Natural Cycles, a Swedish startup that promotes its algorithmic method based on body temperature to track individual fertility as an effective alternative to hormonal birth control, has been wrapped up by the UK advertising regulator who confirmed three complaints of that an announcement by the company last year through the Facebook platform was misleading.
The regulator has banned Natural Cycles from republishing the ad, and warned him not to overdo the effectiveness of his product.
The announcement said that "Natural Cycles is a highly certified contraceptive application that is precise and adapts to the unique menstrual cycle of each woman, register to know her body and avoid pregnancies naturally", and in a video below the text. it was indicated: "Natural Cycles officially offers a new clinically proven alternative for contraceptive methods".
The company has leaned heavily on social media marketing to target its application of & # 39; digital contraception & # 39; for young women.
"We told Natural Cycles Nordic AB Sweden not to say or imply that the application is a highly accurate method of contraception and be careful not to overdo the effectiveness of the application to prevent pregnancy," said the Advertising Standards Authority (ASA). ) when dictating its decision.
While Natural Cycles obtained the EU certification for its contraceptive application in February 2017, and more recently the FDA authorized its commercialization. application as contraception in the USA UU (with the regulator granting its request for De Novo classification this month), those regulatory authorizations come with many warnings about the complexity of the ct product.
The FDA, for example, warns that: "Users should be aware that even with the constant use of the device, there is still the possibility of an unwanted pregnancy."
At the same time, Natural Cycles still has to back up the claims of efficacy that makes the product with the scientific "gold standard" of a randomized control test. Therefore, users who want to compare the efficacy of the product with other more proven contraceptive methods (such as the pill or condoms) can not do so.
No contraceptive method (except abstention) is 100% effective of course, but, as we have previously reported, the aggressive marketing and public relations of Natural Cycles lack nuances and tried to downplay concerns about the complexity of their system and the possibility of failures, although the performance of the product is affected by multiple individual factors, from illness to irregular periods. That runs the risk of being irresponsible.
In the ruling, the ASA notes the relative complexity of the Natural Cycles system versus more established forms of contraception, noting that:
The Natural Cycles application required considerably more user information than most forms of contraception , with the need to take and enter body temperature measurements several times a week, recording when intercourse had occurred, supplemented with LH measurements, abstention or alternative contraceptive methods during the fertile period.
The company also remains under investigation in Sweden by the medical regulator after a local hospital reported a number of unwanted pregnancies among users of the application. A spokesman for the Medical Products Agency told us that he had finalized his investigation and plans to publish the findings next week.
In spite of everything, the Natural Cycles website bills its product as "effective contraception", claiming that the application is "93% effective under typical use" and stating more (and confusingly) that: "By using the application perfectly, that is, if you never have unprotected sex on red days, Natural Cycles is 99% effective, which means 1 woman out of 100 get pregnant during one year of use. "
The perfect use of the application actually means that a woman will accurately measure the daily body temperature without failure or failure, and before even sitting in bed, at least several times a week, entering the data correctly. Forgetting to do it once because, say, you got up to go to the bathroom or you were interrupted before taking or entering a reading could be an imperfect use.
The BBC spoke with a woman who says she made the decision to use the after seeing that 99% effective claim on the marketing of Natural Cycles on Instagram, and subsequently became pregnant while using it. "I was absorbed by this kind of" 99% effectiveness "[claim]," he told the station. "You know" even more effective than the pill "… What could go wrong?"
In its ruling, the regulator said it investigated two issues related to the announcement managed by Natural Cycles on Facebook on July 20, 2017, and both issues were confirmed.
The complaints were that the Natural Cycles announcement included misleading and baseless claims, specifically that the product was: 1. "High precision contraceptive application"; and 2. "Clinically proven alternative to contraceptive methods".
Natural Cycles told ASA that this last statement is, in fact, a quote from an article by Business Insider that "considered correct" and had been reproduced in its commercialization. .
After taking expert tests and reviewing three published articles on cumulative data obtained from the application, the regulator considered that the combination of the two statements was misleading.
We consider that in isolation, the statement "clinically proven alternative to contraceptive methods" was not misleading. However, when presented along with the application "High Precision Contraceptive Application", it contributed to the impression that the application was a precise and reliable method to avoid pregnancies that could be used in place of other established contraceptive methods, including those that highly reliable in the prevention of unwanted pregnancies. Because the evidence did not show that in typical use it was "highly accurate" and because it was significantly less effective than the more reliable contraceptive methods, we believe that in the context of the announcement the claim could be misleading.  ASA also discovered that the ad breached the rules of justification and exaggeration of marketing messages in the category of medicines, medical devices, health-related products and beauty products, in addition to being misleading.
At the time of writing Natural Cycles had not responded to the requests for comments. Update: A spokesperson has now emailed us the following statement in response to the ASA ruling:
We respect the outcome of the investigation by the Advertising Standards Authority of the United Kingdom (ASA) in a Facebook ad, which ran for approximately 4 weeks in mid-2017. The investigation started almost 12 months ago and the notice was removed as soon as we received notification of the complaint.
This research triggered an internal review of all of our announcements and how we communicate more widely, to ensure that our message is clear and provides women with the information they need to determine if Natural Cycles is right for them .
As part of these efforts, each ad is now subjected to a strict approval process by a dedicated working group to ensure that it gives a precise overall impression to the viewer. We actively seek feedback from Natural Cycles users to help us improve the quality of our communications and, moving forward, we plan to work even more closely with HCPs, women and the user community to test and refine our marketing approach.
Natural Cycles has been evaluated and authorized by regulators in Europe and the USA. UU according to the clinical evidence that demonstrates its effectiveness as a contraceptive method.
This report was updated with the comment of the Swedish regulator of medical products and with the comment of Natural Cycles