Poppers
Legal aspects concerning "Poppers"
The collective term "Poppers" refers to a group of liquid and temporarily effective products. They contain amyl nitrite, isopropyl nitrite, cyclohexyl nitrite or mixtures thereof. If the vapours of these highly volatile substances are inhaled, they have a strong vasodilatory effect.
Due to this physiological effect, "poppers" have in the past been defined as functional drugs by the Federal Office for Safety in Health Care (BASG). This classification was also confirmed in 2014 by a ruling of the Administrative Court (see below), whereby the provisions of the Medicines Act applied to the marketing of "Poppers". By a later decision of the European Court of Justice (ECJ, see below) from the same year, the classification of "Poppers" as functional drugs was revoked and is therefore no longer applicable.
No Positive Impact on Health
The ECJ ruling was justified as follows:
The corresponding legal text (substances that "influence" physiological functions - see § 1 section 1 AMG) does not, according to the interpretation of the ECJ, include substances that influence physiological functions but have no positive effect on human health.
"Poppers" have a physiological effect (short-term vasodilatation), but this is not suitable to positively influence human health. It was reasoned that a therapeutic effect that can cure or prevent a disease must be scientifically proven. Since such an effect cannot be proven for "Poppers", the designation as a functional drug is not correct. "Poppers" therefore no longer fall under the provisions of the Medicines Act, meaning that the BASG is not the responsible authority in terms of law enforcement. An exception would be if the advertising for "Poppers" concerning their application were designed to give the impression that these products could prevent, cure or alleviate illnesses. If this is the case, the product in question must be classified as a presentation medicinal product ("Präsentationsarzneimittel"), which in turn makes the provisions of the Medicines Act applicable.
Detailed Legal Information
The Poppers product group was defined as a medicinal product by the Federal Office for Safety in Health Care in 2010 and several times thereafter and was subsequently confirmed by the Administrative Court in 2014 (Administrative Court 2012/10/0189).
However, this distinction of the products "Poppers" as medicinal products is no longer correct due to the decision of the ECJ of 10 July 2014 (Joined Cases C-358/13 and C-181/14). The judgment of the ECJ expressly states that Article 1(2)(b) of Directive 2001/83 (in accordance with Article 1(1)(2) of the AMG) must be interpreted as meaning that the term "influence" under Article 1(2)(b) of Directive 2001/83 (in accordance with Article 1(1)(2) of the AMG) is to be interpreted as meaning that the term "influence" is to be interpreted in accordance with Article 1(2)(b) of Directive 2001/83 (in accordance with Article 1(2) of the AMG). 1 Z2 AMG) must be interpreted as meaning that 'it covers substances which are capable of being beneficial to the functioning of the human organism and, consequently, to human health' (paragraph 37) and 'it does not cover substances the effects of which are limited to a simple influence on physiological functions without being capable of being directly or indirectly beneficial to human health' (paragraph 38)[9]. This is in line with the Opinion of the Advocate General of 12 June 2014 in these proceedings, according to which the provision is to be interpreted as meaning that a significant influence on human physiological functions by a pharmacological effect must be linked to the prevention or cure of a disease or a medical-therapeutic benefit, whereby the therapeutic suitability must be scientifically proven.
No Scientific Evidence
Since no therapeutic suitability can be scientifically proven for the products "Poppers", these products can therefore also not be defined as functional drugs. 1 section 1 no. 1 AMG, as intended for use in or on the human or animal body and as agents with properties for healing or for alleviation or for prevention of human or animal diseases or pathological complaints, such products would have to be defined as presentation camouflage agents.
Further questions regarding the general admissibility of trade with poppers in Austria, as long as these are not to be defined as drugs, do not lie within the competence of the Federal Office for Safety in Health Care.
