Friday, January 05, 2007


In the middle of the night the House passed a bill at the conclusion of the lame duck session known as Adverse Event Reporting legislation for dietary supplements (S.3546). The bill was pushed through the Senate and the House by Senator Orrin Hatch (R-UT), also known as the Hatch-et-man. Many Congressional leaders were hoodwinked by Hatch to back the bill, as he passed around letters of various trade organizations to imply the bill had wide support amongst stakeholders (it does not). Others were most likely bribed with threats to hold other legislation hostage in the Senate unless Hatch-et-man’s bill was passed in the House.

AER legislation will enable doctors to viciously attack vitamin supplements based on Big Pharma propaganda, and with the help of the FDA have effective dietary supplements removed from the market. Despite considerable grass roots pressure the House buckled under to Hatch pressure and AER legislation was ramrodded through in despicable fashion while Americans slept. Americans will pay a heavy toll; the von Eschenbach-run FDA, the AMA, and Big Pharma are quite pleased with this huge legislative victory. So are various traitorous trade organizations within the dietary supplement industry itself that sold you out.

What is AER Legislation and What Does it Mean to You?

The idea put forth by Hatch was that there have been and will be criminal dietary supplement companies and this necessitates the entire supplement industry be subjected to mandatory Adverse Event Reporting so as to weed out the “bad actors.” In his recent Senate testimony Hatch pointed to the problems of ephedra and one bad-apple company, Metabolife, that hid serious ephedra-related adverse event reports from health authorities.

During the last six months it was made very plain, behind the scenes, that anyone in the supplement industry opposing AER legislation would draw the wrath of Hatch-et-man and co-conspirator Tom Harkin (D-IA). The public relations spin from the likes of controlled opposition group Citizens for Health (Jim Turner and Elwood Richard, founder of Now Foods) used to support the bill was to make “safe supplements even safer.”

The growing supplement industry would be demonstrating “maturity” and acting responsibly by accepting these draconian FDA-concocted guidelines for regulation. Anyone opposing the legislation was branded as anti-regulation libertarians, dishonest companies, and fly-by-night operations seeking to scam the unsuspecting public. And if that didn’t work we were all told to accept this legislation now or whatever vitamin-hating Senator Dick Durbin (D-IL) will do in the new Congress will be far worse.

Mandatory AER legislation, especially as written, is unnecessary and unwise. It is nothing but an example of expanded government regulation that will reduce the quality of health for Americans. There is already an FDA-voluntary serious adverse event reporting system in place for dietary supplements known as MedWatch. It is easy for a consumer or health care professional to report a serious adverse health event to the FDA via MedWatch. In fact, this voluntary system had over eight hundred serious adverse event reports on ephedra by the mid 1990s and over nineteen thousand by the time the FDA took ephedra off the market, meaning the existing reporting system worked just fine. Who stood in the way of the FDA taking action on Metabolife? You guessed it: Hatch-et-man and Harkin.

Hatch took in $30,500 in campaign donations from Metabolife during the FDA investigation. This is a drop in the bucket compared to the several million of lobbying money taken in by his son, Scott Hatch, as fully exposed in the LA Times back in 2003. The LA Times article explains how Hatch and Harkin (who controlled FDA budget appropriations) chided the FDA for trying to remove ephedra from the market and got in the way of FDA efforts to do anything. It seems the “bad actors” here are Hatch and Harkin. Why do we need mandatory AER legislation for all supplement companies when the source of the problem, politicians for hire, is easy to identify?

Supplement companies have paid Hatch for favors and mob-like protection on a regular basis. Herbalife did it in the early 90’s ($33,750 to Hatch, $129,752 to Harkin) and now XanGo is doing it ($46,200). Paying off a powerful Senator comes in handy when the FDA looks into blatantly false health claims. When asked to comment on the FDA warning letter, Hatch said, "XanGo is well-known in Utah and throughout the supplement industry for its quality products. I know they will take this seriously and work with the FDA to address these concerns."

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