Herbal supplements 'at a crossroads' amid stricter regulations in APAC

That was the view expressed by Ralf Spreemann, business development manager at German supplier Finzelberg.

The firm specialises in producing herbal extracts for the pharmaceutical market, but also counts supplement manufacturers among its clientele.

According to Spreemann, there is a "worldwide trend to upgrade regulation"​.

"Herbs used for treatment or maintaining well-being are now categorised as medicines, and are therefore at a crossroads."​

A 'dramatic' raise​

Speaking to NutraIngredients-Asia​ at the recent HI South East Asia trade show in Jakarta, he said it had become far more difficult for herbal products to be approved for registration in certain Asian countries.

"Each market in Asia has its own history and identity with herbal products. In Japan, you have kampo medicine, in China you have TCM, and in Indonesia you have jamu, for instance.​

"Our customers usually make herbal medicinal products for treatment or cure, and while our company does not have direct sales to China, many of our customers do.​

"Up until the early 2000s, registering (herbal medicines) in China was much easier than it is today. The CFDA has raised the standards for registering herbal products as health foods as well as pharmaceuticals dramatically."​

He added that if a manufacturer's herbal products had not been registered in the "​good old days"​, it would require a great amount of time and money to do so today.

Rigorous regulation

Indeed, the Chinese health food and supplement markets have become increasingly regulated, with stricter requirements for registration and labelling having been introduced in recent years.

South Korea's Ministry of Food and Drug Safety (MFDS) has also clamped down on herbal medicines, putting them on par with chemical drugs.

This means herbal products are subjected to the same rigorous testing and certification process as chemical drugs: manufacturers looking to register new products must provide data on their origin, development, stability, toxicity, health benefits, clinical trials, use in other countries, and how they compare to similar products already registered in the country.

Conflicting viewpoints

While some may think applying the standards for pharmaceutical drugs to herbal medicines is a step in the right direction as it ensures consumer safety, Spreemann believes it brings about several issues.

"Authorities may not always understand the specifics of herbal preparations, and manufacturers may struggle with regulatory requirements as they would need vast experience in compiling such detailed documentation."​