The document discusses 6 common pitfalls companies face when registering food products in Thailand and how to overcome them. The pitfalls are: 1) misclassifying the food, 2) disclosing too much information about formulations, 3) submitting incorrect documents, 4) forgetting to inform the FDA of changes, 5) using the wrong halal certification, and 6) making exaggerated claims in labels and advertising. The document provides case studies for each pitfall and recommendations on how to correctly classify foods, protect confidential information, submit the proper documentation for things like GMP certificates and analyses, notify the FDA of changes like new manufacturers, get halal certification through the proper Thai authority, and avoid unauthorized health claims under Thai law.

1. byby
Sunan TawesakulwacharaSunan Tawesakulwachara
Regulatory Affairs Regulatory Affairs DepDepartmentartment
Novermber 3, 2010Novermber 3, 2010
6 Pitfalls & Ways to
overcome difficulties in Thai
Food Registration
6 Pitfalls & Ways to
overcome difficulties in Thai
Food Registration

2. Today’s topics – Main Mistakes Today’s topics – Main Mistakes
I. Misclassification of Food
II. Disclosing too much information about the
product Specification
III. Submitting the Incorrect Documents
IV. Forgetting to Amend and Inform the FDA of any
changes
V. Wrong Halal Certification
VI. Overclaiming in labels and advertising materials

3. Mistake 1: Misclassification
of Food
Mistake 1: Misclassification
of Food

4. Misclassification Of Food
Case Study 1
Misclassification Of Food
Case Study 1
• Case Study:
A Company has developed a new energy drink
and is planning to sell it in Thailand. They filed an
application with the Thai FDA for food
supplement . The Thai FDA rejects the
application stating that the category is incorrect.
• Consequence:
An incorrect classification requires a new
application in the correct category which is time‐
consuming and costly.

5. Misclassification of Food
Case Study 2
Misclassification of Food
Case Study 2
• Case study:
The Applicant has already registered its product as a
food in the United States. They apply for the same
category(or similar category) in Thailand. However,
the FDA Official rejects the Application because the
product should be considered as a drug due to its
content.
• Consequence:
A new application has to be filed and with the
requirements for a drug product being more stringent
will need to be proven the safety and efficacy of the
product.

6. Misclassification of Food
How to Avoid the Incorrect
classification
Misclassification of Food
How to Avoid the Incorrect
classification
• Checking the List of ingredients (e.g. is there any food
additive, does it meet the CODEX – internation‐
astandards), and/or,
• Checking the process of manufacture of the product
• Checking the specification of the packaging
materials
• Confirming the quantity to be delivered (e.g. if more
than one pill per day, it might be considered as a
drug)

7. Misclassification of Food
Why it is important to determine
the correct Classification?
Misclassification of Food
Why it is important to determine
the correct Classification?
• Drug –up to 2 years for registration and
proving safety and efficacy
• Specific Controlled Food – up to 65 working
days for registration and analysis to be
conducted
• Prescribed Food – around 35 working days
minimum
• Other foods – no labels and no analysis

8. Misclassification
Examples of Difficult
products to Classify
Misclassification
Examples of Difficult
products to Classify
• Drug
• Specific Controlled Food (e.g. soy milk)
• Prescribed Food to have Quality or Standard
• Prescribed Food to have label
• Other Foods, general Food

9. Mistake 2: Disclosing too much
information concerning the
Formulation Specification
Mistake 2: Disclosing too much
information concerning the
Formulation Specification

10. Disclosure of Formulation
Case Study
Disclosure of Formulation
Case Study
• Case Study
A company has developed a soda drink with a
specific taste. The recipe is confidential and no
protection has been granted to this recipe. The
FDA requires that the list of ingredients equal to
100% has been disclosed.
• Consequence:
Losing the confidentiality of the recipe gained
during many years and not being able to rely on
the protection of trade secret.

11. Disclosure of Formulation
How to use Variations
Disclosure of Formulation
How to use Variations
• Admissibility by the Thai FDA of
a +/‐10% variation of the
amount of ingredient, the total
amount must still be 100%.
• Particularity: For Special
Controlled Food, analyses are
required thus the adaptation of
the +/‐ 10% rule is more difficult
to apply.

12. Mistake 3: Submitting the
Incorrect Documents
Mistake 3: Submitting the
Incorrect Documents

13. Submitting the Incorrect
Documents
Case Study ‐ GMP
Submitting the Incorrect
Documents
Case Study ‐ GMP
• Case Study
A US Company manufacturing a new
cocoa beverage wants to import its
product into Thailand. When
applying in Thailand, the Thai FDA
requests a Good Manufacturing
Practice Certificate, but this company
does not have one.
• Consequence
Delay until the correct documents
are obtained

14. Submitting the Incorrect
Documents
Equivalents to GMP
Submitting the Incorrect
Documents
Equivalents to GMP
• Equivalent to GMP accepted by the Thai FDA
‐ BRC (British Retail Consortium)
‐ ISO (International Organization for
Standardization)
‐ HACCP (Hazard Analytical Control Point)
• The new document should contain the product
name or food category, the manufacturer’s name
and its address. The document has to be legalized
by the government of the country of origin

15. Submitting the Incorrect
Documents
Case Study – Analysis
Submitting the Incorrect
Documents
Case Study – Analysis
• Case Study
The same US company is importing a product
which is listed as special controlled food and thus
the FDA requires an analysis. The product is
arriving at the Port of Bangkok within a few
weeks and needs to be launched as soon as
possible, but a test will take time.
• Consequence
Delay until the analyses are conducted in Thailand

16. Submitting the Incorrect
Documents
Authorized Documents for Analysis
Submitting the Incorrect
Documents
Authorized Documents for Analysis
• An analysis conducted by a Thai recommended
analysis entity can be replaced by :
– Analysis conducted by an ISO17025 laboratory

17. Mistake 4: Forgetting to
Amend/Inform the FDA of
Changes
Mistake 4: Forgetting to
Amend/Inform the FDA of
Changes

18. Absence of Information of the
FDA in case of main change
Case Study
Absence of Information of the
FDA in case of main change
Case Study• Case Study
A Canadian company has applied through its distributor
for a food product license in Thailand and has just
obtained the product certificates. The production is
developing and a new manufacturer is chosen for
handling the ASEAN market.
• Consequence
The products with the new manufacturer’s name are
blocked at Customs because not in compliance with the
import license and product license.

19. Absence of Information of the FDA
in case of main change
Change of the Manufacturer
Absence of Information of the FDA
in case of main change
Change of the Manufacturer
• A new Manufacturer = new Applications
• Possibility to speed up the process if
– Analysis is conducted in Canada in an ISO
17025 recognized laboratory
– Ingredients remain the same

20. Mistake 5: Wrong Halal
Certification
Mistake 5: Wrong Halal
Certification

21. Wrong Halal Certification
Case Study
Wrong Halal Certification
Case Study
• Case Study
• An Italian producer of pre‐cooked Italian food would like
to develop his activity in Thailand. In Italy, an entity has
approved his product as Halal so he included the Halal
symbol on his products. The Thai FDA rejects this symbol
and asks him to remove it.
• Consequence
• In Italy, there is no Halal Certification body recognized,
thus this Italian Company would need to re‐apply for Halal
certification in Thailand.

22. Wrong Halal Certification
Process by the CICOT
Wrong Halal Certification
Process by the CICOT
• In absence of Recognized Halal
Certification Bodies g/cert http://halal‐
””.hub.org/cert
(http://halal‐hub.org/cert body.php),
application with the Central Islamic
Committee in Thailand
– Process : Flow Production process ,
Ingredients – Audit conducted by officer
– Timeframe : 2 months

23. Mistake 6: Over claiming in
labels and advertisements
Mistake 6: Over claiming in
labels and advertisements

24. Over claiming in
labels and advertising materials
Case Study
Over claiming in
labels and advertising materials
Case Study
• Case Study
A Thai company wants to launch a new promotional
campaign for its energy drinks. The new advertising
states that Vitamin B12 can enhance brain function.
The Thai FDA informs the Company that this
statement is unauthorized / unapproved.
• Consequence
The Company has to remove all unauthorized /
unapproved advertising and replace. The FDA will do
press release.

25. Over claiming in Labels and
advertising materials
Applicable Rules
Over claiming in Labels and
advertising materials
Applicable Rules
Section 40 of the Food Act B.E. 2522
“No person shall advertise the benefits, quality or property of food
which is false or which is a deceptive act leading to
misconception.”
Section 31 of the Consumer Protection Act (CPA) B.E. 2522,
“an advertisement may not contain a statement which is unfair to
consumers or which may cause adverse effects to society as a
whole”
Rejection of statements which are false or exaggerated, which
will cause misunderstanding, will adversely affect the national
culture, or will cause disunity

26. • Forbidden to claim that ingredients in the
food product can cure
• Non compliance – Fine of maximum THB
30,000 and/or imprisonment (rarely
applied)
Over claiming in Labels and
advertising materials
Reviewing so as to avoid any
possible Complaints
Over claiming in Labels and
advertising materials
Reviewing so as to avoid any
possible Complaints

27. Example of label

28. SummarySummary
• What do I learn from this?
– Determining the correct classification and
required documents prior to submitting my
application
– Checking local laws in regard to advertising,
Halal certification, etc.

29. Thank youThank you
Sunan Tawesakulwachara
Tel: +66 2 653 5609
Fax: +66 2 653 5678
Email: sunan.t@tillekeandgibbins.com
Website: www.tillekeandgibbins.com

30. AFRIS. AsianFoodRegulationInformationService.
We have the largest database of Asian food regulations in the world and it’s
FREE to use.
We publish a range of communication services, list a very large number of
food events and online educational webinars and continue to grow our Digital
Library.
We look forward to hearing from you soon!
www.asianfoodreg.com
adrienna@asianfoodreg.com