Other major developments included China\u2019s approval of new joint health claims and Taiwan\u2019s proposed reclassification of Traditional Chinese Medicine ingredients under a revised regulatory framework.<\/p>\n
Safety evaluation: Ashwagandha, andrographis and more in the spotlight<\/p>\n
Regulators across the Asia-Pacific region\u2014from Australia and India to South Korea\u2014are intensifying scrutiny of botanicals such as ashwagandha to andrographis in response to a growing number of adverse events reported. <\/p>\n
The Food Safety and Standards Authority of India (FSSAI) in April reiterated the non-use of ashwagandha leaves in crude or extract form and other forms in food products<\/a>. <\/p>\n The regulator\u2019s notice has since sparked massive industry debate, culminating in the filing of an industry petition with the Indian Karnataka High Court, which has temporarily put a pause on the regulator\u2019s ban<\/a> on the use of ashwagandha leaves. <\/p>\n In the same vein, Australia\u2019s Therapeutic Goods Administration (TGA) released a medicine safety advisory<\/a> over ashwagandha supplementation and the \u201cvery rare risk\u201d of liver injury in July. <\/p>\n The Australian regulator also put out a proposal to remove andrographis from the list of low-risk ingredients permitted for use in listed medicines<\/a> on the grounds that current measures might not have been able to reduce the risk of anaphylaxis associated with andrographis use. <\/p>\n Other ingredients under re-evaluation include turmeric, green coffee bean, lemon balm and Garcinia cambogia in South Korea.<\/a> Unlike the routine review process in which functional ingredients are reassessed after 10 years on the market, these three ingredients were re-evaluated because of their association with adverse events. <\/p>\n New approvals: Ingredients with new pathways, dosage formats <\/p>\n Several functional ingredients were given the green light for use in new dosage formats or product types, including coenzyme Q10, melatonin and the human milk oligosaccharide (HMOs) 3\u2019-sialyllactose (3\u2032-SL). <\/p>\n Coenzyme Q10 and melatonin, for instance, can be made into the form of an oral liquid<\/a> in China since March 1 as long as they are formulated as single-ingredient products, China\u2019s State Administration for Market Regulation (SAMR) announced. <\/p>\n The move allows these ingredients to be incorporated into a wider range of formats beyond tablets, granules and hard and soft capsules as the Chinese regulator seeks to cater to the needs of older adults and an aging population. <\/p>\n In addition, China\u2019s National Health Commission (NHC) has approved the use of 3\u2019-sialyllactose (3\u2032-SL) for use in infant formula <\/a>products, bringing the total number of HMOs approved for use in infant formulas to three. The other two HMOs are 2\u2032-fucosyllactose (2\u2032-FL) and Lacto-N-neotetraose (LNnT). <\/p>\n Meanwhile, lycopene and 148 Traditional Chinese Medicine ingredients <\/a>were evaluated for approval under new regulatory pathways by regulators in mainland China and Taiwan, respectively. <\/p>\n All about the labeling: New health claims, warning statements<\/p>\n Product labeling updates in the first half of 2026 included the approval of new health claims and the introduction of new warning statements. <\/p>\n Health products, for example, are permitted to make joint health-related claims for the first time in China since January this year. One of the permitted claims is \u201chelp maintain bone and joint health\u201d, which is now included in the Directory of Health Functions Available to be Claimed by Health Food – Non-nutrition Supplements.<\/a> <\/p>\n Bone and joint health is already a well-established category in China\u2019s dietary supplement space<\/a>. The approval of joint health claims is viewed as a response to growing demand for products that support both healthy aging and active lifestyles. <\/p>\n Australia and New Zealand have also introduced new labeling rules for active nutrition products, specifically Formulated Supplementary Sports Foods (FSSF) containing caffeine. <\/p>\n The local regulator, Food Standards Australia New Zealand (FSANZ), has made it mandatory for such products to include new advisory and warning statements concerning breastfeeding women, <\/a>beyond just pregnant women and children under the age of 15.<\/p>\n Tightening traceability and advertising controls <\/p>\n Mandatory notification is already a feature of Japan\u2019s Foods with Function Claims (FFC), and Singapore is now planning to introduce a notification system focused on promoting product traceability.<\/p>\n In July, Singapore\u2019s Health Sciences Authority (HSA) launched a public consultation<\/a> on a proposal that would require health supplements to be notified before they can be placed on the market.<\/p>\n Companies will need to comply with specific safety, quality, labeling, record-keeping, safety reporting and advertising requirements. Nonetheless, the HSA emphasized that mandatory notification does not amount to official product approval or endorsement. <\/p>\n Product traceability was also top of mind for the Vietnamese authorities after facing a string of counterfeit scandals <\/a>involving infant formulas and supplements last year. <\/p>\n An online product traceability platform verigoods.vn was introduced on July 1 which lists information including product names, manufacturers, distributors, production batch and serial numbers. <\/p>\n Beyond traceability, authorities are also trying to safeguard consumer interest through stricter advertising measures, especially in the livestream commerce space. <\/p>\n