WASHINGTON In response to a lawsuit filed Tuesday in California, which claimed that fish oil supplements allegedly are contaminated with polychlorinated biphenyl, an organization representing the manufacturers and ingredient suppliers of such products said the claims are false.
The Council of Responsible Nutrition issued a statement late Tuesday refuting claims submitted in a lawsuit that names eight makers and sellers of fish oil, shark oil, fish liver oil and shark liver oil supplements that have PCB contamination above the safe harbor limits set for human PCB consumption under California's Proposition 65 — a law requires consumers to be warned about such exposures. Andrew Shao, CRN SVP scientific and regulatory affairs, pointed out that the Food and Drug Administration has established a PCB tolerance level and that the lawyers in this case are "attempting to frame this as a public health concern, when in reality, fish oil has enjoyed decades of safe use."
"PCBs are ubiquitous within the environment, which means that all fish — whether fish found in oceans and rivers or fish oil supplements — contain at least trace amounts of PCBs," Shao said. "The FDA has established a tolerance level for PCBs in fish, which is 2.0 parts per million (ppm, also expressed as mg/kg) or 2,000 parts per billion; in comparison, the Prop 65 daily limit for PCBs for a cancer warning is 90 ng/day, which is significantly lower than what FDA deems safe."
In line with this response, Pharmavite, maker of Nature Made products and one of the manufacturers listed in the lawsuit, said it believes the group performed a single test on one omega-3 fatty acid sample to develop their conclusions.
"Pharmavite believes that the findings presented by the fishoilsafety.com consumer group today are anomalous or in error," the company said in a release. "The magnitude of the science supporting the benefits of consumption of fish oil far outweighs the results of this extremely limited investigation."