Regulations focus: Our 10 most-read regulatory stories of 2022 unveiled

Melatonin, green tea extract: Australian regulator considering changes to rules governing use in supplements​

Australia’s Therapeutic Goods Administration (TGA) has proposed changes to the scheduling of melatonin and green tea extract, with new dosage indications for the former and a completely new entry into the Poisons Standard for the latter.

The hormone melatonin, produced naturally in the pineal gland, helps to regulate the circadian rhythm or natural sleep cycles through its release when the body is exposed to a dim or dark environment.

Consumers often use melatonin products to stimulate production of the hormone in cases of disrupted sleep cycles and as such, can be used to treat jetlag as it can reset what many call the ‘body clock’.

Clearing the air: Singapore regulator provides clearer guidelines on supplements classification​​

Singapore’s Health Sciences Authority (HSA) has provided clearer guidelines on the classification of health supplements and quasi-medicines – two product categories which could similarly contain vitamins and minerals but differ in the number of active ingredients.

One of the key revisions was the introduction of a classification flowchart for health supplements containing vitamins and/or minerals.

The flowchart shows that a vitamin and mineral product is classified as a quasi-medicinal product if it 1) contains VMS as active ingredients, 2) is labelled as a VMS, 3) contains a majority (at least 50 per cent or more) of vitamins or minerals. 

India's new nutra regulations expand scope for NPD and imports – FSSAI’s ex-director​​

New nutraceutical regulations operationalised by the Food Safety and Standards Authority of India (FSSAI) in April this year would made it easier for companies to innovate and import a broader range of supplements, said a former director at the statutory board.

Pradip Chakraborty, a former director at the FSSAI, told NutraIngredients-Asia ​that this was because the new regulations have permitted more types of dosage formats and a higher permissible limit for certain ingredients.

The guidelines, which cover a wider variety of nutraceuticals, also allow companies to introduce new products to the market quicker.

Need to know: The new regulations set to shape APAC’s nutrition sector in 2022​​

From China to South Korea, Australia, India, and South East Asia, these were the regions that have introduced new regulatory developments for the nutrition sector in 2022.

For instance, from January 1 this year, all food and supplements manufacturers exporting products into China have to be registered with the Chinese customs.

Australia’s new Therapeutic Goods Advertising Code also kicked in on Jan 1 this year, which is intended to be a simplified and more liberal version of the previous code.

Quality control: Industry sets self-regulating standards to safeguard NMN quality in China​​

A group of companies making nicotinamide mononucleotide (NMN) and industry big names such as hyaluronic acid specialist Bloomage Biotechnology have published a set of technical standards to safeguard the quality of NMN products sold in China.

The standards, known as ‘Product requirements and test methods for β-nicotinamide mononucleotide’​, were published on August 12.

This has been put in place as there is currently no national standards (known as Guobiao/ GB standards) regulating NMN products in China. 

Trade challenge resolved: Australia and Vietnam reach agreement to solve supplement export dispute​

Australia and Vietnam have agreed to improve access of certain Australian supplements to the Vietnamese market​, after a bureaucratic dispute threatened to hit trade.

Earlier this year, Australia’s Therapeutic Goods Administration (TGA) and Department of Foreign Affairs and Trade (DFAT) announced that the Vietnam Food Authorities (VFA) had agreed to accept​ Certificates of Pharmaceutical Product (CPPs) or Certificates of Listed Product (CLPs) for supplement products from Australia.

Previously, there were uncertainties surrounding export certification requirements, especially since certain supplements and complementary medicines that were regulated as therapeutic goods in Australia were regulated as foods in Vietnam.

Ayurveda regulations: India introduces new rules with sector braced for significant growth​​

The Indian authorities have introduced new regulations on Ayurvedic products, including rules covering health claims and the addition of vitamins and minerals.

The law, named the Food Safety and Standards (Ayurveda Aahara) Regulations, 2022, came into force in May, following a draft notification and public consultation last year.

This move came amid projections of significant ayurvedic growth in India.

US formula crisis: ANZ firms encouraged by Bubs’ success, Fonterra, a2mc submit applications​

Australia’s and New Zealand’s infant formula makers were “encouraged” by the recent success of local brand Bubs’ entry into the US amid the shortage crisis in the country, with a number now examining export opportunities.

The a2 Milk Company and Fonterra had confirmed with us that they have submitted applications to the US FDA.

Some of the products that were granted enforcement discretion by the US FDA were Aptamil First Infant Milk stage 1 by Danone and Mead Johnson / Reckitt, which has been allowed to produce base powder to manufacture Enfamil Stage 1 in its facility in Singapore.

Supply chains interrupted: Customs delays, shipping woes continue to plague APAC nutra and food businesses​​

Food and nutrition-based businesses across APAC had reported continued logistics problems plaguing their supply chains due to rising costs and customs delays, some of which stemmed from the impact of the COVID-19 pandemic.

For instance, customs clearance can delay, especially when a product is assumed to be dairy or animal-derived, according to Selasi Berdie, founder of the Australian company behind the plant-based infant formula and products Sprout Organic.

The high shipping cost was also highlighted by Chief Business Officer of Malaysia’s health and nutrition firm Nova Laboratories, Nicholas Cheong.

China celeb ban: No celebrity endorsement allowed for health supplements - SAMR​

Health supplements brands are prohibited from engaging celebrities to endorse their products, the Chinese authorities have again warned, in a move which an expert says is targeted at a ‘grey area’ for overseas brands.

Seven ministries and departments from China reiterated the rule in the wake of increasing advertisements that make false claims.

Earlier this year, Chinese actress Jing Tian was fined RMB$7.22m (US$1.08m) for engaging in a sales campaign to endorse a fruit and vegetable candy which the Chinese authorities had construed as fake advertising. ​