Post by wyomama on Apr 26, 2007 20:58:50 GMT -5
ACTION ALERT AND UPDATES
APRIL 20, 2006
FDA GUIDANCE DOCUMENT ON COMPLEMENTARY AND ALTERNATIVE MEDICINE (CAM)
You have probably received emails about a new FDA "guidance" document for
Complementary and Alternative Medicine, published in the FDA's website. This
document reminds us that FDA believes that under certain circumstances any
vitamins, supplements, herbs and even vegetables juices can be treated under
current law as FDA-regulated drugs. FDA believes, it appears from the
guidance, that even massage oils could be classified as "medical devices"
subject to FDA approval. The proposal is posted at
www.fda.gov/ohrms/dockets/dockets/06d0480/06d0480.htm.
Before sending out this alert, we consulted with Jim Turner, our General
Counsel, who described this FDA document as an "opening shot of little
significance in itself" but an indication of the direction that the FDA
would like to go in expanding its regulation of complementary and
alternative "medicine" products. That direction could include making the use
of certain products currently important to the practice of complementary and
alternative medicine (CAM) a criminal offense, including certain products
subject to FDA control used in conjunction with nutritional counseling,
wellness consulting and many other alternative practices FDA defines as
"alternative medicine,".
The comment period ends April 30, 2007. We ask all of you to voice your
protest to this draconian proposal by asking FDA to withdraw this guidance,
so that it goes no further. We also suggest that you urge FDA to conduct
one or more public hearings on how it can effectively defer to state laws
governing the practice of medicine, and can comply with the directions of
Federal Courts to restrict its regulatory practices to the least intrusive
actions available under the law.
Go to the Comment Page to file
your comments in support of natural health care.
To submit comments by letter, be sure to reference FDA Document 2006D-0480:
Guidance for Industry on Complementary and Alternative Medicine Products and
Their Regulation by the Food and Drug Administration, and write to
Division of Dockets Management (HFA-305) Food and Drug Administration 5630
Fishers Lane, Room 1061 Rockville, MD 20853
You may also have been hearing a great deal about the European Codex
Alimentarius lately. We are preparing an Information Alert on this subject
and will be sending it out shortly.
APRIL 20, 2006
FDA GUIDANCE DOCUMENT ON COMPLEMENTARY AND ALTERNATIVE MEDICINE (CAM)
You have probably received emails about a new FDA "guidance" document for
Complementary and Alternative Medicine, published in the FDA's website. This
document reminds us that FDA believes that under certain circumstances any
vitamins, supplements, herbs and even vegetables juices can be treated under
current law as FDA-regulated drugs. FDA believes, it appears from the
guidance, that even massage oils could be classified as "medical devices"
subject to FDA approval. The proposal is posted at
www.fda.gov/ohrms/dockets/dockets/06d0480/06d0480.htm.
Before sending out this alert, we consulted with Jim Turner, our General
Counsel, who described this FDA document as an "opening shot of little
significance in itself" but an indication of the direction that the FDA
would like to go in expanding its regulation of complementary and
alternative "medicine" products. That direction could include making the use
of certain products currently important to the practice of complementary and
alternative medicine (CAM) a criminal offense, including certain products
subject to FDA control used in conjunction with nutritional counseling,
wellness consulting and many other alternative practices FDA defines as
"alternative medicine,".
The comment period ends April 30, 2007. We ask all of you to voice your
protest to this draconian proposal by asking FDA to withdraw this guidance,
so that it goes no further. We also suggest that you urge FDA to conduct
one or more public hearings on how it can effectively defer to state laws
governing the practice of medicine, and can comply with the directions of
Federal Courts to restrict its regulatory practices to the least intrusive
actions available under the law.
Go to the Comment Page to file
your comments in support of natural health care.
To submit comments by letter, be sure to reference FDA Document 2006D-0480:
Guidance for Industry on Complementary and Alternative Medicine Products and
Their Regulation by the Food and Drug Administration, and write to
Division of Dockets Management (HFA-305) Food and Drug Administration 5630
Fishers Lane, Room 1061 Rockville, MD 20853
You may also have been hearing a great deal about the European Codex
Alimentarius lately. We are preparing an Information Alert on this subject
and will be sending it out shortly.