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Re: twilko post# 13084

Friday, 10/28/2011 1:51:03 PM

Friday, October 28, 2011 1:51:03 PM

Post# of 30974
"If I say that water might make you feel better, then you are saying I should be banned and water should never be provided to anyone. Right?"

Not quite, no.

What the FDA say is that if you say you have treated the water with magnets, ceramic beads or any other method that you claim transmogrifies the water into a substance which is able to treat or prevent diseases such as cancer, AIDS/HIV or indeed any other illness, then it becomes a drug by the very nature of the claims you ae making for it.

It's really not difficult to understand the FDA definition, which is mirrored in the definition of just about every other Regulatory Authority in the world.

Let's try again:

"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

See how that works? There's a whole string of words, but when you read them in sequence - and you don't have to move your lips to do this, some people do it in their head, but you may find it will help - they form a sentence that explains exactly why it is that AquaLiv and NatuRx are drugs by AQLV's claims and by FDA's definition.

Having established that these products are drugs, it then becomes necessary to do a whole battery of pesky tests before they can be administered under trial conditions to humans, and the a whole pile more troublesome and bureaucratic tests before they can be sold to the public.

Those old curmudgeons FDA are plain pernicketty about not allowing their citizens to be exposed to untested and unproven drugs, and every other Regulatory Authority is just the same.

Here's basic summary of what needs to be done:

"Development & Approval Process (Drugs)


American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world.

The main consumer watchdog in this system is the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER). The center's best-known job is to evaluate new drugs before they can be sold. The center's evaluation not only prevents quackery, but also provides doctors and patients the information they need to use medicines wisely. CDER ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks.

Drug companies seeking to sell a drug in the United States must first test it. The company then sends CDER the evidence from these tests to prove the drug is safe and effective for its intended use. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale. The center doesn't actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards.

Before a drug can be tested in people, the drug company or sponsor performs laboratory and animal tests to discover how the drug works and whether it's likely to be safe and work well in humans. Next, a series of tests in people is begun to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit."


http://www.fda.gov/drugs/developmentapprovalprocess/default.htm

And a more thorough backgrounder can be found here:

http://en.wikipedia.org/wiki/Drug_development

I recommend anyone tempted to buy likely biopharma scams like AQLV to read both before giving their hard-earned money to crooks like Craig Hoffman.

"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