Followers
DSSA Bill a Big win for Big Pharma?
The dietary-supplement industry is fighting a bid by U.S. Sen. John McCain to force it to disclose ingredients and register with the Food and Drug Administration.
Most of the industrialized world has incredibly restrictive laws governing supplements. People worldwide often purchase supplements from the U.S. because they are freely available at low costs. The Dietary Supplement Safety Act of 2010 would also strengthen recall authority of any dietary supplement the FDA finds to be hazardous.
Obviously, forcing small companies to go through the FDA's Billion Dollar drug approval process would be way too expensive for natural substances that can't be patented, and would drive up the costs of Natural Supplements substantially.
Tucson's Food Conspiracy Co-op on Fourth Avenue is urging visitors to its Facebook page to take action against the bill, warning it would "create administrative hurdles that small supplement companies could not take on, leaving only products from large pharmaceutical companies."
McCain, who is teaming on the bill with Sen. Byron Dorgan, D-N.D., held a press conference in early February to tout it, flanked by several athletes, including swimmer Kicker Vencill, who was banned from the Olympics after taking a tainted supplement. He successfully sued the manufacturer but missed out on the Olympics.
Strong Opposition to DSSA
Stung by rapidly escalating criticism about the bill's intent, McCain made a floor speech last week saying he introduced the legislation at the behest of Major League Baseball, the National Football League and the American College of Sports Medicine, along with several other sports organizations.
He recalled the case of Phoenix Suns' star Tom Gugliotta, who almost died in 2000 after taking a "sleep aid" that sent him into a seizure.
But McCain said the bill was also introduced for the half of all Americans who take some kind of supplement. "People have died from taking dietary supplements, including a young mother and wife who lived in my home state, and thousands have had to be hospitalized or seen by a doctor due to an adverse reaction from a dietary supplement."
Of course, McCain didn't introduce a bill to do anything about the more than 100,000 people a year that die from drug interactions from the Pharmaceutical industry.He said it was about "truth in labeling," saying it only makes sense because Americans can get ingredients off the side of a cereal box or a container of yogurt.
McCain spokeswoman Brooke Buchanan said it's important for consumers to know ingredients, too, because some compounds may interact poorly with or nullify their prescription drugs.
Buchanan said the bill has been mischaracterized by opponents. The biggest misconception? "That John McCain is trying to take away people's vitamins. It's just not true. He wants to make is safer for you to take your vitamins."
All of this could change, however, if DSSA passes. DSSA would change key sections of the Federal Food, Drug, and Cosmetic Act (FD&C), undoing protections in the Dietary Supplement Health and Education Act (DSHEA) of 1994, effectively eliminating free access to supplements.
The importance of DSHEA
The passage of DSHEA resulted from millions of Americans who worked hard to reinforce their freedom to buy and sell supplements. At the time, the Food and Drug Administration (FDA) was alleging that nutrients like CoQ10 and selenium were dangerous and should be pulled from the market.
Though weak in some areas, DSHEA established a foundation upon which free access to dietary supplements would be protected from attacks by drug companies and the FDA.
What prompted DSSA?
McCain's DSSA bill emerged in response to illegal steroid use among Major League Baseball players. Likely instigated by pharmaceutical interests, the bill is being posited as necessary to prevent supplement adulteration.
The FDA already has the power to pull supplements from the market that are contaminated but it has not been doing its job. DSSA is not only unnecessary, but it would actually reward the FDA for its failures. DSSA would also strip DSHEA and give full control of the supplement industry to the FDA.
Registration requirements
DSSA would mandate that all supplement companies register with the Secretary of Health and Human Services (HHS), which oversees the FDA. Any company that refuses to register and comply with HHS would be subject to hefty fines, the classification of its products as "adulterated", and their removal from the market. The new system would burden manufacturers with significant new costs that would cause supplement prices to increase. A new taxpayer-funded bureaucracy would also be created to conduct inspections and oversee compliance.
Reporting requirements
DSSA would require all "non-serious adverse events" received by supplement companies to be reported to the government, regardless of whether or not the events are related to the supplements for which they are submitted. Pharmaceutical companies would have access to these reports which they could use to petition the FDA to have supplements removed from the market. The FDA could also arbitrarily pull supplements from the market if it believes it has "reasonable probability" that there may be a problem.
FDA would decide which supplements are legal
Perhaps the most chilling aspect of DSSA is that it would allow the HHS Secretary to establish a list of permitted supplements. Reversing common law, which assumes all is legal unless restricted, DSSA would allow only what is permitted to be legal.
In a nutshell, DSSA would increase supplement costs for consumers, grant incredible new power over the supplement industry to the FDA, and drastically limit the availability of supplements. Drug companies could also use the bill to remove supplements from the market, patent them, and sell them as drugs!
It is absolutely critical to contact your Congressmen and oppose this bill. LifeExtension Magazine has a convenient "Action Alert" page in which to do so.
The importance of DSHEA
The passage of DSHEA resulted from millions of Americans who worked hard to reinforce their freedom to buy and sell supplements. At the time, the Food and Drug Administration (FDA) was alleging that nutrients like CoQ10 and selenium were dangerous and should be pulled from the market.
Of course, today we know that supplements like CoQ10 have can vastly improve human health, and there are studies that show that CoQ10 can be more beneficial than some of the expressive medications that have been approved by the FDA. In a way, CoQ10 is costing big Pharma Billions in additional profits!
Though weak in some areas, DSHEA established a foundation upon which free access to dietary supplements would be protected from attacks by drug companies and the FDA.
What prompted DSSA?
McCain's DSSA bill emerged in response to illegal steroid use among Major League Baseball players. Likely instigated by pharmaceutical interests, the bill is being posited as necessary to prevent supplement adulteration.
The FDA already has the power to pull supplements from the market that are contaminated but it has not been doing its job. DSSA is not only unnecessary, but it would actually reward the FDA for its failures. DSSA would also strip DSHEA and give full control of the supplement industry to the FDA.
Registration requirements
DSSA would mandate that all supplement companies register with the Secretary of Health and Human Services (HHS), which oversees the FDA. Any company that refuses to register and comply with HHS would be subject to hefty fines, the classification of its products as "adulterated", and their removal from the market. The new system would burden manufacturers with significant new costs that would cause supplement prices to increase. A new taxpayer-funded bureaucracy would also be created to conduct inspections and oversee compliance.
Reporting requirements
DSSA would require all "non-serious adverse events" received by supplement companies to be reported to the government, regardless of whether or not the events are related to the supplements for which they are submitted. Pharmaceutical companies would have access to these reports which they could use to petition the FDA to have supplements removed from the market. The FDA could also arbitrarily pull supplements from the market if it believes it has "reasonable probability" that there may be a problem.
FDA would decide which supplements are legal
Perhaps the most chilling aspect of DSSA is that it would allow the HHS Secretary to establish a list of permitted supplements. Reversing common law, which assumes all is legal unless restricted, DSSA would allow only what is permitted to be legal.
In a nutshell, DSSA would increase supplement costs for consumers, grant incredible new power over the supplement industry to the FDA, and drastically limit the availability of supplements. Drug companies could also use the bill to remove supplements from the market, patent them, and sell them as drugs!
It is absolutely critical to contact your Congressmen and oppose this bill. LifeExtension Magazine has a convenient "Action Alert" page in which to do so.
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