See our top 10 most read regulatory stories of 2020, including COVID-19 lockdown and essential business status, South Korea’s control on imported krill oil and more.
Authorities from a raft of countries have stepped out to caution against the advertising of health supplements that claim to prevent or treat the novel coronavirus.
As of Mar 8, the number of COVID-19 infection had exploded to 105,586, with cases reported in 101 countries, territories, and areas. The World Health Organisation (WHO) had increased the global risk assessment level to “very high”.
As individuals sought to safeguard their health, cases of supplements sold at heavily marked-up prices and fake product claims made in relation to COVID-19 prevention had surfaced.
In Vietnam, there had been cases of vitamin C, black garlic syrup, and mouthwash sold at jack up prices, ranging from VND$280k (US$12) to VND$890k (US$38), according to local media Vietnam Plus.
There was widespread confusion among Malaysia’s dietary supplement industry as to whether it was considered an essential service and production could continue under the country’s coronavirus lockdown.
Malaysia begun its two-week Movement Control Order (MCO) on March 18.
On the same day, the government issued a Federal Government Gazette titled “Prevention and Control of Infectious Diseases Regulations 2020” which provided additional information on the essential services that could continue operations.
According to the gazette, essential services include water, oil, gas, health, pharmacies, supermarkets, and food etc.
The New Zealand supplement firms were allowed to continue operations so long as they supplied to 'essential' businesses, such as pharmacies and supermarkets.
Health foods stores, however, were not considered 'essential' businesses.
This was according to a notice titled ‘Guidance for Essential Services’ that the New Zealand Natural Health Products (NZNHP) issued last week.
“We have received advice from the Government that if your business is part of the supply chain for an essential business, it may continue to supply those critical products and services to the essential businesses only,” it said in the notice.
South Korea’s authorities have recalled 12 krill oil products after safety tests found banned substances or excessive use of solvents in the products. This had led the authorities to call for tougher inspections at the customs.
The country’s Ministry of Food and Drug Safety (MFDS) said that 12 out of the 41 krill oil products tested were ‘non-conforming’ to safety standards.
Neubria krill, Zinofin, na+uralplus, Blue Ocean Krill Oil, UltraMax KrillOil 58, NZ Origin’s Antarctica Krill Oil 500, and Clean Krill Oil 1200 were some of the krill oil capsules cited by the authorities in a statement.
The inspection examined the levels of extraction solvents hexane, acetone, ethyl acetate, isopropyl alcohol, and methyl alcohol in the products.
The dietary supplement industry bodies in both Australia and New Zealand sought clarification on whether the sector was classed as an ‘essential service’, as both countries imposed movement restriction to curb the spread of COVID-19.
The Natural Health Product New Zealand (NHPNZ) said in a notice circulated on March 23 that it had written to the Ministry of Business, Innovation, and Employment (MBIE) on the week before to seek clarification.
It added that the MBIE and Ministry of Health (MOH) officials would meet on March 24 to finalise the list of sectors that fall under the ‘essential services’.
Based on the Government’s definition on ‘essential services’, the trade body believes that most, if not all of its members qualify as an essential business since they could be classified as FMCG, and/or primary industries, including food and beverage production and processing, and/or health services.
APAC’s fragmented, and at times volatile, regulatory landscape can be a major headache for supplements and functional foods firms. We featured some of the new rules that had commenced from January and potential new developments.
We spoke to industry stakeholders, regulators, and regulatory consultants, and zoomed into the regulatory developments in five major markets, China, Australia, Thailand, South Korea, and India.
China
China’s State Administration for Market Regulation (SAMR) had issued new guidelines on health food labelling. The guidelines had came into effect on January 1, 2020.
A major change is the inclusion of warning labels on health food packaging, where it must now be displayed in this format: “Health foods are not drugs, and cannot replace drugs to treat diseases.”
The Chinese authorities has allowed the use of six traditional Chinese medicinal herbs as food spices, but manufacturers will not be allowed to attach any health claim under this process.
In an announcement made on Jan 6, China’s National Health Commission (NHC) listed the six herbs as danggui (Angelica sinensis), Shannai (Kaempferia galanga L.), xi hong hua (Crocus sativus L.), cai guo (Amomum tsao-ko), turmeric, and biba (Piper longum L.).
When manufactured as a general food, the product label, indication, advertisement, and promotion content for the herb must adhere to the Food Safety Laws.
As such, the product should not make claims related to disease prevention or disease treatment.
South Korea had introduced new regulations for functional health foods, including the need for manufacturers to adhere to Good Manufacturing Practices (GMP).
Since January, a new piece of policy has been enacted almost each month.
The Ministry of Food and Drug Safety (MFDS) announced a total of nine new policies pertaining to food and health foods before the end of last year.
Of note to the health foods industry is the need to manufacture the products according to the GMP standard.
China has approved three new probiotics strains and the plant oriental penthorum as novel food ingredients.
The three approved probiotic strains are lactobacillus helveticus R0052, bifidobacterium infantis R0033, and bifidobacterium bifidum R0071 from Lallemand Health Solutions. The strains are isolated from dairy products, infant gut, and adult gut respectively.
All of the strains have been approved for use in infant foods, said a statement from the National Health Commission (NHC). Since they are only approved for use in foods and not health foods, they are not allowed to make health claims.
Besides passing safety tests in China, the strains have also gained the Generally Recognised as Safe (GRAS) status in the US.
China had stepped up its compliance checks on food manufacturers and retailers to stem the unauthorised production and sales of special foods, including Foods for Special Medical Purpose (FSMPs).
The initiative had been introduced because the country was facing a new infant nutrition scandal.
Parents of the infants and toddlers affected claimed that their children have suffered health problems such as eczema and skull deformity.
The product in question was a protein solid beverage branded ‘Bei An Min’. It also claims to be a ‘deep hydrolysis protein and lactose-free formula powder’.
