One man’s hangover is another man’s health claim obstacle
The UK based company, launched in June last year, has fragmented off into two separate fronts in order to fit with varying health claim regulations within different EU member states - even though theoretically the same rules apply across all 28 member states of the European Union.
Nobody mention the hangover: Alcotox vs. Vital X
Both products are exactly the same in formulation, founder and director Amjid Yaseen told NutraIngredients, combining amino acids and vitamins including N-Acetyl Cysteine, Alpha Lipoic Acid, L-Glutamine,L-Taurine, Vitamin C, Vitamin B1,Vitamin B5 and Vitamin B6 as well as Glycine, Glutamate and Cysteine.
However the UK “version” does not use the term hangover in its marketing since by UK standards this would denote a medical condition and therefore a medical claim for any product purporting to overcome this.
According to Yaseen, in countries like Ireland however, where Alcotox is now being marketed for sale online, the word hangover can be used as a non-medical term.
There Alcotox marketing states: “Alcotox is the most advanced and powerful formulation for a hangover cure available on the market today. It is designed primarily to target and scavenge acetaldehyde, and stop a hangover in its tracks before it even starts.”
Marketing for the UK version, Vital X, is more conservative with an accent on wellness. “Vital X is a new and innovative dietary supplement for consumers of alcohol. Vital X promotes general health and wellbeing by supporting the body’s natural ability to metabolise alcoholic beverages,” according to the company’s website.
“Real obstacle to the free movement of goods”
Sebastián Romero Melchor, a partner at the Brussels office of K&L Gates and an expert in food and nutrition law issues in the EU, told NutraIngredients that while the EU nutrition and health claims regulation (NHCR) fully harmonised the use of claims in the EU, there remain significant divergences regarding its interpretation by individual member states. “The same can be said as to the classification of products as medicinal or food supplements,” Romero Melchor explained.
“Even the Court of Justice of the EU (ECJ) has ruled that member states can reach different classifications of the same product as food or medicine. This fact represents a real obstacle to the free movement of goods, even bigger than non-harmonised national legislation where, at least, mutual recognition can be invoked."
Reservations over metabolism modification
Romero Melchor said that one problem with 'hangover' supplements may be that authorities could argue that such products exert a, “significant modification of the metabolism” and therefore fall under the EU definition of medicinal products.
The UK Vital X version dodges the hangover issue but claims instead to support the body’s natural ability to metabolise alcoholic beverages.
Romero Melchor said he had previously seen this with an unnamed Belgian food supplement intended for hangovers. In this case a line about, “to use in case of excesses” had to be added.
Alcotox version claims to combat hangovers by targeting the effects of acetaldehyde. The company says it has received advice from a senior examiner from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) that the product will not be deemed medical by UK standards if the term hangover is omitted.
No studies demonstrating the health benefits of the Vital X/Alcotox product specifically have been peer reviewed and published.
“Most of our personally funded investment has gone into the studies and research that we have already conducted with the liver toxicology study at the Liver Research Institute and the Acetaldehyde study with Select Pharma Labs,” Yaseen said.