DIETARY SUPPLEMENT SAFETY ACT OF 2010 - McCaine

[Guest guest]

From his website

http://mccain.senate.gov/public/index.cfm?FuseAction=PressOffice.Speeches & Conten\

tRecord_id=952dda07-b71c-4034-4f34-c38974978f7d

SENATOR JOHN MCCAIN INTRODUCES THE DIETARY SUPPLEMENT SAFETY ACT OF 2010

February 3, 2010

· Like many of you, I am looking forward to watching the Super Bowl this

Sunday and the Winter Olympics later this month. However, a little over a year

ago the NFL suspended six players, including two players from one of the teams

competing this Sunday, for violating the league's anti-doping policy. Several

of the players were surprised that they tested positive for a banned substance

because they used a dietary supplement they believed to be safe and legal.

It is for precisely this reason that today Senators Dorgan and I are proud to

introduce the Dietary Supplement Safety Act of 2010. All Americans should know

the exact ingredients of any dietary supplement they use and the FDA must have

the tools necessary to ensure the safety of dietary supplements.

· This legislation would require dietary supplement manufactures to

register with the FDA and fully disclose the ingredients contained in the

supplement. Surveys have found that a majority of dietary supplement users

believe the FDA approves the safety of dietary supplements prior to market

introduction. However, that is not the case. In fact, dietary supplement

manufacturers' advertised claims of safety and effectiveness are not reviewed or

approved by the FDA.

· Last January, the GAO published a comprehensive report entitled, " The

FDA Should Take Further Actions to Improve Oversight and Consumer Understanding

of Dietary Supplements. " The report stated, " …several factors limit the

agency's ability to detect concerns and remove products from the market. For

example, FDA has limited information on the number and location of dietary

supplement firms, the types of products currently available in the marketplace,

and … once FDA has identified a safety concern, the agency's ability to remove a

product from the market is hindered by a lack of mandatory recall authority… "

· Lastly, the proposed legislation provides the FDA with mandatory recall

authority if a product is found to be unsafe or harmful. It took the FDA ten

years to ban ephedra – a dietary ingredient used for weight loss and

bodybuilding that was found to cause serious medical risks to users including

death. It has been reported that use of ephedra contributed to the deaths of

Baltimore Orioles pitcher Steve Bechler and Minnesota Vikings player Korey

Stringer. Additionally, there are numerous stories of amateur athletes who took

this supplement and experienced serious health problems.

· It is my hope that this legislation will ensure that all Americans,

including athletes, have all the information necessary to make informed decision

when choosing whether to use a dietary supplement, and that the FDA has the

ability to remove any harmful dietary supplements from the market.

The following was from another group ApraxiaDispraxiaBiomedSupport

Sent: Thu, February 4, 2010 5:27:

Subject: Fw: Alert: McCain Bill Attacks Supplements

Senator McCain Files New Bill That Attacks Your Access to Supplements and

Repeals Key Sections of the Dietary Supplement Health and Education Act

TAKE ACTION AND TELL YOUR SENATOR NOT TO CO-SPONSOR THIS BILL

Senator McCain's bill is called The Dietary Supplement Safety Act (DSSA). It

would repeal key sections of the Dietary Supplement Health and Education Act

(DSHEA). DSHEA protects supplements if 1) they are food products that have been

in the food supply and not chemically altered or 2) if they were sold as

supplements prior to 1994, the year that DSHEA was passed. If a supplement fits

one of these two descriptions, the Food and Drug Administration (FDA) cannot

arbitrarily ban it or reclassify it as a drug.

These protections are far from perfect. They discourage companies from

developing new forms of supplements. New supplements may be arbitrarily banned

by the FDA or adopted by drug companies in a way that precludes their further

sale as supplements.

McCain's bill would wipe out even the minimal protections contained in DSHEA. It

would give the FDA full discretion and power to compile a discreet list of

supplements allowed to remain on the market while banning all others.

Everyone knows that the FDA is friendly to drug companies (which pay its bills

and provide good revolving door jobs) and hostile to supplement companies. Under

this bill, this same Agency could quite arbitrarily ban any supplement it wished

or turn it over to drug companies to be developed as a drug and sold for

multiples of its price as a supplement.

The FDA will like this because it believes that it can more easily control a few

industry giants. But isn't it more likely that the industry giants will

eventually gain control over the FDA?

The FDA is already misusing the adverse event reporting process that exists.

Drugs rack up thousands of adverse event reports without any action. Just

recently, the FDA yanked from the market a supplement product based on just a

couple of alleged adverse event reports without even allowing the company (an

old and respected firm) to provide any counter-evidence or counter-argument.

The bill also allows the FDA to yank a product (at the company's expense) if

there is a " reasonable probability " that it is " adulterated " or " misbranded " .

Let's remember that " adulterated " could mean there is a minor record keeping

error on the producer's part and " misbranded " can mean that the producer simply

tells the truth about the product. An " adulterated " and " misbranded " supplement

in Orwellian FDA speak may actually be both completely safe and effective.

We must prevent this bill from gaining traction! Protect your access to

supplements by contacting your senators today and asking them NOT to co-sponsor

the Dietary Supplement Safety Act but rather to oppose it.

TAKE ACTION

McCain's Dietary Supplement Safety Act (DSSA) appears to be supported by the US

Anti-Doping Agency (USADA) which is funded by major league sports teams

including baseball, football and others. The recent suspensions of NFL and other

professional sports figures is much in the news, and the goal of the sports

industry appears to be to shift the spotlight from their players to the

supplements industry. In his comments, Senator McCain cited six NFL players

recently suspended for testing positive for banned substances and purportedly

exposed to these substances through dietary supplements.

The problem here of course is one of illegal sale and use of steroids. So why

dismantle the supplement industry in order to control already illegal

substances?

The FDA currently has complete and total authority to stop illegal steroids and,

more broadly, to regulate dietary supplements. If the agency were doing its job,

it could and would have prevented the sale of illegal steroids. The answer to

this problem is not to give FDA more power. The Agency simply needs to do it's

job.

TAKE ACTION

Why would a bill be offered to solve an illegal steroid problem that does not

really address the steroid problem but instead gives the FDA complete and

arbitrary control over all supplements? The answer is simple.

There are a lot of vested interests which are threatened by supplements. Drug

companies do not like them because they represent a low cost, safer, and often

more effective alternative to drugs. The FDA does not like them because

supplements do not come through the FDA approval process and therefore do not

support the FDA budget.

Why not simply require that supplements be brought through the FDA's drug

approval process? Wouldn't that create a level playing field?

That is probably the argument that Senator McCain has been sold. But it is a

completely false argument. The FDA drug approval process costs as much as a

billion dollars. It is not economically feasible to spend such vast sums on

substances that are not protected by patent, and natural substances cannot

legally be patented.

This is the great " Catch 22 " of American medicine. The FDA, which is supposed to

guard and promote our health, is hostile to the kind of natural medicine—based

on diet, supplements, and exercise—that represents the real future of

healthcare. The Agency has either been captured by drug interests or is trapped

in a catastrophically expensive, toxic, and ineffective patented-drug model.

Senator McCain has no doubt offered this bill in good faith. But he has been

sold a bill of goods by special interests. And he has been naïve enough not to

know that he is being used.

TAKE ACTION

This exceptionally bad bill also requires the reporting of all minor adverse

events related to supplements. This is in addition to the already existing

requirement to report adverse events. This will further stack the deck against

small supplement companies by creating new, unnecessary, even more cumbersome,

and of course very expensive administrative hurdles. The result: the

consolidation of the supplement industry into a few big companies.If passed,

this bill will likely result in the disappearance from store shelves of many

supplements currently on the market. In addition to fewer supplements, there

would likely be much lower doses available. Unbridled authority would be handed

to the FDA, an agency that needs a top to bottom overhaul, not ever more power

over our lives.

If McCain's bill passes, we can look to Europe for a snapshot of what we may be

in for: EFSA, the European Food Safety Authority, has sharply reduced the list

of available supplements and is in process of reducing potencies to ridiculous

levels, such as less beta carotene than can be found in half of a large carrot.

Europeans already look to the US to obtain their dietary supplements. If this

bill passes, where will we obtain ours?

Please take action immediately. Tell your senators NOT to co- sponsor this

legislation and to do everything in their power to defeat it. Then forward this

to your friends and family and ask then to do the same!

Gretchen DuBeau

Legal Director, ANH Int.

Executive Director, ANH-USA