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