Citizen petition on Prop 65
This article was originally published in The Tan Sheet
Executive Summary
California's Proposition 65, when applied to dietary supplements and foods, "causes consumer confusion, "misbrands" safe and wholesome products, and frustrates FDA's ability to carry out its statutory mandates," dietary supplement marketer Swanson Health Products says in a citizen petition submitted to FDA Jan. 18. Therefore, the products should not be included in the act, the firm adds. Submitted on behalf of Swanson by law firm Sedgwick, Detert, Moran & Arnold, the petition maintains that Prop 65's application to supplements and foods is "escalating," and that a private enforcer recently advised Swanson that it plans an "industry-wide enforcement action shortly," which it claims will result in the supplement industry following the requirements it is demanding of the firm. "Private enforcers, seeing the vast amount of money that is to be made, identify more food and dietary products that they can prosecute," Swanson adds. The National Uniformity for Food Act was introduced in Congress in 2006 to unify warning label requirements and pre-empt state-imposed requirements like Prop 65. Though the act was passed by the House that year it is awaiting further action by Congress (1"The Tan Sheet" March 13, 2006, In Brief)...
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California's Office of Environmental Health and Hazard Assessment will hold a public workshop April 18 in Sacramento, Calif. to gather input from stakeholders on Proposition 65 as it relates to beneficial nutrients, which include dietary supplements. OEHAA is considering changing the regulation to allow certain chemicals, which Prop 65 currently lists as toxic, in supplements without a warning label if the firm can prove the chemical is beneficial to human health and the total chemical amount does not exceed the level established in the Dietary Reference Intake Tables of the Food and Nutrition Board of the Institute of Medicine. Swanson Health Products petitioned OEHAA on March 31 urging the office to modify Prop 65 regulations as they apply to food and supplements. In January, Swanson submitted a citizen petition to FDA stating Prop 65 "causes consumer confusion" and is misleading when applied to dietary supplements (1"The Tan Sheet" Jan. 28, 2008, In Brief)...
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