“Many companies feel that the Medicines and Healthcare products Regulatory Agency (MHRA) simply doesn’t have the resources to police the regulation’s implementation so they are openly carrying on as before."
"They are prepared to run the risk of getting their knuckles rapped if it means bigger profits through avoiding the cost of registration,” Greer Deal, director of consultancy Global Regulatory Services, told nutraingredients.com.
Routes to market
But groups like the Alliance for Natural Health continue to emphasise that there are two routes to market for many herbal products such as valerian; that the THMPD was an, “optional registration system” that existed alongside regular food and food supplements law.
“What we are saying is that the doorway to THMPD registrations is too narrow,” said ANH executive and scientific director, Dr Rob Verkerk.
“We don’t want to see it act as a mechanism that allows member states to start clubbing food supplements. The legal advice we have received is that the THMPD has no capacity to influence food supplements law.”
Transition
Deal noted companies have used the seven-year transition period to launch products without THMPD registrations.
“Companies who have complied with the regulation are extremely annoyed that new products have been launched during the transition period as it is very clear that these products should have gone through the registration process,” she said.
Other companies are circumventing the regulation by repositioning their herbal medicines as food supplements, so that they fall outside the scope of the THMPD, according to the British Herbal Medicine Association (BHMA).
“There are clear cases of food supplements that used to be herbal medicinal products,” confirmed BHMA chief Simon Mills.
“As long as regulated and unregulated products co-exist, the regulated products are going to go under because they can’t compete,” said Mills, who blames the regulator rather than the regulation for creating this uneven playing field.
“The law was pretty clear – that companies would have to register new herbal medicinal products. That was what our members thought they were buying into, but now they are finding their products are being traumatically undermined by poorly regulated competition.They feel they have been let down by the MRHA.”
Consistent and clear
The BHMA along with the Quality Herbal Campaign it kicked off in January, has been pressuring the MRHA to ‘be consistent and clear’ and the regulator said it had instigated a crackdown that would grow in intensity during 2012, with greater resources devoted to policing and a public education campaign.
But for BHMA’s membership, it is a case of too little too late. “Some companies have been pulled up but there are still products on shelf that look like they should be herbal medicinal products but are sold as food supplements,” said Mills.