Regulatory focus: Our top 10 most-read regulatory stories of 2021 unveiled

By Tingmin Koe

- Last updated on GMT

Regulatory focus: Our top 10 most-read regulatory stories of 2021 unveiled

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See our 10 most-read regulatory stories of 2021, including Recommended Dietary Allowance (RDA) policies in India, South Korea’s monitoring of krill oil and probiotics, and new standards for fish oil in Thailand.
India’s new RDA rules saw increase in vitamin A, C, zinc levels, while biotin remained unchanged

The Food Safety and Standards Authority of India (FSSAI) published new rules​ on the Recommended Dietary Allowance (RDA) of vitamins and minerals which will come into force from July 1, 2023, with increases in the RDA of calcium, iron, zinc, vitamin A, C, and D etc.

The RDA of vitamin C has increased from 40mg to 80mg for men and 40mg to 65mg for women, while that of zinc went up from 12mg to 17mg for men and 10mg to 13.2mg for women.

On the other hand, the RDA of sodium has been reduced from 2100mg to 2000mg for men but increased from 1900mg to 2000mg for women.

RDA enforcement strife: India warned supplement firms to adhere to regulations

Health supplement firms would be threatened with enforcement action​ if they fail to adhere to permitted recommended dietary allowance (RDA) levels for vitamins and mineral products, regulator FSSAI has said.

The Indian regulator has directed food safety commissioners of all states to ensure health supplements firms comply with the rule. 

Stringent actions may be taken against defaulters, which industry experts told us could include withdrawal of products from the market and revoking of the FSSAI license.

CBD in Singapore: Botanical unlikely to be allowed in supplements in near future

Singapore is unlikely to permit the use of cannabidiol (CBD) in supplements in the near future, despite acknowledging it may have a role to play as a medicine.

Singapore’s Health Science Authority (HSA) has made announcements on CBD's regulatory status in its revised Health Supplements Guidelines.​ 

“[CBD is] not to be used in health supplements. It is developed for use in medicines. Known to affect the mental state,”​ HSA said in the guidelines.

One-year policy: South Korea requires all krill oil imports to be ‘proven safe’

The South Korean authorities introduced a one-year long policy which requires all imported Antarctic krill products, including supplements, to be proven safe​ before they can be successfully imported into the country.

The policy started on September 1, 2020 and would end on August 31, 2021 , said the Ministry of Food and Drug Safety (MFDS). ​  

The regulator is particularly keeping tabs on ethoxyquine – a synthetic antioxidant used as a preservative – as well as the presence of five types of solvents in the Antarctic krill (Euphausia superba​) products. 

Immediate withdrawal: India’s FSSAI enforces ban on nutraceuticals containing PABA

The Food Safety and Standards Authority of India (FSSAI) banned the sale of​ nutraceuticals containing Para Amino Benzoic Acid (PABA).

Food safety departments across Indian states were told to enhance surveillance and enforcement to stop the sales of PABA-containing supplements. Such products should be immediately taken down once found, said FSSAI.

PABA is a precursor of folic acid and exists in dairy products such as eggs, milk, and meat. It is usually used in dietary supplements to improve skin health.

India’s RDA levels: Regulator again revised vitamin and mineral rules with increase in magnesium, biotin

The Food Safety and Standards Authority of India (FSSAI) again amended its rules​ on Recommended Dietary Allowance (RDA) of vitamins and minerals, a matter of weeks after originally publishing updated regulations.

On July 16, 2021, the FSSAI published​ a new set of RDAs, known as RDA 2020, and announced that the new rules will come into force from July 1, 2023. 

The FSSAI said that the latest version, released on August 2, was a “partial modification” ​of the RDA guidelines released on July 16 and was “revised based on revision of RDA 2020 by ICMR-NIN."

Thailand fish oil standards: Firms have two-year transition period to meet new composition and production processes

Thai authorities introduced new standards for fish oil based on the existing CODEX guidelines, where products will need to adhere to specific fatty acid compositions and production process.

Manufacturers and importers have two years to adopt the new specifications​. 

For example, at least 50 per cent of the fatty acids in concentrated and highly concentrated fish oil should be EPA and DHA in the form of triglycerides and or phospholipids.

Non-compliant probiotics: South Korean authorities ordered four products to be removed from shelves

South Korean authorities ordered the withdrawal​ of four imported probiotics after these products repeatedly failed inspection tests.

The products are 1) PB5000 Power Gold Plus from US Pharmatech imported by Mirae Bio, 2) Probiotics 10 Billion from Prime Health, and 3) two batches of capsules from Life Bloom and imported by Jinseong Holdings.

Other than Prime Health, which is from Canada, the other two overseas manufacturers are from the US.  

South Korea’s krill oil complaints: Vegetable oil found in products claimed to be ‘100% krill oil’

South Korean authorities said that a number of products which claimed to be “100 per cent” krill oil, actually contained vegetable oil​ and other blends of oils and fats.

The issue came to light during a joint inspection conducted by the Ministry of Food and Drug Safety (MFDS) and Korea Consumer Agency (KCA).

The two conducted inspection on the quality, safety, and labelling of 26 products claimed to be 100 per cent krill oil and were the top 20 best sellers on the Naver Shopping website.

Miscarriage risk: TGA investigate artemisia species permitted for use in supplements                                

The Therapeutic Goods Administration (TGA) had been conducting investigations on 12 artemisia species​ permitted for use in the country, following scientific reports on how intake of the botanical may lead to miscarriages.

It also issued a warning​ to consumers and health professionals that listed medicines containing the botanical may pose a risk during pregnancy.

Most supplements in Australia are classed as listed medicines – with sponsors able to 'self assess' their products in some situations. The majority of listed medicines are self-selected by consumers and used for self-treatment.

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