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Attorney General Lockyer Reaches Agreement Requiring Novartis to Lower Lead Levels in Antacids
Attorney General Bill Lockyer today announced the filing of a Proposition 65 lawsuit and a stipulated permanent injunction that is anticipated to result in significantly lower lead levels in Maalox Regular and Extra Strength antacids with magnesium hydroxide and aluminum hydroxide.
The lawsuit filed by the Attorney General against Novartis Consumer Health, Inc., alleges that Maalox Antacids with magnesium hydroxide and aluminum hydroxide contain the toxic metal lead at levels that violate the California Safe Drinking Water and Toxic Enforcement Act of 1986, also known as Proposition 65. Lead is a listed reproductive toxin under Proposition 65 and may also threaten human health by interfering with brain development in the young and causing other effects such as hypertension and harm kidney function in adults.
"This permanent injunction should result in consumers getting cleaner low-lead antacid products," Lockyer said. "If the company does not lower the lead levels as promised, it must issue warnings on product labels so Californians can make an informed choice."
Under the stipulated permanent injunction submitted Thursday to the San Francisco Superior Court, Novartis agreed to reduce the lead levels significantly in its liquid antacids to below Proposition 65 levels or to provide the clear and reasonable warning required under Proposition 65 that the product contains a chemical known to cause birth defects or other reproductive harm. Admitting no wrongdoing, Novartis indicated that as of May 6, 1999, it no longer was shipping Extra Strength Maalox into California and would not resume shipment until the product was in compliance with Proposition 65.
Passed by the voters, Proposition 65 is designed to protect the public from exposure to toxic substances known to cause cancer or reproductive toxicity. Sellers of materials that may contain such substances must give clear and reasonable warnings of the risks associated with the products.
The warnings will appear on the label of each Maalox Antacid shipped after July 15, 1999, unless the company can show lead exposure from the antacid is less than 0.5 micrograms, the level set by Proposition 65. The calculation excludes levels occurring naturally in magnesium hydroxide.