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government ban on natural cures?
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government ban on natural cures?

http://www.lef.org/featured-articles/Dietary-Supplement-Safety-Act-of-2010.htm

I've been saying for years as soon as efficatious natural cures are recognized drug companies will seek to ban them and make their own, adding an isotope or 2...and now the legislation proves that's exactly where they are headed.

kiss your milk thistle goodbye...big brother is looking out for you......not

mb
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34 Comments Post a Comment
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1016618_tn?1299941570
Wow that *****, another piece of the republic being onslaughted.

Thanks Merry

Teetom
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206807_tn?1331939784
Not that I am a J. McCain fan but could you at least post the bill? This seams to be a one sided agenda (witch hunt) with out all the facts. At what point should companies be he held accountable for their claims.
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233616_tn?1312790796
point well taken

here's the legislation

http://mccain.senate.gov/public/index.cfm?FuseAction=Files.View&FileStore_id=2fe2fa5d-636b-4705-97df-8318a24f718f

I think the important thing to remember is there is nothing NOW that prevents a pharma from adding a couple of isotopes on to a natural product...in fact, it's where some of their recent advances have stemmed. But the crucial thing is, if thye plan on selling something for hundreds they have to eliminate the competion and unfortunately some unwary senators are playing right into their hands here. Cheese has done slipped of the cracker on this one.

But then, no one was watching when Bechtel made it illegal for the Bolivians to gather their own rainwater...same ideas....WE will sell you what you need...and you will PAY....in that case, they paid 25% of their income for water with no alternatives, the alternatives were made illegal.

actually legislation in canda of a similar nature came out recently...they marched in the streets and stopped it. Of course government owns the banks and research there...and we are well on our way to the same.

mb
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206807_tn?1331939784
The other side of the coin is that there is no law preventing Mat_  from claiming his juicing recipe is a cure for HCV and marketing it. Getting rich and killing millions.
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233616_tn?1312790796
we could learn from canada
http://www.whale.to/a/c51_policy_statement.html

we could learn from Bolivia as well. Bechtel claimed they would bring SAFETY in drinking water to the people...they didn't tell them that they would then buy votes until the water would cost then 25% of their average salaries, they didn't tell them that they would make it illegal to gather rain water from their own roofs to supplement the high cost...but of course, that all did happen.

sounds Orwelian, but when it happens you have to stop acting like these things can't ever happen here. They happen all over the world...why would we be immune.

mb
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206807_tn?1331939784
  Thanks for posting the bill. I will have to read it tomorrow because I have a Migraine and I have to go to work in the morning.
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233616_tn?1312790796
true enough, but then, there was nothing preventing the drug company from charging me 300K for a cure that didn't work. that's 300,000 dollars when all was said and done.
and the "cure" didn't work.
I could have bought the vegetable juice and done as well, and saved 299,000 K.

But one is considered criminal deceit and the other is not...maybe we need to rethink all that. I mean, one set of molecules doesn't hold all the answers, obviously.

mb
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213141_tn?1270665712
"The other side of the coin is that there is no law preventing Mat_  from claiming his juicing recipe is a cure for HCV and marketing it. Getting rich and killing millions."

I would never accept a single penny for any information about how I healed my Mom and Dad. I give away the knowledge for free out of the goodness of my heart. I would never write a book on it, instead I give it away for free on the internet. I can't hold such wonderful information at ransom, it is meant for everyone, at no cost. Not just for me and my parents.

I've already gotten the reward I wanted. My parents were healed. That is greater than any amount of money or power on Earth in my view. My whole family benefitted from my reward. I would have traded the Sun and the Moon for the lives of my parents if I could have. Every single person on this Earth has more value than all the money and riches of the entire World.

Matt Chin
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206807_tn?1331939784
The point was, there is no law preventing you from making such claims and marketing it.
Claims made with no documentation to back it up (Lord knows we have asked for it).
I rest my case.
<<<<Leaving for work
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Avatar_f_tn
"actually legislation in canda of a similar nature came out recently...they marched in the streets and stopped it. Of course government owns the banks and research there...and we are well on our way to the same. "

They must have done that marching in the streets when I was on treatment, because I missed all the hullabaloo.  When I read the bill, I see protection for consumers.  When others read the bill, they talk in extreme measures that you won't be able to buy natural products any more without a prescription, which is false and misleading.

As for the Canadian government owning the banks, that's patently false.  There is a Bank of Canada and the government regulates banking in this country but the government does not own the banks.  The government regulates banking in the U.S. as well and I say this with no criticism, you could have done with better regulations that might have avoided some of the financial collapses you've seen.  Canada wasn't hit nearly as hard, partly BECAUSE of the regulations on the banks that we have in place.  That isn't because our government owns the banks, we simply have better regulations in place.

As for government owning research - I'm not sure how you've stretched into that one either.  Alot of funding for research comes from the government but that doesn't mean it's the only source of funding for research nor does it mean that no research occurs here without the government saying so.
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Avatar_f_tn
well, I am tired of the government using legislation instead of education to "protect" me, especially when it means that they will be using my money to do so, apply it however they want without accountability to me on how they use or misuse it. Legislation to force me to wear seatbelts, and ticketing me for not doing so; if I am stupid enough to know that it saves lives and choose not to use them, so be it. Legislation to ban plastic baby bottles, instead of recalling and educating folks to avoid them, and this before they have proof that there is a real danger. Legislation to force fast food rest. to post nutritional data and to warn of the dangers of wrong foods, because some individuals stuffed their faces and got 200 extra lbs on them! It is the shift from personal responsibility to blaming everyone else for our lack of common sense. I for one don't feel that the govt needs to protect me from vitamin B supplements.  They already restrict the claims they can place on the supplements, and companies are complying, the reputable ones. I doubt that this legislation's wording  will include what people like Matt can claim.  I think that it will affect the reputable companies only. Matt and people like him can still sell their snake oil without restrictions because they are not organized and incorporated.  I say no to that bill. Thank you for posting this.
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148588_tn?1396462308
I'll take an educated populace willing to take responsibility for their behaviour to a law any day - but how common is that nowadays.

Everyone wants the protection of the FDA, CDC, etc, but they also want the freedom to take whatever they want AND to sue everyone in sight for any side effects.

Please feel free to take anything you want, just don't  cause my healthcare premiums to go up. (Oops, semi-political)
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475300_tn?1312426726
If I remember correctly something like this was talked about a few years ago.  I remember being POed about it.  Don't have time right now to look it up right now but will shortly.
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Avatar_f_tn
"'ll take an educated populace willing to take responsibility for their behaviour to a law any day - but how common is that nowadays. "

I'd take good behaviour from humanity over a law any day myself. It also takes a populace with a common integrity that has the same moral code.  That ain't going to happen.  Laws protect from the unprincipled and the unscrupulous.  Unfortunately, they live amongst us.  If people are going to get angry, get angry at those who cause laws to be made.
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Avatar_f_tn
if this law is going to restrict those that are selling their own personal cures or recipes for cures online to whomever believe in them, I can see how it might protect the vulnerable and gullible,or possibly the general population, but it will affect the companies that are already under the Federal Food, Drug and Cosmetic Act regulation Those that are already complying with labeling, dosage, and ingredients' regulations.
Giving FDA free range to interfere anytime they apply their wide classification  and interpretation of "adulteration" and "reformulation" "adverse"  thereby overwhelming the supplement companies with tons of forms, paperwork that they will have to complete and gather each time they decide to add an antioxidant to an existing supplement, (ie Vitamin C now with Acerola), as well as severe penalties, seems like the govt's way of exercising unneeded control of  these companies. It allows FDA to focus in petty items in order to overwhelm, overwork, and stress them financially   each time they have to provide studies that show Acerola is safe to use.
This Bill will not address all those side ads that we see on this and other health related websites, where there are claims of health benefits by using this or another product, or recipe. Sites that are distributors for the supplement manufactured  in another country. I don't see the need for the mentioned amendments in McAin's Bill, it does seem to be aimed to overwhelm reputable supplement companies in the USA, therefore placing undue demands that might eventually  make it difficult to continue manufacturing and selling in this country.  These amendments in this bill go too far, in my view.  I am contacting my representatives and oppose it. This is just MY opinion and view of this Bill as it reads at present.
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Avatar_f_tn
On another note ..."there was nothing preventing the drug company from charging me 300K for a cure that didn't work. that's 300,000 dollars when all was said and done.
and the "cure" didn't work. "  
  The drug company offers you information with the percentage of people that might be cured, the type of determinants that might influence whether you attain RVR and SVR. They have to charge you, much like Jenny Craig would charge you for their services and  items that claim to help you loose excess wt and keep it off. The fact that some do not achieve the goal does not make the charges unfair and deceiving. Some of us do achieve the cure and some of us do loose the excess wt. I can't see any company that will guarantee your money back if you don't get better or keep your wt off. It is unrealistic.
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Avatar_f_tn
I should clarify that MY comments up above have to do with the Canadian bill C-51 and only because merryBe brought Canada into this.  I have no comment on the American bill as I know nothing about it.  
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206807_tn?1331939784
MerryBe, I asked for a copy of the Bill and you responded with a copy of someone’s opinion of a 2 year old Canadian Bill (C-51 Policy Statement - Canadian Natural Health Coalition)
My heart goes out to you (this is sincere and not a cliché) but you need to provide more evidence and less emotion before making such claims.
Please post a copy of the original bill so we can come to our own conclusion. Thanks, Ricky.
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206807_tn?1331939784
Can you post a copy of the actual Bill?  Thanks, R Glass
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206807_tn?1331939784
“Oops, semi-political”
It is hard to bite the tongue at times.
(Sorry for so many post but I am having computer problems.)
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233616_tn?1312790796
here it is, I posted it above, you just missed it

http://mccain.senate.gov/public/index.cfm?FuseAction=Files.View&FileStore_id=2fe2fa5d-636b-4705-97df-8318a24f718f
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233616_tn?1312790796
I agree, and actually that was not my point. I still think people should treat with pharmaceuticals, it's still the best shot anyone has, albeit far from perfect.

My point however, was the imperfection, was the fact that many Rx type cure have 50, or 40 or even only a 5% cure rate....and that should give us pause, and pause to consider whether drug companies can claim the higher ground here, when in fact some of their cures work no better than their "natural" competitors.  Whether not having the high ground they should be allowed to peddle influences in order to restrain any and everything they don't have a stake in.
That's all.

mb
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213141_tn?1270665712
Here's a UTube video showing how things like juicing should at least be considered as alternatives. Not to say we should abandon all practical medicine.... just that some alternatives or forms of complimentary medicine need a much closer look.

I warn you though that the images in this video are graphic showing horrible looking tumors and disfigurement from cancer that was healed with juicing. The before images are very disturbing, the after images are amazing... viewer discretion is advised.

http://www.youtube.com/watch?v=ShqKk3fasZA
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Thanks, I couldn't open the other link
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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.  

  











#  #  #






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Avatar_m_tn
Sen.  John McCain has introduced a horrific bill, S 3002, the “Dietary Supplement Safety [sic] Act of 2010″ (DSSA) designed to end your access to high potency supplements by giving the bloated, corrupt and dangerous FDA MORE power to destroy supplement access.  This bill is  absolutely NOT to be confused with DSHEA, the Dietary Supplements Health and Education Act (1994), which says nutrients are food and, as food, you can have them in any form – and any amount – you like.  If we allow DSSA to pass, we will be living – and dying – under something very much like the European Food Supplements Directive’s anti-supplement restrictions, implementing Codex Alimentarius’ dietary supplements and nutritional restrictions, to the “T” — effective as close to immediately as the Fraud and Death Administration can manage it. Listen to the Dr. Rima Reports as Dr. Rima interviews Sarah Schones, MD, a German Immunologist practicing natural medicine in Germany: .  Food Supplements are going the way of the dodo in the EU.  The US is clearly next unless we act now – in massive numbers, once for each member of your family, at


http://salsa.democracyinaction.org/o/568/t/1128/campaign.jsp?campaign_KEY=26714

Your legal right to access supplements and herbs will, quite frankly, be a thing of the past. As we predicted years ago, the end of the first decade of the new millennium was intended to be when we lost our Health Freedom. Will you let that happen?

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Avatar_m_tn
The bill being spearheaded by Senators John McCain and Byron Dorgan represents the kind of federal regulation that is not only ineffective, but also suffocates innovation in ways that inflict permanent damage to this nation’s economic vitality.

The bill supposedly originates from the controversy surrounding the use of steroids by Major League Baseball players. Since some unethical companies illegally sold steroid drugs as “dietary supplements,” certain members of the Senate (i.e., John McCain and Byron Dorgan) appear to have been deceived into believing that the FDA needs to be given additional power to ban dietary supplements across the board.

The fact is that the FDA has all the legal authority it needs to remove supplements that contain illegal drugs from the market. The FDA has failed to do its job, and there are companies selling dietary supplements that contain prescription drugs. If the FDA continues to fail to do its job, then these companies will continue to sell drug-tainted supplements no matter what new laws are “created” by Congress.

The outrage over this bill expressed by so many supplement consumers is that it gives the FDA broad and arbitrary new powers to remove natural products from the marketplace. Since the FDA (and Congress) is dominated by large pharmaceutical interests, this bill will effectively enable drug companies to control which supplements you have access to.

You may recall the FDA’s ban last year of a more effective form of vitamin B6 (pyridoxamine) because a pharmaceutical company wants to have it approved as an expensive new prescription drug to treat diabetic kidney failure.



http://www.timebomb2000.com/vb/showthread.php?t=354624
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http://www.youtube.com/watch?v=Tbgv8PkO9eo&feature=related
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AEG10041 S.L.C.
111TH CONGRESS
2D SESSION S. ll
To amend the Federal Food, Drug, and Cosmetic Act to more effectively
regulate dietary supplements that may pose safety risks unknown to
consumers.
IN THE SENATE OF THE UNITED STATES
llllllllll
llllllllll introduced the following bill; which was read twice
and referred to the Committee on llllllllll
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
more effectively regulate dietary supplements that may
pose safety risks unknown to consumers.
1 Be it enacted by the Senate and House of Representa2
tives of the United States of America in Congress assembled,
3 SECTION 1. SHORT TITLE.
4 This Act may be cited as the ‘‘Dietary Supplement
5 Safety Act of 2010’’.
February 2, 2010
2
AEG10041 S.L.C.
1 SEC. 2. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND
2 COSMETIC ACT.
3 (a) DEFINITIONS.—Section 201 of the Federal Food,
4 Drug, and Cosmetic Act (21 U.S.C. 321) is amended by
5 adding at the end the following:
6 ‘‘(ss) DIETARY SUPPLEMENT FACILITY.—The term
7 ‘dietary supplement facility’ means any business or oper8
ation engaged in manufacturing, packaging, holding, dis9
tributing, labeling, or licensing a dietary supplement for
10 consumption in the United States.’’.
11 (b) REGISTRATION OF DIETARY SUPPLEMENT FA12
CILITIES.—
13 (1) ADULTERATED FOOD.—Section 402 of the
14 Federal Food, Drug, and Cosmetic Act (21 U.S.C.
15 342) is amended by inserting at the end the fol16
lowing:
17 ‘‘(j) If it is a dietary supplement that is manufac18
tured, packaged, held, distributed, labeled, or licensed by
19 a dietary supplement facility that is not registered with
20 the Secretary.’’.
21 (2) REGISTRATION OF FOOD FACILITIES.—Sec22
tion 415 of the Federal Food, Drug, and Cosmetic
23 Act (21 U.S.C. 350d) is amended—
24 (A) in the section heading, by striking
25 ‘‘FACILITIES’’ and inserting ‘‘AND DIETARY
26 SUPPLEMENT FACILITIES’’; and
February 2, 2010
3
AEG10041 S.L.C.
1 (B) in subsection (a)—
2 (i) in paragraph (2)—
3 (I) by striking ‘‘An entity’’ and
4 inserting the following:
5 ‘‘(A) FOOD FACILITIES.—An entity’’; and
6 (II) by adding at the end the fol7
lowing:
8 ‘‘(B) DIETARY SUPPLEMENT FACILI9
TIES.—
10 ‘‘(i) IN GENERAL.—A dietary supple11
ment facility (referred to in the section as
12 a ‘dietary supplement registrant’) shall
13 submit a registration under paragraph (1)
14 to the Secretary containing information
15 necessary to notify the Secretary of the
16 name and address of each facility at which,
17 and all trade names under which, the die18
tary supplement registrant conducts busi19
ness. At the time of registration, the die20
tary supplement registrant shall also file
21 with the Secretary a list of all dietary sup22
plements manufactured, packaged, held,
23 distributed, labeled, or licensed by the fa24
cility. Such list shall be prepared in such
25 form and manner as the Secretary may
February 2, 2010
4
AEG10041 S.L.C.
1 prescribe, and shall be accompanied by a
2 full list of the ingredients contained in
3 each dietary supplement, and a copy of the
4 labeling used by the facility for each die5
tary supplement.
6 ‘‘(ii) UPDATES.—Each dietary supple7
ment registrant shall update the reg8
istrant’s registration annually on or before
9 the anniversary date of the registrant’s ini10
tial registration. Each dietary supplement
11 registrant shall also update the registrant’s
12 registration to include information regard13
ing any new dietary supplement, or refor14
mulation of an existing dietary supplement,
15 on or before the date such dietary supple16
ment is marketed for consumption in the
17 United States.’’; and
18 (ii) in paragraph (3), by inserting ‘‘or
19 dietary supplement registrant’’ after ‘‘no20
tify the registrant’’.
21 (c) NEW DIETARY INGREDIENTS.—Section 413 of
22 the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
23 350b) is amended—
24 (1) by striking subsection (a) and inserting the
25 following:
February 2, 2010
5
AEG10041 S.L.C.
1 ‘‘(a) IN GENERAL.—A dietary supplement which con2
tains a new dietary ingredient shall be deemed adulterated
3 under section 402(f) unless there is a history of use or
4 other evidence of safety establishing that the dietary ingre5
dient when used under the conditions recommended or
6 suggested in the labeling of the dietary supplement will
7 reasonably be expected to be safe and, at least 75 days
8 before being introduced or delivered for introduction into
9 interstate commerce, the manufacturer or distributor of
10 the dietary ingredient or dietary supplement provides the
11 Secretary with information, including any citation to pub12
lished articles, which is the basis on which the manufac13
turer or distributor has concluded that a dietary supple14
ment containing such dietary ingredient will reasonably be
15 expected to be safe. The Secretary shall keep confidential
16 any information provided under this subsection for 90
17 days following its receipt. After the expiration of such 90
18 days, the Secretary shall place such information on public
19 display, except matters in the information which are trade
20 secrets or otherwise confidential, commercial informa21
tion.’’;
22 (2) in subsection (c), by striking ‘‘was not mar23
keted in the United States before October 15, 1994
24 and does not include any dietary ingredient which
25 was marketed in the United States before October
February 2, 2010
6
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233616_tn?1312790796

AEG10041 S.L.C.
1 15, 1994’’ and inserting ‘‘is not included on the list
2 of ‘Accepted Dietary Ingredients’, to be prepared,
3 published, and maintained by the Secretary’’; and
4 (3) by adding at the end the following:
5 ‘‘(d) MAINTAINING SUBSTANTIATION FILE.—Any
6 person submitting information to the Secretary under sub7
section (a) shall create and maintain a scientifically rea8
sonable substantiation file relating to the claim that the
9 dietary ingredient or dietary supplement will reasonably
10 be expected to be safe. The substantiation file shall be pre11
pared and maintained in such form and manner as the
12 Secretary may prescribe and shall be available for review
13 and inspection by the Secretary upon request.
14 ‘‘(e) EVIDENCE OF COMPLIANCE.—A dietary supple15
ment facility or retailer shall, prior to manufacturing,
16 packaging, holding, distributing, labeling, or licensing the
17 dietary supplement, obtain adequate written evidence from
18 the preceding responsible entity in the chain of commerce
19 that the product is registered as required by section 415
20 and that the requirements of subsection (a) have been
21 met. Such facility or retailer shall maintain such evidence
22 of compliance for review and inspection by the Secretary
23 upon request.’’.
24 (d) CIVIL MONETARY PENALTY FOR NON-COMPLI25
ANCE.—Section 303 of the Federal Food, Drug, and Cos-
February 2, 2010t (21 U.S.C. 333) is amended by adding at the
2 end the following:
7
AEG10041 S.L.C.
1 metic Ac
3 ‘‘(h) CIVIL MONETARY PENALTY FOR NON-COMPLI4
ANCE.—Notwithstanding the provisions of subsection (a),
5 any person who manufacturers, packages, holds, distrib6
utes, labels, or licenses a dietary supplement in violation
7 of section 301, 402, 413, 415, 501, 502, 505, or 761, may,
8 in addition to other penalties imposed in this section, be
9 fined not more than twice the gross profits or other pro10
ceeds derived from the manufacture, packaging, holding,
11 distribution, labeling, or license of such dietary supple12
ment.’’.
13 (e) ADVERSE EVENT REPORTING FOR DIETARY SUP14
PLEMENTS.—Section 761 of the Federal Food, Drug, and
15 Cosmetic Act (21 U.S.C. 379aa–1) is amended—
16 (1) in the section heading, by striking ‘‘SERI17
OUS ADVERSE’’ and inserting ‘‘ADVERSE’’;
18 (2) in subsection (a), by adding at the end the
19 following:
20 ‘‘(4) ADVERSE EVENT REPORT.—The term ‘ad21
verse event report’ means a report of non-serious ad22
verse events that is required to be submitted to the
23 Secretary under subsection (b).’’;
24 (3) in subsection (b)(1)—
February 2, 2010
8
AEG10041 S.L.C.
1 (A) by striking ‘‘The manufacturer’’ and
2 inserting the following:
3 ‘‘(A) SERIOUS ADVERSE EVENTS.—The
4 manufacturer’’; and
5 (B) by adding at the end the following:
6 ‘‘(B) NON-SERIOUS ADVERSE EVENTS.—
7 The manufacturer, packer, holder, distributor,
8 labeler, or licensee of a dietary supplement,
9 whose name appears on the label of a dietary
10 supplement marketed in the United States,
11 shall submit to the Secretary, in such form and
12 manner as the Secretary shall determine, a
13 compilation report of all non-serious adverse
14 events associated with such dietary supplement
15 when used in the United States, accompanied
16 by a copy of the label on or within the retail
17 packaging of such dietary supplement.’’;
18 (4) in subsection (c)(1), by adding at the end:
19 ‘‘The responsible person shall annually submit to the
20 Secretary a compilation report of all non-serious ad21
verse events received during the preceding year.’’;
22 (5) in subsection (e)(1), by adding at the end:
23 ‘‘The responsible person shall maintain records re24
lated to each annually submitted adverse event re25
port for a period of 3 years.’’; and
February 2, 2010
9
AEG10041 S.L.C.
1 (6) in subsection (f), by striking ‘‘or an adverse
2 event report voluntarily submitted’’ and inserting
3 ‘‘or a non-serious adverse report submitted annu4
ally’’.
5 (f) RECALL AUTHORITY FOR DIETARY SUPPLE6
MENTS.—
7 (1) IN GENERAL.—Chapter IV of the Federal
8 Food, Drug, and Cosmetic Act (21 U.S.C. 341 et
9 seq.) is amended by adding at the end the following:
10 ‘‘SEC. 418. RECALL AUTHORITY FOR DIETARY SUPPLE11
MENTS.
12 ‘‘(a) RECALL AUTHORITY.—
13 ‘‘(1) CEASE DISTRIBUTION AND NOTIFICATION
14 ORDER.—
15 ‘‘(A) IN GENERAL.—If the Secretary finds
16 there is a reasonable probability that a dietary
17 supplement or a product marketed or sold as a
18 dietary supplement would cause serious, adverse
19 health consequences or death, or is adulterated
20 or misbranded, the Secretary shall issue a cease
21 distribution and notification order requiring the
22 person named in the order to immediately—
23 ‘‘(i) cease distribution of such dietary
24 supplement or a product marketed or sold
25 as a dietary supplement;
February 2, 2010
10
AEG10041 S.L.C.
1 ‘‘(ii) notify distributors, importers, re2
tailers, and consumers of the order; and
3 ‘‘(iii) instruct those distributors, im4
porters, retailers, and consumers to cease
5 distributing, importing, selling, and using
6 the dietary supplement.
7 ‘‘(B) INFORMAL HEARING.—An order de8
scribed in subparagraph (A) shall provide the
9 person subject to the order with an opportunity
10 for an informal hearing, to be held not later
11 than 10 days after the date of the issuance of
12 the order, on the actions required by the order
13 and on whether the order should be amended to
14 require a recall of the dietary supplement or the
15 product marketed or sold as a dietary supple16
ment. The person subject to the order shall
17 have 5 days to notify the Secretary of the per18
son’s intent to challenge the order. If, after pro19
viding an opportunity for such a hearing, the
20 Secretary determines that inadequate grounds
21 exist to support the actions required by the
22 order, the Secretary shall vacate the order.
23 ‘‘(2) RECALL.—
24 ‘‘(A) IN GENERAL.—If, after providing an
25 opportunity for an informal hearing under
February 2, 2010
11
AEG10041 S.L.C.
1 paragraph (1), the Secretary determines that
2 the order should be amended to include a recall
3 of the dietary supplement or the product mar4
keted or sold as a dietary supplement with re5
spect to which the order was issued, the Sec6
retary shall, except as provided in subpara7
graphs (B) and (C), amend the order to require
8 a recall. The Secretary shall specify a timetable
9 in which the dietary supplement recall will
10 occur and shall require periodic reports to the
11 Secretary describing the progress of the recall.
12 The Secretary shall have the authority to ini13
tiate the action prescribed in this subparagraph
14 regardless of whether or not the person subject
15 to the order elects to exercise the right to chal16
lenge the initial order as permitted under para17
graph (1).
18 ‘‘(B) CONTENT OF AMENDED ORDER.—An
19 amended order under subparagraph (A)—
20 ‘‘(i) shall not include recall of the die21
tary supplement or the product marketed
22 or sold as a dietary supplement from indi23
viduals; and
24 ‘‘(ii) shall provide for notice to indi25
viduals, at the expense of retailers and to
February 2, 2010
12
AEG10041 S.L.C.
1 the satisfaction of the Secretary, subject to
2 the risks associated with the use of such
3 dietary supplement.
4 ‘‘(C) NOTIFICATION.—In providing the no5
tice required by subparagraph (B)(ii), if a sig6
nificant number of such individuals cannot be
7 identified, the Secretary shall notify such indi8
viduals pursuant to section 705(b).’’.
February 2, 2010
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233616_tn?1312790796
sorry this is not pleasant to read, but since you can't access the site here it is...
notice all that has to happen is that someone claims adverse effects to begin the pulling process....this I find disturbing....I mean, haven't they ever seen the placbo effect?  Almost every trial has hundreds of people who think the drug gave them headaches or gas or worse, but it turns out they were on placebo. This bill doesn't require much to pull every natural off the market IMHO


in laymanese these amendments leave it to the vitamain companies to prove the safety, and leave it to the public to report adverse effects.
without billion to fund research, things as docile as say lactoferrin could be banned.
Lactroferrin binds iron and prevents Hepatic cancer by suppressing iron absorption and ergo reducing iron overload in the liver. It is cheap and effective, but can we expect vitamin companies to prove again and again what research has already shown? Or can we predict that a drug compant coming our with a prescription drug to block iron would not themselves manufacture "adverse reports" for the natural?

These seem like benign legal changes, but they may not be. They do not just extend to steroids, or things atheletes have abused, they extend to EVERYTHING.
The millions it might require just to satisfy the FDA in light of false claims of adversity could stop many manufacturers from trying anything new.  By new, we need to consider that many things now commonplace were unknown 20 years ago, such as alpha lipoic acid, etc. Things known to reduce heart disease.
Let's also remember that lukemia was cured with a flower, and that heart disease is as well (digitalis). Many things now in use began with a plant...such as for breats cancer tomoxifen....which the drug companies now have there own non-natural biological equivalent for...so there's no use in acting as if they don't want to get the market cornered...not while they are doing so in front of our eyes.
mb
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206807_tn?1331939784
MB, I am not ignoring you. I have been extremely busy and haven’t had the time get into it. I was having computer problems that day. I can open the links fine now.
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Avatar_m_tn
Like any story there are two sides to this one.  Unregulated supplements kill people on a regular basis.  Desperate patients seeking to find some gift from God buy worthless crap that may harm as much as help them.  A supplement is only as good as the company packaging it and I promise you they also have profit as a motivation.  I also think it stretches credibility to use the word "cure" in the title of this thread.  That's overstating the value of any of these products.  Sad to say but the only drugs that could remotely be called a cure for the disease most people visit this site for (HCV) are Interferon and Ribavirin.
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4452422_tn?1354798687
Amen!
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