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Columnist Michael Levin: California’s Attorney General Takes Action Against Supplement Companies PDF Print E-mail
Written by John Weeks   

Columnist Michael Levin: California’s Attorney General Takes Action Against Supplement Companies

Summary: Integrator adviser and columnist Michael Levin reports on a recent California action, under Proposition 65, against 56 dietary supplement companies. The issue is a level of lead in their products which required informing their customers. Levin uses the column to remind clinicians and administrators of the importance of vigilance of supplement manufacturers about the extent of their quality control plans. The story was brought to Levin's attention through Michael McGuffin and the American Herbal Products Association. 
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Michael Levin
Integrator columnist Michael Levin provides an ongoing service to Integrator readers of bringing to our attention key stories related to the complex world of dietary supplement regulation and production. Levin is well suited for his role. He has held executive positions in both conventional pharma and dietary supplement firms. Links to his other columns are here.

Michael D. Levin
, Founder
Health Business Strategies
12042 SE Sunnyside Road
Clackamas, OR  97015
503-753-3568 (direct)


__________________________________

California’s Attorney General Takes Action Against Supplement Companies

Michael D. Levin, Health Business Strategies

In a move highlighting increasing concerns about dietary supplement purity, a complaint was filed by California’s Office of Attorney General on 12/23/08 against 56 dietary supplement companies whose vitamin/mineral products contained lead above the maximum allowable amount under California Proposition 65 rules [1]. The products involved are labeled for use by women and children.

Proposition 65 is a “duty to inform” rule which requires that products sold in California which contain amounts of known carcinogens or reproductive toxins above a certain threshold must have a consumer warning on its label. The limit for lead is 0.5 mcg/day. Products sold be these companies were found to contain amounts exceeding that limit.

What prompted this action? On April 4, 2007, Congressman Henry Waxman communicated his concerns to FDA about lead contamination reported by Consumerlab.com[2]. More than a year later, in August, 2008, the FDA published its survey data on lead in 324 women’s and children’s vitamins.[3] Of those, five samples would have provided exposure that exceeded 4 mcg/day (8 times the California limit), with one sample – a product labeled for pregnant and lactating women, no less – delivering 8.97 mcg/day (about 18 times above California’s limit). California statute provides for a fine up to $2,500 per violation, per day.

   
 
"This action underscores the
risks taken by supplement
companies that do not carefully
and consistently test their raw
materials and finished products
for purity."

- Michael Levin
 
Is there any legal precedent?  Yes. Almost 12 years ago, in 1997, the California courts approved a settlement with a number of calcium supplement manufacturers in People v. Warner-Lambert.[4] Based on the principle that lead is naturally occurring, the court imposed a settlement limit of 3.5 mcg/day on July 1, 1997 which dropped to 1.0 mcg/day on April 1, 1999. The settlement cost was reported to be $ 850,000[5]. In comparison to the 1997 calcium settlement, the 2008 FDA survey for products labeled only for use by adult women includes > 50 products which exceed the 4/1/99 negotiated calcium settlement of 1.0mcg per day.

This action underscores the risks taken by supplement companies that do not carefully and consistently test their raw materials and finished products for purity. It is also a reminder that California law has (literally) hundreds of strict purity standards applicable to dietary supplements not found in federal law or in official monographs published by the United States Pharmacopeia. While the 0.5 mcg/day lead limit is, some may argue, set too low, it is California’s law. Sellers and buyers alike must take heed or accept the consequences.

[The author gratefully thanks the American Herbal Products Association for bringing this to his attention in advance and as published in the January 2009 issue of the AHPA Report. McGuffin M. 56 dietary supplement marketers named by California AG as defendants in Prop 65 complaint alleging lead content in multi-vitamins; Action follows FDA release of analysis. AHPA Report. 2009; 24(1):3-4. http://www.ahpa.org/portals/0/pdfs/09_01_AHPAReport_Prop65.pdf.]

 



[1] www.courthousenews.com/2008/12/24/LeadVitamins.pdf

[2] http://oversight.house.gov/search/search.asp

[3] http://www.cfsan.fda.gov/~dms/pbvitami.html#ftn2

[4] http://www.calprop65.com/calcium.html

[5]http://209.85.173.132/search?q=cache:yzzd9FumvRoJ:www.publichealthtrust.org/docs/Summary%2520of%2520Settlements%2520and%2520Grants.pdf+prop+65+calcium+lead+settlement+warner+lambert&hl=en&ct=clnk&cd=4&gl=us&client=firefox-a


__________________________________
 
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