Supplement Perspectives

Happy (Early) Birthday, DSHEA!

Michael Lelah, the technical director of NOW Foods, looks at 20 years of DSHEA from a manufacturers perspective.

Happy 20th birthday, DSHEA. You legitimized an industry that is behind the times--nutritional supplements and traditional herbs and medicines have been around for thousands of years! You also legitimized an industry ahead of its time--one that is focused on prevention and wellness instead of curing disease.

In the 20 years of your life you have helped craft the direction for the industry: you have provided a pathway to legitimacy. But you have also been difficult! Because you were born by voice vote and no records, the intent of many of your features and benefits are not well definedand open to interpretationand detractors. There are many. You have spurred some childrenone change involving adverse event reporting, and FDA-driven regulations including cGMPs and draft guidances, the draft NDI guidance being the biggest and most all-affecting.

As a manufacturer, we rely on your words to guide our activities. At NOW we are committed to manufacturing and selling supplements according to your rules and regulations and we work hard at this. Unfortunately, not everyone feels the sameand others taint you and make you fodder for unabashed criticism.

You are very expensive to maintainyou insist on being the Cadillac for an industry more used to being a Chevy. We are finding that the old ways of supply chain and quality assurance and control are outdated. You are able to re-invent yourselfand industry manufacturers are playing catch-up. At NOW we hope we stay ahead of the gamebut this takes much work and money.

You focus on safety, and this is indeed the road to follow, but your detractors fail to count the dead bodies in your wake. Where are these dead bodies anyway? At NOW we have listened to your focus on safety. Despite the lack of dead bodies, we are doing everything we can to enhance the safety of our productsand our customers expect it so.

You give and you takeyou allow us to make some claims for our products, but restrict our ability to make other claims. You continue to challenge us in the new world of the Internet where things are not as cut and dry as when you were born.

But without you we would continue to be burned at the stake. So we celebrate your birthday, DSHEA, and wish you many many more.

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