The italicised portions are taken directly from Docket No. 2006D-0480. Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.
(CAM - Complimentary Alternative Medicine, PHS Act - Pubic Healh Service Act)
"...a product used in a CAM therapy or practice may be subject to regulation as a biological product, cosmetic, drug, device, or food (including food additives and dietary supplements) under the act or the PHS Act. Second, neither the act nor the PHS Act exempts CAM products from regulation."
Translation: Anything used in any system of medicine may now be regulated as a drug or medical device by the FDA. This includes a biofeedback machine, acupuncture needles, a cup of herbal tea, massage oil, a glass of vegetable juice or even a bottle of water.
"...if a person decides to produce and sell raw vegetable juice for use in juice therapy to promote optimal health... [and] 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."
Translation: Raw vegetable juice will be regulated as a drug and must be FDA approved as a drug if it has any health effect whatsoever. Handing a cup of raw vegetable juice to someone and telling them it's good for the detoxification of their liver will get you arrested for practicing medicine without a license and promoting an "unapproved drug."
..."biologically based practices" includes, but is 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 generally be regulated as a drug." ..."functional foods" may be subject to FDA regulation as foods, dietary supplements, or drugs under the Act.
Translation: All foods, supplements, superfoods and functional foods may be reclassified as drugs by the FDA, then regulated off the market.
If... the manipulative and body-based practices involve the use of equipment (such as massage devices) or the application of a product (such as a lotion, cream, or oil) to the skin or other parts of the body, those products may be subject to regulation under the Act."
Translation: Massage oils and creams will be regulated as "drugs" and acupuncture needles as "medical devices." Taking this absurdity one step further, massage therapists who use their fingers to touch patients may have their fingers regulated as "medical devices" and be accused of practicing medicine for merely touching patients.
Under these proposed guidelines, FDA "experts" (the same corrupt officials who reapproved Vioxx after it killed over 50,000 Americans) will decide whether herbs, supplements, vitamins or simple devices like massage stones are to be regulated as drugs and medical devices. If the FDA experts, in their infinite wisdom, decide that these things are to be reclassified, they will essentially be outlawed, stripped from the shelves, and regulated out of existence. Anyone who dares to manufacture, promote or sell such products may be branded a criminal and rounded up by armed FDA agents who have a well established history of suppressing natural medicine.
You have until April 30th to make your voice heard on this issue. First, lodge your complaint through the FDA's docket comment form.
Second, write your representatives. The addresses and email addresses of all Senators and Congressmen are available here. A handwritten letter, in your own words, has a hundred ties th impact of a form letter or email. Please take the time two write and mail a letter, even if it is just two sentances.
Third, spread the word! The full text of the docket is linked at the beginning of this post. There are many natural health advocacy groups who are fighting against this. Join them.
Coing soon....Codex Alimentarius.
Tags: fda, health, vitamins, supplements, massage, government tyranny, natural, organic
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avreysmamma Mar. 30, 2008 at 2:50 PM