Import Alert 99-53

Import Alert # 99-53

Published Date: 09/28/2026

Type: DWPE

DETENTION WITHOUT PHYSICAL EXAMINATION OF FOODS DUE TO NATURALLY OCCURRING TOXINS

One way FDA oversees the safety of the U.S. food supply, including both domestic and imported products, is by monitoring for toxic substances in food and evaluating the potential exposure and health risks posed by these substances. Naturally occurring toxins are poisonous compounds produced by plants, fungi, and animals such as marine organisms as part of normal metabolic processes or defense mechanisms. While many foods contain naturally occurring toxins at levels that do not pose a health concern under typical consumption patterns, food products containing certain toxins might be considered adulterated, and, if adulterated, are subject to refusal of admission under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

One example of a naturally occurring toxin is amygdalin; a cyanogenic glycoside found in various plant products. Apricot kernels and bitter almonds present the greatest safety concern because they contain high concentrations of amygdalin and are often consumed raw or without processing that would reduce amygdalin levels. When these kernels are chewed or ground, amygdalin can release cyanide (prussic acid), a highly toxic compound that may cause adverse health effects ranging from mild symptoms such as weakness and lightheadedness to severe outcomes including seizures, cardiovascular collapse, and death.
Similarly, soursop (Annona muricata) is a tropical fruit native to Central and tropical South America and is also known as graviola, guyabano, guanabana, Brazilian pawpaw, corossol or prickly custard apple. The fruit, leaves, and bark contain neurotoxic compounds known as acetogenins, while the seeds contain particularly high levels of these compounds and are considered inedible. In the scientific literature, acetogenins have been associated with neurodegenerative disorders.

In June 1990, FDA conducted an investigation following a complaint/injury report involving thirty-four adults and children who consumed "Rain Drop" Guanabana Drink imported from Mexico and experienced vomiting within 15 minutes of consumption. Microscopic examination of the product identified cells from Annona muricata seeds in all lot codes examined. In July 2016, soursop juice imported from the Philippines was found to contain cells consistent with soursop seed epidermal cells. Additionally, in September 2017, a soursop (guanabana) drink imported from Mexico was found to contain toxic epidermal cells from guanabana seeds. Over the years, FDA has continued to find that certain food products contain toxic material from the fruit seed that was incorporated into the finished product during the manufacturing process. Thus, FDA has determined that these findings demonstrate that products containing soursop pulp containing seed material continue to be a public health concern.

In the past, shipments of canned and dried morel mushrooms have been detained due to the presence of Gyromitra esculenta. This mushroom species produces monomethylhydrazine (MMH), a toxic compound that can cause severe gastrointestinal illness and, in some cases, death. FDA has also identified Verpa bohemica, another mushroom species that may cause toxic effects in some individuals.

FDA has not established specific tolerances or action levels for most toxins or toxic substances in food. Accordingly, FDA generally evaluates these products on a case-by-case basis to determine whether the type and level of the toxin present may pose a health risk such that the food is considered to be adulterated because it may be injurious to health.

This import alert covers specific firms and their food products that contain levels of toxins or other poisonous or deleterious substances that would ordinarily render the food injurious to health and therefore may be subject to detention without physical examination (DWPE) in accordance with the guidance set forth in FDA's Regulatory Procedures Manual (RPM) Chapter 9-8.

Note: This alert does not cover hazards/products addressed by other import alerts, such as:
-Tetrodotoxin from Puffer Fish covered by Import Alert #16-120
-Hypoglycin A from Ackee fruit covered by Import Alert #21-11
-Alkaloids from Areca (Betel) Nuts covered by Import Alert #23-15
-Mycotoxins covered by Import Alert #23-14

Divisions may detain without physical examination shipments of identified products from firms identified on the Red List of this import alert.

Recommendations for DWPE addition to Red List require documentation of Center/Program concurrence, when the action is not covered by direct reference authority (DRA). Final recommendations for DWPE additions to Red List should be forwarded to the Division of Import Operations (DIO).

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 alert, the owner, consignee, and/or another responsible party to the shipment may provide evidence to FDA that the shipment is not adulterated. Such evidence may include the results of private laboratory analysis of a representative sample of the shipment, which demonstrates that the product does not bear or contain levels of toxins or poisonous or deleterious substances which would ordinarily render it injurious to health.

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 ORA Lab Manual, Volume III, Section 7. Following receipt and review of analytical results, the FDA may, at its discretion, collect and analyze an audit sample before rendering a final decision on the admissibility of the article.

Requests for Removal from Detention Without Physical Examination (REMOVE FROM THE RED LIST):

In order to remove a firm/product from DWPE (remove 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.

For further guidance on removal from DWPE, refer to FDA's 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, they should forward relevant information supporting their request via email to: Importalerts2@fda.hhs.gov.

Requests for removal from DWPE under the Red List of this alert will be referred by DIO to the HFP/Import Enforcement Branch for evaluation.
Questions or issues involving import operations, contact OII, Division of Import Operations (DIO) at (301) 796-0356 or Imports@fda.hhs.gov

Questions or issues with regard to human food on policy, sample collection recommendations, 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

Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to FDAPRIVATELABIMPORTALERTS@fda.hhs.gov.

                                                                                                                                                                  

Human food products

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. [Adulteration, Section 402(a)(1)]

OASIS Charge Code: POISONOUS

Desc: Guanabana Nectar

Notes: DWPE Date- 8/22/2001 Toxic material from the fruit seed was incorporated into the finished product during the manufacturing process.

Desc: Guanabana Nectar

Notes: DWPE Date- 8/22/2001 Toxic material from the fruit seed was incorporated into the finished product during the manufacturing process.

Desc: Guanabana; Soursop

Notes: DWPE Date- 09/18/2009 Toxic material from the fruit seed was incorporated into the finished product during the manufacturing process.

Desc: Guanabana Fruit Beverage

Notes: DWPE Date- 11/20/2007 Toxic material from the fruit seed was incorporated into the finished product during the manufacturing process.

Desc: Mushroom; Morel; Whole (Button) (Fungi)

Notes: DWPE Date- 09/16/2009

Desc: Mind Water-Soursop (Guanabana)

Notes: DWPE Date- 11/01/2017 Toxic material from the fruit seed was incorporated into the finished product during the manufacturing process.

Desc: Mind Water-Soursop (Guanabana)

Notes: DWPE Date- 11/01/2017 Toxic material from the fruit seed was incorporated into the finished product during the manufacturing process.

Desc: Guanabana drink

Notes: DWPE Date- 8/18/1994 Toxic material from the fruit seed was incorporated into the finished product during the manufacturing process.

Desc: Guanabana drink

Notes: DWPE Date- 8/18/1994 Toxic material from the fruit seed was incorporated into the finished product during the manufacturing process.

Desc: Guanabana

Notes: DWPE Date- 8/18/1994 Toxic material from the fruit seed was incorporated into the finished product during the manufacturing process.

Desc: Guanabana

Notes: DWPE Date- 8/18/1994 Toxic material from the fruit seed was incorporated into the finished product during the manufacturing process.

Desc: Soursop

Notes: DWPE Date- 4/23/2001 Toxic material from the fruit seed was incorporated into the finished product during the manufacturing process.

Desc: Guanabana (Other Fruit Products)

Notes: DWPE Date- 4/11/2001 Toxic material from the fruit seed was incorporated into the finished product during the manufacturing process.

Desc: Guanabana (Other Fruit Products)

Notes: DWPE Date- 4/11/2001 Toxic material from the fruit seed was incorporated into the finished product during the manufacturing process.

Desc: Guanabana (Other Fruit Products)

Notes: DWPE Date- 4/11/2001 Toxic material from the fruit seed was incorporated into the finished product during the manufacturing process.

Desc: Soft Dried Soursop

Notes: DWPE Date- 9/16/2026 Product has seeds, which contain high levels of acetogenins rendering them inedible. In scientific literature, acetogenins are described as associated with neurodegenerative disorders.

Desc: Soft Dried Soursop

Notes: DWPE Date- 9/16/2026 Product has seeds, which contain high levels of acetogenins rendering them inedible. In scientific literature, acetogenins are described as associated with neurodegenerative disorders.

Desc: Soft Dried Soursop

Notes: DWPE Date- 9/16/2026 Product has seeds, which contain high levels of acetogenins rendering them inedible. In scientific literature, acetogenins are described as associated with neurodegenerative disorders.

Desc: Soft Dried Soursop

Notes: DWPE Date- 9/16/2026 Product has seeds, which contain high levels of acetogenins rendering them inedible. In scientific literature, acetogenins are described as associated with neurodegenerative disorders.

Desc: Soft Dried Soursop

Notes: DWPE Date- 9/16/2026 Product has seeds, which contain high levels of acetogenins rendering them inedible. In scientific literature, acetogenins are described as associated with neurodegenerative disorders.

Desc: Soft Dried Soursop

Notes: DWPE Date- 9/16/2026 Product has seeds, which contain high levels of acetogenins rendering them inedible. In scientific literature, acetogenins are described as associated with neurodegenerative disorders.

Desc: Soft Dried Soursop

Notes: DWPE Date- 9/16/2026 Product has seeds, which contain high levels of acetogenins rendering them inedible. In scientific literature, acetogenins are described as associated with neurodegenerative disorders.

Desc: Soft Dried Soursop

Notes: DWPE Date- 9/16/2026 Product has seeds, which contain high levels of acetogenins rendering them inedible. In scientific literature, acetogenins are described as associated with neurodegenerative disorders.