CRN’s Mister on DSHEA’s ‘monumental anniversary’, companies choosing a side, and the critical role of contract manufacturers for GMP compliance


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Related tags Dietary supplement Want Food and drug administration

The 20th anniversary of the Dietary Supplements Health and Education Act (DSHEA) is ‘monumental’, says Steve Mister from the CRN, but the industry shouldn’t rest on its laurels too long. ‘The important thing is to figure out what change is necessary to help the industry to continue to grow and then manage that change’.

Speaking with NutraIngredients-USA at the SupplySide West show in Las Vegas, the Council for Responsible Nutrition’s President and CEO told us that the industry needs to manage any change, “both on Capitol Hill and with the FDA, to be in a position of political power and mold what it looks like”​.

Mister also talked about the ‘very positive’ reaction to the call to arms he issued during the CRN’s annual symposium last year​.  “Companies realize that consumers want to trust the products they buy, so you have to take sides with consumers to demonstrate you stand with them,” he said. “That means doing the right thing in terms of manufacturing practices, in terms of being conservative with your claims, in terms of the ingredients that you use.

“Our membership is growing as a result, because our call to arms and CRN membership is a way to distinguish themselves and say, ‘I stand for something’.”

Barriers to entry

But how does the industry stop the fly-by-night opportunities who tarnish the whole supplements space? Is the industry ready to discuss raising the barriers to entry, for example?

“I think some of the barriers to entry will happen without regulation,” ​he said. “As consumers understand what the third party seals like NSF and USP stand for they will start to shop and make decisions for the companies based on their purchasing. That doesn’t require a change in the law, it just means consumers have to better understand how to pick between the good and not so good.

“We’ve seen some severe criminal and civil actions brought to conclusion. We have seen former executives in the industry sentenced to jail time, we have seen injunctions issued to closed down companies, we have seen recalls and seizures of millions dollars of product.

“We’re starting to see an Agency that is growing into these powers. They’re starting to use the tools they have, but unfortunately [the FDA] is not using them enough to send a strong enough deterrent message to the industry.

“A warning letter is not going to be enough of a deterrent.

“I don’t know any way that these active pharmaceutical ingredients get into these products accidentally. Someone is putting them into with knowledge and we need to be using the criminal powers in the Act.”

The critical role of contract manufacturers

Mister added that contract manufacturers, who represent a big force in this industry, have a critical role to play. “An awful lot of the dietary supplements in the US are made by a third party manufacturer […] They become the experts in the GMP process, they become the expert in screening the ingredient suppliers, so it’s very important that they take the GMPs seriously.

“For marketers who are shopping for a contract manufacturers, I would want to know how many times you’ve been inspected, and see you 483 forms before I signed anything.”

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