California
Targeting Safe Supplements
Don't Let Them Succeed
ACT NOW
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 fkammere!
r@oehha.ca.gov.
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
(Click Here
For The Online Petition)
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
Sacramento, California
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
E-mail Opposition:
fkammerer@oehha.ca.gov
National
Health Federation: Established in 1955, the National Health Federation
is a consumer-education, health-freedom organization working to protect
individuals' rights to choose to consume healthy food, take supplements
and use alternative therapies without unnecessary government
restrictions. The NHF is the only such organization with
recognized
observer-delegate status at Codex meetings. www.thenhf.com
Click here
for the permanent link to this press release, use this link to inform
others.
