This was revealed by San Chaithiraphant, attorney in Intellectual Property and Regulatory Affairs at law firm Tilleke & Gibbins, who was speaking at the recently concluded Vitafoods Asia 2018.
Innovation inhibitor?
He was joined by his colleague, regulatory affairs manager Attachai Homhuan, who added that while the infant nutrition industry in Thailand was strictly regulated, there remained several areas where the regulatory process was unclear.
Homhuan said: “In Thailand, companies cannot market food supplements for young children, as the FDA does not allow items like soft gels or fortified gummies to be registered as supplements. Such products must be registered as drugs or candies instead.”
Exceptions are made only for food supplements that contain vitamins and / or minerals up to the RDI (recommended daily intake) set out by Thai authorities, and only for children aged six and above.
Manufacturers are also required to include warnings on their product packaging, stating that these products do not prevent or cure diseases, and should not be consumed by children below six, or pregnant women.
At the same time, labels on food supplements must be “clearly different and capable of easy notice or differentiation”.
Despite these strict rules, there is a lack of clarity when it comes to specific standards.
Chaithiraphant said: “A benchmark for valid opinions is lacking — what makes a label ‘different’, and whose views matter? Is it that of a general consumer, a mother browsing shelves at a supermarket, or a regulator?”
He added that in fact, nothing should be changed to make existing labels on dietary supplements for children different — they already stood out from other products as being catered to children, due to their typically colourful backgrounds and frequent use of some type of cartoon mascot.
It would also be hard to mistake them for infant formula or other complementary foods that qualify as breastmilk substitutes, as the packaging for such dietary supplements tend to be markedly different in the first place.
These stringent regulations despite a lack of clear standards — put in place partially because of pressure from NGOs to ‘promote and protect’ exclusive breastfeeding — could hamper industry innovation and limit options for mothers who may rely on breastmilk substitutes to feed their babies, or whose children may benefit from dietary supplements.
Standards for substitution
While there is a certain obligation to adhere to the WHO’s International Code of Marketing of Breastmilk Substitutes, the code itself has no legal effect. It requires national legislation to implement, and awareness and enforcement vary greatly from one country to another.
Thailand seems to be following that obligation — when it comes to breastmilk substitutes and other such complementary foods in particular, Thai authorities have instituted a complete ban on these items for children below one year old.
Discounts on and free samples of breastmilk substitutes are also banned, and the marketing of complementary infant food to parents of children aged six months and younger is also not permitted.
Violation of any of these rules would result in heavy penalties of up to US$10,000 in fines and / or a year’s imprisonment.
Gifts from manufacturers to healthcare practitioners are also strictly forbidden, as are donations, sponsorships, and participation in symposiums, with rare exceptions authorised by the country’s Ministry of Public Health.
However, Homhuan said: “Breastmilk substitutes are still considered very important — they are essential nutrition. That’s why a proper process must be developed to regulate their registration, production and sale.”
