Page 85 - FoodFocusThailand No.210 SEPTEMBER 2023

STRATEGIC R&D

- The claim about the immune Hence, for research and development of food products with immune-boosting
system is shown on the positive list claims, we shall start by selecting the nutrients with immune claims on the
according to Notification of Thai FDA positive list of Thai FDA. Then, we shall design the product formula to contain
(10 June 2019): Nutrient function such nutrients at the levels that can be considered as “a source of” or “high”. In
claims. The claimed text is in a similar case of using the other essential substances that are not on the positive list as
format as follows. mentioned above, we shall start by selecting the active ingredients with published
(Name of nutrient) contributes clinical trials and systemic review with meta-analysis or have been approved
to the normal function of the by EFSA for its immune function claims. Then, we shall design the product
immune system. formula to contain such ingredients in the amount adequate to provide such
According to the positive list, the immune-promoting function.
nutrients that can be claimed for an
immune effect include vitamin A, B6,
B12, folic acid or folate, vitamin C, More Information Service Info C011
vitamin D, iron, zinc, copper, and
selenium.
2. Other function claims
For other substances not listed
as nutrients on the Thai RDI, such as
plant or a ni mal extracts,
phytochemicals, fatty acids, and
probiotic products, depending on the
food categories, different supporting
evidence is required to make claims
as follows.
- For probiotic products, we shall
follow Notification of Public Health
B.E. 2011: Use of probiotic organisms
in food. Two reports of well-designed
human intervention studies from two
independent organizations are
required.
- For food in hermetically sealed
packages or dietary supplements, we
shall follow FDA’s Guide for the
Public: application for health claim
assessment. One well-designed
human intervention study and one
systemic review with meta-analysis
or scientific opinion from a trustable
organization such as EFSA Scientific
opinion are required. Usually, the
effect of food products on healthy
people on the immune system cannot
be clearly seen. Therefore, the
following designs are commonly used
for clinical trials to support health
claims about the immune system in
one of two ways:
1. The intervention is given
together with standard immune-
boosting procedures such as
vaccination. Comparisons on the
immune response were made
between vaccination with food
products and vaccination with
placebo products which is an imitation
of the product without the claimed
active ingredient.
2. The intervention is given to
immune-defective people such as
healthy volunteers who are having a
common cold.

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