DSHEA has a mixed report card

DSHEA has a mixed report card

Editor's note: On the 20th anniversary of the Dietary Supplements Health and Education Act, New Hope asked several experts to weigh in on the current regulatory atmosphere in the supplements space. Here, Courtney Nichols Gould, co-founder and co-CEO of nutrient-dense gummy brand SmartyPants and the company's head of research and development, Michael Cleary, discuss why DSHEA has a mixed report card.  

Responsible players in the dietary supplement industry had hoped that DSHEA would weed out the liars and cheats and the few products that actually endanger consumers. Twenty years later, the report card is somewhat mixed. FDA has written labeling rules that clarify what can and cannot appear on a supplement label. Products with really outrageous claims are off the shelf and largely unavailable. cGMPs have been established and codified for dietary supplements, following most industry recommendations and assuring safer products. Moreover, FDA has followed these rules with inspections, guidance and, less frequently, enforcement. But, true health & wellness claims for supplement efficacy are severely restricted and require a level of substantiation amounting to the level of scrutiny accorded a new drug application, a standard with a burden that few supplement companies can afford. And because label claims are so limited, consumers cannot distinguish between products built with premium ingredients and their lowest-cost competitors.

We are much more concerned with safety, transparency and making consumers comfortable that the industry is not filled with folks just trying to make a fast buck than we are with being able to make more and more claims, but there is a balance. The fact that we can’t share content in a blog or on Facebook that in any way addresses disease impact—even about nutrients our own products don’t contain—is absurd. The media is free to misreport corollary studies as causal, but we aren’t permitted to share counter evidence. It’s frustrating to see so many of our competitors breaking the rules.

In our experience, government regulation is unlikely to fix this. You will never get enough budget to be effective. This requires consumer pressure for transparency, consistency and quality to kill off the bad habits.

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