NAHRIN AG · 99-39 · SWITZERLAND
For NAHRIN AG · 99-39 · SWITZERLAND, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is SWITZERLAND; product is AGE-DEFY Immunity and Regeneressence Food Supplement | ENERGY Focus & Performance Food Supplement | ENERGY Focus & Performance Food Supplement | AGE-DEFY Immunity and Regeneressence Food Supplement | ENERGY Focus & Performance Food Supplement | AGE-DEFY Immunity and Regeneressence Food Supplement | AGE-DEFY Immunity and Regeneressence Food Supplement | ENERGY Focus & Performance Food Supplement | ENERGY Focus & Performance Food Supplement | AGE-DEFY Immunity and Regeneressence Food Supplement; product code is 54 A - - 02 Vitamin B1 (Thiamine) | 54 A - - 02 Vitamin B1 (Thiamine) | 54 A - - 06 Niacin (Nicotinic Acid) (Vitamin) | 54 A - - 06 Niacin (Nicotinic Acid) (Vitamin) | 54 F - - 33 Astragalus (Milk Vetch Root), (Herbal & Botanicals, not Teas) | 54 F - - 33 Astragalus (Milk Vetch Root), (Herbal & Botanicals, not Teas) | 54 F - - 94 Ashwagandha (Herbal & Botanicals, not Teas) | 54 F - - 94 Ashwagandha (Herbal & Botanicals, not Teas) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C; date published is 07/07/2023; address is Industriestrasse 27 , Sarnen, Obwalden SWITZERLAND, verified against its source on 2026-09-16.
- Firm
- NAHRIN AG verified
- Import alert
- 99-39
- Import alert name
- Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- Country
- SWITZERLAND verified
- Address
- Industriestrasse 27 , Sarnen, Obwalden SWITZERLAND verified
- Date published
- 07/07/2023 verified
- Product code
- 54 A - - 02 Vitamin B1 (Thiamine) | 54 A - - 02 Vitamin B1 (Thiamine) | 54 A - - 06 Niacin (Nicotinic Acid) (Vitamin) | 54 A - - 06 Niacin (Nicotinic Acid) (Vitamin) | 54 F - - 33 Astragalus (Milk Vetch Root), (Herbal & Botanicals, not Teas) | 54 F - - 33 Astragalus (Milk Vetch Root), (Herbal & Botanicals, not Teas) | 54 F - - 94 Ashwagandha (Herbal & Botanicals, not Teas) | 54 F - - 94 Ashwagandha (Herbal & Botanicals, not Teas) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. each item verified
- Product
- AGE-DEFY Immunity and Regeneressence Food Supplement | ENERGY Focus & Performance Food Supplement | ENERGY Focus & Performance Food Supplement | AGE-DEFY Immunity and Regeneressence Food Supplement | ENERGY Focus & Performance Food Supplement | AGE-DEFY Immunity and Regeneressence Food Supplement | AGE-DEFY Immunity and Regeneressence Food Supplement | ENERGY Focus & Performance Food Supplement | ENERGY Focus & Performance Food Supplement | AGE-DEFY Immunity and Regeneressence Food Supplement each item verified
- FDA 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 appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail 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. | 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 appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail 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. | 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 appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail 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. | 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 appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail 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. | 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 appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail 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. | 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 appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail 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. | 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 appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail 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. | 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 appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail 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. | 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 appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail 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. | 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 appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail 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. each item verified
What the source says
NAHRIN AG Date Published : 07/07/2023 Industriestrasse 27 , Sarnen, Obwalden SWITZERLAND 54 A - - 02 Vitamin B1 (Thiamine) Date Published: 07/07/2023 Desc: AGE-DEFY Immunity and Regeneressence Food Supplement 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 appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail 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. 54 A - - 02 Vitamin B1 (Thiamine) Date Published: 07/07/2023 Desc: ENERGY Focus & Performance Food Supplement 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 appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail 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. 54 A - - 06 Niacin (Nicotinic Acid) (Vitamin) Date Published: 07/07/2023 Desc: ENERGY Focus & Performance Food Supplement 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 appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail 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. 54 A - - 06 Niacin (Nicotinic Acid) (Vitamin) Date Published: 07/07/2023 Desc: AGE-DEFY Immunity and Regeneressence Food Supplement 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 appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail 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. 54 F - - 33 Astragalus (Milk Vetch Root), (Herbal & Botanicals, not Teas) Date Published: 07/07/2023 Desc: ENERGY Focus & Performance Food Supplement 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 appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail 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. 54 F - - 33 Astragalus (Milk Vetch Root), (Herbal & Botanicals, not Teas) Date Published: 07/07/2023 Desc: AGE-DEFY Immunity and Regeneressence Food Supplement 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 appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail 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. 54 F - - 94 Ashwagandha (Herbal & Botanicals, not Teas) Date Published: 07/07/2023 Desc: AGE-DEFY Immunity and Regeneressence Food Supplement 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 appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail 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. 54 F - - 94 Ashwagandha (Herbal & Botanicals, not Teas) Date Published: 07/07/2023 Desc: ENERGY Focus & Performance Food Supplement 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 appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail 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. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 07/07/2023 Desc: ENERGY Focus & Performance Food Supplement 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 appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail 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. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 07/07/2023 Desc: AGE-DEFY Immunity and Regeneressence Food Supplement 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 appears to be misbranded within the meaning of: Section 403(i)(2) of the Act in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(h). Section 403(q) of the Act because the presentation of nutrition information on the inner and outer packaging (“Supplement Facts” label) is not in accordance with CFR 101.36 and 101.9. Section 403(s)(2)(B) of the Act in that the label fails to include a statement of identity as a “dietary supplement” on the principal display panel, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product or an appropriately descriptive term indicating the type of dietary ingredients that are in the product [21 CFR 101.3(a) and (g)]. Section 403(s)(2)(C) of the Act in that the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 101.36(d)(1). Section 403(y) of the Act because the labels fail 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.
— accessdata.fda.gov, retrieved 2026-09-16
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html
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