Inspections, Compliance, Enforcement, and Criminal Investigations
Pacific Northwest Tofu, LLC 3/23/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
March 23, 2012
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 12-17 - Amended
Tony Dinh, Owner
Pacific Northwest Tofu LLC
6113 NE 92nd Drive
Portland, Oregon 97220
AMENDED WARNING LETTER
Dear Mr. Dinh:
We are amending our Warning Letter for March 16, 2012, to correct minor errors with the content and formatting of the letter, and we are re-issuing the letter with a March 23, 2012, date. Your expected date of response is now extended to fifteen working days from your receipt of this letter.
On October 24, 2011, through November 14, 2011, the U.S. Food and Drug Administration (FDA) conducted an inspection of your tofu manufacturing operation located at 6113 NE 92nd Drive, Portland, Oregon. During this inspection, FDA investigators collected labels of your products. FDA’s review of these labels has determined that the Dae Han Tofu Company brand products described below are misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 343] and the applicable regulations in Title 21, Code of Federal Regulations, Part 101 [21 CFR Part 101]. You can find the Act and its implementing regulations on the Internet through links on FDA’s web page at www.fda.gov.
1. Nutrient Content Claims
Your Dae Han brand Soft Tofu Silken Style and Reduced Fat Tofu are misbranded within the meaning of section 403(r)(1)(A) of the Act, 21 U.S.C. 343(r)(1)(A), because the labeling for these products bears nutrient content claims that do not comply with the regulations governing the use of these claims. Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food may only be made (except in certain circumstances that do not apply here) if the characterization of the level made in the claim uses terms which are defined in FDA regulations. Specifically,
a. Your Dae Han brand Soft Tofu Silken Style product label bears the nutrient content claim “Low Calorie,” but the product does not meet the requirements to bear this claim. As required by 21 CFR 101.60(b)(2)(i)(A), for foods with a Reference Amount Customarily Consumed (RACC) greater than 30 grams, a food bearing a low calorie claim must not provide more than 40 calories per RACC. The RACC for tofu is 85 grams [21 CFR 101.12(b), Table 2]. Based on your label, an 80 gram serving of your product provides 50 calories. Therefore, your product does not qualify to bear a low calorie claim.
b. Your Dae Han brand Soft Tofu Silken Style product label bears the nutrient content claim "High Protein," but the product does not meet the requirements to bear this claim. As required by 21 CFR 101.54(b), a food bearing a high protein claim must contain 20 percent or more of the Daily Reference Value (a type of Daily Value) for protein per RACC. Your label states that an 80 gram serving of your product provides 10 percent of the Daily Value for protein. Based on this statement, an 85 gram serving (which represents the RACC for tofu, as discussed above) would be expected to contain approximately 11 percent of the Daily Value for protein. Therefore, your product does not qualify to bear a high protein claim.
c. Your Dae Han brand Reduced Fat Tofu product label bears the nutrient content claim "Reduced Fat," but the product does not meet the requirements to bear this claim. As required by 21 CFR 101.62(b)(4)(ii)(A), a label bearing a reduced fat claim must declare, in immediate proximity to the most prominent claim, the identity of the reference food and the percent or fraction that the fat differs between the two foods (e.g. “reduced fat-50 percent less fat than our regular tofu”). Furthermore, as required by 21 CFR 101.62(b)(4)(ii)(B), quantitative information comparing the level of fat in the product per labeled serving with that of the reference food that it replaces (e.g., "Fat content has been reduced from 6 g to 4 g per serving") must be declared adjacent to the most prominent claim or to the nutrition label, except that if the nutrition label is on the information panel, the quantitative information may be located elsewhere on the information panel in accordance with 21 CFR 101.2. Your label fails to bear this information. We also note the requirement in 21 CFR 101.62(b)(4)(i) that in order to bear a reduced fat claim, the food must contain at least 25 percent less fat per RACC than an appropriate reference food as described in 21 CFR 101.13(j)(1).
2. Nutrition Facts Information
Your Dae Han brand Soft Tofu Silken Style, Stir Fried Tofu, Reduced Fat Tofu and Kim Chee (Mild) products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not declared in accordance with 21 CFR 101.9. Specifically,
a. Your Dae Han brand Soft Tofu Silken Style, Stir Fried Tofu, and Reduced Fat Tofu labels fail to declare the amount of trans fat in a serving or if a statement of the trans fat is not required, your labels do not contain the statement “Not a significant source of trans fat” at the bottom of the table of nutrient values as required by 21 CFR 101.9(c)(2)(ii).
b. The serving size declared on your Dae Han brand Kim Chee (Mild) does not meet the requirements in 21 CFR 101.9(b)(2)(iii). The serving size for non-discrete bulk products shall be the amount in household measure that most closely approximates the reference amount for the product category. The RACC for Vegetables, Pickles, all types is 30 grams (21 CFR 101.12(b), Table 2). Your label incorrectly declares the serving size as “1 Tbsp (15g).” The nutrition values and servings per container information provided on the label of your product must be based on the correct serving size.
3. Manufacturer Information
Your Dae Han brand Soft Tofu Silken Style product label is misbranded within the meaning of section 403(e)(1) of the Act, 21 U.S.C. § 343(e)(1) in that the label does not contain an accurate statement of the place of business of the firm as required by 21 CFR 101.5(d). Specifically, your label provides an incorrect address for your firm.
You should take prompt action to correct the labeling violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action such as seizure and/or injunction without further notice.
We have the following comments about your labels:
i. Our investigators observed that you package tofu for distribution to restaurants in 5 gallon buckets bearing label information for soy sauce rather than tofu. These labels must bear accurate labeling in accordance with the requirements of 21 CFR Part 101 and section 403(w) of the Act [21 USC 343(w)].
ii. Your Dae Han brand Stir Fried Tofu and Reduced Fat Tofu labels declare the ingredient “nigari” (magnesium chloride); however, you told our investigators that you no longer use magnesium chloride in any of your tofu products. Your labels must accurately declare the ingredients in your products in accordance with 21 CFR 101.4(a).
iii. We note that your Dae Han brand Stir Fried Tofu label does not declare any type of fat or oil; however the product is identified as being fried. If this product is cooked in oil or another type of fat, it should be declared as an ingredient as required by 21 CFR 101.4.
iv. The net weight and serving size information on your Dae Han brand Soft Tofu Silken Style, Stir Fried Tofu, Reduced Fat Tofu and Kim Chee (mild) labels is inconsistent. The Soft Tofu product declares a net weight of 14 oz. (397 g), but the serving size information states that there are four 80 gram servings per container, which equates to 240 grams of product. Your Stir Fried and Reduced Fat products declare a net weight of 16 oz. (453 g), but the serving size information states that there are two 85 gram servings per container, which equates to 170 grams of product. Your Kim Chee (mild) product declares a net weight of 16 oz. (453.59 g) but the serving size information states that there are 22, 15 gram servings per container, which would result in 330 grams of product.
v. The serving sizes on your products labels are not declared properly. Specifically,
1. Your Dae Han brand Stir Fried Tofu and Reduced Fat Tofu labels fail to express the serving size in a common household measure [21 CFR 101.9(b)(1)].
2. When declaring household measure in terms of ounces, the declaration must include an appropriate visual unit of measure [21 CFR 101.9(b)(5)(iii)]. Your Dae Han brand Soft Tofu Silken Style declares serving size as “3 oz (80 g),” but fails to provide an appropriate visual unit of measure.
vi. The nutrition information on your Dae Han brand Stir Fried Tofu and Reduced Fat Tofu labels do not meet the formatting requirements in 21 CFR 101.9(d). For example, the headings and nutrient names are not bolded or indented properly; bars and hairlines are missing; nutrient information is not aligned properly; address information for the firm is included within the box; and the percent daily value footnote is declared outside of the box.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to Farhana Khan, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington 98021-4426. If you have any questions about this letter, please contact Compliance Officer Khan at 425-483-4968.
Charles M. Breen