Import Alert 23-15

Import Alert # 23-15

Published Date: 05/08/2025

Type: DWPE

***"Detention Without Physical Examination of Food Products Including Finished Dietary Supplements and Bulk Dietary Ingredients, That Are, or That Contain, Areca (Betel) Nuts, and Foodware Made From Areca catechu Palm Leaves”***

Note: The revision of this Import Alert (IA) dated 05/8/2025 updates the title, reason for alert, guidance section including agency contacts, charge code section, and product description. Changes to the import alert are bracketed by asterisks (***).

***The Areca nut is the fruit seed of the tree and is commonly referred to as “betel nut,” because it is often wrapped in betel leaves for chewing. Areca nuts and food products containing areca nuts are also imported to the US, often to be sold in Asian markets as food. The areca palm tree (Areca catechu or A. catechu) grows primarily in South Asia and the Western Pacific Islands. The leaves of the areca palm tree are used to make foodware, including bowls, plates, cups, and cutlery. Foodware made from the leaves of the A. catechu palm is manufactured outside the US but is imported and sold online and in stores in the US by major retailers.

Naturally occurring toxic alkaloids are present in various parts of the areca palm tree, including the leaves and nuts. Chewing areca nut results in exposure to alkaloids including arecoline, which is reported to have cytotoxic, genotoxic, mutagenic, and carcinogenic effects. Additionally, results from FDA migration and extractive studies on foodware made from A. catechu palm leaves has shown that these alkaloids migrate from the product to food under intended use conditions at levels that can result in consumer dietary exposure that raises safety concerns.***

In its 2004 and 2012 evaluations on the carcinogenic risks to humans from areca (betel) nuts, the World Health Organization's International Agency for Research on Cancer (IARC) stated that there is sufficient
evidence to conclude that areca nut chewed with or without tobacco causes oral cancer in humans. It also stated that there is sufficient evidence in experimental animals for the carcinogenicity of areca nut
with or without tobacco (IARC, 2004; 2012). Further, review of the literature indicates that regular consumption of areca nut and areca nut products is associated with a range of persistent adverse systemic
health effects.

***However, the use of the sheath of A. catechu palm leaves in food contact articles does not meet the statutory criteria for general recognition of safety and are therefore not generally recognized as safe (GRAS). This evaluation is based on scientific data and information demonstrating a potential safety concern for dietary exposure to known alkaloid constituents of the A. catechu palm leaf as a result of its use in food contact articles. As the use of A. catechu palm leaf material in foodware is not GRAS and no authorization exists for its use in contact with food, such use is an unsafe food additive as defined under Section 409 of the Federal Food, Drug and Cosmetic Act (FD&C Act - 21 U.S.C. 348(a)).***

***Divisions may detain without physical examination all shipments of food products that are, or that contain, areca (betel) nuts (including powders, extracts, and other forms), including finished dietary supplements and bulk dietary ingredients and foodware (bowls, plates, cups, and cutlery) made from leaves of the A. catechu palm tree.***

Note, this import alert does not apply to areca (betel) nuts that contain, or are packaged with, tobacco, which are considered tobacco products.

Release of Articles Subject to Detention Without Physical Examination Under This Import Alert:

In order to secure release of an individual shipment that is subject to detention without physical examination in accordance with this import alert, the owner, consignee and/or other responsible party should provide all relevant information supporting their request for release to FDA. Information should be submitted to the FDA Division Compliance Office indicated in the 'Notice of FDA Action' notice of detention.

***Questions or issues involving import operations, contact the OII, Division of Import Operations (DIO) at (301) 796-0356 or Imports@fda.hhs.gov

Questions or issues with regard to human food or foodware on policy or any other additional questions, not directly related to a detained entry should be addressed to HFP/Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov

                                                                                                                                                         ***

***Foodware products that are, or that contain leaves of the A. Catechu palm tree***

Food products that are, or that contain, areca (betel) nuts (including powders, extracts, and other forms), including finished dietary supplements and bulk dietary ingredients.

Products subject to this Alert may be described by a different or unfamiliar name. As needed, Divisions should examine and review labels or request information from the importer to verify if the product ***falls within the scope of this import alert. ***

-Areca (betel) nuts and products made from them are also known by various other names, including but not limited to, arec, fructus areca, semen arecae, Areca catechu, supari, pan, paan, pan or paan masala, chaalia, betel quid, etc.
***-Foodware made from the leaves of the A. catechu palm tree such as: palm leaf plates or palm leaf dinnerware.***

For Areca (Betel) Nuts:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous or deleterious substance which would ordinarily render the article injurious to health. Contains: " [Adulteration, Section 402(a)(1)]

OASIS Charge Code: POISONORD

Dietary supplements:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a dietary supplement that contains, or a dietary ingredient that is, a dietary ingredient that renders it adulterated under section 402(a)(1) under the conditions of use recommended or suggested in the labeling of such dietary supplement." [Adulteration, Section 402(f)(1)(D)]

OASIS Charge Code: UNSFDIETUS

Foods containing betel nuts ***and/or foodware made from Areca palm (A. catechu) leaf***:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of Section 409." [Adulteration, Section 402(a)(2)(C)(i)]

OASIS Charge Code: UNSAFE ADD