16 October, 2016

Vitalplant, withdrawn from the market due to non-compliance

In accordance with the regulations, companies dedicated to the distribution of food supplements must, among others and as main obligations, (i) be registered in the Sanitary Registry, (ii) correctly comply with the content and design of the labels of the products and, (iii) notify the placing on the national market of the products to the health authorities.

Regarding the design, presentation and advertising of the labeling, companies must comply with all the requirements and specifications required by the regulations. In addition to the mandatory information that the label must contain based on Regulation 1169/2011 of the European Parliament and of the Council of October 25, 2011 on food information provided to the consumer, all requirements on nutritional information must be completed on the labels of the product, as well as of the health declarations that are identified.

With regard to the notification of the product to the health authorities, the regulations require that in order to facilitate the effective control of food supplements, the person responsible for marketing the product in Spain must notify the health authorities of placing it on the national market, sending them a copy of the product label prior to or simultaneous to the first placing on the market. Hence the importance of the label meeting all the requirements and specifications. The breach of these obligations is typified in the regulations, in general and without prejudice to the specific regulations of each Autonomous Community, as serious or very serious infractions (depending on the seriousness of the breach) punishable by the following financial fines:

• Failure to comply with the rules on labeling, presentation and advertising: penalty between 3,005.07 euros to 15,025.30 euros, which amount may be exceeded up to five times the value of the products or services subject to the infringement.

• Not to notify the product prior to its commercialization: penalty between 3,005.07 euros to 15,025.30, which amount may be exceeded up to five times the value of the products or services subject to the infringement.

In addition to these sanctions, the sanitary authorities may agree on other accessory sanctions such as the temporary closure of the establishment, the confiscation of the adulterated, damaged, falsified, fraudulent, unidentified merchandise or that may entail risk for the consumer or the withdrawal of the products or its immobilization In relation to these obligations, on October 18, 2016, a new alert has been issued by the Ministry of Health of the Xunta de Galicia for the marketing of the product VITALPLANT SPORT capsules as a result of its commercialization as a food supplement despite Not having been notified of its placing on the market to the competent authorities.

The product, in addition, after being analyzed contains the active substances thiosyldenafil and homosyldenafil, derivatives of sildenafil, phosphodiesterase inhibitor. The inclusion of these substances in the product and the lack of declaration of them in their labeling, poses a risk to public health due to the limited knowledge of their pharmacological activities, their pharmacokinetic characteristics and the lack of security profiles.

For this reason, in accordance with the provisions of article 26 of Law 14/1986, of April 25, General of Health, the commercialization of the product has been prohibited in addition to the withdrawal of the market of the copies thereof.