Plan to call fruit juice 'drug' delayed

[Soldier4Christ]

Plan to call fruit juice 'drug' delayed 
Comment period extended to May 29 after plan publicized

A public comment period on a Food and Drug Administration plan to classify vitamins, supplements, herbs and even fruit juice as "drugs" has been extended from April 30 to May 29 after the proposal was publicized in a report by WND.

The extension, which was confirmed in an FDA posting, will allow consumers additional time to comment on the plan, Docket No. 2006D-0480, that opponents say even could classify water as a drug when it is used to "treat" dehydration.

The American Association for Health Freedom, which had petitioned the FDA several weeks ago for an extension, noted that "During April 2007 the FDA came under tremendous pressure from AAHF supporters and many others to extend the CAM Draft Guidance comment period. On April 25, 2007, the FDA website announced the extension of the closing date for public comment from Monday, April 30 to Tuesday, May 29."

On NewsTarget.com self-described Health Ranger Mike Adams noted that the extension came "following widespread criticism by the public" of the plans.

The plan by the agency directed since 2006 by Andrew C. von Eschenbach is the "Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration," which despite the extension remains on a fast track for implementation.

But parents' groups, natural remedy interests, food and herb businesses and others are horrified. A group called Gentle Christian Mothers alerted its constituency in no uncertain terms.

"Please Read!!! The FDA is trying to regulate all things that are considered by them to be treatment for disease. They want to regulate vitamins, herbs, alternative therapies (things like hot stone therapy), even down to juices and holy water," the warning said. "It might mean having to go to a doctor or medical professional for vitamins."

"It does represent a potential major expansion on how foods, therapies, and products could be regulated," said a statement from the Virginia Chapter of the Certified Natural Health Professionals. "Of further concern, is that this document could be used by health freedom 'opposition' and regulators to pressure Congress to change legislation. The language in the document gives us great concern and we cannot allow an agency such as the FDA to finalize the document in its present form."

The groups are urging their constituents, and others, to contact the FDA and express an opinion, or send concerns in writing to: Dockets Management Branch (HFA-305), 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 and reference Docket No. 2006D-0480.

"The document, if approved, specifically medicalizes complementary and alternative therapies, along with the products, supplements, devices and even foods often part of those therapies. By using 'treatment' rather than 'therapy,' – 'medical' rather than 'modality;' the document terminology sets traditional and alternative approaches to well-being and health inside allopathic or conventional medicine in the United States," said Regina Wilshire on her Weight of the Evidence blog.

Members of the Organic Consumers Association also added their voice to the issue, reiterating the AAHF statement that "What the FDA is stating is that they believe that any person (or product) that states 'drink some vegetable juice to prevent [insert disease]' is actually making a drug claim; and if vegetable juice is not recognized by the FDA as a legally available drug in the United States, the person (or manufacturer) making the claim is now subject to prosecution if they are not a medical professional licensed to practice medicine."

"Who is going to fund a $50,000 investigational new drug application to get carrot juice approved as a drug, or the follow-on millions in research dollars to conduct a study on the toxicity ($200,000) and efficacy of carrot juice ($3 million and up.) Keep in mind this would have to be done separately for any disease process carrot juice might have an impact on," the statement said.

The Health Ranger website noted that among other likely developments if the FDA has its way:

    * Growing and selling common garden herbs will get you arrested as a drug dealer.

    * Massage oils and handheld massagers will be regulated as "medical devices."

    * Weight machines will be regulated as "medical devices" and require FDA approval before being sold or used.

    * Raw sprouts and other anti-cancer foods will be regulated as drugs.

    * Bottled water that "treats" dehydration will be regulated as a drug.

    * Foods, supplements, vitamins and homeopathic remedies will disappear from store shelves, pending FDA "review."

    * Vitamin store owners will be arrested and prosecuted for "practicing medicine without a license."

"This could be potentially devastating, not just to my business but to any business relating to supplements," Sophy Winnick, a Felton, Calif., mother of four who has been selling Youngevity products for 10 years, told the Santa Cruz Sentinel. "People better get on the horn about this."

The FDA's "draft guidance" on the issue first appeared in December, but federal officials said it was printed in the Federal Register on Feb. 27, prompting the growing storm of protest.

The FDA has reported that approximately one-third of all adult Americans have reported participating in or using some form of "complementary and alternative medicine" and officials estimate nutritional supplement sales total about $5 billion a year in America.

Adams' alert said what this would mean to consumers, "is that things like vitamins and herbs would be controlled by the FDA, and could possibly require prescriptions from a naturopath, herbologist or some other physician, all of which would require you to pay a health insurance company and contribute to the already back-breaking cost of healthcare in America.

"There are those who do not trust the U.S. government to act in the interest of its citizens over the interests of pharmaceutical companies and health insurance providers," he said. "Those people have good reason to feel this way, and the amount of dangerous – DEADLY, even – pharmaceutical drugs that get recalled … is testament to the fact that human beings can be used as guinea pigs because the FDA allows the pharmaceutical industry to release drugs that haven't been properly tested."

cont'd

[Soldier4Christ]

According to his website, Adams suffered from degenerative disease, was nearly obese and diabetic by 30. He became a student of nutrition and natural therapies and gave up all pharmaceuticals, over-the-counter drugs, caffeine and pursued a natural foods diet with exercise.

He lost 50 pounds, his diabetes symptoms vanished and his blood pressured reached 105/60, so he began a writing and teaching career on his own transformation.

As WND recently reported, Merck and Co. had been donating to state legislators across the nation who in return were working to require young girls to be given Merck's $400 vaccine that prevents a virus that is spread only through sexual contact.

WND also has reported on the mandatory anthrax shots for members of the military, even though they had not been fully tested, and the possibility that government officials also could order civilians to be vaccinated.

An essay by Roger Wicke at Rocky Mountain Hi Herbal noted, "The unstated purpose of the FDA, and similar organizations in many other countries, is and always has been the protection of major pharmaceutical company profits. Expensive testing protocols act as a way to keep drugs and herbs within the control of the international cartels. While such tests may make sense for newly synthesized drugs with no track record in cultural tradition or popular usage, they are inappropriate for herb and food products, especially those with a long history of usage."

The FDA, in its announcement, said the federal government has been investigating and monitoring "complementary and alternative medicine" since 1992. It also said "depending on the … therapy or practice, a product used … may be subject to regulation." It also noted there's nothing in any law to exempt alternative medicine products from regulation.

"Not content to dominate the drug trade and send your prescription drugs into the $tratosphere, the Food & Drug Administration is now trying (yet again) to take over the entire health food and nutritional supplement industry so they can shut it down forever, leaving expensive FDA-approved drugs – with their myriad side effects – as your only option for treating anything from Alzheimer's to zits," wrote Jim Rutz, in a WND column.

"The FDA hacks are pooh-poohing the significance of the new guidelines as toothless suggestions that merely 'clarify' and 'change nothing.' Yeah, right. In truth, they're following the classic procedure for passing outrageous laws that wouldn't have a chance without an incremental, camel-nose-under-the-tent approach," he said.

"In reality, 2006D-0480 would eventually change everything, including your life expectancy. The FDA realizes that alternative medicine has far, far more solutions to chronic diseases than mainline medicine does ... and that panics them…"

WND also has reported on an agreement by the FDA and the Federal Trade Commission to a Trilateral Cooperation Charter with counterparts in Canada and Mexico under the auspices of NAFTA and the Security and Prosperity Partnership of North America that will elevate the crackdown on public access to food supplements and vitamins.

"The purpose is to make an end run around any domestic law that interferes with food and drug multi-national corporate profits," John Hammell, a critic of the plan, told WND.

Hammell is the founder of International Advocates for Health Freedom, an advocacy group created to fight globalists' efforts to regulate alternative health treatments, including herbs, dietary supplements, and vitamins.

"A key goal of the Trilateral Cooperation Charter is to limit the public's access to food supplements and vitamins that are fundamental to many types of alternative medicine," Hammell said. "The Trilateral Cooperation Charter is determined to attack the Dietary Supplement Health and Education Act of 1994 by moving to merge our food and drug regulations with those of Canada and Mexico, both of whom are far more restrictive on dietary supplements."

He believes the agenda of the Trilateral Cooperation Charter reflects a globalist desire to advance the interests of the large pharmaceutical companies by reining in the food supplements industry worldwide.

He points to efforts such as the Codex Alimentarius Commission that was created in 1963 by the Food and Agricultural Organization and the World Health Organization, both official groups within the United Nations.

"The Codex Alimentarius Commission claims that their main purpose is to protect the health of consumers and ensure fair trade practices in the food trade worldwide," Hammell explained to WND. "But the truth is that the Codex Alimentarius Commission is dominated by corporate multi-national interests that do not have as their primary concern the health interests of the people they claim they are in business to protect, not if that health interest is better served by alternative food supplements and alternative medicine. They have a business with disease – it's not in their best interests that people be healthy."

[Brother Jerry]

My response on the FDA webpage

Upon hearing and reading this docket I find it completely hilarious that the FDA would consider the regulation of natural supplements and compounds.  The old fashioned remedies that Grandma used to apply would now be considered a medicinal application and thus under the FDA regulations.  So lock up Granny in the state pen for practicing medicine without a license?  PLEASE get real.

I see several issues with this sort of continued Gment involvement with things.
1) increased overpopulation of prisons...cause you will be locking up garden growers, seed sellers, grandma's, and anyone else who happens to put some backing soda on a sun burn...because that would be medicinal use of the product and thus under regulations.
1a) imagine the increased cost to tax payers on this one!
2) Increased insurance cost across the board.  In order to get my daily dose of carrot juice I must now get a prescription from my doctor.
2a) So much for every American getting insurance plan...cause this would just shoot the cost of that in the foot. 
3)Imagine the increased labor load at the FDA in having to get every household remedy inspected for use and authorized by the FDA?  Do you remember all the little things that grandma used to do to make you feel better?  Heck even a kiss on a boo-boo could be classified as medicinal under these guidelines.  How are going to regulate a kiss?!
3a) Just the massive volume of stuff the FDA would have to process itself would take years to go through.  Until approval of V-8 drink as a dietary supplement happens is someone who uses it illegal?  Grandfathered in?  The cost of this task alone makes it unreasonable.
4) So are the native Americans who still practice their ancient ways going to be in violation of the law?  What if I purchase products from them?  What about religious organizations such as the Quakers, Menonites, etc., would they now be breaking the law?

Look if it is a synthetic drug or something that is made by man.  Then the FDA should have something to say about it.  If it involves the packaging, importing, exporting, and preparation of food items then the FDA should be involved.  And I know there are other areas as well that the FDA is involved in.  But if I can grow it, and use it for whatever purpose, whether it be for eating or for medicinal purpose then back off and let me do it....please note I am not talking about narcotics here but maybe something like aloe plants. 

I saw the concern for this is the growing use of alternative meds and practices.  Instead of trying to figure out how the gment can get more control over things, maybe you should be spending more time trying to figure out why people would do that to begin with....like medication costs are too high, insurance is out of control, malpractice suits are crazy, lazy doctors are not dethroned, etc, etc, etc.  There are many many factors to the growing use of herbal remedies, and most all of them come down to a complete mistrust of the current medical field, whether it be the doctors abilities or the insurance costs and coverages.  People are sick of being jerked around one way or another when it comes to their health. 

Pay attention and ask questions.  Don't ask your think tanks in DC...but ask the people you are there to serve.  They would be more than happy to let you know what they think and how they feel.  Always remember that any employee, department, administration, or anything of gment is not there for the gment, but it is there for the people the gment serves.  You want to serve we the people, then do so.


Strike this docket from the records and forget that this sort of idea ever surfaced to begin with.

Sincerely
Jerry Crawford

[Soldier4Christ]

Good letter.