Import Alert 99-53: Detention without physical examination of foods due to naturally occurring toxins

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