Regulators have always had a difficult time deciding whether botanical ingredients should be classified as food or drug ingredients. Pharmacological effect, depending on the daily dose, is one of the deciding factors, but it seems difficult to agree on exactly what that means. Food supplements in Europe have tried to avoid the issue by being decidedly lower-dosed than their drug counterparts. At the same time, it has become accepted knowledge that even normal food use can have medicinal effects; just look at all the deficiency issues that can be avoided with “5-a-day” (five portions of fruits and vegetables per day).
It seems that the U.K. is now forging ahead by doing away with “unlicensed herbal remedies,” and this may also affect botanical supplements. Regulators seem to be declaring herbal products are potentially unsafe—at least that is what can be gleaned from a statement by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) made on Nov. 21, 2013 at the Food Ingredients Europe (FIE) conference in Frankfurt, Germany.
According to Dr. Linda Anderson from the agency’s Licensing Division, “Natural doesn’t always mean safe, and some unlicensed herbal products can be harmful and some may have serious side effects. It is now nearly 10 years since the implementation of the Traditional Herbal Medicinal Products Directive (THMPD). Companies have had this long to bring products up to appropriate standards and apply for a THMP registration.”
This statement may have some interesting ramifications, according to Dr. Robert Verkerk, executive and scientific director of the Alliance for Natural Health International. Because of the general lack of clarity regarding what constitutes an unregistered herbal medicine and what constitutes a legal botanical food supplement, the category of botanical dietary supplements may also be affected. As a consequence, if the MHRA continues along this path, it may mean that, beginning in April 2014, botanical supplements will disappear from U.K. markets—even those that never had any quality or safety concerns.
MHRA has urged companies to turn their unlicensed herbal remedies into THMPs in order to avoid being taken off the shelves. Those products that fail to do so by April 2014—the deadline cited by the MHRA at FIE in Frankfurt—will be removed from the market. The only alternative for manufacturers would be to give their botanical remedies a full marketing authorization.
Of course, achieving herbal medicine status is not quite so simple, especially if doing so involves a proof of tradition, which is what the Traditional Herbal Medicinal Products category entails. New products with a history of use of less than 30 years will find it difficult to succeed, which is why manufacturers faced with this problem should seek the help of consultants such as analyze & realize with an experience of more than 300 drug and THMP registrations under its belt.
However, the question remains: how will this development affect the whole of the EU? In countries such as Germany, there have long been proponents of the notion that botanical ingredients should be drug ingredients and nothing else, and that some plants simply do not belong in food supplements. The U.K. development would add incentive to those voices. Needless to say that manufacturers of botanical food supplements in all of Europe would soon see themselves faced with enormous added investment for drug authorizations or THMP registrations, just as U.K. manufacturers are now.
However, in an environment where botanical products face difficulties with regard to authorized health claims, manufacturers might be best served by going the drug route with their botanical products. This, however, means manufacturing according to drug Good Manufacturing Practices and drug quality and safety requirements, which can be a major stumbling block for most botanicals.
This route, however, would allow companies to use product-specific and even disease-related claims, which might pay off in the long run. Again, this is a strategic decision that experienced consultants can help evaluate.
All in all, it becomes more and more evident that there is a need for regulators in Europe to step in and clearly mark the borders between food and drug, and between botanical food supplement and herbal remedy. Currently, all that manufacturers have to rely on are court decisions and plant lists with no legal status as guidelines. Definitive, legally binding lists of plants permitted in food products are required. The existence of Project BELFRIT is a testament to the current legal vacuum and possibly a start, but what Europe really needs is a unifying regulation for the marketability of botanicals as food ingredients.
Dr. Joerg Gruenwald is president of analyze & realize ag, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize ag, Waldseeweg 6, 13467 Berlin, Germany, Tel: 49-30-40008100; Fax: 49-30-40008500; E-mail: firstname.lastname@example.org; Website: www.analyze-realize.com.