FDA
The FDA New Dietary Ingredients Guidance
The 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 In July the agency issued a draft Guidance document which sets forth its current thinking concerning provisions of the law that dictate what ingredients can be included in dietary supplement products,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The FDA’s draft Guidance ignores the intent of Congress by seeking to impose insurmountable obstacles to the introduction of new dietary ingredients and includes interpretations that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 views your supplements in the same light as synthetic food preservatives
Greatest Threat Since FDA Tried to Turn
Nutrients into Prescription Drugs!
FDA's scheme to outlaw all nutritional supplements created after 1994 would destroy millions of jobs and devastate economy
Yesterday we reported on the FDA's new scheme for outlawing nearly all nutritional supplements formulated after October, 1994 (http://www.naturalnews.com/032912_F...).
That was just the beginning of this story, because a detailed analysis
of the proposed new regulation reveals extremely disturbing revelations
that would absolutely gut the nutritional products industry if these
regulations are put into practice.
FDA’s New Sneak Attack on Supplements
Just 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On July 1, the US Food and Drug Administration issued draft guidance for complying with the New Dietary Ingredient (NDI) notification protocols contained in the Dietary Supplement Health and Education Act (DSHEA).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.
FDA targets supplement manufacturers, falsely accuses them of selling drugs
(NaturalNews) In the eyes of the US Food and Drug Administration (FDA), there is no difference between a legitimate, scientifically-backed health claim, and a phony, made-up claim, as it concerns food and dietary supplements. Only FDA-approved drugs, you see, provide real health benefits, according to the agency.
FDA Approves New Test for Hepatitis C
Abbott just announced that it has received approval from the U.S. Food and Drug Administration to market its RealTime PCR (polymerase chain reaction) test for measuring the viral load of hepatitis C (HCV), the leading cause of liver cancer in the United States.
