--The FDA's Cult of Tyranny ~~
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-Just who do they think they are? I understand (somewhat), when the FDA watches drug prescriptions being handed out by some that call themselves Doctors, who are no more than OTC supplement and false businesses posing to be Medical Professionals. BUT the FDA are trying to take away our rights to buy (or sell) Nutritional Supplements, natural products.

The below was recently posted in the 'Life Enhancement' magazine. ---
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-FDA Proposes Ban on Supplement Research

-Hard to believe, but while we were sleeping, the FDA created a so-called "guidance document". The gist of this ruling was for "Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application". This seems innocuous enough, but when you consider that it applies to medical foods and supplements, you can start to see the writing on the wall.

-The FDA Doesn't Want You to Be Informed~

If you think that the FDA wants you to have scientific information on supplements think again. Their primary "clients" are the pharmaceutical companies who don't like competition. So in the interest of Big Pharma, the FDA has done everything it can to prevent dissemination of scientific information on food and supplements.

-Because a Supplement May Become a Drug, It Is a Drug

Publishing a paper on a nutrient without an IND will mean that the FDA can ban the nutrient in question to be purchased in supplement form. And of course, the issuance of an IND means that no else can sell it as a supplement, aside from the company that pays for the IND (and the study). The public will no longer be able to obtain the nutrients and supplements that were studied, because the FDA says they may become drugs. But that's an aside, drug status or not. They cannot be sold as supplements.

-Nutritional Innovation Will Be Limited~
Under the guidance, research proposals are becoming "too daunting," which in turn limits innovation. Even in the pharmaceutical industry, on company revealed to the Alliance that a proposed study to investigate a popular medical food for secondary uses was rejected by and IRB for not having an IND.

Don't believe for a moment that the FDA will not ultimately benefit financially or grow in power. Once again from the Alliance: "As soon as the research is conducted and published, these nutrients and supplements would essentially become classified as drugs. This alone will stop most research dead in its tracks, and any research that does occur is likely to eliminate access to the very nutrient being studied. Filing the IND application sets up a process that virtually guarantees that any nutrients that are studied become drugs and can no longer be marketed as supplements once that research is published."

The FDA's actions are "administrative power grabs," in which they are vying for more administrative control not only over medical foods and dietary supplements, but also conventional foods. The tragedy is that the U.S. food science research is suppressed and we are all the worst for it.
--The Need for Action~
-There is a dire need to take action! For some reason, the usual comment procedure has not yet taken place and the FDA has opened a request for comments regarding the burden of filing an IND, the first step toward drug approval.

Please let them know that food nutrition research is different than the drug approval process. And make it clear through their website or letters to IRBs that the guidance has not been finalized and therefore legally cannot be enforced. Send your message today <www.regulations.gov>~~<http://www.fda.gov/RegulatoryInformation/Dockets/Comments/default.htm> [Some of the bills are still being considered, some have not yet been voted on.]