GMPs seen as solution to supplements' dry labbing problem

GMPs seen as solution to supplements' dry labbing problem

Sources say a recent Dateline NBC episode on dry labbing painted an unfair picture of the dietary supplement industry. Are dry labs truly rampant in industry as the show would have you believe?

Industry reaction to the Dateline NBC segment on the practice of dry labbing was universal on one point: The piece failed to put the issue into the context of the overall stellar safety record of the dietary supplement industry. The show used one shoddily manufactured vitamin formula product and a sting at a supplement testing lab to cast doubt on the safety of the entire industry.

The case in point, a vitamin formula product that had toxic levels of selenium, was manufactured in 2008 before more stringent Good Manufacturing Practices (GMP) regulations were put in place for that segment of the industry. A statement from the American Herbal Products Association (AHPA) notes that the product, Total Body Formula, was misbranded from the moment it went on the market. The manufacturer knew there were manufacturing problems and sent the product out anyway.

A number of consumers were harmed by the product, losing their hair and suffering other health problems. The show aired court testimony revealing that workers had seen black flecks in the vitamin mix and strained them out using women’s nylons. So that’s bad actor number one.

Number two appears to be the testing lab that the TV show exposed in a hidden camera operation. Atlas Bioscience, a contract testing lab based in Tucson, Ariz., was given samples spiked with lead and cadmium that its test report failed to note at anywhere near their true levels. Dinesh Patel, the head of the organization, has denied operating a dry lab. The company’s official statement to the show's producers read, "When given misleading information regarding a sample’s makeup, we would not be aware that the data observed is being compromised due to matrix parameters we are not cognizant towards.”

The Dateline segment takes a familiar TV news tactic: using a few extreme examples as a way to try to make a wider point. The point alluded to, but not stated outright, is that the supplement industry is insufficiently regulated.

"The specific situation of a laboratory's failings covered by Dateline NBC is not representative of the responsible supplement industry," said Steven Dentali, chief science officer for AHPA. "The show failed to recognize the expertise found in hundreds of supplement companies that understand how to properly qualify a third-party testing laboratory.”

Dealing with the bad actors

While it seems clear that dry labs and companies that intentionally send out bad product are the exception, not the rule, they do exist. The question is: how to deal with them?

Steve Mister, president and CEO of the Council for Responsible Nutrition, said GMP enforcement will have a greater and greater effect on improving industry practices as time goes on. The regulations have been fully in place now for almost two years, with companies in the smallest tier phased in June, 2010.

"Manufacturers have always had an obligation that what was on the label should in the bottle," Mister said. "But in a post-GMP world manufacturers now have a step-by-step process they have to follow starting with their master manufacturing records, going through their ingredient testing and all the way through to their finished products."

"The other half of this is the testing lab that appears to have intentionally not tested product," he said. "Part of that again is GMPs, because at the end of the day whoever puts their name on the label has 100 percent responsibility to the consumer and FDA to make sure that that product is something that they can stand behind.

"If companies choose to outsource that testing as opposed to doing it in house, they have a responsibility to qualify that vendor in much the same way that they have to qualify their ingredient suppliers."

Mister echoed some the approaches to verifying a lab that Paula Brown, of the British Columbia Institute of Technology, outlined for newhope360 in a story posted before the show aired. Go to your lab in person to make sure it's a real operation, and, if possible, talk to the people who will be doing your tests, not just a saleperson out front.

Trust, but verify your tests

Todd Harrison, an attorney with Washington, D.C.-based law firm Venable LLP, said all the hand wringing surrounding the Dateline report might be an opportunity to reexamine the relationship with supplement marketers and contract manufacturers. Too many of these products are manufactured and sold based solely on specifications put down on a purchase order, Harrison said. It’s time for these relationships to go over exclusively to quality agreements, he said.

"We are a real industry. It is time that we stand up and do what is right," Harrison said.

"Most private label distributors take the position that they are relying on the testing results from the manufacturers rather than sending out independently," he said. "My mantra goes back to Ronald Reagan: Trust, but verify."

Harrison said it should be part of a company’s regular practice to verify the testing done by their contract manufacturers and contract labs.

Implementing all of the suggestions that are arising out of this incident will cost money. But industry observers said it is money well spent, and in fact, money that must be spent and is part of the maturation of the business.

"We are not a nascent industry anymore," Harrison said.

"If we are a $28 billion industry and we are selling people something that they are going to put into their bodies for good health—in order to fulfill that promise to our consumers we have to accept certain responsibilities," Mister said. "That we are testing product to prove that it is what we said it is. That's what GMPs require."

What did you think about Dateline NBC's piece on dry labbing? Tell us.

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