# FDA WARNING_LETTER - Fresh Express Incorporated - June 10, 2010

Source: https://www.keypedia.com/records/warning_letter/fresh-express-incorporated/186a5957-cdaa-4e9a-a474-3b3c0710c5e2

> FDA WARNING_LETTER for Fresh Express Incorporated on June 10, 2010. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Fresh Express Incorporated
- Inspection Date: 2010-06-10
- Product Type: Drugs
- Office Name: San Francisco District Office
- Summary: On October 6, 2010, the FDA issued a Warning Letter to Chiquita Brands International, Inc. and Fresh Express, Incorporated, following an inspection from May 21 to June 10, 2010, at their Salinas, California facility. The inspection revealed multiple misbranding violations under the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR Part 101.

The "Pineapple Bites with Coconut" product was misbranded because its statement of identity, "Pineapple Bites with Coconut," was false and misleading, as it used coconut flavor spray, not actual coconut, violating Section 403(a) of the Act and 21 CFR 101.22(i)(1)(iii).

Both "Pineapple Bites" and "Pineapple Bites with Coconut" products were misbranded due to improper nutrient content claims. The "Plus... Antioxidants" claim lacked the names of specific nutrients or a linking symbol to nutrient names, violating Section 403(r)(1)(A) and 21 CFR 101.54(g)(4). The "Plus Phytonutrients" claim was unauthorized as phytonutrients are not recognized nutrients with established RDIs or DRVs, violating Section 403(r)(2)(A)(i).

The "Only 40 Calories" claim on both products was misleading because,

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Company: https://www.keypedia.com/companies/fresh-express-incorporated/28a731e0-bde9-4030-b53c-d7d4ce8ab372

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df