IA #99-20, 11/14/94, DETENTION WITHOUT PHYSICAL EXAMINATION OF IMPORTED FOOD PRODUCTS DUE TO NLEA VIOLATIONS, 5/24/04 TYPE OF ALERT: DETENTION WITHOUT PHYSICAL EXAMINATION PRODUCT : See Attachment PRODUCT CODE : All Food Product Codes HARMONIZED CODES : Multiple PROBLEM : NLEA Violations (Labeling; Nutrition Information; Health Claims) (MLLM) PAC FOR COLLECTION : 21007 COUNTRY : See Attachment MANUFACTURER/ SHIPPER : See Attachment MANUFACTURER/ SHIPPER I.D.#: See Attachment IMPORTER'S I.D. # : N/A CHARGE :"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts panel) [Misbranded, Section 403 (q)]". And/Or "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling bears an unauthorized nutrient content/health claim (specify) [Misbranded, Section 403(r)(1)(A)/(B)]". And/Or "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded within the meaning of Section 403 in that the label or labeling fails to bear required information (specify, e.g. common or usual name of each ingredient in a standardized food, percent of juice, names of certified colors) [Misbranded, Section 403(i)(2)]". RECOMMENDING OFFICE : CFSAN/OFP/DPPE/Import Programs Branch, HFS-637 REASON FOR ALERT : The Nutritional Labeling and Education Act (NLEA) of 1990 provided FDA with specific authority to require nutrition labeling of most foods regulated by the Agency, both import and domestic, and to require that all nutrient content claims (e.g., "high fiber", "low fat", etc.) and health claims be made consistent with the Agency regulations. Regulations implementing the NLEA labeling provision issued on January 6, 1993. The regulations became effective for health claims and ingredient declarations on May 8, 1993, and became effective for nutrition labeling and other provisions on May 8, 1994. On March 21, 1994, letters were sent to the foreign embassies advising them about the May 8, 1994 effective date for nutrition labeling and the small business exemption provisions. NOTE: Effective date of the regulation was subsequently postponed from May 8, 1994 until August 8, 1994. In conjunction with the guidance in this import alert, the Nutrition Labeling of Imported Foods assignment, which instructs the field to perform label exams on imported foods, began September 19, 1994. This alert will track manufacturer/product/container size (net weight or fluid measure) combinations subject to automatic detention because of NLEA violations. INSTRUCTIONS : The manufacturer/product/container size combinations listed in the Attachment are subject to DWPE. The first time a specific product from a foreign manufacturer/shipper is found to be in violation, districts should issue a Release Notice With Comments in accordance with the instructions listed in the assignment. If the same product from the same manufacturer/shipper is found to be in violation 60 or more days after the initial Release with Comment has been issued, a recommendation for detention should be made in accordance with the assignment. Once a detention has been approved, the manufacturer/shipper and product will be added by CFSAN to the Attachment of this import alert and will be subject to the automatic detention guidance. PRIORITIZATION GUIDANCE : I FOI : No purging is required KEYWORDS : NLEA, labeling, nutrition, labeling violations, misbranded PREPARED BY : David Egelhofer, Import Programs Branch, HFS-637, 202-205-4606; and Linda Wisniowski, DIOP, 301-443-6553 ATTACHMENT - FIRMS ON DWPE DUE TO NLEA VIOLATIONS 5/24/04 BRAZIL (BR) FIRM NAME PRODUCT/PRODUCT CODE VIOLATION Bauducco & Cia, Ltd Cake W/Chocolate Chips Product is misbranded Rau Endres 191 03R[][]01 within the meaning of Guarulhos, 03R[][]99 Section 403(a) in that San Paulo 03/9/04 its labeling is false. Brazil Label declares a 70 g FEI# 1000215702 serving contains 11 g of fat, analysis found 14.8 g of fat per 70 g serving CANADA (CA) Sunny Crunch Body Zone Choco Crisp Product is misbranded Foods Ltd. Nutrition Bar within the meaning of 310 Steelcase Rd.East 41E- - 99 Section 403(a) in that Markham, Canada 10/1/03 the labeling is false. FEI # 3000233223 Specifically the Calcium levels found Were 78.4% and 76.8% of the label declaration. Double Berry Soy Product is misbranded Protein Supplement within the meaning of Bar Section 403(a) in that 41E[][]99 the labeling is false. 3/22/04 Specifically the Potassium levels found Were 62% of the label declaration. GREECE, GR Franca S.A. Fat Free Garlic label bears the P.O. Box 46010 Bagel Chips claim "fat free" 133 41A Liossia 07A--99 but the product Athens, Greece fails to meet the FEI# 1000559895 requirements for the claim INDIA (IN) FIRM NAME PRODUCT/PRODUCT CODE VIOLATION Britannia Industries, Ltd. Jacob's Thin Arrowroot Product is misbranded under 5/1A Hungerford Street Biscuits(Britannia Brand) Sec. 403(i)(2)labeling fails Kolkata 700017 03F[][]99 03H[][]08 to bear an ingredient statement India 03H[][]01 03H[][]99 that lists the common or usual FEI# 3004323793 05/24/04 name of all ingredients, i.e. milk and milk products, dough SHIPPER conditioner, permitted color, antioxidant, edible vegetable Tastel oils and edible starches are 2, Veena Vihar not listed by their common or Dayal Das Road usual names and the sub-ingre- Vile-parle East dients are not listed; product Mumbai 400057 is further misbranded because India label does not bear nutrition FEI# 3004257599 information in the proper format. Vita Maria Gold Biscuits Product is misbranded under (Britannia Brand) Sec. 403(i)(2) labeling fails to 03F[][]99 03H[][]08 bear an ingredient statement 03H[][]01 03H[][]99 that lists the common or usual 05/24/04 name of all ingredients, i.e. milk and milk products, dough condit- ioner, permitted color, antioxidant and edible vegetable oils are not listed by their common or usual names and the subingredients are not liste d; Tropicana World Kerala Fish Curry Sauce Product is subject to Trade Pvt. Ltd. 16Y[][]03 refusal of admission 16/453 Thoppumpady 16Y[][]09 pursuant to Section 801 Cochin, India 16Y[][]17 (a)(3) in that it FEI# 3002971130 16Y[][]99 appears to be 37J[][]05 misbranded in that the 37J[][]23 declared value for 37J[][]99 sodium in the Nutrition 37J[][]05 Facts label does not 3/31/04 meet the compliance requirements of 21 CFR 101.9)g)(5) . Label declares a 65 g serving contains 240 mg of sodium, analysis found 145% of the declared amount of sodium on original analysis and 155% on check analysis. MEXICO, MX FIRM: PRODUCT/ DATE OF PRODUCT CODE DWPE VIOLATION Agroindustrias Deander Jalapeno Peppers, The product's label de Delicias, S.A. de C.V. sliced in #10 cans fails to bear nutrition RFC AID-891 221-HT4 (102 oz.) information as required Carretera Delicias- 24F-E08 by Section 403 (q) of Naica Km.6 24F-I08 the FD&C; Act and 21 CFR Cd. Delicias 5/5/03 101.9 and is not exempt Chihuahua, Mexico CP 33000 under 403(q)(5) of the FEI #1000269734 Act. Dulces Mexicanos Coconut Candy Rolls 4/4/00 Total and Sat. Fat Revolucion #14 Sta. 33H[][]99 Labeled as 0% Cruz de las Huertas Product assayed Tonala, Jalisco, Mexico 7.45 and 6.35gms FEI #3000260709 respectively per Serving Salud Natural ActiKrol brand Glutamic 3/27/03 Label does not bear Mexicano SA de CV Acid Syrup for Children nutrition labeling Av. Inglaterra 3109 54C- - 07 (i.e. supplement facts Col. Arcos Sur Dinamax Jr., a liquid labels) as required Guadalajara, Mexico vitamin supplement under Section FEI # 3002616922 54A- -99 403(q)(5)(F) 54Y- -99 of the Act and 1CFR101.36 Salud Natural Caltron 600 + D 4/16/03 Product is misbranded Mexicano SA de CV calcium supplement because it is not Av. Inglaterra 3109 54B- - 01 labeled as required under Col. Arcos Sur Section 403(q)(5)(F) Guadalajara, Mexico and 21 CFR 101.36 FEI # 3002616922 THAILAND, TH Thai Agri Foods Public Guava drink/21V--04 07/25/01 Misdeclaration of Company, Ltd. Tamarind drink/21V--14 iron and 155/1 Moo 1 Theparak Rd. failure to declare Bangsaothong, Samutprakarn total percentage 10540 Thailand of fruit juice FEI # 3002809249 contained in the product