Australia
Garcinia gummi-gutta and HCA supplements to warn liver harm risk from March 1
From March 1 this year, Australia’s Therapeutic Goods Administration (TGA) will require complementary medicines containing Garcinia gummi-gutta or other ingredients which similarly contain hydroxycitric acid (HCA), to warn consumers of liver harm risks on the product labelling.
Health supplements in Australia are regulated as complementary medicines.
Products containing Garcinia gummi-gutta, for instance, will need to state the warning: “In very rare cases, Garcinia gummi-gutta may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine, or itching.”
Garcinia gummi-gutta, also known as Garcinia cambogia, is a popular ingredient used in weight management supplements.
Aside from the above warning statement, products containing Garcinia gummi-gutta must also not be directed for use in children, or in pregnant or lactating women.
Other than Garcinia gummi-gutta, liver risk warning is also applied to complementary medicines containing calcium hydroxycitrate, Garcinia Quaesita, hydroxycitrate complex, hydroxycitrate acid, potassium hydroxycitrate, and sodium hydroxycitrate – all of which contain HCA as well.
Existing complementary medicines, including both listed and assessed listed medicines, containing ingredients with HCA will have a 12-month transition period to update their labels.
The development came after TGA’s annual review of selected ingredients permitted for use in listed medicines in Australia.
The regulator found that there were growing reports of liver injury associated with HCA as seen from literature reviews.
The TGA also conducted a public consultation on the proposed liver injury warning statement which ended on last September. The TGA also published details of the final decisions on December 2024.
“After public consultation, including advocacy from the Complementary Medicines Australia (CMA), the TGA has decided that listed medicine products containing Garcinia gummi-gutta and other HCA-containing ingredients must include a warning of a very rare risk of liver harm.
“Changes to the ‘Permissible Ingredients Determination’, affecting Garcinia and HCA were published in early December and will come into force on 1 March 2025,” said CMA, which is the industry body of the complementary medicines sector in Australia.
Guidelines on probiotics expected in early 2025
In response to queries from NutraIngredients-Asia, the CMA is also expecting guidelines on two other topics to be published this year.
The first is “Guidelines for the Quality of Listed Probiotic Medicines”, which the CMA expects to be published early this year.
“These guidelines cover one of the most complex areas to regulate in complementary medicines and have been developed in consultation with the industry, CMA and the International Probiotics Association (IPA) among others,” said CMA.
According to the TGA, the guidelines are not mandatory requirements, but could provide transparency to industry by showing what is being considered when the TGA assesses the quality of listed and assessed listed probiotics in a compliance review.
Decision on large size supplements and choking hazard warnings expected to be out this year
The second area where the CMA is expecting updates is labelling requirements and warning statements for health supplements that come in large dosage size. This is to warn consumers of potential choking hazards.
For example, the TGA has proposed for manufacturers to print the statements “warning: large tablets” and “swallow with water” on the product labelling.
The regulator also conducted a public consultation on this issue which ended last July.
“The TGA is still deliberating on the appropriate application of changes to listed medicine labels which are determined to be large solid oral dosage forms intended to be swallowed whole. A decision is now expected in 2025.”
Other works in progress
The CMA also highlighted three other areas where it is working with the TGA on, where it is also expecting new updates to take place this year.
They include “Supplier Assessment, Approval, and Qualification for Listed and Complementary Medicines” and “Sampling and Testing for Listed and Complementary Medicines”.
“These guidance’s aim to streamline supplier qualification processes and clarify testing and sampling requirements.
“In addition to the above two, CMA is also working closely with TGA on the ‘Release for Supply Guidance’.
“The guidance will provide a robust framework for Authorised Persons in the supply chain to ensure compliance before product release. All three guidances are expected to be published next year, enhancing clarity, efficiency, and consistency across the industry,” said the CMA.
China
“Dual Nos” health foods to comply with revised health claims and technical requirements
“Dual Nos” health foods that are currently in production and on sale will need to apply for new registration certificates in China, as the authority has revamped the list of approved health claims and product evaluation guidelines.
“Dual Nos” refer to health foods that do not have 1) a validity period on their product registration certificate and 2) did not have to comply with technical requirements in production and sales.
Their efficacy and health claims were also evaluated based on regulatory guidelines set out in 1996 by China’s former Ministry of Health (MOH) and China State Food and Drug Administration (CFDA). The MOH and CFDA were dissolved in the 2010s and health foods in China are now regulated by the State Administration for Market Regulation (SAMR) set up in 2018.
The 1996 versions of the guidelines were also revamped and replaced with a 2023 version, known as the “Directory of Health Functions Available to be Claimed by Health Food – Non-nutrition Supplements (2023 version).”
In the 2023 version, the number of health functions that non-nutrition supplements can claim has been reduced from 27 to 24 claims.
The claims “boosting lactation”, “promoting growth and development”, and “improving skin oiliness” have been removed in the 2023 version.
While the remaining 24 claims are largely of the same function as before, the authority is requiring companies to rephrase the way these claims are been made.
For example, the claim “enhancing immunity” needs to be rephrased to “aids in enhancing immunity”.
Another example is “alleviating eye fatigue”, which needs to be changed in “alleviating visual fatigue”. Claims such as “losing weight” also needs to be changed into “aids in controlling body fats.”
The SAMR also released 2023 versions of four other documents related to the evaluation and testing of health foods.
They are “Guidelines on Testing and Evaluation of Health Food Functions”, “Testing and Evaluation Methods for Health Food Functions”, “Guidelines on Ethical Review of Health Food Human Feeding Trials”, and “Interpretation to the Directory of Health Functions Available to Be Claimed by Health Food – Non-nutrition Supplements”.
Products claiming to “aid in enhancing immunity”, for instance, will need to redo animal function tests to meet the 2023 guidelines.
With these new documents, existing health foods will need to be evaluated based on the new guidelines and rephrase their health claims to suit the new regulatory requirements.
Under the new arrangements, their health foods registration certificates will also come with a fixed validity period.
While the authority has allowed companies to apply for new registration certificates for their health foods products since August 31, 2023 – with a five-year transition period – there were still details that were only ironed out in year 2024.
As such, regulatory consulting firm CIRS believes that the authority and companies will only go on full steam to register their products this year.
“This year, China’s health foods regulation will likely focus on the change of old product registration certificate - for products with the ‘Dual Nos’.
“The regulatory guidelines have been published in 2023, and in year 2024, evaluation guidelines for health foods testing were published.
“Previously, perhaps because the evaluation guidelines were not yet published, many companies did not have clear guidelines on how to follow the regulatory requirements, and so, this year, it is expected that there would be more activity around this area,” said Shen Yi Lei, senior regulatory consultant at CIRS.
India
Nutra regulatory authority shift not cast in stone yet and industry could still negotiate their terms
There were lots of discussions in India in year 2024 around the potential shift in authority overseeing the nutraceutical sector – with concerns around price control and exports challenge if the drug authority was to take over from the food authority.
However, a former director of the Food Safety and Standards Authority of India (FSSAI) has advised that nothing in cast in stone yet and the industry could still negotiate their interests and terms with the authorities.
Last November, an inter-ministerial committee put forth a list of recommendations on how nutraceuticals should be governed in India.
The committee involved Shri. G. Kamala Vardhana Rao, CEO of FSSAI, and Dr. Rajeev Singh Raghuvanshi, Drugs Controller General of India at Central Drugs Standard Control Organisation (CDSCO) among others.
One of the recommendations, is that nutraceuticals making disease risk reduction (DRR) related claims will be regulated by the CDSCO instead of the FSSAI.
This has sparked much debate and concerns in the industry.
Pradip Chakraborty, a former director at FSSAI, said that there were concerns around price control and export challenges if nutraceuticals were regulated like drugs under the drug authority.
In India, pharmaceuticals can be subjected to fixed pricing, and there are concerns that the same would be applied to nutraceuticals once they are taken over by the CDSCO.
“If price control comes, then nutraceuticals will face problems, because they have to sell it at a fixed price decided by the government.”
This could also have a knock-on effect on nutraceutical exports from India, said Chakraborty.
“If this recommendation is implemented in total, then Indian export of certain nutraceuticals to the US and Europe will face some problems, as they are regulated as drugs in India.
“These are some of the points that have surfaced when I was having discussions with different companies.”
Nonetheless, he said that nothing was cast in stone yet and that the industry could still voice their concerns and negotiate with the authorities.
“Since things are still in the discussion stage, the industry, if they have concerns with some of the provisions, they can definitely submit their representation to the ministries.
“They should submit to their suggestions also and pursue them with the ministries,” he said, adding that going to court could be pursued as a last resort.
Japan
FFC manufacturers to submit notification 120 days before planned sale date from Apr 2025
Manufacturers of Foods with Function Claims (FFC) made using novel raw materials will need to submit their product notification to the Consumer Affairs Agency (CAA) 120 days before the planned product sale date from April 1, 2025.
Products containing raw materials that have a track record of use in Japan will only need to submit their product notification to the CAA 60 days before the planned sale date.
“The 120 days notification period will be applied to FFCs made using new ingredients that do not have any track record of use in Japan and are in the ‘supplement’ formats, such as tablets, capsules, or powder.
“This is because if the product contains some toxins, the toxins will be present in higher concentration in these product formats,” said Hisaaki Kato, president and founder of consultancy firm Smooth Link (Japan).
In Japan, FFC products can be sold in the market after they are being notified to the authority. No approval is required.
During the notification process, companies will need to submit information about their FFC products, such as the ingredient list, the health claims made, and scientific evidence supporting the health claims to the CAA.
The 120-day new policy comes after the Kobayashi Pharmaceutical red yeast rice scandal that had shaken the industry last March.
There were reports of liver injury and even deaths linked to the consumption of the company’s red yeast rice supplements. Puberulic acid derived from blue mould was said to be the culprit behind the adverse health events.
FFC notifications should comply with PRISMA 2020 from Apr 2025
Second, FFC manufacturers will need to adhere to the guidelines of PRISMA 2020 when submitting scientific evidence for their product notification from April this year.
Known as the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020, PRISMA 2020 is an international guideline that sets out the information that should be present in systematic reviews.
This will replace the out-of-date PRISMA 2009.
“As you know, there have been all kinds of negative voices against the FFC system, especially the quality of the research papers used to back up the effectiveness of the products.
“Also, sometimes, there’s a lack of confidence in the value of the clinical trial findings. This is why PRISMA 2020 was introduced to bring up the quality of the scientific information used,” said Kato.
Although FFC products need not be pre-approved by the CAA, companies will need to demonstrate the efficacy of their products by submitting findings from their clinical trials or systematic review.
For companies submitting findings from systematic reviews, they have been following guidelines from PRISMA 2009.
However, following a series of high profile FFC advertising scandals, including one involving Sakura Forest, the CAA announced on September 2023 that it would require companies to follow PRISMA 2020 when submitting information on systematic review.
The case of Sakura Forest showed discrepancies between its product claims and systematic review evidence that the firm had submitted to support the claims.
The need to re-submit systematic review findings based on PRISMA 2020 guidelines is set to affect many FFC manufacturers.
Transition period to GMP and new product labelling
This year, all FFC manufacturers will also continue to enjoy transition period to two other regulatory change – the need to follow GMP standards and revamp their product labelling.
The need to manufacture FFC products in GMP-certified factories started in September last year, with a two-year grace period which will end on September 1, 2026.
All companies would need to comply, no matter the format of their products.
This is also a new requirement which arose due to the Kobayashi Pharmaceutical scandal.
Prior to the scandal, only FFCs in conventional supplement formats, such as tablets, capsules, and powder will need to follow GMP standards.
Some bigger corporations with the means to do so are also already manufacturing their products in GMP-certified factories.
Currently, there are about 200 companies already manufacturing their products in GMP-certified factories.
Kato pointed out that small and medium size enterprises might have difficulties transiting to GMP-certified factories.
The cost of securing GMP certification could also cost 550k yen (US$3,5010, with yearly onsite auditing costs hovering 300k yen (US$1,910) and triennial renewal audit at 480k yen (US$3,056).
“Over 70 per cent of FFC notifiers are the medium small sized companies. They may not be as well-equipped in handling GMP requirements without any help from the raw material suppliers or the consultants.
“Also in Japan, there are two associations that can conduct GMP audit. Smaller companies may be confused as to which one they should be in touch with,” Kato added. One of the bodies that can provide GMP certification is Japan Health and Nutrition Food Associations (JHNFA).
Aside from mandatory GMP requirement, companies will also need to transit to new product labelling requirements by September 1, 2026.
There are six points to take note of, Kato highlighted.
For example, the words “Foods with Function Claims” should be framed and printed on the top of the main surface of the product packaging. The notification number of the product should also be indicated in an adjacent area.
The product should also state that a Foods with Function Claims product is different from Food for Specified Health Use (FOSHU) and that the government has not evaluated the product.
In addition, it should warn consumers about the potential interactions of the product with pharmaceuticals and other active ingredients, as well as risk of overdose. It should also state that it is not intended for treatment or prevention.
“Some products may have to be redesigned, because more information must be displayed on the product packaging. Products in smaller packaging may have a hard time for redesigning and so, a two-year grace period is given.”
He also pointed out that there was still low consumer understanding of FFC products, although the system was introduced 10 years ago in April 2015.
Citing findings from CAA’s Annual Consumer Opinion Survey on Food Labelling released in May 2024, he pointed out that only 19 per cent of the respondents said they knew what FFCs were.
This was only a slight increase from 14.5 per cent seen in year 2016.
“There have been more companies making FFC products as compared to FOSHU products since the former requires lesser amount of time and is less expensive.
“However, consumer awareness is only 19 per cent although nearly 10 years have passed since the FFC system was introduced,” he said, adding that more consumer education would be needed.
“This is why people involved in the FFC system, including the industry associations, the manufacturers will need to put more effort in educating the consumers, otherwise, in the case of Kobayashi Pharmaceutical, many people who died believe that the product could cure or improve their problem.
“However, FFC is just food, there is nothing in it to prevent disease or cure diseases. The point is that they should put more time to educate consumers. Otherwise, the purpose of FFC will not be well understood by consumers,” he said.
South Korea
Customised Health Functional Food System officially launched in Jan 2025
South Korea is officially introducing the Customised Health Functional Food System in January this year, after piloting the system back in July 2020.
To run a customised health functional foods business, companies must first complete official registration as a “Customised Health Functional Food Business.”
This registration is essential for providing personalised services legally, Dr Frank Kim, president of health functional foods, cosmetics, and food regulatory consultancy firm SEAH Bio Solution pointed out.
Businesses are also required to appoint certified professionals known as “Customised Health Functional Food Managers.”
Dr Kim explained that these experts’ role included analysing customer data, such as individual dietary habits and health conditions, and providing tailored product recommendations that meet the unique needs of each customer.
Strict hygiene and safety standards must be always maintained, he added.
“This applies to both the facilities and processes used for repackaging or combining products.
“Ensuring cleanliness and adhering to safety protocols are crucial for delivering high-quality, safe products to consumers. These measures collectively ensure that the service is professional, safe, and personalised,” he told NutraIngredients-Asia.
The official launch of the system is “a significant step towards personalisation in the industry”, he said, adding that Korean consumers were increasingly interested in personalised health products.
For example, only 15 companies were approved to operate a total of 86 customised health functional foods stores back in 2022.
By 2023, this number has exploded to 33 companies running stores in approximately 3,900 locations.
“This rapid growth reflects the increasing interest in personalised health solutions within the market,” said Dr Kim.
The process typically involves personalised health consultations and surveys to assess individual dietary and lifestyle habits. Based on this data, experts such as pharmacists or nutritionists would then recommend products tailored to the individual’s needs.
The products are then repackaged or combined and sold in customised formats, making it convenient for consumers to purchase all their required supplements in a single package, he explained.
“This initiative showcases how South Korea is advancing in personalised healthcare, making health functional foods more accessible and targeted to individual needs while promoting innovation through regulatory flexibility.”
He pointed out that some of the notable players include Lifestyle Project (라이프스타일프로젝트), which runs about 641 stores.
Other major players are Korea Arccell (한국아크셀) with 430 stores and On Doc (온닥터) with 150 stores.
