Power Health Products Ltd · 99-39 · UNITED KINGDOM
For Power Health Products Ltd · 99-39 · UNITED KINGDOM, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is UNITED KINGDOM; product is Viasil | Viasil | Emu Oil Capsules | Emu Oil Capsules | Emu Oil Capsules | Emu Oil Capsules; product code is 54 F - - 12 Ginseng (Herbal & Botanicals, not Teas) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 60 L - - 99 Analgesic, N.E.C. | 62 G - - 99 Anti-Inflammatory N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 10/27/2022; address is Airfield Estate , Pocklington Industrial Estate; E. , York, UNITED KINGDOM, verified against its source on 2026-09-16.
- Firm
- Power Health Products Ltd verified
- Import alert
- 99-39
- Import alert name
- Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- Country
- UNITED KINGDOM verified
- Address
- Airfield Estate , Pocklington Industrial Estate; E. , York, UNITED KINGDOM verified
- Date published
- 10/27/2022 verified
- Product code
- 54 F - - 12 Ginseng (Herbal & Botanicals, not Teas) | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 60 L - - 99 Analgesic, N.E.C. | 62 G - - 99 Anti-Inflammatory N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
- Product
- Viasil | Viasil | Emu Oil Capsules | Emu Oil Capsules | Emu Oil Capsules | Emu Oil Capsules 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(s)(2)(B) of the FD&C Act. Outer box and inner container label missing statement of identity as a "dietary supplement”(21 CFR 101.3(a), (b), (g)). Section 403(q) of the FD&C Act. Outer box and inner container does not comply with 21 CFR 101.36 and 101.9. No heavy bar under “Servings Per Container” (21 CFR 101.36(e)(6)(i)); under the last (b)(2)-dietary ingredient, (21 CFR 101.36(e)(6)(ii)); under the last other dietary ingredient (21 CFR 101.36(e)(6)(i)). Amount per serving not declared for zinc (21 CFR 101.36(b)(2)(i)(A)). Percent of Daily Value not listed for zinc (21 CFR 101.36(b)(2)(iii)). Percent of Daily Value for ingredients listed under the heading “%NRV” (21 CFR 101.36(b)(2)(iii)(A)). No provision in the regulation to use the statement “no daily value present” within the Supplement Facts label. Section 403(i)(2) of the FD&C Act. Outer box and inner label fails to declare all the common or usual names of each ingredient (21 CFR 101.36 and 21 CFR 101.4(h)). Actiful is not the common or usual name for an ingredient. Label appears to list dried botanical extracts, but the term “extract” is not included in the name of the ingredient (21 CFR 101.36(b)(3)(ii)(B)). Product label lists “Korean ginseng”, but this is not a standardized common name (SCN) in the reference Herbs of Commerce (HOC). “Blue Powder Colour Fd & C Blue No. 1” is not the common or usual name for the ingredient. White Coating Solution is not the common or usual name for an ingredient. Section 403(s)(2)(C) of the Act. Missing name for part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). The botanical ingredients Horny Goats Weed, Tribulus, Korean Ginseng, and Ginkgo Biloba do not list the plant part. | 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(s)(2)(B) of the FD&C Act. Outer box and inner container label missing statement of identity as a "dietary supplement”(21 CFR 101.3(a), (b), (g)). Section 403(q) of the FD&C Act. Outer box and inner container does not comply with 21 CFR 101.36 and 101.9. No heavy bar under “Servings Per Container” (21 CFR 101.36(e)(6)(i)); under the last (b)(2)-dietary ingredient, (21 CFR 101.36(e)(6)(ii)); under the last other dietary ingredient (21 CFR 101.36(e)(6)(i)). Amount per serving not declared for zinc (21 CFR 101.36(b)(2)(i)(A)). Percent of Daily Value not listed for zinc (21 CFR 101.36(b)(2)(iii)). Percent of Daily Value for ingredients listed under the heading “%NRV” (21 CFR 101.36(b)(2)(iii)(A)). No provision in the regulation to use the statement “no daily value present” within the Supplement Facts label. Section 403(i)(2) of the FD&C Act. Outer box and inner label fails to declare all the common or usual names of each ingredient (21 CFR 101.36 and 21 CFR 101.4(h)). Actiful is not the common or usual name for an ingredient. Label appears to list dried botanical extracts, but the term “extract” is not included in the name of the ingredient (21 CFR 101.36(b)(3)(ii)(B)). Product label lists “Korean ginseng”, but this is not a standardized common name (SCN) in the reference Herbs of Commerce (HOC). “Blue Powder Colour Fd & C Blue No. 1” is not the common or usual name for the ingredient. White Coating Solution is not the common or usual name for an ingredient. Section 403(s)(2)(C) of the Act. Missing name for part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). The botanical ingredients Horny Goats Weed, Tribulus, Korean Ginseng, and Ginkgo Biloba do not list the plant part. | 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(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the labeling bears a nutrient content claim, but the product does not meet the requirement to bear the claim. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that each ingredient or constituent of an ingredient is not declared on the label by the common or usual name in accordance with 21 CFR 101.4. For example, “Omega 3”, “Omega 6”, and “Omega 9” must be declared by the common or usual name of the specific fatty acid. | 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(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the labeling bears a nutrient content claim, but the product does not meet the requirement to bear the claim. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that each ingredient or constituent of an ingredient is not declared on the label by the common or usual name in accordance with 21 CFR 101.4. For example, “Omega 3”, “Omega 6”, and “Omega 9” must be declared by the common or usual name of the specific fatty acid. | 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(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the labeling bears a nutrient content claim, but the product does not meet the requirement to bear the claim. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that each ingredient or constituent of an ingredient is not declared on the label by the common or usual name in accordance with 21 CFR 101.4. For example, “Omega 3”, “Omega 6”, and “Omega 9” must be declared by the common or usual name of the specific fatty acid. | 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(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the labeling bears a nutrient content claim, but the product does not meet the requirement to bear the claim. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that each ingredient or constituent of an ingredient is not declared on the label by the common or usual name in accordance with 21 CFR 101.4. For example, “Omega 3”, “Omega 6”, and “Omega 9” must be declared by the common or usual name of the specific fatty acid. 10/27/2022 each item verified
What the source says
Power Health Products Ltd Date Published : 10/27/2022 Airfield Estate , Pocklington Industrial Estate; E. , York, UNITED KINGDOM 54 F - - 12 Ginseng (Herbal & Botanicals, not Teas) Date Published: 01/15/2025 Desc: Viasil 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(s)(2)(B) of the FD&C Act. Outer box and inner container label missing statement of identity as a "dietary supplement”(21 CFR 101.3(a), (b), (g)). Section 403(q) of the FD&C Act. Outer box and inner container does not comply with 21 CFR 101.36 and 101.9. No heavy bar under “Servings Per Container” (21 CFR 101.36(e)(6)(i)); under the last (b)(2)-dietary ingredient, (21 CFR 101.36(e)(6)(ii)); under the last other dietary ingredient (21 CFR 101.36(e)(6)(i)). Amount per serving not declared for zinc (21 CFR 101.36(b)(2)(i)(A)). Percent of Daily Value not listed for zinc (21 CFR 101.36(b)(2)(iii)). Percent of Daily Value for ingredients listed under the heading “%NRV” (21 CFR 101.36(b)(2)(iii)(A)). No provision in the regulation to use the statement “no daily value present” within the Supplement Facts label. Section 403(i)(2) of the FD&C Act. Outer box and inner label fails to declare all the common or usual names of each ingredient (21 CFR 101.36 and 21 CFR 101.4(h)). Actiful is not the common or usual name for an ingredient. Label appears to list dried botanical extracts, but the term “extract” is not included in the name of the ingredient (21 CFR 101.36(b)(3)(ii)(B)). Product label lists “Korean ginseng”, but this is not a standardized common name (SCN) in the reference Herbs of Commerce (HOC). “Blue Powder Colour Fd & C Blue No. 1” is not the common or usual name for the ingredient. White Coating Solution is not the common or usual name for an ingredient. Section 403(s)(2)(C) of the Act. Missing name for part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). The botanical ingredients Horny Goats Weed, Tribulus, Korean Ginseng, and Ginkgo Biloba do not list the plant part. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 01/15/2025 Desc: Viasil 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(s)(2)(B) of the FD&C Act. Outer box and inner container label missing statement of identity as a "dietary supplement”(21 CFR 101.3(a), (b), (g)). Section 403(q) of the FD&C Act. Outer box and inner container does not comply with 21 CFR 101.36 and 101.9. No heavy bar under “Servings Per Container” (21 CFR 101.36(e)(6)(i)); under the last (b)(2)-dietary ingredient, (21 CFR 101.36(e)(6)(ii)); under the last other dietary ingredient (21 CFR 101.36(e)(6)(i)). Amount per serving not declared for zinc (21 CFR 101.36(b)(2)(i)(A)). Percent of Daily Value not listed for zinc (21 CFR 101.36(b)(2)(iii)). Percent of Daily Value for ingredients listed under the heading “%NRV” (21 CFR 101.36(b)(2)(iii)(A)). No provision in the regulation to use the statement “no daily value present” within the Supplement Facts label. Section 403(i)(2) of the FD&C Act. Outer box and inner label fails to declare all the common or usual names of each ingredient (21 CFR 101.36 and 21 CFR 101.4(h)). Actiful is not the common or usual name for an ingredient. Label appears to list dried botanical extracts, but the term “extract” is not included in the name of the ingredient (21 CFR 101.36(b)(3)(ii)(B)). Product label lists “Korean ginseng”, but this is not a standardized common name (SCN) in the reference Herbs of Commerce (HOC). “Blue Powder Colour Fd & C Blue No. 1” is not the common or usual name for the ingredient. White Coating Solution is not the common or usual name for an ingredient. Section 403(s)(2)(C) of the Act. Missing name for part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived (21 CFR 101.4(h)(1)). The botanical ingredients Horny Goats Weed, Tribulus, Korean Ginseng, and Ginkgo Biloba do not list the plant part. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 10/27/2022 Desc: Emu Oil Capsules 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(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the labeling bears a nutrient content claim, but the product does not meet the requirement to bear the claim. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that each ingredient or constituent of an ingredient is not declared on the label by the common or usual name in accordance with 21 CFR 101.4. For example, “Omega 3”, “Omega 6”, and “Omega 9” must be declared by the common or usual name of the specific fatty acid. 60 L - - 99 Analgesic, N.E.C. Date Published: 10/27/2022 Desc: Emu Oil Capsules 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(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the labeling bears a nutrient content claim, but the product does not meet the requirement to bear the claim. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that each ingredient or constituent of an ingredient is not declared on the label by the common or usual name in accordance with 21 CFR 101.4. For example, “Omega 3”, “Omega 6”, and “Omega 9” must be declared by the common or usual name of the specific fatty acid. 62 G - - 99 Anti-Inflammatory N.E.C. Date Published: 10/27/2022 Desc: Emu Oil Capsules 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(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the labeling bears a nutrient content claim, but the product does not meet the requirement to bear the claim. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that each ingredient or constituent of an ingredient is not declared on the label by the common or usual name in accordance with 21 CFR 101.4. For example, “Omega 3”, “Omega 6”, and “Omega 9” must be declared by the common or usual name of the specific fatty acid. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 12/19/2023 Desc: Emu Oil Capsules 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(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the labeling bears a nutrient content claim, but the product does not meet the requirement to bear the claim. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that each ingredient or constituent of an ingredient is not declared on the label by the common or usual name in accordance with 21 CFR 101.4. For example, “Omega 3”, “Omega 6”, and “Omega 9” must be declared by the common or usual name of the specific fatty acid. 10/27/2022
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html
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