NOTE: The revision of this Import Alert (IA) dated 05/18/2022 updates the reason for alert, guidance section, agency contacts, and product description section. Changes to the import alert are bracketed by asterisks (***). ***Soursop is a tropical fruit of Annona muricata, an evergreen tree (also known as graviola, guyabano, guanabana, Brazilian pawpaw, corossol or prickly custard apple) that is native to Central and tropical South America. The fruit, along with leaves and bark, contain neurotoxic compounds called acetogenins. The seeds contain high levels of acetogenins rendering them inedible. In the scientific literature, acetogenins are described as associated with neurodegenerative disorders.*** ***This alert was created in June 1990 in response to a complaint/injury report and subsequent FDA investigation, after thirty-four adults and children drank "Rain Drop" Guanabana Drink imported from Mexico and began vomiting within 15 minutes. FDA performed microscopic examination of the product and found cells from Annana muricata seeds in all lot codes examined. In September 2017, a soursop (guanabana)drink from Mexico was found to contain toxic epidermal cells from guanabana seeds. Additionally, in July 2016, soursop juice from the Philippines was found to contain cells similar to soursop seed epidermal cells. FDA has determined that these findings demonstrate that products containing soursop pulp continue to be a public health concern.***
***Guanabana (Soursop) drinks, juices, nectars, refrigerated, frozen, or (ready-to- eat) packaged soursop pulp, juice etc ***
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:" [Adulteration, Section 402(a)(1)] OASIS charge code - POISONOUS
***Divisions may detain, without physical examination, identified products from the firms on the Red List of this alert. Recommendations for additions to the Red List should be forwarded to the Division of Import Operations (DIO). DIO will coordinate review of all recommendations for addition to DWPE with the Center for Food Safety and Applied Nutrition CFSAN.*** Release of Articles Subject to Detention Without Physical Examination under this Import Alert: In order to secure release of an individual shipment subject to DWPE under this import alert, the owner, consignee and/or another responsible party for the affected goods should provide evidence that the product does not contain natural toxins. Such evidence may include private laboratory analysis of a representative sample(s) collected from the affected articles Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration, per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's Laboratory Procedure-Private Laboratory Analytical Packages. Following receipt and review of analytical results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article. Removal from Detention Without Physical Examination (REMOVE FROM RED LIST): ***In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so the agency will have confidence that future entries will be in compliance with the Federal Food Drug and Cosmetic Act (i.e., the Act). For guidance on removal from DWPE, refer to the FDA Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)." *** If a firm and/or a representative thereof would like to petition for removal from DWPE under this Import Alert, all relevant information supporting the request should be forwarded to the following address: Food and Drug Administration Division of Import Operations 12420 Parklawn Drive, ELEM-3109 Rockville, MD 20857 Or, be sent via email to: Importalerts2@fda.hhs.gov. *** Questions or issues involving import operations should be addressed to OII Division of Import Operations (DIO) at (301) 796-0356 or Imports@fda.hhs.gov. Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to FDAPRIVATELABIMPORTALERTS@fda.hhs.gov Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to the Human Foods Program Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov ***
This alert authorizes Detention Without Physical Examination (DWPE) for products matching this alert. Reason: NOTE: The revision of this Import Alert (IA) dated 05/18/2022 updates the reason for alert, guidance section, agency contacts, and product description section. Changes to the import alert are bracketed by asterisks (***). ***Soursop is a tropical fruit of Annona muricata, an evergreen tree (also known as graviola, guyabano, guanabana, Brazilian pawpaw, corossol or prickly custard apple) that is native to Central and tropical South America. The fruit, along with leaves and bark, contain neurotoxic compounds called acetogenins. The seeds contain high levels of acetogenins rendering them inedible. In the scientific literature, acetogenins are described as associated with neurodegenerative disorders.*** ***This alert was created in June 1990 in response to a complaint/injury report and subsequent FDA investigation, after thirty-four adults and children drank "Rain Drop" Guanabana Drink imported from Mexico and began vomiting within 15 minutes. FDA performed microscopic examination of the product and found cells from Annana muricata seeds in all lot codes examined. In September 2017, a soursop (guanabana)drink from Mexico was found to contain toxic epidermal cells from guanabana seeds. Additionally, in July 2016, soursop juice from the Philippines was found to contain cells similar to soursop seed epidermal cells. FDA has determined that these findings demonstrate that products containing soursop pulp continue to be a public health concern.***
Country-specific information is available in the full alert detail on the FDA website.
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