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The STOICA & ASOCIAȚII team, comprising the lawyers Dragoș Bogdan (Managing Partner), Mihai Stănescu (Managing Associate) and Ingrid-Amelia Apetrei (Managing Associate), has secured, at first instance, for its client Terapia S.A., the market leader in this sector in Romania, the right to continue marketing food supplements containing the substance ‘methylene blue’. The Cluj Court of Appeal ordered the suspension of the administrative acts issued by the National Institute of Public Health (INSP), which had annulled the notification certificates – that is, the documents on the basis of which these products may be legally marketed in Romania. The court’s decision halts, at least temporarily, the measure that would have blocked the sale of stock worth over 60 million lei, in a market estimated to be worth over 200 million lei.
The INSP based its decision on an alert issued in 2025, more than a year before the certificates were revoked, via the European RASFF (Rapid Alert System for Food and Feed). This alert, stating that methylene blue was not authorised as a food ingredient in the EU, had been issued by Belgium, without any reference to Terapia S.A.’s products, and was the only one of its kind in the more than 20 years that the RASFF system has been in operation. The INSP based its intervention on Law No. 56/2021, a piece of legislation which, however, expressly excludes herbal food supplements from its scope – that is, precisely the type of product targeted by the cancellation measure.
Dragoș Bogdan: “The absurdity of the cancellation measure – taken more than a year after the alert was issued – stems from a combination of factors which, I hope, merely indicate an excessively bureaucratic approach, rather than a deliberate intervention by the authority to distort the market. On the one hand, according to the relevant European regulations, only substances that were not consumed to any significant extent by the EU population prior to 15 May 1997 are subject to authorisation. However, methylene blue has been documented as being used for medical and therapeutic purposes and as a supplement since the 19th century. I remember my mother forcing me to swallow methylene blue when I was little...
On the other hand – and this strikes me as utterly outrageous – although the INSP has revoked the certificates for the market-leading products, I can now buy methylene blue from a chemist’s without a prescription, over the counter, in a wide variety of forms (including as the pure substance). Furthermore, another 40 supplements containing methylene blue, produced by other companies, are doing just fine; they are not affected in any way by any measure imposed by any authority.”
With a history spanning over 30 years in the business law market, STOICA & ASOCIAȚII has gained national and international recognition in the legal and business worlds through its comprehensive legal assistance and representation of a vast portfolio of clients. Since its establishment in 1995 to the present day, the lawyers at STOICA & ASOCIAȚII have demonstrated that they are a strong team, founded on adherence to its principles: Fidelitas, Integritas, Fortitudo. STOICA & ASOCIAȚII has earned an excellent national and international reputation. Its professional achievements are recognised in the leading legal directories: Chambers Europe, Legal 500, WTR 1000 and IAM Patent 1000.