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(a)(1) The ingredient information required by section 502(n) 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.
(2) The order of listing of ingredients in the advertisement
shall be the same as the order of listing of ingredients on the
label of the product, and the information presented in the
advertisement concerning the quantity of each such ingredient shall
be the same as the corresponding information on the label of the
product.
(3) The advertisement shall not employ a fanciful proprietary
name for the drug or any 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.
(4) The advertisement shall not feature inert or inactive
ingredients in a manner that creates an impression of value greater
than their true functional role in the formulation.
(5) The advertisement shall not designate a drug or ingredient
by a proprietary name that, because of similarity in spelling or
pronunciation, may be confused with the proprietary name or the
established name of a different drug or ingredient.
(b)(1) If an advertisement for a prescription drug bears a
proprietary name or designation for the drug or any ingredient
thereof, the established name, if such there be, corresponding to
such proprietary name or designation shall accompany such
proprietary name or designation each time it is featured in the
advertisement for the drug; but, except as provided below in this
subparagraph, the established name need not be used with the
proprietary name or designation in the running text of the
advertisement. On any page of an advertisement in which the
proprietary name or designation is not featured but is used in the
running text, the established name shall be used at least once in
the running text in association with such proprietary name or
designation and in the same type size used in the running text:
Provided, however, That if the proprietary name or
designation is used in the running text in larger size type, the
established name shall be used at least once in association with,
and in type at least half as large as the type used for, the most
prominent presentation of the proprietary name or designation in
such running text. If any advertisement includes a column with
running text containing detailed information as to composition,
prescribing, side effects, or contraindications and the proprietary
name or designation is used in such column but is not featured
above or below the column, the established name shall be used at
least once in such column of running text in association with such
proprietary name or designation and in the same type size used in
such column of running text: Provided, however, That if the
proprietary name or designation is used in such column of running
text in larger size type, the established name shall be used at
least once in association with, and in type at least half as large
as the type used for, the most prominent presentation of the
proprietary name or designation in such column of running text.
Where the established name is required to accompany or to be used
in association with the proprietary name or designation, the
established name shall be placed in direct conjunction with the
proprietary name or designation, and the relationship between the
proprietary name or designation and the established name shall be
made clear by use of a phrase such as “brand of” preceding the
established name, by brackets surrounding the established name, or
by other suitable means.
(2) The established name shall be printed in letters that are at
least half as large as the letters comprising the proprietary name
or designation with which it is joined, and the established name
shall have a prominence commensurate with the prominence with which
such proprietary name or designation appears, taking into account
all pertinent factors, including typography, layout, contrast, and
other printing features.
(c) In the case of a prescription drug containing two or more
active ingredients, if the advertisement bears a proprietary name
or designation for such mixture and there is no established name
corresponding to such proprietary name or designation, the
quantitative ingredient information required in the advertisement
by section 502(n) of the act shall be placed in direct conjunction
with the most prominent display of the proprietary name or
designation. The prominence of the quantitative ingredient
information shall bear a reasonable relationship to the prominence
of the proprietary name.
(d)(1) If the advertisement employs one proprietary name or
designation to refer to a combination of active ingredients present
in more than one preparation (the individual preparations differing
from each other as to quantities of active ingredients and/or the
form of the finished preparation) and there is no established name
corresponding to such proprietary name or designation, a listing
showing the established names of the active ingredients shall be
placed in direct conjunction with the most prominent display of
such proprietary name or designation. The prominence of this
listing of active ingredients shall bear a reasonable relationship
to the prominence of the proprietary name and the relationship
between such proprietary name or designation, and the listing of
active ingredients shall be made clear by use of such phrase as
“brand of”, preceding the listing of active ingredients.
(2) The advertisement shall prominently display the name of at
least one specific dosage form and shall have the quantitative
ingredient information required by section 502(n) of the act in
direct conjunction with such display. If other dosage forms are
listed in the advertisement, the quantitative ingredient
information for such dosage forms shall appear in direct
conjunction and in equal prominence with the most prominent listing
of the names of such dosage forms.
(e) True statement of information in brief summary relating to
side effects, contraindications, and effectiveness:
(1) When required. All advertisements for any
prescription drug (“prescription drug” as used in this section
means drugs defined in section 503(b)(1) of the act and § 201.105,
applicable to drugs for use by man and veterinary drugs,
respectively), except advertisements described in paragraph (e)(2)
of this section, shall present a true statement of information in
brief summary relating to side effects, contraindications (when
used in this section “side effects, contraindications” include side
effects, warnings, precautions, and contraindications and include
any such information under such headings as cautions, special
considerations, important notes, etc.) and effectiveness.
Advertisements broadcast through media such as radio, television,
or telephone communications systems shall include information
relating to the major side effects and contraindications of the
advertised drugs in the audio or audio and visual parts of the
presentation and unless adequate provision is made for
dissemination of the approved or permitted package labeling in
connection with the broadcast presentation shall contain a brief
summary of all necessary information related to side effects and
contraindications.
(2) Exempt advertisements. The following advertisements
are exempt from the requirements of paragraph (e)(1) of this
section under the conditions specified:
(i) Reminder advertisements. Reminder advertisements are
those which call attention to the name of the drug product but do
not include indications or dosage recommendations for use of the
drug product. These reminder advertisements shall contain only the
proprietary name of the drug product, if any; the established name
of the drug product, if any; the established name of each active
ingredient in the drug product; and, optionally, information
relating to quantitative ingredient statements, dosage form,
quantity of package contents, price, the name and address of the
manufacturer, packer, or distributor or other written, printed, or
graphic matter containing no representation or suggestion relating
to the advertised drug product. If the Commissioner finds that
there is evidence of significant incidence of fatalities or serious
injury associated with the use of a particular prescription drug,
he may withdraw this exemption by so notifying the manufacturer,
packer, or distributor of the drug by letter. Reminder
advertisements, other than those solely intended to convey price
information including, but not limited to, those subject to the
requirements of § 200.200 of this chapter, are not permitted for a
prescription drug product whose labeling contains a boxed warning
relating to a serious hazard associated with the use of the drug
product. Reminder advertisements which are intended to provide
consumers with information concerning the price charged for a
prescription for a drug product are exempt from the requirements of
this section if they meet all of the conditions contained in §
200.200 of this chapter. Reminder advertisements, other than those
subject to the requirements of § 200.200 of this chapter, are not
permitted for a drug for which an announcement has been published
pursuant to a review on the labeling claims for the drug by the
National Academy of Sciences/National Research Council (NAS/NRC),
Drug Efficacy Study Group, and for which no claim has been
evaluated as higher than “possibly effective.” If the Commissioner
finds the circumstances are such that a reminder advertisement may
be misleading to prescribers of drugs subject to NAS/NRC
evaluation, such advertisements will not be allowed and the
manufacturer, packer, or distributor will be notified either in the
publication of the conclusions on the effectiveness of the drug or
by letter.
(ii) Advertisements of bulk-sale drugs. Advertisements of
bulk-sale drugs that promote sale of the drug in bulk packages in
accordance with the practice of the trade solely to be processed,
manufactured, labeled, or repackaged in substantial quantities and
that contain no claims for the therapeutic safety or effectiveness
of the drug.
(iii) Advertisements of prescription-compounding drugs.
Advertisements of prescription-compounding drugs that promote sale
of a drug for use as a prescription chemical or other compound for
use by registered pharmacists in compounding prescriptions if the
drug otherwise complies with the conditions for the labeling
exemption contained in § 201.120 and the advertisement contains no
claims for the therapeutic safety or effectiveness of the drug.
(3) Scope of information to be included; applicability to the
entire advertisement. (i) The requirement of a true statement
of information relating to side effects, contraindications, and
effectiveness applies to the entire advertisement. Untrue or
misleading information in any part of the advertisement will not be
corrected by the inclusion in another distinct part of the
advertisement of a brief statement containing true information
relating to side effects, contraindications, and effectiveness of
the drug. If any part or theme of the advertisement would make the
advertisement false or misleading by reason of the omission of
appropriate qualification or pertinent information, that part or
theme shall include the appropriate qualification or pertinent
information, which may be concise if it is supplemented by a
prominent reference on each page to the presence and location
elsewhere in the advertisement of a more complete discussion of
such qualification or information.
(ii) The information relating to effectiveness is not required
to include information relating to all purposes for which the drug
is intended but may optionally be limited to a true statement of
the effectiveness of the drug for the selected purpose(s) for which
the drug is recommended or suggested in the advertisement. The
information relating to effectiveness shall include specific
indications for use of the drug for purposes claimed in the
advertisement; for example, when an advertisement contains a broad
claim that a drug is an antibacterial agent, the advertisement
shall name a type or types of infections and microorganisms for
which the drug is effective clinically as specifically as required,
approved, or permitted in the drug package labeling.
(iii) The information relating to side effects and
contraindications shall disclose each specific side effect and
contraindication (which include side effects, warnings,
precautions, and contraindications and include any such information
under such headings as cautions, special considerations, important
notes, etc.; see paragraph (e)(1) of this section) contained in
required, approved, or permitted labeling for the advertised drug
dosage form(s): Provided, however,
(a) The side effects and contraindications disclosed may
be limited to those pertinent to the indications for which the drug
is recommended or suggested in the advertisement to the extent that
such limited disclosure has previously been approved or permitted
in drug labeling conforming to the provisions of §§ 201.100 or
201.105; and
(b) The use of a single term for a group of side effects
and contraindications (for example, “blood dyscrasias” for
disclosure of “leukopenia,” “agranulocytosis,” and “neutropenia”)
is permitted only to the extent that the use of such a single term
in place of disclosure of each specific side effect and
contraindication has been previously approved or permitted in drug
labeling conforming to the provisions of §§ 201.100 or 201.105.
(4) Substance of information to be included in brief
summary. (i)(a) An advertisement for a prescription drug
covered by a new-drug application approved pursuant to section 505
of the act after October 10, 1962, or a prescription drug covered
by a new animal drug application approved pursuant to section 512
of the act after August 1, 1969, or any approved supplement
thereto, or for a prescription drug listed in the index pursuant to
section 572 of the act, or any granted modification thereto, shall
not recommend or suggest any use that is not in the labeling
accepted in such approved new-drug application or supplement, new
animal drug application or supplement, or new animal drug index
listing or modification. The advertisement shall present
information from labeling required, approved, permitted, or granted
in a new-drug or new animal drug application or new animal drug
index listing relating to each specific side effect and
contraindication in such labeling that relates to the uses of the
advertised drug dosage form(s) or shall otherwise conform to the
provisions of paragraph (e)(3)(iii) of this section.
(b) If a prescription drug was covered by a new-drug
application or a supplement thereto that became effective prior to
October 10, 1962, an advertisement may recommend or suggest:
(1) Uses contained in the labeling accepted in such
new-drug application and any effective, approved, or permitted
supplement thereto.
(2) Additional uses contained in labeling in commercial
use on October 9, 1962, to the extent that such uses did not cause
the drug to be an unapproved “new drug” as “new drug” was defined
in section 201(p) of the act as then in force, and to the extent
that such uses would be permitted were the drug subject to
paragraph (e)(4)(iii) of this section.
(3) Additional uses contained in labeling in current
commercial use to the extent that such uses do not cause the drug
to be an unapproved “new drug” as defined in section 201(p) of the
act as amended or a “new animal drug” as defined in section 201(v)
of the act as amended.
The advertisement shall present information from labeling required,
approved, or permitted in a new-drug application relating to each
specific side effect and contraindication in such labeling that
relates to the uses of the advertised drug dosage form(s) or shall
otherwise conform to the provisions of paragraph (e)(3)(iii) of
this section.
(ii) In the case of an advertisement for a prescription drug
other than a drug the labeling of which causes it to be an
unapproved “new drug” and other than drugs covered by paragraph
(e)(4)(i) of this section, an advertisement may recommend and
suggest the drug only for those uses contained in the labeling
thereof:
(a) For which the drug is generally recognized as safe
and effective among experts qualified by scientific training and
experience to evaluate the safety and effectiveness of such drugs;
or
(b) For which there exists substantial evidence of safety
and effectiveness, consisting of adequate and well-controlled
investigations, including clinical investigations (as used in this
section “clinical investigations,” “clinical experience,” and
“clinical significance” mean in the case of drugs intended for
administration to man, investigations, experience, or significance
in humans, and in the case of drugs intended for administration to
other animals, investigations, experience, or significance in the
specie or species for which the drug is advertised), by experts
qualified by scientific training and experience to evaluate the
safety and effectiveness of the drug involved, on the basis of
which it can fairly and responsibly be concluded by such experts
that the drug is safe and effective for such uses; or
(c) For which there exists substantial clinical
experience (as used in this section this means substantial clinical
experience adequately documented in medical literature or by other
data (to be supplied to the Food and Drug Administration, if
requested)), on the basis of which it can fairly and responsibly be
concluded by qualified experts that the drug is safe and effective
for such uses; or
(d) For which safety is supported under any of the
preceding clauses in paragraphs (e)(4)(iii) (a), (b),
and (c) of this section and effectiveness is supported under
any other of such clauses.
The advertisement shall present information relating to each
specific side effect and contraindication that is required,
approved, or permitted in the package labeling by §§ 201.100 or
201.105 of this chapter of the drug dosage form(s) or shall
otherwise conform to the provisions of paragraph (e)(3)(iii) of
this section.
(5) “True statement” of information. An advertisement
does not satisfy the requirement that it present a “true statement”
of information in brief summary relating to side effects,
contraindications, and effectiveness if:
(i) It is false or misleading with respect to side effects,
contraindications, or effectiveness; or
(ii) It fails to present a fair balance between information
relating to side effects and contraindications and information
relating to effectiveness of the drug in that the information
relating to effectiveness is presented in greater scope, depth, or
detail than is required by section 502(n) of the act and this
information is not fairly balanced by a presentation of a summary
of true information relating to side effects and contraindications
of the drug; Provided, however, That no advertisement shall
be considered to be in violation of this section if the
presentation of true information relating to side effects and
contraindications is comparable in depth and detail with the claims
for effectiveness or safety.
(iii) It fails to reveal facts material in the light of its
representations or material with respect to consequences that may
result from the use of the drug as recommended or suggested in the
advertisement.
(6) Advertisements that are false, lacking in fair balance,
or otherwise misleading. An advertisement for a prescription
drug is false, lacking in fair balance, or otherwise misleading, or
otherwise violative of section 502(n) of the act, among other
reasons, if it:
(i) Contains a representation or suggestion, not approved or
permitted for use in the labeling, that a drug is better, more
effective, useful in a broader range of conditions or patients (as
used in this section patients means humans and in the case
of veterinary drugs, other animals), safer, has fewer, or less
incidence of, or less serious side effects or contraindications
than has been demonstrated by substantial evidence or substantial
clinical experience (as described in paragraphs (e)(4)(ii)
(b) and (c) of this section) whether or not such
representations are made by comparison with other drugs or
treatments, and whether or not such a representation or suggestion
is made directly or through use of published or unpublished
literature, quotations, or other references.
(ii) Contains a drug comparison that represents or suggests that
a drug is safer or more effective than another drug in some
particular when it has not been demonstrated to be safer or more
effective in such particular by substantial evidence or substantial
clinical experience.
(iii) Contains favorable information or opinions about a drug
previously regarded as valid but which have been rendered invalid
by contrary and more credible recent information, or contains
literature references or quotations that are significantly more
favorable to the drug than has been demonstrated by substantial
evidence or substantial clinical experience.
(iv) Contains a representation or suggestion that a drug is
safer than it has been demonstrated to be by substantial evidence
or substantial clinical experience, by selective presentation of
information from published articles or other references that report
no side effects or minimal side effects with the drug or otherwise
selects information from any source in a way that makes a drug
appear to be safer than has been demonstrated.
(v) Presents information from a study in a way that implies that
the study represents larger or more general experience with the
drug than it actually does.
(vi) Contains references to literature or studies that
misrepresent the effectiveness of a drug by failure to disclose
that claimed results may be due to concomitant therapy, or by
failure to disclose the credible information available concerning
the extent to which claimed results may be due to placebo effect
(information concerning placebo effect is not required unless the
advertisement promotes the drug for use by man).
(vii) Contains favorable data or conclusions from nonclinical
studies of a drug, such as in laboratory animals or in vitro, in a
way that suggests they have clinical significance when in fact no
such clinical significance has been demonstrated.
(viii) Uses a statement by a recognized authority that is
apparently favorable about a drug but fails to refer to concurrent
or more recent unfavorable data or statements from the same
authority on the same subject or subjects.
(ix) Uses a quote or paraphrase out of context to convey a false
or misleading idea.
(x) Uses literature, quotations, or references that purport to
support an advertising claim but in fact do not support the claim
or have relevance to the claim.
(xi) Uses literature, quotations, or references for the purpose
of recommending or suggesting conditions of drug use that are not
approved or permitted in the drug package labeling.
(xii) Offers a combination of drugs for the treatment of
patients suffering from a condition amenable to treatment by any of
the components rather than limiting the indications for use to
patients for whom concomitant therapy as provided by the fixed
combination drug is indicated, unless such condition is included in
the uses permitted under paragraph (e)(4) of this section.
(xiii) Uses a study on normal individuals without disclosing
that the subjects were normal, unless the drug is intended for use
on normal individuals.
(xiv) Uses “statistics” on numbers of patients, or counts of
favorable results or side effects, derived from pooling data from
various insignificant or dissimilar studies in a way that suggests
either that such “statistics” are valid if they are not or that
they are derived from large or significant studies supporting
favorable conclusions when such is not the case.
(xv) Uses erroneously a statistical finding of “no significant
difference” to claim clinical equivalence or to deny or conceal the
potential existence of a real clinical difference.
(xvi) Uses statements or representations that a drug differs
from or does not contain a named drug or category of drugs, or that
it has a greater potency per unit of weight, in a way that suggests
falsely or misleadingly or without substantial evidence or
substantial clinical experience that the advertised drug is safer
or more effective than such other drug or drugs.
(xvii) Uses data favorable to a drug derived from patients
treated with dosages different from those recommended in approved
or permitted labeling if the drug advertised is subject to section
505 of the act, or, in the case of other drugs, if the dosages
employed were different from those recommended in the labeling and
generally recognized as safe and effective. This provision is not
intended to prevent citation of reports of studies that include
some patients treated with dosages different from those authorized,
if the results in such patients are not used.
(xviii) Uses headline, subheadline, or pictorial or other
graphic matter in a way that is misleading.
(xix) Represents or suggests that drug dosages properly
recommended for use in the treatment of certain classes of patients
or disease conditions are safe and effective for the treatment of
other classes of patients or disease conditions when such is not
the case.
(xx) Presents required information relating to side effects or
contraindications by means of a general term for a group in place
of disclosing each specific side effect and contraindication (for
example employs the term blood dyscrasias instead of
“leukopenia,” “agranulocytosis,” “neutropenia,” etc.) unless the
use of such general term conforms to the provisions of paragraph
(e)(3)(iii) of this section.
Provided, however, That any provision of this paragraph
shall be waived with respect to a specified advertisement as set
forth in a written communication from the Food and Drug
Administration on a petition for such a waiver from a person who
would be adversely affected by the enforcement of such provision on
the basis of a showing that the advertisement is not false, lacking
in fair balance, or otherwise misleading, or otherwise violative of
section 502(n) of the act. A petition for such a waiver shall set
forth clearly and concisely the petitioner's interest in the
advertisement, the specific provision of this paragraph from which
a waiver is sought, a complete copy of the advertisement, and a
showing that the advertisement is not false, lacking in fair
balance, or otherwise misleading, or otherwise violative of section
502(n) of the act.
(7) Advertisements that may be false, lacking in fair
balance, or otherwise misleading. An advertisement may be
false, lacking in fair balance, or otherwise misleading or
otherwise violative of section 502(n) of the act if it:
(i) Contains favorable information or conclusions from a study
that is inadequate in design, scope, or conduct to furnish
significant support for such information or conclusions.
(ii) Uses the concept of “statistical significance” to support a
claim that has not been demonstrated to have clinical significance
or validity, or fails to reveal the range of variations around the
quoted average results.
(iii) Uses statistical analyses and techniques on a
retrospective basis to discover and cite findings not soundly
supported by the study, or to suggest scientific validity and rigor
for data from studies the design or protocol of which are not
amenable to formal statistical evaluations.
(iv) Uses tables or graphs to distort or misrepresent the
relationships, trends, differences, or changes among the variables
or products studied; for example, by failing to label abscissa and
ordinate so that the graph creates a misleading impression.
(v) Uses reports or statements represented to be statistical
analyses, interpretations, or evaluations that are inconsistent
with or violate the established principles of statistical theory,
methodology, applied practice, and inference, or that are derived
from clinical studies the design, data, or conduct of which
substantially invalidate the application of statistical analyses,
interpretations, or evaluations.
(vi) Contains claims concerning the mechanism or site of drug
action that are not generally regarded as established by scientific
evidence by experts qualified by scientific training and experience
without disclosing that the claims are not established and the
limitations of the supporting evidence.
(vii) Fails to provide sufficient emphasis for the information
relating to side effects and contraindications, when such
information is contained in a distinct part of an advertisement,
because of repetition or other emphasis in that part of the
advertisement of claims for effectiveness or safety of the
drug.
(viii) Fails to present information relating to side effects and
contraindications with a prominence and readability reasonably
comparable with the presentation of information relating to
effectiveness of the drug, taking into account all implementing
factors such as typography, layout, contrast, headlines,
paragraphing, white space, and any other techniques apt to achieve
emphasis.
(ix) Fails to provide adequate emphasis (for example, by the use
of color scheme, borders, headlines, or copy that extends across
the gutter) for the fact that two facing pages are part of the same
advertisement when one page contains information relating to side
effects and contraindications.
(x) In an advertisement promoting use of the drug in a selected
class of patients (for example, geriatric patients or depressed
patients), fails to present with adequate emphasis the significant
side effects and contraindications or the significant dosage
considerations, when dosage recommendations are included in an
advertisement, especially applicable to that selected class of
patients.
(xi) Fails to present on a page facing another page (or on
another full page) of an advertisement on more than one page,
information relating to side effects and contraindications when
such information is in a distinct part of the advertisement.
(xii) Fails to include on each page or spread of an
advertisement the information relating to side effects and
contraindications or a prominent reference to its presence and
location when it is presented as a distinct part of an
advertisement.
(xiii) Contains information from published or unpublished
reports or opinions falsely or misleadingly represented or
suggested to be authentic or authoritative.
(f)-(i) [Reserved]
(j)(1) No advertisement concerning a particular prescription
drug may be disseminated without prior approval by the Food and
Drug Administration if:
(i) The sponsor or the Food and Drug Administration has received
information that has not been widely publicized in medical
literature that the use of the drug may cause fatalities or serious
damage;
(ii) The Commissioner (or in his absence the officer acting as
Commissioner), after evaluating the reliability of such
information, has notified the sponsor that the information must be
a part of the advertisements for the drug; and
(iii) The sponsor has failed within a reasonable time as
specified in such notification to present to the Food and Drug
Administration a program, adequate in light of the nature of the
information, for assuring that such information will be publicized
promptly and adequately to the medical profession in subsequent
advertisements.
If the Commissioner finds that the program presented is not being
followed, he will notify the sponsor that prior approval of all
advertisements for the particular drug will be required. Nothing in
this paragraph is to be construed as limiting the Commissioner's or
the Secretary's rights, as authorized by law, to issue publicity,
to suspend any new-drug application, to decertify any antibiotic,
or to recommend any regulatory action.
(2) Within a reasonable time after information concerning the
possibility that a drug may cause fatalities or serious damage has
been widely publicized in medical literature, the Food and Drug
Administration shall notify the sponsor of the drug by mail that
prior approval of advertisements for the drug is no longer
necessary.
(3) Dissemination of an advertisement not in compliance with
this paragraph shall be deemed to be an act that causes the drug to
be misbranded under section 502(n) of the act.
(4) Any advertisement may be submitted to the Food and Drug
Administration prior to publication for comment. If the advertiser
is notified that the submitted advertisement is not in violation
and, at some subsequent time, the Food and Drug Administration
changes its opinion, the advertiser will be so notified and will be
given a reasonable time for correction before any regulatory action
is taken under this section. Notification to the advertiser that a
proposed advertisement is or is not considered to be in violation
shall be in written form.
(5) The sponsor shall have an opportunity for a regulatory
hearing before the Food and Drug Administration pursuant to part 16
of this chapter with respect to any determination that prior
approval is required for advertisements concerning a particular
prescription drug, or that a particular advertisement is not
approvable.
(k) An advertisement issued or caused to be issued by the
manufacturer, packer, or distributor of the drug promoted by the
advertisement and which is not in compliance with section 502(n) of
the act and the applicable regulations thereunder shall cause
stocks of such drug in possession of the person responsible for
issuing or causing the issuance of the advertisement, and stocks of
the drug distributed by such person and still in the channels of
commerce, to be misbranded under section 502(n) of the act.
(l)(1) Advertisements subject to section 502(n) of the act
include advertisements in published journals, magazines, other
periodicals, and newspapers, and advertisements broadcast through
media such as radio, television, and telephone communication
systems.
(2) Brochures, booklets, mailing pieces, detailing pieces, file
cards, bulletins, calendars, price lists, catalogs, house organs,
letters, motion picture films, film strips, lantern slides, sound
recordings, exhibits, literature, and reprints and similar pieces
of printed, audio, or visual matter descriptive of a drug and
references published (for example, the “Physicians Desk Reference”)
for use by medical practitioners, pharmacists, or nurses,
containing drug information supplied by the manufacturer, packer,
or distributor of the drug and which are disseminated by or on
behalf of its manufacturer, packer, or distributor are hereby
determined to be labeling as defined in section 201(m) of the
act.
[40 FR 14016, Mar. 27, 1975, as amended at 40 FR 58799, Dec. 18,
1975; 41 FR 48266, Nov. 2, 1976; 42 FR 15674, Mar. 22, 1977; 60 FR
38480, July 27, 1995; 72 FR 69119, Dec. 6, 2007] Effective Date
Note:At 44 FR 37467, June 26, 1979, § 202.1(e)(6) (ii) and (vii)
were revised. At 44 FR 74817, Dec. 18, 1979, paragraphs (e)(6) (ii)
and (vii) were stayed indefinitely. At 64 FR 400, Jan. 5, 1999,
these paragraphs were amended. For the convenience of the user,
paragraphs (e)(6) (ii) and (vii), published at 44 FR 37467, are set
forth below: § 202.1 Prescription-drug advertisements.
(e) * * *
(6) * * *
(ii) Represents or suggests that a prescription drug is safer or
more effective than another drug in some particular when the
difference has not been demonstrated by substantial evidence. An
advertisement for a prescription drug may not, either directly or
by implication, e.g., by use of comparative test data or reference
to published reports, represent that the drug is safer or more
effective than another drug, nor may an advertisement contain a
quantitative statement of safety or effectiveness (a) unless
the representation has been approved as part of the labeling in a
new drug application or biologic license, or (b) if the drug
is not a new drug or biologic, unless the representation of safety
or effectiveness is supported by substantial evidence derived from
adequate and well-controlled studies as defined in §
314.111(a)(5)(ii) of this chapter, or unless the requirement for
adequate and well-controlled studies is waived as provided in §
314.111(a)(5)(ii) of this chapter.
(vii) Suggests, on the basis of favorable data or conclusions
from nonclinical studies of a prescription drug, such as studies in
laboratory animals or in vitro, that the studies have clinical
significance, if clinical significance has not been demonstrated.
Data that demonstrate activity or effectiveness for a prescription
drug in animal or in vitro tests and have not been shown by
adequate and well-controlled clinical studies to pertain to
clinical use may be used in advertising except that (a), in
the case of anti-infective drugs, in vitro data may be included in
the advertisement, if data are immediately preceded by the
statement “The following in vitro data are available but their
clinical significance is unknown” and (b), in the case of other
drug classes, in vitro and animal data that have not been shown to
pertain to clinical use by adequate and well-controlled clinical
studies as defined in § 314.111(a)(5)(ii) of this chapter may not
be used unless the requirement for adequate and well-controlled
studies is waived as provided in § 314.111(a)(5)(ii) of this
chapter.
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