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Archive for April, 2008

Rebuttal on Latest Attack on Dietary Supplements

Written by Debbie LeClear on Apr 20th, 2008 | Filed under: General News & Information

By now, you have probably read the headlines such as “Vitamins May Shorten Users’ Lives,” “Vitamins may increase risk of death,” or “Vitamins A, C and E are ‘a waste of time and may even shorten your life.”

 

These biased articles are based on the latest Cochrane review which more or less copies the JAMA paper from February 2007. 

 

Unfortunately, bad science and misleading media stories are confusing consumers.  As dietary supplements become more popular and threaten the bottom line of traditional medicine and Big Pharma, we see more and more studies and articles that try to convince the public that dietary supplements are useless, unregulated, or even deadly. 

 

Often these studies are superficial and if you scratch the surface you can see the bad science and inaccurate reporting.  AAHF’s international affiliate, Alliance for Natural Health details some of the reasons why this latest round of headlines are based on bad science.

 

The article highlights are below describing why it’s bad science:

 

1. This isn’t new.

 

2. This isn’t research.

 

3. This isn’t meaningful.

 

4. This applies only to synthetic forms of vitamins (as produced by the pharmaceutical industry).

 

5. Natural vitamins and minerals are lifesavers.

 

6. Over the top on synthetics!

 

7. Two bites at the cherry.

 

To read the full article, click here.  Don’t forget to join the American Association for Health Freedom to support our lobbying efforts at the federal and state level or make a tax-deductible donation to the Health Freedom Foundation to help support education and international efforts.



More on Calif Prop 65

Written by Debbie LeClear on Apr 20th, 2008 | Filed under: General News & Information

PRESS RELEASE

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 fkammerer@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)

Inform others to sign our on-line petition-send this link to the press release

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


California Prop 65

Written by Debbie LeClear on Apr 20th, 2008 | Filed under: General News & Information

The State of California plans to regulate supplements in a way that seems opposed to the intent of the DSHEA legislation passed about 12 years ago.  On the surface, the proposals would seem to protect California consumers, however it will likely be used to apply more restrictive legislation to supplements than are currently applied to pharmaceuticals or pesticide residues in foods. 

 

I had an old news article from about 10 years ago that stated that having up to 250 deaths per year from food additives and pesticides was acceptable because the benefit was worth this risk.  I could not find this article, and would be grateful if anyone copied has this or similar information.  In looking for this article, I found other information about risks and benefits.  FDA Commissioner George Larrick stated in an article in Chem and Eng News, April 6, 1964, “There is no such thing as absolute safety in drugs.  There are some drugs that are less liable to cause harmful reactions than others, but people die every year from drugs generally regarded as innocuous.”  This article goes on to paraphrase Commissioner Larrick, “The administration of potent drugs involves a calculated risk where the presumptive benefit is balanced against the possibility of toxic effects…”.

 

Further development of the risk vs benefit ratio is contained in a letter from noted biochemist, Roger Williams, Univ of Texas in his letter of Aug 2, 1962 which opposed pending FDA restrictions on vitamins.  “Back of the proposal is the valid idea that foreign chemicals (drugs) are suspect and their safety needs to be demonstrated before they can be used.  But amino acids and vitamins are not foreign chemicals; they should not be suspect; in reasonable doses they should be considered innocent until they are proved guilty.  Also back of the proposal…is the idea that excessive amounts may be harmful.  While it is unquestionably true that some nutrients, minerals for example, may be highly toxic if given in large doses, vitamins are unusually safe except when given far in excess of the needs.  If vitamins, in reasonable doses, had been found unsafe, their sale would long ago have been restricted…” 

 

He goes on to show that the toxic effects of Vit A were from rats that developed sore eyes at doses of 10,000 times their required dose (equivalent to 1000 softgels of 50,000IU per day for humans).  He also states, “The entire subject of ranges in nutritional needs-with respect to all items needs extensive and intensive investigation.  The Commissioner of Foods and Drugs is therefore urged most earnestly to postpone the enforcement of restrictions which will thwart further research and prevent the application and development of the insurance principle to nutrition and health.”.  Copies of his four page letter are available by fax on request.

 

The promoters of this extension of Proposition 65 fail to consider any benefit from the use of supplements.  The study “Potential Benefits of Functional Foods and Nutraceuticals to Reduce the Risk and Costs of Diseases in Canada” by Bruce Holub, Univ of Guelph states, “It can be readily estimated that the overall minimum savings in direct healthcare costs from introducing efficacious functional foods into the public marketplace with associated health claims for the prevention of chronic diseases amount to approximately $200 billion yearly, plus at least another $100 billion savings when applied to disease management (in North America)”.  Copies of the abbreviated form of this paper are also available by fax.

 

The problem for supplement companies is that it is difficult and costly to have separate formulas and labels for California, and potencies for all products, are likely to be reduced.  I encourage all interested parties to express their concerns to the state of California, including researchers who may find that solid research they have done, cannot be used in the open market..

 

Elwood Richard, Founder

Now Foods  

 

 

 

California, through Prop 65 is now trying to de facto establish upper limits for supplements. This is a brand new proposal. I’m going to start to gather information to understand the implications of this and then what are our options to fight this. It looks like CODEX and EU regulations all over again and much closer to home. This could be very serious.

 

From:

 

California Proposition 65 - Possible State Regulation of Excessive Levels of Nutrients (Vitamins, Minerals and Related Substances) as Substances that Cause Cancer or Reproductive Toxicity - The California EPA Office of Environmental Health Hazard Assessment (OEHHA) has scheduled a workshop for April 18, 2008 in Sacramento seeking ” … Input … Concerning issues that may arise if OEHHA proceeds with such a regulatory proposal … [and] is requesting input on the possibility of adopting specific provisions into the existing ’safe harbor’ warning regulations … That would address the content of warnings for those exposures … ”

Document Title:

 

 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.

OEHHA is requesting input from stakeholders in the enforcement and business communities, as well as other members of the public, concerning issues that may arise if OEHHA proceeds with such a regulatory proposal. In addition, OEHHA is requesting input on the possibility of adopting specific provisions into the existing “safe harbor” warning regulations (Title 22, Cal. Code of Regs., section 12601), that would address the content of warnings for those exposures to listed chemicals that are beneficial nutrients that may require a warning.

On Friday, April 18, 2008 from 10:00 a.m. to Noon in the Sierra Hearing Room at the California Environmental Protection Agency Headquarters Building located at 1001 I Street, Sacramento, California, OEHHA will hold a public workshop for the purpose of gathering input from interested parties concerning the issues raised by these regulatory concepts. Stakeholders are encouraged to provide input concerning these concepts including alternative regulatory language or other approaches that would address these issues.

Interested parties may also submit their ideas in writing.

In order for the comment to be considered at this point in the process it must be received by 5:00 p.m. on Friday, May 2, 2008. Should OEHHA proceed to propose regulations on this issue, additional opportunities for public comment will be provided. All submissions should be directed to:

If you have special accommodations or language needs, please contact Monet Vela at (916) 323-2517 or mvela@oehha.ca.gov by April 11, 2008.

Possible Regulatory Language (Concept only, this is not a formal regulatory proposal):

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.

Source: March 21, 2008 OEHHA Notice

Comments Due By: May 2, 2008

Web site: The March 21, 2008 OEHHA Notice is posted at
http://www.oehha.ca.gov/prop65/law/regs032108.html

Contact: Questions may be directed to Fran Kammerer who is Staff Counsel with OEHHA in Sacramento by e-mail: FKammerer@OEHHA.Ca.gov