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 previously, Natural Cycles’ aggressive marketing and PR has lacked nuance and attempted to downplay concerns about the complexity of its system and the chance of failure even though the product’s performance is impacted by multiple individual factors — from illness, to irregular periods. Which risks being irresponsible.
In the ruling, the ASA flags up the relative complexity of Natural Cycles’ system vs more established forms of contraception — pointing out that:
The Natural Cycles app required considerably more user input than most forms of contraception, with the need to take and input body temperature measurements several times a week, recording when intercourse had taken place, supplemented with LH measurements, abstention or alternative methods of contraception 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 app. A spokesperson for the Medical Products Agency told us that it has finalized its investigation and plans to publish the findings next week.
Despite all that, Natural Cycles’ website bills its product as “effective contraception”, claiming the app is “93% effective under typical use” and making the further (and confusingly worded) claim that: “With using the app perfectly, i.e. if you never have unprotected intercourse on red days, Natural Cycles is 99% effective, which means 1 woman out of 100 get pregnant during one year of use.”
Perfect use of the app actually means a woman would accurately perform daily measurement of her body temperature without fail or fault, and before she’s even sat up in bed, at least several times a week, correctly inputting the data. Forgetting to do so once because — say — you got up to go to the toilet or were otherwise interrupted before taking or inputting a reading could constitute imperfect use.
The BBC spoke to a women who says she made the decision to use the app after seeing that 99% effective claim in Natural Cycles’ marketing on Instagram — and subsequently fell pregnant while using it. “I was sort of sucked into this “99% effective” [claim],” she told the broadcaster. “You know “even more effective than the pill”… What could possibly go wrong?”
In its ruling, the regulator said it investigated two issues related to the advert run by Natural Cycles on Facebook on July 20, 2017, and both issues were upheld.
The complaints were that Natural Cycles’ advert included misleading and unsubstantiated claims — specifically that the product was: 1. “Highly accurate contraceptive app”; and 2. “Clinically tested alternative to birth control methods”.
Natural Cycles told the ASA that the latter claim is in fact a quote from a Business Insider article which it “considered to be correct” and had thus reproduced in its marketing.
After taking expert evidence, and reviewing three published papers on accumulated data obtained from the app, the regulator deemed the combination of the two claims to be misleading.
We considered that in isolation, the claim “clinically tested alternative to birth control methods” was unlikely to mislead. However, when presented alongside the accompanying claim “Highly accurate contraceptive app”, it further contributed to the impression that the app was a precise and reliable method of preventing pregnancies which could be used in place of other established birth control methods, including those which were highly reliable in preventing unwanted pregnancies. Because the evidence did not demonstrate that in typical-use it was “highly accurate” and because it was significantly less effective than the most reliable birth control methods, we considered that in the context of the ad the claim was likely to mislead.
The ASA also found the advert to have breached rules for substantiation and exaggeration of marketing messages in the Medicines, medical devices, health-related products and beauty products category, as well as being misleading.
At the time of writing Natural Cycles had not responded to requests for comment. Update: A spokeswoman has now emailed us the following statement in response to the ASA ruling:
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.
As part of these efforts, every advertisement now undergoes a strict approval process by a dedicated taskforce to ensure that it gives an accurate overall impression to the viewer. We actively seek feedback from Natural Cycles users to help us improve the quality of our communications and, moving forwards, we plan to work even more closely with HCPs, women and our user community to test and refine our marketing approach.
Natural Cycles has been independently evaluated and cleared by regulators in Europe and the US based on clinical evidence demonstrating its effectiveness as a method of contraception.
This report was updated with comment from the Swedish medical products regulator, and with comment from Natural Cycles