13024 Ballantyne Corporate Place, Suite 900 Charlotte, NC28277 United States
Atlanta District Office
Human and Animal Foods Div. 3E
60 Eighth Street N.E.
Atlanta, GA 30309
October 4, 2017
VIA UNITED PARCEL SERVICE
NEXT DAY - SIGNATURE REQUIRED
Brian J. Driscoll, President & CEO
Snyder’s Lance, Inc.
13024 Ballantyne Corporate Place, Suite 900
Charlotte, NC 28277
On June 21, 2017 the U.S, Food & Drug Administration (FDA) collected a surveillance sample (sample# 1004160) of Lance Toast Chee Crackers, 1.75oz. (b)(4) from a retail store in (b)(4) to determine compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and FDA’s food labeling requirements (21 CFR Part 101). You can find the Act and FDA regulations through links on FDA’s web page at www.fda.gov.
FDA analyzed the sample of your Lance Toast Chee Cracker to determine whether the nutrition information on your Nutrition Facts panel accurately reflects the nutrient content of the product. The product label states one serving is one package/ 6 crackers and contains 10% of the Daily Value for iron. However, the sample analysis performed by FDA found the product to contain 51.7% (original) and 57.2% (check) of the declared amount. The analytical worksheets for sample #1004160 are enclosed. Based on these findings, your product is misbranded under Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false or misleading. Specifically, the iron content is less than 80% of the amount declared on the label [21 CFR 101.9(g)(4)(ii)].
You should take prompt action to correct the violations noted in this letter and to prevent these and other violations in the future. Failure to do so may result in enforcement action by FDA without further notice, including, without limitation, seizure and/or injunction.
We offer you the following labeling comments:
The information panel labeling does not meet the requirements in 21 CFR 101.2(e) because the bar code is intervening material within the ingredient list.
The product label does not declare the street address of the firm. Under 21 CFR 101.5(d), the street address is required unless it is shown in a current city directory or telephone directory.
As you may already know, FDA finalized new requirements for nutrition labeling on May 27, 2016. The new Nutrition Facts label includes updates to the required nutrient declarations and formatting requirements. Although FDA has proposed to extend the initial compliance dates of July 26, 2018 or July 26, 2019 (depending on the size of the manufacturer), manufacturers may begin revising labels now to meet the new requirements. For more information on the new requirements, please see http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm.
Within fifteen (15) working days from your receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations noted above. Include in your response documentation to show that correction has been achieved. If you cannot complete all corrections within 15 working days, please state the reason for the delay and the date by which you will complete the corrections.
Please send your reply to the U.S. Food & Drug Administration, Attn: Janice L. King, Compliance Officer, at the address identified in the letterhead. If you have questions regarding any issue in this letter, please contact Ms. King at (843) 746-2990, x16 or by email at Janice.email@example.com.