The action states a number of omega-3 products exceed limits for polychlorinated biphenyl (PCB) established under California’s Proposition 65 rules and demands compensation for consumers of $2500 per person exposed to the PCB-containing products.
It also requests the companies cited, including Solgar, Pharmavite and Omega Protein, cease making the products in question.
The action can be found here.
Dr Douglas MacKay, the vice president of scientific and regulatory affairs at the Council for Responsible Nutrition (CRN), told NutraIngredients-USA.com that the lawsuit was so much “misguided energy” given the nature of Proposition 65 and the complete absence of adverse events.
“California is very aggressive against contaminants but Proposition 65 is about labeling not safety and the levels established in it are much lower than any other regulatory body in the US accepts including the Federal Drug Administration (FDA),” he said.
“It is not uncommon that lawyers look at Proposition 65 levels as a way of making money and it looks like that is the case here.”
Unfortunate
On Omega-3 Awareness Day, the Global Organization for EPA and DHA Omega-3s (GOED), noted thousands of omega-3 products were third-party verified.
“In fact, this industry is among the highest quality and most transparent of all consumer products,” said Adam Ismail, GOED executive director, noting the International Fish Oil Standards program (www.ifosprogram.com) as a place where consumers could access such information.
Ismail added that the PCB levels in the tested products were 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.”
He said that eight years ago the omega-3 industry had developed standards to improve quality and ensure consumer safety which today was found in the GOED Voluntary Monograph. GOED members must sign affidavits agreeing to manufacture and market products to the Monograph standards as a condition of membership.
The Office of Environmental Health Hazard Assessment (OEHHA) has said establishing maximum limits levels for PCBs is a low priority item, due to lack of public demand for one.
CRN noted that the Proposition 65 limit for a cancer warning of 90ng/day was not exceeded in many cases and was nowhere near the FDA limit of 2 parts per million.
“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,” said Andrew Shao, PhD, senior vice president, scientific and regulatory affairs at CRN.