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GUIDANCE DOCUMENT

Guidance for Industry: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product as an Ingredient September 2011

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2009-D-0271
Issued by:
Guidance Issuing Office
Human Foods Program

This guidance is intended for manufacturers who use a pistachio-derived product as an ingredient in a food product. Pistachio-derived products include roasted in-shell pistachios and shelled pistachios (also called kernels) that are roasted or raw. We are issuing this guidance in light of a recent investigation by FDA and the California Department of Public Health of Salmonella species (Salmonella spp.) contamination in pistachio-derived products (Refs. 1 and 2). The producer issued a voluntary recall involving a substantial quantity of its products. Because the recalled pistachio-derived products were used as ingredients in a variety of foods, this recall affected many products and resulted in additional recalls.

Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.  Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain.  In rare circumstances, infection with Salmonella can result in the organism getting into the blood stream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis, and arthritis.

FDA may take enforcement action, including pursuing product seizure, where food has tested positive for Salmonella spp. (Refs. 3 and 4). The circumstances under which food is deemed adulterated are set forth in section 402 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and related prohibitions applicable to adulterated food are contained in section 301 (21 U.S.C. 342 & 331). Consequences for violations of the FD&C Act include seizure, injunction, and criminal prosecution. (See, e.g., sections 301(a) through (c) and section 303(a) of the FD&C Act).

This guidance does not provide recommendations for producers of pistachio-derived products. Importantly, this guidance does not diminish the responsibility of producers of pistachio-derived products to ensure that foods that they produce are not adulterated under the FD&C Act or otherwise in violation of the law. FDA has contacted producers of pistachio-derived products to remind them that our current good manufacturing practice (CGMP) regulations apply to them (Ref. 5).

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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Dockets Management
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2009-D-0271.

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