Alternative Health vs FDA

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OK, I stayed up until the wee hours reading the text of the FDA bills. I put together my comments, and hit enter.


Oh, wait – another new development –

AHH – Newsflash – the link for comments has changed – Click here to leave your comments-

What we are supposed to be reading and commenting on is actually Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration. Aha. There it is. Sorry for the miscommunication – but that’s what was passed on to me. Now it all makes more sense.

Here’s one paragraph that basically sums up the whole thing. Though it is about supplements, the same basic thinking is throughout the document, including the chapter on ‘Food’. It’s only 17 pages long. You should take the time to read it.

“To illustrate how a CAM product might be a “dietary supplement” under section 201 (ff) of the Act, consider botanical products used in naturopathy. (Naturopathy is a CAM whole medical system that views disease as a manifestation of alterations in the processes by which the body heals itself) for example, naturopathic cranberry tablets might be labeled for use to maintain the health of the urinary tract. In this example, the cranberry tablets generally would be regulated as “dietary supplements” under section 201(ff)(l) of the Act if they were labeled for use to “maintain the health of the urinary tract” rather than “prevent urinary tract infections.” The cranberry tablets would be regulated as “drugs” under section 201 (g) of the Act if they were labeled for use to “treat urinary tract infections” even if they were labeled as dietary supplements.”

Here are my comments –

RE: Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration

I would like to comment on the idea that vegetable juice could come under regulation as a drug if used to prevent illness. Of course people eat fruits and vegetables, drink juices, and take supplements to prevent illness. That’s the whole motivation. There is a whole movement to find out more about the benefits of foods and nutrition for just that reason – to stay healthy. We should be screaming from the rooftops about all of the ways that people could be healthier. That would be the American way. But to say that “broccoli removes excess estrogen from your body” now makes it a drug is ludicrous.

To even hint that vitamins, or food items could come under these regulations would be particularly onerous, and drive the costs up to where no one could afford them. As it stands now, eating nutritious food and taking vitamins are relatively inexpensive ways that Americans can control their health issues to some extent.

The concern of the citizens is that the FDA and pharmaceutical industry are tied together to keep Americans sick and drugged for economic benefit. That is the perception. Passing this with any language that takes away the availability of non-medical alternative to managing health will only further cement that perception.

For some reason, the FDA has had an aversion to vitamins. That does not sit well with many of us. I am a 51 year old who has never been in the hospital for anything other than childbirth. I stay healthy on purpose. So do many of my friends and neighbors.

I don’t believe in drugging children instead of letting them get the exercise they need to run off their natural hyperactivity, or taking drugs to help avoid dealing the problems and living as a fully functional member of society, or taking drugs to lose weight. I think we are an over-drugged nation.

Imagine the impact if the FDA were to actually embrace healthy living and encourage the eating of natural foods and taking supplementation to make up for nutritional deficiencies.

Unfortunately, as it stands now, the FDA seems to be the enemy. The FDA is pro drug, and has never endorsed prevention of disease through the use of diet and supplements.

Discussing those issues at this time would not be prudent. The risk assessment portions of pending bill need to be passed and implemented. I would suggest that the discussions that are fueling the fears of Americans be put on the back burner and the important issues on the table such as the ‘unexpected risks’ of drugs now in use be addressed quickly.

Maybe at some future date, the issues of natural health care can be prudently addressed, but I don’t think this is the time. We need to be encouraging people to live healthier, and to educate them about all of the benefits of natural foods – not hiding important information under endless regulation.

Respectfully Submitted,

Carole Pagan

That’s it.

Have a Great Memorial Day Weekend!