Scientific Opinion on the evaluation of the safety in use of Yohimbe (Pausinystalia yohimbe (K. Schum.) Pierre ex Beille)

Abstract

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion evaluating the safety in use of yohimbe bark and its preparations originating from Yohimbe (Pausinystalia yohimbe (K. Schum.) Pierre ex Beille when used in food, e.g. in food supplements. The bark of the plant contains a number of indole alkaloids of biological relevance and preparations of yohimbe bark have been traditionally used as general tonic, performance enhancer and as an aphrodisiac. Food supplements containing yohimbe bark preparations are available nowadays, especially via internet retail. Yohimbine, the major alkaloid of yohimbe bark and raubasine, another alkaloid occurring in lower concentrations in the bark, are used as active ingredients in a number of medicinal products for which adverse effects are described. The Panel reviewed the available scientific data on a possible association between the intake of yohimbe bark and its preparations and potential harmful effects on health. When those data were not available, priority was given to yohimbine, as the only alkaloid for which occurrence had been shown and quantified in food supplements containing yohimbe bark. The Panel concluded that the chemical and toxicological characterisation of yohimbe bark and its preparations for use in food are not adequate to conclude on their safety as ingredients of food, e.g. in food supplements. Thus the Panel could not provide advice on a daily intake of yohimbe bark and its preparations that do not give rise to concerns about harmful effects to health. An estimation of exposure to yohimbine from food supplements was performed showing that theoretical maximum daily intake may exceed the maximum approved daily dose of yohimbine from use as a medicinal product

Dietary Supplements for Erectile Dysfunction: Analysis of Marketed Products, Systematic Review, Meta-Analysis and Rational Use

“…The remaining two EIs, namely, Crocus sativus and Withania somnifera, had only one positive reference. It is noteworthy that in the European Union, yohimbine cannot be sold as a supplement based on the European Food Safety Authority's (EFSA's) scientific opinion [17]. Therefore, two DS, that were found online containing C. yohimbe extract were not considered in the evaluation of the expected efficacy of the various commercial formulations.…”

Assessment of the Impact of Scientific Reports Published by EFSA and GIS on Functional Foods Newly Placed on the Market in Poland

“…Pierre ex Beille) (published 24 July 2013) The opinion states that the Panel was unable to determine the daily intake norms of Pausinystalia yohimbe bark and its preparations, which did not raise concerns as to their adverse impact on health. An assessment of exposure to Pausinystalia yohimbe from dietary supplements was made that showed that the theoretical maximum daily intake may exceed the maximum approved daily dose of Pausinystalia yohimbe used as a medicinal product [ 44 ]; Statement on the post-marketing monitoring of the use of lycopene (published 9 January 2015) The opinion states that on the basis of previous assessments of intake norms performed by EFSA, the data concerning sale, and the data concerning the placement of products on the market provided for the period from July 2009 to June 2012, the Panel concluded that consumption of naturally occurring lycopene and its use as food colour or a new food ingredient within the accepted use levels does not lead to ADI exceeding 0.5 mg/kg bw/day [ 45 ]; Safety of cranberry extract powder as a novel food ingredient pursuant to Regulation (EC) No 258/97 (published 12 May 2017) The opinion indicates that considering the composition, the process of production, supply, and the history of use of cranberry fruit, the Panel considers that the consumption of its derivatives does not give cause for safety concerns. The Panel concludes that cranberry extract powder is a safe food ingredient for the proposed uses and use levels [ 46 ]; Safety of dried aerial parts of Hoodia parviflora as a novel food pursuant to Regulation (EC) No 258/97 (published 19 October 2017) The opinion is a response to the application submitted by the entrepreneur, who proposed a dose of 15 mg/portion, while the available data shows the safe dose to be 9.4 mg/day.…”

“…The opinion states that the Panel was unable to determine the daily intake norms of Pausinystalia yohimbe bark and its preparations, which did not raise concerns as to their adverse impact on health. An assessment of exposure to Pausinystalia yohimbe from dietary supplements was made that showed that the theoretical maximum daily intake may exceed the maximum approved daily dose of Pausinystalia yohimbe used as a medicinal product [ 44 ];…”

A Simple Electrochemical Sensor Based on Graphene Nanoplatelets Modified Glassy Carbon Electrode (GrNPs/GCE) for Highly Sensitive Detection of Yohimbine (YOH)

“…Therefore, both yohimbine and food supplements containing yohimbine are illegal in many countries, e.g., the United Kingdom, Ireland, the Netherlands, Belgium, Denmark, Czech Republic Canada, Australia and New Zealand. 4,5 However, both yohimbine and nutritional supplements containing yohimbine have been used in several countries for increased performance, sex drive and weight loss. [6][7][8] YOH has become a popular street drug due to its sympathomimetic, aphrodisiac, and hallucinogenic properties.…”