E.M.B YARDEN AGRICULTURAL FARM LTD · 99-39 · ISRAEL
For E.M.B YARDEN AGRICULTURAL FARM LTD · 99-39 · ISRAEL, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is ISRAEL; product is DIGESTLIVE capsules Dietary Supplement | DIGESTLIVE capsules Dietary Supplement | DIGESTLIVE capsules Dietary Supplement | DIGESTLIVE capsules Dietary Supplement | DIGESTLIVE capsules Dietary Supplement | DIGESTLIVE capsules Dietary Supplement; product code is 28 N - - 99 Raw Material for Extracts and Flavors, N.E.C. | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 54 F - - 94 Ashwagandha (Herbal & Botanicals, not Teas) | 54 K - - 08 Aloe (Herbal and Botanical (not teas) II (continued)) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C; date published is 12/17/2024; address is 1, Ha-Oman , Beit Shemesh, Hamerkaz ISRAEL, verified against its source on 2026-09-16.
- Firm
- E.M.B YARDEN AGRICULTURAL FARM LTD verified
- Import alert
- 99-39
- Import alert name
- Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- Country
- ISRAEL verified
- Address
- 1, Ha-Oman , Beit Shemesh, Hamerkaz ISRAEL verified
- Date published
- 12/17/2024 verified
- Product code
- 28 N - - 99 Raw Material for Extracts and Flavors, N.E.C. | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 54 F - - 94 Ashwagandha (Herbal & Botanicals, not Teas) | 54 K - - 08 Aloe (Herbal and Botanical (not teas) II (continued)) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. each item verified
- Product
- DIGESTLIVE capsules Dietary Supplement | DIGESTLIVE capsules Dietary Supplement | DIGESTLIVE capsules Dietary Supplement | DIGESTLIVE capsules Dietary Supplement | DIGESTLIVE capsules Dietary Supplement | DIGESTLIVE capsules Dietary Supplement each item verified
- FDA notes
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)(1)(A)]. Serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The product label declares a serving size of “2 Vegan Capsules.” However, the “Suggested Use” instructions state “Take two (2) capsules as needed, up to six (6) capsules daily. Results within 12-24 hours”. Section 403(i)(2) of the Act [21 U.S.C. § 343 (i)(2)] in that each product is fabricated from two or more ingredients, and each ingredient is not declared on the label by the common or usual name, in accordance with 21 CFR 101.4 and 21 CFR 101.36. Product is manufactured into capsules, but the product label fails to list the ingredients used to form the capsules. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)(1)(A)]. Serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The product label declares a serving size of “2 Vegan Capsules.” However, the “Suggested Use” instructions state “Take two (2) capsules as needed, up to six (6) capsules daily. Results within 12-24 hours”. Section 403(i)(2) of the Act [21 U.S.C. § 343 (i)(2)] in that each product is fabricated from two or more ingredients, and each ingredient is not declared on the label by the common or usual name, in accordance with 21 CFR 101.4 and 21 CFR 101.36. Product is manufactured into capsules, but the product label fails to list the ingredients used to form the capsules. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)(1)(A)]. Serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The product label declares a serving size of “2 Vegan Capsules.” However, the “Suggested Use” instructions state “Take two (2) capsules as needed, up to six (6) capsules daily. Results within 12-24 hours”. Section 403(i)(2) of the Act [21 U.S.C. § 343 (i)(2)] in that each product is fabricated from two or more ingredients, and each ingredient is not declared on the label by the common or usual name, in accordance with 21 CFR 101.4 and 21 CFR 101.36. Product is manufactured into capsules, but the product label fails to list the ingredients used to form the capsules. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)(1)(A)]. Serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The product label declares a serving size of “2 Vegan Capsules.” However, the “Suggested Use” instructions state “Take two (2) capsules as needed, up to six (6) capsules daily. Results within 12-24 hours”. Section 403(i)(2) of the Act [21 U.S.C. § 343 (i)(2)] in that each product is fabricated from two or more ingredients, and each ingredient is not declared on the label by the common or usual name, in accordance with 21 CFR 101.4 and 21 CFR 101.36. Product is manufactured into capsules, but the product label fails to list the ingredients used to form the capsules. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)(1)(A)]. Serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The product label declares a serving size of “2 Vegan Capsules.” However, the “Suggested Use” instructions state “Take two (2) capsules as needed, up to six (6) capsules daily. Results within 12-24 hours”. Section 403(i)(2) of the Act [21 U.S.C. § 343 (i)(2)] in that each product is fabricated from two or more ingredients, and each ingredient is not declared on the label by the common or usual name, in accordance with 21 CFR 101.4 and 21 CFR 101.36. Product is manufactured into capsules, but the product label fails to list the ingredients used to form the capsules. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)(1)(A)]. Serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The product label declares a serving size of “2 Vegan Capsules.” However, the “Suggested Use” instructions state “Take two (2) capsules as needed, up to six (6) capsules daily. Results within 12-24 hours”. Section 403(i)(2) of the Act [21 U.S.C. § 343 (i)(2)] in that each product is fabricated from two or more ingredients, and each ingredient is not declared on the label by the common or usual name, in accordance with 21 CFR 101.4 and 21 CFR 101.36. Product is manufactured into capsules, but the product label fails to list the ingredients used to form the capsules. each item verified
What the source says
E.M.B YARDEN AGRICULTURAL FARM LTD Date Published : 12/17/2024 1, Ha-Oman , Beit Shemesh, Hamerkaz ISRAEL 28 N - - 99 Raw Material for Extracts and Flavors, N.E.C. Date Published: 12/17/2024 Desc: DIGESTLIVE capsules Dietary Supplement Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)(1)(A)]. Serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The product label declares a serving size of “2 Vegan Capsules.” However, the “Suggested Use” instructions state “Take two (2) capsules as needed, up to six (6) capsules daily. Results within 12-24 hours”. Section 403(i)(2) of the Act [21 U.S.C. § 343 (i)(2)] in that each product is fabricated from two or more ingredients, and each ingredient is not declared on the label by the common or usual name, in accordance with 21 CFR 101.4 and 21 CFR 101.36. Product is manufactured into capsules, but the product label fails to list the ingredients used to form the capsules. 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 12/17/2024 Desc: DIGESTLIVE capsules Dietary Supplement Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)(1)(A)]. Serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The product label declares a serving size of “2 Vegan Capsules.” However, the “Suggested Use” instructions state “Take two (2) capsules as needed, up to six (6) capsules daily. Results within 12-24 hours”. Section 403(i)(2) of the Act [21 U.S.C. § 343 (i)(2)] in that each product is fabricated from two or more ingredients, and each ingredient is not declared on the label by the common or usual name, in accordance with 21 CFR 101.4 and 21 CFR 101.36. Product is manufactured into capsules, but the product label fails to list the ingredients used to form the capsules. 41 Y - - 99 Dietary Conventional Foods, N.E.C. Date Published: 12/17/2024 Desc: DIGESTLIVE capsules Dietary Supplement Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)(1)(A)]. Serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The product label declares a serving size of “2 Vegan Capsules.” However, the “Suggested Use” instructions state “Take two (2) capsules as needed, up to six (6) capsules daily. Results within 12-24 hours”. Section 403(i)(2) of the Act [21 U.S.C. § 343 (i)(2)] in that each product is fabricated from two or more ingredients, and each ingredient is not declared on the label by the common or usual name, in accordance with 21 CFR 101.4 and 21 CFR 101.36. Product is manufactured into capsules, but the product label fails to list the ingredients used to form the capsules. 54 F - - 94 Ashwagandha (Herbal & Botanicals, not Teas) Date Published: 12/17/2024 Desc: DIGESTLIVE capsules Dietary Supplement Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)(1)(A)]. Serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The product label declares a serving size of “2 Vegan Capsules.” However, the “Suggested Use” instructions state “Take two (2) capsules as needed, up to six (6) capsules daily. Results within 12-24 hours”. Section 403(i)(2) of the Act [21 U.S.C. § 343 (i)(2)] in that each product is fabricated from two or more ingredients, and each ingredient is not declared on the label by the common or usual name, in accordance with 21 CFR 101.4 and 21 CFR 101.36. Product is manufactured into capsules, but the product label fails to list the ingredients used to form the capsules. 54 K - - 08 Aloe (Herbal and Botanical (not teas) II (continued)) Date Published: 12/17/2024 Desc: DIGESTLIVE capsules Dietary Supplement Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)(1)(A)]. Serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The product label declares a serving size of “2 Vegan Capsules.” However, the “Suggested Use” instructions state “Take two (2) capsules as needed, up to six (6) capsules daily. Results within 12-24 hours”. Section 403(i)(2) of the Act [21 U.S.C. § 343 (i)(2)] in that each product is fabricated from two or more ingredients, and each ingredient is not declared on the label by the common or usual name, in accordance with 21 CFR 101.4 and 21 CFR 101.36. Product is manufactured into capsules, but the product label fails to list the ingredients used to form the capsules. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 12/17/2024 Desc: DIGESTLIVE capsules Dietary Supplement Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(q) of the Act [21 U.S.C. 343(q)(1)(A)]. Serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The product label declares a serving size of “2 Vegan Capsules.” However, the “Suggested Use” instructions state “Take two (2) capsules as needed, up to six (6) capsules daily. Results within 12-24 hours”. Section 403(i)(2) of the Act [21 U.S.C. § 343 (i)(2)] in that each product is fabricated from two or more ingredients, and each ingredient is not declared on the label by the common or usual name, in accordance with 21 CFR 101.4 and 21 CFR 101.36. Product is manufactured into capsules, but the product label fails to list the ingredients used to form the capsules.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html
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