INSUBCONTINENT EXCLUSIVE:
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 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 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 itsDe Novo
classification requestthis 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 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 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.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 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.It writes:We considered that in isolation, the claim &clinically tested alternative to birth control methods& was unlikely to
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
