Jim Kababick on 30 years in the industry: ‘Working together to solve our problems is probably the best thing we’ve done to push the industry forward’

By Stephen Daniells

- Last updated on GMT

Related tags phytoforensics quality Dietary supplements DSHEA Good manufacturing practices cGMP

“If people who don’t understand the industry spent a day looking at what goes on behind the curtain, they’d be blown away,” said Jim Kababick, founder of Flora Research Laboratories, as he looked back on 30 years in the industry.

Speaking with NutraIngredients-USA via video, Kababick said that when he looks back on 30 years of labwork and 30 years of sitting on committees in the industry, he marvels at how far the industry has come.

“I’m very optimistic about the future of the industry,” he told us. “It’s come so far. It’s a tight ship compared to what it was. The industry has embraced and engaged science, and very importantly, the industry has embraced collaboration and cooperation. Working together to solve our problems is probably the best thing we’ve done to push the industry forward.

“Technology is advancing with computer science advancing, we can do a lot more without undue burden than we could in the past,” he said.

“It’s a good industry, there’s a lot of great companies out there, and we work with a lot of fantastic companies. Labs have to function as a partner in the quality of a company that they work with. That means, when FDA shows up, or their vendors are not taking the material back because their lab disagrees, you’ve got to be out there to help the client, you’ve got to provide data and support and back-up, and hold a hand sometimes. That matters to companies who are serious about their quality. I see more and more of those companies, and less companies that just want a paper that says everything’s OK so they can sell stuff. That’s a big change.”

Pre-DSHEA, post-DSHEA

Kababick founded Flora in 1993, a year before the passage of the Dietary Supplement Health and Education Act (DSHEA). Pre-DSHEA the industry was the Wild West, said Kababick. “The time before DSHEA, we were fighting for our existence. There was an attempt to change the way the industry would be, and you’d need to end up getting a prescription from your doctor for a bottle of Vitamin C, which is ridiculous,” he said. “It was a very important Act that passed.

“At the time [the early 1990s], the industry was much smaller, there were much less complex products on the market, there were fewer companies involved, and things were a lot simpler. Because of the less evolved market, there weren’t the same kind of challenges that we have today with the large scale of the market. It’s a lot harder today to manage quality than it was back then, in one way. In another, it’s not because of a lot of changes in the science.”

While DSHEA passed in 1994, the industry had to wait until 2007 for the FDA to publish the final rule for current Good Manufacturing Practice for Dietary Supplements (and then a further three years for full implementation across all companies in the industry).

Kababick said that there was a gradual ramping up of quality standards across the industry as the final rule approached, and a lot of companies started preparing for the final rule based on the proposed rule.

“A lot of companies started building in the infrastructure they would need, and that’s substantial. If you’re a large manufacturer with a large number of products, it’s daunting the amount of things you have to do,” he said. “It’s one of things that frustrates me about how major media often covers our industry, which is that it’s unregulated, everybody’s just out there selling snake oil. The reality is that most of the companies in our industry are really good companies that do really good work and make quality products. There are always going to bad actors, but there are bad actors in the food industry, in the legal industry, in medicine, in pharma. I think sometimes our industry is unfairly targeted.”

Phytoforensics

We also reminded Kababick of a 2012 interview with this publication​ where he discussed the value of phytoforensics.  “This is a field that I’ve pushed forward that consists of a variety of techniques, orthogonal analysis techniques, standardized approaches to sample analysis that would help detect contamination and help ensure authenticity,” he explained. “A lot of times, people go in with a targeted screen, so they say, ‘we’re going to look for this’. That’s a bit like putting on a pair of glasses that only sees one wavelength of light, so you can only see things that are red. In that case, you have a limited view of what’s going on. By combining techniques, you can see a lot more.

“That combination of techniques, or crossover analysis was one thing, and then there’s a systematic approach. So, for things like male virility products that might be contaminated with a variety of pharmaceuticals, there’s a logical approach to how you test this, and non-targeted screening is really vital there. That means not just focusing on compounds you know, but opening your scope so you can detect novel compounds that are coming out.”

Kababick also reflected on the events of 2015 and the then New York Attorney General’s investigation, and the recent reports on the identification of toxic yellow oleander in weight loss supplements.

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