Speaking with NutraIngredients-USA’s Hank Schultz at the recent SupplySide West show in Las Vegas, Jason Sapsin, a lawyer in the Denver office of Polsinelli Shughart, said that “traditionally, the dietary supplements industry grew up from a home-grown standpoint”, and that was associated with a “very basic, direct kind of manufacturing process.
“The idea of incorporating more industrial controls and a ‘higher degree of testing’ is foreign to them. I think GMPs are a cultural shift.”
Sapsin said that many smaller companies face the biggest challenges. “It’s not uncommon for a smaller company to come to me following an initial interaction with FDA, maybe the first time they’ve had an FDA inspection, and they are realizing that there is a whole universe of compliance concepts and procedures that they need to implement, really for the first time. And that can be a significant challenge."
So is this driving these companies to go the contract manufacturing route?
“I think in the short term for many of the smaller companies to go with a contract manufacturer model,” he said, “but I prefer to see the companies I work with try to keep that in-house, and to make that initial investment upfront to develop the expertise they need to make the supplements themselves, as they have been doing, but according to good manufacturing practices.
“I think the development of expertise, the education and the thoughtfulness that these companies undergo ultimately leads to a better product and a happier company.”
Jason Sapsin is a member of Polsinelli Shughart's Life Sciences group, leading its FDA practice based in Denver, Colorado. He is a former associate chief counsel in the FDA's Office of Chief Counsel, Washington, D.C.