Inspections, Compliance, Enforcement, and Criminal Investigations
Field Roast Grain Company 20-Apr-05
Department of Health and Human Services
Public Health Service
April 20, 2005
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 05-20
David A. Lee, President
Field Roast Grain Meat Company
1225 S. Angelo Street
Seattle, Washington 98108
Dear Mr. Lee:
On August 5, 2004, an investigator from the Food and Drug Administration (FDA) visited your firm located at 1225 S. Angelo Street, Seattle, Washington. The investigator collected a sample of your Original Field Roast Brand Vegetarian Grain Meat Sliced Smoked Tomato with manufacturing code "042160." The lab analysis of this sample was received by our office on October 22, 2004. You can find the Federal Food, Drug, and Cosmetic Act (the Act) and the food labeling regulations through links on FDA's web page at www.fda.gov.
FDA analyzed the sample to determine whether the information in the Nutrition Facts panel accurately reflects the nutrient content of the product. Your label states that your product contains 25% of the % Daily Value of Vitamin C per serving. The analyzed content of Vitamin C in your product was 2.6% (original analysis) and 0% (check analysis) of the amount of Vitamin C declared on the label.
Your product is misbranded under section 403(a)(1) in that the label is false or misleading because the amount of Vitamin C present is less than 80 percent of the amount declared on the label (see Title 21, Code of Federal Regulations (21 CFR), Part 101.9(g)(4)(ii)).
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
We have the following additional comments for your consideration as you revise the product label to correct the violation noted above:
Your product bears a "Hi Protein" claim but fails to include the percent Daily Value of protein (21 CFR 101.9(c)(7)(i)).
The Nutrition Facts format does not meet the requirements of 21 CFR 101.9(d). For example, the subheading "Amount/serving" is in the wrong location and is not separated from serving size information by a bar (21 CFR 101.9(d)(4)).
If these products are pre-sliced as suggested by the label, the serving size declared must be based on the number of slices and determined in accordance with the procedure described in 21 CFR 101.9(b)(2)(i). For example, for a slice that weighs 50 percent or less of the Reference Amount Customarily Consumed (RACC), the serving size would be the number of whole slices that most closely approximates the RACC for that product.The RACC for substitutes for luncheon meat is 55 grams (21 CFR 101. 12(b), Table 2 - Fish, Shellfish, Game Meats and Meat or Poultry substitutes: Substitute for Luncheon Meat, Meat Spreads, Canadian Bacon, Sausages, and Frankfurters.)
The label bears the claim "GMO free." As explained in the FDA Draft Guidance for Industry regarding "Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering, " the claim "GMO free" is not technically accurate and may be misleading . This Draft Guidance may be viewed through the following link on FDA's web page: http://www.cfsan.fda.govhdmslbiolabgu.html.
Please respond in writing within three (3) weeks from your receipt of this letter, and describe the corrective actions you have taken or are taking, including an explanation of each step being taken to prevent the recurrence of the section 403(a)(1) violation referred to on the first page of this letter. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any question regarding any issue in this letter, please contact Lisa M. Elrand at (425) 483-4913.
Charles M. Breen