DETENTION WITHOUT PHYSICAL EXAMINATION OF DRIED, PRESERVED FRUITS FROM INDICATEDCOUNTRIES/AREAS

NOTE: The revision to this import alert dated 04/4/2013 updates the import alert format/language, modifies the reason for alert and guidance sections, transfers the firms/products on the Red List to the applicable Import Alert (either 45-02 or 45-07), removes the filth charge, clarifies the applicable charges and updates the general product codes for the Peoples Republic of China, Hong Kong Special Administrative Region (SAR) and Taiwan. Changes are noted and bracketed by three asterisks (***).
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FDA conducted an import targeting project for preserved fruits in which samples of preserved, sweetened, dehydrated, candied, dried and/or salted fruits from Southeast Asian countries/areas were collected. Analysis of these samples revealed non-permitted or undeclared color additives and non-nutritive sweeteners, a problem that appears to be pervasive in the industry.

Dried, preserved fruits from Taiwan were found to contain non-nutritive sweeteners (saccharin and/or cyclamates, and one contained dulcin) and unapproved and/or undeclared color additives such as FD&C Yellow #5 (C.I. No. 19140 - tartrazine) FD&C Red #3 (C.I. No. 45430 - Erythrosine), and Carmoisine (C.I. No. 14720 - former ext. D&C Red #10).

Dried, preserved fruits from Hong Kong SAR and the Peoples Republic of China were also found to contain non-nutritive sweeteners, and/or undeclared or non-permitted color additives.

Dried fruit that has not been treated with sweeteners or salt as a preservative are not subject to detention without physical examination under this alert.

Note: Dried, preserved fruits from countries/areas other than Hong Kong SAR, the Peoples Republic of China and Taiwan subject to detention without physical examination due to undeclared and/or non-permitted sweeteners are addressed in Import Alert #45-07, Detention Without Physical Examination of Food Products Containing Illegal Undeclared Sweeteners and undeclared and/or non-permitted colors are addressed in Import Alert #45-02 Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors. ***

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This guidance is intended to apply only to fruits that have been dried and preserved by adding sweeteners or salt. The following fruit products are not subject to detention without physical examination under this Import Alert:
" fruit that is treated by drying only; or,
" dried fruit which only contains preservatives other than sweeteners or salt.

Districts may detain, without physical examination, all shipments of dried, preserved fruits (as indicated above) from the Peoples Republic of China, Hong Kong SAR, and Taiwan, except products from those firms identified on the Green List to this Alert.

Release of Articles Subject to Detention Without Physical Examination Under This Import Alert:

If products are detained without physical examination under this import alert and the owner, consignee and/or other responsible party submits documentation to demonstrate that the fruit is preserved by:
" drying alone,
" food additives other than a sweetener or salt, or
" a means other than by drying and the use of a sweetener and/or salt,
the articles may be released, provided there are no other compliance issues. For questions concerning whether a food additive is considered a salt or sweetener, contact the CFSAN office indicated below.

Otherwise, in order to secure release of an individual shipment subject to detention without physical examination under this import alert, the owner, consignee and/or another responsible party to the shipment should provide the results of private laboratory analysis of a representative sample of the shipment. This evidence, in the form of a private lab analysis, may verify compliance of the article in that the product does not contain undeclared saccharin, cyclamates/dulcin or unsafe color additives.

Proper sampling and analytical records should be submitted to the appropriate FDA District compliance office for consideration per the notice of detention. All analytical findings should be submitted to FDA regardless of the final results. For further information regarding private laboratory analyses, please reference FDAs ORA Lab Manual, volume III, section 7. Following receipt and review of private laboratory results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.

Requests for Removal from Detention Without Physical Examination Under This Import Alert:

In order to remove a firm/product from detention without physical examination, information should be provided to FDA to adequately demonstrate that the firm in question has resolved the conditions that gave rise to the appearance of the violation, so that the Agency will have confidence that future entries will be in compliance.

For guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-6, "Detention Without Physical Examination (DWPE)."

If a firm, shipper or importer wishes to request removal from detention without physical examination, they should forward information supporting their request to FDA at 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

Removal of Exemption from Detention Without Physical Examination Under This Import Alert:

For firms/products that have previously met the criteria for exemption from detention without physical examination under this Import Alert (firms/products on the Green List) will be removed from the Green List if the Agency subsequently establishes one or more of the violations indicated below. Refer to the previous section with respect to reinstatement on the Green List.

For questions or issues involving import operations, contact the Division of Import Operations at (301) 796-0356.

For questions or issues concerning sample preparation or analytical methodology, contact the Office of Regulatory Science at (301) 796-6600.

For questions on policy or sample collection recommendations contact the Office of Compliance, Division of Enforcement, CFSAN, at (240) 402-1750. ***

Import Alert Language last updated: March, 2013

Dried, preserved fruits

For the indicated products from all indicated countries/areas (Peoples Republic of China, Hong Kong SAR, and Taiwan):

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1. Artificial Sweeteners - Undeclared Saccharin:

"The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&CA in that it appears to be misbranded as defined in section 403(i) of the FD&CA. The article appears to contain Saccharin, a non-nutritive sweetener, and its label or labeling fails to list it as an added ingredient. [Misbranding, 403(i)]"

OASIS charge code SACCHARLBL

And,

2. Unsafe Food Additives - Cyclamates and/or Dulcin:

"The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&CA in that it appears to be adulterated as defined in section 402(a)(2)(C)(i) of the FD&CA. The article appears to bear or contain a food additive which is unsafe within the meaning of Section 409. Contains [insert food additive]. . [Adulteration, 402(a)(2)(C)(i)]"

OASIS charge code - UNSAFE ADD

And,

3. Unsafe Color Additives:

"The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&CA in that it appears to be adulterated as defined in section 402(c) of the FD&CA. The article appears to bear or contains a color additive which is unsafe within the meaning of section 721(a). Contains [insert color additive]. . [Adulteration, 402(c)]"

OASIS charge code - UNSAFE COL