A regional press ad for Alpecin Caffeine C1 Shampoo stated “GERMAN ENGINEERING FOR YOUR HAIR” and “Shampoo is too small a word for it. Alpecin provides caffeine to your hair, so it can actually help to reduce hair loss. Simply apply daily and leave on for 2 minutes … to help the Caffeine Complex penetrate your hair and scalp”.
The complainant, a consultant trichologist, challenged whether the claim that Alpecin Caffeine Shampoo could “help to reduce hair loss” could be substantiated.
Dr Kurt Wolff GmbH & Co KG t/a Alpecin said that, following the guidelines of both CAP and the MHRA, they had ensured that claims for their product were cosmetic and did not imply any medicinal action.
Alpecin said topically-applied caffeine had a long history of use with individuals suffering from thinning hair or increased hair loss, generally referred to as androgenetic alopecia (AGA). They said that a single hair follicle grew within a periodic cycle, consisting of three stages: anagen, catagen and telogen. Anagen was the stage of active hair growth, while telogen was the final stage during which the hair shaft would be shed, for example through combing or washing. They stated that under the influence of testosterone, hair follicle growth had been shown to decrease, resulting in hair being shed prematurely. Caffeine was able to counteract the suppression of hair growth induced by testosterone and even stimulate hair growth to the normal level.
Alpecin provided eight full studies, several study summaries and a consumer opinion survey, which they believed supported the claim that Alpecin Caffeine Shampoo could “help to reduce hair loss”.
The ASA noted that the ad stated “Alpecin provides caffeine to your hair, so it can actually help to reduce hair loss”. We considered that consumers would understand this to mean that using the product would result in a reduced rate and quantity of hair loss. We noted that there were a number of different causes of excess hair loss. In the absence of any qualification, we considered the claim implied that the product could reduce hair loss from any of those causes in both men and women.
Because the claim referred to reducing, and not preventing or curing, hair loss, we considered that it would not be understood as medicinal. Nonetheless, Alpecin was required to hold adequate evidence to support the claim. We assessed the evidence provided in full and took expert advice.
We noted that the product had only been tested on subjects with androgenetic alopecia, which mainly affected men. While the sex of the subjects was not made clear in every paper, in those where it was stated, the subjects were all male.
One paper discussed the effect of caffeine on the skin’s barrier function. However, it did not present any evidence to demonstrate that this would affect hair growth and did not relate to the product in question (Alpecin Caffeine C1 Shampoo). Two of the studies were in vitro. We considered that those results were not sufficient to substantiate the efficacy of the product in human subjects.
One of the in vivo studies did not use a control group and it was therefore not possible to determine whether the results were due to the effect of the product. Results were measured using a “hair pull” test. We understood that there were more robust methods of measuring hair loss available. A further in vivo study was tested on chest hair, rather than hair on the scalp. The shampoo was applied neat to the tested area. We did not consider that the testing methodology reflected the way in which users were likely to use the product.
Another study on 66 subjects did not use an appropriate control. Rather than comparing the product to the same formulation minus caffeine, it used a completely different product, which could have influenced participants’ perceptions. Furthermore, the measurements used were all subjective.
An open-label randomised multicentre study on 210 subjects used a slightly more robust method of hair assessment. However, it was non-blinded and did not relate to the product being advertised. The test product was applied twice a day, which we did not consider to be reflective of typical consumer use of a shampoo. A study conducted by Alpecin on 201 men was uncontrolled, non-blinded, and based on self-perceived results. We considered that the methodology of that study was also not sufficiently robust to support the claim.
Alpecin also provided the results of a consumer survey which indicated that a large proportion of 212 men who used the product had noticed a slowdown and reduction in hair loss. However, in the absence of more objective data demonstrating the effect, we did not consider that consumer perception data was sufficient to support the claim that the product could reduce hair loss.
Taking into account the body of evidence as a whole, we considered that we had not seen any studies of the actual product as used by consumers on their scalp using an accurate and objective analysis of hair growth, in a well-designed and well-conducted trial. We concluded that the claim “it can actually help to reduce hair loss” had not been substantiated and was therefore misleading.
The ad breached CAP Code (Edition 12) rules 3.1 3.1 Marketing communications must not materially mislead or be likely to do so. (Misleading advertising), 3.7 3.7 Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation. (Substantiation) and 12.23 12.23 Marketers must be able to provide scientific evidence, if relevant consisting of trials conducted on people, for any claim that their product or therapy can prevent baldness or slow it down, arrest or reverse hair loss, stimulate or improve hair growth, nourish hair roots, strengthen the hair or improve its health as distinct from its appearance. (Hair and scalp).
The ad must not appear again in the form complained of. We told Dr Kurt Wolff GmbH & Co KG t/a Alpecin not to state or imply that their product could reduce hair loss unless they held adequate evidence to support their claims.