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ConsumerLab.com asks USP to adopt safer lead limit for drugs and supplements. Warns that lead contamination may worsen if USP accepts currently proposed allowance.
WHITE PLAINS, NEW YORK — DECEMBER 8, 2008 — ConsumerLab.com petitioned the United States Pharmacopeia (USP) today to lower its proposed limit on lead contamination in drugs and dietary supplements. The USP recently proposed a limit of 10 mcg (micrograms) of lead per daily serving. This amount would permit a children's vitamin, for example, to contain a potentially toxic amount of lead. It would also permit drugs and supplements to unnecessarily expose adults, including pregnant women and their unborn children, to significant amounts of lead.
ConsumerLab.com's tests for lead in over one thousand dietary supplements have shown the vast majority to contain less that half of one microgram of lead per a daily serving. Similarly, FDA tests of multivitamins this year showed the average amount of lead per daily serving to be approximately half of one microgram.
Setting the allowance for lead at 10 mcg is contradictory to FDA policy of reducing lead levels to the lowest amount that can be practicably obtained in manufacturing. In fact, in 2006 the FDA lowered its guidance on the maximum concentration of lead in candy frequently consumed by children to 0.1 ppm (0.1 mcg per gram). If the limit for candy were applied to a drug or supplement (which typically weighs one to two grams per daily serving), it would permit only 0.1 mcg to 0.2 mcg of lead — many times less than the allowance proposed by the USP.
The FDA's Good Manufacturing Practices rule for dietary supplements does not specify limits for contaminants and requires each manufacturer to set its own limit. ConsumerLab.com believes that manufacturers may internally adopt the limit to be chosen by the USP which, if lax, may lead to increased contamination in products.
"From a consumer's perspective, there is no reason to permit ten micrograms of lead in a drug or supplement. Even candy is held to a higher standard," said Dr. Tod Cooperman, President of ConsumerLab.com. Dr. William Obermeyer, Vice President for Research, noted, "It is our hope that USP recognizes that the current proposal may be potentially harmful to children and others and chooses a limit similar to that used by ConsumerLab.com and the State of California." Dr. Obermeyer was a FDA Natural Products Chemist prior to co-founding ConsumerLab.com in 1999.
ConsumerLab.com's letter to the USP is found at www.consumerlab.com/letter/USP_lead. Concerned individuals are encouraged to send their comment to the USP.
ConsumerLab.com is a leading provider of consumer information and independent evaluations of products that affect health and nutrition. The company is privately held and based in Westchester, New York. It has no ownership from, or interest in, companies that manufacture, distribute, or sell consumer products.
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ConsumerLab.com's tests for lead in over one thousand dietary supplements have shown the vast majority to contain less that half of one microgram of lead per a daily serving. Similarly, FDA tests of multivitamins this year showed the average amount of lead per daily serving to be approximately half of one microgram.
Setting the allowance for lead at 10 mcg is contradictory to FDA policy of reducing lead levels to the lowest amount that can be practicably obtained in manufacturing. In fact, in 2006 the FDA lowered its guidance on the maximum concentration of lead in candy frequently consumed by children to 0.1 ppm (0.1 mcg per gram). If the limit for candy were applied to a drug or supplement (which typically weighs one to two grams per daily serving), it would permit only 0.1 mcg to 0.2 mcg of lead — many times less than the allowance proposed by the USP.
The FDA's Good Manufacturing Practices rule for dietary supplements does not specify limits for contaminants and requires each manufacturer to set its own limit. ConsumerLab.com believes that manufacturers may internally adopt the limit to be chosen by the USP which, if lax, may lead to increased contamination in products.
"From a consumer's perspective, there is no reason to permit ten micrograms of lead in a drug or supplement. Even candy is held to a higher standard," said Dr. Tod Cooperman, President of ConsumerLab.com. Dr. William Obermeyer, Vice President for Research, noted, "It is our hope that USP recognizes that the current proposal may be potentially harmful to children and others and chooses a limit similar to that used by ConsumerLab.com and the State of California." Dr. Obermeyer was a FDA Natural Products Chemist prior to co-founding ConsumerLab.com in 1999.
ConsumerLab.com's letter to the USP is found at www.consumerlab.com/letter/USP_lead. Concerned individuals are encouraged to send their comment to the USP.
ConsumerLab.com is a leading provider of consumer information and independent evaluations of products that affect health and nutrition. The company is privately held and based in Westchester, New York. It has no ownership from, or interest in, companies that manufacture, distribute, or sell consumer products.
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