FDA Clarifies Agency Policy on the Adulteration of Food with Foreign Objects

Date: May 05, 1999

In the Federal Register of April 1, 1999, FDA announced the availability of a new Compliance Policy Guide (CPG) on the adulteration of foods with hard or sharp foreign objects. The CPG is intended to assist FDA’s field and headquarters staff in handling enforcement actions against companies whose products are found to contain foreign objects. FDA had no formal policy prior to issuing this guidance document, although some FDA personnel had informally suggested the Agency would not consider enforcement action where foreign objects were less than 10 mm in length.

Under the new CPG, FDA is likely to consider a food containing a foreign object measuring 7mm to 25 mm in length to be adulterated if the food is (1) ready to eat, or (2) requires only minimal preparation such as heating, which would not likely result in eliminating or neutralizing the object. District Offices may seize such food products without first contacting FDA headquarters. District Offices are advised to consult headquarters, however, in the following three scenarios, each of which will be assessed on a case-by-case basis:

    • The foreign object measures 7 mm to 25 mm in length, and requires processing such as e.g., sifting, which might, or might not, remove the foreign object; or

    • The foreign object is less than 7 mm in length but members of a special risk group, e.g., infants, surgery patients, the elderly, are among the intended consumers of the product; or

    • The foreign object is over 25 mm in length.

The Agency will continue to rely on a health hazard review panel under any of the three above-described conditions to assess the mitigating factors, e.g., the intended use of the product, the subsequent processing steps, and other mitigating factors that could eliminate or neutralize the hazard prior to consumption. Even if the review panel finds that the object does not pose a health risk, the food could nevertheless be adulterated and subject to FDA enforcement on the grounds that it is simply "unfit for food" under section 342(a)(3) of the Federal Food, Drug, and Cosmetic Act.

The CPG is not intended to cover certain naturally occurring objects that consumers might expect to find in food (e.g., bones in seafood) or that might be in the food as a result of process failures (e.g., olive pits in pitted olives). Other CPGs may be applicable, however.

FDA is willing to receive comments on the CPG (Docket No. 99D-0463).

For further information, please contact Melvin S. Drozen at 202-434-4222 or drozen@khlaw.com.