Tuesday, April 24, 2007

FDA Wants to regulate juice?

I have already commented, this is absolutely ridiculous!

Dear Reader,

Here’s a good one: Imagine vegetable juice is a drug.

Crazy thought, isn’t it? And yet, this is exactly what FDA officials are thinking. And I’m not speaking hypothetically. They really are thinking: “If vegetable juice is reclassified as a drug, it will be ours to regulate.”

“But why stop at vegetable juice?”

You can bet they’re thinking that too.

Getting juiced

In the e-Alert “This Is It” (4/16/07), I told you about the FDA plan to impose harsh new regulations on dietary supplements (vitamins, minerals, and herbs), and even food products that might be used to treat health problems.

The proposed guidelines appear in a document posted on the FDA web site. And here’s what the document has to say about vegetable juice: “If the juice therapy is intended for use as part of a disease treatment regimen instead of for the general wellness, the vegetable juice would also be subject to regulation as a drug.”

Do you drink lots of orange juice when you come down with a cold? Under the new guidelines, orange juice would be considered a drug.

Do you find relief from arthritis pain when you take chondroitin and glucosamine? That would be considered drug use.

Do you take curcumin (a component of curry) to help inhibit cancer tumor growth? Again: drug use.

One of the worrying aspects of these guidelines is that they’re vague and poorly written. And fuzzy language will work entirely in favor of the FDA when it comes time to interpret the guidelines. HSI Panelist Jon Barron listed these problems that are likely to unfold if the guidelines are adopted:

* More confusion
* More cost
* Less access to health
* Denial of freedom of access

You can read all of Jon’s comments in his blog at www.jonbarron.org.

An unexpected gift?

In recent days a new wrinkle has developed concerning the deadline the FDA set for accepting comments about the proposed guidelines.

Last week, the American Herbal Products Association (AHPA) informed the FDA of an error found in the Federal Register notice that set April 30, 2007 as the deadline for comments. The original draft guidance appeared in the Federal Register on February 27, 2007, along with this note: “Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.”

In a letter to the FDA, an attorney for the AHPA noted that this would put the actual deadline at May 29, 2007, offering the public much more time to submit comments regarding the new guidelines. Unfortunately there’s been no response yet from the FDA about whether the deadline will be extended, so for the moment we have to assume that the deadline for comments is less than a week away. (If that deadline is extended, I’ll let you know about it as soon as we get word.)

In the meantime, it’s time to raise our voices.

First, I strongly urge you share this e-Alert with your friends and family members who value our right to make our own healthcare choices, unimpeded by absurd regulations that would restrict food consumption in the same way drugs are restricted.

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 (be sure to note Docket No. 2006D-0480, and the title of the document: “Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration”): 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 you can be sure, as always, that we here at HSI will be watching this one closely so we can fill you in on further developments.

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