McCain's Dietary Supplement Bill: Attempt to Implement Codex

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McCain's Dietary Supplement Bill: An Attempt to Implement Codex

Alimentarius

Published on 02-24-2010

By Turbeville

http://blacklistednews.com/news-7528-0-5-5--.html

A bill recently introduced to the U.S. Senate, the Dietary Supplement

Safety Act of 2010 (S. 3002), by Senators McCain and Byron Dorgan is

possibly the most direct assault on natural health freedom we have seen for

some time. If passed into law, this bill would require all dietary

supplement manufacturers, distributors, and holders all the way down to the

retail store level to be comprehensively registered. It would also allow for

the arbitrary banning of nutritional supplements by the FDA and the

introduction of deceitful reporting of adverse events related to them.

The legislation effectively gives the FDA carte blanche to do whatever

it wishes in regards to natural supplements.

The cover for this legislation is that it is designed to prevent both

intentional and unintentional steroid adulteration of dietary supplements.

The trigger, according to McCain, was six NFL players who were accused of

doping with supplements tainted with steroids. Even with this being the

case, however, the FDA already has the authority to regulate synthetic

anabolic steroids via the Anabolic Control Act of 2004 which permits them to

do just that. Nevertheless, under the guise of the behavior of six NFL

players, an entire market that has been proven not only very safe but very

healthy will be essentially regulated out of business. (NHF)

The Dietary Supplement Safety Act of 2010 would require registration

of any " business or operation engaged in manufacturing, packaging, holding,

distributing, labeling, or licensing a dietary supplement for consumption in

the United States, " definitions which could possibly include even retail

stores that sell herbal and nutritional products. (DSSA p.2) Currently,

under the Dietary Supplements and Non-Prescription Consumer Protection Act,

small retailers are not required to register. This, however, will change

with the passage of McCain-Dorgan's bill. (NHF)

The switch from the current practices of Serious Adverse Event

Reporting to that of simply Adverse Event Reporting is of concern as well.

Existing law requires the reporting of serious adverse events related to the

supplement in question to be reported for regulatory and recall purposes.

The McCain-Dorgan bill, however, removes the language " Serious Adverse

Event " and replaces it with the term " adverse event, " opening up the

floodgates for the most ridiculous possible claims of adverse events such as

bad taste or even dislike of packaging. This " report everything possible "

stance is will vastly increase the numbers of complaints that will hence be

used to add credence to the arguments for banning supplements in the future.

Not only that, but more government bureaucracies will have to be created in

order to organize and sort through all of the incoming " adverse event

reports. " (NHF)

Yet the most frightening aspect of this bill is the immediate effects

it would have on natural supplements. Currently, due to the Dietary

Supplements Health and Education Act of 1994 (DSHEA), all supplements on the

market prior to October 15, 1994 can lawfully be sold in the United States.

However, the legislation being proposed completely reverses this and defines

a " new dietary supplement " as one that " is not included on the list of

'Accepted Dietary Ingredients', to be prepared, published, and maintained by

the Secretary " (DSSA p.5-6). This seemingly slight change in language

actually removes the grandfathering in of supplements on the market prior to

1994. These new dietary supplements will also be considered " adulterated "

unless " there is a history of use or other evidence of safety establishing

that the dietary ingredient when used under the conditions recommended or

suggested in the labeling of the dietary supplement.. " (DSSA p.5) The

registrants are then required to create and maintain a " scientifically

reasonable substantiation file " which is to be made available for the

Secretary of Health and Human Services to inspect at his/her whim. These

products are to be registered at least 75 days prior to market. (NSF)

As quoted above, the bill also mandates that an " Accepted Dietary

Ingredients " list should be created by the Secretary of HHS which will

replace the current guidelines. Such a list effectively gives the FDA carte

blanche to do whatever it wishes in regards to natural supplements. The FDA

is given absolute authority to determine what supplements are allowed on the

" Accepted Dietary Ingredients " list, thereby granting it the authority to

ban any supplement without due process, scientific merit, or even a hearing

simply by refusing to place it on the ADI list. (NSF) The FDA will also be

able to remove supplements from market even after it has allowed it to be

included on its' list. As the bill states,

" If the Secretary finds there is a reasonable probability that a

dietary supplement or a product marketed or sold as a dietary supplement

would cause serious, adverse, health consequences or death, or is

adulterated or misbranded, the Secretary shall issue a cease distribution

and notification order requiring the person named in the order to

immediately - cease distribution of such dietary supplement or a product

marketed or sold as a dietary supplement; notify distributors, importers,

retailers, and consumers of the order; and instruct those distributors,

importers, retailers, and consumers to cease distributing, importing,

selling, and using the dietary supplement. " (DSSA p.9)

The cost of the recall, of course, will be absorbed by the retailer.

(DSSA p.11)

While the Dietary Supplement Safety Act of 2010 is an egregious attack

on Americans' freedom of choice, it is also a symptom of an even larger

problem. The McCain-Dorgan bill is not just another silly attempt by corrupt

politicians to demonstrate that they still have some value to their

constituents, but an attempt to implement Codex Alimentarius at the national

level and move the United States away from our Common Law heritage. The

European Union has already passed similar legislation in the European Union

Food Supplements Directive which has decimated open access to natural

dietary supplements. Canada has passed laws to the same effect in recent

weeks as well.

Works Cited

" Dietary Supplement Safety Act of 2010. " February 2, 2010.

http://mccain.senate.gov/public/index.cfm?FuseAction=Files.View & FileStore_id=2fe\

2fa5d-636b-4705-97df-8318a24f718f

" Bullet Points on McCain's Anti-Supplement Bill S.3002. " National

Health Federation. http://www.thenhf.com/press_releases/pr_19_feb_2010.html

" McCain Anti-DSHEA Bill a Clear and Present Threat to Health Freedom. "

http://www.healthfreedomusa.org/?p=4608