- 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
-
- =====================================
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- 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:
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- Senate to Consider Vitamin Ban
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- The World Trade Organizationís 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 donít 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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