New EU herbal medicine regulations

Once again the European Union (EU) is far ahead of the US when it comes to protecting consumers from unsafe natural medicines (herbs, vitamins, or supplements).

According to a report from the Natural Standard, the EU recently passed the European Traditional Herbal Medicinal Products Directive (THMPD), which requires ALL herbal medicines in the EU to undergo a regulatory approval process before entering the market.

In the United States, herbs and supplements are classified as a subcategory of food under the Dietary Supplement Health and Education Act (DSHEA). Unlike pharmaceutical drugs, herbs and supplements are NOT required to undergo a formal approval process in the US.

Under the new EU directive, each EU Member State is required to create an herbal medicine registration system. Before selling their herbal products, manufacturers in the United Kingdom (UK) must obtain either a marketing authorization (MA) or a traditional herbal registration (THR).

As with conventional medicines, an MA requires herbal medicines to meet specified safety, quality and efficacy standards. In the event that an herbal product does not meet the standards for the MA, the manufacturer must then apply for a THR, which requires evidence of traditional use, safety and quality.

According to the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, consumers were previously left to “guess whether unlicensed OTC medicines met any particular standards,” and this new directive will allow consumers to make informed choices about herbal medicines.

Unfortunately, consumers in the US are still left to guess.

To learn more about the most popular alternative medicines and therapies, consider picking up a copy of my book, Alternative Medicine: The options, the claims, the evidence, how to choose wisely.