Page 50 - FoodFocusThailand No.193 April 2022

SPECIAL TALK BY FDA

of kratom according to the local folkways, as far as facts are concerned, Application for Permission of Food Products
is largely for herbal and traditionally medicinal purposes, such as Containing Kratom
treatment of gastrointestinal disorders and pain relief. There is no Any individual or enterprise, including food producer, food importer,
information on the history of being consumed as food in any restaurant culinarian, restaurant, hotel, bakery, café, and automatic
documented evidence that indicates its culinary usage. Therefore, beverage vending machine, that wishes to sell a food product
Food products containing kratom are considered as novel food under containing kratom or use kratom in the cooking processes of a
the Notification of the Ministry of Public Health (No.376) B.E.2559 commercial food product are required to apply for a permission
(2016) regarding novel food of which safety for consumption shall be according to the regulations of novel foods safety assessment and
assessed prior to being sold in Thailand. shall submit the corresponding labels to the Food and Drug
Therefore, in order to support the research and development of Administration for approval before use. These regulations adhere to
food products containing kratom on the basis of consumer protection, the conditions of the Notification of the Ministry of Public Health
the Ministry of Public Health has issued, by virtue of the Food Act (No.376) B.E.2559 (2016) Re: Novel Foods. The details of the
B.E.2522 (1979), the Notification of the Ministry of Public Health procedure for the safety assessment of novel foods established by
(No.430) B.E.2564 (2021) entitled Amendment of the Notification of the Food and Drug Administration, along with the contact information
the Ministry of Public Health (No.424) B.E.2564 (2021) issued by of food safety assessment body recognized by the Food and Drug
virtue of the Food Act B.E.2522 (1979) Re: Prescribed Prohibited Administration, can be retrieved on the website of the Food Division.
Food to be Produced, Imported, or Sold. The important points are [https://www.fda.moph.go.th/sites/food/SitePages/View.
summarized as follows: aspx?T=FoodNews&TF=1&IDdata=198 ]
1. The condition on prohibited part of kratom in Item No.52 has For further information regarding the procedure for the submission
been revised. Mitragyna speciosa (Korth.) Havil. (Kratom), including of relevant documents to the agencies of novel foods safety
its whole plant and extract, are prohibited from being produced, assessment and a cost estimation for safety assessment, please
imported, or sold except comply with the certain criteria as follow: directly contact the following FDA-recognized food safety assessment
(1) Commercial cooking processes involving kratom parts or centers:
extracts and commercial food products containing kratom 1. Bureau of Quality and Safety of Food, the Department of
parts or extracts—kratom chewing gum, kratom-infused Medical Sciences, the Ministry of Public Health (http://bqsf.dmsc.
energy drink, kratom salad dressing, kratom-infused coffee, moph.go.th/bqsfWeb/index.php/novelfood/)
kratom cookie, and deep fried breaded kratom leaf, etc.— 2. National Food Institute, the Ministry of Industry (https://www.
shall be assessed for food safety and approved as nfi.or.th/service-single-page.php?id=324)
prescribed in the Notification of the Ministry of Public Health 3. Thailand Risk Assessment Center (TRAC), the Nutrition
(No.376) B.E. 2559 (2016) Re: Novel Food prior to be Promotion Foundation under the royal patronage of Her Royal
produced, imported, or sold. Highness Princess Maha Chakri Sirindhorn (https://inmu2.mahidol.
(2) Food products containing kratom manufactured solely for ac.th/th/trac/)
export shall be subject to the regulations stipulated by the With regard to kratom-derived processed foods and products,
partner countries. such as dried powdered kratom, kratom-aqueous extract, kratom leaf
2. The Notification of the Ministry of Public Health (No.430) tea, and dried powdered kratom in capsule or tablet, that are used in
B.E.2564 (2021) issued by virtue of the Food Act B.E.2522 (1979) the traditional Thai medicine or as herbal health products, the
entitled Amendment of the Notification of the Ministry of Public Health permission request shall be submitted to the Food and Drug
(No.424) B.E.2564 (2021) Re: Prescribed Prohibited Food to be Administration as dictated by the Herbal Products Act B.E.2562
Produced, Imported, or Sold was published in the Royal Thai (2019)
Government Gazette on the 5th of January of B.E.2565 (2022) and
came into force on the 6th of January of B.E.2565 (2022) onward.
3. Any party that violates this Notification shall be deemed More Information Service Info C008
incompliant with the Section 6(8) and be subject to imprisonment of
6 months to 2 years and fine of THB 5,000 to THB 20,000 as dictated
by the Section 50 of the Food Act B.E.2522 (1979). กฎหมายที่่�เก่�ยวข้้อง / Relevant Regulation
ประกาศกระทรวงสาธารณสุข (ฉบัับัท่� 430) พ.ศ. 2564 ออกตามความในพระราชบััญญัติ
อาหาร พ.ศ. 2522 เร่�อง แก้ไขเพิ�มเติมประกาศกระทรวงสาธารณสุข (ฉบัับัท่� 424) พ.ศ.
2564 ออกตามความในพระราชบััญญัติอาหาร พ.ศ. 2522 เร่�อง กำาหนดอาหารท่�
ห้ามผลิิต นำาเข้า หร่อจำำาหน่าย ลิงวันท่� 30 ธันวาคม พ.ศ. 2564 ส่บัค้นได้จำาก
http://www.ratchakitcha.soc.go.th/DATA/PDF/2565/E/002/T_0001.PDF

Notification of the Ministry of Public Health (No.430) B.E.2564 (2021) Issued by
virtue of the Food Act B.E.2522 (1979) entitled Amendment of the Notification of
the Ministry of Public Health (No. 424) B.E.2564 (2021) Re: Prescribed
Prohibited Food to be Produced, Imported, or Sold, dated the 30th of December
of B.E.2564 (2021) Available at: http://www.ratchakitcha.soc.go.th/DATA/
PDF/2565/E/002/T_0001.PDF

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