Inspections, Compliance, Enforcement, and Criminal Investigations
Dae Han Tofu Company 11-May-06
Department of Health and Human Services
Public Health Service
May 11, 2006
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 06-29
Calvin S. Chun, Owner
Dae Han Tofu Company
3340 NW Yeon Avenue, Suite 16
Portland, OR 97210
Dear Mr. Chun:
On January 9-10, 2006, an investigator from the Food and Drug Administration (FDA) visited your firm located at 3340 NW Yeon Avenue, Suite 16, Portland, Oregon. The investigator collected a sample of your Organic Soft Tofu with manufacturing code "USE BY MAR 18" along with labeling from some of your other tofu varieties. FDA reviewed the product labeling, analyzed the sample, and found serious violations of Section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 343] and FDA's food labeling regulations (21 CFR Part 101- Food Labeling). You can find the Act and the food labeling regulations through links on FDA's web page at www.fda.gov.
FDA analyzed the sample of your Organic Soft Tofu product to determine whether the information in the Nutrition Facts panel accurately reflects the nutrient content of the product. The product label states that one serving (3 oz.) contains 6 grams of protein. Our analysis of this product found 3 .6 grams of protein per serving, which is 61% of the amount declared on the label. A check analysis found 3 .8 grams of protein per serving, which is 64% of the labeled amount. Therefore, your product is misbranded under section 403(a)(1) of the Act [21 U.S .C. § 343(a)(1)] in that the product label is false and misleading because the amount of protein present is less than 80 percent of the value declared on the label [see CFR 101.9(g)(4)(ii)].
Additionally, we reviewed the labels for your Organic Soft Tofu, Organic Regular Tofu, Reduced Fat Tofu, Gourmet Firm Tofu, and Hot-N-Spicy Tofu. These products are misbranded under section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because they do not meet the requirements for some of their labeled nutrient content claims, as follows:
Your Organic Soft Tofu, Organic Regular Tofu, Reduced Fat Tofu, Gourmet Firm Tofu, and Hot-N-Spicy Tofu products are misbranded because the product labels include the claim "Low Calorie," but the products do not meet the criteria for this claim set out in 21 CFR 101.60(b)(2)(i)(A). According to the regulation, for foods with a RACC (Reference Amount Customarily Consumed) greater than 30 grams, the food must not provide more than 40 calories per RACC in order to make a "low calorie" claim. The RACC for tofu is 85 grams [21 CFR 101.12(b)]. The serving sizes on your products are either equal to or less than the RACC for tofu, and are labeled to contain greater than 40 calories per serving as follows: Organic Soft Tofu, labeled to contain 50 calories per 80 gram serving; Organic Regular Tofu, labeled to contain 70 calories per 80 gram serving; Reduced Fat Tofu, labeled to contain 100 calories per 85 gram serving; Gourmet Firm Tofu, labeled to contain 110 calories per 85 gram serving; and Hot-N-Spicy Tofu, labeled to contain 160 calories per 85 gram serving.
Your Organic Soft Tofu and Regular Organic Tofu products are misbranded because the product labels include "High Protein" claims, but the products do not meet the criteria for this claim set out in 21 CFR 101.54(b). In order to declare "High Protein," a food must contain 20 percent or more of the Daily Reference Value (DRV) of protein per RACC; the RACC for tofu is 85 grams, and the DRV for protein is 50 grams [21 CFR 101.9(c)(9)]. According to the Nutrition Facts panel information, your Organic Soft Tofu has only 10% of the DRV for protein per 80 gram serving, and your Regular Organic Tofu has only 15% of the DRV for protein per 80 gram serving. Based on our calculations, neither of these products meets the 20 percent requirement per RACC to claim "High Protein" on the product labels.
Your Reduced Fat Tofu contains a "Reduced Fat" claim as part of its statement of identity but fails to comply with the requirements of 21 CFR 101.62(b)(4). The label states that it contains "30% Less Fat Than Our Gourmet Firm Tofu" on the principal display panel, but that statement must be adjacent to the most prominent claim [see 21 CFR 101.13(j)(2)(iii)] or to the nutrition label [21 CFR 101.62(b)(4)(ii)]. Furthermore, for such relative claims about fat content, the label must also declare adjacent to the most prominent claim or to the nutrition label quantitative information comparing the amount of fat in the product per serving with the amount of fat in the reference food that it replaces (for example, "Fat content has been reduced from 6 g to 4 g per serving"). Your label fails to declare quantitative information comparing the level of fat in the product per labeled serving with that of the reference food that it replaces, as required by 21 CFR 101.62(b)(4)(ii)(B).
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.
Please respond in writing within three (3) weeks from your receipt of this letter, as to the specific steps being taken to correct these violations and prevent the recurrence of similar violations. Include any documentation necessary to show that correction has been achieved. 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 deviations.
In addition to the violations described above, FDA has the following comments concerning the labeling of your products:
According to FDA's food labeling regulations, ingredients required to be declared on the label or labeling of a food shall be listed by common or usual name and without intervening material [21 CFR 101.2(e) and 141.4(a)(1)]. For example, statements such as those made in the ingredient list of your Organic Regular Tofu label (i.e., "grown and processed in accordance with Section 26569.11 of the California Health and Safety Code," referring to the soybean ingredient) are not part of the common or usual name of the ingredient to which they refer; rather, they are considered intervening material and should not be included as part of the ingredient statement. We suggest that you review the labeling of all your tofu products to ensure that their ingredient statements comply with the applicable FDA regulations.
Your Organic Soft Tofu, Organic Regular Tofu, Reduced Fat Tofu, Gourmet Firm Tofu, and Hot-N-Spicy Tofu include the claim "Cholesterol Free" on their labels . According to 21 CFR 101.62(d)(1)(i)(D), if a food (e.g., tofu) contains less than 2 mg of cholesterol per RACC without the benefit of special processing, alteration, formulation, or reformulation to lower cholesterol content, and if a cholesterol content claim is made, the label claim must disclose that cholesterol is not usually present in the food (e.g., "tofu, a cholesterol-free food").
We also note the following from the Nutrition Facts panel of your tofu products:
The label for your Organic Regular Tofu fails to declare the number of grams of protein per serving as required under 21 CFR 101.9(c)(7), and the labels for your Reduced Fat Tofu, Gourmet Firm Tofu and Hot-N-Spicy Tofu fail to declare the percent daily value of protein on their labels as required under 21 CFR 101.9(c)(7)(i) when a claim about protein content is made.
The labels for your Organic Soft Tofu and Organic Regular Tofu incorrectly declare the amount of sodium per serving in grams rather than in milligrams as required under 21 CFR 101.9(c)(4).
On your Reduced Fat Tofu, Gourmet Firm Tofu, and Hot-N-Spicy Tofu products, "cholesterol" is misspelled.
Furthermore, we recommend that you review the Nutrition Facts panel labeling format requirements in 21 CFR 101.9(d) to ensure that your products comply.
This letter does not represent a comprehensive review of all of the products distributed by your firm, nor does it represent a complete review of all nutrient content claims and other product labeling. You must ensure all products distributed by your firm comply with the Act and its implementing regulations. 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