In its judgment, the Federal Administrative Court (the Court) dismissed the appeal of a marketing authorisation holder against a ruling of Swissmedic, by which Swissmedic had prohibited, in all media, the advertising claim "reduces hair loss" used for one of the marketing authorisation holder's preparations. The question in dispute was whether that claim was consistent with the last approved medicinal product information and whether it was misleading within the meaning of the Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA) and the Ordinance of 17 October 2001 on Medicinal Product Advertising (Arzneimittel-Werbeverordnung, AWV).

The medicinal product is a non-prescription product belonging to dispensing category D. It’s approved indications are hair and nail growth disorders caused by a deficiency of the vitamin the medicinal product contains. The holder advertised the product in a consumer magazine, a trade journal, and on its website, stating that it reduced hair loss, increased hair and nail thickness, and improved hair and nail quality; the restriction to deficiency-related growth disorders appeared only in small print. Following a third-party report, Swissmedic had found the contested claim misleading and inconsistent with the approved product information, prohibited its publication under threat of a fine, and imposed a fee of CHF 1’000.00. Before the Court, the holder argued that hair loss was merely a sub-category of hair growth disorders and that its efficacy claim was scientifically established.

The Court rejected that argument. It held that the active substance acted at the beginning of the hair cycle (anagen phase) by influencing the growth and differentiation of epidermal cells and improving keratin structures, but could not prevent or reduce the shedding of club hair[1] at the end of the telogen phase; both parties accepted that no clinical data existed for the later phases. The publications relied on by the holder were not capable of substantiating the claim, as they concerned non-pertinent settings, individual case reports of children with a rare metabolic disorder, or review articles in which no randomised trials had been identified. The Court added that a health claim admissible for food supplements under food law had no bearing on the assessment under the TPA and the AWV, and that new scientific findings not yet approved by Swissmedic could not serve as a basis for advertising claims; the appropriate course was to file a variation application.

The Court further held that the claim was misleading in both consumer and professional advertising: for the general public, the term "hair loss" attracted greater attention than "hair growth disorders" and suggested an effect on current hair loss, inviting self-diagnosis of a deficiency that is in fact rare and obscuring other causes requiring medical clarification; for healthcare professionals, referencing unsuitable publications was equally misleading. The claim therefore infringed art. 32 para. 1 let. a and b TPA in conjunction with art. 5 paras. 1 and 3 and art. 16 para. 1 AWV. The prohibition rested on a sufficient statutory basis, served the public interest, and was proportionate.

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[1] Kolbenhaar: Haar in der Telogen-Phase, bei dem der untere Haarfadenpol kolbenartig verhornt ist, sodass ein abstossfähiges Kolbenhaar entsteht. Es wird durch geringe mechanische Einflüsse aus der Kopfhaut herausgelöst oder durch das nachwachsende Haar aus dem Follikel herausgeschoben.