Industry Responds to Lawsuit Against Fish Oil Makers

Washington, D.C.—In the wake of the filing of a lawsuit against fish oil manufacturers over alleged polychlorinated biphenyl (PCB) contamination in their products, the Council for Responsible Nutrition (CRN), based here, released a statement defending the practices of these companies. The lawsuit, filed March 2nd in California, claims the levels of PCBs found in select fish oil brands are in excess of a “safe harbor” limit set by California’s Proposition 65 legislation. The plaintiffs have yet to state what were the actual amounts of PCBs they found during testing.Fish Oil

PCBs are very durable synthetic chemicals used in the past for a variety of industrial applications, especially by the electricity industry. Their production was banned in the United States in 1979, and internationally in 2001. PCBs—known carcinogens—persist to this day in many parts of the environment, especially in bodies of water, where they sometimes contaminate marine life. The fish from which omega-3 fish oil is extracted may have trace amounts of PCBs in them, which is not harmful to humans in these low levels. High-quality manufacturers refine their products to create as pure a product as possible.

For this reason, CRN maintains that fish oil products are safe, with its statement explaining that all fish and fish-based products contain minute amounts of PCBs. CRN notes that the U.S. Food and Drug Administration’s PCB tolerance level for fish as conventional food is much higher (2,000 parts per billion) than the 90 nanograms/day limit set by Prop 65. Fish oil products, CRN argues, contain far lower levels of PCBs because of the refining process they go through. The CRN statement, issued by Andrew Shao, Ph.D., vice president, scientific and regulatory affairs, paints the class action lawsuit as opportunistic, being filed in a state, California, “which has conservative standards that are not law in the rest of the nation.” He also noted, “This lawsuit does nothing to change the strong science supporting the many health benefits of fish oil…The health benefits for fish oil far outweigh any suggested, and unsupported, risks.”  

Initial defendants listed in the lawsuit include CVS Pharmacy, GNC, NOW Health Group, Omega Protein, Pharmavite (Nature Made brand), Rite Aid Corp., Solgar, and Twinlab Corp., all makers of fish oil, shark oil, fish liver oil or shark liver oil products. Twinlab and NOW Foods have publicly responded to the lawsuit by asserting the safety of their products, with the NOW Foods statement reading in part, “NOW fish oils are produced and tested by our suppliers against available industry standards and our manufacturing processes comply with Food & Drug Administration (FDA) regulations for Good Manufacturing Practices.” In a letter to its retailers, Solgar assured its commitment to quality by affirming its compliance with all laws including Prop 65, an integral part of its rigorous QA/QC guidelines.

Twinlab indicated that it previously had been working with the plaintiffs “to develop scientifically valid standards for impurities which can be found in fish oils. There are already several test methods and standards relating to PCBs in fish oils…This lawsuit is about plaintiffs seeking additional standards under California’s Proposition 65, a consumer disclosure law.”

The plaintiffs (environmentalists Chris Manthey, Benson Chiles and the Mateel Justice Foundation) are seeking civil penalties of as much as $2,500 per day for anyone exposed to PCBs through their product. Plus, the defendants would have to locate anyone who bought their fish oil and warn them of their possible PCB exposure. The plaintiffs expect to add more companies to the list as their product testing continues.


Published in WholeFoods Magazine, April 2010