birdog1960 Posted December 19, 2013 Share Posted December 19, 2013 finally, someone http://annals.org/ar...ticleid=1789253 with the guts to say what we've known for years: http://annals.org/ar...ticleid=1789253. sorry, flintstones chewables. Link to comment Share on other sites More sharing options...
4merper4mer Posted December 19, 2013 Share Posted December 19, 2013 Annals.org? Really? Are you drunk? Because you are off by a bookmark or two. This is the Bills forum, not the butt sex forum. Link to comment Share on other sites More sharing options...
BillsFanM.D. Posted December 19, 2013 Share Posted December 19, 2013 For years, my personal 'mantra' has been unless you are eating a really bizarre diet, forget it. It's nice to see some legit observations here confirming the lack of necessity. Link to comment Share on other sites More sharing options...
birdog1960 Posted December 19, 2013 Author Share Posted December 19, 2013 just waiting for herbalife to sue. oh wait, they don't have a case. Link to comment Share on other sites More sharing options...
boyst Posted December 21, 2013 Share Posted December 21, 2013 (edited) For years, my personal 'mantra' has been unless you are eating a really bizarre diet, forget it. It's nice to see some legit observations here confirming the lack of necessity. What some people call silly or strange others just do not understand, simply. I would be curious to know what you think of some of the old school treatments some still use. finally, someone http://annals.org/ar...ticleid=1789253 with the guts to say what we've known for years: http://annals.org/ar...ticleid=1789253. sorry, flintstones chewables. just waiting for herbalife to sue. oh wait, they don't have a case. There is a difference between taking some things and other things. I take a large variety of supplements based on what I am doing. When I am working the farm a lot and really exerting myself doing fencing then I will take bromelain and l-lysiene, as well as put arnica on bruises, and lysiene topically. this helps with muscles and cuts sustained during work. i also generally take my multivitamin because of my extremely exhausting lifestyle. At other times I will take BCAA's since I consume a rather odd diet full of fruit, vegetables and lower natural protein then most. Especially considering I am getting back in to the workout regiment. There are a variety of tonics and tinctures I also take; hops, lavender, vodka, a variety of other things can have big results. supercissis has also helped me. Topical plantain is also good for me. again, i am not a pill junky, nor do i take anything that says it will help you. I take what does help me. I do a variety of unique things most people would not consider. If anyone would like I'll put up some recipes or info on home stuffs. But, next time you're at Lowes, look for the Coleus, grab about 5 leaves, chew and swallow them for an LSD type effect. Edited December 21, 2013 by jboyst62 Link to comment Share on other sites More sharing options...
keepthefaith Posted December 23, 2013 Share Posted December 23, 2013 finally, someone http://annals.org/ar...ticleid=1789253 with the guts to say what we've known for years: http://annals.org/ar...ticleid=1789253. sorry, flintstones chewables. The medical and Pharm industry have been speaking out against vitamin and mineral supplements for decades. It's good for business. Link to comment Share on other sites More sharing options...
birdog1960 Posted January 1, 2014 Author Share Posted January 1, 2014 (edited) The medical and Pharm industry have been speaking out against vitamin and mineral supplements for decades. It's good for business. the authors are academic internists and pharm D's. they're generally not stellar business folks and generally not uberwealthy, although there are rare exceptions. the guys making the big bucks here are the vitamin- supplement hucksters. internists and legitimate drug co's aren't getting rich on a problem that has no ready and profitable true alternative solution. moreover, very few, if any, of this group would knowingly defraud people.. wouldn't you expect the hucksters to do double blinded placebo studies proving the worth of their products if they knew they worked? why not market them as drugs and go through the vigorous scrutiny required to become fda approved? become big leaguers... i once called a vitamin manufacturer after isolating a hepatitis case and attributing it to his co's "muscle building supplement". asked what safety studies had been done and had other cases been discovered, he told me that a large study done at the "University of Canada" had proven it's safety.. when asked exactly where that imaginary institution was, he pleaded ignorance - the first and only honest exchange we had at a time where he should have been very concerned for his customer's health.. this was several years ago before many such even more serious and deadly cases came to light.. the papers cited in the annals are good science and had negative results for vitamins. almost all of the many proceeding studies have had negative or equivocal results. you all provide fine examples of the nonscience of wishful thinking. and placebo effect should not be underestimated. with psych drugs, it sometimes approaches 50% in the control arm of a study. follow the money for motive, as you implied, and it leads exclusively to the hucksters. what the investigators and editorialists in the annals sought and found, was the answer to the question. and it financially benefits them not at all. i'll wager that many of the investigators would have been happier if they found real benefit from some of the stuff. it would represent another weapon in the arsenal of wellness techniques. the fact that you here, and undoubtedly many others worldwide, choose to believe the hucksters and your own personal anecdotes above overwhelming, massive, rigorous and irrefutable evidence shouldn't be surprising. it's happened repeatedly throughout history as has the occurrence of truth- tellers being attacked. it's the basis for many continued examples of quackery such as homeopathic medicine and chelation therapy, to name just two. common or not, it's always a disappointing phenomenon to witness. Edited January 1, 2014 by birdog1960 Link to comment Share on other sites More sharing options...
....lybob Posted January 1, 2014 Share Posted January 1, 2014 Some vitamin products don't contain what is on the label, some vitamin products have what is on the label but the (usually tablet) product passes through unabsorbed, Some cheap vitamins especially from China may have adulterants that are harmful including heavy metals- I'd go with whole foods as much as possible but supplements like B12, K2, and vitamin D have be found beneficial, especially to vegans - I'd like at this time to heap scorn on the FDA who when prevented from deciding what supplements people could and couldn't take also took a hike on testing products to make sure that what was listed on the label was actually in the product and that no dangerous adulterants were contained by the product. Link to comment Share on other sites More sharing options...
DC Tom Posted January 1, 2014 Share Posted January 1, 2014 Some vitamin products don't contain what is on the label, some vitamin products have what is on the label but the (usually tablet) product passes through unabsorbed, Some cheap vitamins especially from China may have adulterants that are harmful including heavy metals- I'd go with whole foods as much as possible but supplements like B12, K2, and vitamin D have be found beneficial, especially to vegans - I'd like at this time to heap scorn on the FDA who when prevented from deciding what supplements people could and couldn't take also took a hike on testing products to make sure that what was listed on the label was actually in the product and that no dangerous adulterants were contained by the product. It's not the FDA's fault. Congress passed a law in the 90's taking "natural" remedies out of their purview (and the FDA refuses to regulate homeopathic "medicine," since it's not in the business of regulating sugar water). The FDA not only has no authority to test supplements, but is legally prohibited from doing so until after dangerous side effects are reported by the public. Link to comment Share on other sites More sharing options...
....lybob Posted January 2, 2014 Share Posted January 2, 2014 It's not the FDA's fault. Congress passed a law in the 90's taking "natural" remedies out of their purview (and the FDA refuses to regulate homeopathic "medicine," since it's not in the business of regulating sugar water). The FDA not only has no authority to test supplements, but is legally prohibited from doing so until after dangerous side effects are reported by the public. The FDA is prohibited from requiring that supplements to go through rigorous testing for safety and efficacy the way that drugs are tested but they are not prohibited from testing whether the ingredients listed on the label are in the product they are also not prohibited from testing the product for harmful adulterants - ie they are not allowed to take creatine off the market for lack of efficacy but they may test to see if your creatine is saw dust, or if your creatine is laced with heavy metals or rat poison or lucky you anabolic steroids. Link to comment Share on other sites More sharing options...
DC Tom Posted January 2, 2014 Share Posted January 2, 2014 The FDA is prohibited from requiring that supplements to go through rigorous testing for safety and efficacy the way that drugs are tested but they are not prohibited from testing whether the ingredients listed on the label are in the product they are also not prohibited from testing the product for harmful adulterants - ie they are not allowed to take creatine off the market for lack of efficacy but they may test to see if your creatine is saw dust, or if your creatine is laced with heavy metals or rat poison or lucky you anabolic steroids. Then you might want to let the FDA know they've been interpreting the DSHEA incorrectly for the past 20 years. Link to comment Share on other sites More sharing options...
....lybob Posted January 2, 2014 Share Posted January 2, 2014 Dietary Supplement Health and Education Act of 1994 An Act To amend the Federal Food, Drug, and Cosmetic Act to establish standards with respect to dietary supplements, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, §1. Short Title; Reference; Table Of Contents. (a) Short Title. This Act may be cited as the "Dietary Supplement Health and Education Act of 1994". (b) Reference. Whenever in this Act an amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act. © Table of Contents. The table of contents of this Act is as follows: Sec. 1. Short title; reference; table of contents. Sec. 2. Findings. Sec. 3. Definitions. Sec. 4. Safety of dietary supplements and burden of proof on FDA. Sec. 5. Dietary supplement claims. Sec. 6. Statements of nutritional support. Sec. 7. Dietary supplement ingredient labeling and nutrition information labeling. Sec. 8. New dietary ingredients. Sec. 9. Good manufacturing practices. Sec. 10. Conforming amendments. Sec. 11. Withdrawal of the regulations and notice. Sec. 12. Commission on dietary supplement labels. Sec. 13. Office of dietary supplements. §2. 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 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; (6)(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; (7) there is a growing need for emphasis on the dissemination of information linking nutrition and long-term good health; (8) 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; (9) 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; (10) 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; (11) 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; (12)(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 © 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; (13) 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 unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers; (14) dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare; and (15)(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. §3. Definitions. (a) Definition of Certain Foods as Dietary Supplements. Section 201 (21 U.S.C. 321) is amended by adding at the end the following: "(ff) The term "dietary supplement" -"(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:"(A) a vitamin; "(B) a mineral; "© an herb or other botanical; "(D) an amino acid; "(E) a 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), ©, (D), or (E); [*]"(2) means a product that - "(A)(i) is intended for ingestion in a form described in section 411©(1)(B)(i); or "(ii) complies with section 411©(1)(B)(ii); "(B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and "© is labeled as a dietary supplement; and [*]"(3) does - "(A) include an article that is approved as a new drug under section 505, certified as an antibiotic under section 507, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262) and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food 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) not include -"(i) an article that is approved as a new drug under section 505, certified as an antibiotic under section 507, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262), or "(ii) an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary's discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this Act. Except for purposes of section 201(g), a dietary supplement shall be deemed to be a food within the meaning of this Act. (b) Exclusion from Definition of Food Additive. Section 201(s) (21 U.S.C. 321(s)) is amended -(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.". [*]© Form of Ingestion. Section 411©(1)(B) (21 U.S.C. 350©(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". §4. Safety of Dietary Supplements and Burden of Proof on FDA. Section 402 (21 U.S.C. 342) is amended by adding at the end the following: "(f)(1) If it is a dietary supplement or contains a dietary ingredient that -"(A) presents a significant or unreasonable risk of illness or injury under -"(i) conditions of use recommended or suggested in labeling, or "(ii) if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use; [*]"(B) is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury; [*]"© the Secretary declares to pose an imminent hazard to public health or safety, except that the authority to make such declaration shall not be delegated and the Secretary shall promptly after such a declaration initiate a proceeding in accordance with sections 554 and 556 of title 5, United States Code, to affirm or withdraw the declaration; or [*]"(D) 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 subparagraph, the United States shall bear the burden of proof on each element to show that a dietary supplement is adulterated. The court shall decide any issue under this paragraph on a de novo basis.[*](2) Before the Secretary may report to a United States attorney a violation of paragraph (1)(A) for a civil proceeding, the person against whom such proceeding would be initiated shall be given appropriate notice and the opportunity to present views, orally and in writing, at least 10 days before such notice, with regard to such proceeding. §5. Dietary Supplement Claims. Chapter IV (21 U.S.C. 341 et seq.) is amended by inserting after section 403A the following new section: DIETARY SUPPLEMENT LABELING EXEMPTIONS "Sec. 403B. (a) IN GENERAL.- A publication, including an article, a chapter in a book, or an official abstract of a peer-reviewed scientific publication that appears in an article and was prepared by the author or the editors of the publication, which is reprinted in its entirety, shall not be defined as labeling when used in connection with the sale of a dietary supplement to consumers when it -"(1) is not false or misleading; "(2) does not promote a particular manufacturer or 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; "(4) if displayed in an establishment, is physically separate from the dietary supplements; and "(5) does not have appended to it any information by sticker or any other method. [*] "(b) APPLICATION. - Subsection (a) 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. [*]"© BURDEN OF PROOF. - In any proceeding brought under subsection (a), the burden of proof shall be on the United States to establish that an article or other such matter is false or misleading.". §6. Statements of Nutritional Support. Section 403® (21 U.S.C. 343®) is amended by adding at the end the following: "(6) For purposes of paragraph ®(1)(B), a statement for a dietary supplement may be made if -"(A) 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, "(B) the manufacturer of the dietary supplement has substantiation that such statement is truthful and not misleading, and "© the statement contains, prominently displayed and in boldface type, the following: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.". A statement under this subparagraph may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases. If the manufacturer of a dietary supplement proposes to make a statement described in the first sentence of this subparagraph in the labeling of the dietary supplement, the manufacturer shall notify the Secretary no later than 30 days after the first marketing of the dietary supplement with such statement that such a statement is being made.". §7. Dietary Supplement Ingredient Labeling and Nutrition Information Labeling. (a) MISBRANDED SUPPLEMENTS. - Section 403 (21 U.S.C. 343) is amended by adding at the end the following: "(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; [*]"© the supplement contains an ingredient described in section 201(ff)(1)©, 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)(5)(F) (21 U.S.C. 343(q)(5)(F)) is amended to read as follows: "(F) A dietary supplement product (including a food to which section 411 applies) shall comply with the requirements of subparagraphs (1) and (2) in a manner which is appropriate for the product and which is specified in regulations of the Secretary which shall provide that -"(i) nutrition information shall first list those dietary ingredients that are present in the product in a significant amount and for which a recommendation for daily consumption has been established by the Secretary, except that a dietary ingredient shall not be required to be listed if it is not present in a significant amount, and shall list any other dietary ingredient present and identified as having no such recommendation; "(ii) the listing of dietary ingredients shall include the quantity of each such ingredient (or of a proprietary blend of such ingredients) per serving; "(iii) the listing of dietary ingredients may include the source of a dietary ingredient; and "(iv) the nutrition information shall immediately precede the ingredient information required under subclause (i), except that no ingredient identified pursuant to subclause (i) shall be required to be identified a second time.". [*] © Percentage Level Claims. Section 403®(2) (21 U.S.C. 343®(2)) is amended by adding after clause (E) the following: "(F) Subclause (i) clause (A) does not apply to a statement in the labeling of a dietary supplement that characterizes the percentage level of a dietary ingredient for which the Secretary has not established a reference daily intake, daily recommended value, or other recommendation for daily consumption.". [*] (d) Vitamins and Minerals. Section 411(b)(2) (21 U.S.C. 350(b)(2)) is amended - (1) by striking "vitamins or minerals" and inserting "dietary supplement ingredients described in section 201(ff)"; (2) by striking "(2)(A)" and inserting "(2)"; and (3) by striking subparagraph (B). [*] (e) Effective Date. Dietary supplements - (1) may be labeled after the date of the enactment of this Act in accordance with the amendments made by this section, and (2) shall be labeled after December 31, 1996, in accordance with such amendments. §8. New Dietary Ingredients. Chapter IV of the Federal Food, Drug, and Cosmetic Act is amended by adding at the end the following: "NEW DIETARY INGREDIENTS "SEC. 413. (a) IN GENERAL.- A dietary supplement which contains a new dietary ingredient shall be deemed adulterated under section 402(f) unless it meets one of the following requirements:"(1) The dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered. "(2) There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides the Secretary with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe. The Secretary shall keep confidential any information provided under paragraph (2) for 90 days following its receipt. After the expiration of such 90 days, the Secretary shall place such information on public display, except matters in the information which are trade secrets or otherwise confidential, commercial information. [*] "(b) PETITION. - Any person may file with the Secretary a petition proposing the issuance of an order prescribing the conditions under which a new dietary ingredient under its intended conditions of use will reasonably be expected to be safe. The Secretary shall make a decision on such petition within 180 days of the date the petition is filed with the Secretary. For purposes of chapter 7 of title 5, United States Code, the decision of the Secretary shall be considered final agency action. [*] "© DEFINITION. - For purposes of this section, the term "new dietary ingredient" means a dietary ingredient that was not marketed in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15, 1994.". §9. Good Manufacturing Practices. Section 402 (21 U.S.C. 342), as amended by section 4, is 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, including regulations requiring, when necessary, expiration date labeling, issued by the Secretary under subparagraph (2). "(2) 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 chapter 5 of title 5, United States Code.". §10. Conforming Amendments. (a) SECTION 201 - The last sentence of section 201(g)(1) (21 U.S.C. 321(g)(1)) is amended to read as follows: "A food or dietary supplement for which a claim, subject to sections 403®(1)(B) and 403®(3) or sections 403®(1)(B) and 403®(5)(D), is made in accordance with the requirements of section 403® 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 not misleading statement is made in accordance with section 403®(6) is not a drug under clause © solely because the label or the labeling contains such a statement.". (b) SECTION 301 - Section 301 (21 U.S.C. 331) is amended by adding at the end the following: (u) The introduction or delivery for introduction into interstate commerce of a dietary supplement that is unsafe under section 413.". © SECTION 403 - Section 403 (21 U.S.C. 343), as amended by section 7, is amended by adding after paragraph (s) the following: "A dietary supplement shall not be deemed misbranded solely because its label or labeling contains directions or conditions of use or warnings.". §11. Withdrawal of the Regulations and Notice. The advance notice of proposed rulemaking concerning dietary supplements published in the Federal Register of June 18, 1993 (58 FR 33690-33700) is null and void and of no force or effect insofar as it applies to dietary supplements. The Secretary of Health and Human Services shall publish a notice in the Federal Register to revoke the item declared to be null and void and of no force or effect under subsection (a). §12. 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. (2) 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. Members and staff of the Commission shall be without bias on the issue of dietary supplements. [*] © FUNCTIONS OF THE COMMISSION. - The Commission shall conduct a study on, and provide recommendations for, the regulation of label claims and statements for dietary supplements, including the use of literature in connection with the sale of dietary supplements and procedures for the evaluation of such claims. In making such recommendations, the Commission shall evaluate how best to provide truthful, scientifically valid, and not misleading information to consumers so that such consumers may make informed and appropriate health care choices for themselves and their families. [*] (d) 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 be necessary to carry out this section. [*] (e) REPORTS AND RECOMMENDATIONS. - (1) 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. (2) RECOMMENDATIONS. - The report described in paragraph (1) shall contain such recommendations, including recommendations for legislation, as the Commission deems appropriate. (3) ACTION ON RECOMMENDATIONS. - Within 90 days of the issuance of the report under paragraph (1), the Secretary of Health and Human Services shall publish in the Federal Register a notice of any recommendation of Commission for changes in regulations of the Secretary for the regulation of dietary supplements and shall include in such notice a notice of proposed rulemaking on such changes together with an opportunity to present views on such changes. Such rulemaking shall be completed not later than 2 years after the date of the issuance of such report. If such rulemaking is not completed on or before the expiration of such 2 years, regulations of the Secretary published in 59 FR 395-426 on January 4, 1994, shall not be in effect. §13. Office of Dietary Supplements. (a) IN GENERAL. - Title IV of the Public Health Service Act is amended by inserting after section 485B (42 U.S.C. 287c-3) the following: " SUBPART 4--OFFICE OF DIETARY SUPPLEMENTS SEC. 485C. 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 -"(1) 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 "(2) to promote scientific study of the benefits of dietary supplements in maintaining health and preventing chronic disease and other health-related conditions. [*] "© DUTIES. - The Director of the Office of Dietary Supplements shall - "(1) 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 Medicine; "(3) serve as the principal advisor to the Secretary and to the Assistant Secretary for Health and 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; "© claims characterizing the relationship between -"(i) 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; [*]"(4) compile a database of scientific research on dietary supplements and individual nutrients; and [*]"(5) coordinate funding relating to dietary supplements for the National Institutes of Health. [*] "(d) DEFINITION. - As used in this section, the term "dietary supplement" has the meaning given the term in section 201(ff) of the Federal Food, Drug, and Cosmetic Act. [*] "(e) AUTHORIZATION OF APPROPRIATIONS. - There are authorized to be appropriated to carry out this section $5,000,000 for fiscal year 1994 and such sums as may be necessary for each subsequent fiscal year.". [*](b) CONFORMING AMENDMENT. - Section 401(b)(2) of the Public Health Service Act (42 U.S.C. 281(b)(2)) is amended by adding at the end the following: "(E) The Office of Dietary Supplements.". Approved October 25, 1994. Link to comment Share on other sites More sharing options...
DC Tom Posted January 2, 2014 Share Posted January 2, 2014 Dietary Supplement Health and Education Act of 1994 An Act To amend the Federal Food, Drug, and Cosmetic Act to establish standards with respect to dietary supplements, and for other purposes. Notably absent being anything that grants the FDA permission to proactively test for fraudulent or adulterated ingredients. Notably PRESENT being text that puts that responsibility on industry, and requires the FDA to only react to consumer complaints. Link to comment Share on other sites More sharing options...
Security Posted January 2, 2014 Share Posted January 2, 2014 Man, I take a multi, a Probiatic, CQ10, Vitamin B-12 (told I deficient by my doctor and need this one), another Vitamin B-complex, Vitamin D, Fish Oil, and Glucosomine Sulfate. I think they help me. Link to comment Share on other sites More sharing options...
Nanker Posted January 2, 2014 Share Posted January 2, 2014 Man, I take a multi, a Probiatic, CQ10, Vitamin B-12 (told I deficient by my doctor and need this one), another Vitamin B-complex, Vitamin D, Fish Oil, and Glucosomine Sulfate. I think they help me. You're an idiot.™(DCTom) [/birdbrain] Link to comment Share on other sites More sharing options...
....lybob Posted January 3, 2014 Share Posted January 3, 2014 Notably absent being anything that grants the FDA permission to proactively test for fraudulent or adulterated ingredients. Notably PRESENT being text that puts that responsibility on industry, and requires the FDA to only react to consumer complaints. There is nothing in that Bill which prevents the FDA from testing "FDA is responsible for Protecting the public health by assuring that foods (except for meat from livestock, poultry and some egg products which are regulated by the U.S. Department of Agriculture) are safe, wholesome, sanitary and properly labeled; ensuring that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective Protecting the public from electronic product radiation Assuring cosmetics and dietary supplements are safe and properly labeled Regulating tobacco products Advancing the public health by helping to speed product innovations FDA's responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions" http://www.fda.gov/aboutfda/transparency/basics/ucm194877.htm You cannot Assure that dietary supplements are safe and properly labeled without testing them, what the DSHEA did was to make a distinction between drugs where the manufacturer had to prove safety and efficacy and supplements where the burden of proof falls on the United States to prove a Supplement unsafe - but their is nothing in the Bill that prohibits testing of supplements to make sure whats on the label is in the products and that there are no adulterants in the product. Link to comment Share on other sites More sharing options...
DC Tom Posted January 3, 2014 Share Posted January 3, 2014 There is nothing in that Bill which prevents the FDA from testing "FDA is responsible for Protecting the public health by assuring that foods (except for meat from livestock, poultry and some egg products which are regulated by the U.S. Department of Agriculture) are safe, wholesome, sanitary and properly labeled; ensuring that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective Protecting the public from electronic product radiation Assuring cosmetics and dietary supplements are safe and properly labeled Regulating tobacco products Advancing the public health by helping to speed product innovations FDA's responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions" http://www.fda.gov/a...s/ucm194877.htm You cannot Assure that dietary supplements are safe and properly labeled without testing them, what the DSHEA did was to make a distinction between drugs where the manufacturer had to prove safety and efficacy and supplements where the burden of proof falls on the United States to prove a Supplement unsafe - but their is nothing in the Bill that prohibits testing of supplements to make sure whats on the label is in the products and that there are no adulterants in the product. According to the FDA there is. Take it up with them; your ignorance and inability to read is boring me. Link to comment Share on other sites More sharing options...
birdog1960 Posted January 3, 2014 Author Share Posted January 3, 2014 Dietary Supplement Health and Education Act of 1994 An Act To amend the Federal Food, Drug, and Cosmetic Act to establish standards with respect to dietary supplements, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, Sec. 1. Short title; reference; table of contents. Sec. 2. Findings. Sec. 3. Definitions. Sec. 4. Safety of dietary supplements and burden of proof on FDA. Sec. 5. Dietary supplement claims. Sec. 6. Statements of nutritional support. Sec. 7. Dietary supplement ingredient labeling and nutrition information labeling. Sec. 8. New dietary ingredients. Sec. 9. Good manufacturing practices. Sec. 10. Conforming amendments. Sec. 11. Withdrawal of the regulations and notice. Sec. 12. Commission on dietary supplement labels. Sec. 13. Office of dietary supplements. §3. Definitions. (a) Definition of Certain Foods as Dietary Supplements. Section 201 (21 U.S.C. 321) is amended by adding at the end the following: "(ff) The term "dietary supplement" - "(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: "(A) a vitamin; "(B) a mineral; "© an herb or other botanical; "(D) an amino acid; "(E) a 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), ©, (D), or (E); [*]"(2) means a product that - "(A)(i) is intended for ingestion in a form described in section 411©(1)(B)(i); or "(ii) complies with section 411©(1)(B)(ii); "(B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and "© is labeled as a dietary supplement; and [*]"(3) does - "(A) include an article that is approved as a new drug under section 505, certified as an antibiotic under section 507, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262) and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food 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) not include - "(i) an article that is approved as a new drug under section 505, certified as an antibiotic under section 507, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262), or "(ii) an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary's discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this Act. Except for purposes of section 201(g), a dietary supplement shall be deemed to be a food within the meaning of this Act. (b) Exclusion from Definition of Food Additive. Section 201(s) (21 U.S.C. 321(s)) is amended - (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.". [*]© Form of Ingestion. Section 411©(1)(B) (21 U.S.C. 350©(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". §5. Dietary Supplement Claims. Chapter IV (21 U.S.C. 341 et seq.) is amended by inserting after section 403A the following new section: DIETARY SUPPLEMENT LABELING EXEMPTIONS "Sec. 403B. (a) IN GENERAL.- A publication, including an article, a chapter in a book, or an official abstract of a peer-reviewed scientific publication that appears in an article and was prepared by the author or the editors of the publication, which is reprinted in its entirety, shall not be defined as labeling when used in connection with the sale of a dietary supplement to consumers when it - "(1) is not false or misleading; "(2) does not promote a particular manufacturer or 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; "(4) if displayed in an establishment, is physically separate from the dietary supplements; and "(5) does not have appended to it any information by sticker or any other method. [*]"(b) APPLICATION. - Subsection (a) 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. [*]"© BURDEN OF PROOF. - In any proceeding brought under subsection (a), the burden of proof shall be on the United States to establish that an article or other such matter is false or misleading.". §7. Dietary Supplement Ingredient Labeling and Nutrition Information Labeling. (a) MISBRANDED SUPPLEMENTS. - Section 403 (21 U.S.C. 343) is amended by adding at the end the following: "(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; [*]"© the supplement contains an ingredient described in section 201(ff)(1)©, 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)(5)(F) (21 U.S.C. 343(q)(5)(F)) is amended to read as follows: "(F) A dietary supplement product (including a food to which section 411 applies) shall comply with the requirements of subparagraphs (1) and (2) in a manner which is appropriate for the product and which is specified in regulations of the Secretary which shall provide that - "(i) nutrition information shall first list those dietary ingredients that are present in the product in a significant amount and for which a recommendation for daily consumption has been established by the Secretary, except that a dietary ingredient shall not be required to be listed if it is not present in a significant amount, and shall list any other dietary ingredient present and identified as having no such recommendation; "(ii) the listing of dietary ingredients shall include the quantity of each such ingredient (or of a proprietary blend of such ingredients) per serving; "(iii) the listing of dietary ingredients may include the source of a dietary ingredient; and "(iv) the nutrition information shall immediately precede the ingredient information required under subclause (i), except that no ingredient identified pursuant to subclause (i) shall be required to be identified a second time.". [*]© Percentage Level Claims. Section 403®(2) (21 U.S.C. 343®(2)) is amended by adding after clause (E) the following: "(F) Subclause (i) clause (A) does not apply to a statement in the labeling of a dietary supplement that characterizes the percentage level of a dietary ingredient for which the Secretary has not established a reference daily intake, daily recommended value, or other recommendation for daily consumption.".[*](d) Vitamins and Minerals. Section 411(b)(2) (21 U.S.C. 350(b)(2)) is amended - (1) by striking "vitamins or minerals" and inserting "dietary supplement ingredients described in section 201(ff)"; (2) by striking "(2)(A)" and inserting "(2)"; and (3) by striking subparagraph (B). [*](e) Effective Date. Dietary supplements - (1) may be labeled after the date of the enactment of this Act in accordance with the amendments made by this section, and (2) shall be labeled after December 31, 1996, in accordance with such amendments. §9. Good Manufacturing Practices. Section 402 (21 U.S.C. 342), as amended by section 4, is 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, including regulations requiring, when necessary, expiration date labeling, issued by the Secretary under subparagraph (2). "(2) 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 chapter 5 of title 5, United States Code.". §11. Withdrawal of the Regulations and Notice. The advance notice of proposed rulemaking concerning dietary supplements published in the Federal Register of June 18, 1993 (58 FR 33690-33700) is null and void and of no force or effect insofar as it applies to dietary supplements. The Secretary of Health and Human Services shall publish a notice in the Federal Register to revoke the item declared to be null and void and of no force or effect under subsection (a). §13. Office of Dietary Supplements. (a) IN GENERAL. - Title IV of the Public Health Service Act is amended by inserting after section 485B (42 U.S.C. 287c-3) the following: " SUBPART 4--OFFICE OF DIETARY SUPPLEMENTS SEC. 485C. 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 - "(1) 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 "(2) to promote scientific study of the benefits of dietary supplements in maintaining health and preventing chronic disease and other health-related conditions. [*]"© DUTIES. - The Director of the Office of Dietary Supplements shall - "(1) 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 Medicine; "(3) serve as the principal advisor to the Secretary and to the Assistant Secretary for Health and 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; "© claims characterizing the relationship between - "(i) 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; [*]"(4) compile a database of scientific research on dietary supplements and individual nutrients; and [*]"(5) coordinate funding relating to dietary supplements for the National Institutes of Health. [*]"(d) DEFINITION. - As used in this section, the term "dietary supplement" has the meaning given the term in section 201(ff) of the Federal Food, Drug, and Cosmetic Act. [*]"(e) AUTHORIZATION OF APPROPRIATIONS. - There are authorized to be appropriated to carry out this section $5,000,000 for fiscal year 1994 and such sums as may be necessary for each subsequent fiscal year.". [*](b) CONFORMING AMENDMENT. - Section 401(b)(2) of the Public Health Service Act (42 U.S.C. 281(b)(2)) is amended by adding at the end the following: "(E) The Office of Dietary Supplements.". Approved October 25, 1994. irrefutable evidence that our corrupt system is not working. this must have been written by insiders in the vitamin and supplement industry (just like many of the recently passed banking regulations). i wonder what the payment was and to whom it was given for this piece of shiet. it helps absolutely no one except the hucksters. and a directorship in the nih? yet the definitive paper on the subject gets published by a group completely divorced from that office in a similarly separate publication. this shameful piece of legislation calls for at least a couple of immediate changes imo: first an expert governmental medical board like that used in the uk and envisioned by tom daschle to oversee and write legislation on such issues and to set healthcare policy. second and more importantly, campaign finance reform. Link to comment Share on other sites More sharing options...
DC Tom Posted January 3, 2014 Share Posted January 3, 2014 irrefutable evidence that our corrupt system is not working. this must have been written by insiders in the vitamin and supplement industry (just like many of the recently passed banking regulations). i wonder what the payment was and to whom it was given for this piece of shiet. it helps absolutely no one except the hucksters. and a directorship in the nih? yet the definitive paper on the subject gets published by a group completely divorced from that office in a similarly separate publication. this shameful piece of legislation calls for at least a couple of immediate changes imo: first an expert governmental medical board like that used in the uk and envisioned by tom daschle to oversee and write legislation on such issues and to set healthcare policy. second and more importantly, campaign finance reform. I have a short history of it somewhere around here. Most briefly: the law was a sop to homeopaths, who didn't want their "medicine" regulated, lest it become known that they were selling placebos. Link to comment Share on other sites More sharing options...
boyst Posted January 3, 2014 Share Posted January 3, 2014 (edited) Do you guys even want to know what I take?! Jeesh, I'd be laughed off from posting ever again: Glutamine, arginine, lysiene, bromelain, raspberry keyones/coffeebeane extract, milk thistle, protein powder, fish oil, vit c, multivitamin, choline, CLA, creatine, a thermogenic, probiotic, claritan, diphenhydramine and maybe 5 or 6 more depending on whats going on. Edited January 3, 2014 by jboyst62 Link to comment Share on other sites More sharing options...
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