Sunday, April 29, 2007

FDA Is Strongarming The Vitamin Industry

If you are like me and enjoy taking supplements as part of your low-carb lifestyle, then you will definitely want to read this World Net Daily story about something the Food & Drug Administration (FDA) is currently proposing that could directly impact your life. This may sound like a very sick joke, but it is DEAD SERIOUS!

According to FDA Docket No. 2006D-0480, aka the "Draft Guidance for Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration," the government agency would take over regulation of all vitamins, supplements, and any other natural health remedies. What would this mean? Well, any natural remedy items, even bottled water, would then be considered "drugs" coming under the strongarm authority of the FDA.

In fact, pretty much anything and everything that can be used to treat disease would fall under FDA control. Here's the language they use in this draft proposal:

Biologically based products include, but not limited to botanicals, animal-derived extracts, vitamins, minerals, fatty acids, amino acids, proteins, prebiotics and probiotics, whole diets and “functional foods.” A botanical product intended for use in treating a disease would be generally regulated as a drug. “Functional foods” may be subject to FDA regulation as foods dietary supplements, or drugs under the Act.

If the manipulative and body-based practices involve the use of equipment (such as massage devices) or the application of a product (such as lotion, cream, or oil) to the skin or other parts of the body, those products may be subject to regulation under the ACT.

Does all this sound preposterous? Think again. Imagine this:

Do you own a home gym for medical purposes? It would need FDA approval for use or commerce. How about heading down to your local drugstore to find your favorite vitamins? Good luck because the FDA would need to give their go-ahead. In fact, any store caught selling vitamins without the FDA's magic stamp could be prosecuted for "practicing medicine." Yikes!

FDA Commissioner Dr. Andrew C. von Eschenbach has put this draft guidance on the fast-track for implementation, but they are soliciting feedback from concerned citizens through May 29, 2007. The original date was set for Monday, April 30, 2007, but they decided to extend it for an additional month since there has been such an outcry from the public. You can send your concerned comments and reaction to the FDA about this by using their feedback form.

With one out of every three Americans using nondrug treatments for their health at an estimated cost of $5 billion annually, it appears the FDA is watching out for their buddies in the pharmaceutical industry. The medical establishment doesn't like the fact that people are getting healthy without the use of their overpriced medications. Sure, there are SOME drugs that do some fantastic work, but a lot of people find equally effective relief from all-natural homeopathic remedies.

Ever since I've been taking supplements like so many do on a daily basis as part of my low-carb lifestyle, I have not had to see the doctor because I haven't been sick. That's a fact that apparently doesn't sit too well with the medical profession. It's not all of them, but the people in powerful positions are none too happy that they're losing out on "business" from people who are supposed to be sick. Twisted, ain't it?

We've already seen severe restrictions to vitamins in our neighboring countries Mexico and Canada as well as in Europe where you even need a prescription from a doctor to have access to them. EEEEK! Don't you know the FDA would love to bring this policy to the good ole United States of America. They've been working on it for a while now.

I've previously blogged about the concerted effort to outlaw vitamins in this country before, but the FDA has stepped it up. What makes this bad is the outright corruption that already exists in that government entity and it's well-documented. Can you say Vioxx? Or their approval of the wheat gluten imported from China that was responsible for the pet food contamination that killed thousands of beloved pets? Shall I continue?

From allowing spray-on viruses for luncheon meats to their controversial approval of a risky over-the-counter weight loss drug, the FDA is no friend of the natural health community. Why else would they describe livin' la vida low-carb as "sheer nonsense?" Oh yeah, that's right, eating this healthy is a threat to the drug companies, too!

If you care about this issue as much as I do, then leave your feedback for the FDA TODAY! You have until May 29, 2007 to voice your concerns about this important issue. Let Commissioner von Eschenbach hear from us all!

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Blogger Pot Kettle Black said...

So, here are your choices:
1- An unregulated market (current state)
2- A market with regulation similar to pharmaceuticals (proposed state)

I will take choice #2. Why?
1- Statements. There is currently no regulatory body watching the claims made by the vitamin and supplement community to make sure they actually do what they claim to. I would greatly prefer a world with a third party lab test for efficacy required before statements are made.
2- Quality. Currently, there is no way for you to know if you are getting what you are paying for when you buy a supplement. You don't know about concentration, quality, etc.

Jimmy, I think you are giving in to some fear mongering from the CORPORATE ENTITIES who produce vitamins and minerals. Key line: "With one out of every three Americans using nondrug treatments for their health at an estimated cost of $5 billion annually..." This is a BIG Business that is:
a) Involved in people's health
b) completely unregulated as to quality
c) completely unregulated as to claims
d) currently due to b&c possessed of a huge competitive advantage over the traditional medical produce establishment.

As to your fear mongering:
"Do you own a home gym for medical purposes? It would need FDA approval for use or commerce. How about heading down to your local drugstore to find your favorite vitamins? Good luck because the FDA would need to give their go-ahead. In fact, any store caught selling vitamins without the FDA's magic stamp could be prosecuted for 'practicing medicine.'"

#1 - gym equipment (ie weights) are outside the purview of the FDA, even with this proposed change in the law.
#2 - Use is not personal use. The phrase 'use & commerce' means trade. If you don't sell admissions to your home gym, there is no 'use and commerce'.
#3 - As to Vitamins, why shouldn't someone regulate the claims and quality of them? What if taking alpha-tocopherol alone for your Vit E isn't effective (it's not by the research I have read)? Should a Vit E be sold that is 100% Alpha-tocopherol? Many are. And how do you know that you are getting what it says you're getting on the label? Consumer Reports did a study and they conclusively said you don't.

Jimmy, the hype and paranoia about this is the junction of soon-to-be-regulated scam artists and anti-government libertarians. Ask your local libertarian who is going to guarantee your quality on something you can't monitor for yourself.

4/30/2007 1:42 PM  
Blogger Science4u1959 said...

von Eschenbach? Sounds very German to me. Hmmm. Like I said before, there are no good Government intentions anymore.

Pot Kettle Black: Did you read the actual text of S1082? It is not exactly reassuring. In fact it would completely defunct Dietary Supplement Health and Education Act of 1994 (also called the DSHEA). What is more, however, is that S.1082 would actually create a pharmaceutical company inside the FDA called the Reagan-Udall Foundation for the Food and Drug Administration, and it gives them incredible powers. In fact so many powers that it is un-democratic. And the way they are pushing this is highly suspect too. It is scheduled for an unrecorded voice vote in the Senate. Apparently Sen.Kennedy (who should be ashamed to blemish his famous family name on this) doesn't want us to see how our Senators voted on this voluminous 262 page piece of legislation.

I've already seen it called "easily the most Orwellian piece of legislation to come at us since the Patriot Act" and I've heard comments from several legal experts in the same vain. Not very reassuring either.

I think Jimmy is right... this legislation is a very real threat to your and our health, and to democracy. Again, there are no good Government intentions anymore...

4/30/2007 2:29 PM  
Blogger Ed Bellinger said...

Hi Jimmy,
I take over the counter digestive enzymes because they cost less than 20 dollars a month I was using perscription enzymes but they cost over 400 a month and I have no insurance. The over the counter ones actually work because I no longer have any pacreatic action because of cancer and surgury. They are a life saver even though the FDA claims there is no proof they work.

4/30/2007 4:45 PM  
Blogger Jimmy Moore said...

PERFECT example, Ed! Those OTC digestive enzymes that help you so much now would rise in cost to the same price as the prescription version if the FDA gets their grubby hands on them. This isn't a game--we need to let them know how much we abhor what they are proposing. I shared my story, how about you?

4/30/2007 4:56 PM  
Blogger CB said...

Hey Jimmy, sorry, but I have to disagree with you on this one.

Full disclosure: I work in an FDA-regulated industry (pharmaceutical) - though I work for a small- to mid-size pharma company. My job duties revolve completely around 21 CFR Part 211 (current Good Manufacturing Practices).

That said, I don't work *for* the FDA; so I certainly no shill for the agency.

On to my point: the original (and fundamental) purpose of the Food and Drug Act is to ensure the safety and efficacy of drug products.

My company sells, among other things, prescription vitamins. Seeing the difference in regulation between our vitamins and our more regulated drug products, I shudder to think of the state of non-regulated OTC vitamins.

I am all for taking OTC vitamins. I, like probably most of the rest of your readers, take supplements. But the truth is, a non-regulated OTC vitamin comes with absolutely NO guarantee of its purity, potency, identity, strength, or quality.

If you would like a more in-depth description of what such regulation would mean, I would be happy to try to help answer questions. But IMHO, expanding FDA regulation to OTC vitamins would be a good - not a bad - thing.

5/01/2007 10:57 PM  

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