Ancient Greenfields · 99-39 · INDIA
For Ancient Greenfields · 99-39 · INDIA, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is INDIA; product is Ashwagandha Powder | Moringa Capsule | Ashwagandha Powder | Moringa Capsule | Moringa Capsule | Moringa Capsule; product code is 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 54 A - - 99 Vitamin, N.E.C. | 54 F - - 94 Ashwagandha (Herbal & Botanicals, not Teas) | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 J - - 10 Moringa Oleifera (Herbal and Botanical Teas II, (continued) | 54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd; date published is 02/28/2018; address is 4/159-A2, Vadavalli to Kanuvai Road , Kalappanaickenpalayam , Coimbatore, Tamil Nadu INDIA, verified against its source on 2026-09-16.
- Firm
- Ancient Greenfields verified
- Import alert
- 99-39
- Import alert name
- Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- Country
- INDIA verified
- Address
- 4/159-A2, Vadavalli to Kanuvai Road , Kalappanaickenpalayam , Coimbatore, Tamil Nadu INDIA verified
- Date published
- 02/28/2018 verified
- Product code
- 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 54 A - - 99 Vitamin, N.E.C. | 54 F - - 94 Ashwagandha (Herbal & Botanicals, not Teas) | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 J - - 10 Moringa Oleifera (Herbal and Botanical Teas II, (continued) | 54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd each item verified
- Product
- Ashwagandha Powder | Moringa Capsule | Ashwagandha Powder | Moringa Capsule | Moringa Capsule | Moringa Capsule each item verified
- FDA notes
- 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(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. “Domestic address or domestic phone number” means a complete address or phone number. The label for this product does not include a complete address or phone number. Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)) in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. For example, the product label declares the dietary ingredient organic ashwagandha root powder but fails to state the quantitative amount by weight per serving, as required by 21 CFR 101.36(b)(3)(ii). | The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product is misbranded within the meaning of: - Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. § 379aa-1], may receive a report of a serious adverse event with the dietary supplement. - Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the supplement facts label nutrition labeling is not in accord with 21 CFR 101.36. Specifically, the article product labels list other ingredients within the Supplement Facts label, which is not in accordance with 21 CFR 101.4(g). - Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labels bear nutrient content claims, but the products do not meet the requirements to make such claims. | 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(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. “Domestic address or domestic phone number” means a complete address or phone number. The label for this product does not include a complete address or phone number. Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)) in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. For example, the product label declares the dietary ingredient organic ashwagandha root powder but fails to state the quantitative amount by weight per serving, as required by 21 CFR 101.36(b)(3)(ii). | The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product is misbranded within the meaning of: - Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. § 379aa-1], may receive a report of a serious adverse event with the dietary supplement. - Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the supplement facts label nutrition labeling is not in accord with 21 CFR 101.36. Specifically, the article product labels list other ingredients within the Supplement Facts label, which is not in accordance with 21 CFR 101.4(g). - Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labels bear nutrient content claims, but the products do not meet the requirements to make such claims. | The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product is misbranded within the meaning of: - Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. § 379aa-1], may receive a report of a serious adverse event with the dietary supplement. - Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the supplement facts label nutrition labeling is not in accord with 21 CFR 101.36. Specifically, the article product labels list other ingredients within the Supplement Facts label, which is not in accordance with 21 CFR 101.4(g). - Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labels bear nutrient content claims, but the products do not meet the requirements to make such claims. | The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product is misbranded within the meaning of: - Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. § 379aa-1], may receive a report of a serious adverse event with the dietary supplement. - Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the supplement facts label nutrition labeling is not in accord with 21 CFR 101.36. Specifically, the article product labels list other ingredients within the Supplement Facts label, which is not in accordance with 21 CFR 101.4(g). - Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labels bear nutrient content claims, but the products do not meet the requirements to make such claims. each item verified
What the source says
Ancient Greenfields Date Published : 02/28/2018 4/159-A2, Vadavalli to Kanuvai Road , Kalappanaickenpalayam , Coimbatore, Tamil Nadu INDIA 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 08/17/2022 Desc: Ashwagandha Powder Notes: 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(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. “Domestic address or domestic phone number” means a complete address or phone number. The label for this product does not include a complete address or phone number. Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)) in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. For example, the product label declares the dietary ingredient organic ashwagandha root powder but fails to state the quantitative amount by weight per serving, as required by 21 CFR 101.36(b)(3)(ii). 54 A - - 99 Vitamin, N.E.C. Date Published: 02/28/2018 Desc: Moringa Capsule Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product is misbranded within the meaning of: - Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. § 379aa-1], may receive a report of a serious adverse event with the dietary supplement. - Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the supplement facts label nutrition labeling is not in accord with 21 CFR 101.36. Specifically, the article product labels list other ingredients within the Supplement Facts label, which is not in accordance with 21 CFR 101.4(g). - Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labels bear nutrient content claims, but the products do not meet the requirements to make such claims. 54 F - - 94 Ashwagandha (Herbal & Botanicals, not Teas) Date Published: 08/17/2022 Desc: Ashwagandha Powder Notes: 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(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement. “Domestic address or domestic phone number” means a complete address or phone number. The label for this product does not include a complete address or phone number. Section 403(q) of the Act (21 U.S.C. 343 (q)(5)(F)) in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. For example, the product label declares the dietary ingredient organic ashwagandha root powder but fails to state the quantitative amount by weight per serving, as required by 21 CFR 101.36(b)(3)(ii). 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 02/28/2018 Desc: Moringa Capsule Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product is misbranded within the meaning of: - Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. § 379aa-1], may receive a report of a serious adverse event with the dietary supplement. - Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the supplement facts label nutrition labeling is not in accord with 21 CFR 101.36. Specifically, the article product labels list other ingredients within the Supplement Facts label, which is not in accordance with 21 CFR 101.4(g). - Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labels bear nutrient content claims, but the products do not meet the requirements to make such claims. 54 J - - 10 Moringa Oleifera (Herbal and Botanical Teas II, (continued) Date Published: 02/28/2018 Desc: Moringa Capsule Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product is misbranded within the meaning of: - Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. § 379aa-1], may receive a report of a serious adverse event with the dietary supplement. - Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the supplement facts label nutrition labeling is not in accord with 21 CFR 101.36. Specifically, the article product labels list other ingredients within the Supplement Facts label, which is not in accordance with 21 CFR 101.4(g). - Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labels bear nutrient content claims, but the products do not meet the requirements to make such claims. 54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd Date Published: 02/28/2018 Desc: Moringa Capsule Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product is misbranded within the meaning of: - Section 403(y) of the Act in that the label fails to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. § 379aa-1], may receive a report of a serious adverse event with the dietary supplement. - Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the supplement facts label nutrition labeling is not in accord with 21 CFR 101.36. Specifically, the article product labels list other ingredients within the Supplement Facts label, which is not in accordance with 21 CFR 101.4(g). - Section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labels bear nutrient content claims, but the products do not meet the requirements to make such claims.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html
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