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The Food and Drug Administration (FDA) has ruled that the vitamin B6 compound, pyridoxamine dihydrochloride, cannot be used in dietary supplements.
The decision, in response to a petition from a North Carolina-based firm called Biostratum, provoked the Washington DC-based Council for Responsible Nutrition (CRN) to issue a statement warning that a precedent could be established that could see the status of other ingredients challenged.
Biostratum and CRN have been debating the status of the ingredient via FDA petitions since at July, 2005. Biostratum is the manufacturer of a pyridoxamine-based drug called Pyridorin designed to prevent the progression of diabetic nephropathy (kidney disease).
BioStratum Incorporated, a development-stage biopharmaceutical company focused on novel therapies for diabetes and diabetic complications, today announced that new human safety and efficacy data on its lead drug candidate, Pyridorin(TM), was the focus of two presentations made at the American Diabetes Association's 64th Scientific Sessions. The conference is being held June 4-8, 2004, in Orlando, Florida.
Pyridorin, a small molecule that uniquely inhibits the formation of harmful advanced glycation end-products (AGEs), has been granted Fast Track status by the FDA and has recently completed Phase II clinical trials for the treatment of diabetic kidney disease. AGEs are widely held to be a cause of diabetic complications such as kidney disease (nephropathy), blindness (retinopathy), and nerve damage (neuropathy).
DURHAM - After pumping about $100 million over 11 years into a biotech company developing a promising treatment for diabetic kidney disease, investors in BioStratum discovered the drug's only active ingredient is sold on the Internet to anybody with a credit card.
The lack of intellectual property protection surrounding BioStratum's drug Pyridorin is scaring away many potential partners from funding the drug's third phase of clinical trials - typically the final tests before a drug is approved and sold commercially.
Originally posted by tothetenthpower
And the war against Vitamins starts today!!
I had a friend a few years ago say that they would systematically start banning vitamins and the FDA would attempt to control the food we eat.
Well seems step 2 is already complete with the Modified Crop Seeds and now the Vitamins can have they're share of the oppression as well.
Originally posted by TheRandom1
Seems everyone is too caught up in the fear mongering to address a few good questions.
FDA further states that "the marketing of pyridoxamine in a dietary supplement is essentially equivalent to the marketing of an investigational new drug as a dietary supplement." Thus, it appears that FDA regards products containing pyridoxamine as drugs subject the new drug provisions of the FDC Act.
Originally posted by TheRandom1
If Vitamin B6 is really BANNED then why CAN I buy it from Wal-Mart WITHOUT a prescription?
Is it because the ban has not gone into effect yet?
Is it because the form of B6 you get from Wal-Mart is junk?
WHY CAN WE STILL BUY B6 IF IT HAS BEEN BANNED?
Just to note, I put it in big letter to get attention because people tend to get caught up in the fear and ignore good questions they may punch a hole in there theory.
Originally posted by dubiousone
Table salt, sugar, most spices, water, and even the air you breathe are dangerous if taken in the wrong way. Should those substances be regulated?
Originally posted by ImaginaryReality1984
I'm sorry, so because it can harm you if used incorrectly it needs to be prescribed? Well by that measure we should put pretty much everything on prescription that we consume because everything is a poison in the right doses. Even water can kill you so why not a prescription for that?
FDA Regulation of Salt and Sodium
Salt is regulated as a GRAS ingredient per 21 CFR 182.1
• FDA has commented previously on salt’s GRAS status and has
chosen labeling, rather than ingredient regulation to encourage
lower sodium intakes.
• Sodium is part of the mandatory elements for nutrition labeling.
• Nutrient content claims and health claims related to sodium
can be made voluntarily on food products consistent with
regulations; sodium content is included in disclosure &
TITLE 21--FOOD AND DRUGS
(20) For purposes of ingredient labeling, the termsugar shall refer to sucrose, which is obtained from sugar cane or sugar beets in accordance with the provisions of 184.1854 of this chapter.
(ii) "Sugars": A statement of the number of grams of sugars in a serving, except that label declaration of sugars content is not required for products that contain less than 1 gram of sugars in a serving if no claims are made about sweeteners, sugars, or sugar alcohol content. Except as provided for in paragraph (f) of this section, if a statement of the sugars content is not required and, as a result, not declared, the statement "Not a significant source of sugars" shall be placed at the bottom of the table of nutrient values in the same type size. Sugars shall be defined as the sum of all free mono- and disaccharides (such as glucose, fructose, lactose, and sucrose). Sugars content shall be indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement "Contains less then 1 gram" or "less than 1 gram" may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.
Yadda..Yadda… To much there to copy.
Bottled Water Regulations
Regulating Bottled Water
In the U.S., bottled water and tap water are regulated by two different agencies; the FDA regulates bottled water and the U.S. Environmental Protection Agency (EPA) regulates tap water (also referred to as municipal water or public drinking water). EPA's Office of Ground Water and Drinking Water has issued extensive regulations on the production, distribution and quality of drinking water, including regulations on source water protection, operation of drinking water systems, contaminant levels and reporting requirements/
The U.S. Environmental Protection Agency (EPA or sometimes USEPA) is an agency of the federal government of the United States charged to regulate chemicals and protect human health by safeguarding the natural environment: air, water, and land.
Originally posted by JBA2848
Heres a link to a story that came out I guess to back up there support of banning something healthy by making people beleive the vitamin is useless. But yet they will create a drug from it and sell it to you for a couple hundred dollars a month. Stop wasting money on vitamins!!!
An article in the February 9 issue of Archives of Internal Medicine reported that multivitamin use did not protect the 161,808 postmenopausal women enrolled in the Women's Health I More..nitiative Study from common forms of cancer, heart attacks, or strokes. And the numbers of deaths during the 8 years of the study were the same in vitamin users as in non-users. Still, it is important to recognize that this was an observational study, not a more meaningful clinical trial. Although these findings apply only to women, other studies have failed to show benefits of multivitamins in older men.
These results are not at all surprising for several reasons. No large study has shown that multivitamins significantly benefit healthy men and women. In addition, for some years physicians prescribed folic acid and vitamins B12 and B6 in the hopes of preventing heart attacks and strokes by lowering blood levels of homocysteine. (High blood levels of homocysteine are associated with an increased risk of coronary and other vascular diseases.) A number of recent studies, however, have shown that, while these vitamins do lower homocysteine levels, they do not prevent heart attacks or strokes.
Division of Endocrinology, Ohio State University, 485 McCampbell, 1581 Dodd Dr., Columbus, OH 43210, USA. email@example.com
BACKGROUND: The efficacy of calcium with vitamin D supplementation for preventing hip and other fractures in healthy postmenopausal women remains equivocal. METHODS: We recruited 36,282 postmenopausal women, 50 to 79 years of age, who were already enrolled in a Women's Health Initiative (WHI) clinical trial. We randomly assigned participants to receive 1000 mg of elemental [corrected] calcium as calcium carbonate with 400 IU of vitamin D3 daily or placebo. Fractures were ascertained for an average follow-up period of 7.0 years. Bone density was measured at three WHI centers. RESULTS: Hip bone density was 1.06 percent higher in the calcium plus vitamin D group than in the placebo group (P...
With all the medical advances in the 20 th century, Vitamin D3 deficiency is still an epidemic. Fifteen to twenty minutes of sunshine each day, in the nude, helps your body manufacture about 10,000 to 15,000 iu’s of vitamin D3 per day. The problem is that most people avoid the sun these days due to fears of skin cancer. Just think about plants and what happens to them when they avoid the sun. They wither & die.
Did you know that vitamin D3 deficiency can result in Obesity, Type 2 Diabetes, High Blood Pressure, Depression, Psoriasis, Fibromyalgia, Chronic Fatigue Syndrome, Kidney Stones, Osteoporosis, & Neuro-degenerative disease including Alzheimer’s Disease. Eventually, Vitamin D deficiency may even lead to Cancer (especially breast, prostate, and colon cancers). Vitamin D3 is believed to play a role in controlling the immune system (possibly reducing one’s risk of cancer and autoimmune diseases), increasing neuro-muscular function and decreasing falls, improving mood, protecting the brain against toxic chemicals, and potentially reducing pain.
Vitamin D3 is both a vitamin and a hormone. It acts as a vitamin when it binds with calcium for proper absorption. Humans cannot digest calcium without adequate amounts of Vitamin D3.
The most common reasons for Vitamin D3 deficiency in the United States relates to lack of exposure to sunlight and infrequent consumption of cold water fish such as wild salmon, mackerel & sardines.
A standard blood chemistry panel will provide your doctor with your levels of vitamin D3. The test is called 25(OH)D. The existing guidelines state that a deficiency is anything below 50nmol/l, but recent studies show that 80 nmol/l is needed to keep healthy bones and enable vitamin D to perform its other roles in the body.
Foods have been supplemented with Vitamin D, but this has not resulted in an overall increase in Vitamin D levels. This is likely because food and supplement manufacturers rely on an inexpensive form of synthetic Vitamin D called “ergocalciferol”- a form of Vitamin D2.
If you have bone loss or osteoporosis, spend 20 minutes daily in the sunshine with 40% of your skin surface exposed. Morning sun is best; Don’t allow your skin to burn. Tanning Beds do not provide Vitamin D3.
Eat foods high in Vitamin D3 including Cod liver oil, fortified milk, salmon, mackerel, & sardines, egg yolks, beef liver. If you take Vitamin D supplements make sure it is Vitamin D3 and not D2. Take Vitamin D3 supplements with food. I usually recommend Vitamin D3 2000iu-5000iu/ day depending on lab levels.
Nutrition and Well-Being A to Z :: Ca-De
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Calcium is one of the most important elements in the diet because it is a structural component of bones, teeth, and soft tissues and is essential in many of the body's metabolic processes. It accounts for 1 to 2 percent of adult body weight, 99 percent of which is stored in bones and teeth. On the cellular level, calcium is used to regulate the permeability and electrical properties of biological membranes (such as cell walls), which in turn control muscle and nerve functions, glandular secretions, and blood vessel dilation and contraction. Calcium is also essential for proper blood clotting.
Because of its biological importance, calcium levels are carefully controlled in various compartments of the body. The three major regulators of blood calcium are parathyroid hormone (PTH), vitamin D, and calcitonin. PTH is normally released by the four parathyroid glands in the neck in response to low calcium levels in the bloodstream (hypocalcemia). PTH acts in three main ways: (1) It causes the gastrointestinal tract to increase calcium absorption from food, (2) it causes the bones to release some of their calcium stores, and (3) it causes the kidneys to excrete more phosphorous, which indirectly raises calcium levels.
Vitamin D works together with PTH on the bone and kidney and is necessary for intestinal absorption of calcium. Vitamin D can either be obtained from the diet or produced in the skin when it is exposed to sunlight. Insufficient vitamin D from these sources can result in rickets in children and osteomalacia in adults, conditions that result in bone deformities. Calcitonin, a hormone released by the thyroid, parathyroid, and thymus glands, lowers blood levels by promoting the deposition of calcium into bone.
Most dietary calcium is absorbed in the small intestine and transported in the bloodstream bound to albumin, a simple protein. Because of this method of transport, levels of albumin can also influence blood calcium measurements. Calcium is deposited in bone with phosphorous in a crystalline form of calcium phosphate.
Deficiency and Toxicity
Because bone stores of calcium can be used to maintain adequate blood calcium levels, short-term dietary deficiency of calcium generally does not result in significantly low blood calcium levels. But, over the long term, dietary deficiency eventually depletes bone stores, rendering the bones weak and prone to fracture. A low blood calcium level is more often the result of a disturbance in the body's calcium regulating mechanisms, such as insufficient PTH or vitamin D, rather than dietary deficiency. When calcium levels fall too low, nerve and muscle impairments can result. Skeletal muscles can spasm and the heart can beat abnormally—it can even cease functioning.
Toxicity from calcium is not common because the gastrointestinal tract normally limits the amount of calcium absorbed. Therefore, short-term intake of large amounts of calcium does not generally produce any ill effects aside from constipation and an increased risk of kidney stones. However, more severe toxicity can occur when excess calcium is ingested over long periods, or when calcium is combined with increased amounts of vitamin D, which increases calcium absorption. Calcium toxicity is also sometimes found after excessive intravenous administration of calcium. Toxicity is manifested by abnormal deposition of calcium in tissues and by elevated blood calcium levels (hypercalcemia). However, hypercalcemia is often due to other causes, such as abnormally high amounts of PTH. Usually, under these circumstances, bone density is lost and the resulting hypercalcemia can cause kidney stones and abdominal pain. Some cancers can also cause hypercalcemia, either by secreting abnormal proteins that act like PTH or by invading and killing bone cells causing them to release calcium. Very high levels of calcium can result in appetite loss, nausea, vomiting, abdominal pain, confusion, seizures, and even coma.
Requirements and Supplementation
Dietary calcium requirements depend in part upon whether the body is growing or making new bone or milk. Requirements are therefore greatest during childhood, adolescence, pregnancy, and breastfeeding. Recommended daily intake (of elemental calcium) varies accordingly: 400 mg for
Supplement Elemental calcium by weight Comment
Calcium carbonate 40% • Most commonly used
• Less well absorbed in persons with decreased stomach acid (e.g., elderly or those on anti-acid medicines)
• Natural preparations from oyster shell or bone meal may contain contaminants such as lead
• Least expensive
Calcium citrate 21% • Better absorbed, especially by those with decreased stomach acid
• May protect against kidney stones
• More expensive.
Calcium phosphate 38% or 31% • Tricalcium or dicalcium phosphate
• Used more in Europe
• Absorption similar to calcium carbonate
Calcium gluconate 9% • Used intravenously for severe hypocalcemia
• Well absorbed orally, but low content of elemental calcium
• Very expensive
Calcium glubionate 6.5% • Available as syrup for children
• Low content elemental calcium.
Calcium lactate 13% • Well absorbed, but low content elemental calcium.
SOURCE: Gregory, Philip J. (2000) "Calcium Salts." Prescriber's Letter. Document #160313.
calcium from food sources is better absorbed than calcium taken as supplements. Children absorb a higher percentage of their ingested calcium than adults because their needs during growth spurts may be two or three times greater per body weight than adults. Vitamin D is necessary for intestinal absorption, making Vitamin D–fortified milk a very well-absorbed form of calcium. Older persons may not consume or make as much vitamin D as is optimal, so their calcium absorption may be decreased. Vitamin C and lactose (the sugar found in milk) enhance calcium absorption, whereas meals high in fat or protein may decrease absorption. Excess phosphorous consumption (as in carbonated sodas) can decrease calcium absorption in the intestines. High dietary fiber and phytate (a form of phytic acid found in dietary fiber and the husks of whole grains) may also decrease dietary calcium absorption in some areas of the world. Intestinal pH also affects calcium absorption—absorption is optimal with normal stomach acidity generated at meal times. Thus, persons with reduced stomach acidity (e.g., elderly persons, or persons on acid-reducing medicines) do not absorb calcium as well as others do.
Calcium supplements are widely used in the treatment and prevention of osteoporosis. Supplements are also recommended, or are being investigated, for a number of conditions, including hypertension, colon cancer, cardiovascular disease, premenstrual syndrome, obesity, stroke, and preeclampsia (a complication of pregnancy). There are several forms of calcium salts used as supplements. They vary in their content of elemental calcium, the amount effectively absorbed by the body, and cost. Whatever the specific form, the supplement should be taken with meals to maximize absorption.
Calcium is one of the most important macronutrients for the body's growth and function. Sufficient amounts are important in preventing many diseases. Calcium levels are tightly controlled by a complex interaction of hormones and vitamins. Dietary requirements vary throughout life and are greatest during periods of growth and pregnancy. However, recent reports suggest that many people do not get sufficient amounts of calcium in their diet. Various calcium supplements are available when dietary intake is inadequate.
. For example I know of several plants native to my area which are used in currently made cardiac medication, but if you do not use the right part of the plant, harvest it at the right time, and in the right amount, you can easily end up poisoning yourself.
Originally posted by asmeone2
I am holding up my first 3 fingers, read between the lines, that is what I think of you, FDA.