Singapore’s Health Science Authority (HSA) recently made announcements on CBD's regulatory status in its revised Health Supplements Guidelines.
“[CBD is] not to be used in health supplements. It is developed for use in medicines. Known to affect the mental state,” HSA said in the guidelines.
The announcement has clarified the status of CBD in Singapore, said Poon Wai Mun, regulatory affairs consultant at Wong SJ Asia.
“The regulatory status of CBD wasn’t clearly stated in any of the [existing] regulations, though we know it wasn’t permitted. This new update of the Health Supplements Guidelines has provided clarity on its regulatory status,” she told NutraIngredients-Asia.
CBD is derived from the cannabis plant, but its regulatory status has not been clearly defined prior to this announcement. Other derivatives from the cannabis plant, such as cannabinol, cannabinol derivatives, cannabis, and cannabis resin are listed in the Class A controlled drug list.
The announcement can also be interpreted as a confirmation by the HSA on the prohibition of CBD use in health supplements, Wong said, adding that it was unlikely for CBD to be permitted for use in health supplements in the near term.
“While the new update suggests the possibility of CBD being registered as medicinal product, I do not think it will be accepted as a health supplement or nutraceutical ingredient in the near future.
“We would need to wait for the availability of more evidence of safe use before we see any sign of the authority relaxing control,” she said.
At the moment, there are only two approved cases of medicinal cannabis use reported in Singapore. Both were for epilepsy patients who failed to respond to therapies and all other registered medicines for treatment.
A search on HSA's Register of Therapeutic Products also yielded no record of registered products containing CBD.
Regional CBD guidelines
Elsewhere in other parts of South East Asia, hemp seed and hemp seed protein containing CBD have been approved for use in Thailand.
In March, we reported that Thailand’s Ministry of Public Health has published a notification specifying requirements for hemp seed, hemp seed oil, hemp seed protein products and the notification has been published in the royal gazette.
For example, hemp seed and hemp seed protein can be used in supplements and hemp seed protein powder with a maximum tetrahydrocannabinol (THC) limit of 2mg/kg and CBD at 3mg/kg.
“All other ASEAN Member States have very strict rules on the use of cannabis-derived products. The CBD products will only be for domestic use in Thailand,” Wong said, when asked if the harmonisation of rules in ASEAN would lead to the opening of CBD health supplement markets in the region.
Within the APAC region, Australia currently has the most developed medicinal cannabis and CBD regulatory framework and commercial market.
Last September, the country’s regulator, the Therapeutic Goods Administration (TGA) has decided to down-schedule CBD to a schedule 3 substance.
In this case, CBD can be used as a schedule 3 substance in oral, oral mucosal, and sublingual formulations for therapeutic use upon pharmacist’s advice. No prescription from the doctor is needed.
Elsewhere in New Zealand, CBD are prescription-only medicines.
Eyes on Europe and US
For many Australia-based medicinal cannabis and CBD supplement firms, their main targets are the North American and European markets – as these regions are more liberal on CBD use. However, there are also regulatory challenges seen in these markets.
ASX-listed Elixinol said it was seeing the CBD market conditions improving in the US with increased retail footfall and consumer acceptance.
However, in Europe, CBD remained a high-priced novel purchase and the COVID-19 pandemic has led to consumers spending in favour of essential staples.
In addition, major UK retailers have been reluctant to engage with the category and have been waiting for the Food Safety Authority (FSA) to publish a list of CBD products which were supported by valid novel foods applications, said the company.
THE UK’s FSA previously announced that firms planning to market ingestible CBD products would need to submit an application for Novel Foods in order to keep their products on shelves beyond March 2021.
Bod Australia, another ASX-listed firm, said in July that it was expanding its CBII brand of CBD products in the UK with online retailers Lookfantastic and Feelunique.
It also received a maiden AUD$312k (US$229k) purchase order for its CBD products from the US.