RESPONSE TO THE NEWS CONCERNING THE FDA NOT NEEDING PROOF TO STOP THE SALE OF SUPPLEMENTS

By Arthur M. Evangelista, a former FDA Investigator
Web Site: http://www.qualityassurance.synthasite.com



Posted: 04 April 2004


The Associated Press recently released a news story entitled, "FDA clarifies rules for banning supplements: Agency doesn't need proof of harm to stop sales," which may be found at: http://www.msnbc.msn.com/id/4648840.

"FDA doesn't need proof of harm to stop sales"....WE MUST STOP THIS CRIMINAL CRAZINESS !!!!!!!

"FDA clarifies rules for banning supplements." Don't you mean illegal control of supplements on behalf of the corrupted, criminal, and murdering pharmaceutical cartels??

"Agency doesn't need proof of harm to stop sales"....SAYS WHO ???

This AP news story reads as follows:

Updated: 7:42 p.m. ET April 01, 2004

WASHINGTON - The Food and Drug Administration doesn't need direct evidence of human harm before taking steps to curb sales of a dietary supplement, an advisory panel reported Thursday.

Data from animals, test-tube studies, even similar products can suffice, the panel said.

Still, Congress should require manufacturers to report customers' side effects, thus easing constraints lawmakers have placed on the FDA's ability to protect the public from dangerous supplements, the Institute of Medicine concluded Thursday.

The report promises to bolster new FDA efforts to crack down on risky supplements - and challenges long-held assumptions that the agency must prove an ingredient unsafe before pulling it off the market.

Proof of harm unnecessary....[its called TYRANNY and CORRUPTION!!] Not true, concluded a panel of well-known scientists from the institute and its sister agency, the National Research Council. "You don't have to have proof of harm," stressed Barbara Schneeman, vice provost and a nutritionist at the University of California, Davis, who headed the panel.

The law requires the FDA to demonstrate significant or unreasonable risk from a supplement, something the panel insisted can be done with less strict evidence. The report provides FDA with step-by-step instructions on how to evaluate supplement safety when there isn't clear-cut human data.

[Then, tell me how FDA can remove supplements without clear-cut human data ?????????? SMELLS LIKE FRAUD ALREADY !!!!!!]

By setting a scientific framework for the FDA's work, "it's certainly our hope this is going to allow them to be more effective in identifying substances that could pose a risk for harm to human health," Schneeman explained.

[Like Teflon, aspartame, fluoride, mercury, irradiated or GM foods, bovine growth hormone, certain plastics, chemtrails, MSG, and on, and on.......]

Contrary to frequent claims by supplement proponents, neither an absence of reports of side effects nor a product's long history of use automatically mean it's safe, the report cautioned.

[THEN TELL ME WHAT THE HELL DOES?? IF NOT EMPIRICAL EVIDENCE, THEN WHAT THE HELL ARE THESE PEOPLE TALKING ABOUT???? So, even though I never have a problem with my vitamin C, the FDA BASICALLY NEEDS NO REASON AT ALL TO REMOVE VITAMIN C FROM USE!!!! THIS IS EXACTLY WHAT THEY ARE TELLING YOU HERE...PAY ATTENTION!!!!! THIS IS ILLEGAL...and TOTALLY CORRUPTED!!!]

Indeed, legal "constraints imposed on the FDA make it difficult for the health of the American public to be adequately protected," [PROTECTED FROM THE FDA THAT IS...] the report concluded, calling on Congress to better fund the FDA's oversight of supplement safety - and to mandate manufacturers' reporting of customers' side effects, just like medication makers must.

Sen. Richard Durbin, D-Ill., has introduced legislation for side-effect reporting; support is uncertain.

Industry loosely regulated
The $19 billion dietary supplement industry with products ranging from mainstream vitamins to controversial hormones and stimulants is loosely regulated. A 1994 law sought by the industry means that, unlike most medications, most supplements sold today never had to be proven safe, much less proven to bring any health benefit.

The burden is on the FDA's $10 million dietary supplements office, with a staff of 25, to uncover enough evidence to push risky ones off the market. Later this month, the heart attack- and stroke-causing herb ephedra is slated to become the first supplement formally banned under the law's provisions.

That ban comes after 155 deaths that were linked to the herbal stimulant and a pitched eight-year battle with ephedra supporters. The FDA at first said it lacked enough proof of harm for a major crackdown but later reversed that position. In December the agency set a legal precedent by making ephedra's actions inside the body key to its risk analysis, rather than simply trying to prove it caused individual deaths. [Just an EXCUSE!]

End of AP Article

DEAR FRIENDS: COME MONDAY (April 5th), EACH AND EVERYONE OF US MUST CONTACT and CALL THE FDA AND OUR CONGRESSIONAL CRIMINALS TO STOP THIS PROFOUND PHARMACEUTICAL-REGULATORY FRAUD AND CRIMINAL DECISION-MAKING ABOUT NATURAL SUPPLEMENTS!!

THIS PLAYS RIGHT INTO THE PHARMACEUTICAL CARTELS HANDS....THIS CONFIRMS OUR PREMISE ABOUT THE DRUG FIRMS KEEPING THE PUBLIC SICK....AS HUMAN DRUG CASH MACHINES!!!!

SLAVERY DOESN'T SIT WELL WITH ME.....

Arthur Evangelista

"The liberties of our country, the freedom of our civil Constitution, are worth defending at all hazards; and it is our duty to defend them against all attacks. We have received them as a fair inheritance from our worthy ancestors: they purchased them for us with toil and danger and expense of treasure and blood, and transmitted them to us with care and diligence. It will bring an everlasting mark of infamy on the present generation, enlightened as it is, if we should suffer them to be wrested from us by violence without a struggle, or to be cheated out of them by the artifices of false and designing men." -- Samuel Adams