Darryl Sullivan is director of scientific and regulatory affairs at Madison, WI-based Covance Laboratories, one of the largest contract labs in the world. Sullivan outlined for the group what a good quality control program at a dietary supplement manufacturer should look like. Sullivan, who is also chair of the AOAC stakeholder panel on dietary supplements, noted the importance of complying with good manufacturing practices (GMPs) as mandated under the Dietary Supplement Health and Education Act (DSHEA).
“There is a lot of negative publicity about dietary supplements and what could and may be wrong with them. Mostly what we have heard lately are the bad things. But I told them if a company has a good quality control program they can really assure high quality products go out onto the market,” Sullivan told NutraIngredients-USA. Sullivan was one of two presenters at the meeting, the other being Frank Jaksch, CEO of ChormaDex, who focused more specifically on the subject of DNA barcode testing.
“I talked about how to test the raw materials, and I touched on how tests should be scientifically valid and fit for purpose. I was pleased with the attentiveness because this stuff can be pretty dense. I sensed that they appreciated the information and they appreciated that there were these kinds of programs out there,” Sullivan said.
Improving industry
Sullivan said he has worked in analytical chemical testing for 35 years and has been involved with dietary supplements testing for the past 15. In that time he said he has seen a marked improvement in the quality control measures of the business.
“I have seen lots of improvement. I have seen a lot of high quality testing programs. We’re using better methods now with greater specificity. I think there is no comparison with 15 years ago with the quality that is being built into products today. I think with GMPs the threat of FDA looking over their shoulder is motivating some companies to do the right thing,” he said.
Sullivan said that pat of a good quality control program has to take into account the moving goalposts that are part of the game in a dynamic, global market.
“You can’t just buy a material that is supposedly 100% Wisconsin ginseng and put it into your product. You need to have checks and balances and testing to support that identification. You need to verify that everything you put into your finished product is what it says it is,” he said.
“But beyond that, three is a lot more focus now on what the other potential adulterants and contaminants are in these products. People are concerned with the imported botanicals for a potential heavy microbial load, heavy metals content, or obscure pesticides. There are pesticides that I haven’t seen for 20 years in the US and now they are coming in in materials from China,” Sullivan said.