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ConsumerLab.com rails at GMPs

By staff reporter, 17-Jul-2007

Related topics: Regulation

Controversial supplements industry watchdog ConsumerLab.com has criticised the recently issued Good Manufacturing Practices (GMPs), saying they are not strong enough to prevent a company manufacturing a 'bad' supplement.

The GMPs form part of the 1994 Dietary Supplement Health and Education Act (DSHEA), but it took until last month for them to be issued by the FDA in their final form. The long delay was seen as detrimental to the reputation of the industry, the respectable side of which has always sought to uphold good standards.

ConsumerLab.com has a troubled relationship with the supplements industry, and its latest stance flies in the face of the broad welcome that the GMPs have received.

As Andrew Shao, vice president of scientific and regulatory affairs for the Council for Responsible Nutrition (CRN), said at the time the GMPs were published: "For the responsible companies in the industry, they've probably been doing this for over ten years," said Shao. "It should really be a minor adjustment."

For companies that are not already adhering to food GMPs, Shao said the new practices will be "a wake-up call".

Likewise Daniel Fabricant, vice president of scientific and regulatory affairs for the Natural Products Association (NPA) said that his organisation is, for the most part, happy and that the GMPs will be good for the industry.

However ConsumerLab.com levels that the GMPs are insufficient since while they require all ingredients going into supplements to be tested, they do not specify testing methods and standards.

Company president Tod Cooperman said that the absence of a limit on lead and other contaminants is also problematic. "Contamination is a well-known problem with some herbal and mineral supplements," alleges ConsumerLab.com.

The company sees it as problematic that the GMPs leave it up to individual manufacturers to determine acceptable levels.

ConsumerLab.com's business is built around testing supplement products in popular categories. Products seen to fall short can be the subject of negative publicity - such as The Vitamin Shoppe's women's multivitamin product, which was withdrawn from sale in January following allegations of a high lead content.

The Vitamin Shoppe launched an investigation into the case, but also questioned the integrity of ConsumerLab's testing and intentions.

Vitamin Shoppe CEO Tom Tolworthy said at the time: "Our industry badly needs an independent testing procedure that truly has the best interests of the consumer at heart," although he did not elaborate on what form testing could take or where funding for such an entity could come from.

ConsumerLab.com has now said that it is making available its own index on methods and standards available free of charge to industry, academia and the public on its website.

It has also initiated an ingredients testing program called CL-cGMP Verified Testing Program", which it said aims to reduce the incidence of ingredients being tested several times by different manufacturers.

Other companies to have launched business initiatives off the back of the GMPs include Global Lifescience Solutions (GLS), an NSF International Company, which performs preliminary audits to ensure a facility is in full compliance with GMPs; and Pharmaceutical Consulting Services, which is offering consultation on regulatory compliance issues.