| US CODE -
TITLE 15
CHAPTER 39 § 1451
§ 1451. Congressional declaration of policy
Informed consumers are essential to the fair and efficient functioning of
a free market economy. Packages and their labels should enable consumers to
obtain accurate information as to the quantity of the contents and should
facilitate value comparisons. Therefore, it is hereby declared to be the
policy of the Congress to assist consumers and manufacturers in reaching
these goals in the marketing of consumer goods.
CFR, Title 21, Chapter 1, Part
201: Labeling
Sec. 201.6 Drugs: Misleading
statements.
(b) The labeling of a drug which
contains two or more ingredients may be misleading by reason, among other
reasons, of the designation of such drug in such labeling by a name which
includes or suggests the name of one or more but not all such ingredients,
even though the names of all such ingredients are stated elsewhere in the
labeling.
[41 FR 6908, Feb. 13, 1976]
Sec. 201.10 Drugs: Statement of ingredients.
(a) The ingredient information
required by section 502(e) of the Federal Food, Drug, and Cosmetic Act shall
appear together, without any intervening written, printed, or graphic
matter, except the proprietary names of ingredients, which may be included
with the listing of established names, and such statements that are
specifically required for certain ingredients by the act or regulations in
this chapter.
(b) The term ingredient applies to
any substance in the drug, whether added to the formulation as a single
substance or in admixture with other substances.
(c) The labeling of a drug may be
misleading by reason (among other reasons) of:
(1) The order in which the names of
the ingredients present in the drug appear in the labeling, or the relative
prominence otherwise given such names.
(2) Failure to reveal the proportion
of, or other fact with respect to, an ingredient present in such drug, when
such proportion or other fact is material in the light of the representation
that such ingredient is present in such drug.
(3) The employment of a fanciful
proprietary name for a drug or ingredient in such a manner as to imply that
the drug or ingredient has some unique effectiveness or composition when, in
fact, the drug or ingredient is a common substance, the limitations of which
are readily recognized when the drug or ingredient is listed by its
established name.
42 USC §300aa-26
(a) General Rule
Not later than 1 year after December 22, 1987, the
Secretary shall develop and disseminate vaccine information materials for
distribution by health care providers to the legal representatives of any
child or to any other individual receiving a vaccine set forth in the
Vaccine Injury Table. Such materials shall be published in the Federal
Register and may be revised.
(b) Development and revision of materials
Such materials shall be developed or revised -
(1) after notice to the public and 60 days of
comment thereon, and
(2) in consultation with the Advisory
Commission on Childhood Vaccines, appropriate health care providers and
parent organizations, the Centers for Disease Control and Prevention, and
the Food and Drug Administration.
(c) Information requirements
The information in such materials shall be based on available data
and information, shall be presented in understandable terms and
shall include -
(1) a concise description of the benefits of the vaccine,
(2) a concise description of the risks
associated with the vaccine,
(3) a statement of the availability of the
National Vaccine Injury Compensation Program, and
(4) such other relevant information as may be
determined by the Secretary.
(d) Health care provider duties
On and after a date determined by the Secretary which
is -
(1) after the Secretary develops the information materials required
by subsection (a) of this section, and
(2) not later than 6 months after the date such
materials are published in the Federal Register, each health care provider
who administers a vaccine set forth in the Vaccine Injury Table shall
provide to the legal representatives of any child or to any other individual
to whom such provider intends to administer such vaccine a copy of the
information materials developed pursuant to subsection (a) of this
section, supplemented with visual presentations or oral explanations, in
appropriate cases. Such materials shall be provided prior to the
administration of such vaccine.
USC 42 § 289g–1 (c) and (g)
http://www4.law.cornell.edu/uscode/42/289g-1.html
(c)
Informed consent
of researcher and donee
In research carried out under
subsection (a) of this section,
human fetal tissue may be used only
if the individual with the principal
responsibility for conducting the
research involved makes a statement,
made in writing and signed by the
individual, declaring that the
individual—
(1)
is aware that—
(A)
the tissue
is human fetal tissue;
(B)
the tissue
may have been obtained pursuant
to a spontaneous or induced
abortion or pursuant to a
stillbirth; and
(C)
the tissue
was donated for research
purposes;
(2)
has provided
such information to other
individuals with responsibilities
regarding the research;
(g)
“Human fetal
tissue” defined
For purposes of this section, the
term “human fetal tissue” means
tissue or cells obtained from a dead
human embryo or fetus after a
spontaneous or induced abortion, or
after a stillbirth
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