Reply To: Scripts 2010

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The Benefits of Saturated Fats

The much-maligned saturated fats­which Americans are trying to avoid­are not the cause of our modern diseases. In fact, they play many important roles in the body chemistry:

  • Saturated fatty acids constitute at least 50% of the cell membranes. They are what gives our cells necessary stiffness and integrity.
  • They play a vital role in the health of our bones. For calcium to be effectively incorporated into the skeletal structure, at least 50% of the dietary fats should be saturated. (38)
  • They lower Lp(a), a substance in the blood that indicates proneness to heart disease. (39) They protect the liver from alcohol and other toxins, such as Tylenol. (40)
  • They enhance the immune system. (41)
  • They are needed for the proper utilization of essential fatty acids.
  • Elongated omega-3 fatty acids are better retained in the tissues when the diet is rich in saturated fats. (42)
  • Saturated 18-carbon stearic acid and 16-carbon palmitic acid are the preferred foods for the heart, which is why the fat around the heart muscle is highly saturated. (43) The heart draws on this reserve of fat in times of stress.
  • Short- and medium-chain saturated fatty acids have important antimicrobial properties. They protect us against harmful microorganisms in the digestive tract.

The scientific evidence, honestly evaluated, does not support the assertion that “artery-clogging” saturated fats cause heart disease. (44) Actually, evaluation of the fat in artery clogs reveals that only about 26% is saturated. The rest is unsaturated, of which more than half is polyunsaturated. (45)

 Health benefits of Butter

“Research undertaken at The University of Auckland suggests that dairy foods may reduce the occurrence and symptoms of asthma and other allergic diseases. University studies have shown that mice with allergic conditions show a reduced reaction to allergens when fed a diet enriched with fatty acids derived from milk. These fatty acids have anti-inflammatory properties and occur naturally in cow’s milk but are not present in margarine.  The reduction of butter consumption and the subsequent increase in margarine use in the Western World occurred at the same time as the increased incidence of asthma, eczema and other allergic diseases. In New Zealand , margarine was not available in shops until 1971. “A number of studies have shown that butter consumption is associated with a reduction in allergic disease,” says Dr Peter Black from the University’s Faculty of Medical and Health Sciences. “We believe that 10g per day of butter enriched with these natural fatty acids should help control symptoms of asthma.We are currently conducting a study to look at this.”

 Stearic Acid found innocent

Despite the huge ramifications this discovery might have to nutritionists who continually warn us against consuming saturated fats, this news has managed to miss the worldwide media.  The reason is quite obvious, nobody knows what stearic acid is! Contrary to the notion we get from nutritionists, saturated fats are a range of different molecules, of which one of the most common is stearic acid. The requital of stearic acid occurred from studies using Shea butter, a tropical nut oil that contains most of its saturated content as stearic acid. A study found that  The effect of fats high in individual, prevalent saturated dietary fatty acids on lipoproteins and hemostatic variables in young healthy subjects was  evaluated in a randomized metabolic feeding study. The results indicate that  intake of shea butter high in stearic acid favorably affects blood lipids and  factor VII coagulant activity in young men. –  The American Journal of Clinical Nutrition. Bethesda: Feb 1994. Vol. 59, Iss.  2;  pg. 371 This is on top of previous studies that have concluded that stearic acid does not raise cholesterol levels, and even suggestions that stearic acid should not need to be counted as a ‘saturated fat’ for labelling purposes. The only reason why saturated fats are considered bad is that they are meant to raise cholesterol levels, which in turn are correlated to a higher risk in Coronary Heart Disease. Although, there have been many other attempts to link saturated fat consumption to diabetes and cancer, essentially it is the cholesterol/heart disease links that has formed the basis of saturated fat’s bad image. So if I play by the rules and assume everything about saturated fats and cholesterol are essentially true, but exclude stearic acid from the equation, I come to quite a startling discovery: Beef tallow, the fat that has been demonised as the heart-disease cause, is in fact mostly made of fats that help the heart.

The composition if beef fat is as follows:

40% mono unsaturated (oleic and palmitoleic)
22% stearic acid
3% myristic (saturated)
25% palmitic (saturated)
4% polyunsaturated
5% rumanitic trans-fats

As the nutritionists tell us mono unsaturated fats, and polyunsaturated fats help lower cholesterol, we have 66% of beef tallow composed of fats that have favorable effects for the heart!  This leaves the remaining 34% to be responsible for cholesterol raising. While myristic and palmitic acid have been suggested to raise cholesterol, studies so far have produced contradictory results with regard to these components. Even the Heart Foundation have noted that evidence that palm oil (which is high in palmitic acid) raises cholesterol is inconclusive.

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ORAC = OYGEN RADICAL ABSORBANCE CAPACITY

ORAC is a standardised test adopted by the U.S. Department of Agriculture to measure the Total Antioxidant Potency of foods and nutritional supplements. This standardised test was developed by Dr. Guohua Cao, a physician and chemist at the National Institute on Ageing in Baltimore, Maryland. It provides a very precise way of establishing the Free Radical destroying or neutralising power of a particular food, supplement or compound. The ORAC unit has become one accepted industry standard for measuring antioxidants. The antioxidant test combines a measure of both the time an antioxidant took to react and also its antioxidant capacity in a given sample. The ORAC unit then combines them into one measure, making it the first in vitro assay method for measuring total antioxidant potential. It is easily expressed as per 100 grams of sample. The recommended daily antioxidant dose should add up to 5000 ORAC units each day. Looking at Table 1 below, it is clear that one has to be quite selective in the foods chosen so as to easily achieve this. If you at bananas alone, you would need to eat 2.4 kilograms of bananas to get your daily ORAC dose! You would however, only need to eat 87 grams of prunes. In a study of 36 older people, boosting fruit and vegetable intake to reach 3,200 ORAC units a day increased the antioxidant potential of the blood by 10 to 15%; enough to have an impact on disease prevention (Holly, 2003). The ORAC is not the ultimate unit, however, as different antioxidants have different effects. Lycopene protects against prostate cancer and is found in tomatoes, strawberries and pink grapefruit. Lycopene is the predominate carotenoid in plasma, and various tissues including the prostate gland (Lucich, 2001). Research (ref.) has shown spinach to be more effective than strawberries (which score higher in the ORAC assay) when measured as blood antioxidant scores. The researchers conjecture that it may be due to specific compounds or a specific combination of them in the greens. Spinach caused the biggest change in a test between spinach, strawberries, and red wine (all high-ORAC foods) and 1,250 milligrams of vitamin C.

 Table 1. ORAC (Antioxidant) Units of Selected Fruits and Vegetables
   
 Food Source ORAC units/100 grams (3.5 oz)
   
 Health Supplements ORAC Units Grams to supply RDA
 Clove oil (Syzigium aromaticum) 10,786,875 0.046
 Thyme oil (Thymus vulgaris) 159,590 3.1
 Oregano oil (Origanum compactum) 152,007 3.3
 Aspalathox (rooibos tea extract, 20%) 375,000 1.3
 Vit C 189,000 2.6
 Vit E 135,000 3.7
 ORAC + 74,600 6.7
 Dark Chocolate 13,120 38.1
 Milk Chocolate 6,740 74.2
 Rooibos tea (200ml) 750 133
Blackstrap molasses (TE/100 g dry solids)8860
 Fruits 
 Chinese Wolfberries 25300 20
 Prunes 5,770 87
 Pomegranates 3,307 151
 Raisins 2,830 177
 Bilberry 4,460 112
 Blueberries 2,400 208
 Blackberries 2,036 246
 Strawberries 1,540 325
 Raspberries 1,220 410
 Black Raspberries 7,700 65
 Red Raspberries 2,400 208
 Plums 949 527
 Oranges 750 667
 Cherries 670 746
 Red grapes 739 677
 Pink grapefruit 495 1010
 White grapefruit 460 1087
 Apples 218 2294
 Banana 210 2381
 Pears 134 3731
 Watermelon 100 5000
 Vegetables  
 Garlic 1939 
 Spinach 1,770 282
 Steamed spinach 909 550
 Yellow squash 1,150 435
 Brussels sprouts 980 510
 Alfalfa sprouts 930 538
 Broccoli 880 568
 Broccoli flowers 890 562
 Beets 840 595
 Avocado 782 639
 Red bell pepper 710 704
 Baked beans 503 994
 Onions 450 1111
 Corn 400 1250
 Peas, Frozen 375 1333
 Eggplant 390 1282
 Potato 300 1667
 Sweet Potato 295 1695
 Cabbage 295 1695
 Cauliflower 385 1299
 Carrot 210 2381
 Tomato 195 2564
 Cucumber 60 8333

 

Other essential oils are also strong antioxidants with a high ORAC value:

Sandalwood (Santalum Album) 1,655
Roman Chamomile (Chamaemelum nobile)2,446
Juniper (Juniperus osteosperma) 2,517
Rosemary (Rosmarinus officinalis) 3,309
Lavender (Lavendula angustifolia) 3,669
Spearmint (Mentha spicata) 5,398
Helichrysum (Helichrysum italicum)17,420 
Lemongrass (Cymbopogen flexuosus) 17,765
Orange (Citrus aurantium)18,898
Eucalyptus (Eucalyptus globulus)24,157 
Rose of Sharon (Cistus ladanifer) 38,648 
Cinnamon Bark (Cinnamamum verum) 103,448
Mountain Savory (Satureja montana) 113,071
Oregano (Origanum compactum)153,007 
Thyme (Thymus vulgaris)159,590 
Clove (Syzigium aromaticum) 10,786,875 

 

Essential oils really potent antioxidants. A drop of Clove oil contains 400 times more antioxidant per unit volume than wolfberries, the most powerful of all know fruits.

Other antioxidant measurement units

Three assays methods for the determination of total antioxidant capacity are found in published literature: the oxygen radical absorbance capacity (ORAC) assay, the Randox Trolox-equivalent antioxidant capacity (Randox-TEAC) assay, and the ferric reducing ability (FRAP) assay (Cao & Pior, 2002). The FRAP assay is simple and inexpensive but does not measure the SH-group-containing antioxidants. The ORAC assay has high specificity and responds to numerous antioxidants. The ORAC method is chemically more relevant to chain-breaking antioxidants activity, while the FRAP has some drawbacks such as interference, reaction kinetics, and quantitation methods. On the basis of the ORAC results, green pepper, spinach, purple onion, broccoli, beet, and cauliflower are the leading sources of antioxidant activities against the peroxyl radicals (Ou et al, 2002).ORAC is a standardised test adopted by the U.S. Department of Agriculture to measure the Total Antioxidant Potency of foods and nutritional supplements. This standardised test was developed by Dr. Guohua Cao, a physician and chemist at the National Institute on Ageing in Baltimore, Maryland. It provides a very precise way of establishing the Free Radical destroying or neutralising power of a particular food, supplement or compound. The ORAC unit has become one accepted industry standard for measuring antioxidants. The antioxidant test combines a measure of both the time an antioxidant took to react and also its antioxidant capacity in a given sample. The ORAC unit then combines them into one measure, making it the first in vitro assay method for measuring total antioxidant potential. It is easily expressed as per 100 grams of sample. The recommended daily antioxidant dose should add up to 5000 ORAC units each day. Looking at Table 1 below, it is clear that one has to be quite selective in the foods chosen so as to easily achieve this. If you at bananas alone, you would need to eat 2.4 kilograms of bananas to get your daily ORAC dose! You would however, only need to eat 87 grams of prunes. In a study of 36 older people, boosting fruit and vegetable intake to reach 3,200 ORAC units a day increased the antioxidant potential of the blood by 10 to 15%; enough to have an impact on disease prevention  For anybody who could handle the smell, a drop of clove oil would give the required ORAC dose. There are however doubts as to whether ingesting clove oil (Syzigium aromaticum) is safe~~~– It is safe—always use a carrier oil —honey—syrup—never ever take this straight~~~Wolfberries (Lyceum barbarum) is a fruit from the Ningxia Province, China, where some people have lived to over 120 years. The ORAC is not the ultimate unit, however, as different antioxidants have different effects. Lycopene protects against prostate cancer and is found in tomatoes, strawberries and pink grapefruit. Lycopene is the predominate carotenoid in plasma, and various tissues including the prostate gland (Lucich, 2001). Research (ref.) has shown spinach to be more effective than strawberries (which score higher in the ORAC assay) when measured as blood antioxidant scores. The researchers conjecture that it may be due to specific compounds or a specific combination of them in the greens. Spinach caused the biggest change in a test between spinach, strawberries, and red wine (all high-ORAC foods) and 1,250 milligrams of vitamin C.

Other antioxidant measurement units

Three assays metnods for the determination of total antioxidant capacity are found in published literature: the oxygen radical absorbance capacity (ORAC) assay, the Randox Trolox-equivalent antioxidant capacity (Randox-TEAC) assay, and the ferric reducing ability (FRAP) assay (Cao & Pior, 2002). The FRAP assay is simple and inexpensive but does not measure the SH-group-containing antioxidants. The ORAC assay has high specificity and responds to numerous antioxidants. The ORAC method is chemically more relevant to chain-breaking antioxidants activity, while the FRAP has some drawbacks such as interference, reaction kinetics, and quantitation methods. On the basis of the ORAC results, green pepper, spinach, purple onion, broccoli, beet, and cauliflower are the leading sources of antioxidant activities against the peroxyl radicals (Ou et al, 2002).

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Dietary Supplement  Health and Education Act of 1994

  1. 784–AN ACT

To amend the Federal Food, Drug, and Cosmetic Act to establish standards with respect to dietary supplements, and for other purposes 103D CONGRESS 2D SESSION S. 784

AN ACT

 To amend the Federal Food, Drug, and Cosmetic Act to establish standards with respect to dietary supplements, and for other purposes.

 1 Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,  SECTION 1. SHORT TITLE. 4 This Act may be cited as the ‘‘Dietary Supplement  Health and Education Act of 1994’’. 2

 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 foodmay 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