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Contraception app Natural Cycles’ Facebook ad banned for being misleading

Natural Cycles, a Swedish startup which touts its body temperature-based algorithmic method for tracking individual fertility as an effective alternative to hormonal birth control, has been wrapped by the UK advertising regulator which today upheld three complaints that an advert the company ran last year via Facebook’s platform was misleading. The regulator has banned Natural Cycles from running the advert again, and warned it against exaggerating the efficacy of its product. The ad had stated that “Natural Cycles is a highly accurate, certified, contraceptive app that adapts to every woman’s unique menstrual cycle. Sign up to get to know your body and prevent pregnancies naturally”, and in a video below the text it had also stated: “Natural Cycles officially offers a new, clinically tested alternative to birth control methods”. The company has leaned heavily on social media marketing to target its ‘digital contraception’ app at young women. “We told Natural Cycles Nordic AB Sweden not to state or imply that the app was a highly accurate method of contraception and to take care not to exaggerate the efficacy of the app in preventing pregnancies,” said the Advertising Standards Authority (ASA) handing down its decision. While Natural Cycles gained EU certification for its app as a contraceptive in February 2017, and most recently FDA clearance for marketing the app as a contraception in the US (with the regulator granting its De Novo classification request this month), those regulatory clearances come with plenty of caveats about the complexity of the product. The FDA, for example, warns that: “Users must be aware that even with consistent use of the device, there is still a possibility of unintended pregnancy.” At the same time, Natural Cycles has yet to back up the efficacy claims it makes for the product with the scientific ‘gold standard’ of a randomized control trial. So users wanting to be able to compare the product’s efficacy against other more tried and tested birth control methods (such as the pill or condoms) are not able to do so. No birth control method (barring abstention) is 100% effective of course but, as we’ve reported…

The FDA OK’d an app as a form of birth control

Don’t want to get pregnant? There’s a Food and Drug Administration approved app for that. The FDA has just given the go ahead for Swedish app Natural Cycles to market itself as a form of birth control in the U.S. Natural Cycles was already in use as a way to prevent pregnancy in certain European countries. However, this is the first time a so-called ‘digital contraceptive’ has been approved in America. The app works using an algorithm based on data given by women using the app such as daily body temperature and monthly menstrual cycles. It then calculates the exact window of days each month a woman is most fertile and therefore likely to conceive. Women can then see which days the app recommends they should avoid having sex or use protection to avoid getting pregnant. Tracking your cycle to determine a fertile window has long been used to either become pregnant or avoid conceiving. However, Natural Cycles put a scientific spin on the age-old method by evaluating over 15,000 women to determine its algorithm had an effectiveness rate with a margin of error of 1.8 percent for “perfect use” and a 6 percent failure rate for “typical use.” What that means is almost two in every 100 women could likely conceive on a different date than the calculated fertile window. That’s not exactly fool-proof but it is higher than many other contraceptive methods. A condom, for instance, has an 18 percent margin of error rate, according to the Centers for Disease Control (CDC). And though the app makers were able to convince the FDA of its effectiveness, at least one hospital in Stockholm has opened an investigation with Sweden’s Medical Products Agency (MPA) after it recorded 37 unwanted pregnancies among women who said they had been using the app as their contraception method. “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,” assistant director for the health of women in the FDA’s Center for Devices and Radiological Health Terri…

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