DSHEA 2.0

5/18/19

By Elan Sudberg

I’ve been ruminating on the adage, ‘what got you here won’t get you there’ as I turn 40 this month, as we strategize the future of Alkemist Labs, as the industry evolves, and as legacy regulations ripen. DSHEA was written before the internet was a thing, passed in 1994 and then just a handful of years later, Alkemist Labs was born in 1997. We had slow dial up (remember that noise???) and a fax machine (remember that noise???). What were exciting new developments in their day would be a hindrance now, but it’s helpful to look back as we consider how to move forward.

Prior to DSHEA the dietary supplement industry was but a sore point for the FDA. Perceived by FDA as a bunch of hippie snake oil salesmen, the Agency made it clear its mission was to prevent such trade. While good companies did exist back then, and many matured into the banner companies of today, the industry was void of relevant regulation, definitions, and guidance. DSHEA made it possible to establish definitions for ingredients and combinations of such, giving rise to vocabulary used to describe the dietary supplement industry. From that point on, DSHEA established safeguards like cGMPs (21CFR 111) and NDIs.

Much of our success can be attributed to DSHEA. If Alkemist Labs had a grandfather his name would be DSHEA 1.0. He would be 25 years old and have fathered a son named cGMPs, who would have fathered a handful of labs that have now mostly consolidated into a few Goliaths.

Throughout the years there have been some minor advances to the rules but only short-lived publicity stunts like using a DNA method developed for dinosaur bones on plants that produced inaccurate conclusions and created excitement, have been impactful enough to change how we ensure quality. Even then, the laws have remained largely unchanged, yet the industry found the internet and tons of money and new players and new ingredients and and and…

It’s been said that this industry was forged in the 60’s by and for people who ran and owned companies “with a sense of commons and community.” Today it’s dominated by big pharma, big food and big tech.

There is rumbling of a DSHEA 2.0 (I’d call it 25.0) but DSHEA 1.0’s architects are legitimately concerned if the next generation of leadership is up for the challenge. The head count is underwhelming for players to take on the new role of industry champion with the will and political expertise to engage in what smells like a DSHEA reorg. None of the members of Congress who were involved in DSHEA 1.0 are still there to introduce and move new legislation forward, and a highly partisan Congress is not likely to improve their productivity, which makes meaningful change look doubtful.

There is hope, though, as next generation transparency becomes an expectation of tomorrow’s consumers and that unstoppable movement forces the industry’s hand to adapt once again. Mandatory product registration is a good start and would help to catch us up the rest of civilization. Yes, it’d be painful, but it’d also be extra painful for those unscrupulous players we are trying to remove. Of course, better governance of NDI’s is a clear need and on the heels of product registration. FDA assigned fit-for-purpose test methods would be super cool so we can stop spinning our wheels and accept that Alkemist Labs offers the best plant ID testing in the West, in the East, in the South and of course the North. Cause based companies with integrity and philosophy to life and health written into their corporate mission will dominate the landscape. Lastly, within this industry, a new generation of leaders is growing into the next sergeants, colonels and generals. While we may have not had the opportunity to be hardened on the battle field as some of our legacy leaders, we are ready to take this industry to its next highest level.

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