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Thursday, February 09, 2012 4:43:31 AM
You can say it as many times as you like, but I'm right. Calling it "alternative medicine" doesn't alter the fact that by the definiton of the FDA, it's a drug.
Here is the FDA definition of a drug:
"How does the law define a drug?
The FD&C Act defines drugs, in part, by their intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)]."
http://www.fda.gov/cosmetics/guidancecomplianceregulatoryinformation/ucm074201.htm
And here is an example of the Warning letters that they send to companies who try to use the "Alternative Medicine" argument to circumvent the law:
"This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at xxxxxxx in December 2011 and has determined that your products xxxxx and xxxxxxx are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your products with these claims violates the Act. You can find the Act and its implementing regulations through links at FDA's home page at www.fda.gov1.....
New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a)of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective....."
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm286652.htm
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm285654.htm
And there is no "Get out of Jail Free" card with so-called disclaimers, either:
http://en.wikipedia.org/wiki/XanGo
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=68037779&txt2find=warning|Letter
"It is difficult to get a man to understand something, when his salary depends upon his not understanding it."
Upton Sinclair
"Nobody ever went broke underestimating the intelligence of the American public."
H. L. Mencken
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