Latex Condoms; User Labeling; Expiration Dating

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 1201 6,9601 $9,2802 $125,2801

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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