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9 Reasons S. 3002 Has to Go

By James Gormley, Senior Policy Advisor, Citizens for Health
More Info @ The Gormley Files

1. No phase-in period or “effective date”. Since legitimate dietary supplement companies and health-food stores would not have even one day to come into compliance with the new law, they would effectively be breaking the law the day after S. 3002 is passed.

2. Registration of supplement licensors. S. 3002 would require outfits that license dietary supplements to register their “facilities” under the FDA Food Facility program established by the Bioterrorism Act of 2002. Including these requirements would go against the purposes of the Bioterrorism Act and would serve no useful purpose other than creating more bureaucracy and red tape.

3. Registration of health-food stores. S. 3002 is unclear as to whether the current retailer exception to the Bioterrorism Act registration requirement is intended to be honored for supplement retailers.

4. Product and ingredient registration. The product/ingredient registration process included in S. 3002 is unclear in its use of the terms “ingredients” and “labeling.” As worded, S. 3002 would apparently require duplicate, therefore unnecessary, registration of every product at every point in its distribution! This would be an incredible burden, one that would mandate annual updates, and one that would not protect any proprietary information that is not required on product labels but that that may be required to be submitted in the registration process.

5. Replacement of new dietary ingredient (NDI) requirements with an FDA positive list. FDA received information between 1996 and 1998 from dietary supplement trade associations to record ingredients believed to be marketed in the U.S. prior to the passage of DSHEA. If there is any lack of clarity as to what dietary ingredients are “old,” the agency should initiate rulemaking to formally adopt the ingredients directly submitted by the trade associations.

6. Retailer evidence of compliance. The bill’s proposal to require health-food stores to obtain evidence of compliance with product registration and NDI notifications is would be ridiculously burdensome and something that is not required for other regulated goods.

7. Civil penalties. The bill would establish new, unnecessary civil penalties despite the fact that current law already imposes adequate fines and penalties for violations of the Food Drug and Cosmetic Act.

8. Non-serious adverse event reports. The FDA itself has made it clear that it would not be helpful for the agency to receive boatloads of minor or trivial (and probably not substantiated) adverse event reports associated with dietary supplements. Under current law, dietary supplement companies are already required to maintain records of all adverse event reports for 6 years and the FDA has the authority to inspect these records at any time.

9. FDA recall and “cease distribution” authority. S. 3002, as well as other food safety legislation already introduced in the 111th Congress (such as S. 510), would provide FDA with authority to mandate products recalls when health risks are presented by marketed products, which is fine. However, what is not fine is that S. 3002 would obligate the agency to issue a “cease distribution” order for any supplement identified as adulterated or misbranded, even in the absence of any perceived health risk.

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16 Responses to “9 Reasons S. 3002 Has to Go”

By Karen-Lynette Bauer - 4 March 2010 Reply

What can we do to stop this fascist juggernaut? It’s all about more profits to the pharmaceutical industry, and more control to medical doctors, and elimination of choice about how to manage our personal health.

We need concrete steps to take. I’ve signed every petition, written to my congress people. What else can we DO? How do we take it to the people, to get them to wake up to the fact that their ability to choose how to treat their own health problems is going up in smoke?

By Jeff - 4 March 2010 Reply

Two suggestions for Karen-Lynette:

1. Send emails to all the members of the HELP committee, which is considering this bill (especially the Democrats and John McCain):
http://help.senate.gov/

2. Send an email to Supplement Safety Now, the coalition of sports groups backing S.3002. Demand they withdraw support for McCain’s bill:
http://www.supplementsafetynow.com/about-us/contact-us.aspx

By Dorothy Capes - 9 March 2010 Reply

I am totally against this bill!!

By Dorothy Capes - 9 March 2010 Reply

Totally.Can’t believe that you John McCain submitted this bill.
With draw it now.

By Pam Nelson - 10 March 2010 Reply

Pam Nelson ND CNHP CMT Please oppose this bill
if you only new how many people are alive and healthy today
due to supplements and herbs. Herbs are plants and plants are
food given to by God. Stop the BILL

By B. Dyjak - 10 March 2010 Reply

Senator McCain is part of the problem, albeit, a small part. In case you haven’t noticed, this administration is dedicated to annihilating our freedoms, and eradicating our republic. Whether they will succeed remains to be seen. God willing, they won’t, but they will inevitably do damage. How much, is up to us.

By Michael Bayouth - 10 March 2010 Reply

This is not reasonable for we who use suppliments over the counter in Health Food Stores… as well as other reasons, this Bill is not reasonable.

By Aleta Garrison - 10 March 2010 Reply

Since we are limited in our ability to obtain health coverage it only makes since to take care of our bodies as a preventative measure before we get sick. Allot of us can’t afford organic fruits and vegetables so we rely on vitamins and supplements to fill in where our diets are lacking. After reading the letter to McCain it sounds like they want to prevent companies that take advantage of folks that are relying on vitamins and supplements as a true form of health and prevention. It is unfortunate that there are companies that lie and cheat the poor consumer but there are businesses that do just that. Perhaps the intention is good but the outcome will be bad. Maybe the bill can be reworked or rewritten to eliminate the cumbersome bureaucracy that bogs down good intentions.

By Bobbie Hallig - 10 March 2010 Reply

The power of drug companies never ceases to amaze me. Now they want to control the supplements and our right to them. I guess this will create a kind of black market for some substances. We need to stop this.

By Becky Stewart - 10 March 2010 Reply

Senator McCain,

I cannot believe that you of all people (the presidential candidate I voted for and highly respected!) would want to take away our rights as citizens to purchase supplements that will keep us healthy and fit. Since 1999 I have held fast to a lifestyle of regular supplements and fresh juicing. I can count on one hand how many times I have been sick & had to visit a doctor. Preventive health is where EVERYONE’S attention should be. Doctor offices are overcrowded and getting worse because of people’s choices and very little preventive health education!!! Let’s look in the right direction. Most of the sick people just keep getting sicker! Western medicine is broken! My question to you is why are you wanting to pass this bill???? Is someone paying you off????????????

By bee - 10 March 2010 Reply

We try to be healthy and you all want to take that away to be on drugs. To control the masses and we have to get everything from you guys. Not fair at all I would ask you to not pass this bill

By RUTH DWYER - 14 March 2010 Reply

I am 83 years YOUNG because of choosing to use Vitamins and Minerals to supplement the unhealthy American Diet. We do not know the extent of which nutrients are missing from prepared foods, nor do we know how nutrient dense the soils that grow our food really are. Fact: We the P:eople are, in fact, largely in charge of our own health and to mess with our freedom to purchase Vitamins and Minerals is nothing but a murky, self-serving plan devised by Big Pharma and the FDA for unlimited power, and money and believe me, they want both. There is so much more that could be revealed about this latest challenge to our health but just knowing what is driving them is of first importance. It is all about the Money! And with Money comes the Power!

So, America, please wake up and protest, protest, protest! Your freedoms are being eroded one by one!

By Rick Roybal - 30 March 2010 Reply

Phascist Pharma bastards

By Diane Pacicha - 20 April 2010 Reply

They are trying to take away our rights to choose what we want for our own bodies. And how good we feel after taking vitamins.

By Sue Blake - 14 May 2010 Reply

My question is how many have died from vitamin supplements VS Prescription drugs ??????? When I say prescription, I mean legal and illegally taken.
Folks they don’t want us to have any help or way to treat ourselves when the Obamacare bomb hits.
McCain i a wolf in sheep clothing….

By Shirleyann - 2 November 2010 Reply

Statistics prove prescription drugs are 16,400% more deadly than terrorists
Well, forget “what if.” The tragedy is happening right now. Over 750,000 people actually do die in the United States every year, although not from plane crashes. They die from something far more common and rarely perceived by the public as dangerous: modern medicine.

According to the groundbreaking 2003 medical report Death by Medicine, by Drs. Gary Null, Carolyn Dean, Martin Feldman, Debora Rasio and Dorothy Smith, 783,936 people in the United States die every year from conventional medicine mistakes. That’s the equivalent of six jumbo jet crashes a day for an entire year. But where is the media attention for this tragedy? Where is the government support for stopping these medical mistakes before they happen?

only a fraction of medical errors are reported, according to the study. Actual medical mistakes are likely to be 20 times higher than the reported number because doctors fear retaliation for those mistakes

pharmaceutical industry uses to influence medicine: Null’s study cites an ABC report that said pharmaceutical companies spend over $2 billion sending doctors to more than 314,000 events every year. While doctors are riding the dollar of pharmaceutical companies, enjoying all the many perks of these “events,” how likely are they to question the validity of drug companies or their products?

If the Obama Administration really wants to save lives — a lot of lives — it needs look no further than the chemical war has been declared on Americans by Big Pharma.

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