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Fish Oil Supplement Makers, Sellers Sued Re PCBs

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Several makers of fish oil supplements, and retailers CVS, GNC and Rite Aid have been hit with a lawsuit under California's Proposition 65.

The suit, filed Tuesday in the state's Superior Court in San Francisco, charges that the defendants are marketing products containing PCB levels that exceed the law's limits for human consumption of these contaminants, and illegally failing to disclose this to consumers.

Filed by the Mateel Environmental Justice Foundation and two individual plaintiffs, the suit is based on tests of 10 fish-oil supplements that the plaintiffs said they had conducted by independent labs.

Supplements shown by the tests to have PCB (polychlorinated biphenyl) levels above the "safe harbor" consumption limits set by Proposition 65 include ones produced by Omega Protein, Inc. (the world's largest Omega-3 fish oil producer, per Reuters), Now Health Group, Inc., Pharmavite LLC (Nature Made brand), Solgar, Inc. and TwinLab Corp., according to the lawsuit.

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The suit names CVS Pharmacy, Inc., General Nutrition Corp. (GNC) and Rite Aid Corp. as retailers of some of the products at issue, but no store brands were tested in this first round of research, according to David Roe, one of the plaintiffs' attorneys. The plaintiffs held a Web press conference Wednesday to announce the lawsuit.

PCBs are manmade industrial chemicals that have been officially recognized for 20 years as causing cancer and reproductive toxicity, and whose manufacture has been banned by Congress since 1979, according to the plaintiffs. Taking over-the-counter supplements for the heart-health and other benefits associated with the Omega-3 fatty acids in fish oil has become increasingly common, but PCBs linger on in many bodies of water and can become concentrated in fish and their oils, they said.

Proposition 65, passed by California in 1986, seeks to limit the public's exposure to carcinogens or other harmful chemicals, and in some cases goes beyond federal law/standards. California's law set daily PCB intake levels representing "no significant risk" for causing cancer, but there is no official safety level regarding reproductive toxicity, the plaintiffs said.

The Food and Drug Administration (FDA) has no official standards regarding the levels of PCBs tolerable for human consumption, according to Roe. The Environmental Protection Agency has been researching PCB/dioxin standards for about two decades -- also without issuing guidelines, he said.

The suit contends that the supplements industry is well aware that fish oil supplements can be high in PCBs. "That's why many of them say their supplements have been 'treated' to remove or reduce PCBs," stated Chris Manthey, one of the plaintiffs. "But since they don't say how much PCB contamination is still left, even consumers who choose 'treated' supplements can't know what PCB levels they're swallowing along with their daily Omega-3."

The PCB levels varied very widely among the 10 products tested, indicating that fish oil products by necessity do not have to have high levels, said Roe. Those with the lowest overall levels of PCBs at the recommended daily dose were, in order, Solgar Norwegian Cod Liver Oil, TwinLab Norwegian Cod Liver Oil, GNC Liquid Norwegian Cod Liver Oil and TwinLab Emulsified Norwegian Cod Liver Oil. Some of the highest levels were found, in order, in Now Foods Salmon Oil, Now Foods Double Strength Cod Liver Oil and Nature Made Cod Liver Oil, according to the chart of results released to the media.

There are more than 100 fish oil supplement products on the market, and Roe said that Mateel will expand its tests to more of these going forward and add names to the suit, if necessary. The testing and the lawsuit are intended to force companies either to eliminate PCBs or reduce them below the "safe harbor" limits, and forcing disclosure of high levels in some products is a practical means of achieving that goal, he said.

After contacting several of the defendants, Supermarket News reported that GNC expressed confidence in its cod liver oil and all of its fish oil products. Pharmavite stressed that its Nature Made products comply with all FDA, individual state (including Proposition 65) and European Commission standards, adding that the brand's fish oil products have been awarded for purity, potency and quality by the U.S. Pharmacoeia Verification Program and rated a "best choice" in a survey conducted by the nonprofit Environmental Defense.

Rite Aid was not yet familiar with the suit, and CVS said its policy is not to comment on pending litigation, according to Supermarket News.

The Mateel foundation, a law firm based in Eureka, Calif., has handled numerous Proposition 65 cases, including some dealing with non-consumable products such as PVC-coated wire and lumber treated with toxic chemicals.

The two individual plaintiffs in the suit (the other is Benson Chiles) are residents of New Jersey. Citizens from any state can elect to file suits under Proposition 65.

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