‘India’s nutra industry could die’: Experts not in favour of drug regulator taking over governance of thriving sector
There has been extensive debate in India on whether the drug authority should take over the regulatory control of nutraceuticals since February this year.
The debate was sparked by the government’s formation of a five-member panel in examining the possibility of shifting nutraceutical regulatory control from the Food Safety and Standards Authority of India (FSSAI) to the Central Drugs Standard Control Organisation (CDSCO).
One of the concerns that the industry had, was their worries of how the arrangement could stifle the development of the nutraceutical sector.
Ashwagandha warning: Australian officials issue safety advisory, highlight risks of unregulated, overseas products
Australia’s Therapeutic Goods Administration (TGA) released a safety advisory in February warning the risk of gastrointestinal symptoms linked to ashwagandha (Withania somnifera) supplements bought online from overseas.
Sixteen cases were hospitalisation as a result of severe gastrointestinal side effects. There were also 12 reports of liver problems related to ashwagandha supplements consumption.
Ashwagandha is widely used as a Ayurvedic medicine and can be bought in Australia’s supermarkets, health food shops and pharmacies without a prescription or health professional’s advice.
Thailand enforcing new maximum RDIs for nine vitamins and minerals from July 2
Thailand has enforced new maximum levels for the Recommended Daily Intakes (RDIs) of nine vitamins and minerals from July 2 this year.
The RDI of vitamin C, for example, has been raised from 60mg to 1,000mg, while that of vitamin D was increased from 5 µg to 15 µg.
Meanwhile, food supplements produced prior to the date of enforcement can still be sold in the market – but no more than three years from the date of notification, which is on July 1, 2027.
Philippines to replace 33-year-old vitamins and minerals regulation, maximum daily limits set
The Food and Drug Administration (FDA) of Philippines said in January that it would be reclassifying vitamins and minerals either as food or dietary supplement, instead of the existing arrangement where it is categorised as either food or drug.
Known as the “Guidelines for the Classification of Vitamins and Minerals for Food/Dietary Supplements under Processed Food Product”, the new framework will replace the existing “Guidelines for the Classification of Vitamins and Minerals as Drug or as Food” set in 1991.
The new guidelines would also set maximum levels for a total of 26 vitamins and minerals. For example, the daily maximum level for vitamin C would be set at 1,000mg, vitamin D at 25mcg, and calcium at 1,200mg.
Policy priorities: The need-to-know nutraceutical regulations set to shape the APAC sector in 2024
From China, Taiwan, South Korea, Australia, to Japan, we summed up the need-to-know nutraceutical related regulations that were put in place across Asia-Pacific this year.
Taiwan, for instance, has required health foods, including fish oil and red yeast rice products to comply with new labelling rules since January 1st this year.
Australia, on the other hand, has implemented new warning statements to ingredients that are deemed as having “low-negligible risk changes”, such as green tea extract and curcumin.
India’s food and drug authorities in talks over which body controls vitamins and minerals above RDA
There were robust discussions between India’s food and drug regulators, as well as the industry, on whether vitamins and minerals with dosage levels higher than one recommended dietary allowance (RDA) and upper limits should be regulated by the drug regulator instead.
At the moment, vitamins and minerals higher than one RDA or upper limit will be considered as pharmaceuticals, except for Foods for Special Medical Purpose and Foods for Special Dietary Use (FSDU) – which are both regulated by the food authority.
The discussions were sparked by the formation of a five-member panel by the government to examine the possibility of shifting nutraceutical regulatory control from the Food Safety and Standards Authority of India (FSSAI) to the Central Drugs Standard Control Organisation (CDSCO).
China approved nearly 600 infant formulas in 2023 – new national standards data
China had approved nearly 600 infant formulas based on the new GuoBiao (GB) or national standards last year, following the implementation of new regulations.
China’s State Administration of Market Regulation (SAMR) implemented new regulatory requirements for infant formulas last February.
It said in June this year that a total of 592 infant formulas and 97 companies were approved when the country fully transited to the new regulations last year.
Third pathway: Malaysia’s new ‘modern claims’ system could drive more clinical research and business
The introduction of a new ‘modern claims’ system in Malaysia has been welcomed by industry players as it could drive more clinical research, expand new product options for consumers, and open local and international market opportunities.
Companies can apply for modern claims on natural products since April 4 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 National Pharmaceutical Regulatory Agency (NPRA).
Probiotic regulation call: Hong Kong Consumer Council urges government to set up legislation to oversee category
The Hong Kong Consumer Council has urged the government to set up legislations to regulate dietary supplements, including probiotics.
The Council made the announcement when releasing the findings of its review of 40 commercially available probiotics products back in January.
The review found that out of the 40 products assessed, two contained Enterococcus faecalis. This is a strain which the Council said was not recommended by the Joint FAO / WHO Working Group for use as a probiotic, due to safety concerns.
Kobayashi knock-on effect: Japanese functional foods businesses legally bound to four new rules from Sep
Manufacturers of Foods with Function Claims (FFC) in Japan are legally bound to four new requirements since September 1st.
The move came as the authorities sought to tighten regulations on FFC after Kobayashi Pharmaceutical’s red yeast rice scandal broke out in March.
One of the new requirements is that manufacturers are required to report cases of health hazards related to their products to Japan’s Consumer Affairs Agency (CAA).
