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 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:



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