- 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).
-
-
-
- Comment
-
- From Mary Sparrowdancer
- sparrowdancer1@earthlink.net
- 8-6-3
-
- Since comments were asked for regarding the wording and
interpretation of this Bill, here are a few of my own ---
-
- First of all, under Definitions:
-
- `(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.
-
- If the reported "adverse event" does not
even have to be "causally related to the dietary supplement,"
then theoretically, any "adverse event" can be reported
following purchase or ingestion of any dietary supplement.
-
- My second comment addresses what appears to be an
impossible, vaguely defined, time-consuming assignment of surveillance
and reporting of all "adverse events" - whether or not the events
are known to be "causally related to the dietary supplement."
This responsibility is to be assigned to the "manufacturer
of a dietary supplement, and each packer or distributor..."
-
- As it is written above, everyone involved in the
sale of a dietary supplement could be forced to investigate and submit detailed
reports of each "adverse event" (whether or not the event is
known to be "casually related to the dietary supplement"). These
- reports are to be filed within 15 days of the actual
event and submitted to "the Secretary," who may then at
will require additional reports, maintenance of surveillance, etc., for
up to three years. (Presumably, "Secretary" refers to Secretary
of the US Dept. of Health and Human Services, Tommy Thompson.)
-
- This appears to be an open door for "overkill." Anything
known as a "dietary
- supplement" - including vitamins - can certainly
be included in the planned cross hairs.
-
- My third comment is the most important and I have saved
it for last. It addresses the reasoning behind the new proposed regulations. One
wonders for what purpose additional regulations are being proposed when
the safety and health of Americans are currently at an all-time low. American
health has been compromised due in part to conglomerate marketing
that effectively bypasses rules and regulations, and due in part to
the conglomerate's personnel arriving through Washington's revolving doors
in order to work within the government's various rules and regulations
divisions.
-
- According to the Center for Food Safety and Applied Nutrition,
the FDA regulates "dietary supplements" in accordance with to
the "Dietary Supplement Health and Education Act of 1994 (DSHEA)."
Under those guidelines, product safety is regulated. It is interesting
to note that of all ingested products being monitored,
- tobacco (backed by enormous conglomerates) is specifically
excluded. Additionally, on March 21, 2000, the Supreme Court found that the
FDA lacks authority to regulate tobacco.
-
- Soy is another example of a substance (backed by
enormous conglomerates) that made its way through the various rules
and regulations already in place --- and then arrived unimpeded in the
American diet. It is now in almost every product on the grocery shelves,
in spite of the fact that it was not given GRAS (Generally Recognized
as Safe) status as a food, but was granted GRAS status for industrial
use as a binder in cardboard boxes.
-
- In 1999, when the FDA issued Docket # 98P-0683, "Food
Labeling: Health Claims; Soy Protein and Coronary Heart Disease,"
in which certain FDA personnel authorized the soy-promoting conglomerates
to advertise soy as a heart-healthy food, other individuals within the
FDA and elsewhere rose in protest. FDA expert soy researchers
Daniel Doerge and Daniel Sheehan protested over serious health
concerns as a result of soy consumption. Doerge and Sheehan
stated, "It is unreasonable to approve the health claim until complete
safety studies of soy protein are conducted." These two FDA experts
also noted that one of the reports issued from within the FDA erroneously
contained the statement that "soy protein foods are GRAS," when
in fact this statement was not true. They stated, "It would seem appropriate
for FDA to speak with a single voice regarding soy protein isolate."
-
- It would seem appropriate if all government agencies
spoke with a single voice for the American people and worked jointly for
the health and safety of us all --- but the clear fact is that
in case after case, it is the best interest of chemical, agricultural
and pharmaceutical conglomerates that are now the number
one priority of this increasingly bizarre government.
-
- The American people do not need more regulations. What
we need is to awaken to our own responsibilities --- and to take
back the control of our personal health. Health care should have
never been taken away from the individual and placed into the hands of
politicians and lobbyists.
-
- Let them at least leave our vitamins alone so that we can continue
to offset the stress being caused by this conglomerate mess.
-
-
- Mary Sparrowdancer
- <http://www.sparrowdancer.com>www.sparrowdancer.com
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