herbs
The FDA New Dietary Ingredients Guidance
Posted November 19th, 2011 by adminThe Food and Drug Administration (FDA) has recently commenced a new assault against the dietary supplement industry – one that could threaten the availability of supplements currently on the market and that will discourage manufacturers from innovating new and more beneficial products in the future. In July the agency issued a draft Guidance document which sets forth its current thinking concerning provisions of the law that dictate what ingredients can be included in dietary supplement products, and what information companies must submit to the FDA if they desire to market a supplement that contains a new dietary ingredient (i.e., one that was not sold prior to October 15, 1994).
The FDA’s draft Guidance ignores the intent of Congress by seeking to impose insurmountable obstacles to the introduction of new dietary ingredients and includes interpretations that will threaten the continued sale of supplements if even the most minute of changes are made. If the Guideline is finalized and enforced by the FDA it will go a long way towards establishing the agency’s long-standing goal of requiring pre-market approval for dietary supplements.
The following are a few highlights of the Guidance document:
FDA’s New Sneak Attack on Supplements
Posted July 15th, 2011 by adminJust before the July 4 holiday weekend, hoping to limit media attention, the FDA dropped a bomb on dietary supplements. Don’t let them get away with it! A new Action Alert.
On July 1, the US Food and Drug Administration issued draft guidance for complying with the New Dietary Ingredient (NDI) notification protocols contained in the Dietary Supplement Health and Education Act (DSHEA). Ever since DSHEA was enacted in 1994, supplement manufacturers have had very little guidance on what counts as an NDI and when or how to send an NDI notification. The government has arbitrarily ignored or enforced this section of DSHEA, doing as it liked, without spelling out the rules.
Why does this matter? Because when you hear New Dietary Ingredient (NDI), substitute “New Supplement” in your mind. What we are dealing with here is whether the supplement industry is allowed to innovate and create new supplements—and if so, under what rules.
Hundreds of herbal remedies now outlawed across Europe
Posted May 25th, 2011 by admin(NaturalNews) Live in Europe? Get your herbs while they last. New rules put forth by the European Union (EU) will ban the sale of certain herbal remedies that have been used for centuries.
Traditional herbs such a St. John's Wort or Echinacea must now meet strict licensing guidelines in order to be sold, while other lesser-known herbs that haven't been "traditionally" used in the last 30 years won't even make the cut to reach consumer shelves. Only those products that have been "assessed" by the Medicine and Healthcare products Regulatory Agency (MHRA) will be available for purchase. The real kicker? Even approved products will only be recommended for minor ailments such as the common cold, which means that product labeling may no longer be allowed to convey the potent health benefits of widely-used herbal remedies.
According the the EU, the laws were put in place to protect consumers from the "damaging" effects of traditional herbal remedies. The subtext of that statement, of course, is that herbal remedies can sometimes have dangerous interactions when taken with prescription drugs. Used alone, however, herbal supplements rarely pose a problem. With so many people taking prescription drugs, it's clear that the EU's move to ban herbal products is a monopolistic attack on the alternative health movement. While they can't admit the dangerous and deadly side effects of manufactured drugs, they can shift the blame to herbs.
Dark Times for Herbal Medicine in Europe
Posted March 24th, 2011 by adminOur European Office, is preparing for a legal challenge against EU herb laws.
As we reported to you last November, thousands of products associated with traditional medicine will soon become illegal throughout the European Union (EU). And more and more, EU legislation influences US domestic policy, especially where health-related laws are concerned. The EU threat to herbal medicine is real, and we urge you to take stock of what’s going on so we can collectively jump in the minute anything similar emerges from US regulators. After all, it was that joint action from consumers and health organizations back in 1994 that has kept US regulations over dietary supplements relatively sane. But let’s not forget that this kind of freedom needs to be fought for every step of the way.
Here’s what our colleagues in the ANH Europe office are able to relay to you.
The EU has passed a stunning 139,338 directives, regulations and decisions since 1980. While it previously allowed European countries (now referred to as EU “member states”) to make up their own rules controlling natural healthcare products, there has been a push since around 2000 to control this area by rules formulated primarily by unelected bureaucrats in Brussels.
One of the laws that is set to devastate herbal medicines and products EU-wide, the Traditional Herbal Medicinal Products Directive (THMPD, also known as Directive 2004/24/EC) successfully passed into European law back in 2004. The law will be implemented fully on May 1 this year, and ANH-Intl has exhausted all options other than legal challenge in its efforts to protect the fundamental rights and freedoms of European citizens.
Zero Deaths from Vitamins, Minerals, Amino Acids or Herbs
Posted January 13th, 2011 by adminPoison Control Statistics Prove Supplements' Safety Yet Again
(OMNS Jan 5, 2011) There was not even one death caused by a dietary supplement in 2009, according to the most recent information collected by the U.S. National Poison Data System.
The new 200-page annual report of the American Association of Poison Control Centers, published in the journal Clinical Toxicology, 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, herb, or dietary mineral supplement.
Two people died from non-nutritional mineral poisoning, one from a sodium salt and one from an iron salt or iron. On page 1139, the AAPCC report specifically indicates that the iron fatality was not from a nutritional supplement. One other person is alleged to have died from an "Unknown Dietary Supplement or Homeopathic Agent." This claim remains speculative, as no verification information was provided.
60 poison centers provide coast-to-coast data for the U.S. National Poison Data System, "one of the few real-time national surveillance systems in existence, providing a model public health surveillance system for all types of exposures, public health event identification, resilience response and situational awareness tracking."
Over half of the U.S. population takes daily nutritional supplements. Even if each of those people took only one single tablet daily, that makes 155,000,000 individual doses per day, for a total of nearly 57 billion doses annually. Since many persons take more than just one vitamin or mineral tablet, actual consumption is considerably higher, and the safety of nutritional supplements is all the more remarkable.
If nutritional supplements are allegedly so "dangerous," as the FDA and news media so often claim,
then where are the bodies?
