Federal Register, Volume 61 Issue 102 (Friday, May 24, 1996)

[Federal Register Volume 61, Number 102 (Friday, May 24, 1996)]
[Proposed Rules]
[Pages 26140-26145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13174]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 801

[Docket No. 95N-0374]
RIN 0910-AA32

Latex Condoms; User Labeling; Expiration Dating

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a proposed
regulation that would require the labeling of latex condoms to contain
an expiration date based upon physical and mechanical testing performed
after exposing the product to varying conditions that age latex.
Studies show that latex condoms degrade over time. Such degradation has
a significant effect on the product's ability to provide a barrier to
sexually transmitted disease (STD) agents, including the human
immunodeficiency virus (HIV). This requirement is being proposed in
order to provide consumers with essential information regarding the
safe use of these products.

DATES: Written comments on this proposed rule by August 22, 1996.
Written comments on the information collection requirements should be
submitted by June 24, 1996. FDA proposes that any final rule that may
be issue based on this proposal become effective 180 days after the
date of its publication in the Federal Register.

ADDRESSES: Submit written comments on this proposed rule to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857. Submit written comments on
the information collection requirements to the Office of Information
and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St.
NW., rm. 10235, Washington, DC 20503, Attn: Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Donald E. Marlowe, Center for Devices
and Radiological Health (HFZ-150), Food and Drug Administration, 12200
Wilkins Ave., Rockville, MD 20852, 301-443-7003.

SUPPLEMENTARY INFORMATION:

I. Background

It is estimated that over 1 million persons in the United States
are infected with HIV (Ref. 1). HIV is transmitted primarily through
sexual contact; however, nonsexual transmission has occurred in health
care settings as a result of contact with infected blood. Additionally,
HIV has been isolated from other body fluids in addition to blood. With
the prevalence of HIV infection and the risk of transmission of other
infections, the importance of the quality of an effective barrier to
the transmission of infection is crucial.
Numerous studies in the scientific literature, including the
proceedings of a conference on ``Latex as a Barrier Material''
sponsored by FDA in 1989, have addressed and overwhelmingly supported
the use of latex membranes, such as condoms and medical gloves, as
effective barriers against the transmission of various disease agents,
including hepatitis, HIV, and other infections (Ref. 2). The Centers
for Disease Control and Prevention (CDC) and the Surgeon General of the
Public Health Service have recommended, on the basis of evidence that
latex provides a barrier against the transmission of STD's, that latex
condoms should be used according to instructions with every act of
intercourse for maximum protection against STD's (Ref. 3). Two recent
studies involving serodiscordant heterosexual couples (i.e., one
partner is HIV positive, the other HIV negative) indicate that using
latex condoms substantially reduces the risk of HIV transmission (Refs.
4 and 5). In one study, none of the 123 partners who used condoms
consistently became infected while 12 (10 percent) of 122 partners who
used condoms inconsistently became infected (Ref. 4). In the second
study, 3 (2 percent) of the 171 consistent condom users became infected
compared to 8 (15 percent) of 55 inconsistent condom users (Ref. 5).
The effectiveness of latex condoms as a barrier, however, is
dependent upon the integrity of the latex material. Degradation of
latex film products (e.g., the embrittlement of the latex film, an
increase in the porosity of the membrane, or other loss of physical
properties) occurs when latex is exposed to various types of
environmental conditions (such as elevated temperature, fluorescent
lights, or ozone) normally experienced in product use, shipment, or
storage situations. Exposure to these environmental conditions degrades
the film progressively over time, and may result in bursts, rips, tears
or seepage that allows the transmission of infectious agents.
To understand the effects of aging and other storage conditions on
latex properties, the State of Washington's Board of Pharmacy initiated
an FDA-sponsored study of the material integrity

[[Page 26141]]

of latex condoms (the FDA/Washington study) in July 1989 (Ref. 6). This
study was designed to investigate the effects of aging on latex condoms
by studying burst pressure, burst volume, tensile strength, and
elongation at breakage, after storage over different periods of time at
varying temperatures. The study examined dry (nonlubricated) condoms
and various types of lubricated condoms, produced by the major domestic
condom manufacturers. The study consisted of two parts--laboratory
testing, which ran for 3 years, and field testing, which is an ongoing
study of normal condom aging at eight sites representing varying
temperatures, elevations, and humidity conditions.
At the laboratories of the FDA/Washington study, packaged and
unpackaged latex condoms were exposed to temperatures of 20 and 30
deg.C (representing room temperature) for up to 5 years. In order to
represent exposure to the upper extreme of environmental temperatures,
condoms were exposed for 100 days to a temperature of 45 deg.C. Also,
to accelerate the aging process of the latex, condoms were exposed to
temperatures of 70 and 85 deg.C for up to 100 days (Refs. 7 through
9). The study revealed that exposed condoms (i.e., condoms not
protected by packaging) degraded to the point of being unusable within
1 year at room temperature, and at higher temperatures in as little as
10 days. The FDA/Washington study further shows that latex condoms
stored in intact plastic packages also degrade over time, though at a
much slower rate. The results of the FDA/Washington study demonstrate
that aging and other conditions can significantly affect the integrity,
strength, and quality of latex essential to maintaining a barrier
against the transmission of disease.
At a meeting with the agency, condom manufacturers and FDA agreed
that, based upon the American Society for Testing and Materials (ASTM)
standards and the FDA/Washington study, two accelerated aging test
conditions (i.e., storage for 7 days at 70 deg.C and storage for 90
days at 40 to 50 deg.C) properly evaluate aging properties of latex
films. Given the evidence that aging affects the latex barrier
properties of condoms that prevent the transmission of infectious
agents, the agency believes latex condoms should not be used after
aging has compromised latex barrier properties. Accordingly, FDA
believes that such products should bear expiration dates, based upon
appropriate testing, that will inform the user when these products
should no longer be used. FDA is therefore proposing that latex condoms
bear expiration dates.
Proposed Sec. 801.435(c) would require an expiration date to appear
on the primary packaging (i.e., the individual package), as well as
higher levels of labeling, such as the case containing individually
packaged products to ensure visibility.
To establish the expiration date, FDA is proposing to require
manufacturers to subject their products to certain aging condition
environments prior to conducting physical and mechanical testing that
will demonstrate the product will maintain its barrier properties
during the labeled shelf life of the product. The accelerated aging
conditions would be based on data and test protocols proposed by the
industry, and supported by existing condom standards (Ref. 10), and the
findings of the Mandel and FDA/Washington studies (Refs. 7 and 6).
Specifically, FDA in proposed Sec. 801.435(d) would require that a
manufacturer, before performing tests on products that demonstrate
physical and mechanical integrity of the product, subject products from
three discrete and random lots to each of the following conditions: (1)
Storage unpackaged for the maximum amount of time the manufacturer
allows the product to remain unpackaged after manufacture, followed by
storage of the packaged product at 70 deg.C (plus or minus 2 deg.C)
for 7 days; (2) storage unpackaged for the maximum amount of time the
manufacturer allows the product to remain unpackaged after manufacture,
followed by storage of the packaged product at 40 to 50 deg.C (plus or
minus 2 deg.C) for 90 days; and (3) storage unpackaged for the maximum
amount of time the manufacturer allows the product to remain unpackaged
after manufacture, followed by storage of the packaged product at 15 to
30 deg.C for the stated shelf life of the product.
Under proposed Sec. 801.435(e), if the latex barrier properties are
adequate (i.e., pass the manufacturer's reasonable physical and
mechanical integrity tests) after undergoing the 70 deg.C /7-day and
40 to 50 deg.C/90-day tests, the product may be labeled with an
expiration date of up to 5 years. If the product, after storage at
either 7- or 90-day test conditions, fails to meet the manufacturer's
physical or mechanical integrity tests, the labeled shelf life of the
product would be required to be demonstrated by real-time storage data
at 15 to 30 deg.C. Products that pass the 7- and 90-day test
conditions, would be required to undergo confirmation tests after the
product has been stored at 15 to 30 deg.C for the stated shelf life.
If the product fails the 15 to 30 deg.C confirmation test, the product
would be required to be relabeled to represent the actual shelf life
supported by real time data.
Although FDA would not require manufacturers of currently marketed
products to submit new 510(k) submissions prior to marketing condoms
with expiration dates, all testing data must be retained in each
company's files as required by 21 CFR 820.180, and remain available for
FDA inspection. New 510(k) submissions should include data to establish
labeled expiration dates.
The agency believes that the proposed 180-day time period between
the publication date of the final rule and the effective date of the
final rule would be sufficient time to conduct the required tests and
ensure that all latex condoms being initially introduced into
interstate commerce will bear an expiration date. Latex condoms
introduced into interstate commerce after the effective date of a final
rule based on this proposal, which do not bear appropriate expiration
dates would be considered to be misbranded under sections 201(n),
502(a) and (f)(1) of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 321(n), 352(a) and (f)(1)) in that their labeling fails to
contain facts material to the consequences of their use, and fails to
bear adequate directions for use.

II. Statement of Law

Section 701(a) of the act (21 U.S.C. 371(a)) authorizes FDA to
issue substantive binding regulations for the efficient enforcement of
the act. Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609
(1973); see also Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S.
645, 653 (1973); National Ass'n of Pharmaceutical Manufacturers v. FDA,
637 F.2d 877 (2d Cir. 1981); National Confectioners Ass'n v. Califano,
569 F.2d 690 (D.C. Cir 1978); National Nutritional Foods Ass'n v.
Weinberger, 512 F.2d 688 (2d Cir.) cert. denied, 423 U.S. 825 (1975).
Under the proposed rule, any latex condom that is not labeled as
required and that is introduced or delivered for introduction into
commerce after the effective date of a final rule would be misbranded
under sections 201(n) and 502(a) and (f)(1) of the act (21 U.S.C.
321(n) and 352(a) and (f)(1)). Section 502(a) of the act provides that
a device is misbranded if ``its labeling is false or misleading in any
particular.'' Section 201(n) of the act provides that, in determining
whether labeling of a regulated article (such as a device) is
misleading:

[[Page 26142]]

* * * there shall be taken into account * * * not only
representations made or suggested by statement, word, design,
device, or any combination thereof, but also the extent to which the
labeling * * * fails to reveal facts material in the light of such
representations or material with respect to consequences which may
result from the use of the article to which the labeling * * *
relates * * *.-
The shelf life of latex condoms is material information that
consumers need in order to safely use latex products. The omission of
shelf life would constitute an omission of a material fact and would
render latex condoms without an expiration date misbranded within the
meaning of section 502(a) of the act. The courts have upheld FDA's
authority to prevent false and misleading labeling by promulgating
regulations requiring label warnings and other affirmative disclosures,
see, e.g., Cosmetic, Toiletry and Fragrance Association v. Schmidt, 409
F. Supp. 57 (D.D.C. 1976), aff'd without opinion, Civil No. 75-1715
(D.C. Cir. August 19, 1977), even in the absence of a proven cause and
effect relationship between product usage and harm, Council for
Responsible Nutrition v. Goyan, Civil No. 80-1124 (D.D.C. August 1,
1980).
Section 502(f)(1) of the act provides that a device is also
misbranded unless its labeling bears adequate directions for use.
Adequate directions for use means adequate directions under which a
layperson can use a device safely and for the purpose for which it is
intended (see 21 CFR 801.4 and 801.5). Information concerning latex
condom shelf life is necessary to allow lay users to use these products
safely by avoiding use of products that may have degraded. Failure to
include such information would render the products misbranded under
section 502(f)(1) of the act.
FDA may impose testing requirements in a labeling regulation issued
under its general rulemaking authority. See, e.g., American Frozen Food
Inst. v. Mathews, 413 F. Supp. 548 (D.D.C. 1976), aff'd per curiam sub
nom. American Frozen Food Inst. v. Califano, 555 F.2d 1059 (D.C. Cir
1977); see also National Nutritional Foods Ass'n v. Weinberger, supra.
Thus, FDA may require that all latex condom manufacturers use the same
conditions to test aging to ensure that the expiration date reflects
the period of time a product can be used safely. A similar requirement
is imposed in 21 CFR 801.430(f) for absorbency tests for menstrual
tampons, and in 21 CFR 801.420(c)(4) on hearing aid manufacturers and
distributors who must determine and state technical data values for
hearing aid labeling in accordance with specified test procedures. The
hearing aid regulation has been upheld. American Speech and Hearing
Ass'n v. Califano, Medical Devices Report (CCH) No. 77-1327
Secs. 15004, 15007 (D.D.C. August 23, 1977), aff'd No. 77-1327 (D.C.
Cir. Dec. 19, 1977). Food regulations issued under section 701(a) of
the act also impose many such specific testing requirements (see, e.g.,
21 CFR 113.40 (tests for low-acid canned foods); 21 CFR
155.190(b)(2)(i) (test for determining drained weight of canned
tomatoes); 21 CFR 161.190 (method for determining color designation of
tuna)).
Consumers must be aware of the potential for degradation of latex
condoms in order to safely use such products to provide a barrier from
infectious agents. Accordingly, FDA believes that the shelf life is a
material fact to the consequences of use of latex condoms. FDA also
believes that a shelf life is necessary to provide the consumer with
adequate directions for use. After the effective date of the final
regulation, FDA will consider latex condoms that do not provide this
information to be misbranded under sections 201(n), 502(a) and (f)(1)
of the act because they fail to contain facts material to the
consequences of their use, and fail to bear adequate directions for
use.

III. Preemption

FDA advises that any labeling requirement based upon this proposal
would, under section 521(a) of the act (21 U.S.C. 360k(a)), preempt any
State or local requirement that is different from, or in addition to,
FDA's labeling requirement. Section 521(a) of the act provides that no
State or local government may establish any requirement applicable
under the act if such requirement is different from, or in addition to,
a requirement which is applicable to the device under the act.
In 1991, the State of Washington requested an advisory opinion
regarding the preemption of its State requirement that condom labels
bear a 3-year expiration date. One condom manufacturer had objected to
the State law, on the grounds that its 510(k) clearance included
labeling for a 5-year shelf life. The agency determined that the State
requirement was not preempted by section 521(a) of the act because, at
that time, there was no counterpart Federal requirement with respect to
expiration date labeling for condoms. FDA's ``General Guidance for
Modifying Condom Labeling to Include Shelf Life'' (Ref. 11) provided
premarket notification procedures for manufacturers who choose
voluntarily to affix shelf life dates to their condom packages. That
document did not establish a ``requirement'' within the meaning of
section 521(a) of the act. This proposed rule, when final, however,
would constitute a requirement which will preempt any State or local
requirement regarding the expiration date labeling of latex condoms
which is different from, or in addition to, the final regulation.

IV. Labeling For Other Latex-Film Products

The agency recognizes that the unique packaging of latex condoms
(i.e., product sealed individually in air-tight packages) makes it
difficult to extrapolate the data relating to latex condoms to other
latex-film medical devices that have packaging which may provide a
different level of protection from environmental conditions. Given the
evidence that aging affects the integrity of latex films, FDA believes
that medical devices containing or composed of a latex film should
provide information regarding the age of the latex film. In order to
address this issue, FDA is initiating a study to determine at what rate
latex gloves degrade under various environmental conditions.
Until the agency compiles sufficient data to propose an expiration
date for latex devices other than condoms, the agency is considering
whether to require devices containing or consisting of latex films,
other than latex condoms, to be labeled with the date of manufacture
(i.e., the date the latex film was formed by dipping). Although the
date of manufacture provides no information about the expected life of
the product, it will provide age information. Based upon such age
information, consumers may make a more informed choice regarding the
use of the product.
Furthermore, as shown in the FDA/Washington study cited above,
latex films are far more stable in intact packages than when exposed.
Because the normal use of some products (such as nonsterile examination
gloves, sold in dispenser boxes of 100), includes storage in opened
packages, FDA is also considering additional labeling information
requirements for products normally dispensed in open containers,
including the statement ``Heat and light accelerate the degradation of
latex films. Store opened containers away from heat and light.''
FDA invites advance comments on these issues. Meanwhile, FDA
encourages manufacturers to voluntarily provide information to
consumers regarding the age of latex film devices, and additional
educational materials and ancillary information regarding the

[[Page 26143]]

stability and best storage conditions of such products, as appropriate.

V. Environmental Impact

The agency has determined under 21 CFR 25.24(a)(11) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.

VI. Analysis of Impacts

FDA has examined the impacts of the proposed rule under Executive
order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the proposed
rule is not a significant regulatory action as defined by the Executive
Order and so is not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. This proposed regulation would require physical and
mechanical integrity tests. Because condom manufacturers routinely
conduct such tests on their products, the required testing would affect
manufacturers only by establishing storage conditions prior to testing
such products. This proposed rule would also require a labeling change.
The proposed 180-day time period between the publication date and
effective date of the final rule based upon this proposal would allow
most manufacturers to exhaust their existing supply of labels.
Accordingly, for the above-stated reasons, the agency certifies that
the proposed rule will not have a significant economic impact on small
entities. Therefore, under the Regulatory Flexibility Act, no further
analysis is required.

VII. Paperwork Reduction Act of 1995

This proposed rule contains information collections which are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995. The title, description, and
respondent description of the information collection are shown below
with an estimate of the annual reporting burden. Included in the
estimate is the time for reviewing instructions, gathering and
maintaining the data needed, and completing and reviewing the
collection of information.
With respect to the following collection of information, FDA
invites comments on: (1) Whether the proposed collection of information
is necessary for proper performance of FDA's functions, including
whether the information will have practical utility; (2) the accuracy
of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Title: Labeling Requirements for Latex Condoms--Expiration Date
Labeling.
Description: These information collection requirements apply to
condom manufacturers. This proposed rule expands the labeling of latex
condoms to contain an expiration date. The expiration date must be
supported by data from quality control tests demonstrating physical and
mechanical integrity of three random lots of the same product which
were stored under accelerated and real time conditions. Quality control
testing under accelerated conditions must include tests of: (1)
Unpackaged bulk product for the maximum amount of time the manufacturer
allows the product to remain unpackaged; (2) packaged product stored at
a specified temperature for 7 days; and (3) packaged product stored at
a specified temperature for 90 days. Quality control testing must also
be done under real time conditions, i.e., on packaged product at a
specified temperature for the entire expiration period (up to 5 years).
The recording of shelf life testing by condom manufacturers is used
to support the inclusion of expiration dating on the labeling of latex
condoms. Information concerning latex condom shelf life is necessary to
allow lay users to use these products safely by avoiding use of
products that may have degraded. The effectiveness of latex condoms as
a barrier to the transmission of infectious agents is dependent upon
the integrity of the latex material. The shelf life of latex condoms is
material information that consumers need in order to safely use latex
products.
Condom manufacturers will use the information collected from the
testing to establish the expiration date to be printed on the labeling
and purchasers will use the information collected to determine likely
effectiveness.
Section 510(h) of the act (21 U.S.C. 360(h)) requires that condom
manufacturers as device manufacturers be inspected at least once in a
2-year period. During that inspection, FDA inspectors will review the
test records used to support the expiration date in order to ensure
that the expiration date is accurate.
Description of Respondents: Businesses or other for profit
organizations.

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Estimated Annual Recordkeeping Burden
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Annual Frequency of Total Operating and
21 CFR Section No. of Recordkeepers Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours Total Capital Costs Maintenance Costs
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801.435(d) 58 1 58 120^{1 6,960^{1 $9,280^{2 $125,280^{1
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\1\ The annual burden reported here represents a year in which a manufacturer would have conducted testing at 0 days, 7 days, 90 days, and 5 years (in support of a labeled expiration period of
5 years). However, FDA expects that testing at 0 days, 7 days, and 90 days would be conducted during 1 year to justify a 5-year expiration period, and that testing on 5-year-old product
would be conducted in another year.
\2\ Capital costs are one time start-up costs and consist of a revision of policies and procedures.

As required by section 3507(d) of the Paperwork Reduction Act of
1995, FDA has submitted the collections of information contained in the
proposed rule to OMB for review. Other organizations and individuals
should submit comments on the information collection requirements by
June 24, 1996, and should direct them to the

[[Page 26144]]

Office of Information and Regulatory Affairs, OMB, New Executive Office
Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Desk
Officer for FDA.

VIII. Comments

Interested persons may, on or before August 22, 1996, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.

IX. References

The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Center for Disease Control and Prevention, ``HIV Prevalence
Estimates and AIDS Case Projections for The United States: Report
Based Upon a Workshop,'' Morbidity and Mortality Weekly Report, vol.
39/No. RR-16, November 30, 1990.
2. Conference on Latex as a Barrier Material, University of
Maryland, (sponsored by FDA), May 1989.
3. Center for Disease Control, ``Update: Barrier Protection
Against HIV Infection and Other Sexually Transmitted Diseases,''
Morbidity and Mortality Weekly Report, vol. 42/No. 30, August 6,
1993.
4. DeVincenzi, L., European Study Group on Heterosexual
Transmission of HIV, Heterosexual Transmission of HIV in a European
Cohort of Couples (abstract No. WSCO2-1), vol.1, IXth International
Conference on AIDS/HIV STD World Congress. Berlin, 83, June 9, 1993.
5. Saracco, A., M. Musicco, A. Nicolosi, et al., ``Man-to-Woman
Sexual Transmission of HIV: Longitudinal Study of 343 Steady
Partners of Infected Men,'' Journal of Acquired Immune Deficiency
Syndrome, 6:497-502, 1993.
6. Final Report: Lubricated Latex Condoms--Study of the Effects
of Environmental Parameters on Deterioration: Program for
Appropriate Technology in Health (PATH), FDA Contract No. 223-88-
4285, October 1993.
7. Mandel, J. et al., ``Measurement of the Aging of Rubber
Vulcanizates'' Journal of Research of the National Bureau of
Standards, vol. 63C, No. 2, October-December, 1959.
8. Barker, L. R., Accelerated and Long-Term Ageing of Natural
Rubber Vulcanisates: Journal of Natural Rubber Research, vol. 2, No.
4, pp. 201-213 (1987).
9. Barker, L. R., Accelerated Long-Term Ageing of Natural Rubber
Vulcanisates, Part 2: Results From Ageing Tests at 40 C, Journal of
Natural Rubber Research, vol. 5, No. 3, pp. 266-274, 1990.
10. ASTM D 3492, Standard Specification for Rubber
Contraceptives (Condoms), American Society for Testing and
Materials, Philadelphia, PA.
11. ``General Guidance for Modifying Condom Labeling to Include
Shelf Life,'' Division of Small Manufacturers Assistance, Center for
Devices and Radiological Health, Rockville, MD.

List of Subjects in 21 CFR Part 801

Labeling, Medical devices, Reporting and recordkeeping
requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 801 be amended as follows:

PART 801--LABELING

1. The authority citation for 21 CFR part 801 continues to read as
follows:

Authority: Secs. 201, 301, 501, 502, 507, 519, 520, 701, 704 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351,
352, 357, 360i, 360j, 371, 374).

2. New Sec. 801.435 is added to subpart H to read as follows:

Sec. 801.435 User labeling for latex condoms.

(a) This section applies to the subset of condoms as identified in
Sec. 884.5300 of this chapter, and condoms with spermicidal lubricant
as identified in Sec. 884.5310, which products are formed from latex
films.
(b) Data show that the material integrity of latex condoms degrades
over time. To protect the public health and minimize the risk of device
failure, latex condoms must bear an expiration date which is supported
by testing as described in paragraph (d) of this section.
(c) The expiration date, as demonstrated by testing procedures
described in paragraph (d) of this section, must be displayed
prominently and legibly on the primary packaging (e.g., individual
package), and higher levels of packaging (e.g., boxes of condoms), in
order to ensure visibility of the expiration date.
(d) The expiration date must be supported by data from reasonable
quality control tests demonstrating the physical and mechanical
integrity of the product after three discrete and random lots of the
same product have been subjected to each of the following conditions:
(1) Storage of unpackaged bulk product for the maximum amount of
time the manufacturer allows the product to remain unpackaged, followed
by storage of the packaged product at 70 deg.C (plus or minus 2
deg.C) for 7 days;
(2) Storage of unpackaged bulk product for the maximum amount of
time the manufacturer allows the product to remain unpackaged, followed
by storage of the packaged product at a selected temperature between 40
and 50 deg.C (plus or minus 2 deg.C) for 90 days; and
(3) Storage of unpackaged bulk product for the maximum amount of
time the manufacturer allows the product to remain unpackaged, followed
by storage of the packaged product at a monitored or controlled
temperature between 15 and 30 deg.C for the lifetime of the product
(real-time storage).
(e) If a product fails the manufacturer's reasonable quality
control tests for physical and mechanical integrity after the
completion of the accelerated storage tests described in paragraphs
(d)(1) and (d)(2) of this section, the product expiration date must be
demonstrated by real-time storage conditions described in paragraph
(d)(3) of this section. If all of the products tested after storage at
temperatures as described in paragraphs (d)(1) and (d)(2) of this
section pass the manufacturer's reasonable physical and mechanical
integrity tests, the manufacturer may label the product with an
expiration date of up to 5 years from the date of product packaging. If
the extrapolated expiration date, under paragraphs (d)(1) and (d)(2) of
this section, is used, the labeled expiration date must be confirmed by
reasonable physical and mechanical integrity tests performed at the end
of the stated expiration period as described in paragraph (d)(3) of
this section. If the data from tests following real-time storage
described in paragraph (d)(3) of this section fails to confirm the
extrapolated expiration date, the manufacturer must, at that time,
relabel the product to reflect the actual shelf life.
(f) The time period upon which the expiration date is based shall
start with the date of packaging.
(g) All testing data must be retained in each company's files, as
required by Sec. 820.180 of this chapter, and shall be made available,
upon request, for inspection by FDA.
(h) Any latex condom not labeled with an expiration date as
required by paragraph (c) of this section, and delivered for
introduction into interstate commerce after the effective date of this
regulation is misbranded under sections 201(n) and 502(a) and (f) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(n), 352(a) and
(f)).

[[Page 26145]]

Dated: May 17, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-13174 Filed 5-23-96; 8:45 am]
BILLING CODE 4160-01-F}}}}