Is dry labbing the dirty secret of the dietary supplements industry?

The practice of dry labbing, or approving test samples without actually doing any tests, has occurred in the supplements industry for years. Now a national TV show on the subject may provide the "seed event" to spur action on the problem.

Dry labbing—the practice of reporting the results of chemical analysis without actually getting your equipment wet—has been the dirty secret of the dietary supplement business for years. It’s not going away anytime soon; in fact, according to a leading expert, it’s getting worse. And on Sunday, March 18, NBC's Dateline will tackle the topic.

“It’s an activity set that’s been going on as long I’ve been around and that’s twelve years,” said Frank Jaksch, founder and chief scientific officer of ChromaDex, a company that provides testing services. “It’s a problem that has gotten worse over the years.”

Jaksch defines dry labbing this way: A specimen is sent in to one of these labs, no tests are ever performed on the specimen and yet a report is generated and sent on to the customer.

Some less sophisticated companies have been defrauded by dry labs, and end up taking the fallacious results at face value. But Jaksch said in other cases companies might collude with labs to get the results they want on the specimens they send in, specimens they may know to be substandard.

“There are definitely willing participants. There are also a lot of companies that don’t know this is happening,” he said.

Paula Brown, of the British Columbia Institute of Technology (BCIT), agrees with Jaksch on the timeline and scope of the issue.

“I and my colleagues from contract laboratories have been well aware of this problem for many years. It is a challenge for reputable contract laboratories to explain to clients that the test they are asking for doesn't actually exist or to explain why it is that the other lab was able to give them a 'pass' when their analysis clearly does not,” she said.

But Brown, who directs the institute’s Natural Health and Food Products Research Group, stops short of alleging outright collusion between companies and the labs they contract with.

"They may wonder why a certain lab is so much cheaper and never gives them a 'fail,'" she said, "but I do not think there is a direct communication between the company and the lab that goes so far as to actually request fake data."

In either case, the ingredient suppliers and finished goods manufacturers own the responsibility for the quality and safety of their products. Beside the issue of simple fraud, dry labbing violates the law by failing to measure up to the standards set out in GMP regulations. And beyond the manufacture of poor quality, inefficacious products and the risk of civil liability and criminal penalties, dry labbing can pose a real risk to public health.

“I can point to a case where the actions of a dry lab directly resulted in death. It doesn't get riskier than that. In that case it was microbial testing of water, but water was not the only thing that laboratory was, or wasn't in that case, testing,” Brown said.

Why does dry labbing persist?

So why has dry labbing gone on for so long? One reason is that barriers to entry are so low, Jaksch said.  It’s possible to buy a bunch of used equipment on eBay and set up a lab that might appear capable of performing tests in as little as two weeks. It’s the analytical chemistry equivalent of criminals who set up printers to churn out bad checks.

And action on the issue is complicated by civil liability concerns.  No executive or company wants to be the lone crusading knight at the head of the army who gets cut off at the knees by the trial lawyers. Proof of the practice is difficult to come by without investigative authority.

Jaksch has long advocated for a concerted effort by industry to end this practice, and has spoken of a "seed event" that might provoke action. Such an event is now in the offing; Jaksch will make a national television appearance Sunday on a segment of NBC's Dateline program to talk about dry labbing, and more national media reports on the practice are sure to follow. The cat will shortly be out of the bag.


How companies can protect themselves

Both Brown and Jaksch said there are some common sense approaches that companies can take to avoid being taken in by a dry lab.

“Take time and care in choosing the contract laboratory you intend to work with and never 'lab shop' or buy on price,” Brown said. “While spending a lot of money does not guarantee results, you can be pretty sure that if a lab is charging far less than most competitors, there is a reason.”

Jaksch recommended being suspicious of labs that are too eager to please; for example, labs that don’t balk when being asked for unreasonably short turnaround times. Like making fine wine, certain analytical tests just can’t be rushed.

“Fast turnaround times for any lab that’s doing legitimate testing is a tough situation. For example, yeast and mold takes at least four or five days because the culture takes time to grow. Most people don’t know what the challenges and limitations are for the thousands of tests that can be done. I'm not saying it isn't complicated,” he said.

Jaksch laid out four regular practices companies can follow to foil dry labs:

  • Don’t be too specific about what sort of result you expect. A specimen has to be identified, of course. But providing a specification that’s too detailed gives a dry lab the result that they know you want and that they can feed back to you.
  • Regularly send in challenge samples, samples that you know will not meet your specifications. This could extend to what Jaksch called a set of “up and down” results. Tell your lab something is in the sample that isn’t, and put something in another sample that you don’t disclose. If you get a “pass,” you’ve got your red flag.
  • Make regular verification of your testing labs part of your Standard Operating Procedures.
  • Finally, get some boots on the ground. Visit the labs in person and watch equipment and personnel in action.

Association of analytical labs

Jaksch is hopeful that pan-industry action can be taken to help corral the issue. A coalition of analytical labs could provide certification that member labs are operating in an above-board fashion and are in compliance with GMP regulations.

“I think that’s a great idea, but I guess the devil is in the details on something like that,” he said.

Brown agrees: “Back in 1999, BCIT ran a pilot study to look at laboratory testing of dietary supplements. Over the next decade we ran a number of lab proficiency exercises and determined that there are barriers to a practical accreditation program—namely reliable reference materials and validated methods.

“As more methods and reference materials become available and as the industry becomes more accustomed to requesting laboratories demonstrate their methods are appropriate for intended use, contract testing of dietary supplements will evolve,” she said.

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