Saturday, October 13, 2007

U.S. marshals seize supplements promoted as cures

See my notes at the end of this story - Tony Isaacs

Fri Oct 12, 3:36 PM ET

WASHINGTON (Reuters) - U.S. marshals seized $71,000 worth of goods from a Florida company that illegally marketed supplements to treat serious conditions such as diabetes, anemia and high blood pressure, the U.S. Food and Drug Administration said on Friday. It said FulLife Natural Options, Inc., of Boca Raton, Florida, was marketing Charantea Ampalaya Capsules and Charantea Ampalaya Tea as an unapproved drug.

"These claims are evident in the products' labeling, including promotional literature and FulLife's Internet Web site," the FDA said in a statement.

"Despite FDA's warnings, the firm failed to bring its marketing into compliance with the law. During subsequent inspections, FDA inspectors found that the offending claims were still being made."

It said marshals also raided Charron Nutrition of Tallahassee, Florida, last August, which was promoting its Glucobetic, Neuro-betic, Ocu-Comp, Atri-Oxi, Super-Flex, MSM-1000, and Atri-E-400 capsules as treatments for diabetes, arthritis and other serious health conditions.


Thank God it was a plant that has been used for centuries instead of a real aproved drug like Fosmax, Gardasil, Avandia . . . .

People, this is an example of what the fight for health freedom is all about! It is exactly what the FDA, through their underlings at the State of Texas Agencies, are intending to do to Utopia Silver.

The public spoke loudly about their desire to have access to dietary supplements when DSHEA was passed over mainstream objections. The supreme court has ruled more than once on the issue of first amendment protection of freedom of commercial speech as it specifically applies to vitamins, minerals and supplements. And our forefathers damned sure did not envision a government agency run amuck that would so go against the will of the people and the law itself.

Let's take a closer look at what this is all about:

Here is the "horrible" and dangerous offending website:

But where are all the outrageous claims? Looks lke a pretty good site to me. Commercial but reasoned, and a lot of good information too. Let's see that the FDA warning letter can tell us about what it was the FDA found objectionable

Doctor and patient testimonials? Factual statements about a natural plant? What they are talking about here is Bitter Melon (Momordica charantia) - with a history of safe and effective uses dating back centuries. Note this excellent description of bitter melon on the RainTree Rainforest Plant Database:

Take a good look at what bitter melon has been used for, all the countries it has been used in, and just look at all of the many, many studies that actually have been performed. And yet, the FDA contends that it has not been proven safe and effective? Only by rigging the rules to make up their own definitions!

Let's be real - the problem with the studies is that they were not conducted by a pharmaceutical company to support an altered and patentable abomination. Look at this language in the FDA letter and see how they use it to suppress competition to their lords and masters and circumvent the will of the people and supreme law of the land:

Furthermore, your product is not generally recognized as safe and effective for the above referenced conditions and therefore, the product is also a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. 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. Your product "Chararttea" is also misbranded within the meaning of section 502(f)(1) of the Act, in that the labeling for this drug fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)].

This is just such total hogwash. We all know how little harm dietary supplements cause, despite the FDA and a trillion dollar industry's best attempts to make mountains out of every mole hill they can find or allege to find. How can there be ANY doubt as to who the FDA serves? It surely is not the will of the people, nor is it anywhere near the will of our founding fathers or our constitution.

As Thomas Jefferson observed, the government is supposed to be a servant of the people and not vice versa. And as oour founding fathers wisely decreed in the Declaration of Independence, when the government fails to serve the people and their unalienable rights, it is our duty to change the government or replace it.

In the instance of the FDA, which has become a law and government unto itself, the time to exercise that duty seems to have arrived and then some.

An outrage!

Tony Isaacs