[Federal Register Volume 60, Number 158 (Wednesday, August 16, 1995)]
[Notices]
[Pages 42578-42581]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20245]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0259]


Over-the-Counter Drug Labeling; Public Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
hearing to discuss over-the-counter (OTC) drug labeling issues. The 
purpose of the hearing is to solicit information and views concerning 
various aspects of OTC drug labeling design that would improve the 
communication of information to consumers. The agency is particularly 
interested in hearing from individuals, industry, consumer groups, 
health professionals, and researchers with expertise in communicating 
information to consumers, skills in design, and insight into consumer 
needs and desires with respect to OTC drug labeling. In addition, the 
agency is soliciting written comments and/or data on the costs and 
benefits of an improved labeling format.

DATES: The public hearing will be held on September 29, 1995, from 8 
a.m. to 3 p.m. Mail or FAX notices of participation to be received by 
FDA by September 15, 1995. The Nonprescription Drugs Advisory Committee 
will meet from 3 p.m. to 4 p.m., following the public hearing. This 
meeting will be open to the public. Written comments will be accepted 
until December 29, 1995.

ADDRESSES: The public hearing will be held at the Parklawn Bldg., 
conference rooms D and E, 5600 Fishers Lane, Rockville, MD 20857. 
Submit written notices of participation and comments to the Dockets 
Management Branch (HFA-305), ATTN: OTC Drug Labeling Hearing, Food and 
Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, 
or FAX written notices of participation and comments to the Dockets 
Management Branch, ATTN: OTC Drug Labeling Hearing, 301-594-3215. Two 
copies of any comments are to be submitted, except that individuals may 
submit one copy. Comments are to be identified with Docket No. 95N-
0259. Transcripts of the hearing will be available for review at the 
Dockets Management Branch (address above). Information specified in 
this notice can be received by calling 301-594-5000 or sending a self-
addressed stamped envelope with your request to the contact person 
listed below.

FOR FURTHER INFORMATION CONTACT: Michael D. Kennedy, Center for Drug 
Evaluation and Research (HFD-820), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20857, 301-594-1006.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Federal Food, Drug, and Cosmetic Act (the act), FDA has 
the responsibility to help ensure the safety and effectiveness of OTC 
drug products and to regulate their labels and labeling. The agency is 
engaged in an ongoing comprehensive review of the thousands of OTC drug 
products available to consumers without a prescription. As a result of 
that review, the agency has required, through notice-and-comment 
rulemaking, specific language to be included in the labeling of many 
OTC drug products, which describes the uses, directions, warnings, drug 
interactions, precautions, active ingredients, and other information 
that a consumer would need to know to use the product safely and 
effectively.
    With escalating health care costs and the OTC availability of more 
products once obtainable only by prescription, self-medication is on 
the rise. Consequently, it is increasingly important that consumers 
read, understand, and behave in accordance with the information on OTC 
drug labels and labeling.
    FDA regulations require that the OTC drug product labeling present 
and display information in such a manner as to render it ``likely to be 
read and understood by the ordinary individual, including individuals 
of low comprehension, under customary conditions of purchase and 
use.''\1\ (21 CFR 330.10(a)(4)(v)). Despite this regulation, many 
consumers have complained that OTC drug labels are difficult to 
understand and that the print size is too small. For example, in 1991, 
FDA received a citizen's petition requesting regulatory standards for 
the print size and style of OTC drug product labeling. In the Federal 
Register of March 6, 1991 (56 FR 9363), the agency sought comments on 
this petition and other issues related to label legibility and 
readability. FDA received many comments criticizing the print size and 
complexity of current OTC drug labels and labeling.

    \1\ Consistent with the act, ``labeling'' refers to ``all labels 
and other written, printed, or graphic matter (1) upon any article 
or any of its containers or wrappers, or (2) accompanying such 
article.'' (21 U.S.C. 321(m)).
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    The Nonprescription Drug Manufacturers Association (NDMA) has 
developed ``Label Readability Guidelines'' (NDMA Guidelines) for its 
members to use for guidance in designing OTC drug labels. These 
guidelines have served to provide advice on improving the legibility of 
OTC drug labeling. Copies of the NDMA guidelines are available from FDA 
by calling or writing the contact person listed above. FDA commends the 
drug industry for recognizing the need to improve OTC drug labeling 
features and for initiating voluntary readability guidelines. FDA, 
however, is firmly committed to further improving OTC drug labels and 
labeling and making them easier to read and understand. To date, the 
agency primarily has worked with manufacturers and consumers in this 
effort. In January 1995, FDA staff served as chairpersons and 
participated in a workshop with the Drug Information Association to 
discuss OTC drug labeling. The workshop was attended by consumers, 
industry, government officials, and academicians. The purpose was to 
explore perspectives on how to communicate OTC drug information more 
effectively to consumers through product labeling.
    As part of this ongoing effort to improve OTC drug labeling, FDA is 
examining different formats that could be used to communicate drug 
information to consumers in a more effective manner. FDA is now also 
examining the question of whether a standardized format would aid in 
achieving the goals of improved communication. The Part 15 hearing 
announced in this notice is intended to seek public comment on various 
issues specifically related to the format of OTC drug labeling. In 
order to further understand consumer needs for OTC label design, FDA is 
also seeking public comments regarding consumer use and behavior 
related to OTC drug labeling.
    The agency also recognizes that the terms and text required on OTC 
drug labeling could be improved to make the information easier to 
understand. The agency intends to hold one or more public meetings in 
the near future to discuss these issues. 

[[Page 42579]]


II. Scope of the Hearing

    In light of the many complex scientific and public health issues 
involved in communicating OTC drug information to consumers, FDA is 
soliciting broad public participation and comment on OTC drug labeling 
format issues and information regarding consumer use and behavior 
related to OTC drug labeling. The agency encourages individuals, 
industry, consumer groups, health professionals, and researchers with 
particular expertise in this area, as well as other interested persons, 
to respond to this notice. The agency strongly encourages persons who 
cannot attend the hearing to send information relevant to the topics 
and questions listed below to the Dockets Management Branch (address 
above). Comments should be identified with Docket No. 95N-0259.
    Topics and questions to be considered during the hearing include:

A. Consumer Use of OTC Drug Labeling
    (1) What information is available that characterizes consumer use 
of OTC drug labeling? For example, surveys and studies that require 
consumers to maintain diaries about their choice and use of OTC drugs 
have been performed to measure consumer use of OTC drugs. To what 
extent do these and other studies indicate the sources of information 
consumers use, such as OTC drug labeling, when deciding whether to use 
an OTC drug product (rather than consulting a physician or trying a 
nondrug remedy)?
    (2) What studies exist describing whether consumers understand 
product labeling that may be applicable to OTC drug products (e.g., 
information provided on or with consumer products other than OTC drug 
products)? To what extent do consumers rely on OTC drug labeling 
information when choosing among competing products and when actually 
using an OTC drug product (e.g., consulting directions for use)?
    (3) How would one expect label usage to vary with the type of 
product and consumer characteristics that affect the communication of 
information, such as literacy level, vision ability, etc.?

B. Legibility of OTC Drug Labeling
    (1) What features of OTC drug labeling design should be considered 
to assure that labeling is legible to consumers? Should a performance 
standard be used to assure legibility (for example, should labeling be 
considered acceptably legible only if a certain percentage of consumers 
with defined vision ability, under defined lighting levels, correctly 
perceive a predetermined level of labeling information)?
    (2) Currently, there are no required minimum standards for type 
size or other label design features for OTC drug labeling. Section 
502(c) of the act (21 U.S.C. 352(c)) states that the information must 
appear with such ``conspicuousness * * * as to render it likely to be 
read and understood by the ordinary individual under customary 
conditions of purchase * * *.'' As stated earlier in this notice, many 
consumers have written the agency complaining that the type size on 
many OTC drug products is so small that they cannot read the 
information. Since then, the industry has taken strides to make OTC 
labeling more legible. The NDMA Guidelines set forth a voluntary 
minimum type size of 6 point for most OTC drug packages and 4.5 point 
for small packages. By comparison, newspaper type size is usually 9 to 
10 point. Should OTC drug labeling on currently marketed products be 
more legible? Should FDA set minimum standards for type size for OTC 
drug labeling? If so, what should the standards be? Should the 
standards vary depending on the size of the label? What about 
particularly small packages?
    (3) Currently, there are no required minimum standards for other 
factors that affect the communication of information on OTC drug 
labeling, such as color, contrast, type style, spacing, and white 
space. Should FDA set minimum standards for these features? If so, what 
should the standards be? In addition, there are no standards for 
factors that affect readability, such as use of uppercase and lowercase 
letters, instead of all uppercase, and use of boldface and other 
highlighting techniques. Should FDA set minimum standards for these 
features? If so, what should they be? What other drug labeling design 
features are needed to improve legibility (e.g., would reducing the 
amount of information on the label improve information communication by 
allowing for increased white space between lines of text, layout, or 
design of information)?
    (4) How do label features, such as type size, type style, contrast, 
spacing, etc., influence consumers' attention to and ``willingness to 
read'' the OTC drug labeling? How critical is this aspect for 
information processing (i.e., how do OTC drug labeling design features 
influence consumer motivation to read the label)?

C. OTC Drug Labeling Design Features
    (1) The agency recently imposed a standardized format for labels on 
food products, pursuant to the Nutrition Labeling and Education Act of 
1990. The purpose of the standardized format is to enable the public to 
readily observe and comprehend nutrition information and to understand 
its relative significance in products. FDA recognizes that the type of 
information listed on food labels is different in some respects from 
the type of information on OTC drug labeling. The agency also 
recognizes that standardization may inhibit flexibility in designing 
labeling. Nonetheless, FDA believes that standardization of format 
would help consumers know what information to look for and where to 
find it. What benefits to the communication of information would a 
uniform, standardized OTC drug labeling format provide to the consumer? 
What other benefits would a uniform, standardized format provide to the 
consumer?
    (2) FDA recently approved switches from prescription to OTC status 
for two similar drugs intended to treat heartburn and acid indigestion. 
Each product's labeling was designed by the manufacturer with the 
intention of providing maximum communication of information, yet the 
labeling formats used for the two products are very different. Also, a 
major OTC drug pharmaceutical company recently has redesigned its 
labels, using a different format. (Examples of these labels are 
available from FDA by calling or writing the contact person listed 
above.) Is it desirable to have a uniform format for OTC drug labeling 
to convey drug information or should manufacturers have the flexibility 
to utilize a few different formats or should any format be acceptable 
to convey this information?
    (3) If the OTC drug labeling format were standardized, what 
features should be made consistent on all labeling (e.g., order of 
information, major headings or subheadings for information, use of 
lines or boxes around information, certain labeling statements)?
    (4) Headings are often used to signal where particular information 
can be found. If OTC drug labeling were standardized, what headings are 
suitable for the information placed on the OTC drug label? Current 
headings use ``key words,'' such as ``active ingredients,'' ``uses,'' 
``directions,'' ``warnings,'' ``inactive ingredients.'' Are key word 
headings suitable for OTC drug labeling? Would different headings be 
desirable, such as those in ``Question and Answer'' style, (e.g., 
``What is in [name of drug]?,'' ``What is [name of drug] used for?'' 
``How do I use [name of drug]?'' ``What should I be aware of about 
[name of drug]?'' ``When should I not use [name of drug]?'') 
Considering size constraints of OTC drug labels, should the information 
required in OTC 

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drug labeling have a title such as ``DRUG FACTS'' to distinguish it 
from other information in the labeling that is not required, yet is 
useful for the consumer, e.g., claims of pleasant taste, 1-800 
telephone number for information, money back guarantee information?
    (5) Is the order of information placed on the label important? If 
so, if OTC drug labeling format were standardized, what order of 
information is most appropriate? (e.g., active ingredient, indications 
for use, directions for use, warnings, precautions, drug interactions, 
inactive ingredients, storage information, description of tamper 
resistant feature(s), 1-800 telephone number, UPC bar code)
    (6) Symbols, pictograms, and icons that describe the text are 
sometimes used on OTC drug products to call attention to, or represent, 
certain information about the product. For example, to call attention 
to the standard warning ``As with any drug, if you are pregnant or 
nursing a baby, seek the advice of a health professional before using 
this product,'' some manufacturers place next to the text a pictogram, 
which is a circle enclosing a silhouette of a pregnant woman with a 
line crossing the circle. This pictogram, however, could be interpreted 
to mean that the product prevents pregnancy. Thus, pictograms and icons 
may or may not be clear in their representation and may confuse the 
consumer. If the OTC drug labeling format were standardized, are there 
any particular pictograms and icons that should be used on OTC drug 
labeling? If used, how can consumer confusion as to their meaning be 
reduced?
    (7) If OTC drug labeling format were standardized, should different 
types of information be separated in the labeling, using techniques 
such as boxing and bold lines? If so, where and when should boxes/lines 
be used? How would distinguishing between different types of 
information in this way benefit consumers?
    (8) Should any other features be considered for standardization?
    (9) In 1994, FDA staff from the Office of OTC Drug Evaluation 
presented an early prototype format for OTC drug labeling to FDA's 
Nonprescription Drugs Advisory Committee for comment. Copies of some 
mock-ups using the prototype format are available by calling or writing 
the contact person listed above. What features of the format are 
desirable? What features of the format could be improved?

D. Consumer Comprehension
    (1) Even if consumers can perceive and are willing to read OTC drug 
labeling, they may not comprehend the content of this labeling. What 
design features need to be considered to make labeling information 
understandable?
    (2) A number of guidances for designing labeling text are 
available, including test methods for evaluating readability, computer 
programs for improving grammar, and manuals for labeling format design 
are available. How should these guidances be used to design 
comprehensible text for OTC drug labeling? To what extent can one rely 
on these guidances to assure consumer comprehension?
    (3) For certain drug products that have been switched from 
prescription to OTC status, the agency has asked the applicant to 
conduct studies of consumer comprehension of the proposed OTC drug 
labeling prior to approval of the switch. What testing methods are most 
useful for these types of comprehension studies?

E. Behavioral Issues
    (1) As more prescription drug products are considered for OTC 
switches, consumers are being asked to make more complicated judgments 
about the appropriateness of these products for their personal use. For 
example, certain products are approved for OTC use only for recurrence 
of a condition that was initially diagnosed by a physician. To what 
extent can OTC drug labeling influence consumer judgments and behaviors 
that are necessary for the safe and effective use of these products? 
Does OTC drug labeling need to contain persuasive messages to encourage 
behavioral compliance with the directions for use?
    (2) How can FDA be assured that the labeling is sufficient to 
ensure safe and effective use of the OTC drug product? What types of 
testing methods need to be used, and under what conditions, to measure 
the ability of OTC drug labeling to communicate important information 
to consumers and influence behavior?
    (3) Since consumers vary considerably in their literacy level and 
in their ability to read and understand OTC drug labeling, how can FDA 
be assured that the effects of any labeling studies are generalizable 
to the population of potential users of the product? What additional 
consumer characteristics need to be considered to assure label 
comprehension and usage measures are applicable to the universe of 
consumers?

III. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public 
hearing will be held in accordance with 21 CFR part 15. The presiding 
officer will be the Commissioner of Food and Drugs or his designee. The 
presiding officer will be accompanied by a panel of Public Health 
Service employees with relevant expertise.
    Persons who wish to participate in the part 15 hearing must file a 
written or facsimile notice of participation with the Dockets 
Management Branch (address or FAX number above) by September 11, 1995. 
To ensure timely handling, the outer envelope should be clearly marked 
with Docket No. 95N-0259 and the statement ``OTC Drug Labeling 
Hearing.'' Groups should submit two copies. The notice of participation 
should contain the speaker's name, address, telephone number, FAX 
number, business affiliation, if any, a brief summary of the 
presentation, and approximate amount of time requested for the 
presentation.
    The agency requests that persons or groups having similar interests 
consolidate their presentations and present them through a single 
representative. FDA will allocate the time available for the hearing 
among the persons who properly file notices of participation. If time 
permits, FDA may allow participation at the conclusion of the hearing 
from interested persons attending the hearing who did not submit a 
written notice of participation.
    After reviewing the notices of participation and accompanying 
information, FDA will schedule each appearance and notify each 
participant by mail, telephone, or FAX, of the time allotted to the 
person and the approximate time the person's presentation is scheduled 
to begin. The hearing schedule will be available at the hearing. After 
the hearing, the schedule will be placed on file in the Dockets 
Management Branch (address above) under Docket Number 95N-0259.
    Under Sec. 15.30(f), the hearing is informal and the rules of 
evidence do not apply. The presiding officer and any panel members may 
question any person during or at the conclusion of their presentation. 
No other person attending the hearing may question a person making a 
presentation or interrupt the presentation of a participant.
    Public hearings under part 15 are subject to FDA's guideline (21 
CFR part 10, subpart C) concerning the policy and procedures for 
electronic media coverage of FDA's public administrative proceedings. 
Under Sec. 10.205, representatives of the electronic media may be 
permitted, subject to certain limitations, to videotape, film, or 
otherwise record FDA's public administrative proceedings, including 
presentations by participants. The 

[[Page 42581]]
hearing will be transcribed as required in Sec. 15.30(b). Orders for 
copies of the transcript can be placed at the meeting or through the 
Dockets Management Branch (address above).
    Any disabled persons requiring special accommodations in order to 
attend the hearing should direct those needs to the contact person 
listed above.
    To the extent that the conditions for the hearing, as described in 
this notice, conflict with any provisions set out in part 15, this 
notice acts as a waiver of those provisions as specified in 
Sec. 15.30(h).
    To permit time for all interested persons to submit data, 
information, or views on this subject, the administrative record of the 
hearing will remain open following the hearing until December 29, 1995.

IV. Additional Request for Information

    In order to assess the costs and benefits of enhanced OTC drug 
product labeling, written submissions to FDA on the following topics 
would be helpful:
    (1) How frequently do companies reprint OTC drug product labels and 
labeling? How frequently are labels redesigned?
    (2) What are the itemized costs involved in changing OTC drug 
labels and labeling (e.g., design, plate, reprinting, additional 
colors)?
    (3) If FDA were to propose a new OTC drug labeling format, what 
strategies could be used to lessen the cost to industry? For example, 
what lead time would allow manufacturers to use up existing labeling 
inventories?
    (4) What are the benefits to consumers from improvements in OTC 
drug labeling?
    Written comments addressing cost components should address, where 
applicable, one-time versus annual costs, differences in brand versus 
private-label costs, and implications for small businesses. The agency 
is most interested in cost data expressed in dollars, staff hours, and 
personnel (professional, technical, or support). Quantitative measures 
of benefits are considered most desirable, but discussions of anecdotal 
and/or qualitative benefits are also welcomed. Submit comments to the 
Dockets Management Branch (address above) identified with Docket No. 
95N-0259.

    Dated: August 10, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-20245 Filed 8-15-95; 8:45 am]
BILLING CODE 4160-01-F