Despite safety of supplements, FDA insists on regulation - Health Supreme NewsGrabs 15 January 2012
The new 203-page annual report of the American Association of Poison Control Centers, published online here, shows zero deaths from multiple vitamins; zero deaths from any of the B vitamins; zero deaths from vitamins A, C, D, or E; and zero deaths from any other vitamin.
Additionally, there were no deaths whatsoever from any amino acid or dietary mineral supplement.
Three people died from non-supplement mineral poisoning: two from medical use of sodium and one from non-supplemental iron. On page 131, the AAPCC report specifically indicates that the iron fatality was not from a nutritional supplement.
More telling about the FDA’s strategy for more heavy-handed regulation is the statement that “If you look at the numbers of NDI submissions versus the number of supplements introduced to the market since 1994, it would appear there is a significant lag in compliance.” On its face, the marketplace has changed over the last seventeen years. But who is responsible for this 17-year lag in compliance?
The Dietary Supplement Health and Education Act of 1994 (DSHEA) required manufacturers to submit pre-market notification applications for supplements and new ingredients when there is a history of use or other evidence establishing that an ingredient is safe when used as directed. The FDA has 75 days to accept or reject the application. A non-decision by the FDA means that the Agency accepts the evidence and that the product has complied, is approved, and can be marketed to the consuming public. Alternatively, a formal petition for a review and FDA issuance of an order prescribing the conditions under which a new dietary ingredient can be used and reasonably be expected to be safe, with the FDA having to respond within 180 days, can be filed. Again, shouldn’t a non-decision on a petition be considered as final Agency approval? If the Agency does not issue a decision either way, or if it cannot find a decision that was issued over the previous seventeen years, has it been the industry or the FDA itself who has not been in compliance with DSHEA?
Apparently, the FDA believes that manufacturers and suppliers have not met the FDA’s own self-interpreted DSHEA burden of proof standard to show to the FDA that there is reasonable evidence that supplements and new ingredients in supplements are safe.I wish the FDA were that efficient on pharmaceuticals...
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Every system of regulation has its pros and cons. The labelling of health-related foods should be based on scientific evidence, always bearing in mind harmonisation with global international standards. There should be a harmonisation of food regulations around the world. Economic growth and urbanisation are not enough evidence of the future growth of nutraceuticals, health demographic trends also support these growth forecasts. Consumers are deeply concerned about how their health care is managed, administered and priced. As health care cost has become high the consumers are frustrated with the expensive disease-treatment approach predominant in modern medicine; the consumer is now seeking alternative beneficial products like dietary supplement, functional food and nutraceuticals.
With innovative delivery mechanism to facilitate the use of nutraceuticals amongst its target groups, the world market is expected to witness a gradual shift toward natural ingredients.The article discusses several of the major food regulatory systems and compares them. It becomes obvious that there are huge national differences in how to treat foods and in particular healthy foods. The question is: If those laws are to be somehow brought closer to each other, which would be the model to follow? I believe such a model (for ideal food legislation) needs to be worked out, to balance the current attempts - such as Codex Alimentarius - to put in the international food laws that are written by the large corporations.
Other supporters of herbal medicine worry that the rules are too demanding and could ban some therapies on which people depend. Adam Smith, science and communications officer for the Alliance for Natural Health International (ANHI) in Dorking, United Kingdom, a non-governmental campaign group promoting the use of herbal medicines and other approaches to healthcare, fears that patients will lose out on some Asian medicines because they have not been used in Europe for the requisite 15 years, even though they have been consumed in East Asia for considerably longer.
ANHI also detects a perceived bias in the THMPD towards products developed in the West, which often contain just one herb. Traditional Asian products contain mixtures of several herbs — making it difficult, time consuming and expensive to meet the directive's requirement to identify and quantify the active botanical ingredients or other biological agents in a herbal product. “These technical assessments require expensive methods,” says Smith. “The cost burden is a problem, particularly for small businesses,” he adds.
Middleton agrees that conducting scientific analyses are “tough” — even for products containing just one herb...
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More information out there...
There is a lot more information out there about natural health and pharmaceutical medicine that I cannot cover ... but fortunately other sources for this kind of information exist.
Dr Mercola has a good health blog
Mike Adams publishes Natural News.
In the UK we have the One Click Group.
The Dr Rath Foundation campaigns for a New Healthcare System.
Natural health and nutrition on La Leva di Archimede
Food, Agriculture and more on the Organic Consumers Association site.
The individual is supreme and finds the way through intuition
posted by Sepp Hasslberger on Sunday January 15 2012
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