ConsumerLab.com says criticism by dietary supplement industry experts and advocates is inaccurate and reflects their regard for the industry rather than consumers.

ConsumerLab July 17 announced two initiatives related to good manufacturing practices - access at no charge to an online index of its testing methods and standards for supplement categories, and a testing program "designed to help companies more economically meet new GMP testing requirements."

However, in the announcement ConsumerLab President Tod Cooperman also describes the GMP final rule as lax, saying it allows "a company to manufacture a 'bad' supplement."

Because the rule allows manufacturers to choose methods and standards for judging the identity of ingredients in their products, manufacturers can use testing methods that "allow the production of supplements of low quality or with very little real ingredient," Dr. Cooperman says in the announcement.

In a July 18 statement, CRN questions ConsumerLab's business practices and testing methods.

CRN President and CEO Steve Mister questions "whether the CL methods are the most appropriate ways to analyze particular ingredients or contaminants in the matrix of the finished product."

However, CRN agrees that ConsumerLab "is finally making public without a fee its testing methods and standards - both of which have previously been unavailable for public scrutiny," Mister says.

Cooperman takes issue with that characterization. "It's grossly incorrect, the CRN statement," he told "The Tan Sheet" July 19.

ConsumerLab's testing methods and standards "have always been publicly available, freely," he said, adding, "All we did was organize it in a way that it's even easier to find it all in one place" for the GMP testing initiative.

Supplement industry attorney Marc Ullman also criticized ConsumerLab's GMP announcement.

"It is understandable that a business built on the notion that the only way to ensure quality is to test, and then set up test procedures and reporting mechanisms designed to scare consumers into believing that only companies that pay to participate in its programs sell quality products, would find the GMPs threatening," Ullman says in a blog distributed to industry stakeholders.

Additionally, the information in ConsumerLab's announcement "reveals its fundamental misunderstanding of these regulations," Ullman adds.

He says the GMP final rule does not specify methods and standards for testing each supplement ingredient because "it is virtually impossible to designate one method or set of standards by which companies should test such a vast array of ingredients."

And rather than instruct industry how to ensure the quality of their products, the final rule makes "it perfectly clear that companies are expected to take steps to ensure the quality of their products, and that this includes ensuring that those products are not contaminated," Ullman says.

Cooperman either does not understand the GMP, "or has intentionally misrepresented what this regulation is all about in order to scare consumers for his own purposes," Ullman added.

ConsumerLab not only does not agree with industry about the GMP rule, it also looks at the regulations from a consumer's point of view rather than the industry's, Cooperman said.

"I don't think there's going to be much faith in the GMP if it's not going to cause improvements. The fact that there are no quality standards in the GMPs has been glossed over by the industry. I know consumers appreciate the fact that someone is out there looking out for them," he said.

CRN declined to comment on Cooperman's response to Mister's statement.

In the statement, Mister says ConsumerLab's announcement "is not surprising as it is a for-profit business that makes money from supplement companies who pay for CL's passing grades."

Cooperman said firms pay for its testing services, but those payments do not determine the test results. For its tests, ConsumerLab purchases products made by firms that do not pay for its services as well as those made by its customers.

"We report exactly what we find from those reviews that we conduct," Cooperman said. "A company comes to us voluntarily and asks us to test their product and they own those results. If it passes, we're happy to add it to our list as an approved product, but they're not paying for a passing grade," he adds.

Mister also points out while ConsumerLab and other private laboratories and consultants can perform ingredient verification services, manufacturers are responsible for GMP compliance.

"What the final GMPs make clear though is that manufacturers must be accountable for their supplements - reliance on suppliers, third party labs, or private testing services will not relieve companies who don't produce quality product for consumers. That is the central tenet of the GMPs," Mister says.

The GMP final rule FDA published June 25 places the onus of compliance completely on manufacturers and does not apply to suppliers or producers of raw ingredients (¹ Also see "Supplement GMPs Stress Responsibility, Put Firms In Driver’s Seat For Testing" - Pink Sheet, 25 June, 2007., p. 3).

Cooperman said he realizes ConsumerLab is one of numerous labs that conduct ingredient testing for suppliers as well as for supplement manufacturers.

However, ConsumerLab's initiative focuses on suppliers paying once for a test of lots to cover ingredients they provide to multiple manufacturers, he says.

"We see the supplier really funding much of the cost in a way to help their customers meet the GMP requirements. But it's certainly a third party program," Cooperman said.

After the Federal Trade Commission declined to investigate a complaint CRN filed, ConsumerLab filed a suit alleging defamation in 2005. A New York state court judge dismissed eight of ConsumerLab's nine charges (² Also see "FTC Drops CRN ConsumerLab Complaint; Testing Firm Will Sue Trade Group" - Pink Sheet, 21 March, 2005., p. 16 and ³ Also see "ConsumerLab/CRN Suit Centers On Defamation; Other Allegations Dropped" - Pink Sheet, 29 May, 2006., p. 9).

CRN said ConsumerLab's decision in November 2006 to dismiss the suit came as it prepared to ask the court to require additional information from ConsumerLab about its business practices (⁴ 'The Tan Sheet' Nov. 20, 2006, In Brief).

- Malcolm Spicer (m.spicer@elsevier.com)

ConsumerLab And Industry Trade Words Over GMP Testing Initiative

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