This is a non-destructive test applied to all condoms. Each condom is tested to see if it blocks electricity. An intact condom should not allow electricity to pass through it. The next tests are all destructive, a tested condom cannot be sold. Used by the Food and Drug Administration, this test involves filling a condom with 10 ounces of water and looking for leaks.
A method used by many European countries, Canada, and now the U. Regardless of which specific test is used, condom testing involves taking a sample of several condoms from a batch and calculating the fraction that pass the test. The condoms tested are thus a sample sampling model of the others in the batch.
In the US, a batch of condoms cannot be sold if 5 or more condoms per fail the test. So, to sum it up, you can be relatively confident that any condom sold in the U.
You must also look for the exp dates, lot numbers and health advisories printed on the actual condom packet or foil. Labeling should indicate that condom use does not eliminate the risk of pregnancy and also indicate the importance of correct and consistent use.
Labeling should indicate that consumers should consult a health care provider if they have questions about birth control options, particularly because of health reasons for avoiding pregnancy. Labeling should include information comparing the percentage of women experiencing unintended pregnancy during one year of use of latex condoms with rates experienced during one year of use of other contraceptive methods available in the U.
The information should address, at minimum, typical use rates. Labeling should indicate that condom use does not eliminate the risk of STIs and also indicate the importance of correct and consistent use. Labeling should indicate that latex condoms reduce the risk of transmission of STIs by providing a barrier against the source of the infection.
Labeling should indicate condoms are less effective against STIs such as Human Papillomavirus HPV and herpes that can also be spread by contact with infected skin that is not covered by the condom.
Labeling should indicate that consumers who believe they have an STI should contact a health care provider. Labeling should indicate that for more information on latex condoms or STIs, consumers should contact a health care provider or public health agency. This section provides guidance on the labeling of latex condoms grouped according to the issues identified in Table 1 of Section V of this document. Generally, there are three different levels of packaging for latex condoms:.
The recommendations in this section indicate the level s of packaging where the labeling should appear and provide examples of labeling statements that adequately address the issues identified in Table 1. Example statements appear in the guidance in italics to make them easier to identify, but FDA is not recommending italic font be used in actual labeling. The back of the retail package should contain a box entitled Important Information. The first statements in this box should indicate that latex condom use does not completely eliminate the risk of pregnancy and highlight the importance of correct and consistent use.
These statements should also include the information described in Section VI. The following is an example of such statements:. To get the most protection from a latex condom, use one correctly every time you have sex. Please see directions for use inside the package. The package insert should include a statement that consumers should consult a health care provider if they have questions about birth control options, particularly because of health reasons for avoiding pregnancy.
The following is an example of such a statement:. The package insert should also contain contraceptive effectiveness information comparing the percentage of women experiencing unintended pregnancy during one year of use of latex condoms with rates experienced during one year of use of other contraceptive options available in the U.
This information should at minimum include typical use rates. This information is intended to enable contraceptive users to compare alternatives and make appropriate choices.
We recommend that you develop your contraceptive effectiveness information from Hatcher, Trussell, et al. Contraceptive Technology: Nineteenth Revised Edition. The back of the retail package should have a box entitled Important Information. The first statements in this box should indicate that latex condom use does not completely eliminate the risk of STIs and highlight the importance of correct and consistent use.
STIs can be transmitted in various ways, including transmission to or from the head of the penis and transmission by contact with infected skin not covered by the condom. The degree of protection provided by latex condoms depends on whether the condom provides a barrier against the source of the infection.
To reflect this, the Important Information box on the back of the retail package should contain the following information. The first statement, after the statements addressing the information discussed in sections VI. This message should also refer consumers to the location in the labeling of additional information on STI protection. Another statement should suggest that consumers who believe they have an STI should contact a health care provider and that for more information on latex condoms or STIs, consumers should contact a health care provider or public health agency.
The package insert of latex condoms should contain a section stating that latex condoms reduce the risk of STIs by providing a barrier against the source of infection. The section should also explain that condoms are less effective against STIs, such as HPV and herpes, that can also be spread by contact with infected skin not covered by the condom. The following is an example of an acceptable statement:. Latex condoms reduce the risk of transmitting STIs by providing a barrier against the source of the infection.
The package insert should also refer consumers to health care providers if they believe they have an STI. The package insert should notify the consumer that for additional information on latex condoms and STIs a health care provider or public health agency should be contacted.
Latex condoms must include adequate directions for use to avoid being misbranded section f of the Act, 21 U. Adequate directions for use will also help address the issue of incorrect or inconsistent use. Precautions should also address this issue. We provide examples of appropriate directions for use and precautions for latex condoms below. Manufacturers may have additional directions for use, precautions, or other information that they believe is necessary for proper use of their products.
Such additional information is acceptable as long as it does not conflict with or detract from the statements recommended in this guidance or equivalent statements or any other applicable requirements see Section III.
The following set of statements is an example of acceptable directions for use for latex condoms: 4. Pictorial representations of each direction for use are recommended. Properly chosen and placed illustrations re-emphasize the text, make it more meaningful, and reduce the burden of details in the text. Graphics should:. Label statements appearing in italics are those recommended in Section VI of the current guidance. Other label statements, discussed in Section III of this guidance, appear in regular font.
This difference in font styles is used only to identify the labeling recommended by this guidance as a special control. FDA is not recommending italic font for the actual label statements provided by manufacturers. In recognition of the variety of ways that manufacturers may configure their labeling to satisfy their statutory and regulatory labeling obligations as well as incorporate the recommendations of this guidance, this section does not include a full mock-up of a package insert, but gives only selected examples of recommended language.
Recently, Veru decided to take FC2 condoms off of pharmacy shelves and make them available exclusively through prescription. Renaming the female condom would set the stage for greater inclusivity, especially when it comes to the LGBTQ community.
An increasing number of people have begun to use the female condom for anal sex, and degendering the product makes it more accessible to a broader group of people. When it comes to sexual health, we need to make sure that all people, regardless of their gender identity or sexual orientation, have the medical information they need to lead healthy and safe lives.
Join us in supporting this FDA proposal! Policy Updates.
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