WASHINGTON, D.C., March 2, 2010 — In response to a press conference today held to announce a lawsuit against fish oil dietary supplement manufacturers and retailers, the Council for Responsible Nutrition (CRN), the leading trade association representing the dietary supplement industry, issued the following statement:
Statement by Andrew Shao, Ph.D., senior vice president, scientific and regulatory affairs, CRN:
“Fish oil supplements are among the safest, most beneficial health products on the market. Today’s announcement of a lawsuit against companies manufacturing or selling popular products is just that—a lawsuit looking for media attention, not a public safety concern for consumers.
CRN 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. Further, the information disclosed during the press conference danced around the details, offering a lack of specificity to the general public about the levels of polychlorinated biphenyl (PCB) compounds found in the fish oil products that were tested. Though the lawyers suggest that the levels of PCBs found in these products far exceed what is acceptable by Prop 65 standards, the actual levels of PCBs found in the majority of these products do not appear to exceed the Prop 65 limit (90 ng/day). Furthermore, they fail to mention that the Food and Drug Administration’s (FDA) tolerance level for PCBs in fish (2,000 parts per billion) far exceeds the levels of PCBs found in fish oil.
It is important to put this into context. 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. In fact, conventional food forms of fish contain higher levels of PCBs than fish oil supplements in part because supplement fish oil products go through a refining process which reduces PCBs and other contaminants. 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. The lawyers are using California’s Prop 65 statute to bring attention to their case by attempting to frame this as a public health concern, when in reality, fish oil has enjoyed decades of safe use.
The bottom line is that consumers, whether they live in California or elsewhere, should continue to feel confident in the safety and efficacy of their fish oil supplements. This lawsuit does nothing to change the strong science supporting the many health benefits of fish oil, which range from cardiovascular health to cognitive development of infants and young children, and the very low thresholds of PCBs which apparently trigger a labeling requirement in California cannot be extrapolated to demonstrate any actual risks at those levels. The health benefits for fish oil far outweigh any suggested, and unsupported, risks.”
*According to Nutrition Business Journal, U.S. consumer sales of fish and animal oil dietary supplements totaled $739 million, a growth of 18% in 2008.
The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing dietary supplement manufacturers and ingredient suppliers. In addition to complying with a host of federal and state regulations governing dietary supplements in the areas of manufacturing, marketing, quality control and safety, our 70+ manufacturer and supplier members also agree to adhere to additional voluntary guidelines as well as CRN’s Code of Ethics. Visit www.crnusa.org.