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April 27, 2007 at 13:38:43

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FDA ATTACKS HEALTH SUPPLEMENTS- April 30 deadline for comment

by Anne Mendenhall     Page 1 of 1 page(s)

www.opednews.com

 

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For anyone using or supporting alternative products or procedures .. this is a heads up. Please read and heed immediately. Time is short for making comment. I have put this information together from several sources.

FDA, which has jurisdiction over what goes into our mouths, skin, veins and muscles, has a draft document that proposes to reclassify dietary supplements as medicines, not food which they currently are. This has alarming ramifications.

Vitamins, minerals, herbs, essential oils, Ayurvedic products, homeopathic remedies, nutritional supplements, plant enzymes, et al, if classed as ‘medicine’, must be subjected to all the standard drug testing procedures and must be procured only via prescription which must be issued only by a medical doctor. It’s not a stretch to predict that cranberry juice used to treat bladder infection or garlic used to treat respiratory infection will be considered ‘medicine’ and regulated as such. Only licensed medical doctors may prescribe ‘medicines.’ Anyone else who advises, advocates, counsels, distributes, markets, recommends or suggests use of any of the alternative ‘medicines’ is practicing medicine without a license. Alternative procedures used to treat what AMA might see fit now or in the future to classify as a ‘disease’ [i.e. ‘restless leg syndrome’] would then be ‘practicing medicine’. Aromatherapy, auricular therapy, biofeedback, color therapy, homeopathy, hypnotism, naturopathy, neurotherapy, nutritional consulting, reflexology, sound therapy and wellness consulting are among the alternative health modalities being redefined as "Alternative Medicine."

The new FDA terminology is CAM standing for Complementary and Alternative Medicines, not Modalities.

Click below for the FDA Docket # 2006D-0480 "Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration; Availability"

http://www.accessdata.fda.gov/scripts/oc/dockets/comments/getDocketInfo.cfm?EC_DOCUMENT_ID=1451&SORT=&MAXROWS=15&START=136&CID=&AGENCY=FDA

Link to proposed policy document on FDA site. http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-3259.htm

This is all about pharmaceuticals implementing Codex Alimentarius to eliminate competition from low cost and easily available alternatives.

To read more and to comment to FDA go to http://www.healthfreedomusa.org./

Contact your Senator or Congressperson to let them know what you think at this site:
http://www.congress.org/

Our health is highly dependent upon having quick and easy access to alternatives. Send your comments right now to FDA with the docket number.

 

Take action -- click here to contact your local newspaper or congress people:
FDA Attack on Health Supplements

Click here to see the most recent messages sent to congressional reps and local newspapers

http://truthspeakertwo.blogspot.com

I am a retired Biodynamic farmer, a retired farm certification director, and a lifelong community activist.

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Kathryn Hedges is an election activist, biology graduate student, and photographer living in Humboldt County, California.
khedges1Kathryn Hedges is an election activist, biology graduate student, and photographer living in Humboldt County, California.

Health Food industry misleads customers into attacking FDA

Thank you for bringing this to my attention.

I don't know if the author is affiliated with the health food industry or is just re-posting this information like a chain letter. As a biologist in a city full of people who fall for every new natural medicine fad, I'm just tired of all this rampant ignorance and those who make money from it.

Every few years, when the FDA comes back to the idea of regulating the supplements industry for consumer protection, the industry deluges their customers with pleas to protect it against the FDA. These pleas invariably turn out to be distortions of the actual proposed regulations, and generally contradict the examples given in the text! I went to the FDA website and actually read the document, all 14 pages of it. The FDA is not saying that "cranberry juice will be considered a prescription drug" unless someone insists on saying it is a treatment for a medical condition. If they say it's "beneficial for urinary health" they can sell as much of it as they like, as long as it meets safe production standards. 

The "complementary and alternative medicine" industry has gotten big enough that they have a lot to lose if sales drop when they have to stop promoting unproven materials as medicine. If it's a supplement, call it a supplement; if it's a food, call it a food; if it's a drug, it should be subject to the same standards of safety and efficacy as mainstream pharmaceuticals. If the industry can't meet these standards, maybe the public needs to be protected from it. All they have to do to avoid the ridiculous "prescription from an M.D. to drink cranberry juice" scenario is (a) be careful in the wording on the label and (b) don't act like a doctor and "prescribe" it to treat a condition. 

Here's what I posted to the FDA. Thank you for giving me the opportunity to speak up from the scientific point of view.

I agree that Complementary and Alternative Medicine products that are marketed and used as drugs and medical devices should be regulated as such to protect consumers from unsafe and ineffective products. Although I'm not sure I trust the FDA these days, there are too many gullible consumers who think anything at the health food store is safe and effective. And there are too many quacks who make a fortune off them by selling New Age "natural remedies," many of which don't contain standardized ingredients or are contaminated. Before I studied biology, friends talked me into taking Chinese medicine for allergies that worked great--because it was laced with prednisone. I didn't know that, so my doctor didn't know when I went for minor laparoscopic surgery, and I ended up hemorrhaging severely; this led to peritoneal adhesions post-operatively. People also don't understand that natural things can be unsafe because they make a false dichotomy between manufactured chemicals and naturally-occurring chemicals. Plants are not manufacturing drugs to help us--they're conducting biological warfare on pests, and some of these compounds can have beneficial uses (subject to proper dosage). As a graduate student in physiology/toxicology with a background in chemistry, I've learned a lot about how various chemicals interact with the body. Unfortunately, most people who believe in CAM either don't know their science or don't know how to apply it to real life. The health food industry is an industry too--the suppliers of those bottles of herb capsules are making money just like Big Pharma does on theirs. So they go around lobbying people and claiming this legislation will outlaw cranberry juice because you can drink it to prevent UTIs. No, it just outlaws selling it with a label saying "Prevents UTIs!" or telling customers they should just get some juice instead of going to an M.D. for treatment. If their argument has merit, they shouldn't have to distort the truth to support their cause. Alternative medicine is still medicine, and I agree these products should be regulated as such.

I'm sure my voice will be drowned out by the many lemmings who don't bother to read the real document and believe the types of claims the author makes in this post.

by khedges1 (0 articles, 0 quicklinks, 1 diaries, 19 comments) on Saturday, April 28, 2007 at 3:26:59 AM
 


I am a retired Biodynamic farmer, a retired farm certification director, and a lifelong community activist.
Anne MendenhallI am a retired Biodynamic farmer, a retired farm certification director, and a lifelong community activist.

author reply

First let me say that at the eleventh hour, shortly after I submitted this article to OpEd News,  FDA extended the comment period to May 29.

I believe the threat is real.  I am not involved in the health supplement industry except as a consumer and I most definitely want to be able to access the products which I choose to use for my health.

I believe that a major tactic of those trying to limit our freedoms is to say 'why worry, we're really not doing anything differently' or 'we are doing this to protect the public which is confused'.  Sorry but I am not confused.  This is a major push to get Codex Alimentarius guidance on vitamins, etc inserted into law.  Codex is controlled by major players in world markets, not by people concerned about my freedoms.

Here is a section of the new FDA guidance:

These statutory definitions cover some CAM products.
a, neither the Act nor the PHs Act exempts
CAM products from
regulation. This means, for example, if a person decides to produce and
sell raw vegetable juice for use in juice therapy to promote optimal health,
that product is a food subject to the requirements for foods in the Act and
FDA regulations, including the hazard analysis and critical control point
(HACCP) system requirements for juices in 21 CFR part 120. 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 under the Act.

In other words, if I just want a drink and reach for cranberry juice, all is well.  If I intend to use it in any form for a physical complication, it becomes regulated.  Many of the alternative products I use for my health have no other use except to control a physical health condition, therefore could not be on the market under this guidance.

Every law that ever took away a freedom is promoted on the basis of helping us.  Thanks, but I will fight for the right to make my own decisions.  Having had some experience with Codex guidance in the past, I believe this threat is real and I take it seriously that unless we stand up for our freedoms, we will lose them.  It happens every day while we look the other way or are told it's really nothing to worry about.. 
 

by Anne Mendenhall (5 articles, 0 quicklinks, 0 diaries, 8 comments) on Saturday, April 28, 2007 at 6:21:32 AM
 


Professor Bagnolo is a Renaissance man: Cultural Anthropologist, Architectural designer, painter, writer, novelist, theologian. As a child prodigy, abed with polio for almost two years, with an off the charts IQ, reading at the graduate level by 5th grade, offered an opportunity to skip three grades at age 8.Later He was a recipient of an Art Institute scholarship at age 11, a Ford Foundation Fellowship in Anthropology and in Painting and a merit scholarship in art, and was appointed a Graduate ...

to see more of bio, click on member name

Professor Emeritus Peter BagnoloProfessor Bagnolo is a Renaissance man: Cultural Anthropologist, Architectural designer, painter, writer, novelist, theologian. As a child prodigy, abed with polio for almost two years, with an off the charts IQ, reading at the graduate level by 5th grade, offered an opportunity to skip three grades at age 8.Later He was a recipient of an Art Institute scholarship at age 11, a Ford Foundation Fellowship in Anthropology and in Painting and a merit scholarship in art, and was appointed a Graduate ...

to see more of bio, click on member name

Anne

Professor Emeritus Peter Bagnolo, here. I share your feelings about the ever covetous AMA. If I have my way, there will be a purging of such "organizations". Isn't it interesting that very forces of evil who hate unions, love unions of the super wealthy corporate manipulators.

The Military, Medical, Industrial Complex is a part of the most evil cabal ever seen on this planet. Monsanto and others in the toxic chemical "legalized" drug dealers of the world cabal, cannot patent unmolested plants and only recently since the Supreme court was defecated upon by Fascist Presidencies, have they been allowed to "patent" Pesticide laden genetically engineered plants. They are a part of the Culture of Death which decrees that since they cannot patent living things which are natural, as God made them through his marvelous science of math and the laws of physics, they have declared war on what God Hath wrought.

These are monsters only in power through their contempt for Humankind and the God who made us.

They eschew the inexpensive health giving in many unengineered, organic natural healing plants, herbs and other healing elements. More Americans have been slaughtered by toxic drugs, and hospitals then by wars, auto accidents and murderers, in recent years, it is time to strip these pernicious avaristic gluttons of their access to the corridors of power.

The writer who chastised you has about as much conscience as a block of stone. Let him debate me on the next in a series of articles, let us see how he fairs against a scientist. My column will be up next week, my third attack on the Huns of "medicine". The altruistic Hippocrates must be turning over in his grave at what the Huns of the AMA have brought to the healing arts. They fear truth and love lies. But their day is coming and not far off, and we will be happy to see the "Medical Terrorists" out of business, when American "Legalized" lethal drug dealers are gone and the major universities become the medical centers of drug research, manufacture, and sales and the evil of overt advertising the addict millions to crap which side-effects are worse than what ails people.

by Professor Emeritus Peter Bagnolo (144 articles, 1 quicklinks, 95 diaries, 1311 comments) on Saturday, April 28, 2007 at 2:42:19 PM
 


woman leftover from the '60's and proud of it.  very interested in issues of racism, classism, sexism and homophobia.  also, holistic health issues and health freedom of choice.  still believe that you are either part of the problem or part of the solution--there is no fence sitting.
tanyawoman leftover from the '60's and proud of it.  very interested in issues of racism, classism, sexism and homophobia.  also, holistic health issues and health freedom of choice.  still believe that you are either part of the problem or part of the solution--there is no fence sitting.

another attack pending 4-30-07

thanks for post.  i was trying to write an article on this but ran out of time.  what needs to be noted is that the Senate is due to vote on S.1082 tomorrow, Monday, April 30, 2007.  This legislation puts the FDA in business, officially, with the Big Pharma industry and gives the FDA more authority to legislate against holistic products.  It needs immediate attention. 

 You can read more on this at the Life Extension website

www.lef.org   

 sorry, but this blog wont allow the full url for the article but you can access it easily once on the site.  there is an 'action' button for convenience.

 time is very short.  what is most notable is the Ted Kennedy is a supporter of this legislation!  so much for liberal congresspeople.

 

tanya 

 

by tanya (0 articles, 0 quicklinks, 0 diaries, 34 comments) on Sunday, April 29, 2007 at 4:06:53 PM
 

 

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