Dietary supplement industry needs ‘cultural shift’ to deal with GMPs

By Hank Schultz

- Last updated on GMT

Supplement manufacturers – particularly smaller companies – need a ‘cultural shift’ to cope with the demands of good manufacturing practices (GMPs), says a former associate chief counsel with FDA.

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.

Related topics: Regulation, GMPs, QA & QC

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3 comments

@lara

Posted by Darren,

Interesting to read your comment about the medicinal mushroom niche. I want to add some nuances, though.

You say: "not a single producer of medicinal mushroom extracts has any form of certification" but this is exaggerated. The Chinese are the main producers of these supplements, and in recent years they improved their standards tremendously. The majority of Chinese exporters are currently at least ISO and GMP certified. A simple AliBaba visit will confirm this.

The American producers, however, are lagging significantly. Not a single one has GMP certification, let alone ISO/HACCP. And this is very worrying.

You're right.

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cGMP has become world-wide-standards for pharmaceuticals ,FS/DS and Trditional Medicines.

Posted by Bambang I Iskandar/Industrial Pharmacist,

Agree that GMP in US FS/DS urgently requires "cultural shift" n must be done in faster speed- also with "shock therapy" when needed. I've been using several US made FS/DS with confident n consider them "meet specifications" but "become shocked" when reading new findings by US FDA inspection recently of "non compliance small companies. GMP enforcement's badly needed but GMP Participation Programme must be accomplished as now being done in other parts of the world.Categorizing industry on GMP requirements :pharmac,FS/DS/TM - incl manufacturer of Ingredients.Try the best ways to maintain the labels : US as world producer/supplier of these kind of Human presently basic needed stuffs.Bravo

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GMP should be compulsary

Posted by Lara,

Oddly enough, when checking on the various supplement producers, the majority of them have no certification at all. Some boast about bottling their pills in a 'GMP standard' production center, but what about the production/manufacturing of those pills ? No GMP, no HACCP, etc..

E.g. not a single producer of medicinal mushroom extracts has any form of certification, and some of these are moving 100's of tonnes annually.

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