what’s going to be a series of attacks,” Israelsen told NewHope360. “How much can we take as an industry? Is this our Volkswagon moment? This is a big mess, and it will go on for months and years. There will be big reverberations in the supply chain, because suppliers will bear the cost of testing.”
He said the New York attorney general has a large, smart staff of lawyers that see an easy target that will get him headlines all the way to his eventual election as New York governor.
“The AG wants to stand up at their annual meeting and say we transformed the dietary supplement industry, what Congress and the FDA hasn’t been willing to do,” said Israelsen. “And they might be right.”
He said the eventual upshot is an industry with fewer raw material vendors and simpler formulas from manufacturers because the cost of testing so many ingredients in boutique batches will just not be worth the expense.
The art of the possible
To date, the only industry response has been a letter signed by heads of all the trade groups to Congress requesting that the current office of dietary supplements within the Food and Drug Administration be elevated to a division, which would provide a platform for easier enforcement action against fly-by-night scofflaws that do the industry much PR damage.
Not good enough, said Mark LeDoux, president of Natural Alternatives International, who is leading the industry charge to implement tangible, significant changes.
“I’m concerned with the level of inaction in this space,” said LeDoux. “We need to stop with the bias that we can’t improve the supply chain. The ask in return is bona fide health claims. Consumers are demanding it. Why can’t consumers hear that coQ10 does this and this?”
McGuffin wants to go one step further and get not just health claims but drug claims.
“We want something back for consumers,” he said. “We lost red yeast rice. The deal today is if the drug industry gets there first they get a monopoly, but if a supplement gets there first we get to share it. That doesn’t sound fair to me.”
Which all sounds great, but there’s a reason the middle name of the FDA is “Drug.” Monumental task doesn’t begin to describe the odds of the pharmaceutical industry giving up a fundamental part of its value proposition to what’s perceived as health products with very questionable quality, let alone efficacy.
Twenty years ago, in the run-up to the passage of the seminal 1994 Dietary Supplement Health and Education Act, the supplements industry did not have such public concerns about product quality as it does today.
A more realistic legislative response might be pre-market notification, tightened rules around supply-chain integrity, leading to improved consumer confidence. Broader health claims might come after that, but not likely in concurrence with it.
“This is not something we can get easily,” said Mister. “We need to do other things first that are doable.”