Fish Oils & Proposition 65 in California
Statement on fish oil purity.
Most fish oil products meet even the stringent California Proposition 65 requirements. This is due to molecular distillation of some products and in the case of Minami using supercritical Co2 extraction process resulting in extremely low levels of any pollutant at a much lower level of heat processing.
The fish oil products brought into question of the plaintiffs appear to be only natural fish oils that have had little processing and exhibit a full complement of fish oil's attributes. They are taken from pristine waters seeking the lowest possible levels of pollutants. All of these natural fish oils meet every standard of purity and safety established by governments, trade organizations and international safety monitoring agencies, thus making them one of the most established safe products available, but possibly, yet to be proven not meeting the California's Proposition 65, which I and many others voted for not realizing that it would result in lawsuits that are sometimes unfair and unnecessary. Michael
Prop 65 - More Than We Want It To Be*
Quick History - Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986, was enacted as a ballot initiative in November 1986. It was intended to protect California citizens and the State's drinking water sources from chemicals known to cause cancer, birth defects or other reproductive harm, and to inform citizens about exposures to such chemicals.
Enforcement is carried out through civil lawsuits brought by the California Attorney General, other district attorneys, and private parties "acting in the public interest", providing notice of the alleged violation to the Attorney General, the appropriate district attorney and city attorney, and the business accused of the violation.
It turns out that almost everything in the state is affected by environmental pollution and by chemical manufacturers' products. Unfortunately, all that a company must do is label the product, building, or substance with a Prop 65 label and it is now within the law. Another unfortunate aspect of Prop 65, is it has become a boon to private attorneys whose businesses collect damages from any business violating the law or presumably violating the law.
In the health food industry companies are very concerned with safety. Herbs must not have more than 10 parts per million of lead according to the FDA and 5 parts per million according to international standards. However, most companies insist on less than 3 parts per million level. an amount possible by growing herbs in pristine conditions. Prop 65, however, requires warning labels for anything over .5 parts per million- virtually impossible for a whole herb- so the law recognizes this and allows higher amounts where it is naturally occurring.
What can and does happen is an herbal company gets sued by a so-called private citizen and the legal costs to prove the lead is naturally occurring is costly, but the costs of a legal battle are very great, so a settlement outside the court is sought as a less expensive solution resulting in a significant sum paid to the attorney. The attorney then seeks his next victim, all in the "public interest", following the requirements established by the Proposition. If the case is taken to court and the defendant wins after spending a small fortune proving "Natural occurrence" there is no recourse against the attorney who brought the harassment suit to regain costs because the suit was brought in the "public interest". Also, the law prevents the Attorney General's right and duty to protect the public interest against future violations by private parties reaching settlement agreements.
Another big defect in Prop 65 is that the board which determines whether a chemical is cancer producing or not are sometimes ill informed, for example, a substance that prevents cancer gets labeled as producing cancer. This appears to be the case of natural progesterone versus synthetic progesterone where both substances were regarded as one in the same- yet very different! So here we have an important nutrient wearing an unjustified statement that is contrary to truth! "The sky is red not blue, the committee says it's true." lifeasitslived.com Michael LeVesque
GOED Issues Reassurance on Fish Oils
2010/03/04 - GOED
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.”
NPICenter.com
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Here's a comment someone left on SFGate regarding the fish oils that is a good perspective.
The studies that indicate an overall health benefit to consuming fish oils were done in the last few decades. The oils used in those studies would almost certainly have been contaminated with varying levels of PCBs (they are ubiquitous in the marine environment and bio-accumulate in fish at the top of the food chain) yet they demonstrated improved health relative to those not taking the oils.
If you are really freaked out about the potential for PCBs in your salmon oil, or if you happen to be a vegetarian, flax seed oil is also a good source of EFA's. Only a matter of time before lawyers find a contaminant there too. Now that instruments can detect concentrations on the order of 1 part per trillion, a tiny amount of any contaminant with a name can be found in virtually any product.
CRN Says There are No Safety Issues With Fish Oil
2010/03/03 - Council for Responsible Nutrition (CRN)
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.”
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*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.
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