“A USP Verified certification means that USP has audited the facility, the process and the product and has determined that it meets USP standards. It mainly reinforces the fact that these manufacturers and committed to quality,” Steinford told NutraIngredients-USA.
Kingdomway is the largest CoQ10 manufacturer in the world, Steinford said, so having it achieve this certification, which is part of USP's voluntary Verified Dietary Supplement Ingredients Program, was an important step for the overall market.
Setting a standard
Steinford said there is a USP monograph on CoQ10 and the members of his organization adhere to it. But that’s not necessarily the end of the quality story. The monograph sets a specification for the finished ingredient and lays out what testing procedures to use to verify it. It doesn’t say anything about what happened upstream.
“The monograph just speaks to what the quality of the finished product ought to look like,” Steinford said. “It doesn’t say anything about the process and what standards that has been audited to. All of the members of the association are now USP audited.”
Steinford said this reassurance is especially important in the production of CoQ10. Manufactures make the molecule via either a bacterial or yeast fermentation process, and fermentation processes by their nature have a higher potential for variability, meaning the added assurance of the certifications is welcome, he said.
In addition to fostering the quality basis of the industry, Steinford said part of the new association’s mission will be to build the data behind the ingredient, both in its physiological effects and its market acceptance. A new study that is not quite ready for release has shown some interesting preliminary results, Steinford said.
“We did a survey of cardiologists. Among the things we found was that 71% of cardiologists are recommending CoQ10 for their patients. It was the No.1 recommended supplement for muscle fatigue and soreness associated with statin usage,” he said.