Swanson Health Products Files Citizen Petition Requesting FDA Action to Block Application of Proposition 65 to Foods and Dietary SupplementsJanuary 25, 2008
North Dakota-based food and dietary supplement manufacturer Swanson Health Products, Inc. (“Swanson”) filed a Citizen Petition with FDA dated January 18, 2008, requesting the Agency to “take all appropriate steps to prevent California’s Safe Drinking Water and toxic Enforcement Act (‘Proposition 65’) from being applied to foods and dietary supplements, on the ground that Proposition 65 on its face, and as applied, conflicts irreconcilably” with the Federal Food, Drug and Cosmetic Act (“FDC Act”), and FDA regulations.
Proposition 65 requires all products sold in California containing any chemical “known to the state” to cause cancer or reproductive harm to bear a warning statement to that effect. Consequently, while most nutrients commonly incorporated into dietary supplements are biologically essential, because the same nutrients at a higher level, or in a different molecular form, are known to be carcinogenic or mutagenic, the presence of such nutrients requires the product to bear a warning statement. As reflected in Swanson’s Petition, the specific wording of many Proposition 65 warnings for foods and dietary supplements sold in California, as well as the level of the substance that triggers the requirement, is often determined piecemeal through private settlement negotiations ending citizen-initiated lawsuits brought to enforce the requirement. Swanson claims in its Petition that such warning statements confuse and mislead consumers with regard to the safety and FDA compliance of foods and dietary supplements, and thus cause these products to be “misbranded” under the FDC Act.
Swanson notes that for certain food products, such as canned tuna (possibly containing mercury) and fried foods (potentially containing acrylamide), FDA has already expressed its view that Proposition 65 conflicts with the FDC Act. For example, the Petition cites an August 12, 2005 letter from then FDA Commissioner Lester Crawford to California Attorney General Bill Lockyer, and a March 21, 2007 letter from Terry C. Troxell, Ph.D., Director, Office of Plant and Dairy Foods, Center for Food Safety and Applied Nutrition, to Joan Denton, Director, California Office of Environmental Health Hazard Assessment, and California Deputy Attorney General Ed Weil. Swanson argues that “the time is right” for FDA now to take broader and more general action to preclude the interference of Proposition 65 with its statutory mandate, especially in light of the agency’s newly announced Food Protection Plan initiative.
Persons wishing to submit comments on the Petition may do so electronically by visiting www.regulations.gov and searching for the Petition. By regulation, FDA is required to respond to a Citizen Petition within 180 days. In practice, FDA usually sends a letter to the petitioner on or about the date of the deadline stating that the Agency has received the petition, but needs more time to respond. While we are unaware of accurate statistics on FDA responses to petitions, many if not most petitions receive no response for years, and many others never receive any FDA response.