This Is It

This Is It

This might be the most important e-Alert I’ll ever send you.

Your healthcare freedom is constantly under attack. And as we’ve just discovered, that freedom has suddenly come under fire as never before.

Always something

Most HSI members won’t be surprised to learn that the FDA has launched a plan to impose new regulations on alternative healthcare – regulations that are far more severe than existing regs.

Attempts like this aren’t new, of course. Over the years we’ve diligently monitored such actions so that we can keep you informed through the e-Alert, the HSI Members Alert, and our web site.

Just last month I told you about a new senate bill called the Safe Drug Compounding Act that would limit the freedom of women to choose a safe alternative to synthetic hormone replacement therapy. So far, there’s no further news about the progress of that completely unnecessary act, but now a much larger threat looms.

This past December, the FDA quietly put a document on its web site titled “Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.” This document is open to public comments until April 30, 2007 – just a few days from now.

After that, FDA officials will evaluate the comments and decide if they dare proceed with a regulation that might actually make it a crime to take vitamin C for a cold without a prescription.

Sound extreme? Absolutely! This is the most extreme attempt to control the sale and use of dietary supplements I’ve ever seen.

The cards are stacked

The FDA document is 14 pages long, but here’s what it boils down t If you use an herbal or dietary supplement to stay healthy or to help prevent an ailment, that’s fine. But if any supplement is used to treat a symptom, then it’s a medicine and will be regulated by the FDA, just like any prescription drug.

And there’s a qualifying statement to that second part: The supplement will be exempted if it is “generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.”

In other words, the freedom to use a supplement to treat a condition will be at the discretion of FDA experts. And given the track record of FDA experts, this is really bad news.

With this spacious latitude, there’s no telling just how far the FDA might go to restrict access to supplements. For instance, they could take a widely used supplement off the market if the label states a benefit; such as using lutein to reduce the damage from age-related macular degeneration, or using chondroitin and glucosamine to reduce joint pain, or using probiotics to address digestive problems – the list goes on and on.

As HSI Panelist Jon Barron points out on his web site (jonbarron.org), under the proposed FDA guidelines even bottled water might be considered a drug if used to alleviate severe dehydration, which is an emergency medical condition.

Time to act!

Just think of all the e-Alerts I’ve sent you with details about supplements that address health problems. All of those supplements might become so tightly regulated that you would have to get a doctor’s prescription to use them.

Of all the times to raise our voices, none is more important than this time.

You can find the full text of the FDA document at this link:
http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf

And you can use this link to submit your comments:
http://www.accessdata.fda.gov/scripts/oc/dockets/comments/COMMENTSMain.CFM?EC_DOCUMENT_ID=1451&SUBTYP=CONTINUE&CID=&AGENCY=FDA

In addition, we also need to let our representatives in Washington know that we strongly resist this attack on our healthcare freedom. You can find the names and e-mail addresses for your congressmen at this web site: congress.org.

And finally, I hope you’ll forward this e-Alert to other people you know who value our right to make our own healthcare choices.