"Detention Without Physical Examination of Dried Fungus (Mushrooms) from Hong Kong and PROC for Filth"

Reason for Alert

Note: The revision of this Import Alert (IA) dated 10/26/2022 updates the reason for alert and guidance sections including agency contacts charge code language, and product codes. Changes to the import alert are bracketed by asterisks (***). This alert was initially issued due to detention for filth of 20 of 22 samples (91%) of dried fungus (mushrooms) from Hong Kong and the Peoples Republic of China (PROC), during October 1, 1981 through March 31, 1982. The 20 detentions represented shipments from 14 different packers. At that time, it was reported that the products were repacked or from the PROC, even though the shippers were from Hong Kong. Therefore, both countries were combined.

Product Description

Dried Fungus, Dried Mushrooms (includes freeze dried fungus and mushrooms)

Charge

***The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance, or be otherwise unfit for food [Adulteration, Section 402(a)(3)] ** OASIS charge code - FILTHY

Guidance

***Divisions may detain, without physical examination, all shipments of dried fungi and dried mushrooms for filth from Hong Kong and Peoples Republic of China, except for those firms listed on the Green List of this Alert. Mushroom powder and pulverized/ground mushrooms (made my milling/griding of whole dried mushrooms) are subject to DWPE under this alert. *** Mushroom/fungi extract are excluded from DWPE under this alert, as those products undergo further processing (e.g., extracted, filtrated, and dried) in a way that would reduce or remove filth, if present, in the dried mushroom product. ***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 other responsible party for the affected goods should provide evidence which demonstrates that the product does not contain filth. Such evidence may include private laboratory analysis of samples. 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 (ADD to GREEN LIST): In order to add a firm's product to the Green List of this Import Alert, information should be provided to the Agency to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). ***Per Chapter 9 of the RPM, a minimum of five (5) consecutive non-violative commercial shipments should be offered for import before the Agency may consider that the appearance of the violation has been removed. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). If a firm/product is subject to DWPE on this Import Alert and is also subject to DWPE for the same underlying violation on another filth-related Import Alert, then a request can be made to DIO that the firm or product be removed from DWPE on both Import Alerts based on the same information. For further guidance on removal from DWPE, refer to FDA's RPM, Chapter 9-8, "Detention without Physical Examination (DWPE)."*** If a firm and/or a representative thereof would like to submit a 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 ***

Affected Countries (2)