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To: "Health Freedom, Codex Issues
From: John Hammell
Date: Tue, 08 Jan 2002 16:24:21 -0500

IAHF List: This well written article by Leanne Wylet and Helen Lawler of Patients for Alternative Medicine underscores my concerns about how we're being set up for harmonization to grossly restrictive Codex vitamin standards. Please use this article to educate your Senators and Congressmen for the need for a REAL oversight hearing on the Codex vitamin issue since the hearing on March 201, 2001 held by Congressman Burton was whitewashed due to the pervasive interests of the pharmaceutical companies that dominate the vitamin trade associations. Take this article to your local health food store and get the owner to read it. Then urge him to quit NNFA, since NNFA is lying to its members, falsely claiming that US domestic vitamin laws "aren't subject" to harmonization to Codex standards. This lie is being promulgated by Parry, Romani, DeConcini, and Symms- the PR firm on Capital Hill that "represents" NNFA..... er.... at least it represents SOME of NNFA..... like Pfizer (Capsugel) and the other pharmaceutical interests that CONTROL NNFA because its members LET them...

Legislative Alert, January 7, 2002

A Risk Assessment Model

Is Access to Supplements at Risk?

by Leanne Wylet, BA and Helen Lawler, MA

"The Risk Assessment Model for Vitamin A. . ." is based on assumptions which should be alarming to anyone whose health or business depends on freedom of access to food supplements. This is not the first risk assessment document, nor is it likely to be the last. Patients for Alternative Medicine, (formerly Patient Coalition for Naturopathic Physicians) has been compiling information on food supplement access since 1993. The goals of the World Health Organization (WHO) and the Food and Drug Administration (FDA) include establishing risk assessment models and risk management policies for every vitamin and mineral known to be beneficial for human health.

Originally established for pesticide residues and food additives, "Risk assessment is a systematic means of evaluating the probability of occurrence of adverse health effects in humans from excess exposure to an environmental agent (in this case a nutrient) . . ." p. 48 We are concerned about the assumptions underlying this and other risk assessment documents. As you read through the following quotes please look for consistent patterns, and statements not supported by facts. Consider how the underlying assumptions if carried to their logical conclusions could affect access to food supplements and alternative medicine.

1. "The setting of a UL (upper limit) does not indicate that nutrient intakes greater than the Recommended Daily Allowance (RDA) or Adequate Intake (AI) are recommended as being beneficial to an individual. Many individuals are self-medicating with nutrients for curative or treatment purposes. It is beyond the scope of this report to address the possible therapeutic benefits of higher nutrient intakes that may offset the risk of adverse effects." p. 48

2. "Like all chemical agents, nutrients can produce adverse health effects if their intake . . . is excessive." p.48

3. "Scientific information about various adverse effects and their relationships to intake levels varies greatly and depends on the nature, comprehensiveness, and quality of available data." p. 48

4. "The fraction of the population consistently consuming a nutrient at intake levels in excess of the UL is potentially at risk of adverse health effects."

5. ". . . members of the general population should not routinely exceed the UL . . ." p.48

6. "The risk is generally expressed as the fraction of the exposed population, if any, having nutrient intakes above the UL"

7. "When possible, the UL is based on a no-observed-adverse-effect level (NOAEL), which is the highest intake . . . of a nutrient at which no adverse effects have been observed in the individuals studied. . . . If there are no adequate data demonstrating a NOAEL, than a lowest-observable-adverse-effect-level (LOAEL) may be used. A LOAEL is the lowest intake . . . at which an adverse effect has been identified." p. 51

8. "It is clear, however, that the addition of nutrients to a diet through the ingestion of large amounts of highly fortified food or non-food sources such as supplements (or both) may (at some level) pose a risk of adverse health effects."

9. "Even within relatively homogeneous life stage groups, there is a range of sensitivities to toxic effects. The model . . . excludes populations with extreme and distinct vulnerabilities. Such subpopulations consist of individuals needing medical supervision; they are better served through the use of public health screening, product labeling, or other individualized health care strategies. Such populations may not be at negligible risk when their intakes reach the UL developed for the healthy population." p. 53

10. "In the context of toxicity, the bioavailability of an ingested nutrient can be defined as its accessibility to normal metabolic and physiological processes. Bioavailability influences a nutrient's beneficial effects at physiological levels of intake and also may affect the nature and severity of toxicity due to excess intakes. The concentration and chemical form of the nutrient, the nutrition and health of the individual, and excretory losses all affect bioavailability." p 53

11. "Nutrient-nutrient interactions may be considered either as a critical endpoint on which to base a UL, or as supportive evidence for a UL based on another endpoint." p. 54

12. "Because adverse effects are almost certain to occur for any nutrient at some level of intake, it should be assumed that such effects may occur for nutrients for which a scientifically documentable UL cannot now be derived. Until a UL is set or an alternative approach to identifying protective limits is developed, intakes greater than the Recommended Dietary Allowance or Adequate Intake should be viewed with caution." p. 58

We would appreciate your input on the following questions:

1. How do the above quotes fit with your understanding of the role of nutrition in the treatment of chronic ailments and/or disease?

2. If public policy is changed to prevent consumers from "self-medicating with nutrients" how with that effect the economic viability of wholesale and retail health food distributors?

3. If public policy is changed to prevent consumers from "self-medicating with nutrients" how will that effect the supply of supplements now prescribed by alternative care providers?

4. Why do we need another risk assessment model to define excessive doses of nutrients?

5. Why do the FDA and the World Health Organization think the need is so urgent that limits should be established even for nutrients for which they acknowledge that scientific data is currently inadequate?

6. If ULs are established at low levels to protect the most susceptible members of the general population, why should it be assumed that less susceptible individuals are at risk from higher doses?

7. How would public health screening is a method for identifying individuals with "extreme and distinct vulnerabilities" affect individuals "if any" who need higher doses?

8. Are public health nurses trained to recognize any but the classic symptoms of nutrient deficiency?

9. Wouldn't mass public health screening for potential nutrient toxicity also increase pressure for universal vaccination?

10. What role would alternative health care providers have in the screening process? Would they even receive referrals from the public health nurses?

11. In your experience, what proportion of the general population is affected by reduced bioavailability due to poor assimilation?

12. How would you compare the risks of self-medication between over-the-counter drugs and therapeutic doses of nutrients?

13. How can public policy based on these assumptions be expected to protect consumer access to food supplements?

14. If this Risk Assessment model is adopted as the basis of U.S. public policy, will the WHO definition of food supplements as drugs supercede current laws protecting food supplements from harmonization?

15. Why should we assume that intakes above the recommended daily allowance are safe only for nutrients for which a UL has been established?

16. Would public policies based on this risk assessment model more likely benefit consumers, alternative care providers, producers and retailers of food supplements, and/or multinational pharmaceutical companies?

17. If you think our selection of quotes is biased, have you read the whole report to evaluate the quotes in their original context?

We are also interested in your input on the following related questions:

1. What difference will it make that Codex is at stage 3, if language in brackets in Codex documents and public policies about to be enacted Europe are based on risk assessment models like this one?

2. If (more than likely) pending laws based on risk assessment models for nutrients are enacted in Europe this year, could that lead to the threat of WTO trade sanctions against the U.S. for the purpose of compelling harmonization?

3. How can consumers' access to food supplements be protected when the trade associations originally established by and for the food supplement producers and retailers are depending on the same lobbyists used by multinational pharmaceutical companies?

4. How can small food supplement businesses contributing relatively lower rates of dues compete for representation on the boards of trade associations against multinational corporations with vitamin-producing subsidiaries?

5. Why were expert witnesses who support access to food supplements denied permission to speak at the Congressional Oversight Hearing, where those same trade associations spoke in favor of harmonization? We welcome your questions on topics related to access to food supplements and alternative medicine.

Time is running out, but we can still make a difference if informed citizens and patients, as well as doctors, can be organized for maximum impact on state and federal governments.

The PfAM Legislative Marketing Plan is an effective tool designed to activate patients/concerned individuals in support of Naturopathic Physicians. This support increases the effectiveness of your lobbyist by responding to bills as attention is called to them. Please see the enclosed list of additional materials now available. You will soon be able to purchase materials and consultation services, and support Patients for Alternative Medicine on-line through our web site: ""

For more information: A Model for the Development of Tolerable Upper Intake Levels, National Academy Press, Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, . . . ""

Wylet, Leanne; "Post March 20 Oversight Hearing Questions for Dan Burton and Congressional Research Service," Legislative Alert, June, 2001

Graham, Gray; "Codex German Standards are Not the Answer," The Patients' Voice, Winter, 2001

"Continued Access to Dietary Supplements at Extreme Risk," Patients for Alternative Medicine, legislative alert, October 23, 2000

"Emergency Alert: EU Vitamin Directive . . .," "" "International Conference on Harmonization: Draft Guidance on Good Manufacturing Practice for Active Pharmaceutical Ingredients," Federal Register, Docket # 00D-1418, August 1, 2000

Harris, Suzanne; "SB830, The Federal Food, Drug and Cosmetic Act: Asking the right questions, finding the right answers," ""

Wylet, Leanne; "Codex: Potential International Food Supplement Laws," The Patients' Voice, Winter, 2000,

"Delegation Report 21st Session, Codex Committee on Nutrition and Foods for Special Dietary Use," ""

Rath, Matthias; "Stop the Abuse of Codex Alimentarius by the Pharma Cartel. . ." and "Open Letter . . . to the Health Food Community, USA," ""

Rosenstreich, Jan; "Banning Vitamins and Herbs, Canada joins the club," ""

Manthey, Merrily; "Harborview, King County Trauma Center, Emergency room studies of vitamins E and C," One Voice, Autumn, 1999

Wylet, Leanne; "Codex Alert: 'Risk Analysis' for Consumer Rights" "Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body," Federal Register, Docket #98N-0044, April 29, 1998.

Manthey, Merrily; "King County Council Leading the Way for Choice, A call for natural medicine in county employee insurance benefits," One Voice, Spring, 1998

"Cholestin: FDA Policy re Intended Use," One Voice, Summer, 1998

Reprints of articles from back issues of The Patients' Voice, and One Voice, are available for a $2.00 handling fee and SASE to PO Box 1154, Wenatchee, WA 98807, (509) 884-0717, or . Some of this material is also available on line at "" . Donations, memberships, and sponsors are appreciated. PfAM is an all-volunteer organization in need of funds to cover basic operating expenses. What you can do:

1. Contact your own senators and representatives and communicate your views on risk assessment and risk management for nutrients. Capitol Switchboard: 1-800-335-4949, or see: ""

Suggested comment: Vitamins, minerals and herbs already have standards of quality and labeling set. For instance, safety and efficacy have been proven by Dr. Linus Pauling and Dr. Matthias Rath's Orthomolecular protocols. Besides, the "Risk Assessment" model used by the FDA and Codex was not done by scientific methods. Dr. Malter has clearly shown this in his rebuttal to their NAS risk assessment paper. Because these products have been proven safe, regulation should not be a priority issue. The pressure to regulate these natural products is related more to the FDA, Codex and the economic interests of pharmaceutical companies than public safety. From a health standpoint, decreasing availability and increasing the price of these products will result in a drastic increase in health care costs because of the increase in illnesses, diseases and deaths. Individuals should have the right to govern what they ingest into their bodies.

2. Sign the online petition to protect global access to vitamins at: ""

3. Network this information widely. We can't count on television or newspapers to get the word out.

4. Support Patients for Alternative Medicine (PfAM) and other true grass roots organizations such as dedicated to freedom of choice in health care