Since June 2012, when its appendix was published, the Health Claims Regulation EC 1924/2006 has been in effect in Europe. Currently, there is an interim period during which products carrying old claims can be sold off; but by December of this year, only the generic (Article 13.1) health claims on the positive list can be used on the labels of nutrition products, including dietary supplements. The only exceptions are Foods for Particular Nutritional Purposes, which have their own positive list, and product-specific health claims applied for and approved by the EU Commission.
Glancing at the positive list of generic claims, it becomes apparent quickly that there are no claims for botanical ingredients. The reason for this is simple: the claim evaluations have been put on hold, with no deadline for the final assessment in sight.
Why has the European Food Safety Authority (EFSA) put assessment of the botanical claims on hold? There are a number of reasons. To prove efficacy, a Traditional Herbal Medicinal Product (note the “medicinal”) needs nothing more than a proof of tradition (a continuous use of the product for 30 years on the market) in order to carry health claims. If the same ingredients are to be used in a dietary supplement, which is part of the food category, EFSA requires no less than gold standard clinical trials as proof of efficacy in order to carry a product-specific health claim. It seems that the requirements for a medicinal product are actually lower than for a food product.
Let us think through the implications for a minute. Dietary supplements are targeted at the general population (i.e., healthy people, not patients). In order to carry a health claim, a randomized, double-blind, placebo-controlled clinical trial with a sufficiently high number of subjects must be conducted proving efficacy, and EFSA requires that the study population be equivalent to the target population. In effect, the trial must prove that healthy subjects get ... what, more healthy?
Clinical research organizations (CROs) are using cleverly chosen, approved biomarkers as study end points, but the fact remains it is not as simple to prove the efficacy of an ingredient on healthy people as it is on patients—especially since the dosage of a dietary supplement must, by definition, be below the pharmacologically active range. How do you prove efficacy of a necessarily inactive ingredient on healthy people?
These different standards have led EFSA to put the assessment of botanical health claims on hold.
What does this mean for health claims made on herbal products right now? In Europe, and especially in Germany, herbals have a long tradition in the health sector, with products ranging from infusions to extracts in capsule form. Many plants that are clearly medicinal such as ginkgo biloba and St. John’s wort are being sold in dietary supplements, at daily dosages below the pharmacologically effective range—and have been for decades. These old products can continue to use their claims until the health claim situation for botanicals is resolved, but what about new products?
The simple answer is they cannot use any health claims. The only way for a new supplement product containing botanicals to put health claims on its label is to add a vitamin or mineral or other substance that can carry approved health claims, and use those. As long as this situation continues, the only way a purely botanical product can carry health claims is through registration as a medicinal (Traditional Herbal Medicinal) product.
This is a pretty dismal situation for European botanicals. Unless EFSA decides to re-think its criteria for approving a health claim, most of the applied health claims for botanicals will be rejected, and thus, even if and when an assessment is made, it still won’t be possible for most botanicals to carry health claims. In fact, the herbal medicinal products route is looking more and more attractive for manufacturers; they will have to invest in a clinical trial in any case, so they might as well aim for the higher margins that a drug product can offer.
In the present situation, it is generally good advice to seek out the counsel of experienced consultancies such as analyze & realize in order to determine the best way forward.
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.