Wednesday, April 25, 2007

Food & Drug Administration To Regulate Alternatives

Happened upon an item that should concern all of us who are interested in taking responsibility for our own health as much as possible, including being informed about vitamins, herbal products, and even the kind of water we consume.

World Net Daily reports

FDA looks to regulate natural substances as drugs, with prescriptions from doctors

The Food and Drug Administration says vitamins, supplements, herbs and other natural substances, including water when it is used to "treat" dehydration, should be classified as drugs, and opponents have only until April 30 to express their concern about the proposals under Docket No. 2006D-0480...

The site links to a form to comment by the deadline which is Monday, April 30th.

The Healthy News Service also provides an informative article with the same link to the comment form, and mailing address for comments...

Another site, newstarget, posts an article Health freedom action alert: FDA attempting to regulate supplements, herbs and juices as "drugs" which outlines what is happening and contains action items.

That article references Jon Barron's informative piece which includes the link to the FDA document in pdf.

What to say if you want to comment on the FDA's Draft Guidelines?

We're trying to obtain an educated and well-informed comment for your information, and ours.

Check back soon.

Form link

FDA's Latest 'Guidance Document' on Complementary & Alternative Medicine

Published on Thursday, April 19, 2007
by Healthy News Service
WHY NOW? Why did the FDA create this document? There are a couple of theories. One is that the National Center for Complementary and Alternative Medicine (NCCAM) asked the FDA to "harmonize" with their way of thinking. Another idea is that importation of products (which is a major concern to the FDA) will soon be a top issue. Functional foods could also be a target (as forewarned by the FDA December meeting on functional foods - read about our response and presentation). Regardless of the why, we do know that the health freedom community was not consulted in the preparation of the document. Furthermore, the clumping of food, products, medical devices, and therapies makes for an awkward, confusing, and unconstitutional "way of thinking" and does not represent what is best for the consumer.

THE IMPACT The draft guidance, when finalized, will represent the agency's current thinking on the regulation of complementary and alternative medicine products by FDA. Though it does not change the law, it does represent a potential major expansion on how foods, therapies, and products could be regulated. 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.

ACTION The comment period expires on April 30. It has been our experience that citizen letters to the FDA during the comment period rarely have an impact on the FDA's decision-making process. This is important to know, since the appropriate response to this situation is not to just be busy (as in writing letters to the FDA) but to be effective. What the FDA has told us is that they want to hear from practitioner groups and trade associations. Remember, that the FDA officials are not elected and generally the wishes of the public fall on deaf ears.

The two things that are most likely to influence the FDA's actions as it pertains to the issues outlined in this document are: Members of Congress who have a variety of mechanisms for shaping the authority of the FDA. State Attorneys General who can threaten legal action if the agency tries to usurp the authority of the states in regulating health care activities within their states.

In consideration of the above, we are taking these actions: We are alerting our Congressional friends about this issue, and asking them to take appropriate action. We will notify you when it is time to write to these elected officials and make your wishes known. We have commissioned an extensive, legal response to the guidance that has the kind of technical detail the FDA bureaucracy wants (or actually DOESN'T want) to see as they strive to give this document the force of law. We are planning to communicate with the proper officials in each state to notify them of the potential for federal interference in state regulatory activities. If you do write the FDA, please send a copy of your concerns to your representatives in Congress. These elected officials DO care about your opinion and your voice matters. Go to to contact Congress.

SUMMARY We believe the CAM Regulation Guidance would set the tone of the FDA in regards to functional foods; alternative medicine therapy, devices, and products; as well as dietary supplements and could help set the stage for future legislation that would restrict access. While public comments to the FDA by individuals are a course of action, we want you to be aware that fighting FDA's "way of thinking" will need a stronger course of action and we are prepared to follow though. We have fought the FDA before and have been successful.

There are numerous issues facing the health freedom community that need attention where your action can make a big different: a draft bill to restrict access to individualized/compounding medicine, the right of the practitioner to practice being threatened by individual states, and Rep. Dingall wanting to "kill" dietary supplements because they are a "snake" to be killed.

Please know that we are working diligently on the important issues facing the health freedom community. It takes both time and money and your financial support is greatly appreciated.

SUBMIT COMMENTS If you would like to submit your written comments to the FDA, please use one of the following methods

MAIL: Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20853

EMAIL: Click here

NOTE: No matter which method, be sure to refer to Docket No. 2006D-0480

Feds eye control of vitamins, supplements – even water!
FDA looks to regulate natural substances as drugs, with prescriptions from doctors

Posted: April 24, 2007
9:30 p.m. Eastern
By Bob Unruh © 2007 WorldNetDaily

The Food and Drug Administration says vitamins, supplements, herbs and other natural substances, including water when it is used to "treat" dehydration, should be classified as drugs, and opponents have only until April 30 to express their concern about the proposals under Docket No. 2006D-0480.

The government agency under the direction of Andrew C. von Eschenbach, who became commissioner in 2006, also has put its "Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration" 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."...

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.

On the NewsTarget website, self-described "Health Ranger" Mike Adams posted one of the alerts.

"What this means to consumers, according to the proposal as outlined in FDA Docket number 2006D-0480, 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," he wrote...

"This move by the FDA is designed to once and for all destroy the 1994 DSHEA law that has made supplements 'legal' while eliminating nutritional supplements and natural medicine from the United States, ensuring monopoly profits and control by drug companies and the FDA," he said.

"Under these proposed guidelines, FDA 'experts' (the same corrupt officials who re-approved 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," Adams continued. "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."

"This is not a drill. It really is time to be alarmed," he said. "Nothing else I've written about this year is as important as this sinister plot to destroy natural medicine and force the American population to resort to dangerous prescription medications sold at monopoly prices under a system of medical tyranny."

For example, he cited wording directly from the FDA plans: "…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 regiment…, the vegetable juice would also be subject to regulation as a drug." ...

Link to comment form

Docket Management Comment Form
Docket: 2006D-0480 - Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration; Availability

No comments: