The approval went to local firm Nova Wellness Group Berhad’s Hepar-P – a liver health product made with Phyllanthus niruri extract.
According to the company, the product was approved to make the modern claim as a “natural liver support”.
The modern claims system was introduced on April 4th this year.
A modern claim is one that 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 regulator.
There are in total three types of claims that natural products can make in Malaysia.
They are traditional claims, modern claims, and therapeutic claims.
The requirements for therapeutic claims are the strictest as they must be substantiated with clinical evidence and require medical intervention for diagnosis and therapy.
Modern claims are in between traditional and therapeutic claims.
While scientific evidence is crucial when applying for a modern claim, the evidence could be based on clinical studies, peer-reviewed published articles, animal, and in-vitro studies etc.
Traditional claims, on the other hand, can be made based on knowledge, skills, and practices based on theories, beliefs, and experiences indigenous to a specific culture.
The claims are also meant for maintaining health and prevention, diagnosis, improvement, or treatment of physical and mental illness.
In response to queries from NutraIngredients-Asia, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) said that more than 12,000 natural products making traditional claims were registered with the Drug Control Authority (DCA) as of October 2024.
One product has been registered under the therapeutic claim system in July 2023.
As for modern claims, it is only Nova Wellness that has received the approval as of October 2024.
“Since the issuance of the Guideline on natural products with the modern claim in April 2024, NPRA has received five applications for the modern claim category from the industry.
“As of October 2024, one product was registered under the natural product with the modern claim category,” said a spokesman from NPRA.
The system has been welcomed by industry players as it could encourage companies to conduct more clinical research, and provide more product varieties for consumers.
Common pitfalls to avoid
There are three common pitfalls that companies should avoid when applying for modern claims, said NPRA.
First is insufficient evidence for support the claim.
All modern claims applications have to be substantiated by good quality and reliable scientific evidence relevant to the claims.
“The claims shall be based on evidence from a range of sources, including but not limited to clinical studies, peer-reviewed published articles, monographs, pharmacopoeias, textbooks, regulatory authority reports, animal (in vivo), and in vitro studies.”
For Nova Wellness’s Hepar-P, the product is backed by a 52-week clinical trial involving 226 individuals diagnosed with non-alcoholic fatty liver disease (NAFLD).
Findings were published in the journal Heliyon last year, which showed significant improvement in liver fibrosis scores and reduction in elevated liver-specific enzymes.
It also demonstrated safety for long-term use with doses up to 3,000mg per day.
The second pitfall to avoid, is the inability to provide additional quality document as required.
The compulsory quality documents include the certificate of analysis (CoA) of the active ingredient of the herbal substance and herbal preparation in the form of a quantified extract.
The other compulsory documents are identification test and quantitative assay on the finished product, in addition to other existing required tests, such as microbial contamination and heavy metal contamination tests.
Third is the lack of safety evidence.
Documents of safety evidence include documented history or traditional use of the active ingredient.
“However, if toxic effects have been reported or insufficient documented safety evidence and doubts concerning the product/active ingredient, submission of toxicity studies is required.”
