Nutritional Supplement Bylaws Nutritional Supplement Nutritional Supplements
Nutritional supplements are the latest craze of the current health market with each passing day a new nutritional supplement is being developed. But unfortunately not all nutritional supplements are of equal significance and according to the FDA assessment most of the nutritional supplements contain illegal or banned substances that impose risk to consumer health.
FDA is taking further steps to regulate the manufacturing of the nutritional supplements; The Dietary Supplement Health & Education Act of 1994 (DSHEA) announces nutritional supplements to be products intended to supplement the diet. But the FDA argues DSHEA strictly limits the FDA in regulating a growing industry. A newly issued report from the General Accounting Office claims the FDA does not have the resources to satisfactorily regulate nutritional supplements. The GAO report appears to be part of an orchestrated effort to soften the public up for a main change in the categorization and regulation of nutritional supplements.
Unlike drugs which must be approved for safety and effectiveness before entering the marketplace, nutritional supplements marketed before 1994 are supposed to be safe. FDA must reveal that a product presents a significant or unreasonable risk to the public to get it off the market. But that may change.
A threatening sign of things to come – the FDA just classified a form of vitamin B6 (pyridoxine) as a new drug (Pyridorin, Biostratum).
Despite recent outburst of food borne ailment (Salmonella in peanuts) and approval of poisonous or problematic drugs (recently Vioxx, Seroquel, many others) compared against few if any reported deaths in the recently implemented Adverse Event Reporting for nutritional supplements, the Federal government is aiming its regulatory muscle at vitamin, mineral and herbal pills.
Despite the reality that nutritional supplements are far safer than table salt, aspirin, vaccines and many FDA-approved drugs, they are being demonized. Year after year, reviews conducted by poison control centers show nutritional supplements to be the safest products of all.
In misdirection, it appears nutritional supplements are being mischaracterized as potentially hazardous and in need of greater regulatory oversight. This leads to the opportunity of FDA placing supplements under the same regulatory body that supervises drugs.
The FDA seems to be covering for the sins of the drug companies, which is pushing for faster appreciation of new drugs, which led to the Vioxx fiasco (it is estimated 20,000 Americans died prematurely from taking this anti-inflammatory drug that should have never been approved by the FDA). Vioxx, if you remember, was advertized as being safer than other anti-inflammatory drugs such as ibuprofen and aspirin.
Just recently it was exposed that salespeople for a U.S. drug company told doctors that an anti-psychotic drug (Seroquel- $4.45 billion in sales 2008) didn’t cause diabetes more than two years after the drug maker warned physicians in Japan of potential links to the disease. Twelve serious cases (including 1 death) of hyperglycaemia, diabetic ketoacidosis and diabetic coma here causally linked with the drug. What penalties a drug company will entertain from the FDA for this type of obvious misdeed is mysterious.
Substantial efforts have been taken to induce the public to be suspicious of nutritional supplements. Just when DSHEA was being deliberated for passage in Congress in October of 1994, suddenly a report was published in New England Journal of Medicine claiming beta carotene tablets increased the risk of death among smokers in Finland. But examination of the published paper showed beta carotene barely increased mortality rates at all (by less than 1%).
For years the FDA drug its feet in publishing Good Manufacturing Practices (GMP) for the nutritional supplement business, while pointing fingers at and sanctioning supplement manufacturers who made trivial quality products, often mislabeled for dosage or for making bogus marketing claims. Only recently has the FDA completed GMP guidelines for nutritional supplements.
In 2006 the FDA drew fire when it declared tart cherry supplements to be “new drugs” because manufacturers claimed their products had powerful anti-inflammatory properties. Another agency of the government, the US Department of Agriculture, published a study showing tart cherry extract is as helpful as ibuprofen in reducing inflammation. Ibuprofen can cause gastric disorders that can lead to bleeding ulcers and even death. Tart cherry extract has no reported side effects. In this manner the FDA limits free speech and the public is deprived of learning ways to live healthy naturally and practice self care.
In 1994 Americans wrote more letters to Congress to maintain access to nutritional supplements than on any other section of legislation to date.
Imagine you are on a cruise ship where people are getting sick from Norovirus in unhygienic shellfish, and the ship’s doctor is providing poorly-made sea-sick medicine that is making people ill as well, and the captain neglect these problems, declares he doesn’t have adequate authority over people taking vitamin pills below-decks and demands everybody unload their vitamin pills overboard. This is what is going on at the FDA today.
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