What Do Medical Devices Have To Do With Food?Posted: August 15, 2016 | |
In the last post of last year, we reported on the use of health claims for food products directed at weight loss. In essence, the level playing field is pretty limited. The Claims Regulation does not allow using any claims that make reference to the rate or amount of weight loss. Under certain conditions, it is allowed to market a food product stating that its consumption will decrease the sense of hunger or increase the sense of satiety, but that’s about it. Early this summer, the Dutch Advertising Code Committee (Reclame Code Commissie, “RCC”) ruled in a case relating to weight loss, but considered the claims made therein were not inappropriate. What was the background of this case and what type of product was involved? All those who are interested in advertising products targeting weight loss, keep on reading.
Self-regulation of Marketing Food Products in the Netherlands
The RCC is a self-regulatory body of the Dutch Advertising Code Authority, ruling on complaints that can be lodged by both companies and individuals. Rulings are made based on the Dutch Advertising Code and a number of satellite codes, such as The Advertising Code for Food Products and the Code for Advertising directed at Children and Young People. The RCC also bases its Rulings on the advertising provisions contained in the Dutch Civil Code, as well as on particular provisions from the Claims Regulation and the Food Information to Consumers Regulation. Although the RCC Rulings are not legally binding, there is a high degree of compliance (about 96%). This is explained by the fact that the Dutch Advertising Code Authority has been put in place by joint decision of the Dutch advertising companies, whom make a yearly contribution for its operation in proportion to their marketing budget.
Clearance and monitoring services
Clearing and monitoring services regarding the advertising of products based on various self-regulatory codes used by the RCC are offered by Inspection Board Health Products (Keuringsraad “KOAG/KAG”). The products targeted by KOAG/KAG are pharmaceuticals, medical devices and health products. The latter are described as products presented in a pharmaceutical form or claiming a health related primary function without qualifying as a pharmaceutical. Those are what we typically call borderline products. Hiring the clearance services of KOAG/KAG for the advertising of one of the products within its remit has certain advantages, as KOAG/KAG has the informal arrangement with the Dutch Food Authority that approved commercials shall not be subject to enforcement actions.
Facts of the XL-S Medical Case
The case in which the RCC ruled this summer, related to the product XL-S Medical marketed by Omega Pharma. The product is marketed in pills and promotes the formula of a healthy diet, enough exercise and using XL-S Medical. In the TV commercial subject to complaint, the famous Dutch singer René Froger arrives on his bike with a basket plenty of fruits and vegetables hanging from its steering wheel. Two ladies along the road enthousiastically greet him and ask “Hey René, what’s the score?” Before the singer replies to the ladies, one sees him attach to the wall a paper stating: “interim score: minus 8 kilo”. And the singer to confirm to the ladies, “Oh yes, I already lost 8 kilos, I feel great!” Finally a voice-over states: “Follow René and also lose 8 kilos. Before using this medical device, read the instructions.”
According to the plaintiff, it is prohibited to make this type of claims for this type of product. In order to substantiate the complaint, reference is made to particular information displayed at the website of the Dutch Food Safety Authority translating the prohibition laid down in article 12 (b) of the Claims Regulation. More concretely, according to this information it is prohibited to state that the consumption of a particular food product will result in the loss of X kilo’s in Y weeks. Also, it is not permitted to show testimonials “before” and “after” the use of a particular food product. The rationale is that the extent to which weight loss is achieved not only depends from the use of a particular food product, but also on what more the consumer at stake will eat and on how much exercise he/she gets.
In defence, Omega Pharma states that XL-S Medical is not a food product, but a medical device. In fact, this is a class IIb medical device market under CE-number CE0197. It is recommended that this product is taken in addition to regular food and it contains ingredients that lower the appetite and calorie uptake from food. Such product is not subject to the rules applicable on advertising food products, but to the Advertising Code Medical Devices. According to this code, it is not allowed to claim that the consumption of a particular product shall result in the loss of a certain amount of weight in a certain amount of time. It is allowed however to state the actual weight loss as a result of its use. Moreover, the singer René Froger indeed lost 8 kilos, by doing a lot of exercise, having a healthy diet and using XL-S Medical. As the commercial does not state a specific time frame during which this was achieved, the commercial is in line with article 7.2 of the Advertising Code for Medical Devices. The defence presented by Omega Pharma was endorsed by the RCC. Moreover, this commercial obtained pre-market clearance from KOAG/KAG.
This Ruling shows that depending on the qualification of a product, different rules may be applicable on the marketing thereof. The decisive factor in order to decide whether a product qualifies as a food product or a medical device, is it actual activity. Most slimming products, based on their physiological or nutritional activity, qualify as food supplements and are subject to the Claims Regulation. The product at stake however had a particular physical activity and as a result, it qualified as a medical device. On the one hand, this entails more preparatory actions before marketing, such as assessment by a notified body when a class IIb device is involved, like the in the present case. On the other hand, this qualification may offer advantages in the marketing thereof. It is therefore of the essence to begin with the end in mind when marketing borderline products: know what type of product is at stake and what is the applicable regulatory framework. Also, consider using pre-launch clearing services as described herein.