|
CALIFORNIA PROPOSITION 65 PETITION
Regulatory Update Project, Beneficial Nutrients Regulatory Concept
Don't Let California Limit Vitamin & Mineral Potencies
March 24, 2008
I am responding to OEHHA’s request for comments on its proposed regulatory concept and draft language to classify all beneficial nutrients with above-RDA potencies as cancer-causing agents under Proposition 65 unless proven otherwise. Because California’s Proposition 65 has nationwide impact due to the size and reach of the California market, great harm will be done within and without the State to natural and healthy substances that have a long history of being incredibly safe and effective and that are needed by our bodies.
It is absolutely impossible to imagine that anyone of even low intelligence could conceive of this proposed concept. It flies in the face of both common sense and scientific facts.
First of all, in your proposed regulation, you still use the old “RDA” term instead of the correct “RDI” (or Recommended Dietary Intake) term. There is no longer any such reference as “RDA” and your use of an obsolete term calls your Agency’s credibility into question. Besides, the RDAs, now RDIs, were never conceived to be a measure of nutrient safety but only a measure of minimum human nutritional needs.
Secondly, and more importantly, vitamin-and-mineral dietary supplements are beneficial nutrients that are incredibly safe, with a health-safety record not even touchable by FDA-approved drugs, foods, or government-licensed medicine. As an example, there was not even one death caused by vitamins in 2005, according to the most recent statistics available from the U.S. National Poisoning and Exposure Database. The 129-page annual report of the American Association of Poison Control Centers published in the journal Clinical Toxicology shows zero deaths from multiple vitamins; zero deaths from any of the B vitamins; zero deaths from Vitamins A, C, D, or E; and zero deaths from any other vitamin.
Remember, over half of the U.S. population takes daily vitamin supplements. Even if each of those people took only one single tablet per day, that makes 145,000,000 individual doses per day, for a total of over 53 billion doses annually. Since many persons take additional vitamins, the numbers are considerably higher, and the safety of vitamins all the more remarkable. (See Orthomolecular Medicine News Service, “Poison Control Statistics Prove Supplements’ Safety” (Feb. 23, 2007); and Lai MW, Klein-Schwartz W, Rodgers GC et al., “2005 Annual Report of the American Association of Poison Control Centers' national poisoning and exposure database,” Clin Toxicol (Phila). 2006; 44(6-7):803-932 (available at http://www.aapcc.org/Annual%20Reports/05report/2005%20Publsihed.pdf, see vitamin statistics in Table 22); and any Annual Report of the American Association of Poison Control Centers from 1983-2005 at: http://www.aapcc.org/annual.htm.) The safety statistics for vitamins and minerals during the 22 years preceding 2005 are equally impressive especially when considered in light of the thousands of deaths annually from foods and the hundreds of thousands of deaths annually from FDA-approved drugs. Even the over-the-counter drug Ibuprofen is connected with some 17,000 deaths annually.
Thirdly, there are no valid clinical studies that demonstrate natural vitamin-and-mineral supplements to be carcinogenic. Indeed, to the contrary, numerous properly-conducted studies prove that they are anti-carcinogenic even, or especially, at high doses. (See, e.g., Elmore AR, “Final report of the safety assessment of L-Ascorbic Acid, Calcium Ascorbate, Magnesium Ascorbate, Magnesium Ascorbyl Phosphate, Sodium Ascorbate, and Sodium Ascorbyl Phosphate as used in cosmetics,” Int J Toxicol 2005;24 Suppl 2:51-111; Cosmetic Ingredient Review Expert Panel, “Final report of the safety assessment of niacinamide and niacin,” Int J Toxicol 2005;24 Suppl 5:1-31; Fiume MZ and Cosmetic Ingredient Review Expert Panel, “Final report on the safety assessment of biotin,” Int J Toxico, 2001;20 Suppl 4:1-12; and Douglas JF, Huff J, and Peters AC, “No evidence of carcinogenicity for L-ascorbic acid (vitamin C) in rodents,” J Toxicol Environ Health, 1984;14(4):605-9.) Why would your Agency want to use precious taxpayers’ dollars to place such healthful items on the Proposition 65 list as carcinogenic substances?
Fourthly, the science is clear: dietary supplements provide clear and substantial benefits – particularly at higher doses. Whether it is folic acid preventing birth defects to Vitamin D lowering high blood pressure and reducing cancer rates to Vitamin C helping to prevent heart attacks, the scientific and clinical literature is both substantial and irrefutable.
In short, your Agency has no science to support its position, and the common sense and wealth of evidence contradicting your position is so substantial that it will absolutely destroy your Agency’s credibility as well as damage the entire premise underlying Proposition 65 and its list, thereby weakening consumer warnings against true carcinogens. Therefore, you are strongly urged to completely withdraw any and all efforts on your part to pursue this regulatory “concept” before great harm is done to you and the public’s health.
|