James Neal-Kababick, director of Flora Research Laboratories, told NutraIngredients-USA that the recent Dateline NBC investigative segment on the safety of supplements and allegations of dry labbing practices shed light on an issue that “has been going on too long”.
However, the segment “hurt the image and reputation of the whole industry”.
It will also cast doubt on all labs, he said, and will make the job of legitimate labs harder because there will be increased suspicion from clients.
There is some disagreement within the industry as to how widespread dry labbing is. According to Kababick, the issue is not as big as spiking of supplements with pharmaceuticals. The Oregon-based analytical expert said he has seen about 40 reports in 3 years that were bogus.
“For me, some of the dry labbing schemes are so elaborate that I can’t help but think that it would be easier to do the real analysis than to create false documents.”
“Most of us [in the analytical community, some people in government agencies, and some in the industry at large] know which labs are dry labs or at least horrifically incompetent,” he said.
Kababick explained that another issue that is less comfortable for companies is that if it they have been using a lab for several years and they have suspicions that it is involved in dry labbing, then what does that mean for four years of product? This is why it is important for companies to get to know their labs, he said.
But getting to know the lab and testing them is hard for companies because this obviously requires a greater budget.
“I’m definitely seeing a lot more companies than not visiting us, and I expect this to continue to grow.”
Commenting on the Dateline NBC show, Kababick said the segment started off by noting that most supplement manufacturers are respectable but then went on to sensationalize the issue.
“The program,” he said, “kind of implied that the industry is running wild.
“That is not a fair portrayal of what is going on in the industry. There is better science, we have GMPs, and many companies take this very seriously.
“In a lot of ways I am very proud of the accomplishments of this industry over the last 20 years. There has been a tremendous forward movement.”
The forward movement needs to continue and “industry needs to tighten things up even more”, said Kababick.
So will GMP compliance solve the dry labbing problem, as many have suggested? “Compliance and adequate enforcement,” he said.
“It is incumbent upon any company that puts its name on a product to ensure that every part of its production program is tight. If you don’t know how to do one part then bring in someone who does.
“There is not a lot of mercy at FDA, and they are often responding to adverse event reporting (AERs).”
Analytical laboratories will sometimes have to bring bad news to their clients when a product does not pass the tests, and this can be hard to hear.
“I tell potential clients, don’t use our labs if you don’t want to know what’s going on.”
If FDA keeps enforcing the GMPs and fully enforces lot sampling then some products are not going to be around, he said, because it will cost too much to sample and test them.
Kababick noted that Flora Research has been inspected twice by FDA
To watch the Dateline segment online, please click here.