Prop 65 Suit Alleges Lead Contamination Of Calcium Supplements
This article was originally published in The Tan Sheet
Supplement firm Giantceutical denies allegations that lead levels in its BioCalth Calcium L-threonate products require a special warning label under Proposition 65 in a Nov. 23 filing
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LEAD IN CALCIUM PROP 65 SETTLEMENTS UPHELD BY CALIF. SUPERIOR COURT on June 23. Superior Court Judge William Cahill approved California Attorney General Dan Lungren's proposed settlements with eight dietary supplement and antacid manufacturers regarding lead levels in calcium supplements. The AG filed suit on Feb. 6 charging Warner-Lambert (Rolaids), SmithKline Beecham (Tums, Os-Cal), American Home Products (Caltrate), Schering-Plough (Di-Gel), Pharmavite (Nature Made), General Nutrition, Perrigo, Twin Labs and Source Naturals with selling products containing lead in excess of limits set in the state's Proposition 65 and not bearing the prescribed warnings ("The Tan Sheet" Feb. 10, p. 7).
NINE CALCIUM ANTACID, SUPPLEMENT FIRMS BEING SUED BY CALIFORNIA AG because their products contain lead in excess of limits established in Proposition 65 and do not bear the required warnings, the complaint charges. "Each defendant has, in the course of doing business, knowingly and intentionally exposed individuals to lead, a chemical known to the state of California to cause cancer and reproductive toxicity, without first giving clear and reasonable warning to such individuals," State Attorney General Daniel Lungren alleges. Prop 65 sets a limit of .5 mcg per day for lead.
LEAD LIMITS IN CALCIUM SUPPLEMENTS, ANTACIDS REQUESTED in a citizen petition filed by the Natural Resources Defense Council on Jan. 27. In the petition, NRDC, a national, non-profit environmental group with over 350,000 members, asks FDA to promulgate a regulation setting Good Manufacturing Practices for calcium dietary supplements and carbonate antacid products specifying an upper limit of .5 mcg lead per maximum recommended daily dosage. FDA does not have a mandatory standard for lead in calcium-containing products, but can rely on the 3 ppm lead tolerance level specified by the U.S. Pharmacopeia and the National Academy of Sciences' food chemicals codex to regulate products with the mineral.