(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert Name:
Reason for Alert:
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.
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
Areca nuts are also known by various other names such as arec, fructus areca, and semen arecae.
which would ordinarily render the article injurious to health. Contains: " [Adulteration, Section 402(a)(1)]
OASIS Charge Code: POISONORD
"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
(23 A - - 14) Betel Nut, In Shell
(54 J - - 11) Betel Nut (Herbal and Botanical Teas II, continued)
(54 K - - 11) Betel Nut (Herbal and Botanicals, not Teas II)
(23 B - - 14) Betel Nut, Shelled
(23 C - - 14) Betel Nut, Butter
(23 D - - 14) Betel Nut, Paste
(23 E - - 14) Betel Nut, Spread
(23 O - - 14) Betel Nut, Nut Flour/Meal