"There is a definite trend toward increased regulations in all markets worldwide," says ChromaDex co-founder and CEO Frank Jaksch, Jr. "This will continue, and from a research perspective, the trend also has shifted over the last three or four years toward functional foods and beverages, rather than dietary supplements."
From Jaksch's perspective, this is good news indeed because his company is the only one he's aware of whose focus is on creating reference standards and materials for suppliers and manufacturers. These standards are the purified substances and physical compounds by which others can compare the ingredient or product they have received and know for certain that it is what it claims to be.
"We design biological reference tools to help our customers determine a match, and for human and animal studies," Jaksch says. "Our company has the only extensive line of reference materials, and our customers are spread out all over the world, with the bulk of them in the US and Canada, and somewhere between 35 per cent and 40 per cent international." ChromaDex has strategic partnerships with numerous other companies overseas, such as LGC Standards, which sells ChromaDex products to EU markets.
Headquartered in Irvine, California, since its inception in 1999, ChromaDex has more than 50 employees, and a laboratory in Boulder, Colorado. "At least 60 per cent to 70 per cent of our employees have a chemistry background, even the salespeople," Jaksch says.
The new GMPs and other regulatory pressures worldwide are going to mean big changes in the industry, Jaksch believes. "Quality control is going to be paramount, and you can't have quality control without references standards. As well, you have to take a multiple-tier approach to quality. These are complex products that require complex solutions.
"Many companies employ a single testing strategy — NIR [near infrared] or FTIR [Fourier transform infrared spectroscopy], for instance. That's a big mistake — it is not scientifically valid by itself, and doesn't give you the whole answer. Melamine was a result of an NIR testing. This kind of nonspecific test needs to go away."
A lot of the blame for poor quality or outright fraud, Jaksch feels, falls on the purchasers' side of the equation. "They've had the blinders on. They don't want to know. It's all been about price-point shopping. If the drum is labelled ginkgo, they accept it based on the paperwork. Certificates of Analysis aren't worth the paper they are printed on. But with the new GMPs, you're going to start seeing planning and risk management that doesn't happen now. You're going to see manufacturers signing real contracts with suppliers that stipulate, 'If you fail and something goes wrong, you're going to get sued.'"
This, he believes, will quickly lead to a weeding-out process, like the one that happened in the '90s with pharmaceutical companies. "It is clear now that the market needs to take a more pro-active approach toward quality. It will require investment." Ultimately, he says, it comes down to enforcement, though. "There are a lot of companies out there that don't think the FDA is going to do anything."
Beyond quality of content, an even bigger question looms — one of efficacy. "It gets down to this basic fact," he says, "if the test has nothing to do with the efficacy, what's the relevancy?"
He cites a typical standard for St Johns wort and its level of hypericin, the component that inhibits monoamine oxidase, a bodily chemical associated with depression. "Tests can determine if there is the .3 per cent hypericin required to pass the GMPs, but that doesn't guarantee the efficacy. We do a lot of hoodia testing … now prove to me that 125mg does anything."
Regardless of whether these deeper questions eventually are addressed, Jaksch is highly confident about ChromaDex's future. "With this increasing demand for quality control, there isn't another company in a better position to capitalize on that. You simply can't do quality control without references."