More on Calif Prop 65
California Targeting Safe Supplements
Don’t Let Them Succeed
March 24, 2008
CALIFORNIA‘S PROPOSITION 65 AFFECTS EVERYONE
California - ever known for its luscious beauty, endless energy, and general wackiness - is on the verge of stepping off the edge of the cliff yet again. A trial balloon is being floated by California’s Office of Environmental Health Hazard Assessment (OEHHA) to limit the potency of vitamin-and-mineral supplements under California’s Proposition 65 as cancer-causing agents.
Proposition 65’s history is well-known within the State. In November 1986, voters in the State of California approved Proposition 65, in the belief that its passage would help protect them from toxic chemicals in the environment. Officially known as the “Safe Drinking Water and Toxic Enforcement Act of 1986,” almost everyone these days just calls it Prop 65. Prop 65 requires the State to publish a list of those chemicals “known” to cause cancer or birth defects or other reproductive harm. This list is updated at least annually and has ballooned to include some 775 chemicals. Although Prop 65 uses the term “known,” in the real world substances on the list are not necessarily known to cause cancer but are only those that could, under certain circumstances, pose a risk of cancer based upon the interpretation of existing scientific data, such as animal studies.
Prop 65 also requires businesses with 10 or more employees to notify Californians about the presence of listed chemicals in their products, in consumers’ and employees’ homes or workplaces, or that are released into the environment. The law further prohibits California businesses from knowingly discharging significant amounts of listed chemicals into drinking-water sources. OEHHA administers this program.
Scott Tips, the President and General Counsel of the National Health Federation, notes that, “Without the warnings on listed products, private legal bounty hunters can sue those companies in violation of Prop 65, even though no harm from the products is ever demonstrated, and exact enormous legal and other costs. While some (not much) good has resulted from Prop 65, like all government programs the good intentions quickly lead to enormously bad consequences that far outstrip any possible good. One easy example of this is the Prop 65 listing of natural progesterone as a cancer-causing agent when in fact it helps counteract the carcinogenic effects of estrogen. Natural, bioidentical progesterone is an important hormone-replacement therapy for women, many of whom have been unfortunately scared away from its health benefits by the Prop 65 warnings that are mandated on the product.”
“Without such warnings,” Mr. Tips continues, “the products and their manufacturers and distributors are sitting ducks. In fact, one growth industry spawned by Prop 65 consists of numerous private law firms dedicated to shooting first and asking questions later in a “no prisoners taken” attempt to earn huge legal fees while doing a bare-minimum of public good. The State and County governments may also bring legal action, but often it is these vulture firms that are first out of the gate to win the jackpot. After all, BMWs and exotic vacations must be paid for somehow.”
OEHHA, it says, is proposing regulatory language - in concept only and not as a formal regulatory proposal, mind you - that would essentially classify all vitamin-and-mineral dietary supplements with above-RDA potencies (note they still use the old Recommended Daily Allowance term instead of the correct RDI, or Recommended Dietary Intake) as cancer-causing agents unless proven otherwise. Because California’s Prop 65 has nationwide impact due to the size of the market, consumers can easily imagine the harm this will do with substances that have a long history of being incredibly safe and effective.
Here is what OEHHA wrote in a typical, late-Friday release (March 21, 2008):
”Certain chemicals or compounds such as vitamins and minerals are necessary to promote human health or to ensure the healthy growth of food crops. Excessive exposures to these same chemicals or compounds can cause cancer or adverse reproductive effects. OEHHA is seeking a way to balance the need for these nutrients with the necessity for providing Proposition 65 warnings for exposures to listed chemicals in foods. OEHHA has developed draft regulatory language that addresses this issue, which can be found below.” (emphasis added)
OEHHA has then proposed the following regulatory “concept” (conveniently worded already by the Agency’s legal department):
”Section 1250X. Exposure to Beneficial Nutrients in a Food
(a) Human consumption of a food shall not constitute an “exposure” for purposes of Section 25249.6 of the Act to a listed chemical in a food if the person causing the exposure to the chemical can show that the chemical is a nutrient that is beneficial to human health and that the total amount of the chemical consumed in a food, whether naturally occurring, intentionally added to the food, or otherwise present, does not exceed the level established in subsection (c).
(b) For purposes of this section, a chemical is beneficial to human health if a daily value or allowance has been established for the chemical or compound by the Food and Nutrition Board of the Institute of Medicine, National Academies.
(c) This section applies only to exposures that do not exceed the Recommended Daily Allowance (RDA) established in the Dietary Reference Intake Tables of the Food and Nutrition Board of the Institute of Medicine, National Academies, current edition, if one is established. If no RDA is established, this section applies only to exposures that do not exceed 20 percent (20%) of the Tolerable Upper Intake Level established in the Dietary Reference Intake Tables of the Food and Nutrition Board of the Institute of Medicine, National Academies, current edition.” (emphasis added)
In its Notice, OEHHA has set two key dates for public input: (1) A public meeting on April 18, 2008, to be held from 10:00 a.m. to 12:00 noon in the Sierra Hearing Room at the California Environmental Protection Agency Headquarters Building located at 1001 I Street, Sacramento, California, where OEHHA will hold a public workshop for the ostensible purpose of gathering input from interested parties concerning the issues raised by these regulatory “concepts”; and (2) Written submissions to be received from all interested parties no later than 5:00 p.m. on Friday, May 2, 2008, directed to the attention of Fran Kammerer, Staff Counsel, Office of Environmental Health Hazard Assessment, 1001 I Street, Sacramento, California 95812; or by e-mail to .
The National Health Federation has already consulted with outside legal counsel specialized in this area of law for the express purpose of stopping this idea from proceeding beyond its conceptual stage. NHF will be in attendance at the April 18th meeting and will be submitting cogent written comments, assisted by scientific and legal experts, opposing this regulatory “concept.” The Federation is also exploring legal action against the Agency should it proceed in any way with implementing its concept. This is critical and will affect individuals, supplement manufacturers, and vitamin retailers. This is not just a California issue. Anyone who depends on supplements for their health or livelihood must voice their opposition.
In the meantime, the NHF asks all interested parties to sign our on-line petition opposing this ridiculous concept, which the Federation will then personally submit to OEHHA. (Go to http://thenhf.com/press_releases/prop65_petition.htm.) The NHF also asks all interested parties to provide us with any scientific and legal data that they might have supporting our position that vitamins and minerals are not carcinogenic and therefore do not belong on the Proposition 65 list, so that all pertinent information may be included into the Federation’s comments and possible lawsuit.
March 21, 2008 OEHHA Notice http://www.oehha.ca.gov/prop65/law/regs032108.html
April 18, 2008 Public Hearing
10:00 a.m. to 12:00 noon
Sierra Hearing Room
California Environmental Protection Agency Headquarters Building located
1001 I Street
Please attend and voice your opposition.
Written opposition submissions:
Directed to the attention of Fran Kammerer, Staff Counsel
Office of Environmental Health Hazard Assessment
1001 I Street
Sacramento, California 95812
Comments due by May 2, 2008