It started with a new book, Vitamania, which was critical of dietary supplements; followed by the New York Attorney General’s investigation of herbal supplements; continued with FDA’s advisory and recall of the synthetic stimulant BMPEA; and most recently, has spread to Congress, with Senators Blumenthal and Durbin introducing amendments to a defense funding bill that would require third-party certification of all dietary supplements sold on military bases. On the one hand, these are signs indicating that changes are in the air for this industry.

On the other hand though, our dietary supplement consumers appear to be committed to their supplement regimens. Despite the unfavorable news stories consumers see and hear in the media, supplement sales have managed to edge upward throughout this timeframe (albeit not as much as past years). According to sales data, loyal supplement users have continued to purchase these products—although the industry may never know whether it has lost potential new customers who won’t begin a supplement regimen because they were scared off by the negative press. Despite the resilient sales numbers, a more critical, but harder to ascertain, measurement is the impact these events have had on consumer confidence in our products. Does our core consumer just filter out the bad stories? Or does the drumbeat of negative news coverage slowly erode that trust?

‘Frail Canaries’
In either case, the dietary supplement industry has been portrayed as the metaphorical wounded deer in the woods right now, weakened and open to attack, and likely to attract circling vultures from opportunistic plaintiffs’ attorneys, consumer advocates and our critics in Congress. I prefer, however, to think in metaphorical terms of a canary in the coal mine. When the bird dies, smart miners know it’s time to pump in more oxygen, or get out of the mine entirely. And we’ve got some mighty frail canaries right about now.

If we sustain this recent round of attacks unscathed, the danger here is a misbelief that the dietary supplement industry is invulnerable, that these setbacks are not signs of a looming storm. Instead, we must observe these signs and begin to consider how to get ahead of potential problems. We can’t afford to do nothing.

The Dietary Supplement Health & Education Act (DSHEA) has served consumers and industry well for the past 20 years. It seems that critics of DSHEA often suggest dietary supplements should be subject to the same pre-market approval processes established for drugs. Aside from the obvious limitations of pre-market review—drugs do get recalled from the market even after undergoing extensive pre-market approval—the tendency to see the regulatory world as either/or can limit the opportunity to craft more appropriate and creative solutions to the issues faced by supplements.

There are other, incremental regulatory options than full, pre-market review on the one hand, and maintaining the tenets of DSHEA, enshrined as they were first enacted back in 1994, on the other. We have already demonstrated with the passage of the adverse event reporting law in 2006 and the Food Safety Modernization Act in 2011—both of which amended DSHEA—that every statute can benefit from thoughtful improvements.

Examining the Teacup
So it’s time to read the tea leaves and begin some candid, introspective conversations about the future regulation of dietary supplements. Where has DSHEA been especially successful at spurring innovation and assuring consumer access? Where have disreputable firms taken advantage of loopholes or ignored the law with impunity? Performing an honest reflective assessment of what’s working and what isn’t is a good place to start.

Next, we need to decide what options we can put on the table for discussion. Would a product registration or a label database give FDA illumination into the dark corners of the industry? Does a preference system make sense for products that have received a valid third-party certification when FDA prioritizes its GMP inspections? Does evolving scientific research blur the lines between food and medicine, or between disease and wellness, to a degree that the distinctions between structure/function and disease claims need to be reexamined? These are discussions we need to have now, and are having at CRN, so that we are not caught by surprise when reformers ask what the next generation of regulation should look like. Better to be driving the train than standing in front of it.

And thirdly, we need to assess our political strengths and reinforce where we are vulnerable. Driving policy in Washington, D.C. demands a combination of high-level operatives; adept negotiation and compromise; understanding where to draw the line; grassroots; campaign contributions and access to decision makers; scrupulous ethics and credibility. I was proud to read in Congressional Quarterly Weekly in June that “[t]he supplements industry knows how to work the Hill, and usually gets its way.” That’s the reputation you want in the halls of D.C., but in reality, political capital is hard-earned and easily spent, so everyone in the industry has to play a part to earn that reputation.

There is a tendency after making it through a difficult time to sit back, make some tea and engage in self-congratulation. Smart leaders don’t just make tea though, they read those tea leaves for what comes next. They know change is constant and what worked well in the past may not serve you in the future. They reassess, recalibrate and restock. Now is the time for the dietary supplement industry to examine the bottom of the teacup.