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Special Report: Industry responds to Prop 65 fish oil lawsuit

Eight makers of fish oil supplements were recently named in a California lawsuit for polychlorinated biphenyls (PCB) contamination levels allegedly above the "safe harbor" limits set for human PCB intake as determined by California Proposition 65. The suit, filed by an environmental group called, lists the following defendants: CVS Pharmacy, General Nutrition Corp, Now Health, Omega Protein, Pharmavite LLC, Rite Aid Corp, Solgar and TwinLab Corp and names 10 respective brands (see list below). The lawsuit states that the products exceed the tolerable PCB levels and they lack consumer warning labels deemed mandatory by California law. According to a press statement, the plaintiffs are continuing to conduct more tests and expect to add more brands and retailers to the suit.

The Prop 65 legislation, which passed in 1986, has a history of raising awareness among consumers about potentially-toxic chemicals in products such as lead in canned peaches and in this case PCBs in fish oil. Prop 65 is also notorious among manufacturers because the so-called "safe harbor" limits are in some cases significantly lower than federally-set restrictions for potentially dangerous toxins in food and beverages. It isn't clear even in this case whether this Prop 65 action will hold water in a legal fish tank. "This lawsuit was not filed by the state of California or any governmental authority but was filed by private plaintiffs \[in California\]," according to a statement from NOW Foods, a company named in the suit.

While none of the products noted in the suit exceed FDA tolerable levels for PCBs, a few of the samples stood out for one single reason — the source of fish oil (see the charts below for the list).

The common denominator among the products that exceeded the Prop 65 safe harbor limits is that they were all derived from predator species high on the food chain — cod, shark and salmon.

All types of fish, whether for consumption as food or supplements, contain some level of contamination. It's impossible to get around it. But for many years, grandma's favourite health tonic, cod liver oil, has been of concern. Research dating back as far as the 1970s shows persistent problems with PCBs in cod liver oil because one of the liver's functions is to remove toxins from the bloodstream. Other studies have shown similar results for salmon and shark oils. It is well known that fish higher on the food chain have higher levels of contaminants (see sidebar).

Fish-oil industry experts say the suit gives consumers the impression that all fish oil is toxic. This is misleading since as much as 93 per cent of all refined fish oils are made from anchovies and sardines. Both species are lower on the food chain fish and thus have lower PCB levels, according to a Frost and Sullivan report.

"The plaintiffs unfortunately only tested one of these types of oils, which actually had PCB content well within the Safe Harbor provisions of Proposition 65. While the plaintiffs raise an important issue," said Adam Ismail, Executive Director of Global Organization for EPA and DHA Omega-3s (GOED), "it is unfortunate that they are implying that most fish oils are unsafe and that the industry is hiding information on such vital nutrients."

This case brings to light a long-standing disagreement in what is considered safe. The Food and Drug Administration sets the tolerance level for PCBs at 2,000 parts per billion, EPA's limit is four times lower than FDA's and Prop 65's limit is lower still at 90 nanograms per day (one nanogram per day is equal to a billionth of a gram per day).

That said, the various tolerance limits have very distinct limitations. For instance, the EPA limit is based on PCB exposure for caught fish, essentially for sport fisherman. Conversely, FDA sets its limits for commercial food and beverage consumption based on a lifetime of exposure. The Prop 65 limit is calculated with the lowest risk tolerance of all. Prop 65 tolerance limits are determined by NSRL (No Significant Risk Levels), which according the California Environmental Protection Agency means the number calculated to result in one excess case of cancer in an exposed population of 100,000.

"CRN \[Council for Responsible Nutrition) believes the suit was filed in California in order to take advantage of a state law, Prop 65, which has conservative standards that are not law in the rest of the nation," said Andrew Shao, PhD, senior vice president, scientific and regulatory affairs.

The suit also gives the impression that the fish oils industry has ignored concerns about fish oil quality and safety. Ismail says this couldn't be further from the truth. "Eight years ago the industry collaborated to develop strict standards to improve quality and ensure consumer safety. This standard, formerly the CRN Voluntary Monograph, is now known as the GOED Voluntary Monograph and has helped the industry grow rapidly and responsibly by pre-emptively addressing quality issues, he said. "GOED members must sign affidavits agreeing to manufacture and market products to the Monograph standards as a condition of membership."

For instance, one GOED member company, Nordic Naturals, is focused on far exceeding any required purity standards. Joar Opheim, CEO and founder says his company has "taken a proactive approach to provide individuals with information regarding the purity, safety, and efficacy of its fish oils." The company tests its products down to one part per trillion of non-ortho and mono-ortho PCBs (the most harmful PCBs which are not covered by Prop 65) and total PCBs.

Opheim notes that Nordic Natural Products are well below the Prop 65 limit of 0.09µg/kg (0.09ppm or 90ppb).

The other issue the suit glosses over is Maximum Allowable Dose Levels (MADLs), associated with chemicals that may cause reproductive toxicity. "While NSRLs have been set for PCBs in California, MADLs have not," said Ismail, "This group (the plaintiffs) is actually asserting that since no regulatory body has set a limit related to reproductive toxicity, the default level should be zero." Ismail said that toxicological assessments have not supported this position, but with Prop 65, the burden of proof is on the defendants, not the plaintiffs, in lawsuits to establish Safe Harbor limits.

While MADLs for PCBs are cited in the suit, according to GOED, even the California Environmental Protection Agency has not addressed the issue with any urgency. Dr. Harry B. Rice, GOED's director of regulatory and scientific affairs said, "The Office of Environmental Health Hazard Assessment (OEHHA) has assigned its lowest priority to the project, based in part on a lack of need."

Twinlab, a company named in the suit, says this action isn't really a surprise. The company says it has been working with the plaintiffs who filed another Prop 65 case in San Francisco to develop scientifically-valid standards for fish oil impurities. "There are already several test methods and standards relating to PCBs in fish oils. Twinlab uses suppliers for its fish oils which adhere to these voluntary safety standards. This lawsuit is about plaintiffs seeking additional standards under California's Proposition 65, a consumer disclosure law," said the company's statement on the matter. Twinlab's Chief Science Officer, Greg Grochoski said all their fish oil products, including Norwegian Cod Liver Oil and Emulsified Norwegian Cod Liver Oil, are molecularly distilled and tested for purity.

While brands like Nordic Naturals and TwinLab have vigorous processes that treat the oils to remove contaminants, FDA doesn't require companies to tell the consumer just how much remain. This case could present an opportunity for more transparency. "Companies—supplement or foods—do not declare PCB levels in their products. In this lawsuit, the plaintiffs focus on fish oil supplements but also mention that higher levels of PCBs could be found in fish meal and fish oil destined for animal feeds, because they are not typically treated for removal of toxins," saidKantha Shelke, PhD, principle of Corvus Blue and editor at large of Functional Ingredients. "This is an opportunity for supplement and food companies to declare the levels of PCBs in their products as a way to assuage consumer fear and to differentiate themselves from the 'suspect' products," she said.

Ratio of highest to lowest - 70:1

Ratio of highest to lowest - 240:1

Brands named in the suit

  1. Nature Made Cod Liver Oil
  2. Nature Made Odorless Fish Oil
  3. TwinLab Norwegian Cod Liver Oil
  4. TwinLab Emulsified Norwegian Cod Liver Oil
  5. Now Foods Shark Liver Oil
  6. Now Foods Double Strength Cod Liver Oil
  7. Now Foods Salmon Oil
  8. Solgar 100% Pure Norwegian Shark Liver Oil Complex
  9. Solgar Norwegian Cod Liver Oil
  10. GNC Liquid Norwegian Cod Liver Oil

Will fish oils sales be dead in the water?
It isn't clear yet whether the suit will stop consumers from taking fish oil supplements. According to Nutrition Business Journal, U.S. consumer sales of fish and animal oil dietary supplements totaled $739 million on growth of 18% in 2008.

According to Natural Food Merchandiser interviews, retailers believe the suit lacks credibility and consumer may see through it. " just saw this on Good Morning America. I must say, I was pleased because typically these programs jump all over these things and say, 'yeah, this is terrible.' Just one sample, one bottle, whatever—they said it wasn't a representative sampling. The doctor on the show even said it wasn't a fair lawsuit because they only looked at certain brands. He wasn't jumping on the bandwagon," said Carole Childers, owner of All Ways Healthy Natural Food Center in Lake Zurich, Ill.

"I think as a whole we go in cycles. Right now, we're coming up with this whole problem with supplements and government regulation. I think this is part of it. This is a crazy lawsuit. In my store I'm a nutritionist and I recommend fish oil all the time. I use three brands that I trust and I know are checked diligently. We have to do a little bit of the work ourselves. If you're going to Wal-Mart and buying cheap brands, well, you get what you pay for. The government shouldn't be regulating supplements; they're not drugs. Next, they'll be passing laws on vitamin C. I'll continue my business as usual," she said.

See NBJ's Blogs on the fish-oil case and more comments from retailers on NFM.

Problems with PCBs magnify over time
According to the Environmental Protection Agency, a number of studies, including the Mayes (General Electric) Rat Study, show that PCBs cause cancer in animals and are probable human carcinogens. Other non cancerous health hazards are well known such as lower intellectual functions and problems in the nervous, immune, and reproductive systems. (See EPA Administrator Carol Browner's testimony before the Committee on Environmental Conservation of the New York State Assembly, July 9, 1998.)

PCBs are a group of chemicals that contains 209 individual compounds (known as congeners). The EPA considers all PCB mixtures to be toxic. One of the greatest risks for humans comes consuming fish tainted with PCBs because the contamination is concentrated, known at PCB bioaccumulation. Bioaccumulation occurs because PCBs persist in fatty tissues. While each individual forage fish, such as a sardine or anchovy, might have only tiny amounts of PCBs in its tissues, the toxins became concentrated as the predator fish consumes hundreds and hundreds of smaller fish over its lifespan.

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