“This bill will save lives and restore America’s confidence in the use of dietary supplements.”
Those were the words of Senator Dick Durbin last March when he introduced Senate Bill 722 (S. 722) titled the “Dietary Supplement Safety Act of 2003.”
What Senator Durbin didn’t mention is that S. 722 will broadly expand the FDA’s authority to control the dietary supplement market.
Simply put: these regulations will seriously inhibit your current freedom to make your own health decisions. But there is something you can do to help prevent this from happening.
Lives left behind
First let’s talk about saving lives.
There are many hundreds of deaths each year associated with aspirin and acetaminophen. (By some estimates, aspirin-related deaths alone number more than 1,000 per year.) These pain killers are manufactured by many companies, but the major players are Bayer (the maker of Bayer Aspirin, of course), and Johnson & Johnson (the maker of Tylenol) – two of the largest drug companies in the world. They both have deep pockets to fuel very aggressive lobbying efforts in Washington.
So don’t expect to hear any senators calling for a ban of aspirin or acetaminophen. (Deaths? What deaths?)
Ephedra, on the other hand, is a sitting duck.
S. 722 doesn’t mention any specific supplements, but Senator Durbin’s press release uses the recent controversy surrounding ephedra to promote the fear of supplements. Senator Durbin states that 117 deaths have been attributed to ephedra. (That’s 117 deaths TOTAL – not 117 per year.) What he doesn’t mention is that almost all of these deaths involved a synthetic form of ephedra – a drug, in other words – called ephedrine, in which the active agent of ephedra is boosted to levels that can be dangerous if not taken as directed.
When used properly, ephedrine is a strong weapon in the battle to control your weight. And, more important, the actual herb ephedra is an effective treatment for asthma. If ephedra is banned, the main winners will be pharmaceutical companies that make asthma drugs.
So when you hear lawmakers talking about “saving lives,” and “protecting the public,” be aware that their targets are very selective when it comes to the products they want to see banned.
Get out your handkerchiefs
Senator Durbin wants you to think that the poor folks over at the FDA are working with their hands tied behind their backs. His press release states, “The burden is currently placed on the U.S. Food & Drug Administration (FDA) to prove that they are unsafe before the agency can take any action against dangerous dietary supplements.” And according to Durbin, “this places an unreasonably high hurdle in the path of effective agency action.”
Senator Durbin knows better. The FDA currently has the power to pull any product off the market that it deems to be unsafe.
The inquisition
Under S. 722, the FDA will have the power to remove an entire class of supplements from the market if there is even a single serious adverse reaction complaint filed. This will be the case even if the complaint is filed by someone who has used the supplement in contradiction to the instructions and warnings of the manufacturer.
In such an instance, the manufacturer will be required to demonstrate the safety of the supplement. This process is expected to put a heavy financial burden on accused manufacturers – heavy enough to drive some out of business. For those supplements that do reach the evaluation stage, the FDA will set the standards for the evaluations and then determine if the standards are met. In effect, the FDA will act as prosecutor, judge, and jury, while accused manufacturers foot the bill against a stacked deck.
That’s like asking a death row inmate to pay an electric bill in advance for his electrocution.
Chipping away at freedom
Will S. 722 save lives? I seriously doubt it. Behind this bill there’s a naive idea that a law to strengthen regulations can make everything all right. And yet the current regulations that promise safety for prescription drug users somehow let many thousands of lives slip through the cracks every year. Increased regulations can’t guarantee safety, but they do guarantee greater power for regulators.
And when that power is increased, what then? Here’s a comment from a recent e-mail I received from HSI Panelist Allan Spreen, M.D.: “I’m convinced the Dietary Supplement Safety Act is merely a stepping stone to complete control. The FDA has been very upset about the passage of DSHEA (the Dietary Supplement Health and Education Act (DSHEA) of 1994 – specifically designed to help protect the supplement industry from unnecessary constraints). I think the FDA will piecemeal DSHEA away as fast as possible, if possible (and I believe it is).”
S. 722 may come before the Senate for a vote before the end of this month. And although it has good support, its passage is not a foregone conclusion. I strongly urge you to take a moment to send a brief letter or e-mail to your state Senators. (You can easily find Congressional addresses and e-mail addresses at congress.org just by entering your zip code.)
Tell your Senators that you oppose S. 722 (the “Dietary Supplement Safety Act of 2003”), which will limit your freedom to make your own health care choices with the responsible use of dietary supplements. Tell them that S. 722 unnecessarily expands the authority of the Food and Drug Administration, while offering no more protection for consumers than is already granted under the Dietary Supplement Health and Education Act (DSHEA) of 1994.
Think of S. 722 is a staging area from which the FDA will prepare to slowly but surely dismantle the dietary supplement freedom that we’ve enjoyed for almost a decade under DSHEA. The first line of defense is to convince our senators that this act is unnecessary and will do more harm than good.
Please share this e-Alert with a friend and help get the word out about S. 722.
To Your Good Health,
Jenny Thompson
Health Sciences Institute
Sources:
“Dietary Supplement Safety Act of 2003” Senate Bill 722, 3/26/03, congress.org
“Durbin Moves to Prevent Sale of Dangerous Dietary Supplements like Ephedra” Dick Durbin Press Release, 3/26/03, durbin.senate.gov
“FDA Moving to Dismantle DSHEA” Smart Publications, 4/25/03, smart-publications.com
“An Urgent Call to Action: Your Right to Use Nutritional Supplements is in Jeopardy” Julian Whitaker, M.D., 7/17/03, drwhitaker.com
“Toxicity, Acetaminophen” Susan E. Farrell, M.D., emedicine.com
