GOED Issues Reassurance on Fish Oils

“While the plaintiffs raise an important issue,” said Ismail, “it is unfortunate that they are implying that most fish oils are unsafe and that the industry is hiding information on such vital nutrients.”

5 Mar 2010 --- In response to a lawsuit being filed against eight dietary supplement brands and retailers, the Global Organization for EPA and DHA Omega-3s (GOED) is reassuring the industry and consumers that fish oils manufactured by its members, and the market in general, meet the highest quality standards available. “We have complete confidence in the safety of the fish oil supplement market, which has been validated through multiple third-party reviews by industry watchdogs on thousands of products,” said Adam Ismail, Executive Director of GOED. “In fact, this industry is among the highest quality and most transparent of all consumer products,” he added.

There are multiple resources in the public domain where consumers can get more information on the quality of their products, including the International Fish Oil Standards program (www.ifosprogram.com).  Furthermore, a recent report by Frost & Sullivan found that 93% of the refined fish oils on the market in the United States are produced from anchovy and sardine oils.  However, 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 Ismail, “it is unfortunate that they are implying that most fish oils are unsafe and that the industry is hiding information on such vital nutrients.” 

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.  GOED members must sign affidavits agreeing to manufacture and market products to the Monograph standards as a condition of membership. Additionally, GOED continues to update the Monograph based on all relevant legislation worldwide, including Proposition 65’s  No Significant Risk Levels (NSRLs) related to carcinogenic activity and Maximum Allowable Dose  Levels  (MADLs) related to chemicals causing reproductive toxicity .

“While NSRLs have been set for PCBs in California, MADLs have not,” said Ismail, “This group is actually asserting that since no regulatory body has set a limit related to reproductive toxicity, the default level should be zero.”  Thus far, toxicological assessments have not supported this position, but due to the unique nature of Proposition 65, the burden of proof is on the defendants in lawsuits to establish Safe Harbor limits. 

“In addition, setting a MADL for PCBs appears to be of low-priority to the California Environmental Protection Agency,” said Dr. Harry B. Rice, GOED’s Director of Regulatory and Scientific Affairs, “the Office of Environmental Health Hazard Assessment (OEHHA) has assigned its lowest priority to the project, based in part on a lack of need.”

NOW is included in a group of defendants named in a lawsuit that claims that three of our fish oil products are in violation of the limits under California’s Proposition 65. Proposition 65 often applies to very small levels of chemicals – levels that in some cases are much lower than those permitted by other laws. This lawsuit was not filed by the state of California or any governmental authority but was filed by private plaintiffs, the company noted.

The company said in a statement, “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.  Clinical studies have shown many health benefits from consuming fish oil. Fish oil supplementation offers a convenient and affordable way for many consumers to gain these health benefits. NOW has demonstrated our commitment to your safety by producing high quality natural products. We continue to stand behind this commitment.”