[Federal Register Volume 62, Number 187 (Friday, September 26, 1997)]
[Rules and Regulations]
[Pages 50497-50502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25587]


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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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule 
that requires 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 diseases (STD's), including human immunodeficiency 
virus (HIV). This requirement is established in order to provide 
consumers with essential information regarding the safe use of these 
products.

EFFECTIVE DATE: March 25, 1998.

FOR FURTHER INFORMATION CONTACT: Donald E. Marlowe, Center for Devices 
and Radiological Health (HFZ-100), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-2444.

SUPPLEMENTARY INFORMATION:

I. Background

     It is estimated that over 1 million persons in the United States 
are infected with HIV (Ref. 1). Although nonsexual transmission can 
occur, HIV is transmitted primarily through sexual contact. With the 
prevalence of HIV infection and the risk of transmission of other 
STD's, the importance of the quality of an effective barrier to the 
transmission of infection is crucial. Because latex membranes, such as 
condoms and medical gloves, are effective barriers against the spread 
of various diseases, including hepatitis, HIV, and other STD's (Refs. 
2, 4, and 5), the Centers for Disease Control and Prevention and the 
Surgeon General of the Public Health Service have recommended that 
latex condoms be used according to instructions with every act of 
intercourse for maximum protection against STD's (Ref. 3).
    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 conditions. Exposure to these environmental conditions degrade 
the film progressively over time and may result in bursts, rips, tears, 
or seepages that allow the transmission of disease.
    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 of latex condoms (the 
FDA/Washington study) in July of 1989 (Ref. 6). At the laboratories of 
the FDA/Washington study, packaged and unpackaged latex condoms were 
exposed to 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.
    Based upon these findings, using standards established by the 
American Society for Testing and Materials (ASTM), and following 
meetings with condom manufacturers, the agency published in the Federal 
Register of May 24, 1996 (61 FR 26140), a proposed rule that would 
require latex condoms to be labeled with an expiration date. 
Specifically, FDA proposed that, to ensure visibility of the expiration 
date by customers, an expiration date must 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 establish the expiration date, FDA proposed 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

[[Page 50498]]

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.
    If the latex barrier properties are adequate (i.e., pass the 
manufacturer's physical and mechanical integrity tests) after 
undergoing the 70  deg.C/7-day and 40 to 50  deg.C/90-day tests, the 
proposal provided for that product to 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.
    This final rule incorporates the principles described in the 
proposed rule and requires latex condoms to bear expiration dates after 
being subjected to appropriate testing. When a labeling change is made 
to comply with this rule, products currently cleared for marketing 
would not be required to submit a new 510(k). FDA will modify agency 
guidance to reflect this policy. Of course, latex condom products that 
have not been cleared for marketing are still required to submit to FDA 
a 510(k) premarket notification.

II. Summary of Comments

    The agency received only three comments on the proposed rule, two 
of which addressed the economic impact of the rule, but not its 
content. The remaining comment, submitted by a trade association, was 
generally supportive of the proposed rule but raised several issues 
warranting further consideration.

A. General

    1. The comment stated that the proposed rule did not distinguish 
between the testing requirements applicable to new products as opposed 
to currently marketed products. The comment suggests that some 
currently marketed products may already be labeled with an expiration 
date that has been cleared by the agency. To require these products to 
undergo testing following accelerated and intermediate aging would be 
unnecessarily redundant if the existing cleared expiration date has 
been established by real time testing.
    The agency agrees that, where a product bears an expiration date 
based on appropriate integrity tests following storage in real time, 
accelerated aging and testing are redundant and should not be required. 
This position is reflected in the final rule that has been modified 
accordingly in new Sec. 801.435(f).
    The agency stresses that testing data supporting an expiration date 
must be available for inspection by the agency, regardless of whether 
the agency previously cleared product labeling which bears an 
expiration date. If such data is not available for inspection, the 
manufacturer must generate shelf life data with accelerated and real 
time storage and testing.
    2. The comment suggested that the introductory paragraph of 
proposed Sec. 801.435(d) be modified to read,
    ``The expiration date must be supported by the data from 
reasonable quality control tests demonstrating the physical and 
mechanical integrity of the product after three discrete and typical 
lots of the product have been subjected to each of the following 
conditions.'' (Emphasis added.)
 The language in the proposed rule stated, ``* * * after three discrete 
and random lots of the same product have been subjected to each of the 
following conditions.'' (Emphasis added.)
    The agency recognizes that manufacturers of new products, or new 
formulations, may not have produced a sufficient number of lots to 
allow a truly random selection for testing. The purpose of selecting 
random lots is to ensure that the tests are conducted on products that 
are representative of the products being produced. The word 
``representative'' is more commonly used in the context of sampling 
analyses than its synonym, ``typical.'' The agency believes the comment 
that suggested substituting the word ``typical'' for ``random'' is 
appropriately addressed by substituting the word ``representative'' for 
the word ``random.'' The final regulation has been modified 
accordingly.
    The agency also recognizes that the proposed requirement to conduct 
testing on lots of the same product needs further clarification in 
light of the agency's October 1989 ``General Guidance for Modifying 
Condom Labeling to Include Shelf Life,'' that states that shelf life 
data may not be needed for each variation from a ``standard'' condom. 
The agency continues to consider its October 1989 guidance to be an 
accurate statement of agency policy. FDA recognizes that a manufacturer 
may produce several variations of a tested condom, including variations 
of packaging, design (e.g., texture, thickness, etc.), latex 
formulation (including color additives), dusting powders, spermicides, 
desensitizers, and lubricants. As stated in the agency guidance, ``FDA 
recognizes that some variations may not warrant separate shelf life 
testing.'' Certain variations, however, may affect condom strength, 
integrity, and even response to environmental factors in a variety of 
ways. Therefore, the regulation has been revised to state in 
Sec. 801.435(g) that, if a manufacturer applies shelf life data to a 
variation of the tested condom, the manufacturer must document and 
provide upon request appropriate justification.
    3. The comment stated that the requirement that the condoms to be 
tested be stored unpackaged for the maximum amount of time the 
manufacturer allows the product to remain unpackaged, before packaging, 
storage, and testing, is unnecessary and overly burdensome. The comment 
states that this provision would require manufacturers to develop new 
data for holding periods with respect to products that are currently 
labeled with approved expiration dating.
    The agency disagrees that this provision is unnecessary and overly 
burdensome. Degradation of latex films is cumulative. Shelf life data 
derived from a lot of condoms that were packaged the day following 
production may not necessarily be applicable to the same product that 
is left unpackaged for 180 days. In requiring a manufacturer to conduct 
tests on products that have been stored unpackaged for the maximum time 
the manufacturer allows the product to remain unpackaged, the agency is 
ensuring that the integrity of the tested products would be 
representative of the products receiving the greatest exposure to 
environmental conditions. Thus, shelf life data generated by testing 
these products could be applied with the greatest confidence.
    As discussed in comment 1 in section II.A of this document, the 
agency believes that currently cleared expiration dates that have been 
determined by real time testing of the product may continue to be 
applied. In the event this real time testing did not account for time 
periods products remain unpackaged, however, manufacturers would be 
required to perform confirmation testing to account for maximum holding 
periods for their products that are already labeled with an expiration 
date. This testing will be initiated by the effective date of the

[[Page 50499]]

regulation. Until the confirmation tests are completed, the previously 
cleared products may remain on the market labeled with the expiration 
date based on previous real time testing. The regulation has been 
modified in Sec. 801.435(f) to clarify this issue.
    4. The comment objected to the requirement that new premarket 
notification submissions, required under section 510(k) of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(k)), for latex 
condoms should include data to establish labeled expiration dates, 
especially in light of the agency's allowance that such data need only 
be held as part of the manufacturing records for currently marketed 
products. This comment suggested that new 510(k) submissions only be 
required to state the claimed expiration dating period, and identify 
whether it has been tentatively established through accelerated aging 
or established under real time conditions consistent with the 
requirements of Sec. 801.435.
    The agency agrees with this comment. The agency believes that a 
510(k) submission that includes statements that appropriate tests were 
performed and that the condoms passed appropriate mechanical and 
physical integrity tests should not generally have to include 
underlying test data. FDA intends to revise its existing guidance on 
510(k) submissions for latex condoms to reflect its position that 
underlying data for expiration dating should not be submitted. All 
shelf life data generated under the requirements of this final rule 
shall be retained in each company's files, as required by Sec. 820.180 
(21 CFR 820.180), and shall be made available upon request for 
inspection by FDA.
    5. The comment requests that the agency draw a clear distinction in 
the regulation between closed-ended latex condoms, that are used for 
prevention of STD transmission and pregnancy, and open-ended condom 
catheters that are used for continence and chronic care.
    The agency confirms that the rule does not apply to open-ended 
condom catheters. The agency, however, does not believe that the 
regulation requires any modification to clarify this issue. As proposed 
and finalized, the regulation states that ``this section applies to the 
subset of condoms as identified in Sec. 884.5300, and condoms with 
spermicidal lubricant as identified in Sec. 884.5310 of this chapter, 
which products are formed from latex films.'' Sections 884.5300 and 
884.5310 (21 CFR 884.5300 and 884.5310) specifically describe the 
intended uses of closed ended condoms. The regulation, therefore, 
clearly establishes that open-ended condom catheters are not subject to 
this rule.
    Moreover, in order to avoid future confusion, the agency is taking 
this opportunity to clarify the fact that this rule does not apply to 
female condoms. Female condoms are distinguished from the products 
identified in the scope of this rule in two significant details: (1) 
Sections 884.5300 and 884.5310 do not describe female condoms, and (2) 
female condoms are formed from polyurethane, not latex.
    6. The agency is also taking this opportunity to clarify its 
position regarding latex condoms that are sold with spermicidal 
lubricants. Such products are currently cleared for marketing provided 
they bear labeling that reflects expiration dates and statements 
relating to the spermicidal agents. On August 9, 1982, in response to a 
petition by Schmidt Laboratories, Inc., FDA issued an order 
reclassifying a condom with a spermicidal lubricant (nonoxyl-9) from 
class III to class II. In the preamble to the final rule published in 
the Federal Register of October 29, 1982 (47 FR 49021), which 
reclassified generic condoms with spermicidal lubricants into class II, 
FDA advised that the generic device was reclassified into class II only 
insofar as its labeling bore an expiration date for the spermicidal 
agent and the following statement ``The expiration date on this product 
applies only to the spermicidal agent in it.''
    Because the effectiveness of condoms with spermicidal lubricants 
depends on both the integrity of the latex and the stability of the 
spermicide, the expiration date should warn against use of the product 
after a date that either the spermicide or the latex could be 
ineffective. FDA is advising that it would consider a condom with 
spermicidal lubricant that bears the earlier expiration date that is 
related to the condom's latex or spermicidal properties, substantially 
equivalent to a class II condom with spermicidal lubricant under 
Sec. 884.5310.
    FDA has added Sec. 801.435(h) to the final rule to state that if a 
latex condom contains spermicide, and the expiration date based upon 
spermicidal stability testing is different from the expiration date 
based on latex integrity testing, the product shall bear only the 
earlier expiration date. Accordingly, the statement required by the 
August 9, 1982, Reclassification Order that ``The expiration date on 
this product applies only to the spermicidal agent in it'' would be 
incorrect and shall not appear on the labeling of latex condoms with 
spermicidal lubricants following the effective date of this regulation. 
Any labeling changes to comply with Sec. 801.435(h) will not require 
the filing of a new 510(k).
    This regulation does not impose new testing requirements to 
determine expiration dates based upon spermicide stability. 
Manufacturers should continue to perform the appropriate tests to 
determine spermicide amount and biological activity that have supported 
the expiration dating for the spermicide in the past.

B. Comments on the Economic Impact

    7. The agency received two comments addressing the economic impact 
of the proposed rule. One comment stated that the agency significantly 
underestimated the cost burden of establishing an expiration date for 
latex condoms because, in order to accurately establish shelf life 
data, a manufacturer would need to test packaging integrity, packaging 
material, and lubricants used, as well as latex compound integrity.
    The agency disagrees. The testing requirements in the proposed and 
final rules would provide shelf life data based upon the aggregate 
effect of the factors identified by the comment. The agency believes 
that no real purpose would be served by additionally requiring the 
suggested tests.
    8. One comment suggested that requiring manufacturers of new 
products to submit shelf life data with their 510(k) submissions 
subjects manufacturers of those products to an additional 
administrative burden that is unnecessarily restrictive and may delay 
the public access to new and improved products.
    As discussed in comment 4 in section II.A of this document, the 
agency has revised its position and is not requiring that manufacturers 
submit shelf life data with their 510(k) submissions. Instead, shelf 
life data shall be retained in each company's files, as required by 
Sec. 820.180, and shall be made available upon request for inspection 
by FDA.

C. Comments on the Estimated Recordkeeping Burden

    9. One comment stated that the agency significantly underestimated 
the recordkeeping burden that would be created by shelf life testing. 
The comment stated that the number of condom variations that would 
require testing is much higher than estimated, however, no guidance was 
given for estimating the number more accurately. The comment also 
stated that the industry practice in gathering real time testing data 
is to test the product each year. That is, instead of testing the 
product at 0 days, 7 days (accelerated

[[Page 50500]]

aging), 90 days (intermediate aging), and 5 years (real time) as 
discussed in the paperwork burden section of the proposed rule (61 FR 
26140 at 26143), manufacturers would actually be testing at 0 days, 7 
days, 90 days, 1 year, 2 years, 3 years, 4 years, and 5 years. This 
would represent a doubling of the testing burden for each product over 
the course of 5 years.
    The agency agrees that the testing of products in intermediate 
years 1, 2, 3, and 4 is an appropriate and customary method of 
gathering real time shelf life data. This would be reflected in the 
burden chart as a doubling of the estimated burden. However, in 
response to other comments, the agency has required manufacturers of 
latex condoms that already have expiration dating data, based on real 
time testing, to do only a confirmation test, as appropriate. These 
products would be required to be tested only once in 5 years. The 
Paperwork Reduction Act analysis is modified to address these changes 
in testing frequency.
    Moreover, the agency has adjusted the Paperwork Reduction statement 
to address the comment stating that manufacturers would be required to 
collect expiration dating data for more than one variation of a 
standard condom. The agency has attributed an average of two variations 
that would require testing for each standard condom considered in its 
original estimate. Furthermore, the agency has provided that 
manufacturers may apply expiration dating data collected on a standard 
to a variation of the standard, provided the manufacturer documents its 
justification. The burden estimates have been modified to reflect the 
cost of such documentation.
    The Paperwork Reduction Act analysis is further modified to 
annualize the cost of shelf life testing over 5 years. Whereas the 
proposed Paperwork Reduction Act analysis reflected an annual burden of 
testing products at 0 days, 7 days, 90 days, and 5 years, the agency 
has determined that it would be more appropriate to consider the 
testing of products at 0 days, 7 days, 90 days, 1 year, 2 years, 3 
years, 4 years, and 5 years, as a burden spread out over the 5 years it 
would take to complete the tests.

III. 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.

IV. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), as 
amended by Subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995 
(Pub. L. 104-4). 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 final rule is consistent with 
the regulatory philosophy and principles identified in the Executive 
Order. In addition, the final 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 regulation requires physical and mechanical 
integrity tests. Because condom manufacturers routinely conduct such 
tests on their products as part of their quality control practices, the 
required testing would affect manufacturers primarily by establishing 
storage conditions prior to testing such products, and increasing 
sampling sizes subjected to testing. This rule also requires a labeling 
change. However, the 180-day time period between the publication date 
and effective date of this rule will allow most manufacturers to 
exhaust their existing supply of labels. Accordingly, the agency 
certifies that the final rule will not have a significant economic 
impact on small entities. Therefore, under the Regulatory Flexibility 
Act, no further analysis is required.

V. Paperwork Reduction Act of 1995

    This final 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 collections are shown below and an 
estimate of the annual recordkeeping and periodic 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.
    Title: Labeling Requirements for Latex Condoms--Expiration Date 
Labeling.
    Description: These information collection requirements apply to 
manufacturers of latex condoms. This rule expands the labeling of latex 
condoms to include an expiration date. The expiration date must be 
supported by data from quality control tests demonstrating physical and 
mechanical integrity of three sample lots of the product being tested 
that were stored under accelerated and real time aging conditions. 
Quality control testing under accelerated aging conditions must include 
tests of unpackaged bulk product for the maximum amount of time the 
manufacturer allows the product to remain unpackaged, followed by: (1) 
Storage of the packaged product at 70  deg.C (plus or minus 2  deg.C) 
for 7 days; (2) 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 the packaged product at a monitored or 
controlled temperature between 15 and 30  deg.C for the lifetime of the 
product (up to 5 years). Manufacturers who already have shelf life data 
based upon real time testing are not required to perform the 7-day and 
90-day accelerated aging testing.
    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 have degraded. The effectiveness of latex condoms as a 
barrier 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 the product.
    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 the 
likely effectiveness of the product.
    Section 510(h) of the act, 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.

[[Page 50501]]



                                                          Estimated Annual Recordkeeping Burden                                                         
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                                                          Annual                                                                        Total Operating 
           21 CFR Section                 No. of       Frequency per   Total Annual      Hours per      Total Hours    Total Capital    and Maintenance 
                                       Recordkeepers   Recordkeeping      Records      Recordkeeper                        Costs             Costs      
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.435(d)                                 58               1              58              96           5,568         $1,856\1\        $94,655\2\       
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Capital costs are one time start-up costs and consist of a revision of policies and procedures. These costs have been annualized over a period of 5 
  years.                                                                                                                                                
\2\ The annual burden reported here represents the recordkeeping burden of testing a product of 0 days, 7 days, 90 days, 1 year, 2 years, 3 years, 4    
  years, and 5 years. The cost of this burden is annualized over the 5-year period required to conduct all the necessary testing.                       

    The agency received one comment on the Paperwork Reduction Act 
statement of the proposed rule. As discussed in comment 9 in section 
II.C of this document, the agency has adjusted the estimated burden 
according to the suggestions made by the comment. The revised estimated 
burden has been adjusted to include the burden of testing a product at 
intermediate years during real time aging, and the burden of testing 
more than one variation on a standard condom. The revised estimated 
burden reflects a burden annualized over the 5 years required to 
perform all necessary testing.
    Persons are not required to respond to a collection of information 
unless it displays a currently valid OMB control number. This final 
rule contains information collection requirements which have been 
submitted to OMB for approval. FDA will publish a notice in the Federal 
Register prior to the effective date of this final rule of OMB's 
decision to approve, modify, or disapprove the information collection 
requirements.

VI. 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 and Prevention, ``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. WS-CO2-1), vol. 1, IXth 
International Conference on AIDS/IVth 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 Vulcanizates,'' Journal of Natural Rubber Research, vol. 2, 
No. 4, pp. 201-213, 1987.
    9. Barker, L. R., ``Accelerated Long-Term Ageing of Natural 
Rubber Vulcanizates, Part 2: Results From Aging 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,'' FDA Guidance Document.

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, 21 CFR 
part 801 is amended as follows:
    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 of this chapter, which products are 
formed from latex films.
    (b) Data show that the material integrity of latex condoms degrade 
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 paragraphs (d) and (h) of this section.
    (c) The expiration date, as demonstrated by testing procedures 
required by paragraphs (d) and (h) of this section, must be displayed 
prominently and legibly on the primary packaging (i.e., individual 
package), and higher levels of packaging (e.g., boxes of condoms), in 
order to ensure visibility of the expiration date by consumers.
    (d) Except as provided under paragraph (f) of this section, the 
expiration date must be supported by data demonstrating physical and 
mechanical integrity of the product after three discrete and 
representative lots of the 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 physical and mechanical integrity tests 
commonly used by industry 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 
physical and mechanical

[[Page 50502]]

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 
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) Products that already have established shelf life data based 
upon real time storage and testing and have such storage and testing 
data available for inspection are not required to confirm such data 
using accelerated and intermediate aging data described in paragraphs 
(d)(1) and (d)(2) of this section. If, however, such real time 
expiration dates were based upon testing of products that were not 
first left unpackaged for the maximum amount of time as described in 
paragraph (d)(3) of this section, the real time testing must be 
confirmed by testing products consistent with the requirements of 
paragraph (d)(3) of this section. This testing shall be initiated no 
later than the effective date of this regulation. Until the 
confirmation testing in accordance with paragraph (d)(3) of this 
section is completed, the product may remain on the market labeled with 
the expiration date based upon previous real time testing.
    (g) If a manufacturer uses testing data from one product to support 
expiration dating on any variation of that product, the manufacturer 
must document and provide, upon request, an appropriate justification 
for the application of the testing data to the variation of the tested 
product.
    (h) If a latex condom contains a spermicide, and the expiration 
date based on spermicidal stability testing is different from the 
expiration date based upon latex integrity testing, the product shall 
bear only the earlier expiration date.
    (i) The time period upon which the expiration date is based shall 
start with the date of packaging.
    (j) As provided in part 820 of this chapter, all testing data must 
be retained in each company's files, and shall be made available upon 
request for inspection by the Food and Drug Administration.
    (k) Any latex condom not labeled with an expiration date as 
required by paragraph (c) of this section, and initially 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 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(n) and 352(a) and 
(f)).

    Dated: August 20, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-25587 Filed 9-25-97; 8:45 am]
BILLING CODE 4160-01-F