California Proposes Supplement Restrictions

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California Proposes Supplement Restrictions

 

Elwood Richard <elwood.richard wrote: California

Proposes Supplement Restrictions

Fri, 21 Mar 2008 15:15:50 -0500

" Elwood Richard " <elwood.richard

" Lou Richard " <lou.richard

 

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st1\:*{behavior:url(#default#ieooui) } 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

 

 

 

 

 

Michael Lelah Friday, March 21, 2008 5:47 AM

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.

 

Daniel Fabricant [dfabricant] Sent:

Friday, March 21, 2008 4:39 AM

FW: 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 A

 

 

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: The title of the March 21, 2008 OEHHA Notice is " Proposition 65:

Request for Public Participation, Notice of Public Workshop - Proposition 65

Regulatory Update Project, Beneficial Nutrients Regulatory Concept "

 

Organization: Proposition 65 Implementation Office of the California EPA Office

of Environmental Health Hazard Assessment (OEHHA)

 

Summary: The text of the OEHHA March 21, 2008 Notice follows

 

Proposition 65Request for Public Participation, Notice of Public Workshop -

Proposition 65 Regulatory Update Project, Beneficial Nutrients Regulatory

Concept

 

[03/21/08]

 

The Office of Environmental Health Hazard Assessment (OEHHA) is the lead agency

for implementation of Proposition 65 (The Safe Drinking Water and Toxic

Enforcement Act of 1986, Health and Safety Code section 25249.5, et. seq.,

hereafter referred to as Proposition 65 or the Act). As part of its

responsibilities related to Proposition 65, OEHHA maintains the regulations

implementing the Act. These regulations can be found in Title 22 of the

California Code of Regulations, sections 12000-14000 inclusive.

 

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.

 

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 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

©. (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. © 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

 

 

 

 

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