Page 66 - FoodFocusThailand No.238 January-February 2026

STRONG QC & QA

(2) Any substance used as food or food ingredients to which involves uncertainty factors, often limiting allowable intake.
has been applied a production process not currently used, where If higher intake levels are desired, clinical studies in humans
that process gives rise to significant changes in the composition become necessary.
or structure of such food which affect their nutritional value,
metabolism or level of undesirable substances. What are the objectives and methodological
Such ingredients to be used in food products must approaches for designing human clinical studies
be classified as novel foods and therefore require safety in the case of novel foods?
assessment under the Notification of the Ministry of Public Answer: To establish the No Observed Adverse Effect
Health (No. 376) B.E. 2559 (2016) Re: Novel Food. Further Level (NOAEL) for novel foods, randomized controlled trials
details are available on the website of the Food Division of the (RCTs) in clinical studies are required. Key design elements
Thai Food and Drug Administration . include:
5
1.3 If listed in positive list 2 but used outside specified 4.1 Study groups: A test group receiving the product and
conditions: The product is assessed as non-novel food. a control group receiving a placebo.
A safety report is prepared by the Risk Assessment Center and 4.2 Dose levels: 2–3 different intake doses of the test
submitted to the Thai FDA for consideration. substance.
4.3 Alternative design: If multiple groups are not used,
Do raw materials previously used as medicines outcomes may be assessed within a single group at different
or herbal remedies require a safety assessment? time points (baseline, mid-study, end).
Answer: Even if a substance has previously been 4.4 Participants: Healthy volunteers with comparable
consumed as medicines or herbal remedies, its use as food baseline characteristics, with clear inclusion/exclusion criteria.
requires safety assessment. The reasons are the frequency of 4.5 Statistical rigor: Proper calculation of sample size.
intake: food consumption is more frequent and easier accessed 4.6 Duration: At least 12 weeks of exposure.
than medicinal use, and population differences: medicines are Outcomes of the risk assessment include adverse health
intended for patients, while food is consumed by the general effects and biomarkers such as hematological parameters,
population. Therefore, the maximum daily intake must be blood biochemistry, immune indicators, and gastrointestinal
assessed to determine safe consumption levels in food products function. However, liver and kidney function markers, i.e.,
or dietary supplements. Scientific evidence may support safety, AST, ALT, ALP, creatinine, and blood urea nitrogen (BUN)
but manufacturers must also comply with Thai FDA quality must be determined.
standards for the relevant product category.
Increasing intake levels of non-novel foods:
If a product is classified as a Novel Food, what types If a product is classified as non-novel food but
of research or safety testings are required? entrepreneurs wish to increase intake levels beyond Thai
Answer: Since novel foods lack prior consumption history, FDA limits, how should research study and safety testing
examples include a plant traditionally consumed for its fruit or be conducted?
seeds but now proposed for use of stem bark as dietary fiber, Answer: Randomized controlled trials (RCTs) should
and leaves that are usually eaten fresh but are instead extracted be conducted in healthy volunteers at intake levels equal
with 90% ethanol, yielding different active compounds. Both to or higher than the proposed increased intake. The study
cases require safety assessment to establish safe daily intake results must demonstrate no abnormalities in hematological
levels, for which preliminary safety testing includes: parameters, blood biochemistry, or any adverse health effects
3.1 In the case of extracts, it is necessary to identify the active at the proposed intake level.
compounds to be used for quality control and standardization. Based on preliminary responses compiled by TRAC,
3.2 Genotoxicity studies. the author hopes this information will serve as guidance
3.3 Sub-chronic toxicity studies or chronic toxicity studies for entrepreneurs in making decisions when entering the
in the body systems of experimental animals. safety assessment process, including the determination of
Testing must follow OECD guidelines. If animal studies show appropriate intake levels, forms of consumption, and suitable
safety, the results may support human clinical studies. Toxicity study designs for the safety evaluation of novel food products.
studies also help determine acceptable daily intake levels
for humans. However, extrapolating from animals to humans
More Information Service Info C011

ข้้อมููลเพิ่่�มูเติ่มู / Additional Information
ผู้้�ประกอบการสามารถนััดหมายเพื่่�อเข้�ารับคำำาปรึกษากับศู้นัย์ประเมินัคำวามเส่�ยง
ประเทศูไทย (TRAC) ได�ทางเว็บไซต์์: https://tracthailand.com/
Entrepreneurs may schedule a consultation with the TRAC via the
website: https://tracthailand.com/

เอกสารอ้างอ่ง / References
1 https://food.fda.moph.go.th/database-food/category/positive-nega
tive-list
2 https://food.fda.moph.go.th/database-food/category/negativelists
3 https://food.fda.moph.go.th/database-food/category/positivelists1
4 https://food.fda.moph.go.th/database-food/category/positivelists2
66 FOOD FOCUS THAILAND JAN-FEB 2026 5 https://food.fda.moph.go.th/food-law/f-na-novel-food

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