Bio-Health investing in legislation compliance under the Traditional Herbal Medicinal Products Directive (THMPD)

 

Hidden investment

 

The demands of legislation compliance have kept some lights under a bushel for years. Alistair Forrest talks to Bio-Health whose expenditure adds gravitas to herbal medicine.

While others have spent their hard-earned cash on marketing support, Kent-based herbal devotee Bio-Health has ploughed most of its resources into compliance under the Traditional Herbal Medicinal Products Directive (THMPD).

This places Bio-Health in an enviable position and suitably armed to help independent retailers forge ahead in the brave new world of herbal licensing and traditional herbal registrations (THRs). While some herbal products remain as food supplements with a history of food use (e.g. cinnamon, garlic, ginger, fenugreek etc), others are used as therapeutic medicines (echinacea, sage, saw palmetto, SJW etc) and are subject to THMPD.

Since April 30 last year, retailers and pharmacies can no longer stock herbal remedies that do not have the appropriate license or registration, although they have been allowed to sell through unlicensed products bought in before that date. This means the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) can show a red card to an unlicensed product, although in reality officialdom has been slow to react and has yet to differentiate meaningfully between what is a herbal medicine and what is a food supplement.

That has not stopped Bio-Health and other like-minded companies forging ahead with very expensive technical documentation to support its large range of herbals. Out of more than 120 products, Bio-Health now has thirteen Traditional Herbal Registrations (THRs) that confirm product quality and safety, including its first Irish Medicines Board registration for Valdrian (valerian root), and a dozen “marketing authorisations” or licenses. That has cost Bio-Health in excess of half-a-million, a huge chunk of budget for a small company.

 

herbal-medicines-range

Herbal Medicinal Products

Out of more than 120 products, Bio-Health now has thirteen Traditional Herbal Registrations (THRs) that confirm product quality and safety.

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Marketing director June Crisp explains the thinking behind the Bio-Health policy. “Every product with a THR has warnings that both retailers and pharmacists should know. The pharmacists understand that, but sadly some independent retailers don’t. But we are in a position now that anyone stocking an unlicensed medicinal herbal product, or one without a THR, is breaking the law.”

An example of this working in practice is Black Cohosh. A few years ago the industry was put on red alert because someone taking the herb (not Bio-Health’s) died from severe liver damage. This was of great concern to June Crisp because she played a major part in introducing Black Cohosh to the UK and the Bio-Health product has not had one case of an adverse reaction, ever.

Never mind that the red alert involved a heavy drinker who had taken a different species of the herb, if Black Cohosh is perceived to cause liver failure then the long arm of the law will reach right into every corner of the health food trade.

Since the THMPD became law in 2004, and way before that, Bio-Health has monitored all ADRs reported globally and both June and MD Vic Perfitt have burned midnight oil making sure that each herbal dossier is thoroughly researched and presented correctly. To do this properly they have diverted marketing budget, and now this stands Bio-Health in good stead to help educate retailers on this vital aspect of trading law.

“No one loves herbals as much as us,” said June. “I manage my health by them and try to help retailers do the same for their customers. The THR regulations are crucially important in bringing assurances to the customers and that’s why we have spent so much on ensuring that we have a safe and sound product range.

We have done it ourselves, completely independently with no backers and no links to drug companies. The result is a range of additive-free, science-backed herbal medicines for the independent trade. Like others we could have kicked and screamed that they are ‘food supplements’ or ‘botanicals’ but the fact is they are herbal medicines and subject to law.”

“And,” she added, “we are delighted to share what we have learned with any independent retailer with an open mind about the legalities of these wonderful herbal medicines.”