Australia
Mecobalamin labeling mandatory from May 1
From May 1, all medicines, including complementary medicines containing vitamin B12 in the form of mecobalamin or comethylcobalamin, must reflect only the name ‘mecobalamin’ on the product label. Nutraceuticals are regulated as complementary medicines in Australia.
This is part of the Therapeutic Goods Administration’s (TGA) participation efforts in the International Harmonisation of Ingredient Names (IHIN) project, where medicinal ingredients with dual names are transitioned from dual-labeled to sole names.
The transition period for most dual-labeled ingredients started on May 1, 2023 and ends April 30, 2026, which means that products released from May 1, 2026, must show the sole name.
A search on the Australian Register of Therapeutic Goods (ARTG) database shows that the majority of vitamin B12 labeling transitions have been completed, with 411 results shown when mecobalamin was searched.
TGO 92 to be replaced by October 1
From October 1, 2026, the Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92) will be ‘sunset’ or automatically revoked. These standards will need to be replaced with new rules before the sunset date.
TGO 92 relates to the kinds of information required to be included on the label of non-prescription medicines, including complementary medicines.
To prepare for the new rules, the TGA has started a public consultation on its proposed labelling changes. The consultation ends on February 24, 2026.
Some of the proposals include updating the substances and warnings that must be declared on medicine labels. These substances range from marine molluscs such as mussel, oyster, sepia, or squid oil, the preservative sulfites, to probiotics and postbiotics.
In the case of marine molluscs, the TGA is proposing to include in the product labelling the phrase ‘contains mollusc’ or ‘contains mollusc products’.
As for sulfites, the TGA is proposing to declare them as an inactive ingredient or excipient, regardless of concentration, so long as they are present. This is in response to concerns of sulfite sensitivity.
The TGA also proposed updating the requirements to clearly distinguish between live and non-viable biological active ingredients, such as probiotics and postbiotics.
Specifically, it has proposed to continue the current requirements in TGO 92 for probiotics, but the quantity of active ingredients that are “non-viable biological organisms” or postbiotics to be expressed as: “the number of non-viable organisms present per metric unit for liquids and powders and as the number of non-viable organisms present per dosage unit for other dosage forms.”
Another proposed change is to display the term “microgram” in full instead of “µg”, as the latter can be mistaken for ‘mg’. The exception is only when the term “microgram” does not fit on the label and is a label on a small, or a small or very small container, based on TGO 92 and TGO 91 standards, respectively.
The TGA is proposing a transition period of up to three years for the changed requirements, to align with the business cycle and allow manufacturers time to update their labels.
“We note that medicine labels are typically changed every three years as part of business-as-usual activities, allowing many changes to be made without exceptional costs,” the TGA said.
However, it proposed that complementary medicines with large solid oral dosage forms have a shorter transition period of two years, as a safety warning is needed sooner.
China
GACC Decree No. 280 to be implemented from June 1
Overseas manufacturers selling health supplements in China may be able to register their manufacturing facilities with the Chinese authorities directly from June 1.
This is because the General Administration of Customs of China will be implementing a new policy known as “Regulations on the Registration and Administration of Overseas Manufacturers of Imported Food (Decree No. 280)” from June 1.
This is expected to reduce the barrier to entry for overseas products, including health supplements.
At the moment, overseas health supplements manufacturers must undergo a government-recommended process to register their factories with GACC. This is part of the existing Decree No. 248, which will be replaced by Decree No. 280.
Under the new decree, only overseas manufacturers whose products fall under the “Catalogue of Foods that Require Official Recommendation Registration Letters” will need to undergo evaluation and secure a recommendation from their local competent authorities, such as the Therapeutic Goods Administration in the case of Australia.
The Catalogue, which is expected to contain “high-risk” foods such as dairy products, is not yet officially released.
However, it had been released for public consultation last January to February. Based on the public consultation documents, health foods, special dietary foods, unroasted coffee beans and cocoa beans, edible fats and oils were excluded from the Catalogue.
If health supplements remain omitted from the catalogue, overseas manufacturers will be able to process facility registrations directly with the GACC, without official recommendation letters from their home country’s competent authorities.
“If this Catalogue is formally implemented, the registration cycle and difficulty for related products entering the Chinese market are expected to be reduced, which would be a significant benefit for consumers and the market,” said Hangzhou-based regulatory consultancy CIRS.
In addition, Decree No. 280 states that products sold via cross-border e-commerce (CBEC) are exempt from registration requirements, which provides clarity to manufacturers selling into China via this route.
The new decree also provides an automatic renewal of overseas factories for another five years.
However, automatic renewal is not applicable for overseas manufacturers producing certain imported food categories, and they must renew their application three to 12 months before their existing registration expires. This list of products will be separately announced by the GACC.
Indonesia
All health supplements must be halal-certified from Oct. 17
From October 17, all health supplement products circulating in Indonesia must be halal-certified and must display the Indonesian halal logo on the packaging.
This follows the introduction of mandatory halal certification for Traditional Medicines, Quasi Drugs, and Health Supplement products that began in stages from October 17, 2021.
Halal certification is required for both local and foreign manufacturers selling in Indonesia.
This is part of the Indonesian authority’s plans to make halal certification mandatory for all products sold in the country, including food, beverages, cosmetics, health supplements, and pharmaceuticals.
The Halal Product Assurance Organizing Agency (BPJPH) has been set up to oversee the implementation of halal certification, and the certification process has been sped up by allowing online submission and monitoring of halal certification.
Health supplement industry body the Asosiasi Pengusaha Suplemen Kesehatan Indonesia (APSKI) pointed out that there could be instances where halal raw materials could be difficult to obtain. Examples include enzyme components, gelatin, and animal extracts.
There could also be a higher production cost as a result of replacing non-halal ingredients with halal alternatives and halal certification costs. Still, halal certification could offer business opportunities in the global halal market.
Japan
GMP, new product labeling for FFC mandatory from September 1
Japan is enforcing Good Manufacturing Practices (GMP) and new product labeling requirements for Foods with Function Claims (FFC) from September 1.
The GMP rule was first introduced in September 2024, and a two-year grace period was given.
All companies are required to comply with the GMP requirement, no matter the formats of their products. In Japan, FFCs are present in the form of conventional supplement formats like tablets, capsules, and powder to functional foods like chocolates and beverages.
The GMP requirement was added following the red yeast rice saga started by Kobayashi Pharmaceutical. Before this, only FFC in conventional supplement formats had to follow GMP standards.
At the same time, FFC manufacturers will have to follow a new set of labeling requirements from September 1.
For example, the term “Foods with Function Claims” should be printed at the top of the product’s front packaging.
The notification number of the FFC should also be indicated in an adjacent area. In Japan, all FFCs come with a notification number that follows an alphabet indicating the year. Products launched in 2015—the year the FFC framework was introduced—have their notification number starting with “A” and “J” for products launched last year.
The packaging of an FFC product should also state that it is different from Food for Specified Health Use (FOSHU) and that the government has not evaluated the product.
The product labeling should also state the potential interactions of its ingredients with pharmaceuticals and other active ingredients, as well as the risk of overdosing.
South Korea
Stricter labeling for high caffeine, sugar alcohol products from Jan. 1
From Jan. 1, under the revised Enforcement Decree of the Act on Labeling and Advertising of Foods, all food and beverage products containing over 0.15 mg of guarana will have to come with a high caffeine warning label.
The warnings could be presented as “contains high caffeine” or “total caffeine content at XX mg’ or “XX mg caffeine content per serving”.
This is in response to concerns over excessive intake of caffeine from guarana products.
South Korea’s Ministry of Food and Drug Safety (MFDS) has warned that guarana seeds can contain more caffeine than coffee beans, with some products containing over 200 mg of caffeine per serving.
There must also be a mandatory caution statement warning that the product is “not recommended for children, pregnant women, or people sensitive to caffeine.”
Similarly, from Jan. 1, products containing sugar alcohols, such as mannitol, xylitol, and maltitol as the main sweetener, will have to provide details on the content of the said sugar alcohol on the product packaging.
“This information must be located near the details of the other raw materials, and there must be a warning that excessive intake of this product may cause diarrhea,” the MFDS indicated.
An example of such a warning statement is “Sugar alcohol (D-sorbitol 4%, D-maltitol 10%). Excessive consumption of products containing sugar alcohols may cause diarrhoea if consumed.”
Vietnam
GMP or HACCP may be required for health supplements from September 1
Health supplements manufacturers in Vietnam may need to adhere to GMP or Hazard Analysis and Critical Control Points (HACCP) or equivalent standards from September 1.
This requirement may also apply to manufacturers producing medical nutritional foods, foods for special diets, food supplements, and nutritional products for children up to 36 months of age.
Aside from GMP and HACCP, manufacturers may also choose to follow other equivalent frameworks, such as the ISO 22000 Food Safety Management System, the International Food Standard (IFS), or the Global Standard for Food Safety (BRC), or the Food Safety System Certification (FSSC 22000), or equivalent certification.
This is according to a draft proposal to amend Decree No. 15/2018/ND-CP announced by the Vietnam Food Administration (VFA).
The Vietnamese authorities have been tightening the regulations of health food products following a series of scandals involving the large-scale production and trading of counterfeit health supplements and infant formula last year.
The proposals to amend Decree No. 15/2018/ND-CP are aimed at addressing limitations and inadequacies related to self-declaration, registration of product declarations, advertising, and post-inspection, the VFA stated.
The proposals have also referenced the standards of the United States, Japan, Australia, Canada, South Korea, and China.
Aside from GMP or HACCP requirements, the VFA has proposed that food supplements would require product declaration registration.
At the moment, as food supplements are not clearly defined in Decree No. 15/2018/ND-CP, they are not included in the food groups requiring product declaration registration and belong to the group of pre-packaged processed foods that can be self-declared.
“This leads to situations where organizations and individuals declare the wrong product group, with many health supplements self-identifying as food supplements and self-declaring,” according to the VFA. “Furthermore, because advertising content is not required to be registered with the competent authority, businesses often exaggerate the features and benefits of their products.”
