Import Alert 23-15

Import Alert # 23-15

Published Date: 12/13/2023

Type: DWPE

"Detention Without Physical Examination of Food Products That Are, or That Contain, Areca (Betel) Nuts, Including Finished Dietary Supplements and Bulk Dietary Ingredients"

Areca nut is the fruit seed of the areca palm tree (Areca catechu), which grows primarily in South Asia and the Western Pacific islands. The nut 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 imported to the US, often to be sold in Asian markets as food.

Chewing areca nut results in exposure to alkaloids including arecoline, which is reported to have cytotoxic, genotoxic, mutagenic, and carcinogenic effects. 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.

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.

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

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 ORA, Division of Import Operations at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov

Questions or issues on policy or any other additional questions, should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch at CFSANEnforcement@fda.hhs.gov

                                                                                                                                                               

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

Areca nuts are also known by various other names such as arec, fructus areca, and semen arecae.

"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:
"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