Prop 65 Calcium Supplement/Antacid Litigation

Court Approves AG Settlements with Calcium Supplement and Antacid Manufacturers

On June 20, 1997, Judge William Cahill of the San Francisco Superior Court granted the motion of California Attorney General Daniel Lungren to approve a settlement with a number of manufacturers of calcium supplements and antacids over naturally occurring lead. The settlement, reached in People v. Warner-Lambert , imposes strict levels of lead in these products, requiring warnings for exposures in excess of the "safe harbor" level of 0.5 micrograms plus the naturally occurring levels. These are set in the proposed settlement at 3.5 micrograms on July 1, 1997, and 1.0 micrograms on April 1, 1999. See Attorney General Press Release. The parties continue to negotiate over the lowest feasible lead levels for multivitamins and multiminerals. Judge Cahill is expected to rule on the proposed settlements prior to his July 1 reassignment to the Criminal Court.

A similar lawsuit, filed by the Natural Resources Defense Council, had been stayed pending the settlement. Although the AG's office had been in negotiations with the defendants, NRDC first served 60 day notices, then filed a complaint under the Unfair Competition Act, seeking a temporary restraining order prohibiting the defendants from selling these products without Prop 65 warnings. On the date of the hearing, the AG filed a Prop 65 complaint, and appeared at the TRO hearing to argue that he should be given the opportunity to finalize a settlement as the primary enforcement authority in the state.

The NRDC filed opposition to the settlement. Among the claims raised by NRDC's were that the settlement is based on an incorrect level of naturally occurring lead prior to April 1999, as Leiner Health Products Group and SmithKline have allegedly lower lead levels in their products. NRDC also argued that the settlement should not have included cost as a factor in determining the lowest feasible level of naturally occurring lead in the future. Following approval of the settlement, NRDC settled with most of the defendants in the Attorney General's action. Terms of these settlements varied, and they are generally not available.

NRDC had earlier reached a settlement with Leiner, which purported to provide for the lowest level of naturally-occurring lead in calcium supplements. See story or NRDC's press release. The Leiner settlement was unique in that no 60 day notice was sent, and it also contains a provision that will tag the ultimate lead content of Leiner's products to levels set in any settlements reached by the Attorney General. NRDC also settled prior to the hearing with SmithKline Beecham Consumer Healthcare, manufacturer of Tums antacids and Oscal supplements.

NRDC has some information on calcium supplements on the Web, including a Calcium Supplements and Lead FAQ, and a condensed version of NRDC's citizen petition to FDA to initiate a rulemaking that would impose the Prop 65 standard of 0.5 micrograms of lead per day from calcium supplements and antacids.

Meanwhile, another private enforcement action has been filed by Lorraine Gallagher against the manufacturers sued by the Attorney General and NRDC. The action is nearly identical in allegations to the NRDC's.

This page last updated August 1997