The honor system isn’t working.
In the wake of yesterday’s claims by the New York State attorney general’s office that major retailers have been selling adulterated herbal supplements, the best way forward for the nutritional supplements industry will be to accept at least a bit more oversight.
However well-intentioned DSHEA might have been, that 1994 law opened the door to cheating and malfeasance that, even if committed by only a minority of players, is destroying public trust. It has also put honest companies in the unfortunate position of having to compete with shady players who—operating within the DSHEA framework—use rampant adulteration to achieve price points that legitimate brands can’t match.
Industry often portrays DSHEA as a regulatory law. The truth is that it was passed as a bulwark against oversight. No amount of boilerplate arguments about the merits of self-regulation will overcome the fact that when someone Googles “DSHEA,” the top result is a Wikipedia entry with this as its second sentence:
Under the act, supplements are mainly unregulated, without proof of effectiveness or safety needed to market a supplement, as well as dietary supplements being classified as foods instead of as drugs.
That’s the accepted wisdom now. Yes, DSHEA passed in part because of consumer demand. But let’s be honest: That demand was stoked by industry campaigns like the sensationalist Mel Gibson ad that convinced people that the FDA was going to take away their vitamins (which, if you recall the FDA stance back then, was a distinct possibility).
Twenty-one years later, consumers are bombarded with studies that question the efficacy of vitamins and stories claiming that supplement brands aren’t even selling what they claim to be. Fears that the FDA might take away people’s supplements have been replaced by a constant media drumbeat of: “You may not be buying what you think you’re buying, and even if you are, it might not do you any good.”
That’s not an argument the industry can press release its way out of. Consumers are no longer willing to accept a system in which anyone can sell anything until it’s proven to be ineffective or dangerous. We’re not calling for pharmaceutical-industry-level regulation; some sort of pre-market approval would go a long way toward righting the industry. And the longer we wait to revisit DSHEA, the less of an industry there will be left to save.
There are legitimate concerns about the science at the heart of the New York case. Identity testing is incredibly complex. And it seems pretty clear that DNA bar coding is the wrong method to use for botanicals, since DNA is unlikely to be intact in botanical extracts. But that’s simply too complex a message for most consumers. “Major Retailers Selling Tainted Supplements” will get people to click on a story. “NY Attorney General Should Have Used High Performance Thin Layer Chromatography Instead of DNA Bar Coding for Supplement Study” will not.
In terms of PR, the test argument is generally a losing one anyway. In the 1990s, as news stories began emerging about rampant use of performance-enhancing drugs in Major League Baseball, the players’ union raised legitimate concerns about the accuracy of drug tests. In the eyes of already suspicious fans, those arguments made the sport look even dirtier. Whether or not testing was imperfect, and whether or not most players were in fact clean, the perception was that the union was providing cover for cheats. It was only when the union accepted third-party testing that trust began to be restored—and that honest players could once again compete on a level field.
Of course, the players’ union comprised people who knew baseball better than anyone else in the world; it was in no way founded to shelter cheats. Likewise, the early leaders of the supplement industry—the architects of DSHEA—found their way to this space out of real passion for health and wellbeing. They know the supplement space better than anyone, and they drafted DSHEA with the knowledge that brands in this space had only the best of intentions.
But the unintended consequence was a gold rush that attracted unsavory players. Truly honest people exist, but so do opportunists. Without an effective way to filter out the latter, they end up ruining it for everyone.
"The longer we wait to revisit #DSHEA, the less of an industry there will be left to save," writes @johnwbradley http://ow.ly/IrsYJ
Like it did with baseball, the media stepped into the regulatory vacuum. As we’re seeing today, that can quickly spiral out of control. The New York attorney general went after botanicals in response to a 2013 New York Times story that pointed to widespread fraud in the supplements industry. Given the choice between a reporter on a mission—with a very public forum in which to vent—or an FDA regulator working behind the scenes, which would you choose?
Yes, regulation often devolves into a morass of paperwork, bureaucrats, and weeks that stretch into months. Our government was designed to move at the speed of horse, which is incredibly frustrating for people working at the cutting edge of nutritional science and laboratory innovation. But the alternative is a situation in which consumers can’t tell the good from the bad, and honest brands have to compete with those who refuse to play by the rules.
Even if the New York case falls apart on scientific technicalities once it gets to a judge, this industry is quickly losing in the court of public opinion.