GEREZGHER AMARE DESTA · 99-39 · ETHIOPIA

Product code, Product and FDA notes

22 G - - 99 Other Fruit and Fruit Products, N.E.C. Date Published: 02/04/2025 Desc: BULA (ETHIOPIAN BALTNA BULA) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(a)(1) of the FD&C Act [21 U.S.C. § 343(a)] because the statement of “3 servings per container (75g),” is not correct when the Net Weight of the package is declared as “500gm.” Section 403(f) of the FD&C Act [21 U.S.C. § 343(f)] because the labels bear a foreign language, as such, all mandatory label information must be provided for in both the foreign language and English as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the FD&C Act [21 U.S.C. §343(i)(1)] because the statements of identity on the labels are not appropriately descriptive in accordance with 21 CFR 101.3(b). Section 403(q) of the FD&C Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) is not in a correct format as required by 21 CFR 101.9. 24 B - - 22 Mixed bean/seed sprouts, Dried or Paste Date Published: 02/04/2025 Desc: HELBET POWDER (ETHIOPIAN BALTNA HILBET FLOUR) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the FD&C Act [21 U.S.C. § 343(f)] because the labels bear a foreign language, as such, all mandatory label information must be provided for in both the foreign language and English as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the FD&C Act [21 U.S.C. §343(i)(1)] because the statements of identity on the labels are not appropriately descriptive in accordance with 21 CFR 101.3(b). Section 403(q) of the FD&C Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) is not in a correct format as required by 21 CFR 101.9. 25 L - - 99 Root & Tuber Vegetable, Dried or Paste, N.E.C. Date Published: 02/04/2025 Desc: BULA (ETHIOPIAN BALTNA BULA) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(a)(1) of the FD&C Act [21 U.S.C. § 343(a)] because the statement of “3 servings per container (75g),” is not correct when the Net Weight of the package is declared as “500gm.” Section 403(f) of the FD&C Act [21 U.S.C. § 343(f)] because the labels bear a foreign language, as such, all mandatory label information must be provided for in both the foreign language and English as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the FD&C Act [21 U.S.C. §343(i)(1)] because the statements of identity on the labels are not appropriately descriptive in accordance with 21 CFR 101.3(b). Section 403(q) of the FD&C Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) is not in a correct format as required by 21 CFR 101.9. 28 F - - 99 Mixed Spice and Seasonings, Ground, Cracked, without Salt, N.E.C. Date Published: 02/04/2025 Desc: BERBERE (ETHIOPIAN BALTNA SPICED PEPPER) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the FD&C Act [21 U.S.C. § 343(f)] because the labels bear a foreign language, as such, all mandatory label information must be provided for in both the foreign language and English as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the FD&C Act [21 U.S.C. §343(i)(1)] because the statements of identity on the labels are not appropriately descriptive in accordance with 21 CFR 101.3(b). Section 403(q) of the FD&C Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) is not in a correct format as required by 21 CFR 101.9. 28 F - - 99 Mixed Spice and Seasonings, Ground, Cracked, without Salt, N.E.C. Date Published: 02/04/2025 Desc: BEKLE (ETHIOPIAN BALTNA BARELY MALT POWDER) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the FD&C Act [21 U.S.C. § 343(f)] because the labels bear a foreign language, as such, all mandatory label information must be provided for in both the foreign language and English as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the FD&C Act [21 U.S.C. §343(i)(1)] because the statements of identity on the labels are not appropriately descriptive in accordance with 21 CFR 101.3(b). Section 403(q) of the FD&C Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) is not in a correct format as required by 21 CFR 101.9. 38 C - - 28 Mixed Vegetable Soup, Dried Date Published: 02/04/2025 Desc: METEN SHERO (ETHIOPIAN BALTNA SHIRO) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the FD&C Act [21 U.S.C. § 343(f)] because the labels bear a foreign language, as such, all mandatory label information must be provided for in both the foreign language and English as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the FD&C Act [21 U.S.C. §343(i)(1)] because the statements of identity on the labels are not appropriately descriptive in accordance with 21 CFR 101.3(b). Section 403(q) of the FD&C Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) is not in a correct format as required by 21 CFR 101.9. 38 C - - 28 Mixed Vegetable Soup, Dried Date Published: 02/04/2025 Desc: ATMITE EHILE (ETHIOPIAN BALTNA GRUEL) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the FD&C Act [21 U.S.C. § 343(f)] because the labels bear a foreign language, as such, all mandatory label information must be provided for in both the foreign language and English as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the FD&C Act [21 U.S.C. §343(i)(1)] because the statements of identity on the labels are not appropriately descriptive in accordance with 21 CFR 101.3(b). Section 403(q) of the FD&C Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) is not in a correct format as required by 21 CFR 101.9. 38 C - - 99 Dried Soup, N.E.C. Date Published: 02/04/2025 Desc: METEN SHERO (ETHIOPIAN BALTNA SHIRO) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the FD&C Act [21 U.S.C. § 343(f)] because the labels bear a foreign language, as such, all mandatory label information must be provided for in both the foreign language and English as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the FD&C Act [21 U.S.C. §343(i)(1)] because the statements of identity on the labels are not appropriately descriptive in accordance with 21 CFR 101.3(b). Section 403(q) of the FD&C Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) is not in a correct format as required by 21 CFR 101.9. 38 C - - 99 Dried Soup, N.E.C. Date Published: 02/04/2025 Desc: ATMITE EHILE (ETHIOPIAN BALTNA GRUEL) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the FD&C Act [21 U.S.C. § 343(f)] because the labels bear a foreign language, as such, all mandatory label information must be provided for in both the foreign language and English as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the FD&C Act [21 U.S.C. §343(i)(1)] because the statements of identity on the labels are not appropriately descriptive in accordance with 21 CFR 101.3(b). Section 403(q) of the FD&C Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) is not in a correct format as required by 21 CFR 101.9. 54 F - - 40 Buckthorn (Herbal & Botanicals, not Teas) Date Published: 02/04/2025 Desc: BUCKTHORN POWDER (ETHIOPIAN BALTNA BUCKTHORN POWDER) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appear to be misbranded within the meaning of: Section 403(f) of the FD&C Act [21 U.S.C. § 343(f)] because the labels bear a foreign language, as such, all mandatory label information must be provided for in both the foreign language and English as required by 21 CFR 101.15(c)(2). Section 403(i)(1) of the FD&C Act [21 U.S.C. §343(i)(1)] because the statements of identity on the labels are not appropriately descriptive in accordance with 21 CFR 101.3(b). Section 403(q) of the FD&C Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) is not in a correct format as required by 21 CFR 101.9.