Friday, April 18, 2008

Proposition 65: A California law to limit dosage of dietary supplements

A California law that has been in effect since 1986 to promote clean drinking water and keep toxic substances that cause cancer and birth defects out of consumer products is now going to be used to limit the amount of vitamins and minerals in dietary supplements or be faced with having to include a warning they exceed safe levels, if opposition isn’t mounted. The idea seems ludicrous.

First, for chemicals to be subject to this law, called Proposition 65, they have to be on a list of potentially toxic molecules. But vitamins and minerals aren’t on the list, with the exception of vitamin A as a potentially problematic vitamin in high doses which may (or may not) increase the risk for birth defects.

A chemical gets listed if the state's “qualified experts"-two independent committees of scientists and health professionals appointed by the Governor-find that the chemical has been clearly shown to cause cancer or birth defects or other reproductive harm.

Even more troublesome is that manufacturers of dietary supplements, under Prop. 65, would be forced to test every product they sell for 800 different chemicals, with any detectable amount assumed to pose a risk. At $200 cost to test each for each chemical on the Prop. 65 list, a company would have to spend $160,000 for each product to comply with this law.

To enforce Prop. 65, private attorneys can file against any company and obtain 25% of the civil penalty plus attorney’s fees and costs. This unleashes a witch hunt on vitamins with the objective to plunder supplement companies rather than protect the public.

Under Prop. 65, the limitation on vitamins and minerals would not to exceed the Recommended Daily Allowance (“RDA”) established by the Food and Nutrition Board of the Institute of Medicine (“IOM”). If no RDA is established, then the total amount cannot exceed 20% of the Tolerable Upper Intake established by the IOM. A chemical would be considered “beneficial to human health” only if a daily value or allowance has been established by the IOM.

There are big problems here. First, this law was written to limit toxic chemicals from getting into groundwater. However, nutrients like thiamine (vitamin B1) and iron are already added to fertilizers to aid in plant growth and health. Both iron and thiamine are growth factors for cancer cells, so they could be construed to be carcinogens, yet they are both essential nutrients.

The Upper Safe Limit for iron is 45 mg, and typically 65 mg is prescribed during pregnancy. So iron pills for pregnancy would be required to have a Prop. 65 warning, which appears to be counterproductive to the idea of why the law was passed.

The Safe Upper Limit for folic acid is 1000 micrograms (mcg), same as 1 milligram (mg). However, doctors commonly prescribe 5 mg of folic acid for women during pregnancy to prevent birth defects (spina bifida, anencephaly). So folic acid supplements would also be required to include a Prop. 65 warning label, and if this scares pregnant women away from these pills and results in a rise in birth defects, it would be an obvious backfire to the intent of this law.

The Safe Upper Limit for vitamin D is 2000 IU, which is obviously an outdated limit since 15 minutes of sunshine would produce about the same amount of natural vitamin D with no known side effects. Since virtually all African American pregnant women are abjectly deficient in vitamin D (Blacks require up to 10 times more sun exposure to make the same amount of vitamin D as Caucasians), a Prop. 65 warning on vitamin D supplements could possibly cause African American women to back away from vitamin D pills, resulting in widespread rickets among newborns and toddlers.

It certainly will be interesting to see how Prop. 65 gets enforced when it comes to dietary supplements. – Copyright 2008 Bill Sardi, Knowledge of Health, Inc.

Labels: minerals, prop 65, upper limits, vitamins