[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<SUP>1                      6,960<SUP>1             $9,280<SUP>2               $125,280<SUP>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