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  • FTC Also Challenges HIV Protection Claims as Unsubstantiated--
  • Johnson & Johnson Subsidiary to Settle the Charges--

Claim: "Studies show that up to 18.5 percent of condoms will fail."

False, according to the Federal Trade Commission. This statistic actually derives from a report estimating that 18.5 percent of couples who use condoms, but are less likely than average to use them correctly or consistently, will experience an accidental pregnancy over a one-year period. The statistic cited in the ads therefore does not represent a per-condom failure rate, the FTC staff said.

This challenged claim, along with several other allegedly misleading claims -- including that one in six condoms develops tiny holes during use -- were included in a 1994 advertising campaign for K-Y Plus Nonoxynol-9 Spermicidal Lubricant, a product of Johnson & Johnson Consumer Products, Inc. The FTC has obtained a settlement agreement from the company to resolve charges stemming from the campaign, which touted the product as "condom insurance" to protect against unwanted pregnancy, HIV and other sexually-transmitted diseases.

Johnson & Johnson Consumer Products, a subsidiary of the personal health-care products giant Johnson & Johnson, is based in Skillman, New Jersey. The K-Y product line recently was transferred to another Johnson & Johnson subsidiary and the settlement would be binding on Johnson & Johnson Consumer Products, its parent corporation, and all other Johnson & Johnson subsidiaries.

K-Y Plus was introduced in 1994 as a personal lubricant with an added spermicide called nonoxynol-9. Print ads for the new product appeared in numerous women's and parent's magazines and in professional journals through the fall of 1994. Advertisements cited by the FTC in its complaint detailing misleading advertising charges against the company include statements such as:

  • "Introducing condom insurance"; and
  • "New K-Y Plus, because one out of six condoms fails."

According to the FTC complaint, through these and other statements in the ads, Johnson & Johnson Consumer Products falsely claimed that scientific tests show that up to 18.5 percent of condoms will fail, leaving users vulnerable to pregnancy and sexually-transmitted diseases. The publication cited by Johnson & Johnson Consumer Products actually reports a per-couple, per-year accidental pregnancy rate ranging from 9.8 percent to 18.5 percent, however, the FTC staff said. Recent statistics indicate that 12 percent of women in typical couples who choose condoms as their method of birth control will become pregnant within a year. The statistics further indicate that, assuming perfect and consistent use, this per-couple failure rate drops to only 3 percent.

The FTC complaint also alleges that the company failed to have adequate substantiation to support various other claims in the ads, including that one in six condoms develops tiny holes during use which are big enough for sperm, HIV and other viruses to pass through, and that K-Y Plus prevents these holes and protects against HIV and other viruses.

Johnson & Johnson Consumer Products and corporate officers of its parent company, Johnson & Johnson, have signed a proposed consent agreement to settle these allegations, and the agreement is being announced today for public comment. Under the proposed settlement, the signing parties would be prohibited from misrepresenting in any manner the results or conclusions of any test or study concerning any over-the-counter products with a use relating to human reproduction, reproductive organs or sexually transmitted diseases. The settlement also would require them to have competent and reliable scientific evidence for any claims about the efficacy of over-the-counter contraceptives or products to protect against sexually-transmitted diseases. In addition, when advertising any personal lubricant and/or spermicide, they would be required to have competent and reliable scientific evidence to back up claims regarding:

  • the failure rate of any contraceptive method;
  • the ability of the product to protect against the development of tiny holes in condomsduring use;
  • the ability of the product to protect against HIV and other viruses; and
  • the health-related benefits of the product.

The settlement also contains various reporting provisions that would assist the FTC in monitoring compliance.

The Commission vote to accept the proposed consent agreement for public comment was 5-0, with Commissioner Mary L. Azcuenaga issuing a statement in which she said she concurred"except to the extent that the proposed order imposes obligations on Johnson & Johnson (the parent company...), which is not named in the accompanying complaint." The consent agreement will be published in the Federal Register shortly and will be subject to public comment for 60 days, after which the Commission will determine whether to make it final and binding. Comments should be addressed to FTC, Office of the Secretary, 6th Street and Pennsylvania Avenue, N.W., Washington, D.C. 20580.

NOTE: A consent agreement is for settlement purposes only and does not constitute an admission of a law violation. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of $10,000.

Copies of the complaint, proposed consent agreement, an analysis of the agreement to assist the public in commenting, and Commissioner Azcuenaga's concurring statement are available from the FTC"s Public Reference Branch, Room 130, 6th Street and Pennsylvania Avenue, N.W., Washington, D.C. 20580: 202-326-2222; TTY for the hearing impaired 1-866-653-4261. To find out the latest news as it happens, call the FTC's NewsPhone at 202-326- 2710. FTC news releases and other documents also are available on the Internet at the FTC's World Wide Web Site at http://www.ftc.gov

(FTC File No. 943 3277)

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