EK
SEC. 2. FINDINGS AND PURPOSE.
(a) FINDINGS.—Congress finds that— (1) improving the health status of United States citizens ranks at the top of the national priorities of the Federal Government; (2) the importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention have been documented increasingly in scientific studies; (3)(A) there is a definitive link between the ingestion of certain nutrients or dietary supplements and the prevention of chronic diseases such as cancer, heart disease, and osteoporosis; and (B) clinical research has shown that several chronic diseases can be prevented simply with a healthful diet, such as a diet that is low in fat, saturated fat, cholesterol, and sodium, with a high proportion of plant-based foods; (4) healthful diets may mitigate the need for expensive medical procedures, such as coronary bypass surgery or angioplasty; (5) preventive health measures, including education, good nutrition, and appropriate use of safe nutritional supplements will limit the incidence of chronic diseases, and reduce long-term health care expenditures; S 784 ES –(A) promotion of good health and healthy lifestyles improves and extends lives while reducing health care expenditures; and (B) reduction in health care expenditures is of paramount importance to the future of the country and the economic well-being of the country; there is a growing need for emphasis on the dissemination of information linking nutrition and long-term good health; consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements; (A) national surveys have revealed that almost 50 percent of the 260,000,000 Americans regularly consume dietary supplements of vitamins, minerals, or herbs as a means of improving their nutrition; and (B) nearly all consumers indicate that dietary supplements should not be regulated as drugs; studies indicate that consumers are placing increased reliance on the use of nontraditional health care providers to avoid the excessive costs of traditional medical services and to obtain more holistic consideration of their needs; S 784 ES the United States will spend over $1,000,000,000,000 on health care in 1994, which is about 12 percent of the Gross National Product of the United States, and this amount and percentage will continue to increase unless significant efforts are undertaken to reverse the increase; (A) the nutritional supplement industry is an integral part of the economy of the United States; (B) the industry consistently projects a positive trade balance; and (C) the estimated 600 dietary supplement manufacturers in the United States produce approximately 4,000 products, with total annual sales of such products alone reaching at least $4,000,000,000; although the Federal Government should take swift action against products that are unsafe or adulterated, the Federal Government should not take any actions to impose regulatory barriers limiting or slowing the flow of safe products and needed information to consumers; dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare; and S 784 ES (A) legislative action that protects the right of access of consumers to safe dietary supplements is necessary in order to promote wellness; and (B) a rational Federal framework must be established to supersede the current ad hoc, patchwork regulatory policy on dietary supplements. (b) PURPOSE.—It is the purpose of this Act to— (1) improve the health status of the people of the United States and help constrain runaway health care spending by ensuring that the Federal Government erects no regulatory barriers that impede the ability of consumers to improve their nutrition through the free choice of safe dietary supplements; (2) clarify that—
(A) dietary supplements are not drugs or food additives;
(B) dietary supplements should not be regulated as drugs;
(C) regulations relating to food additives are not applicable to dietary supplements and their ingredients used for food additive purposes, including stabilizers, processing agents, or preservatives; and
(D) the burden of proof is on the Food and Drug Administration to prove that a product is unsafe before it can be removed from the marketplace; (3) establish a new definition of a dietary supplement that differentiates dietary supplements from conventional foods, while recognizing the broad range of food ingredients used to supplement the diet;
(4) strengthen the current enforcement authority of the Food and Drug Administration by providing to the Administration additional mechanisms to take enforcement action against unsafe or fraudulent products;
(5) establish a series of labeling requirements that will provide consumers with greater information and assurance about the quality and content of dietary supplements, while at the same time assuring the consumers the freedom to use the supplements of their choice;
(6) provide new administrative and judicial review procedures to affected parties if the Food and Drug Administration takes certain actions to enforce dietary supplement requirements; and
(7) establish a Commission on Dietary Supplement Labels within the executive branch to develop recommendations on a procedure to evaluate health claims for dietary supplements and provide recommendations to the President and the Congress.
SEC. 3. DEFINITIONS.
(a) DEFINITION OF CERTAIN FOODS AS DIETARY SUPPLEMENTS.—Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the following: The term ‘dietary supplement’ means—
‘‘(1) a product intended to supplement the diet by increasing the total dietary intake that bears or contains one or more of the following dietary ingredients:
‘‘(A) a vitamin;
‘‘(B) a mineral;
‘‘(C) an herb or other botanical;
‘‘(D) an amino acid;
‘‘(E) another dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
‘‘(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), (E) or
(F); a product that‘‘(A)(i) is intended for ingestion in a form described in section 411(c)(1)(B)(i); or ‘‘(ii) complies with section 411(c)(1)(B)(ii); and ‘‘(B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and
‘‘(C) is labeled as a dietary supplement.’’.
(b) EXCLUSION FROM DEFINITION OF DRUG.—Section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)) is amended by adding at the end the following new subparagraph: ‘‘(3) The term ‘drug’ does not include a dietary supplement as defined in paragraph (ff), except that ‘‘(A) an article that is approved as a new drug, certified as an antibiotic (under section 355 or 357), or licensed as a biologic (under section 351 of the Public Health Service Act (42 U.S.C. 262 et seq.)) and was, prior to such approval, certification or license, marketed as a dietary supplement or as a food, may continue to be offered for sale as a dietary supplement unless the Secretary has issued a regulation, after notice and comment, finding that the article when used as or in a dietary supplement under the conditions of use and dosages set forth in the labeling for such dietary supplement, is unlawful under section 402(f); and ‘‘(B) an article that is approved as a new drug, certified as an antibiotic (under section 355 or 357), or licensed as a biologic (under section 351 of the Public Health Service Act (42 U.S.C. 262 et seq.)) and was not prior thereto marketed as a dietary supplement or as a food, may not be considered as a dietary ingredient or dietary supplement unless the Secretary has issued a regulation, after notice and comment, finding that the article would be lawful under section 402(f) under the conditions of use and dosages set forth in the recommended labeling for such article.’’.
(c) EXCLUSION FROM DEFINITION OF FOOD ADDITIVE.—
Section 201(s) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(s)) is amende(1) by striking ‘‘or’’ at the end of subparagraph (4);
(2) by striking the period at the end of subparagraph
(5) and inserting ‘‘; or’’; and
(3) by adding at the end the following new subparagraph:
‘‘(6) an ingredient described in paragraph (ff)
in, or intended for use in, a dietary supplement.’’.
(d) FORM OF INGESTION.—Section 411(c)(1)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350(c)(1)(B)) is amended(1) in clause (i), by inserting ‘‘powder, softgel, gelcap,’’ after ‘‘capsule,’’; and (2) in clause (ii), by striking ‘‘does not simulate and’’. SEC. 4. SAFETY OF DIETARY SUPPLEMENTS AND BURDEN OF PROOF ON FDA. Section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342) is amended by adding at the end the following:
‘‘(f) If it is a dietary supplement that ‘‘(1) the Secretary finds, after rulemaking, presents a substantial and unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling; ‘‘(2) the Secretary declares to pose an imminent and substantial hazard to public health or safety, except that the authority to make such declaration shall not be delegated and the Secretary shall promptly thereafter convene rulemaking pursuant to section 701(e), (f), and (g) to affirm or withdraw the declaration; or ‘‘(3) is or contains a dietary ingredient that renders it adulterated under paragraph (a)(1) under the conditions of use recommended or suggested in the labeling of such dietary supplement. In any proceeding under this section, the United States bears the burden of proof on each element to show that a dietary supplement is dulterated.’’. SEC. 5. DIETARY SUPPLEMENT CLAIMS. (a) SUPPLEMENT CLAIMS.—Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amended by inserting after section 403A the following new section: ‘‘DIETARY SUPPLEMENT LABELING EXEMPTIONS ‘‘SEC. 403B. An article, another publication, a chapter in books, or the official abstract of a peer-reviewed scientific publication that appears in the article and was prepared by the author or the editors of the publication, reprinted in its entirety, shall not be defined as labeling when used in connection with the sale of dietary supplements to consumers when it—
‘‘(1) is not false or misleading;
‘‘(2) does not promote a particular brand of a dietary supplement;
‘‘(3) is displayed or presented, or is displayed or presented with other such items on the same subject matter, so as to present a balanced view of the available scientific information on a dietary supplement; and ‘‘(4) if displayed in an establishment, is physically separate from the dietary supplements. This section shall not apply to or restrict a retailer or wholesaler of dietary supplements in any way whatsoever in the sale of books or other publications as a part of the business of such retailer or wholesaler. In any proceeding under this section, the burden of proof shall be on the United States to establish that an article or other such matter is false or misleading.’’.
SEC. 6. STATEMENTS OF NUTRITIONAL SUPPORT.
Section 403(r)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(r)(1)) is amended by adding the following new sentence at the end:‘‘For purposes of this subparagraph, a statement for a dietary supplement shall not be considered a claim of the relationship of a nutrient or dietary ingredient to a disease or health-related condition if the statement does not claim to diagnose, prevent, mitigate, treat, or cure a specific disease or class of diseases. A statement for a dietary supplement may be made if the statement claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or describes general well-being from consumption of a nutrient or dietary ingredient.’’.
SEC. 7. CONFORMING AMENDMENTS.
(a) SECTION 201.—The next to the last sentence of section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)) (as amended by section 3(b)) is amended to read as follows: ‘‘A food or dietary supplement for which a claim, subject to section 403(r)(1)(B) and 403(r)(3) or section 403(r)(1)(B) and 403(r)(5)(D), is made in accordance with the requirements of section 403(r) is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and nonmisleading statement is made in accordance with section 403(r)(1) is not a drug solely because the label or the labeling contains such a statement.’’. (b) SECTION 403.—Section 403 (21 U.S.C. 343) is amended by adding at the end the following: ‘‘A dietary supplement shall not be deemed misbranded solely because its label or labeling contains directions or conditions of use or warnings.’’.
SEC. 8. ADMINISTRATIVE AND JUDICIAL REVIEW.
The Federal Food, Drug, and Cosmetic Act is amended by adding at the end of chapter III (21 U.S.C. 331 et seq.) the following new section:
‘‘SEC. 311. WARNING LETTERS. —‘‘Any warning letter or similar written threat of enforcement under the Federal Food, Drug, and Cosmetic Act constitutes final agency action for the purpose of obtaining judicial review under chapter 7 of title 5, United States Code, if the matter with respect to such letter or threat is not resolved within 60 days from the date such letter or threat is delivered to any person subject to this Act. In any proceeding for judicial review of a warning letter or similar written threat of enforcement under the Act, the United States bears the burden of proof on each element of each alleged violation of law described.’’. SEC. 9. WITHDRAWAL OF THE REGULATIONS AND NOTICE. (a) IN GENERAL.—The advance notice of proposed rulemaking concerning dietary supplements published in the Federal Register of June 18, 1993 (58 FR 33690– 33700), the notices of proposed rulemaking concerning nutrition labeling for dietary supplements and nutrient content claims for dietary supplements published in the Federal Register of June 18, 1993 (58 FR 33715–33731 and 58 FR 33731–33751), and the final rules and notices published in the Federal Register of January 4, 1994 concerning nutrition labeling for dietary supplements and nutrient content claims for dietary supplements (59 FR 354– 378 and 378–395) are null and void and of no force or effect insofar as they apply to dietary supplements. Final regulations and notices published in the Federal Register of January 4, 1994 concerning health claims for dietary supplements under the Nutrition Labeling and Education Act of 1990 (59 FR 395–426) shall not be affected by this section and shall remain in effect until 120 days after the date of the submission of the final report of the Commission established under section 11 to the President and to Congress, or 28 months after the date of enactment of this Act, whichever is earlier.
(b) NOTICE OF REVOCATION.—The Secretary of Health and Human Services shall publish notices in the Federal Register to revoke all of the items declared to be null and void and of no force or effect under subsection (a).
(c) ISSUANCE OF REGULATIONS.—Notwithstanding any provision of the Nutrition Labeling and Education Act of 1990(1) no regulation is required to be issued pursuant to such Act with respect to dietary supplements of vitamins, minerals, herbs, amino acids, or other similar nutritional substances; and no regulation that is issued in whole or in part pursuant to such Act shall have any force or effect with respect to any dietary supplement of vitamins, minerals, herbs, amino acids, or other similar nutritional substances unless such regulation is issued pursuant to rulemaking proceedings that are initiated by an advance notice of proposed rule-making that is published no earlier than 2 years after the date of enactment of this Act, and followed by, at least, a notice of proposed rulemaking prior to issuance of the final regulation, except insofar as the regulation authorizes the use of labeling about calcium, folic acid, or other matters and does not prohibit the use of any labeling SEC. 10. DIETARY SUPPLEMENT INGREDIENT LABELING
AND NUTRITION INFORMATION LABELING.
(a) MISBRANDED SUPPLEMENTS.—Section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the following new paragraph: ‘‘(s) If‘‘(1) it is a dietary supplement; and ‘‘(2)(A) the label or labeling of the supplement fails to list‘‘(i) the name of each ingredient of the supplement that is described in section 201(ff); and ‘‘(ii)(I) the quantity of each such ingredient; or ‘‘(II) with respect to a proprietary blend of such ingredients, the total quantity of all ingredients in the blend; ‘‘(B) the label or labeling of the dietary supplement fails to identify the product by using the term ‘dietary supplement’, which term may be modified with the name of such an ingredient; ‘‘(C) the supplement contains an ingredient described in section 201(ff) (1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived; ‘‘(D) the supplement—
‘‘(i) is covered by the specifications of an official compendium;
‘‘(ii) is represented as conforming to the specifications of an official compendium; and ‘‘(iii) fails to so conform; or
‘‘(E) the supplement‘‘(i) is not covered by the specifications of an official compendium; and ‘‘(ii)(I) fails to have the identity and strength that the supplement is represented to have; or ‘‘(II) fails to meet the quality (including tablet or capsule disintegration), purity, or compositional specifications, based on validated assay or other appropriate methods, that the supplement is represented to meet.’’
(b) SUPPLEMENT LISTING ON NUTRITION LABELING.—Section 403(q)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(1)) is amended by adding at the end the following: ‘‘A dietary supplement may bear on the nutrition label or in labeling a listing and quantity of ingredients that have not been deemed essential nutrients by the Secretary if such ingredients are prominently identified as not having been shown to be essential or not having an established daily value.’’.
(c) DIETARY SUPPLEMENT LABELING EXEMPTIONS. Section 403(q)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(5)) is amended by adding at the end the following new clause: ‘‘(H) The labels of dietary supplements shall not be required to bear the nutrition information under subparagraph (1), but shall be required to list immediately above the ingredient listing the amount of nutrients required by the Secretary to be listed pursuant to clause (C), (D) or (E) of subparagraph (1) or clause (A) of subparagraph that are present in significant amounts in the supplement.’’.
(d) VITAMINS AND MINERALS.—Section 411(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350(b)(2)) is amended by striking ‘‘vitamins and minerals’’ and inserting ‘‘dietary supplement ingredients described in section 201(ff)’’; by striking ‘‘(A)’’ and inserting ;and by striking subparagraph (B). SEC. 11. COMMISSION ON DIETARY SUPPLEMENT LABELS. (a) ESTABLISHMENT.—There shall be established as an independent agency within the executive branch a commission to be known as the Commission on Dietary Supplement Labels (hereafter in this section referred to as the ‘‘Commission’’). (b) MEMBERSHIP.— (1) COMPOSITION.—The Commission shall be composed of 7 members who shall be appointed by the President.
EXPERTISE REQUIREMENT.—The members of the Commission shall consist of individuals with expertise and experience in dietary supplements and in the manufacture, regulation, distribution, and use of such supplements. At least three of the members of the Commission shall be qualified by scientific training and experience to evaluate the benefits to health of the use of dietary supplements and one of such three members shall have experience in pharmacognosy, medical botany, traditional herbal medicine, or other related sciences. No member of the Commission shall be biased against dietary supplements. (c) FUNCTIONS OF THE COMMISSION.—The Commission shall conduct a study on, and provide recommendations for, the regulation of label claims for dietary supplements, including procedures for the evaluation of such claims. In making such recommendations, the Commission shall evaluate how best to provide truthful and nonmisleading information to consumers so that such consumers may make informed health care choices for themselves and their families. (d) REPORTS AND RECOMMENDATIONS. FINAL REPORT REQUIRED.—Not later than 24 months after the date of enactment of this Act, the Commission shall prepare and submit to the President and to the Congress a final report on the study required by this section. RECOMMENDATIONS.—The report described in paragraph (1) shall contain such recommendations, including recommendations for legislation, as the Commission deems appropriate. (e) ADMINISTRATIVE POWERS OF THE COMMISSION.— (1) HEARINGS.—The Commission may hold hearings, sit and act at such times and places, take such testimony, and receive such evidence as the Commission considers advisable to carry out the purposes of this section.
(2) INFORMATION FROM FEDERAL AGENCIES. The Commission may secure directly from any Federal department or agency such information as the Commission considers necessary to carry out the provisions of this section.
(3) AUTHORIZATION OF APPROPRIATIONS. There are authorized to be appropriated such sums as may necessary to carry out the provisions of this section. SEC. 12. GOOD MANUFACTURING PRACTICES. Section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342) (as amended by section 4) is further amended by adding at the end the following: ‘‘(g)(1) If it is a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations issued by the Secretary under subparagraph. The Secretary may by regulation prescribe good manufacturing practices for dietary supplements. Such regulations shall be modeled after current good manufacturing practice regulations for food and may not impose standards for which there is no current and generally available analytical methodology. No standard of current good manufacturing practice may be imposed unless such standard is included in a regulation promulgated after notice and opportunity for comment in accordance with the Administrative Procedure Act.’’. SEC. 13. OFFICE OF DIETARY SUPPLEMENTS. (a) IN GENERAL.—Title IV of the Public Health Service Act is amended by inserting after section 486 (42 U.S.C. 287c–3) the following: ‘‘Subpart 4—Office of Dietary Supplements ‘‘SEC. 486E. DIETARY SUPPLEMENTS. ‘‘(a) ESTABLISHMENT.—The Secretary shall establish an Office of Dietary Supplements within the National Institutes of Health. ‘‘(b) PURPOSE.—The purposes of the Office are to explore more fully the potential role of dietary supplements as a significant part of the efforts of the United States to improve health care; and to promote scientific study of the benefits of dietary supplements in maintaining health and preventing chronic disease and other health-related conditions. ‘‘(c) DUTIES.—The Director of the Office of Dietary Supplements shall conduct and coordinate scientific research within the National Institutes of Health relating to dietary supplements and the extent to which the use of dietary supplements can limit or reduce the risk of diseases such as heart disease, cancer, birth defects, osteoporosis, cataracts, or prostatism; ‘‘(2) collect and compile the results of scientific research relating to dietary supplements, including scientific data from foreign sources or the Office of Alternative Medical Practice; serve as the principal advisor to the Secretary and to the Assistant Secretary for Health, and to provide advice to the Director of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, and the Commissioner of Food and Drugs, on issues relating to dietary supplements including ‘‘(A) dietary intake regulations; ‘‘(B) the safety of dietary supplements; ‘‘(C) claims characterizing the relationship between dietary supplements; and ‘(ii)(I) prevention of disease or other health-related conditions; and ‘‘(II) maintenance of health; and ‘‘(D) scientific issues arising in connection with the labeling and composition of dietary supplements; compile a database of scientific research on dietary supplements and individual nutrients; and coordinate funding relating to dietary supplements for the National Institutes of Health.
1 ‘‘(d) DEFINITION.—As used in this section, the term
2 ‘dietary supplement’ has the meaning given the term in
3 section 201(ff) of the Federal Food, Drug, and Cosmetic
4 Act (21 U.S.C. 321(ff)).
5 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There
6 are authorized to be appropriated to carry out this section
7 $5,000,000 for fiscal year 1994 and such sums as may
8 be necessary for each subsequent fiscal year.’’.
9 (b) CONFORMING AMENDMENT.—Section 401(b)(2)
10 of the Public Health Service Act (42 U.S.C. 281(b)(2))
11 is amended by adding at the end the following:
12 ‘‘(E) The Office of Dietary Supplements.’’.
Passed the Senate August 13 (legislative day, August
11), 1994.
Attest: Secretary.
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Plaster—Healing with Clay and Essential Oils
Clay and Essential oils have been use throughout time to cause healing and regenerating and detoxing poisons out of the body either topically or internally—here is a recipe that may assist a lot with skin issues from psoriasis –eczema—acne—topical pinworms—lice—scabies—metal or non metal particulates imbedded in the skin —regeneration of skin cells—antioxidant properties antifungal and antibacterial—re invigorating the skin—ØØØYou will need clay—gelatin—water—aloe vera—essential oils in this case we will use these 4 ( juniper—thyme—lemon or lemon grass-and pine )-wormwood tincture ——All the oils add 3 drops—add 1 dropper full of wormwood—add ¼ cup of aloe vera juice or inner fillet—1 tablespoon of gelatin—and ¼ cup to ½ and mix all in a bowl til it becomes have way soppy and firm then apply lightly and in small coats in problem areas—this will dry and draw out poisons as well as let in the content of the oils and the wormwood—it will sting—tingle—and Chill at the same time—this will definitely draw out heat and can be used as well with someone feverish––Caution it does chill the system so to make this more effective consume some fat –butter—coconut oil—avocado—almond—etc reason being you will actually taste the oils in the system via through the skin and this will assist the effect—-if you need to drink something warm do so—you will seal this seal a wound in some cases within the first topical application—you may see it disinfect the skin—you may see parasites and other particulates actually comeout in a bath as a result of this—you can see the skin heal and restore–Now these are just some examples of the essential oils you can use—there is a book out by Jean Valnet called the The Practice of Aromatherapy—it is one of the best books I have seen with the practical uses of essential oils and this one I would definitely encourage—get it used or new
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The Myths of Vegetarianism—RECIPE for a Nutritional FAT
Canada’s Food Safety System Fails International Comparisons, Expert Argues
The following was issued by the United States Congress in 1936 Excerpts from Senate Document 264
Healing SALT Recipe
Footnotes
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The Myths of Vegetarianism
by Stephen Byrnes, ND, PhD, RNCP
“An unflinching determination to take the whole evidence into account is the only method of preservation against the fluctuating extremes of fashionable opinion” — Alfred North Whitehead Bill and Tanya sat before me in my office in a sombre mood: they had just lost their first baby in the second month of pregnancy. Tanya was particularly upset: “Why did this happen to me? Why did I miscarry my baby?” The young couple had come to see me mostly because of Tanya’s recurrent respiratory infections, but also wanted some advice as to how they could avoid the heartache of another failed pregnancy. —Upon questioning Tanya about her diet, I quickly saw the cause of her infections, as well as her miscarriage: she had virtually no fat in her diet and was also mostly a vegetarian. Because of the plentiful media rhetoric about the supposed dangers of animal product consumption, as opposed to the supposed health benefits of the vegetarian lifestyle, Tanya had deliberately removed such things as cream, butter, meats and fish from her diet. Although she liked liver, she avoided it due to worries over “toxins.” Tanya and Bill left with a bottle of vitamin A, other supplements and a dietary prescription that included plentiful amounts of animal fats and meat. Upon leaving my office, Tanya looked at me and said ruefully: “I just don’t know what to believe sometimes. Everywhere I look there is all this low-fat, vegetarian stuff recommended. I followed it, and look what happened.” I assured her that if she and her husband changed their diets and allowed sufficient time for her weakened uterus to heal, they would be happy parents in due time. As they left, I shook my head in disbelief and concern: I knew they were not the only ones. Along with the saturated fat and cholesterol scares of the past several decades has come the notion that vegetarianism is a healthier dietary option for people. It seems as if every health expert and government health agency is urging people to eat fewer animal products and consume more vegetables, grains, fruits and legumes. Along with these exhortations have come assertions and studies supposedly proving that vegetarianism is healthier for people and that meat consumption causes sickness and death. Several medical authorities, however, have questioned these data, but their objections have been largely ignored. As we shall see, many of the vegetarian claims cannot be substantiated and some are simply false and dangerous. There are benefits to vegetarian diets for certain health conditions, and some people function better on less fat and protein, but, as a practitioner who has dealt with several former vegans (total vegetarians), I know full well the dangerous effects of a diet devoid of healthful animal products.It is my hope that all readers will more carefully evaluate their position on vegetarianism after reading this article. It is important to note that there are different types of vegetarianism, including lacto-vegetarian diets (dairy products included) and lacto-ovo-vegetarian diets (dairy products and eggs included). The nutritional caveats that follow are primarily directed at veganism, or a diet totally lacking in animal products.
MYTH #1:
Meat consumption contributes to famine and depletes the Earth’s natural resources.
Some have argued that cows and sheep require pasturage that could be better used to raise grains to feed starving millions in Third World countries. Additionally, claims are made that raising livestock requires more water than raising plant foods. Both arguments are illogical and simplistic. The pasturage argument ignores the fact that a large portion of our Earth’s dry land is unsuited to cultivation. The open range and desert and mountainous areas yield their fruits to grazing animals (1). Unfortunately, the bulk of commercial livestock are not range fed, but stall fed. They do not ingest grasses and shrubs (like they should), but are fed an unnatural array of grains and soybeans. It is true that these foods could be fed to humans. The argument here, then, is not that eating meat depletes the Earth’s resources, but that commercial farming methods do. Such methods also subject livestock to deplorable living conditions where infections, antibiotics, steroids and synthetic hormones are common. These all lead to an unhealthy animal and, by extension, an unhealthy food product. Organically raised livestock, then, is a healthier and more humane choice (see myth #15 for more on this topic). —As for the claims that raising livestock requires more water than raising plant foods, water that livestock drink would be drunk by them anyway, even if they were not being raised for food. Additionally, the urine of grazing animals, which mostly comprises water, is rich in nitrogen which helps replenish the soil. Much of the water used in commercial livestock farming, however, is used up in growing the various grains and soybeans fed to the animals. If a concerted effort were made to return to the ecologically sound “mixed farm,” (described below), then such huge expenditures of water would be unnecessary. A far more serious threat to humanity, and the Earth, is the monoculture of grains and legumes, advocated by some vegetarian groups, which depletes the soil and requires the heavy use of artificial fertilisers and dangerous pesticides; pesticides that must first be tested on animals for safety (2). The solution? Astute writers on this dilemma have pointed out: The educated consumer and the enlightened farmer together can bring about a return of the mixed farm, where cultivation of fruits, vegetables and grains is combined with the raising of livestock and fowl in a manner that is efficient, economical and environmentally friendly. For example, chickens running free in garden areas eat insect pests, while providing high-quality eggs; sheep grazing in orchards obviate the need for herbicides; and cows grazing in woodlands and other marginal areas provide rich, pure milk, making these lands economically viable for the farmer. It is not animal cultivation that leads to hunger and famine, but unwise agricultural practices and monopolistic distribution systems. (3) The “mixed farm” is also healthier for the soil, which will yield more crops if managed according to traditional guidelines. British organic farmer and dairyman Mark Purdey has accurately pointed out that a crop field on a mixed farm will yield up to five harvests a year, while a “mono-cropped” one will only yield one or two (4). Which farm is producing more food for the world’s peoples? Purdey well sums up the ecological horrors of “battery farming” by saying: Our agricultural establishments could do very well to outlaw the business- besotted farmers running intensive livestock units, battery systems and beef-burger bureaucracies; with all their wastages, deplorable cruelty, anti-ozone slurry systems; drug/chemical induced immunotoxicity resulting in B.S.E. [see myth # 13] amd salmoella, rain forest eradication, etc. Our future direction must strike the happy, healthy medium of mixed farms, resurrecting the old traditional extensive system as a basic framework, then bolstering up productivity to present day demands by incorporating a more updated application of biological science into farming systems. (5)
MYTH #2: *******= Look at the footnote!!!
Vitamin B12 can be obtained from plant sources.
Of all the myths, this is perhaps the most dangerous. Vegans who do not supplement their diet with vitamin B12 will eventually get anaemia (a fatal condition) as well as severe nervous and digestive system damage (6). Claims are made that B12 is present in certain algae, tempeh *****(a fermented soy product) and brewer’s yeast. All of them are false. Like the niacin in corn, the B12 analogues present in algae and tempeh are not bioavailable. We know this because studies done on people’s blood levels of B12 remained the same after they ate spirulina and tempeh; there was no change, clearly indicating no absorption by the body (7). Further, the ingestion of too much soy increases the body’s need for B12 (8). Brewer’s yeast does not contain B12 naturally; it is always fortified from an outside source. Some vegetarian authorities claim that B12 is produced by certain fermenting bacteria in the intestines. This may be true, but it is in a form unusable by the body. B12 requires intrinsic factor from the stomach for proper absorption in the ileum. Since the bacterial product does not have intrinsic factor bound to it, it cannot be absorbed (9). It is true that vegans living in certain parts of India do not suffer from vitamin B12 deficiency. This has led some to conclude that plant foods do provide this vitamin. This conclusion, however, is erroneous as many small insects, their eggs, larvae and/or residue, are left on the plant foods these people consume, due to non-use of pesticides and inefficient cleaning methods. This is how these people obtain their vitamin B12. This contention is borne out by the fact that when Indian Hindus migrated to England, they came down with pernicious anaemia within a few years. In England, the food supply is cleaner, and insect residues are completely removed from plant foods (10). The only reliable and absorbable sources of vitamin B12 are animal products, especially organ meats and eggs (11). Though present in lesser amounts, milk products do contain B12. Vegans, therefore, should consider adding dairy products into their diets. If dairy cannot be tolerated, eggs, preferably from free-run hens, are a virtual necessity. —That vitamin B12 can only be obtained from animal products is one of the strongest arguments against veganism being a “normal” way of human eating. Today, vegans can avoid anaemia by taking supplemental vitamins or fortified foods. If those same people had lived just a few decades ago, when these products were unavailable, they would have died. In my own practice, I recently saved two vegans from death from anaemia by convincing them to eat generous amounts of dairy products. Both of these sickly gentlemen thought their B12 needs were being met by tempeh and spirulina. They weren’t.
MYTH #3:
The body can convert omega-6 fatty acids into omega-3 fatty acids as it needs.
This falsehood is akin to myth number two. Omega 3 and 6 fatty acids are polyunsaturated fats of which two, linolenic (an omega-3) and linoleic (an omega 6), are essential to human life and must be obtained from food as the body cannot synthesise them. Although very small amounts of omega 3 linolenic acid are found in whole grains and dark green leafy vegetables, it is principally found in animal foods (especially fish and eggs), as well as flax seed oil. Omega 6 linoleic acid is mostly found in vegetables, but small amounts are present in certain animal fats. To assuage vegans who fear they may not get enough omega 3 linolenic acid, some vegetarian sources assert that the body can simply convert excess omega 6 linoleic acid into omega 3 linolenic acid, and other omega 3 fatty acids such as EPA and DHA, two fatty acids intimately involved in the health of the brain and immune system. Renowned lipid biochemist Dr Mary Enig, of the University of Maryland, and other authorities have shown that the body cannot change the omega number of fatty acids. The body can change the fatty acid’s degree of saturation and also its molecular length, but not its omega number (12). In other words, omega 6 fatty acids can only be converted into other omega 6 fatty acids; omega 3s only into other omega 3s. Again, I have seen the results of this misinformation in my practice. I’ve had several patients of Northern European descent with severe mental and immune problems caused by a lack of EPA and DHA, two omega-3 fatty acids not found in plant foods (DHA is found in small amounts in some algae). People native to warmer climates in the world can manufacture these fatty acids from other omega-3s, but those of Northern European or Innuit descent cannot. Since their ancestors ate so much EPA- and DHA-rich fish, their bodies eventually lost the ability to manufacture these fatty acids (13). For these people, vegetarianism is impossible; they must consume either eggs or fish in order to survive. There is also a very real danger from consuming too many omega-6 fatty acids, principally found in vegetables. The body requires both omega-6 and omega-3 fatty acids. However, when the body’s cells are overloaded with omega-6s, their ability to utilise the omega-3 is inhibited (14).
Chronically low levels of omega-3 fatty acids are associated with higher cancer rates and immune dysfunction. Excessive levels of omega-6 fatty acids are also strongly correlated with a high incidence of cardiovascular disease (as is excessive consumption of refined sugar and trans-fatty acids) [15].
MYTH #4: The body’s needs for vitamin A can be entirely obtained from plant foods. —-Vitamin A is principally found in animal products. Plants do contain beta-carotene, a substance that the body can convert into vitamin A. The impression given by some vegetarian sources is that beta-carotene is just as good as vitamin A. This is not true. Firstly, the conversion from carotene to vitamin A can only take place in the presence of bile salts. This means that fat must be eaten with the carotenes to stimulate bile secretion. Additionally, infants and people with hypothyroidism, gall bladder problems or diabetes either cannot make the conversion or do so very poorly. Lastly, the body’s conversion from carotene to vitamin A is not very efficient: it takes 46 units of carotene to make one unit of vitamin A. What this means is that the sweet potato (containing about 25,000 units of beta-carotene) you just ate will only convert into about 4,000 units of vitamin A (assuming you ate it with fat and do not have a thyroid or gall bladder problem) [16]. Relying on plant sources for vitamin A, then, is not a very wise idea. This is why good-old-fashioned butter is a virtual must in any diet. Butter from pasture-fed cows is rich in vitamin A and will provide the intestines with the fatty material needed to convert vegetable carotenes into active vitamin A. Vitamin A is all-important in our diets, for it enables the body to use proteins and minerals (17).
MYTH #5: Meat-eaters have higher rates of heart and kidney disease, cancer, obesity and osteoporosis than vegetarians. —Such stupendous claims are hard to reconcile with historical and anthropological facts. All of the diseases mentioned are primarily 20th century occurrences, yet people have been eating meat and animal fat for thousands of years. Further, there are several native peoples around the world (the Innu, Masai, Swiss, Greeks, etc.) whose traditional diets are very rich in animal products, but do not suffer from the above-mentioned maladies (18). This shows that other factors besides animal foods are at work in these diseases. Several studies have supposedly shown that meat consumption is the cause of heart disease, cancer and bone loss, but such studies, honestly evaluated, show no such thing (19). For example, the studies that supposedly proved that meat consumption among the Innuit caused high rates of osteoporosis, failed to note other dietary factors that contributed to bone loss (and to the other chronic diseases listed in myth #5). Things such as refined sugar consumption, alcoholism and a junk food consumption equalled more bone loss were not done with real meat but with fractionated protein powders (20). Certainly, when protein is consumed in such an unnatural fashion, separated from the fat-soluble nutrients required for its absorption and assimilation, it will lead to problems. Because of this, the current use of fat-free protein powders as “food supplements”, and low-fat or non-fat dairy products should be avoided. Trimming off visible fat from meats and removing duck and chicken skin before eating should also be discouraged. Despite claims that studies have shown that meat consumption increased the risk for heart disease (21), their authors actually found the opposite. For example, in a 1984 analysis of a 1978 study of Seventh Day Adventists (who are largely vegetarian), H. A. Kahn concluded, “Although our results add some substantial facts to the diet-disease question, we recognize how remote they are from establishing, for example, that men who frequently eat meat or women who rarely eat salad are thereby shortening their lives” (21). A similar conclusion was reached by D.A. Snowden (21). Despite these startling admissions, the studies nevertheless concluded the exact opposite and urged people to reduce animal foods from their diets. Further, both of these studies threw out certain dietary data that clearly showed no connection between eggs, cheese, whole milk, and fat attached to meat (all high fat and cholesterol foods) and heart disease. Statistician Dr. Russel Smith concluded, “In effect the Kahn [and Snowden] study is yet another example of negative results which are messaged and misinterpreted to support the politically correct assertions that vegetarians live longer lives.” When all of the data are taken into account, the actual differences of heart disease between vegetarians and non-vegetarians in these studies was less than 1%: hardly a significant amount (22). It should be noted here that Seventh Day Adventists are often studied in population analyses to prove that a vegetarian diet is healthier and is associated with a lower risk for heart disease and cancer (but see the last paragraph in this section). While it is true that most members of this Christian denomination do not eat meat, they also do not smoke, drink alcohol, or drink coffee or tea, all of which may be factors in promoting cancer and heart disease (23). The Mormons are a religious group often overlooked in vegetarian studies. Although their Church urges moderation, Mormons do not abstain from meat. Mormonism’s founder, Joseph Smith, declared a diet devoid of animal products as “not of God.” As with the Adventists, Mormons avoid tobacco, alcohol, and caffeine. Despite being meat eaters, a study of Utah Mormons showed they had a 22% lower rate for cancer in general and a 34% lower mortality for colon cancer than the US average (24). A study of Puerto Ricans, who eat large amounts of fatty pork, nevertheless revealed very low rates of colon and breast cancer (25). Similar results can be adduced to demonstrate that meat consumption by itself does not correlate with cancer, heart disease, osteoporosis, kidney disease, or obesity (26). Obviously, other factors are at work. It is usually claimed that vegetarians have lower cancer rates than meat-eaters, but a 1994 study of California Seventh Day Adventists (who are largely vegetarian) showed that, while they did have lower rates of some cancers (e.g., breast), they had significantly higher rates of several others (brain, skin, uterine, cervical and ovarian)! (27)