Botanical food supplements have less than six months to achieve herbal medicines status or be removed from shelves in the UK – but the sector says the law remains unclear.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) this morning announced the April 2014 deadline, citing safety concerns in firmly enforcing the 2004 Traditional Herbal Medicinal Products Directive (THMPD).
“Natural doesn’t always mean safe and some unlicensed herbal products can be harmful and some may have serious side effects,” said Dr Linda Anderson from the MHRA’s Licensing Division.
“It is now nearly ten years since the implementation of the [THMPD]. Companies have had this time to bring products up to appropriate standards and apply for a [THMPD] registration.”
Dr Robert Verkerk, executive and scientific director of the Alliance for Natural Health International (ANH-I), said despite the action, the food-medicine borderline remained unclear, along with the MHRA’s position on it.
“There is still a real lack of clarity as to what constitutes an unregistered herbal medicine versus a legal botanical food supplement,” Dr Verkerk told us this morning.
“The European Court of Justice (ECJ) has developed some useful case law on this, but different EU member states, including the UK, have run rough-shod across these precedents.”
“Many companies that have long histories of selling high-quality botanical food supplements that have never been associated with adverse events are left in a quandary as to how the MHRA will respond to them, especially after the ‘sell-through’ expires next year.”
Dr Verkerk said the picture was further complicated by a food supplement exemption that remained in the law – Section 12(2) of the 1968 Medicines Act.
“But if recent determinations by the MHRA are anything to go by, it seems likely that the MHRA will further step up its enforcement operations next year. This will likely cause the loss from the market of food supplement products that have no quality or safety concerns, as well as significantly reduced consumer choice.”
The THMPD became active in April 2011, but its market implementation has differed among the EU’s 28 member states, giving products sell-through periods.
From FIE, Jean-Christophe Mano, executive manager at French firm Pharmanager agreed with Dr Verkerk that EU law implied the maintenance of a dual route to market, and he noted that the precedent had been established in Spain and other EU member states.
An MHRA consultation on the matter can be found here