The FDA Approved a Digital Birth Control App This Month. It’s Raised Some Controversy

August 30, 2018, 8:16 PM UTC

Earlier this month, the Food and Drug Administration (FDA) green lit a digital birth control app called Natural Cycles. It’s meant to be a more natural, if tech-fueled, option for women who might not want to take hormones to prevent (or plan out) pregnancy. But the app is reportedly under fire over a Facebook ad that claims Natural Cycles is a “highly accurate” birth control method—adding to criticism that a number of women using the app had unintended pregnancies and eventually had to get abortions.

The U.K.’s Advertising Standards Authority (ASA), the nation’s ad watchdog, concluded that a Facebook ad claiming the app was “clinically tested” and “highly accurate” was, well, not necessarily accurate, according to The Verge, since it could mislead consumers into thinking that Natural Cycles suffices as an unimpeachable alternative to hormonal birth control. Given existing user complaints—including claims that more than three dozen women had to get abortions after using the app—those claims have drawn some pushback.

Natural Cycles had not responded to a Fortune request for comment as of press time. We’ll update this post if it does. UPDATE: Natural Cycles issued the following response: “We respect the outcome of the investigation by the UK Advertising Standards Authority (ASA) into one Facebook advertisement, which ran for approximately 4 weeks in mid-2017. The investigation was initiated nearly 12 months ago and the advertisement was removed as soon as we were notified of the complaint. This investigation triggered an internal review of all our advertisements and the way that we communicate more broadly, to ensure our message is clear and provides women with the information they need to determine if Natural Cycles is right for them.”

The company’s tech relies on women taking daily temperature readings and recording menstrual cycle data in the app, which then uses a program to estimate days of fertility. Or, as the FDA put it a few weeks ago: “Natural Cycles contains an algorithm that calculates the days of the month a woman is likely to be fertile based on daily body temperature readings and menstrual cycle information, a method of contraception called fertility awareness. Designed for mobile devices, it is intended for use in pre-menopausal women aged 18 and older.”

The agency went on to note that “no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device.”

That latter caveat is what makes the issue more complicated. Natural Cycles’ studies show that just 1% of women who use the app correctly become pregnant; but many typical consumers, at least to date, haven’t been using the technology perfectly. And yet—in another twist—its effectiveness for a “typical” rather than “perfect” user may still be comparable to hormonal birth control (though not as effective as an IUD).

The early studies on birth control apps have painted a bit of a mixed picture, which can make assessing them difficult (especially on such a personal health care issue). The question is whether longer-term data will vindicate the technology and foster a market for less invasive birth control and family planning.

This post has been update to include a response from Natural Cycles.

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