IAHF Webmaster: Breaking News, Whats New, What to Do, S.722
IAHF List: What follows are my current thoughts regarding an American bill called S.722 which many here are up in arms about, but which I do NOT consider to be a legitimate threat at the current time. Read on to see why and to understand my thinking on this.
Even if you live outside the USA its still important to read this because the Cartel uses the same diversionary tactics globally. They don't want us to focus on whats REALLY going on. I will reassess S.722 in the fall when congress goes back into session and we can see whether or not Durbin and Sweeny picked up any cosponsors for their bills which DO threaten to repeal the Dietary Supplement Health and Education Act, but read on to see my thoughts: At the very end you can read the text of S.722
At 09:57 PM 8/5/03 -0700, you wrote:
8-5-2003
Hi, John. I saw this on Jeff Rense's site early this morning- you may
know about Dick Durbin already, but I knew it couldn't hurt to send this
anyway. Thanks for the newsletters!
Best regards,
Brian
http://totm.iuma.com/
I will NOT send this out because it is a RED HERRING. Durbin's bill only has 3 cosponsors. 96% of all bills that are introduced are KILLED and are NEVER PASSED INTO LAW. This bill does NOT have a head of steam behind it, and a far BIGGER threat, a REAL threat is if ANH is not able to get the donations they need to sustain their lawsuit to overturn the EU FSD. They have to file their lawsuit by mid September, and far too many people are getting all up in arms about a bill that is going NOWHERE.
I watched the ephedra hearing that just took place recently in the House. FDA Commissioner McLellan was grilled by Congressman Greenwood and others who tried hard to get him to say that "DSHEA ties FDA's hands keeping them from protecting the public, and FDA needs help from Congress to rectify the situation." But McLellan refused to give them that. He would not say what they wanted him to say, and THAT is going to make it EXTREMELY UNLIKELY that this bill will move.
A good way to tell how much interest there is in a bill is to simply ask the guy at the documents room on Capital Hill who doles out copies of bills to members of Congress, their staffs and the public how many COPIES of a bill he has handed out to interested people. I've checked, and frankly hardly ANYONE is asking for copies of Durbin's bill or Sweeny's house bill.
Why not? You have to remember something, there are THOUSANDS of bills introduced in DC all the time, and the average member of Congress can't even REMOTELY stay up on all of them. These bills swim upstream like salmon trying to reach the headwaters of a river, and most never make it, most die, only the best of the best of the best survive the winnowing process and Durbin's bill is DOA, Dead on Arrival- it aint' goin ANYWHERE, but it really COULD distract a lot of people from a very REAL THREAT: the threat of the EU Food Supplement Directive not being overturned in court if ANH doesn't get the money they need to do the job properly for all of us.
You have to remember something here: The FDA is operating off a BACK DOOR plan...... they have been quietly setting us up using the machinery of international law, which most people just IGNORE, and believe me, ignorance is BLISS.
FDA is quietly rubbing their hands together in gleeful anticipation of a future WTO Trade Dispute which they've been getting away with setting us up to LOSE for several YEARS now, but the average poorly informed American is utterly CLUELESS to these manipulations and can't think their way out of a paper bag. They just aren't seeing the global chess board that FDA and their international counterparts which are all networked via a UN entity called ICDRA see.
ICDRA is the UN umbrella group that coordinates the world's FDA's and also the world's governments, getting legislation introduced that attacks us at times to keep us from FOCUSING n the REAL threat.
That is my perception of Durbin's and Sweeney's bills- they serve as domestic diversions to what is going on OFFSHORE.
People damn well better start grasping the implications of our having joined the WTO, but most have no clue, very few have ever read any of the GATT trade agreement.
Very few have ever read the SPS or TBT Agreements, much less understand their implications.
Well I HAVE read these trade agreements, and I understand the FINE PRINT.
Thats why I have not sounded an alarm about Durbin's bill or Sweenys. They're on my radar screen, believe me, or I wouldn't have taken the time to watch the Ephedra hearing that just took place in the House. Its just that I happen to have some inside knowledge of whats going on on Capital Hill that most people do NOT have, and I can tell you that Metabolife has an ARMY of lobbyists on the Hill and so far they've kept S.722 bottled up tight- they're just not moving.
How eager do you really think Congress is to be deluged with angry phone calls, letters, faxes the way they were during the campaign to pass DSHEA in '94?
Trust me, they HATE it when one issue ties up their phones and faxes keeping them from getting OTHER work done, and even though a lot of people are no longer in Congress who were back then, what happened in '94 is LEGENDARY on Capital Hill, and there will NOT be a lot of members EAGER to climb aboard Durbin's bill or Sweenys, only to be POUNDED by angry constituents who will vote them out of office if they do.
I might REASSESS the threat level posed by Durbin and Sweeney's bills in the fall, after Congress has gone back into session and we have a chance to see if the bills picked up any appreciable number of cosponsors due to the ephedra hearing that took place recently, but as of right now, we MUST stay focused on getting ANH the funds they need to overturn the FSD in court, because if we FAIL to do that, its ALL OVER.
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>From Rense.com:
URGENT - STOP Senator
Dick Durbin's War On Vitamins!
>From Archaeos Prime
8-5-3
Dear America,
Below is my email to Senator Dick Durbin, who has introduced The Dietary
Supplement Safety Act of 2003, Senate Bill 722. This bill would, if passed,
ban all but the weakest vitamin supplements from store shelves, forcing the
average consumer to pay sky-high prescription costs to obtain effective
doses for general health maintenance. That's IF they could afford them at
all, and IF any health insurance they MIGHT have would even cover them.
You can help me STOP this madness by contacting your Senators as well.
Archaeos Prime -- Renegade Patriot
=====================================
Senator Durbin,
Millions of Americans are unable to understand what you're thinking about by
introducing The Dietary Supplement Safety Act of 2003, Senate Bill 722. The
low-cost availability of vitamins helps to keep people healthier, avoiding
sickness better and keeping American healthcare costs lower.
Forcing vitamins to require prescription for use by the average person will
accomplish the following at best:
1) Eliminate the ability of low-income people or those without
employer-provided healthcare plans to purchase vitamins AT ALL.
2) Cause a price-gouging hike in vitamin costs, which then only the rich or
the fairly-well-off could afford on any continual basis.
3) Raise incidents of general sickness through lack of proper nutritional
supplements (to offset the low-nutrition junkfoods rampant in our society).
4) Raise the costs of medical care across the board due to increased
illnesses.
5) Raise incidents of cancer specifically.
6) Cause a greater loss of manhours worked in the American workplace across
all industries.
7) Load your pockets full of extra short-term cash, along with your
pharmaceutical industry friends.
I'm sure there would be many more cascading effects I haven't even
considered yet.
If you have any sincere concerns about unregulated and ineffectual
"watered-down" vitamins, this is certainly not the path to rectifying that
situation. The proper action would be to introduce an FDA-enforcable
regulatory bill requiring higher standards in common vitamin production
within the current vitamin market structure. Why are you not addressing this
issue instead?
Please explain for me and your constituents the reasoning behind this
action, and how it could ever possibly make the lives of the average
American better and healthier. And also please be sure not to underestimate
our understanding of the real effects this bill would have, if passed.
Millions of us fully comprehend the bill's future long-term impacts across
average American society and family health, as well as the medical, vitamin
and pharmaceutical markets.
Below is the news update from Whitley Streiber's Unknown Country which has
spurred my inquiry. I and many others I'm BCC'ing are looking forward to
your reply. I'll type out and email your hardcopy letter to update them, or
your email reply would also be greatly appreciated and forwarded to all
included.
Sincerely,
Archaeos Prime
Renegade Patriot
Illinois Resident
(Real name and address provided to the Senator only)
====================================================
>From Whitley Strieber's Unknowncountry.com Newsletter:
Senate to Consider Vitamin Ban
The World Trade OrganizationÃs food and drug regulatory body is controlled
by big drug companies, and they are trying to use it to make all but the
smallest doses of vitamins illegal to purchase without a prescription
worldwide. The Dietary Supplement Safety Act of 2003, Senate Bill 722, would
do just that in the US, by effectively regulating out of existence the sale
of almost all vitamin supplements at higher potencies, except by
prescription.
The bill has been introduced by Democratic Senator Dick Durbin, --
http://durbin.senate.gov/ -- a strong advocate of the WTO and sponsor of
much pro-drug company legislation.
To help prevent this sellout of the American people to Big Drugs, write in
protest to Senate Bill 722 to your senators. Tell them what many of them
donÃt know: SB 722 is NOT TRUTHFUL in its intentions. It will open the door
to devastatingly harsh regulation. Senators Hillary Clinton of New York and
Diane Feinstein of California have also declared themselves in support of
the bill. Find out how to contact your senators here: http://www.senate.gov
Supplement Group Found to Reduce Cancer Risk
At a time when the US Senate is considering making large-dose vitamins
unavailable to the American public except with prescriptions at drug prices,
an extensive study has revealed that a specific mega-dose supplement group
can dramatically reduce cancer risk.
A total of 13,000 men and women aged 30 to 65 took part in the study, which
found that regular use of a particular supplement group reduced cancer risk
37% in men and 31% in women. The supplement group is: 6mg of beta-carotene,
120mg of vitamin C, 90mg of vitamin E, 100 micrograms of selenium, and 20
milligrams of zinc.
Under SB 722, supplements at these dosages would be available only as
prescription drugs. To read more about the study click here:
http://news.bbc.co.uk/2/hi/health/3122033.stm
S.722 Hype or of Fact?
>From Frederick Zierold
Jeff,
I have found a copy of the current bill being introduced into congress
regarding the diet and supplement issue. I suggest everyone read what is
being passed before we all panic.
I reviewed it and it does appear reasonable. I would love to hear other
people who are against this explain why and what line they object to.
http://www.congress.org/congressorg/webreturn/?url=http
://thomas.loc.gov/cgi-bin/query/z?c108:S.722:
Fred
The Actual Text Of S. 722
108th CONGRESS
1st Session
S. 722
To amend the Federal Food, Drug, and Cosmetic Act to require that
manufacturers of dietary supplements submit to the Food and Drug
Administration reports on adverse experiences with dietary supplements, and
for other purposes.
IN THE SENATE OF THE UNITED STATES
March 26, 2003
Mr. DURBIN introduced the following bill; which was read twice and referred
to the Committee on Health, Education, Labor, and Pensions
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to require that
manufacturers of dietary supplements submit to the Food and Drug
Administration reports on adverse experiences with dietary supplements, and
for other purposes.
Be it enacted by the Senate and House of Representatives of the United
States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the `Dietary Supplement Safety Act of 2003'.
SEC. 2. ADVERSE EXPERIENCES WITH DIETARY SUPPLEMENTS.
(a) IN GENERAL- Chapter IV of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 341 et seq.) is amended by adding at the end the following:
`SEC. 416. ADVERSE EXPERIENCES WITH DIETARY SUPPLEMENTS.
`(a) DEFINITIONS- In this section:
`(1) ADVERSE DIETARY SUPPLEMENT EXPERIENCE- The term `adverse dietary
supplement experience' means an adverse event that is associated with the
use of a dietary supplement in a human, without regard to whether the event
is known to be causally related to the dietary supplement.
`(2) SERIOUS ADVERSE DIETARY SUPPLEMENT EXPERIENCE- The term `serious
adverse dietary supplement experience' means an adverse dietary supplement
experience that--
`(A) results in--
`(i) death;
`(ii) a life-threatening condition;
`(iii) inpatient hospitalization or prolongation of hospitalization;
`(iv) a persistent or significant disability or incapacity; or
`(v) a congenital anomaly, birth defect, or other effect regarding
pregnancy, including premature labor or low birth weight; or
`(B) requires medical or surgical intervention to prevent 1 of the outcomes
described in subparagraph (A).
`(b) REPORTING AND REVIEW-
`(1) SERIOUS ADVERSE DIETARY SUPPLEMENT EXPERIENCES-
`(A) IN GENERAL- Each manufacturer of a dietary supplement, and each packer
or distributor of a dietary supplement the name of which appears on the
labeling of the dietary supplement--
`(i) shall develop written procedures for--
`(I) surveillance, receipt, and evaluation of information on adverse dietary
supplement experiences associated with use of the dietary supplement; and
`(II) submission to the Secretary of reports under this subsection;
`(ii) as soon as practicable after, but in no event later than 15 calendar
days after, initial receipt of information with respect to a serious adverse
dietary supplement experience, shall submit to the Secretary--
`(I) the information; and
`(II) a copy of the current labeling for the dietary supplement;
`(iii)(I) shall promptly investigate the adverse dietary supplement
experience; and
`(II)(aa) if additional information is obtained, shall submit to the
Secretary a report describing the information--
`(AA) not later than 15 days after obtaining the information; or
`(BB) at the request of the Secretary; or
`(bb) if no additional information is obtained, shall maintain records of
the steps taken to seek additional information.
`(B) ELIMINATION OF DUPLICATIVE REPORTING-
`(i) IN GENERAL- To avoid duplicative reporting under this subsection, the
Secretary may establish a procedure under which--
`(I) a packer or distributor of a dietary supplement may submit a report to
the manufacturer of the dietary supplement; and
`(II) the manufacturer shall transmit the report to the Secretary.
`(ii) REQUIREMENT- A procedure under clause (i) shall ensure that the
Secretary receives reports within the applicable period of time specified in
subparagraph (A).
`(C) CLINICAL EVALUATIONS BY THE SECRETARY-
`(i) IN GENERAL- The Secretary shall conduct a clinical evaluation of each
serious adverse dietary supplement experience with a patient that is
reported to the Secretary under subparagraph (A).
`(ii) UNWILLING PATIENT- The Secretary is not required to conduct a clinical
evaluation under clause (i) to the extent that any unwillingness of the
patient (or the next of kin for the patient, as the case
may be) to cooperate with the evaluation makes it impracticable to conduct
the evaluation.
`(2) PERIODIC ADVERSE DIETARY SUPPLEMENT EXPERIENCE REPORTING- A
manufacturer of a dietary supplement shall annually (or at such shorter
intervals as the Secretary may require), in accordance with such
requirements as the Secretary may establish, submit to the Secretary a
report that discloses all information received with respect to adverse
dietary supplement experiences not previously reported under paragraph (1).
`(3) REVIEW REGARDING ADVERSE DIETARY SUPPLEMENT EXPERIENCES-
`(A) IN GENERAL- Promptly after a manufacturer of a dietary supplement
receives from a consumer, or obtains by any other means, any information on
an adverse dietary supplement experience, the manufacturer shall review the
information.
`(B) APPLICABILITY- Subparagraph (A)--
`(i) applies to information without regard to the source of the information,
foreign or domestic; and
`(ii) includes information derived from sources such as--
`(I) commercial marketing experience;
`(II) postmarketing investigations;
`(III) postmarketing surveillance;
`(IV) studies;
`(V) reports in the scientific literature; and
`(VI) unpublished scientific papers.
`(4) ADDITIONAL REPORTING REQUIREMENTS- In addition to the requirements of
paragraphs (1) and (2), the Secretary may establish such requirements
regarding the reporting of information on adverse dietary supplement
experiences as the Secretary determines to be appropriate to protect the
public health.
`(5) WAIVERS- The Secretary may grant a waiver from the requirement of
paragraph (1), (2), or (3) with respect to a dietary supplement if the
Secretary determines that compliance with the requirement is not necessary
to protect the public health.
`(6) SYSTEM FOR COORDINATION OF REPORTS RECEIVED BY THE SECRETARY- With
respect to reports of adverse dietary supplement experiences submitted to
the Secretary (whether required under this subsection or otherwise), the
Secretary shall establish a system to--
`(A) receive the reports;
`(B) refer the reports to the appropriate officials within the Food and Drug
Administration;
`(C) store and retrieve the reports;
`(D) store and retrieve records of activities carried out in response to the
reports; and
`(E) carry out such other administrative functions regarding the reports as
the Secretary determines to be appropriate.
`(7) DATA COLLECTION BY SECRETARY-
`(A) IN GENERAL- The Secretary shall carry out a program to collect data on
serious adverse dietary supplement experiences, in addition to receiving
reports required in this subsection.
`(B) COOPERATION- In carrying out the program, the Secretary shall seek the
cooperation of appropriate public and private entities, including entities
that respond to medical emergencies.
`(8) AUTHORIZATION OF APPROPRIATIONS- There is authorized to be appropriated
to carry out this subsection $10,000,000 for fiscal year 2003 and each
fiscal year thereafter.
`(c) POSTMARKET SURVEILLANCE-
`(1) AUTHORITY TO REQUIRE SURVEILLANCE- The Secretary may by order require a
manufacturer of a dietary supplement to conduct postmarket surveillance for
the dietary supplement if the Secretary determines that there is a
reasonable possibility that a use or expected use of the dietary supplement
by a significant number of consumers may result in serious adverse
experiences.
`(2) SURVEILLANCE PLAN-
`(A) IN GENERAL- Not later than 30 days after receiving from the Secretary
an order under paragraph (1) to conduct surveillance for a dietary
supplement, a manufacturer shall submit to the Secretary, for the approval
of the Secretary, a plan for the required surveillance.
`(B) QUALIFICATIONS REGARDING SURVEILLANCE; DATA REGARDING ADVERSE DIETARY
SUPPLEMENT EXPERIENCES- Not later than 60 days after a plan is submitted to
the Secretary under subparagraph (A), the Secretary shall determine
whether--
`(i) the person designated to conduct the surveillance has appropriate
qualifications and experience to conduct the surveillance; and
`(ii) the plan will result in the collection of useful data that will
disclose adverse dietary supplement experiences or other information
necessary to protect the public health.
`(3) SURVEILLANCE PERIOD- In consultation with a manufacturer of a dietary
supplement that is required to conduct surveillance under paragraph (1), the
Secretary may by order require a prospective surveillance period for the
manufacturer of not more than--
`(A) 3 years; or
`(B) such longer period as may be determined--
`(i) by agreement between the Secretary and the manufacturer; or
`(ii) if the Secretary and the manufacturer cannot agree, through a dispute
resolution process established by the Secretary by regulation.
`(d) SAFETY REVIEW FOR POSSIBLY DANGEROUS DIETARY SUPPLEMENTS-
`(1) IN GENERAL- If a clinical evaluation by the Secretary of 1 or more
serious adverse events indicates that a dietary supplement or a dietary
ingredient contained in a dietary supplement appears to present a
significant or unreasonable risk of illness, the Secretary may require the
manufacturers of the dietary supplement, or of a dietary ingredient
contained in a dietary supplement, to submit to the Secretary data
demonstrating that the dietary supplement containing the dietary ingredient
is safe.
`(2) APPROVAL OR DISAPPROVAL OF CONTINUED MARKETING- As soon as practicable
after receiving data required under paragraph (1), the Secretary shall
review the data and issue a determination that--
`(A)(i) the dietary supplement is safe; and
`(ii) the continued marketing of the dietary supplement is approved; or
`(B)(i) the dietary supplement is not safe or has not been shown to be safe
under ordinary or frequent conditions of use; and
`(ii) the continued marketing of the dietary supplement is disapproved.'.
(b) PROHIBITED ACTS- Section 301 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 331) is amended by adding at the end the following:
`(hh) ADVERSE DIETARY SUPPLEMENT EXPERIENCES-
`(1) FAILURE TO COMPLY- The failure of a person to submit a report or comply
with any other requirement under section 416.
`(2) DISAPPROVAL OF CONTINUED MARKETING- The continued marketing of a
dietary supplement by any person after the Secretary issues a determination
under section 416(d)(2)(B) that--
`(A) the dietary supplement is not safe or has not been shown to be safe
under ordinary conditions of use; and
`(B) the continued marketing of the dietary supplement is disapproved.'.
SEC. 3. STIMULANTS.
(a) DEFINITION OF STIMULANT- Section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the following:
`(nn) STIMULANT- The term `stimulant' means a dietary ingredient that has a
stimulant effect on the cardiovascular system or the central nervous system
of a human by any means, including--
`(1) speeding metabolism;
`(2) increasing heart rate;
`(3) constricting blood vessels; or
`(4) causing the body to release adrenaline.'.
(b) PREMARKET APPROVAL- Chapter IV of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 341 et seq.) (as amended by section 2(a)) is amended by
adding at the end the following:
`SEC. 417. STIMULANTS.
`(a) IN GENERAL- No person shall introduce or deliver for introduction into
interstate commerce a dietary supplement containing a stimulant unless an
approval of the dietary supplement under this section is in effect.
`(b) APPROVAL- The Secretary shall approve an application for premarket
approval of a dietary supplement containing a stimulant if the manufacturer
of the stimulant demonstrates that the dietary supplement is safe under
ordinary or frequent conditions of use.
`(c) COMBINATIONS OF STIMULANTS- In the case of a dietary supplement that
contains a combination of stimulants, the Secretary, in determining the
safety of the dietary supplement, shall consider the interaction of the
various stimulants contained in the dietary supplement.
`(d) ACTION ON APPLICATION- The Secretary shall approve or disapprove an
application for premarket approval of a dietary supplement containing a
stimulant not later than 180 days after receiving the application.'.
(c) ADULTERATED FOOD- Section 402 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 342) is amended by adding at the end the following:
`(i) DIETARY SUPPLEMENTS CONTAINING A STIMULANT- If the food is a dietary
supplement containing a stimulant for which the Secretary has not granted
premarket approval under section 417.
`(j) EFFECT OF SECTION- Nothing in this section affects any other law
(including a regulation) applicable to caffeine used as a food or drug.'.
(d) REGULATIONS- Not later than 1 year after the date of enactment of this
Act, the Secretary of Health and Human Services shall issue guidance for
implementing the amendments made by this section.
(e) EFFECTIVE DATE-
(1) IN GENERAL- Except as provided in paragraph (2), the amendments made by
this section--
(A) apply to dietary supplements manufactured before, on, or after the date
of enactment of this Act; and
(B) take effect on the date that is 180 days after the date of enactment of
this Act.
(2) ALREADY-MARKETED DIETARY SUPPLEMENTS- The amendments made by this
section do not apply to a dietary supplement that has been marketed before
the date of enactment of this Act until the date that is 2 years after the
date of enactment of this Act.
SEC. 4. STEROID PRECURSORS.
(a) FEDERAL FOOD, DRUG, AND COSMETIC ACT- Section 201(ff)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(ff)(1)) is amended by striking
`(other than tobacco)' and inserting `(other than tobacco or a product that
bears or contains an anabolic steroid (including a substance that is
chemically and pharmacologically related to testosterone but not including
an estrogen, progestin, or corticosteroid))'.
(b) CONTROLLED SUBSTANCES ACT-
(1) DEFINITION OF ANABOLIC STEROID- Section 102(41)(A) of the Controlled
Substances Act (21 U.S.C. 802(41)(A)) is amended--
(A) by striking `that promotes muscle growth, and includes--' and inserting
`that promotes muscle growth or is advertised or used to promote muscle
growth.
`(B) The term `anabolic steroid' includes--'; and
(B) by striking `(B)(i)' and inserting `(C)(i)'.
(2) EXCLUSION FROM SCHEDULE- Section 201(g)(1) of the Controlled Substances
Act (21 U.S.C. 811(g)(1)) is amended by striking `if such substance' and all
that follows and inserting `if the substance--
`(A) is approved as being safe and effective for its intended use under
section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); or
`(B) is lawfully marketed under an over-the-counter monograph issued by the
Food and Drug Administration.'.
SEC. 5. AGENCY EXPERTISE AND AUTHORITY.
Section 402(f)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
342(f)(1)) is amended by striking the matter following subparagraph (D).
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