FDA issues betel nut import alert

EDITOR'S NOTE

The U.S. Food and Drug Administration has issued an import alert for the detention without physical examination of food products that are or contain betel nut (also known as arcea nut from the plant of origin, Areca catechu), including finished dietary supplements and bulk dietary ingredients. The import alert excludes betel nuts that contain or are packaged with tobacco, as these are considered tobacco products.

Import Alert Name:

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

Reason for Alert:

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.

Guidance:

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.