| Public Health Service Food and Drug Administration |
| Baltimore District Office 6000 Metro Drive, Suite 101 Baltimore. MD 21215 Telephone: (410) 779-5454 Fax: (410) 779-5703 |
Department of Health and Human ServicesFEI: 1119572
WARNING LETTER
CMS# 100766
June 3, 2010
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Ms. Kelly A. Tassinari, General Manager
Twin Oaks Community Foods, Inc.
138 Twin Oaks Road
Louisa, VA 23093
Dear Ms. Tassinari:
The United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 138 Twin Oaks Road, Louisa, VA on December 15-16, 18, 2009, and February 11, 2010. The inspection determined that your firm is a tofu and vegetarian sausage manufacturer and distributes these products in interstate commerce. During the inspection, our investigators collected label samples from your Organic Tofu Extra Firm, Vegetarian Pate, and Vegetarian Sausage Extra Chewy Breakfast Style products. Based on our review of your product labels, your Organic Tofu Extra Firm, Vegetarian Pate, and Vegetarian Sausage Extra Chewy Breakfast Style products are misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343]. Regulations implementing the food labeling requirements of the Act can be found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and FDA regulations through links in FDA's home page at www.fda.gov.
Under section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)], a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in food labeling without complying with the requirements related to the use of the terms defined by regulation for such nutrient content claim misbrands the product under section 403(r)(1)(A) of the Act [21 U.S.C. §343(r)(1)(A)].
The labels of your Vegetarian Pate and Vegetarian Sausage Extra Chewy Breakfast Style products bear a nutrient content claim as defined by 21 CFR 101.13(b)(1) because the product label makes a direct statement about the level of a nutrient in the food. Specifically, your product labels bear the statement "saturated fat free." However, these products do not meet the labeling requirements that are set forth in 21 CFR 101.62(c) for this nutrient content claim.
Under 21 CFR 101.62(c), to use the term "saturated fat free" a food must disclose the level of total fat in the food in immediate proximity to such claim each time the claim is made and in type that is no less than one-half the size of the type used for the claim. Declaration of total fat may be omitted when the food contains less than 0.5g of total fat per reference amount customarily consumed (RACC). Your Vegetarian Pate and Vegetarian Sausage Extra Chewy Breakfast Style products contain greater than 0.5g of total fat. Therefore, you must disclose the level of total fat in these products in immediate proximity to the "saturated fat free" claims.
Under 21 CFR 101.62(c)(1), to use the term "saturated fat free" a food must not contain any ingredient that is generally understood by consumers to contain saturated fat unless the listing of the ingredient in the ingredient statement is followed by an asterisk that refers to the statement below the list of ingredients which states, "adds a trivial amount of saturated fat," "adds a negligible amount of saturated fat," or "adds a dietarily insignificant amount of saturated fat. " Your Vegetarian Sausage Extra Chewy Breakfast Style product contains olive oil which is an added ingredient generally understood to contain saturated fat. Therefore, to use the term "saturated fat free" in association with this product, the amount of saturated fat added by olive oil must be trivial, negligible, or insignificant and the label must contain an appropriate statement, in accordance with the above referenced regulation.
Further, your products are also misbranded under section 403(q) of the Act [21 U.S.C. 343(q)] because the nutrition information on their labels does not comply with the requirements in FDA's regulations [21 CFR 101.9]. For example:
• The serving declaration for your Vegetarian Pate and Vegetarian Sausage Extra Chewy Breakfast Style products are not expressed in common household measure as required [21 CFR 101.9(b)(5)]. The serving size must be determined based on the RACC [21 CFR 101.12(b)]. For labeling purposes, the term common household measure means cup, tablespoon, teaspoon, piece, slice, fraction (e.g., 1/4 pizza), ounce (oz), fluid ounce (fl oz), or other common household equipment used to package food products (e.g., jar, tray).
• The labels for your Vegetarian Pate and Vegetarian Sausage Extra Chewy Breakfast Style products fail to contain information about the caloric content derived from total fat, a statement of the number of grams of trans fat, a statement of the number of grams of sugars, and a declaration of vitamin A, vitamin C, calcium and iron as a percent of the reference daily intake (RDI) in a serving of the products, as required by 21 CFR I01.9(c).
• Your Organic Tofu Extra Firm product does not contain a statement of the number of grams of trans fat in a serving or if a statement of the trans fat is not required, your product does not contain the statement "Not a significant source of trans fat" at the bottom of the table of nutrient values [21 CFR 101.9(c)(2)(ii)].
More information regarding trans fat labeling can be accessed on our website at http://www.fda.gov/Food/LabelingNutrition/Consumerlnformation/ucml09832.htm.
The above violations concern certain labeling requirements and are not meant to be an all-inclusive list of deficiencies on your labels. Other label violations can subject the food to legal action. It is your responsibility to ensure that all of your products are labeled in compliance with all applicable statues enforced by FDA. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action, including seizure and/or injunction without further notice.
In addition to the above violations, we also have several observations regarding your labeling:
• We note that your Organic Tofu Extra Firm product uses "and/or" labeling in a manner that appears to be inconsistent with 21 CFR 101.4(b). Your Organic Tofu Extra Firm product label declares "natural nigari, derived from sea water, and/or calcium chloride." We advise against using "and/or," unless nigari and calcium chloride are firming agents present in your product according to the conditions described in 101.4(b)(19) or fall within some other use of "and/or" authorized by 21 CFR 101.4(b).
• We also note that the nutrition facts information for your Vegetarian Pate, Vegetarian Sausage Extra Chewy Breakfast Style, and Organic Tofu Extra Firm products are not in the format required by 21 CFR 101.9(d). The products use a simplified format but do not appear to qualify for the use of the simplified format or the linear format. Based on 21 CFR 101.9(f), your Vegetarian Pate, Vegetarian Sausage Extra Chewy Breakfast Style, and Organic Tofu Extra Firm products do not qualify for the simplified format because they do not contain insignificant amounts of eight or more of the following: Calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium and iron. Your Vegetarian Pate and Vegetarian Sausage Extra Chewy Breakfast Style products are not qualified to display the Nutrition Facts panel in a linear fashion under 21 CFR 101.9(j)(13), because the package shape or size does not limit the use of a standard vertical column or tabular display on any label panel. You should ensure that the nutritional information on the labels for these products is displayed in accordance with FDA's labeling regulations.
• Your Vegetarian Pate product label contains a health claim ("Soluble fiber from whole oat flour, as part of a low saturated fat, low cholesterol diet, may reduce the risk of heart disease.") but does not comply with the labeling requirements to use this health claim. The health claim on your label does not specify the daily dietary intake of the soluble fiber source necessary to reduce the risk of coronary heart disease or the amount of soluble fiber in one serving of the product as required by 21 CFR 101.81.
FDA acknowledges receipt of your letter dated February 16, 2010. FDA reviewed your response and found it to be inadequate as your firm did not propose reasonable timeframes by which your labels would be revised to comply with all applicable statutory and regulatory requirements.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as copies of the new labels for the products that your firm manufactures and distributes, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the U.S. Food and Drug Administration, Attention: Anne Aberdeen, Compliance Officer, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have questions regarding any issues in this letter, please contact Ms. Aberdeen at (410) 779-5134.
Sincerely,
/s/
Evelyn Bonnin
District Director
Baltimore District
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