Attachment_1.doc

Attachment 1

GUIDELINES FOR STATE COVERAGE OF NLEA

UNDER FOOD INSPECTION CONTRACTS

SEPTEMBER 1994 *

The requirements of the Nutrition Labeling and Education Act will be covered by FDA in accordance with the instructions in the field assignment: “Implementation of Mandatory Nutrition Labeling Requirements” August 2, 1994. This assignment emphasizes violations involving format and observations of the label rather than analyses for the quantity of nutrients declared. The 9/20/94 memo to the FDA Districts: “Mandatory Nutrition Labeling Requirements - Amended Instructions and Additional Guidance” supplements the assignment and includes instructions for the States.

States will include NLEA coverage in their contract inspection programs in accordance with the following guidelines:

1. Collect labels from non-exempt product(s) being manufactured or labeled during a contract inspection, up to a maximum of 3 products. Obtain 4 copies of each label and include them as exhibits with the inspection report, unless otherwise instructed by the FDA District Co-Project Officer. Determine whether the product(s) are shipped in interstate commerce and include the information in the inspection report. A form letter regarding label compliance will also be left with the firm when labels are collected.

2. States with trained personnel will review the labels to determine compliance with the 5 violations being emphasized; these violations are described in the FDA field assignment. The review should be conducted by trained personnel who may be inspectors/sanitarians, supervisors, compliance officers, etc.

3. Report the State’s assessment of the labels’ compliance in the inspection report or endorsement. For example, 3 labels examined and appear to be in compliance; or 2 labels examined and the label for (product name) appears to be in violation of (area of emphasis, regulation, etc).

4. The FDA District/Headquarters will review the labels to confirm the states assessment, and to determine the appropriate follow-up. A state agency who has the authority and desires to obtain correction should, discuss this with the district. Any state follow-up or regulatory actions shall be coordinated with the FDA District.

5. During routine contract surveillance inspections the States will not be required to collect physical samples of the product for state or FDA analyses. However, a state may be requested to conduct a contract re-inspection to obtain a sample of a potentially violative product for FDA analysis. An example is when a sample is needed to determine whether a “fat free” claim is supported, (area of emphasis No. 4.)

* Edited 7/09