Law kicks in April 6, 2016
Downer? Could the UK Psychoactive Substances Act spell disaster for the food & supplements industry?
While the Act states it is not intended to target mildly psychoactive nutrients and specifically exempts controlled drugs, medicinal products, alcohol, nicotine and tobacco products, caffeine and food – the definition of what constitutes a food is open to interpretation, says Brian Kelly, a London and Brussels-based regulatory lawyer at EU law firm Covington & Burling.
And that could spell trouble for foodstuffs and ingredients that can have mild psychoactive effects like ginseng, valerian, nutmeg, taurine, guarana, chocolate that could, in theory at least, find themselves snagged in the law’s ‘new and synthetic psychoactive substances’ dragnet.
Poorly drafted?
“Despite criticism and proposed amendments about unintended targets the law has been pushed through,” Kelly told us. “It’s a poorly drafted law when it comes to food.
“The actual scientific experts involved in helping pull the principles together recognised the impact an overly broad definition would have. Take energy drinks - the experts recommended expressly excluding energy drinks.
“But this fell out of the list of exempted substances yet energy drinks are entirely legitimate and have been consumed for decades.”
“You don’t need to be a lawyer to see how subjective the definitions and exemptions are.”
Nutmegged?
A little puzzled, we asked if a food or ingredient is approved for use in the food supply, how could it then fall foul of the Psychoactive Substances Act?
Kelly said the ambiguity lies in an unclear demarcation between a food or ingredient and a potentially psychoactive substance.
Nutmeg or nutmeg extracts are normally consumed as a food or ingredient, meaning an exemption is likely as a defined food or food ingredient.
But... Kelly notes an ingredient may be added to a another product “so the definition already does not make sense from a legal perspective.”
The problem then for nutmeg is that it contains the psychoactive substance, myristicin, which is naturally occurring but not approved in the European Union as a food ingredient.
And there is the rub. How would such a substance and its host ingredient – nutmeg – be regarded by the Act.
Enforcement agency behaviour
While it is possible the Act could be amended, the key to how it will function once it kicks into play on April 6 will be determined by the behaviour of enforcement authorities like the UK Food Standards Agency (FSA) and local Trading Standards bodies, along with police.
“Amendments are possible but the ambiguity can be addressed by enforcement agency guidance,” Kelly said. “The enforcement agencies can address it be focusing on legal highs and not targeting legitimate food supplements.”
Industry has been calling for this type of guidance.
The Act has been written due to an increasing number of adverse events associated with the use of ‘legal high’ products – usually by young people in night clubs and at parties. These include paranoia, seizures, hospitalisation and death.
Dr Robert Verkerk, executive and scientific director at the Alliance for Natural Health-International (ANH-I) said his group was watching a similar situation in Germany and was concerned EU member state laws were being provoked by a 2014 European Court of Justice (ECJ) ruling on the definition of a medicinal product.
"We are concerned that the definitions of psychoactive substances in the national laws are so broad that they will entrap both existing ‘legal highs’ and a wide variety of psychoactive natural products," Dr Verkerk said.
"The natural products industry already suffers the wrath of an overly broad definition and scope in EU medicines law – this will serve as an additional club that regulators can use arbitrarily. It’s especially troubling when there are a variety of natural products that are so effective in managing mood and anxiety, among the biggest current burdens on mainstream healthcare."
NHS on legal highs
The UK National Health Service (NHS) has a page devoted to ‘legal highs’. It states: “Legal highs are substances that have similar effects to illegal drugs like cocaine or cannabis. They are sometimes called club drugs or new psychoactive substances (NPS).
"Many of these drugs are now controlled, but some are still legal to possess. This does not mean they are safe or approved for people to use. Some drugs marketed as legal highs actually contain ingredients that are illegal to possess.”
Bye bye legal high
The law has come into being because of deaths and health problems associated with the use of legal high products like ‘Whitey’, ‘Charlie Sheen’, ‘Clockwork Orange’, ‘Herbal Haze’, ‘Psyclone’ ‘Gogaine’, ‘Rave’, and ‘Pink Panthers’ based on often yet-to-be-regulated ‘research chemicals’ and herbal extracts.
The pills and powders often come with a warning they are ‘not for human consumption’.
Ahead of its April 6 implementation the new law is already having an effect with legal high websites posting notes of imminent closure.
Leading legal high vendor Iceheadshop urged users to ‘***GRAB YOUR FAVORITES NOW BEFORE THEY ARE GONE FOR GOOD***’.
‘***WE ARE CLOSING - DUE TO NPS BLANKET BAN 6TH APRIL WE ARE WINDING DOWN & RUNNING DOWN STOCKS***’
The site goes on to state: "Here at ICE Headshop we proudly stock every research pill and UK legal high grade research chemical out there. Our research chemical pills have been tried and tested by thousands of professors up and down the United Kingdom. All of our pills and pellets for sale at ICE Headshop are patented and packaged in heat sealed compliant wraps."
Encouragingly it adds: "Please Note: Research pills and pellets are not for human consumption or for sale to anyone under 18 years old."