| Public Health Service Food and Drug Administration |
| San Francisco District 1431 Harbor Bay Parkway Alameda, CA 94501-7070 Telephone: (510) 337-6700 |
Department of Health and Human Services
November 3, 2011
VIA UPS
Mr. Vinh Vi Tat, Manager
Tan Hung Bakery
1038 Revere Avenue
San Francisco, CA 94124
WARNING LETTER
Dear Mr. Vinh Vi Tat,
The Food and Drug Administration (FDA) conducted an inspection on June 22nd through 28th, 2011 of your food manufacturing facility located at 1038 Revere Avenue, San Francisco, California. During the inspection, our investigator collected labels of your products. Based on our review, we have determined that your bread products 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 may find the Act and FDA regulations through links at FDA's home page at http://www.fda.gov
False or Misleading
Your "French Mini Bread" product is misbranded within the meaning of section 403(a)(l) of the Act [21 U.S.C. 343(a)(1)] in that the label is false or misleading. Specifically, the ingredient statement of this product includes "butter"; however, our investigators determined that butter is not used to manufacture this product.
Food Allergens
Your products, "Sweet Roll," "Sweet Raisin Bread;" "Sweet Dry Pork Bread," "French Mini Bread," "French Butter Small Breads," "Butter French Bread" and "French Small Bread" are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)]. Specifically, your product labels fail to identify the following major food allergens.
• "Sweet Roll"- eggs, milk (high heat milk solids, butter), wheat (enriched flour, bleached, enriched flour), soy (margarine)
• "Sweet Raisin Bread"- wheat (enriched flour, bleached enriched flour)
• "Sweet Dry Pork Bread"- wheat (enriched flour, bleached enriched flour, cooked dried pork)
• "French Mini Bread"- wheat (enriched flour, bleached enriched flour, dough conditioner), milk (high heat milk solids),
• "French Butter Small Bread"-wheat (enriched flour, bleached enriched flour, dough conditioner), milk (high heat milk solids, butter)
• "Butter French Bread" and "French Small Bread"- wheat (enriched flour, bleached enriched flour, dough conditioner), milk (high heat milk solids, butter)
If the soybean oil used to manufacture the "Sweet Raisin Bread" and "Sweet Dry Pork Bread" is not highly refined, the declaration of the soy allergen may be made as part of the name "soybean oil" in the ingredients statement. If the soybean oil is highly refined, then "soy" must be declared as part of the margarine and/or cooked dried pork sub-ingredients or within a "Contains" statement as described below.
Section 201(qq) of the Act [21 U.S.C. § 321(qq)] defines "major food allergens" as milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans; as well as any food ingredient containing protein derived from one of these foods, with the exception of highly refined oils. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient bearing or containing, a major food allergen, unless either:
(A) The word "contains," followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients [Section 403(w)(1)(A) of the Act; 21 U.S.C. § 343(w)(1)(A)]; or
(B) The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., "Enriched Flour (Wheat)"), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen) [Section 403(a)(1)(B) of the Act; 21 U.S.C. § 343(w)(1)(B)].
Common or Usual Name of Food
Your "French Butter Small Bread," "French Small Bread," "Mini French Bread," and "Sweet Roll" products are misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] because the labels fail to declare the common or usual name of the food in accordance with 21 CFR 101.3. Specifically,
• Your "French Butter Small Bread" and "French Small Bread" packages do not bear any information.
• You use the same "Sweet French Roll French Bread" label for your "Mini French Bread" and "Sweet Roll" products. These products have different names and formulations; therefore, the name "Sweet French Roll French Bread" is not an appropriately descriptive statement of identity for these unique products.
The following baked bread products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they are fabricated from two or more ingredients but the labels fail to list the common or usual name of each ingredient, in accordance with 21 CFR 101.4. For example:
1. Several of your product labels fail to list all of the ingredients contained in your products in accordance with 21 CFR 101.4. Specifically, the following products fail to declare the following ingredients:
• "Sweet Roll"- margarine, eggs, corn oil, high heat milk solids, imitation vanilla flavor
• "Sweet Raisin Bread"- butter, corn oil, imitation vanilla flavor, raisins
• "Sweet Dry Pork Bread"- butter, corn oil, imitation vanilla flavor
• "French Mini Bread".: high heat milk solids, dough conditioners
• "Butter French Bread"- high heat milk solids, dough conditioners
• "French Butter Small Bread"- bleached, enriched flour (b)(4) All-Purpose Flour Bleached · Enriched) enriched flour (b)(4) High Gluten Flour), salt, sugar, dry yeast, water, vegetable shortening, high heat milk solids, butter, and dough conditioners
• "French Small Bread" -bleached, enriched flour ( (b)(4) All-purpose Flour Bleached · Enriched) enriched flour (b)(4) High Gluten Flour), salt, sugar, dry yeast, water, vegetable shortening, high heat milk solids, and dough conditioners
2. Several of your products are made with multi-component ingredients; however, your labels fail to declare the sub-ingredients of these ingredients in accordance with 21 CFR 101.4(b)(2). Specifically, the following product labels fail to declare the sub-ingredients of the following multi-component ingredients:
• "Sweet Roll"-enriched flour, margarine, high heat milk solids
• "Sweet Raisin Bread"-enriched flour, margarine, high heat milk solids
• "Sweet Dry Pork Bread" -enriched flour, margarine, cooked dried pork, high heat milk solids
• "French Mini Bread" -enriched flour, high heat milk solids, dough conditioners
• "Butter French Bread"-enriched flour, high heat milk solids, dough conditioners
• "French Butter Small Bread" -bleached, enriched flour, enriched flour, high heat milk solids, dough conditioners
• "French Small Bread"- bleached, enriched flour; enriched flour, high heat milk solids, dough conditioners
The requirement to list component ingredients (or "sub-ingredients") may be met by either parenthetically listing the component ingredients after the common or usual name of the multi-component ingredient, or by listing the component ingredients without listing the multi-component ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food [21 CFR 101.4(b)(2)].
3. Your "Sweet Pork Bread" and "Sweet Raisin Bread" labels fail to declare an ingredient by the appropriate common or usual name in accordance with 21 CFR 101.4(a)(1). Based on our observations during the inspection, you are using (b)(4) High Heat Milk Solids in the production of these products; however, your ingredient statement declares "non-fat dry milk." Non-fat dry milk is an ingredient in high heat milk solids and is a standardized food in accordance with 21 CFR 131.125; therefore, non-fat dry milk is not an appropriate common or usual name for high heat milk solids.
Nutrition Labeling
Your "Sweet Roll" and "French Mini Bread" product labels are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] because the nutrition information does not comply with the requirements in 21 CFR 101.9. Specifically, the product labels do not include a statement of the number of grams of trans fat in a serving, as required by 21 CFR 101.9(c)(2)(ii). Additional information on trans fat labeling requirements can be found on our website at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/
FoodLabelingNutrition/ucm053479.htm
We note that you were granted a small business nutrition labeling exemption for your "Sweet Roll" and "French Mini Bread" products. However, in accordance with 21 CFR 101.9(j), this exemption only applies provided that the food bears no nutrition claims or other nutrition information in any context on the label or in labeling or advertising. Claims or other nutrition information subject the food to the provisions of 21 CFR 101.9. Both your "Sweet Roll" and "French Mini Bread" product labels bear nutrition information.
Your "French Small Bread," and "French Butter Small Bread" products are also misbranded within the meaning of section 403(e) of the Act [21 U.S.C. 343(e)] in that they fail to bear a label containing (1) the name and place of business of the manufacturer, packer, or distributor [21 CFR 101.5]; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count [21 CFR 101.105].
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your product labels to ensure that they do not violate the Act.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
We have the following comments about your product labels:
1. Your product labels declare the following as ingredients in your products; however, based on our observations and the information you provided during the inspection, your products do not actually contain these ingredients:
• Sweet Rolls- vegetable shortening
• Sweet Raisin Bread- soybean oil
• Sweet Dry Pork Bread- soybean oil
Your ingredients declarations must accurately reflect the ingredients in your products.
2. You use the same "Sweet French Roll French Bread" label for your "Mini French Bread" and "Sweet Roll" products. These products have different formulations; therefore, it is unlikely that the same nutrition facts panel would be accurate for both products.
3. The serving size in the Nutrition Facts panels of your "Sweet Roll" and "French Mini Bread" product labels is not declared in common household units. In accordance with 21 CFR 101.9(b)(5)(iv) a description of the individual unit shall be used for products in discrete units (e.g., piece, slice, cracker, bar). Your products are made in the form of rolls; however, your serving size declaration states "1¾ OZ (50g/1½ slice)."
4. The net quantity of contents declarations on your "Sweet Rolls," "French Mini Bread" and "Butter French Bread" labels are not placed on the principal display panel within the bottom 30 percent of the area of the label panel in lines generally parallel to the base on which the package rests as it is designed to be displayed [21 CFR 101.105(f)].
5. Your products, "Sweet Roll," "Sweet Raisin Bread," "Sweet Dry Pork Bread," "French Mini Bread," "French Butter Small Breads," "Butter French Bread" and "French Small Bread" fail to declare the term "net weight" in accordance with 21 CFR 101.1050)(3).
Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that corrective action has been achieved. If all corrective actions cannot be completed within fifteen working days, please state the reason for the delay and the time within which the corrections will be completed.
Your written response should be directed to Darlene Almogela, Director, Compliance Branch, U.S. Food and Drug Administration, San Francisco District, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding any issue in this letter, please contact Brandon L. Bridgman, Compliance Officer at 510-337-6794.
Sincerely,
/S/
Barbara J. Cassens
Director
San Francisco District
U.S. Food and Drug Administration
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