FDA Update #2

In another recent post from the Life Extension Foundation, there is great concern over the potential expansion of FDA powers with Senate legislation S1082. Read on and follow the links if you are concerned about your rights and the safety of the American drug market. Be Well, Janis


U.S. Health Freedom on Verge of Collapse
This article has been reprinted with permission from Newswithviews.com
Major Expansion of FDA Powers will Target Dietary Supplements

A new attack against health freedom, drug safety, and dietary supplements was launched last week by Senator Edward Kennedy (D-MA) with major support from Michael Enzi (R-WY). It is called the Food and Drug Administration Revitalization Act (S1082). This legislation was planned over the past few years working hand-in-glove with the FDA’s dysfunctional management and legal team – meaning this legislation was written for the profits of Big Pharma and Big Biotech AT THE EXPENSE OF SAFETY AND HUMAN HEALTH.

S1082 is a Trojan Horse bill that pretends to address safety issues. Unbelievably, the bill turns the FDA into a drug development company that will expose Americans to new and dangerous biological drugs that have little testing to prove safety or effectiveness. And to top it off, the bill gives broad new regulatory powers to the FDA that can be used to frivolously attack dietary supplements and forward the FDA management’s anti-American globalization agenda.

On April 18, 2007, S1082 was approved by the HELP committee ...and now moves to the floor of the Senate. In a slick move, Kennedy has attached his long-planned FDA/Big Pharma “reform” measures to the renewal of PDUFA (Prescription Drug User Fee Act). Current PDUFA law expires later this year and must be reviewed by Congress. PDUFA allows Big Pharma to pay the FDA fees to speed the approval of its drugs. The new Kennedy bill will increase these FDA bribes to 380 million dollars in 2008, well over 50% of the FDA budget for new drug approvals. This is like paying the mob for protection. Kennedy, by replacing the existing PDUFA law with this new bill (S1082), is ensuring that his twisted legislation is the one that will be put before the Senate for a vote.

Click here for complete article on the Life Extension Foundation website.

FDA limits on supplements and complementary practices update

Friends, I have been receiving petitions and emails regarding the FDA shutting down our ability to purchase supplements OTC (over the counter). This email from my Reiki newsletter clearly sets the record straight. Though it is addressing Reiki practitioners, the information is just as valuable in understanding what the actual facts are. I hate to see the frivolous amount of time and energy people spend on forwarding inaccurate emails, so read on if this concerns you at all. Thanks for reading! Janis

April 27, 2007

Information on FDA ruling not factual

Dear Students of Reiki,

Recently there have been many emails circulating on the internet warning about a new ruling the FDA is about to create that would threaten the practice of Reiki and other complementary practices making it illegal to practice unless you’re a medically licensed health care provider. The emails have also said that our right to use vitamins and herbs will also be threatened by this new ruling so that they will only be available by a doctor’s prescription and even then at very low dosages. People have been asked to protest this ruling by sending emails to the FDA by April 30.

This information is not based on fact. The practice of Reiki isn’t being threatened by any proposed FDA ruling, nor is our right to access vitamins and herbs. The information passed around on the Internet has for some reason been distorted and misrepresented.

In December 2006, the FDA issued a guidance document that commented on an existing ruling. They are not proposing anything new. To summarize part of the existing ruling, it indicates that if a vitamin, herb or food manufacturer states that their product will cure an illness, that manufacturer must first get permission from the FDA before making such a statement. The same is true for any practice such as Reiki. If a Reiki practitioner claims that Reiki will cure an illness, then the practitioner must get permission from the FDA before making that claim.

The National Health Freedom Coalition has reviewed this issue and written a clarification document that I suggest you read for further information. Look specifically at points 5 and 6. http://www.nationalhealthfreedom.org/AlertFDAguidanceDoc.html

Here’s the link to the FDA document http://www.fda.gov/cber/gdlns/altmed.pdf

Sincerely,
William Lee Rand,
President, The International Center for Reiki Training