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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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Arbitrary Or Not, Prop 65 Standards Look Likely To Continue – Experts

Firms marketing food and supplement products in California should expect Proposition 65 enforcement actions to continue because, even as industry calls for FDA to intervene, chances for relief will not come soon, experts say

Prop 65 meeting

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)...

NUFA passes House

An amendment to the "National Uniformity for Food Act" by Rep. Joe Barton (R-Tex.) "clarifies that uniformity in notification requirements for warnings does not apply to warnings related to dietary supplements." The amended version of H.R. 4167 passed the House March 8 in a 283-139 vote. The bill would prevent state-imposed food labeling requirements (1"The Tan Sheet" March 6, 2006, p. 7). An amendment by Rep. Henry Waxman (D-Calif.) and three other lawmakers which would still require food labeling notifications related to cancer and birth defect risks was not adopted before the legislation passed. The American Herbal Products Association and National Nutritional Foods Association stated they would seek inclusion of supplements in a Senate companion bill. Council for Responsible Nutrition President Steve Mister said the amendment was "very disappointing but not totally unexpected," since supplements have been expressly excluded from other versions of the bill since its first introduction in 1998. CRN will work to educate lawmakers that supplements are safe and to eliminate confusion about their regulation by FDA...





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