Natural Cycles, Becomes First Birth Control App to Get US FDA Approval, Was Earlier Investigated for Misleading Claims

Last week, controversial birth control app Natural Cycles became the first app to be officially approved by the FDA in the US. The app was founded by a Switzerland couple Elina Berglund and Raoul Scherwitzl and earlier in July this year, the Advertising Standards Authority received three complaints from individuals using the contraception app. The complaints came following reports earlier in the year that 37 women who’d been using the app as a form of contraception had become pregnant.

The complainants voiced their opposition to the app’s description: ‘highly accurate, certified, contraceptive app that adapts to every woman’s unique menstrual cycle’ and it was a ‘clinically-tested alternative to birth control methods’. In response to the accusation, Natural Cycles stated that unplanned pregnancies are an ‘inevitable reality’ when using any form of contraception. Due to the ongoing investigation, Natural Cycles declined to comment earlier but told People that they ‘have every confidence in the effectiveness of their product’. After having been certified by the European Union last year, it’s now the first contraceptive smartphone app to also be officially approved in the US.

In a statement released by FDA announcing its approval, it explains the methodology of the app. “The app, called Natural Cycles, contains an algorithm that calculates the days of the month a woman is likely to be fertile based on daily body temperature reading and menstrual cycle information, a method of contraception called fertility awareness,” the statement reads. Using a basal body thermometer, a woman is expected to take her temperature orally upon waking and enter the data into the app. Throughout the month, Natural Cycles will give a woman a ‘green light’ if her temperature reading indicates a less fertile day and a ‘red light’ if it’s one of her most fertile days.

The FDA reports that Natural Cycles has a ‘perfect use’ failure rate of 1.8% in clinical studies, meaning that 1.8 in 100 women who use the app for a year will become pregnant, either because the app misreported a day as not fertile or because of their form of protection failed on a fertile day. Terri Cornelison, MD, Ph.D., assistant director for the health of woman in the FDA’s Centre for Devices and Radiological Health stated that women should be aware that unplanned pregnancies can always occur when using any time of birth control.

Cornelison said, “Consumers are increasingly using digital health technologies to inform their everyday health decisions, and this new app can provide an effective method of contraception if it’s used carefully and correctly.” The company celebrated the FDA announcement on their Twitter page on Friday. They wrote: “We are delighted that the US Food and Drug Administration (FDA) has cleared Natural Cycles as the first digital method of birth control in the US.”

(The above story first appeared on LatestLY on Aug 16, 2018 12:49 PM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).