thai fda food registration process
TRANSCRIPT
bybySunan 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
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
Mistake 1: Misclassification of Food
Mistake 1: Misclassification of Food
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.
Misclassification of FoodCase Study 2
Misclassification of FoodCase 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.
Misclassification of FoodHow to Avoid the Incorrect
classification
Misclassification of FoodHow 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)
Misclassification of FoodWhy it is important to determine
the correct Classification?
Misclassification of FoodWhy 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
MisclassificationExamples of Difficult products to Classify
MisclassificationExamples 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
Mistake 2: Disclosing too much information concerning the Formulation Specification
Mistake 2: Disclosing too much information concerning the Formulation Specification
Disclosure of FormulationCase Study
Disclosure of FormulationCase 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.
Disclosure of FormulationHow to use Variations
Disclosure of FormulationHow 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.
Mistake 3: Submitting the Incorrect Documents
Mistake 3: Submitting the Incorrect Documents
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
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
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
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
Mistake 4: Forgetting to Amend/Inform the FDA of
Changes
Mistake 4: Forgetting to Amend/Inform the FDA of
Changes
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.
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
Mistake 5: Wrong Halal Certification
Mistake 5: Wrong Halal Certification
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.
Wrong Halal CertificationProcess by the CICOT
Wrong Halal CertificationProcess 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
Mistake 6: Over claiming in labels and advertisementsMistake 6: Over claiming in labels and advertisements
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.
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
• 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
Example of label
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.
Thank youThank you
Sunan TawesakulwacharaTel: +66 2 653 5609Fax: +66 2 653 5678
Email: [email protected]: www.tillekeandgibbins.com
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