Lower Lead Limits For Calcium-Containing Products Shelved By FDA
This article was originally published in The Tan Sheet
Executive Summary
FDA is not adopting new, lower lead limits for calcium-containing supplements and antacids at this time but "is actively investigating the feasibility of establishing lower limits," the agency tells the Council for Responsible Nutrition and the Consumer Healthcare Products Association in a Sept. 28 letter.
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FDA is not adopting new, lower lead limits for calcium-containing supplements and antacids at this time but "is actively investigating the feasibility of establishing lower limits," the agency tells the Council for Responsible Nutrition and the Consumer Healthcare Products Association in a Sept. 28 letter. FDA has asked the U.S. Pharmacopeia to review any analytical methods that may be used to establish a lower USP standard for lead in calcium-containing products. The agency's letter grants a June 10, 1997 citizen petition filed jointly by CRN and CHPA, then known as the Nonprescription Drug Manufacturers Association, asking FDA to maintain the current system for establishing lead limits in antacids and supplements (1 (Also see "Calcium lead limit sought by NRDC "not scientifically defensible" or "feasible," FDA told." - Pink Sheet, 23 Jun, 1997.)). The trade groups argued FDA should continue to rely on tolerance levels, established by the National Academy of Sciences Food Chemical Codex and USP, of 3 parts per million for lead in calcium carbonate. The groups' filing was in response to a January 1997 petition from the Natural Resources Defense Council asking FDA to establish an upper lead limit of .5 mcg per maximum recommended daily dosage for calcium products (2 (Also see "Lead limits in calcium supplements, antacids requested in NRDC citizen petition." - Pink Sheet, 3 Feb, 1997.)). In its response to the CRN/CHPA petition, FDA cites a March 11 letter from Center for Drug Evaluation & Research Office of Pharmaceutical Science Compendial Operations Staff Chief Yana Ruth Mille to USP Senior VP and General Counsel Joseph Valentino. Mille's letter references an April 1998 correspondence from Valentino to FDA, in which Valentino stated the USP Subcommittee on Nonprescription Drugs and Nutritional Supplements recognized limitations in analytical methodology used for setting regulatory limits. Valentino said the subcommittee, at some future time, would consider "an alternative analytical method capable of determining lead content at very low levels, along with a lower practical limit." "We urge you to investigate acceptable analytical methods for the determination of smaller amounts of lead in calcium-containing products," Mille wrote, providing USP with information on graphite furnace and ICP-MS methods used in California. |