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Questions for Yetley and for L.Robert Lake of FDA re Codex Vitamin Issue

By John C. Hammell, President
International Advocates for Health Freedom
POB 625 Floyd, VA 24091
http://www.iahf.com jham@iahf.com
800-333-2553 N.America

At meetings of the CCNFSDU in Germany- it is not legal for the FDA to advocate positions that are inconsistent with current US Dietary Supplement laws.

(1) Given this, on agenda item #6, Vitamins and Minerals, in section 5.9, why is the FDA making the revision that "All labels should bear a statement that the supplement be taken on advice of a nutritionist, dietician or a medical doctor"?

(2) How is this recommendation in any way consistent with DSHEA via which consumers can benefit from truthful health claims made on the label at the point of sale?

(3) How does the FDA justify using up valuable space on the label to make this unnecessarily pedantic recommendation, when it uses up valuable space on the label that could be used for the purpose of educating consumers to the healing properties of vitamins and minerals for preventive purposes so as to keep people healthy, and out of hospitals and away from doctors and pharmacies?

(4) How can the vitamin consuming American public possibly trust the FDAs assertion that Codex doesnt in any way threaten to impact American dietary supplement laws given the agencys long history of bias against dietary supplements- especially given the agencys unwillingness to obey the law with regards to the Pearson first amendment position, wherein Pearson was forced to sue the Agency last year to force the FDA to comply with the Judges decision that the agency had to allow a label claim for folic acid in the prevention of neural tube defects? (FDA forced to stop breaking law in Pearson v Thomson http://www.emord.com/publicat.htm "Pearson v Thomson" )

(5) Isnt it true that the EU Vitamin Directive was just shoved down the throats of vitamin consumers all over the European Union despite a sufficient volume of email necessary to crash the server at the EU Parliament on March 13, 2002, the day of the vote and that the European Parliament labeled Matthias Rath, MD a "terrorist" and used armed guards to block him from entering the European Parliament building in Strousborg, Belgium on the day of the vote? Isnt it true that Rath and Pauling developed a nutritional protocol that successfully prevents heart disease, the worlds number one killer disease? Isnt it true that the largest sector of pharmaceutical sales lies in the area of heart drugs, and isnt it true that Rath and Paulings discovery poses an enormous economic threat which multinational pharmaceutical interests now seek to block via global harmonization including Codex? (http://www.petition450.org, http://www.dr-rath-research.org

(6) Isnt it true that on July 27 at 3:30 am a 330 page Trade Bill which few in Congress read, and which wasnt even available to read til only hours before the vote was rammed through in a Midnight Massacre by a vote of 215-212? Isnt it true that this bill gives Bush unilateral authority to negotiate on such matters as the Free Trade Area of the Americas with hardly any input from Congress? [Statement of Lori Wallach: Global Trade Watch div Public Citizen http://www.citizen.org/trade/]

(7) Isnt it true that the purpose of the FTAA is to establish a version of the EU Dictatorship in the western hemisphere in order to continue this process of global harmonization via which the sovereignty of all nations, including ours, is being destroyed as the laws, world wide are being harmonized and made the same? http://www.citizen.org/trade/]

(8) On March 17, 1997, didnt acting FDA Commissioner Michael A. Friedman make a speech before the Senate Labor Committee in which he stated "FDA plans to amend its regulations and procedures for consideration of standards adopted by Codex. This action is being taken to provide for the systematic review of Codex standards in order to enhance consumer protection, promote international harmonization, and fulfill the obligations of the United States under international agreements."(??)

[Answer: yes, he did, and this is a direct quote from the FDA/CFSAN Federal Register 62 FR 36243July 7, 1997 http://www.fda.gov/ola/1997/319.html speech of Michael A. Friedman]

[In his speech, Friedman was referring to our obligations under the SPS, TBT and Mutual Recognition Agreements.]

(9) Wouldnt it be a violation of the Administrative Procedures Act for FDA to act in the way Friedman is suggesting- to modify FDA regulations on a basis of international standards that were not developed in accordance with American law? [Answer: yes, it would be, and there was a court case that OSHA lost in which they attempted to modify their regulations pertaining to asbestos on a basis of some scientific findings of an international regulatory body. The court struck down OSHAs regs in this case as illegal because they werent developed in accordance with the Administrative Procedures Act.]

(10) Isnt it true that the only legal basis on which a country can refuse to harmonize its domestic vitamin laws to a finalized Codex vitamin standard is on a basis of safety?

[Answer: yes-

[See SPS Agreement, Article 3, Paragraph 3 - in the context of Paragraphs 1-3:

http://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm

1. To harmonize sanitary and phytosanitary measures on as wide a basis as possible, Members shall base their sanitary or phytosanitary measures on international standards, guidelines or recommendations, where they exist, except as otherwise provided for in this Agreement, and in particular in paragraph 3.

2. Sanitary or phytosanitary measures which conform to international standards, guidelines or recommendations shall be deemed to be necessary to protect human, animal or plant life or health, and presumed to be consistent with the relevant provisions of this Agreement and of GATT 1994.

3. Members may introduce or maintain sanitary or phytosanitary measures which result in a higher level of sanitary or phytosanitary protection than would be achieved by measures based on the relevant international standards, guidelines or recommendations, if there is a scientific justification, or as a consequence of the level of sanitary or phytosanitary protection a Member determines to be appropriate in accordance with the relevant provisions of paragraphs 1 through 8 of Article 5.(2) Notwithstanding the above, all measures which result in a level of sanitary or phytosanitary protection different from that which would be achieved by measures based on international standards, guidelines or recommendations shall not be inconsistent with any other provision of this Agreement.

(11) Isnt it true that the FDA (with help from the pharmaceutically dominated vitamin trade associations) are are setting us up to lose in a future WTO Trade Dispute by undermining our ability to defend our domestic vitamin laws on a basis of safety by generating bogus safety data via the National Academy of Sciences, a non governmental body that is not subject to the Freedom of Information Act so that we cant get the raw data behind their papers, or complete information from them pertaining to possible conflicts of interest involving the authors of these papers?

[Answer: Yes:

This is why the FDA has hired the pharmaceutically dominated "National Academy of Sciences" to generate a supposed "framework" by which the safety of dietary supplements can be evaluated. http://www.nap.edu/catalog/10456.html?se_side

By hiring the NAS to generate this supposed "framework" the FDA is attempting to hide behind the fact that NAS is not subject to the Freedom of Information Act, so no one can get the raw data behind NAS's supposed "safety pronouncements". Also, NAS certainly isn't interested in protecting the American people from conflicts of interest in the composition of their "safety panel", and the American people certainly were never consulted when this panel was assembled.

This forces American vitamin consumers, vitamin companies and health food stores to put NAS "safety panelists" Barbara Schneeman, PhD, Daniel Azarnoff, MD, Cindy Lynn Christiansen, PhD, Alice M. Clark, PhD, Norman R.Farnsworth, PhD, Adriane Fugh-Berman, MD, Ted Gansler, MD, Philip Gruzelian MD, Elizabeth Jeffery, PhD, Joseph Lau, MD, Susan Percival, PhD, and Cheryl L.Rock, Ph.D, RD, under a microscope in order to scrutinize their pharmaceutical associations, research grants, and biases in general that would skew the outcome of their current witch hunt against Chaparral, Chromium Picolinate, Glucosamine, Melatonin, Saw Palmetto, and Shark Cartilage.

The FDA would have the American people believe that Codex "in no way" threatens to undermine US domestic vitamin laws including Proxmire, NLEA and DSHEA.

While it is true that there mere existence of a finalized Codex vitamin standard could not, but itself impact US domestic vitamin law, the threat of forcing changes to our vitamin laws stems from our membership in the World Trade Organization- and the fact that the WTO has an international court called the Dispute Settlement Body that does not follow US courts rules of evidence, and which is rigged to support the greed driven agendas of multinational corporations which seek to harmonize the laws world wide to destroy the sovereignty of nations and to force all vitamin consumers, world wide, under the thumb of a global totalitarian state in which people are totally disenfranchised.

In a letter to Congressman Dan Burton that is publicly posted at http://www.iahf.com (click on spinning globe) Congressmen Ron Paul and Peter De Fazio state that in a 1999 Report, the Congressional Research Service has confirmed that "As a member of the WTO, the United States does commit to act in accordance with the rules of the multilateral body. It [the US] is legally obligated to insure that national laws do not conflict with WTO rules."


In red, below, you will find IAHF's comments to FDA's US Draft Position as of July, 2002-Proposed Draft Guidelines for Vitamin and Mineral Supplements

U.S. DRAFT POSITION
AS OF JULY, 2002

PROPOSED DRAFT GUIDELINES
FOR VITAMIN AND MINERAL SUPPLEMENTS
(AT STEP 4)

AGENDA ITEM No. 6

BACKGROUND

Reference:

- Report of the 23rd Session (ALINORM 03/26, Paras 18-40 and Appendix II)

- Government comments at Step 3 (CX/NFSDU 02 /6) not yet available

The Committee is invited to consider the proposed draft guidelines as amended during the last Session of the Committee and in light of the government comments received.

U.S. DRAFT POSITION

General Comments:

The United States supports consumer choice and access to dietary supplements that are safe and are labeled in a truthful and non-misleading manner.

In making this statement, the FDA arrogantly presumes to represent the United States. Actually, the American people, Congress and the US courts (which FDA is trying to get around via Codex manipulations) do support consumer choice and access to dietary supplements, but the FDA does not, never has, and never will. Due to this extreme criminal attitude of the FDA's, the FDA has dragged their feet in implementing the Pearson v Schalala court decision in which the FDA lost on first amendment grounds.

Due to FDA's refusal to allow a label claim on folic acid that the court had previously ordered FDA to allow, Pearson, et al were forced to sue the FDA again in order to stop the FDA from continuing to cause children from being born with crippling birth defects such as spina bifida due to the FDA not allowing pregnant women to learn, on the label of folic acid supplements, of their value in preventing neural tube defects.

Information below is from http://www.emord.com/publicat.htm "Pearson v Thomson"

DURK PEARSON, et al., Plaintiffs, v. TOMMY G. THOMPSON, et al., Defendants.

Civil Action No. 00-2724 (GK)

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

2001 U.S. Dist. LEXIS 6560

May 7, 2001, Decided

May 9, 2001, Filed

"Plaintiffs previously filed a motion for a preliminary injunction, seeking to enjoin the implementation of an FDA decision which prohibited them from including on their dietary supplements' labels the following health claim: ".8 mg of folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form" ("Folic Acid Claim").

On February 2, 2001, this Court granted Plaintiffs' motion, finding that Defendants had violated the First Amendment in refusing to approve Plaintiffs' Folic Acid Claim, with or without disclaimers, and ordering that the case be immediately remanded to the FDA "for the purpose of drafting one or more short, succinct, and accurate alternative disclaimers, which may be chosen by Plaintiffs to accompany their Folic Acid Claim." See Pearson v. Shalala, 130 F. Supp. 2d 105, 121 (D.D.C. 2001) ("Pearson II"). The Court suggested that the FDA consider two disclaimers in particular, [*3] and anticipated that the agency would "complete its task within 60 days." Id. at 120 & n.34. n3

n3 For a detailed statutory and factual background of this case, see Pearson II, 130 F. Supp. 2d at 107-112.

On February 16, 2001, Defendants filed a Motion for Reconsideration of the Court's February 2, 2001 Order. n4 This Motion is now before the Court. Upon consideration of the Motion, Opposition, Reply, and the entire record herein, for the reasons stated below, Defendants' Motion for Reconsideration [ # 29] is denied."

The United States notes that the Codex Guidelines for Vitamin and Mineral Supplements will not, in any way, adversely affect the availability of safe and truthfully labeled supplement products in the U.S. marketplace or to U.S. consumers. The absence of science-based Codex guidelines, however, could adversely affect the ability of U.S. manufacturers to compete in the international marketplace.

The is a deliberately misleading statement by the FDA, which as already established above, does not in fact represent the American people, the Congress or the US courts. The FDA routinely ignores the American people, the Congress, and the Courts as established above. The FDA is a genocidal criminal agency which regards itself to be above the law, as clearly established above. The fact is that the FDA represents the multinational pharmaceutical industry, and there is a revolving door between the FDA and the pharmaceutical industry.

This is why the FDA has hired the pharmaceutically dominated "National Academy of Sciences" to generate a supposed "framework" by which the safety of dietary supplements can be evaluated. http://www.nap.edu/catalog/10456.html?se_side

By hiring the NAS to generate this supposed "framework" the FDA is attempting to hide behind the fact that NAS is not subject to the Freedom of Information Act, so no one can get the raw data behind NAS's supposed "safety pronouncements". Also, NAS certainly isn't interested in protecting the American people from conflicts of interest in the composition of their "safety panel", and the American people certainly were never consulted when this panel was assembled.

This forces American vitamin consumers, vitamin companies and health food stores to put NAS "safety panelists" Barbara Schneeman, PhD, Daniel Azarnoff, MD, Cindy Lynn Christiansen, PhD, Alice M. Clark, PhD, Norman R.Farnsworth, PhD, Adriane Fugh-Berman, MD, Ted Gansler, MD, Philip Gruzelian MD, Elizabeth Jeffery, PhD, Joseph Lau, MD, Susan Percival, PhD, and Cheryl L.Rock, Ph.D, RD, under a microscope in order to scrutinize their pharmaceutical associations, research grants, and biases in general that would skew the outcome of their current witch hunt against Chaparral, Chromium Picolinate, Glucosamine, Melatonin, Saw Palmetto, and Shark Cartilage.

FDA asserts that "The United States notes that the Codex Guidelines for Vitamin and Mineral Supplements will not, in any way, adversely affect the availability of safe and truthfully labeled supplement products in the U.S. marketplace or to U.S. consumers. The absence of science-based Codex guidelines, however, could adversely affect the ability of U.S. manufacturers to compete in the international marketplace."

The FDA is well aware that the only legal basis on which any country can refuse to harmonize its domestic laws to an international standard, such as a Codex vitamin standard is on a basis of safety. This is why the FDA and their pharmaceutical cronies at NAS are working overtime to create false definitions of dietary supplement safety- they're trying to undermine the American people's and Congress's ability to defend US Dietary Supplement laws in the event of a future WTO Trade Dispute launched by a pharmaceutical company against us demanding that Congress repeal Proxmire and DSHEA, which FDA would love to see happen. Since FDA can't beat the American people on US soil, the FDA is going offshore to set us up to lose in a WTO Trade Dispute before the WTO's Dispute Settlement Panel, an international court that does not follow the US courts rules of evidence, an international court which is so thoroughly rigged to defend the multinational corporations greed driven interests that every decision has gone against the environment, against the public health, against human rights, against labor rights....

Only Dr.Yetley, an unelected bureaucrat from the FDA would have standing to appear before the WTO's Dispute Settlement Body in the event of a trade dispute against the USA over our dietary supplement laws, and she is clearly bought and paid for. No private citizen, no matter how well qualified, not even the late Linus Pauling, PhD (if he were still alive) would have standing to appear before the WTO's Dispute Settlement Body in defense of our dietary supplement laws.... Durk Pearson would certainly not be allowed to appear before them, nor would Julian Whitaker MD...FDA knows all of this.....

Congressmen Ron Paul (R-TX) and Peter De Fazio (D-OR) also realize this, and so does the Congressional Research Service: see gif file of letter to Congressman Burton at http://iahf.com/index2.html

[See SPS Agreement, Article 3, Paragraph 3 - in the context of Paragraphs 1-3:

http://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm

1. To harmonize sanitary and phytosanitary measures on as wide a basis as possible, Members shall base their sanitary or phytosanitary measures on international standards, guidelines or recommendations, where they exist, except as otherwise provided for in this Agreement, and in particular in paragraph 3.

2. Sanitary or phytosanitary measures which conform to international standards, guidelines or recommendations shall be deemed to be necessary to protect human, animal or plant life or health, and presumed to be consistent with the relevant provisions of this Agreement and of GATT 1994.

3. Members may introduce or maintain sanitary or phytosanitary measures which result in a higher level of sanitary or phytosanitary protection than would be achieved by measures based on the relevant international standards, guidelines or recommendations, if there is a scientific justification, or as a consequence of the level of sanitary or phytosanitary protection a Member determines to be appropriate in accordance with the relevant provisions of paragraphs 1 through 8 of Article 5.(2) Notwithstanding the above, all measures which result in a level of sanitary or phytosanitary protection different from that which would be achieved by measures based on international standards, guidelines or recommendations shall not be inconsistent with any other provision of this Agreement.

This is why the FDA is so hard at work via their pharmaceutical cronies at NAS to create false definitions of vitamin safety via this so called "framework" and via the fraudulent application of a toxicology model originally intended for the evaluation of toxic pharmaceutical drugs to safe vitamins and minerals.

Because foods contain many substances that promote health, consumers should be encouraged to select a wide variety of healthful foods. However, we also note that, from a public health perspective, some people need a vitamin-mineral supplement to meet specific nutrient needs. For example, women who could become pregnant are advised to eat foods fortified with folic acid or to take a folic acid supplement in addition to consuming folate-rich foods to reduce the risk of some serious birth defects. Older adults and people with little exposure to sunlight may need a vitamin D supplement. Health care providers may advise pregnant women to take an iron supplement or adults over the age of 50 to get their vitamin B12 from a supplement or fortified foods.

We also recognize that supplements of some nutrients, such as vitamin A and selenium, can be harmful if taken in large amounts.

In the spirit of the protection of international fair trade practices and the science-based resolution of international trade disputes, we support the development of CODEX guidelines for vitamin and mineral supplements that do not unduly limit consumer access to safe and truthfully labeled dietary supplement products.

What a misleading statement. As discussed above, the FDA has done everything in its power to BLOCK pregnant women from learning the truth about the power of folic acid to prevent neural tube defects. In this statement, FDA is PRETENDING to be on the side of consumers, while simultaneously having NAS go on about the business of concocting bogus supposed "safety concerns" about Chaparral, Chromium Picolinate, Glucosamine, Melatonin, Saw Palmetto, and Shark Cartilage as a prelude to attempting to railroad these safe substances off the market on a basis of trumped up "safety concerns." http://www.nap.edu/catalog/10456.html?se_side The FDA is setting us up to lose in a future WTO trade dispute by creating false definitions of vitamin safety. Along these same lines, the FDA had NAS generate the bogus paper titled "A Risk Assessment Model for Establishing Upper Intake Levels for Nutrients" http://www.iahf.com/nas/nutrisk.html

The fraudulence of this paper has been established via Richard Malter's Rebuttal http://www.iahf.com/nas/nasrebut.html , Bill Sardi "The Perils and Pitfalls of Harmonized Food Supplements" http://www.iahf.com/nas/20001128.html and Brian Leibovitz,PhD "The ABCs of Confusion as a Weapon" http://www.iahf.com/leibovitz/jon.html#confuse

By participating in the creation of a Codex vitamin standard, the FDA is in direct violation of the will of the American people, and the will of Congress as clearly expressed under Section 803(c) of the Food Drug and Cosmetic Act by section 410 (b) of the FDA Modernization Act of 1997 (FDAMA), Public Law No. 105-115, 111 Stat 2297.

Through a fraudulent interpretation of this amendment (Paragraph (c)(5) to FDAMA by FDA attorney L.Robert Lake of FDA, FDA is continuing in its efforts to set up American supplement laws for harmonization to a grossly restrictive Codex vitamin standard.

[See letter of June 20, 2001 to Secretary Tommy Thomson, US Dept. of Health and Human Services from Congressman Ron Paul, to be posted at http://iahf.com/index2.html] [See Written Comments Submitted on the Codex Vitamin Issue by IAHF to the House Government Reform Committee ("Oversight" Committee)http://iahf.com/index2.html]

With regards to FDA's proposed changes to the language below in development of a Codex vitamin standard, IAHF rejects the contention that an RDA based approach OR a supposed "safety based" approach as determined by the pharmaceutically biased NAS is consistent with current US law. Furthermore, IAHF contends that it is not legal under current US law for the FDA to participate at all in the development of a Codex vitamin standard.

IAHF certainly opposes the last sentence of FDA's proposed changes below wherein FDA asserts that "All labels should bear a statement that the supplement should be taken on an advice of a nutritionist, a dietician or a medical doctor." IAHF opposes this statement as an unecessary waste of valuable space on the label which should be used to convey truthful health information about the healing qualities of vitamins and minerals, something which both the FDA and the Codex Commission clearly oppose in direct violation of US law which FDA and the Codex Commission combined with a WTO Dispute Settlement Panel are clearly intent on dismantling, along with a little help from the pharmaceutically dominated vitamin trade associations and the Dietary Supplement Working Group of the Trans Atlantic Business Dialogue which has publicly vowed to harmonize US dietary supplement laws to the EU's draconian standards, and to Codex: U.S. and European Leaders Agree on

Principles to Harmonize Dietary Supplement Regulations http://www.crnusa.org/shellnr112000.html

(Long Live the 2nd Amendment Right to Bear Arms.)

Date: Sat, 17 Feb 2001

Comments on Specific Sections:

NOTE: For all sections of these guidelines in which either "shall" or "must" is now used, we recommend that this be changed to "should", since this is a guideline rather than a Codex standard.

PREAMBLE

We recommend that the following revision:

"These guidelines are intended to ensure a high level of protection and to facilitate informed choice for consumers of vitamin and mineral supplements. Most people who have access to a balanced diet can usually obtain all the nutrients they require from their normal diet. Because foods contain many substances that promote health, people should therefore be encouraged to select a balanced diet from food before considering any vitamin and mineral supplement. In cases where the intake from the diet is insufficient or where consumers consider their diet requires supplementation, vitamin and mineral supplements serve to supplement the daily diet."

Rationale: The preamble should clearly state the purpose of the guideline. The addition of the first sentence to the current Preamble paragraph meets this need.

1. SCOPE

1.1 We recommend the following revision:

"These guidelines apply to vitamin and mineral supplements intended for use in supplementing the daily diet [if and where necessary] with vitamins and/or minerals. These Guidelines apply to vitamin and mineral supplements which are regulated as foods.

Rationale:

1. "if and where necessary" is inconsistent with the Preamble language; Moreover, this phrase is not relevant to this section which addresses the scope of products that are covered.

2. The last sentence is redundant with 1.2 below and is, therefore, unnecessary.

1.2 We recommend the following revision:

"It is left to national authorities to decide whether vitamin and mineral supplements are drugs or foods. These Guidelines do apply in those jurisdictions where to products defined in 2.1 are regulated as foods."

Rationale: Codex Alimentarius guidelines only apply to products regulated as foods. Therefore, reference to national authorities which regulate these products as drugs is unnecessary.

2. DEFINITIONS

2.1 We recommend the following revision:

"Vitamin and mineral supplements for the purpose of these guidelines derive their nutritional relevance primarily from the minerals and/or vitamins they contain. Vitamin and mineral supplements are sources in concentrated forms of those nutrients alone or in combinations, marketed in capsules, tablets, powders, solutions etc., not in conventional food form and do not provide a significant amount of energy. [They serve to supplement the daily diet with these nutrients in cases when the intake from food is insufficient or where the consumers consider their diet requires supplementation."]

Rationale:

1. The usefulness and meaning of the phrase do not provide a significant amount of energy is not clear and appears unnecessary.

2. The last sentence is unnecessary. It is redundant with the Preamble language. If it is retained in 2.1, it should be deleted from the Preamble.

3. COMPOSITION

3.1 SELECTION OF VITAMINS AND MINERALS

3.1.2 We recommend the following revision:

"The selection of admissible vitamin and mineral sources should be based on criteria considerations such as safety and bioavailability. In addition, where available, purity criteria should take into account the FAO/WHO or Pharmacopoeias purity standards. [and national legislation, where applicable].

Rationale: We do not believe that it is necessary to include "admissible". Specific reference to national legislation runs contrary to the spirit of international fair trade practices. Moreover, it is unnecessary, since it is protected under provisions of the WTO agreements.

3.1.3 We recommend deleting the following bracketed section:

[3.1.3 The use of individual vitamins and minerals in supplements can be [limited] for reasons of health protection and consumer safety, taking into account regional or national peculiarities concerning the supply situation of the population."]

Rationale: This section, which limits the levels of vitamins and minerals, is more appropriately addressed in provisions covered by Section 3.2 on Contents than it is in section 3.1 on selection.

3.2. CONTENTS OF VITAMINS AND MINERALS

3.2.1 We recommend the following revision:

"The minimum level of each vitamin and/or mineral in a vitamin and mineral supplement per daily portion of consumption as suggested by the manufacturer should be [15% to 33%] of the recommended daily intake as determined by FAO/WHO."

Rationale: The 15% level is consistent with the amount that a food product must contain (per serving or per 100g) to claim on its label that it is a source of a vitamin or mineral based on recently adopted Codex provisions for conditions for vitamin and mineral claims.

3.2.2 We recommend deleting the first option:

[ The maximum level of each vitamin and/or mineral contained in a vitamin and mineral supplement per daily portion of consumption as suggested by the manufacturer should not exceed [100%] of the recommended daily intake as determined by FAO/WHO.]

Rationale: FDA believes that the setting of maximum levels, when needed, should be based on science-based assessment of safety (as is done in the second option for 3.2.2. below) rather than through an arbitrary application of a % of the recommended daily intake level (as is done in the option directly above).

We recommend retaining the second option with the following revision:

[Maximum amounts of vitamins and minerals in vitamin and mineral supplements per daily portion of consumption as recommended by the manufacturer shall should be set, takeing the following criteria into account:

(a) upper safe levels of vitamins and minerals established by scientific risk assessment based on generally accepted scientific data, taking into consideration, as appropriate, the varying degrees of sensitivity of different consumer groups;

(b) the daily intake of vitamins and minerals from other dietary sources.

When the maximum levels are set, due account should be taken to the reference intake values of vitamins and minerals for the population.]

Rationale:

1. As a guideline rather than a standard, the use of should rather than shall is appropriate.

2. The last sentence seems unnecessary if a science-based risk assessment approach is used to set maximum limits.

3.2.3 We recommend deleting the text in this section.

"For vitamins and minerals with a narrow safety margin between the recommended daily intake and the adverse effect level, different maximum limits for the daily dose may be established at the national level."

Rationale: Safety issues would be covered by the provisions in 3.2.2 (a) and (b).

4. PACKAGING

4.1 We recommend the following revision:

"The product shall should be packed in containers which will safeguard the hygienic and other qualities of the food."

4.2 We recommend the following revision:

"The containers, including packaging material, shall should be made only of substances which are safe and suitable for their intended use. Where the Codex Alimentarius Commission has established a standard for any such substance used as packaging material, that standard shall apply."

5. LABELLING

[5.2 We recommend the following revision:

[" The name of the product shall should be vitamin and mineral supplement or dietary mineral/vitamin preparation to supplement the diet with , with an indication of the nutrients contained therein."]

Rationale: The last phrase is more appropriately addressed in 5.3 below.

[5.3 We recommend the following revision:

["The amount of the vitamins and minerals present in the product shall should be declared in the labeling in numerical form. The units to be used shall be units of weight consistent with the Codex Guidelines on Nutrition Labeling."]

5.4 We recommend the following revision:

"The amounts of the vitamin and minerals declared shall should be those per portion of the product as recommended for daily consumption on the labeling and per unit dose form, as appropriate."

5.5 We recommend the following revision:

"Information on vitamins and minerals shall should also be expressed as a percentage of the reference values mentioned, as the case may be, in the Codex Guidelines on Nutrition Labelling."]

5.6 We recommend the following revision:

"The label must should indicate the recommendations on how to take the product (quantity, frequency, special conditions)."

5.7 We recommend the following revision:

"The label must should contain a warning statement [if the product contains an significant amount of a nutrient that has been shown through science-based risk assessment to be a health hazard under conditions of use. with respect to the toxicity level."]

[5.8 We recommend the following revision:

"The label must should not state or imply that contain a statement: supplements can not be used for the replacement of meals on a long term basis.

5.9 We recommend the following revision:

"All labels shall should bear a statement that the supplement should be taken on an advice of a nutritionist, a dietician or a medical doctor."]