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From: ironjustice on 26 Jun 2008 10:53 Health Freedom Warning: Drug Company Seeks to Outlaw Vitamin B6 to Protect Pharma Profits www.naturalnews.com/023514.html (NaturalNews) Big Pharma is constantly finding new ways to destroy the natural supplements market, in much the same way that the American Medical Association once sought to destroy the chiropractic industry (for which it was later found guilty of conspiracy in U.S. courts, by the way). The latest attack against vitamins comes from an FDA petition filed by Medicure Pharma, Inc., which has astonishingly asked the FDA to ban the sale of Vitamin B6! Who loves ya. Tom Jesus Was A Vegetarian! http://tinyurl.com/2r2nkh Man Is A Herbivore! http://tinyurl.com/4rq595 DEAD PEOPLE WALKING http://tinyurl.com/zk9fk
From: Ron Peterson on 26 Jun 2008 14:01 On Jun 26, 9:53 am, "ironjust...(a)aol.com" <ironjust...(a)aol.com> wrote: > Health Freedom Warning: Drug Company Seeks to Outlaw Vitamin B6 to > Protect Pharma Profits > www.naturalnews.com/023514.html FDALawBlog gives the following less biased take: Medicure Pharma submitted a citizen petition to FDA that asserts that all dietary supplements containing pyridoxal 5-phosphate (P5P supplements) are adulterated under FDC Act § 402(f). The petition asserts that P5P (a form of vitamin B6) is a new dietary ingredient which has neither been present in the food supply as an article used for food in a form in which the food has not been chemically altered, nor has it been the subject of a new dietary ingredient notification. The petition further asserts that those supplements were therefore not lawfully marketed prior to the date on which the investigation of P5P as a drug triggered the dietary supplement exclusionary clause in FDC Act § 201(ff)(3)(B)(ii). The petition asks FDA to remove all P5P supplements from the market, or in the alternative, to initiate rulemaking under FDC Act § 201(ff)(3)(A) to exclude them from the statutory definition of a dietary supplement. Medicure Pharma is investigating a drug product under an Investigational New Drug Application that contains P5P as its active ingredient, and the company contends that marketing of P5P supplements undermines the companys incentive to continue developing its drug product. The success or failure of the petition will turn on a few issues. First, the petition contends that P5P is a new dietary ingredient because it was not marketed before October 15, 1994. This is certain to prompt a thorough search on the part of P5P supplement manufacturers for evidence of marketing prior to that date. Second, the petition contends that P5P has not been present in the food supply as an article used for food within the meaning of FDC Act § 413(a)(1) because the presence of P5P in foods is incidental. However, the Institute of Medicine recognizes that P5P is one of the major forms of vitamin B6 in animal tissues, and that animal tissues are a source of vitamin B6. Third, the petition contends that even extensive marketing of a dietary supplement does not forestall application of the dietary supplement exclusionary clause if the supplement was marketed unlawfully. Although the petition acknowledges that a plain reading of the exclusionary clause does not support this view, the petition asks FDA to read the term lawfully (as in lawfully marketed) into the exclusionary clause on the ground that not doing so would yield absurd results. Finally, the petition contends that, even if P5P is lawfully marketed as a dietary supplement, FDA can prohibit any further marketing under section 201(ff)(3)(A) to help preserve incentives for new drug development. In doing so, the petition fails to acknowledge that FDAs rulemaking authority under FDC Act § 201(ff)(3)(A) is tied to a finding of adulteration under § 402(f), a finding that could be difficult to support in the case of a form of vitamin B6. -- Ron
From: Paul T. Holland on 26 Jun 2008 16:43 while i am in agreement that there is much in need of change re the fda and other gov offices as to how, why, and with whom they collaborate in the decision making process of regulation and enforcement - this bunch lobbies against virtually any proposal, regulation, or activity in the name of 'protecting' the individual - all the while making an extremely good living promoting their own products and services free from the very same regulations that the pharmas have to abide by - regulations that when applied fairly do help to protect the public good. the website, naturenews, owned by a registered taiwanese corp - 'truth publishing', with anonymous site registration, is situated outside the usa 'specifically' for the purpose of not being under the jurisdiction of any us fed or state laws their own words: "Furthermore, NaturalNews.com will never share its subscriber database with any government agency such as the FDA. In fact, Truth Publishing (the company that owns NaturalNews.com) operates outside the United States and does not answer to U.S. authorities." as to the statements, claims, or commentaries made - while they claim to be so independent of advertising and the like - in realty they are the creation of the supplement industry and the primary listed editor/author is a guy named mike adams - easy to find here in the states with seminars, books, etc. while i have occasionally read an unbiased piece they've put out - the overwhelming majority is so slanted it cannot be read as 'news' of any sort - the 'truth' of their publishing is that they don't want to be bothered with having you know who they really are - while they write promoting a very particular agenda of let us do whatever we want. they are simply pushing product, no diff from the medical pharmas that they rail against their interest is in trying to protect themselves from having to be regulated as to product purity, efficacy as shown by studies and trials vs the 'claims' made anecdotally, and, they sell a lot of their books as of result of the other website(s) Ron Peterson wrote: > > On Jun 26, 9:53 am, "ironjust...(a)aol.com" <ironjust...(a)aol.com> wrote: > > Health Freedom Warning: Drug Company Seeks to Outlaw Vitamin B6 to > > Protect Pharma Profits > > > www.naturalnews.com/023514.html > > FDALawBlog gives the following less biased take: > Medicure Pharma submitted a citizen petition to FDA that asserts that > all dietary supplements containing pyridoxal 5�-phosphate (�P5P > supplements�) are adulterated under FDC Act � 402(f). The petition > asserts that P5P (a form of vitamin B6) is a new dietary ingredient > which has neither been present in the food supply as an article used > for food in a form in which the food has not been chemically altered, > nor has it been the subject of a new dietary ingredient notification. > The petition further asserts that those supplements were therefore not > lawfully marketed prior to the date on which the investigation of P5P > as a drug triggered the dietary supplement exclusionary clause in FDC > Act � 201(ff)(3)(B)(ii). The petition asks FDA to remove all P5P > supplements from the market, or in the alternative, to initiate > rulemaking under FDC Act � 201(ff)(3)(A) to exclude them from the > statutory definition of a dietary supplement. Medicure Pharma is > investigating a drug product under an Investigational New Drug > Application that contains P5P as its active ingredient, and the > company contends that marketing of P5P supplements undermines the > company�s incentive to continue developing its drug product. > > The success or failure of the petition will turn on a few issues. > First, the petition contends that P5P is a new dietary ingredient > because it was not marketed before October 15, 1994. This is certain > to prompt a thorough search on the part of P5P supplement > manufacturers for evidence of marketing prior to that date. Second, > the petition contends that P5P has not been �present in the food > supply as an article used for food� within the meaning of FDC Act � > 413(a)(1) because the presence of P5P in foods is �incidental.� > However, the Institute of Medicine recognizes that P5P is one of the > major forms of vitamin B6 in animal tissues, and that animal tissues > are a source of vitamin B6. Third, the petition contends that even > extensive marketing of a dietary supplement does not forestall > application of the dietary supplement exclusionary clause if the > supplement was marketed unlawfully. Although the petition acknowledges > that a plain reading of the exclusionary clause does not support this > view, the petition asks FDA to read the term �lawfully� (as in > �lawfully marketed�) into the exclusionary clause on the ground that > not doing so would yield absurd results. Finally, the petition > contends that, even if P5P is lawfully marketed as a dietary > supplement, FDA can prohibit any further marketing under section > 201(ff)(3)(A) to help preserve incentives for new drug development. In > doing so, the petition fails to acknowledge that FDA�s rulemaking > authority under FDC Act � 201(ff)(3)(A) is tied to a finding of > adulteration under � 402(f), a finding that could be difficult to > support in the case of a form of vitamin B6. > > -- > Ron
From: Nomen Nescio on 26 Jun 2008 18:30 Always Learning wrote: > Minerals, supplements do nothing to cure > illnesses or pain, period. You're discounting the placebo effect.
From: Larry Hoover on 26 Jun 2008 18:56 "Always Learning" <noPublicEmail(a)this.time> wrote in message news:bb18645md03987lsg1d9j32t4vu3ftvlbq(a)zzz.com... > If vitamins and minerals [by themselves] cured any disorder or pain > then doctors would prescribe them. Haven't you heard of people taking niacin to reduce blood cholesterol? On doctors' instructions? Vitamin D for osteoporosis? It is pretty easy to disprove such a blanket denial. Pain can indeed be treated by supplements, but pain is a symptom of over 1000 disorders, so I'm not going to make specific suggestions. You have to consider the cause of the pain before you consider treating it. Anyway..... Instead of cure, how about prevention? The first abstract is written by Bruce Ames, a pre-eminent expert on mutagenesis. And the second one was one of over a thousand articles about disease states related to low vitamin D status....I just picked the first one I saw. I added some emphasis to the latter. Mutat Res. 2001 Apr 18;475(1-2):7-20. DNA damage from micronutrient deficiencies is likely to be a major cause of cancer. Ames BN. University of California, 94720-3202, Berkeley, CA, USA. bnames(a)uclink4.berkeley.edu A deficiency of any of the micronutrients: folic acid, Vitamin B12, Vitamin B6, niacin, Vitamin C, Vitamin E, iron, or zinc, mimics radiation in damaging DNA by causing single- and double-strand breaks, oxidative lesions, or both. For example, the percentage of the US population that has a low intake (<50% of the RDA) for each of these eight micronutrients ranges from 2 to >20%. A level of folate deficiency causing chromosome breaks was present in approximately 10% of the US population, and in a much higher percentage of the poor. Folate deficiency causes extensive incorporation of uracil into human DNA (4 million/cell), leading to chromosomal breaks. This mechanism is the likely cause of the increased colon cancer risk associated with low folate intake. Some evidence, and mechanistic considerations, suggest that Vitamin B12 (14% US elderly) and B6 (10% of US) deficiencies also cause high uracil and chromosome breaks. Micronutrient deficiency may explain, in good part, why the quarter of the population that eats the fewest fruits and vegetables (five portions a day is advised) has about double the cancer rate for most types of cancer when compared to the quarter with the highest intake. For example, 80% of American children and adolescents and 68% of adults do not eat five portions a day. Common micronutrient deficiencies are likely to damage DNA by the same mechanism as radiation and many chemicals, appear to be orders of magnitude more important, and should be compared for perspective. Remedying micronutrient deficiencies should lead to a major improvement in health and an increase in longevity at low cost. Am J Clin Nutr. 2008 Apr;87(4):1080S-6S. Vitamin D deficiency: a worldwide problem with health consequences.Holick MF, Chen TC. Department of Medicine, Boston University School of Medicine, 715 Albany Street, M-1013, Boston, MA 02118, USA. mfholick(a)bu.edu Vitamin D deficiency is now recognized as a pandemic. The major cause of vitamin D deficiency is the lack of appreciation that sun exposure in moderation is the major source of vitamin D for most humans. Very few foods naturally contain vitamin D, and foods that are fortified with vitamin D are often inadequate to satisfy either a child's or an adult's vitamin D requirement. Vitamin D deficiency causes rickets in children and will precipitate and exacerbate osteopenia, osteoporosis, and fractures in adults. ***Vitamin D deficiency has been associated with increased risk of common cancers, autoimmune diseases, hypertension, and infectious diseases.*** A circulating level of 25-hydroxyvitamin D of >75 nmol/L, or 30 ng/mL, is required to maximize vitamin D's beneficial effects for health. In the absence of adequate sun exposure, at least 800-1000 IU vitamin D3/d may be needed to achieve this in children and adults. Vitamin D2 may be equally effective for maintaining circulating concentrations of 25-hydroxyvitamin D when given in physiologic concentrations. Lar
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