Dental health supplements: Taiwan removes animal studies, revises clinical trial requirements
The new assessment framework is also renamed as “Efficacy Assessment Method of Health Food for Dental Care” (健康食品之牙齿保健功效评估方法) from the former title “Function Assessment Method of Health Food for Dental Care” (健康食品之牙齿保健功能评估方法).
The new framework was announced and made effective by the Taiwan FDA on March 8 after proposals were lodged last year.
Animal studies are removed under the framework. There are also changes made to the recruitment criteria for the study participants.
For instance, the former requirement of recruiting study participants with a Decayed, Missing and Filled Teeth index of between five to 15 is removed.
Other requirements, such as recruiting participants who are above 20 years old, have at least 20 natural teeth, and having one million CFU of Streptococcus mutans per millilitre of saliva remains.
In addition, the need to measure the CFU of Lactobacillus found in the participants’ dental plaque is removed.
Other requirements, including measuring the pH level of dental plaques, the volume of dental plaques, and the CFU of Streptococcus mutans, remain.
The FDA said it recognised that Streptococcus mutans was the main culprit for most cases of tooth decay and that decreasing the amount of this bacteria could lower the incidence of tooth decay.
Streptococcus mutans could be found in dental plaque, also known as dental biofilm.
Under the new framework, the health claims allowed include “helps to increase the pH value of dental plaque in the oral cavity”, “helps to reduce the accumulation of dental plaque in the oral cavity”, “helps to reduce the number of Streptococcus mutans in the oral cavity,” or other scientifically-backed claims.
The previously permitted claim “helps to reduce the number of Lactobacillus in the oral cavity” is also removed.
The FDA’s announcement follows a public consultation that took place last year.
Last February, the FDA also announced a ban on animal studies for health foods making blood pressure claims, and earlier in 2021, for health foods making anti-fatigue claims.
Animal rights organisation, People for the Ethical Treatment of Animals (PETA), said it was pushing for the FDA to also prohibit health food firms from mutilating rats in their attempts to make joint-protection health claims.