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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CPG Sec. 560.100 Importation of Unlabeled Foods - Exemption Under *21 CFR 101.100(d)*

 

 

BACKGROUND:

*FDA's former policy was that the exemptions in 21 CFR 101.100(d) from certain labeling requirements for foods which are to be processed, labeled, or repacked, apply only where both the person who introduces such shipment into interstate commerce and the operator of the establishment where such food is to be processed, labeled, or repacked, reside in the United States.*

*In 1969, General Counsel advised that there is no sound basis for not acknowledging a labeling agreement as provided for in 21 CFR 101.100(d)(2) so long as one party signing such agreement is subject to United States jurisdiction.*

POLICY:

Unlabeled foods may be imported if (a) the person or firm who ships the food from the foreign country is the operator of the establishment in the United States where such food will be *processed, labeled, or repacked, or (b) the shipment is made to an establishment in the United States under a written agreement as provided for in 21 CFR 101.100(d)(2).*

In either instance, the operator of the establishment in the United States must be subject to the jurisdiction of the Federal Food, Drug, and Cosmetic Act.

As provided for in *21 CFR 101.100(e)*, the exemption becomes void ab initio if any part of the food comprising the shipment is adulterated or misbranded when it leaves the establishment where it was to be *processed, labeled, or repacked.*

In instances involving relabeling agreements between a foreign shipper and the operator of an establishment in the United States, the exemption expires upon refusal by the operator of the establishment where the food is to be *processed, labeled, or repacked to make available for inspection a copy of the agreement (21 CFR 101.100(e).*

*Material between asterisks is new or revised.*

Issued: 12/3/73
Revised: 10/1/80, 7/19/89