The UK has enacted new legislation to address the issue of so-called ‘legal highs’ following a number of cases of paranoia, seizures, hospitalisation and even death after consumption of certain psychoactive substances.  The Psychoactive Substances Act 2016 (the “Act”) was granted Royal Assent on 28 January 2016.  It is expected to come into force on 6 April 2016.  The Act makes it an offence to produce, supply, offer to supply, possess with intent to supply, possess in a custodial institution, import or export psychoactive substances.

A psychoactive substance is defined very broadly to cover “any substance which is capable of producing a psychoactive effect in a person who consumes it”.  A substance produces a psychoactive effect in a person if it affects the person’s mental functioning or emotional state  by stimulating or depressing the person’s central nervous system.  There are a number of specific exemptions, including controlled drugs, medicinal products, alcohol, nicotine and tobacco products, caffeine and food.  However, the definition of food has left a number of questions since it does not align with the legal definition of food set out in EU Regulation 178/2002.  Rather, the Act defines food as:

Any substance which—

            (a) is ordinarily consumed as food, and

            (b) does not contain a prohibited ingredient (emphasis added).

In this paragraph—

  • “food” includes drink;
  • “prohibited ingredient”, in relation to a substance, means any

psychoactive substance—

            (a) which is not naturally occurring in the substance, and

            (b) the use of which in or on food is not authorised by an EU instrument.

The authorities have stated that the Act is not intended to capture foods with a “negligible” psychoactive effect, such as chocolate and nutmeg, but concerns were raised during the legislative debates that the Act could capture inadvertently a much broader range of food substances, including energy drinks and certain botanical ingredients used in foods and dietary supplements.  It is hoped that guidance from the enforcement authorities will make clear exactly which foods and drinks are exempted.

Tags: Food & Beverage, Food & Drug Regulatory
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Photo of Brian Kelly Brian Kelly

Brian Kelly is a partner in the European Life Sciences group and also co-chair of Covington’s Global Food Industry Group. Brian’s practice focuses on EU food and drug regulatory law, public and administrative proceedings, EU procurement advice and challenges, internal investigations, European Union…

Brian Kelly is a partner in the European Life Sciences group and also co-chair of Covington’s Global Food Industry Group. Brian’s practice focuses on EU food and drug regulatory law, public and administrative proceedings, EU procurement advice and challenges, internal investigations, European Union law, and product liability and safety. The Chambers Europe Guide to the legal profession lists Brian as part of our “world-class [regulatory and public affairs] team and describes him as a notable practitioner who is “very ambitious, thorough with a sharp intellect”. The Chambers UK Guide quotes clients saying: “his communication and work ethic stand out, he is very hard-working and dedicated when it comes to his cases.”

Brian’s advice on general regulatory matters across all sectors includes borderline determinations, food classifications, tissue and stem cell regulation, adverse event and other reporting obligations, manufacturing controls, labeling and promotion, pricing and reimbursement/procurement, procurement/tenders (including emergency use tenders, EU-wide tenders, Covid-19-related tenders), product life cycle management (foods and medicines), nanotechnology, and anti-bribery and corruption advice. Brian has also been advising on UK and European “Brexit” related issues including tariffs.

Brian has also advised and co-ordinated international projects on advertising/promotion, clinical research, data protection, the regulatory status of borderline products, food/cosmetic ingredient reviews and advises on regulatory aspects of corporate/commercial deals, particularly regulatory due diligence.

Brian is also experienced in representing clients in administrative and enforcement proceedings before regulatory authorities and in the UK and EU courts.

Brian is an honorary lecturer at University College London.

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