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25 July 2018
Labelling notification for dietary supplements
Further to a notice filed by the European Specialist Sports Nutrition Alliance, the Italian Competition Authority (AGCM) – which enforces laws on deceptive advertising and commercial practices pursuant to the Italian Consumer Code as well as assessing the correct use of nutrition or health claims – launched an investigation into the online sale of dietary supplements in Italy based on claims of non-compliance with the relevant Italian regulatory provisions, resulting in misleading actions.
Article 10(1) of Legislative Decree 169 of 21 May 2004 (implementing EU Directive 2002/46/EC concerning food supplements) stipulates that "at the moment of first commercialisation of a [food supplement] the concerned enterprise shall inform the Ministry of Health by submitting a copy of the labelling used for such product".
The notification must be performed by the food business operator responsible for the commercialisation of the related food supplement in Italy. Specifically, considering Article 8(1) of EU Regulation 1169/2011 on the provision of food information to consumers, "the food business operator responsible for the food information shall be the operator under whose name or business name the food is marketed or, if that operator is not established in the Union, the importer into the Union market".
In its 18 June 2018 bulletin, the AGCM published three decisions which were based on similar grounds and delivered in three sets of proceedings involving different online sellers of dietary supplements. The supplements were:
While the circumstances of these cases were different, similar conclusions were drawn based on:
The AGCM found that (via online sales from overseas) the sellers had placed on the Italian market dietary supplements whose labelling had not been notified to the Ministry of Health. The AGCM pointed out that such notification is a condition for the lawful commercialisation of food supplements on the Italian market, which aims to enable the Ministry of Health to prevent manufacturers from placing products on the market that fail to comply with Italian regulations on food supplements. The AGCM stated that, according to claims found on the websites of the online sellers under investigation, the presentation of the products would:
have misled the consumers as to the actual features of the products, creating the wrong impression that the sale of the advertised products is lawful and is thus performed in full compliance with the applicable regulation. Therefore consumers may be prompted to choose the advertised dietary supplements on the basis of an erroneous understanding, so that their economic behaviour is adversely affected.
However, a clear statement that the products were fully compliant with Italian law was put forward in only one case. The same conclusion was drawn in the other two cases on the ground that the overall online presentation and promotion of the products would have suggested to consumers that the products were regulatory compliant.
The number of dietary supplements and the variety of uses for which they are promoted has significantly increased in recent years, as has the direct number of purchases of said products online.
In this context, the AGCM's general role is to ensure that consumers obtain accurate information concerning dietary supplements so that they can make informed decisions concerning these products. Indeed, the AGCM's enforcement action is mainly focused on detecting and removing false and misleading claims (eg, weight loss supplements and products advertised as guaranteeing immediate results which could cause serious health risks).
Such cases are quite different from those described above. Once a lack of regulatory compliance is found, the potential impact on consumer protection must be carefully considered on a case-by-case basis. In the present proceedings, the AGCM found that the lack of compliance would have inevitably misled consumers regarding an essential feature of the products, even when no advertising claims were specifically made in that sense. It is reasonable that regulatory compliance for the commercialisation of a product is usually assumed by consumers. However, the conclusion that any lack of compliance automatically amounts to misleading advertising appears to be far-fetched. In the present case, it is disputable that there was an advertising claim specifically referring to notification on the product labels or a reference that the ministerial notification is mandatory under Italian law. Therefore, the omission cannot be regarded as inevitably misleading due to the lack of information regarding an essential feature of the products.
The AGCM decisions may be appealed before the Lazio Regional Administrative Court. It will be interesting to see the thoughts of the administrative judges in relation to the abovementioned issues.
For further information on this topic please contact Riccardo Fruscalzo, Eugenia Gambarara or Giulia Mariuz at Hogan Lovells Studio Legale by telephone (+39 02 7202 521) or email (firstname.lastname@example.org, email@example.com or firstname.lastname@example.org). The Hogan Lovells Studio Legale website can be accessed at www.hoganlovells.com.
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