Bio-Health says herbal product firms have no excuses on EC regulation
Bio-Health has just secured registration for post-menstrual syndrome product Periagna (agnus-castus) under the THMPD (Traditional Herbal Medicines Product Directive), which all products sold within the EU must be licensed under by an April 30 deadline.
Passed in 2004, the THMPD ruled that manufacturers selling herbal products making medicinal claims had seven years to register their products by submitting a supporting dossier - for what is essentially a licensing application - under the auspices of national bodies, such as the UK’s MHRA (Medicines and Healthcare Products Regulatory Agency).
Once products demonstrate ‘safety and quality’ upon the basis of accepted scientific monographs, a license is granted that includes the ability to make health claims, a factor (given the high success rate for applications) that is attracting interest amongst food supplement manufacturers and herbal ingredient suppliers frustrated by the 2006 nutrition and health claims regulation.
More registrations in pipeline
Bio-Health sales and marketing director June Crisp told NutraIngredients.com that the latest registration meant the firm now had five registered products: “We hope to have three more products registered by the end of April, and are looking to register another 4 within the next six to seven months,” she said.
Manufacturers who don’t apply for registration under the relevant EC directive face having their products stripped off shelves after the EU’s April 30 deadline, and with thousands of products reportedly unregistered throughout the union – concerns are growing in some quarters for the industry’s future.
So did Crisp fear that the failure of industry rivals to register products could lead to PR problems for herbal product makers, if regulators start to demand that products are removed from shelves, and media outlets reported negatively?
PR disaster for herbal products?
Said Crisp:“Who knows what’s going to happen? My feeling is that once the public recognises the differences between licensed and unlicensed products then it’s obvious which one they will go for.
“OK, you could argue that unlicensed St. John’s wort is just the same, but it isn’t. We can prove our products, and ultimately those that aren’t licensed won’t be on the shelves after April 30 and the 2-3 year sell-through thereafter.”
Ultimately, Crisp said, industry and the larger herbal product firms in particular had no excuse for not licensing products: “Look, we’re the smallest firm in the industry [employing 15 staff'] but we’ve been around a long time, have a lot of expertise in herbal medicines, and always wanted to see them legalised.”
"We used to have legal sanction under s.12.2 [of the UK Medicines Act 1968, which exempted herbal medicines from licensing provided they were produced via traditional, non-industrial methods] but that law went seven years ago."
Bio-Health proud of registration work
Crisp added that the regulatory process had become easier as Bio-Health has gained experience in making applications under the THMPD, after a certain amount of “trial and error” in the early days, although she noted that labelling was still one particularly difficult area.
“For the last seven years we’ve spent nothing as a company on PR or marketing, because all our spare money (on a revenue basis) has gone on gaining approvals under the THMPD,” said Crisp.
"Each registration costs around €70,000-€80,000, but we're proud to have achieved our registrations because we believe in herbal medicine. In the days prior to registration when the industry was unregulated so many people challenged us, shot us down left, right and centre. We realised years ago that we had to demonstrate product quality and efficacy in such a way."
