Third pathway: Malaysia’s new ‘modern claims’ system could drive more clinical research and business
Companies could apply for modern claims on natural products since April 4 by following the “Guideline on Natural Products with Modern Claim” published by National Pharmaceutical Regulatory Agency (NPRA).
A modern claim is made “based on scientific evidence which is limited to supporting and enhancing health, risk reduction or aiding / assisting in the management of a disease / condition or symptoms that are expected to naturally resolve within a timely manner (self-limiting),” according to the NPRA.
The move has opened a third pathway for natural products seeking to make health claims. Based on the official definition, natural products consist of one or more naturally occurring substances of a plant, animal or mineral, of parts thereof.
Prior to the introduction of modern claims, natural products could only make either 1) traditional claims based on theories, beliefs, and experiences indigenous to a specific culture or 2) therapeutic claims which must be substantiated with clinical evidence.
While both modern and therapeutic claims require clinical evidence, the former addresses disease or symptoms that are self-limiting – meaning they would resolve on its own, whereas the latter is for conditions that are not self-limiting.
This also means that the level of claims permitted for modern claims would not surpass the allowable level of claims for therapeutic claims.
Still, introducing modern claims would bring benefits to both the industry, research community, and the consumers, Abdul Razak Mohd Isa, CEO of Kuala Lumpur-based biopharmaceutical company Medika Natura told NutraIngredients-Asia.
For one, the move would give recognition to new scientific evidence that have emerged over the years on the benefits of botanicals and herbal products.
"You might have noticed that many universities have been conducting research on plant-based natural ingredients. However, for many years, most of their research has been published in reputable journals. Unfortunately, there have been no regulatory guidelines available to recognise this data.
"For many years, only traditional medicine claims have been allowed for natural products, and this does not do justice to the new scientific discoveries made by Malaysian local researchers," he said.
Allowing modern claims could also incentivise natural product companies to conduct more clinical research.
This could in turn drive international attention to the health benefits of Malaysia’s homegrown botanicals as well.
Speaking from his own experience, Razak said that his company has been preparing one of its products in making therapeutic claims since the framework was introduced in 2019.
Published evidence on how supplementation of its patented Labisia pumila standardised extract (SKF7®) had significantly reduced waist circumference had drawn attention from overseas companies, especially those from South Korea.
The company is now preparing to launch its supplement product containing SKF7® in South Korea with a local business partner.
At the moment, the company sells its SKF7® supplement under the brand name Labeesity in Malaysia, including online via its official website, as well as via clinics and pharmacies.
“I will say that the introduction of modern claims is going to open a lot of opportunities, because it will encourage more companies and universities to conduct more research and that there's a commercial exit to that.
“That will also impact both local and potentially international business activities because you might have to publish your data, and your publication might be seen by potential business partners outside of Malaysia”.
The company is currently taking a two-pronged approach where it is preparing to apply for modern claims for SKF7® and running a phase III trial to meet the requirement for making therapeutic claims.
Regulatory consultant Wai Mun Poon, principal regulatory consultant at Wong SJ Asia, similarly said that the move would allow companies to make higher level claims that came with emerging research evidence.
“Traditional claims include examples like symptomatic relief of cough, sore throat etc but over time, what we saw was the development and ways to standardise the active ingredients for a lot of these products. That is why it's possible for more research to be conducted on these ingredients for higher level claims.”
Some companies might not be ready for it
However, some natural product manufacturers might not be sufficiently equipped in making modern claims, Poon pointed out.
First, they might not be experienced in running clinical trials that are required for making modern claims.
Second, as the requirements for making modern claims closely mirrored that of pharmaceutical products, their existing manufacturing facilities might not be able to meet these requirements.
“The requirements for making modern claims are quite different from the existing traditional medicine claims and are drafted based on drug registration guidelines instead.
“As such, if any company wishes to go through this route, their manufacturing facility and R&D would need to meet pharmaceutical level requirements,” she said.
Consumers to benefit
On the other hand, Razak believes that introducing modern claims would also give patients the option to integrate natural products into their medical regime.
Using his metabolic health supplement Labeesity as an example, he said that patients could have the option to consume natural products like Labeesity instead of using anti-obesity drugs that could produce side-effects.
“We want to offer patients the option to choose our natural ingredients over synthetic drugs because we have noticed numerous complaints regarding the side effects associated with synthetic medications.
"This is why it is important for us to work on the therapeutic claim so that we can provide evidence-based natural product options to the patients."
What exactly is the difference
Citing the example of Ginkgo biloba L., folium as an active ingredient, the NPRA had illustrated how traditional, modern, and therapeutic claims could be made.
A modern claim, for instance, could be “herbal product used to enhance cognition”, with the product showing the concentration of flavonoids and terpenoids present in the extract.
A traditional claim, would for example, be “traditionally used to improve blood circulation”, and the product need not present the concentration of flavonoids and terpenoids present.
A therapeutic claim will be able to make the highest-level claim, such as “improve cognition for patients with Alzheimer’s Disease.” However, the product will need to show more details on the extract. An example will be “Folium Ginkgo biloba standardised to 24 per cent flavonoid glycosides and 6 per cent terpene lactones”.
