Reference Source

Nutracrea Inc. · 99-39 · CANADA

For Nutracrea Inc. · 99-39 · CANADA, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is CANADA; product is Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); TANGY PEACH RiNGZ | Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula);BLUE FREEZE | Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); GRAPE WHITE NORTH | Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); RED WHITE & BOOM | Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); RED WHITE & BOOM | Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); TANGY PEACH RiNGZ | Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula);BLUE FREEZE | Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); GRAPE WHITE NORTH; product code is 54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 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. | 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 06/14/2023; address is 486 Bergeron St , Sainte-Eulalie, Quebec CANADA, verified against its source on 2026-09-16.

Firm
Nutracrea Inc. verified
Import alert
99-39
Import alert name
Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
Country
CANADA verified
Address
486 Bergeron St , Sainte-Eulalie, Quebec CANADA verified
Date published
06/14/2023 verified
Product code
54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) | 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. | 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
Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); TANGY PEACH RiNGZ | Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula);BLUE FREEZE | Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); GRAPE WHITE NORTH | Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); RED WHITE & BOOM | Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); RED WHITE & BOOM | Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); TANGY PEACH RiNGZ | Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula);BLUE FREEZE | Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); GRAPE WHITE NORTH 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(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the label fails to declare the serving size as required by 21 CFR 101.36(b)(1)(i). Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of the nutrition information on the labeling of the article does not comply with 21 CFR 101.36 and 101.9(c). Section 403(s)(2)(C) of the Act because the labels fail to specify the part of the plant from which black pepper is derived. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that 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) may receive a report of a serious adverse event with such 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(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the label fails to declare the serving size as required by 21 CFR 101.36(b)(1)(i). Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of the nutrition information on the labeling of the article does not comply with 21 CFR 101.36 and 101.9(c). Section 403(s)(2)(C) of the Act because the labels fail to specify the part of the plant from which black pepper is derived. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that 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) may receive a report of a serious adverse event with such 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(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the label fails to declare the serving size as required by 21 CFR 101.36(b)(1)(i). Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of the nutrition information on the labeling of the article does not comply with 21 CFR 101.36 and 101.9(c). Section 403(s)(2)(C) of the Act because the labels fail to specify the part of the plant from which black pepper is derived. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that 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) may receive a report of a serious adverse event with such 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(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the label fails to declare the serving size as required by 21 CFR 101.36(b)(1)(i). Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of the nutrition information on the labeling of the article does not comply with 21 CFR 101.36 and 101.9(c). Section 403(s)(2)(C) of the Act because the labels fail to specify the part of the plant from which black pepper is derived. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that 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) may receive a report of a serious adverse event with such 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(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the label fails to declare the serving size as required by 21 CFR 101.36(b)(1)(i). Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of the nutrition information on the labeling of the article does not comply with 21 CFR 101.36 and 101.9(c). Section 403(s)(2)(C) of the Act because the labels fail to specify the part of the plant from which black pepper is derived. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that 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) may receive a report of a serious adverse event with such 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(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the label fails to declare the serving size as required by 21 CFR 101.36(b)(1)(i). Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of the nutrition information on the labeling of the article does not comply with 21 CFR 101.36 and 101.9(c). Section 403(s)(2)(C) of the Act because the labels fail to specify the part of the plant from which black pepper is derived. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that 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) may receive a report of a serious adverse event with such 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(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the label fails to declare the serving size as required by 21 CFR 101.36(b)(1)(i). Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of the nutrition information on the labeling of the article does not comply with 21 CFR 101.36 and 101.9(c). Section 403(s)(2)(C) of the Act because the labels fail to specify the part of the plant from which black pepper is derived. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that 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) may receive a report of a serious adverse event with such 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(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the label fails to declare the serving size as required by 21 CFR 101.36(b)(1)(i). Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of the nutrition information on the labeling of the article does not comply with 21 CFR 101.36 and 101.9(c). Section 403(s)(2)(C) of the Act because the labels fail to specify the part of the plant from which black pepper is derived. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that 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) may receive a report of a serious adverse event with such dietary supplement. each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Nutracrea Inc. Date Published : 06/14/2023 486 Bergeron St , Sainte-Eulalie, Quebec CANADA 54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) Date Published: 06/14/2023 Desc: Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); TANGY PEACH RiNGZ 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(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the label fails to declare the serving size as required by 21 CFR 101.36(b)(1)(i). Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of the nutrition information on the labeling of the article does not comply with 21 CFR 101.36 and 101.9(c). Section 403(s)(2)(C) of the Act because the labels fail to specify the part of the plant from which black pepper is derived. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that 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) may receive a report of a serious adverse event with such dietary supplement. 54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) Date Published: 06/14/2023 Desc: Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula);BLUE FREEZE 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(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the label fails to declare the serving size as required by 21 CFR 101.36(b)(1)(i). Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of the nutrition information on the labeling of the article does not comply with 21 CFR 101.36 and 101.9(c). Section 403(s)(2)(C) of the Act because the labels fail to specify the part of the plant from which black pepper is derived. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that 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) may receive a report of a serious adverse event with such dietary supplement. 54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) Date Published: 06/14/2023 Desc: Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); GRAPE WHITE NORTH 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(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the label fails to declare the serving size as required by 21 CFR 101.36(b)(1)(i). Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of the nutrition information on the labeling of the article does not comply with 21 CFR 101.36 and 101.9(c). Section 403(s)(2)(C) of the Act because the labels fail to specify the part of the plant from which black pepper is derived. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that 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) may receive a report of a serious adverse event with such dietary supplement. 54 Y - - 11 Whey Protein Powder (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.) Date Published: 06/14/2023 Desc: Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); RED WHITE & BOOM 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(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the label fails to declare the serving size as required by 21 CFR 101.36(b)(1)(i). Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of the nutrition information on the labeling of the article does not comply with 21 CFR 101.36 and 101.9(c). Section 403(s)(2)(C) of the Act because the labels fail to specify the part of the plant from which black pepper is derived. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that 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) may receive a report of a serious adverse event with such dietary supplement. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 06/14/2023 Desc: Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); RED WHITE & BOOM 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(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the label fails to declare the serving size as required by 21 CFR 101.36(b)(1)(i). Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of the nutrition information on the labeling of the article does not comply with 21 CFR 101.36 and 101.9(c). Section 403(s)(2)(C) of the Act because the labels fail to specify the part of the plant from which black pepper is derived. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that 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) may receive a report of a serious adverse event with such dietary supplement. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 06/14/2023 Desc: Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); TANGY PEACH RiNGZ 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(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the label fails to declare the serving size as required by 21 CFR 101.36(b)(1)(i). Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of the nutrition information on the labeling of the article does not comply with 21 CFR 101.36 and 101.9(c). Section 403(s)(2)(C) of the Act because the labels fail to specify the part of the plant from which black pepper is derived. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that 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) may receive a report of a serious adverse event with such dietary supplement. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 06/14/2023 Desc: Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula);BLUE FREEZE 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(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the label fails to declare the serving size as required by 21 CFR 101.36(b)(1)(i). Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of the nutrition information on the labeling of the article does not comply with 21 CFR 101.36 and 101.9(c). Section 403(s)(2)(C) of the Act because the labels fail to specify the part of the plant from which black pepper is derived. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that 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) may receive a report of a serious adverse event with such dietary supplement. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 06/14/2023 Desc: Beyond Yourself Powder Dietary Supplement (Pre Pump; Super Set Maximum Vasodilating Pump Preworkout Formula); GRAPE WHITE NORTH 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(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the label fails to declare the serving size as required by 21 CFR 101.36(b)(1)(i). Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because the presentation of the nutrition information on the labeling of the article does not comply with 21 CFR 101.36 and 101.9(c). Section 403(s)(2)(C) of the Act because the labels fail to specify the part of the plant from which black pepper is derived. Section 403(y) of the Act [21 U.S.C. § 343(y)] in that 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) may receive a report of a serious adverse event with such dietary supplement.

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