Reference Source

GeoSilica Iceland · 99-39 · ICELAND

For GeoSilica Iceland · 99-39 · ICELAND, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is ICELAND; product is Geosilica Silica Supplement | Recover Muscle and Nerves Minerals | Geosilica Silica Supplement | Geosilica Silica Supplement | Recover Muscle and Nerves Minerals; product code is 54 A - - 99 Vitamin, N.E.C. | 54 A - - 99 Vitamin, N.E.C. | 54 B - - 99 Mineral N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 06/05/2018; address is Granasbraut 506 , Reykjanesba, ICELAND, verified against its source on 2026-09-16.

Firm
GeoSilica Iceland verified
Import alert
99-39
Import alert name
Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
Country
ICELAND verified
Address
Granasbraut 506 , Reykjanesba, ICELAND verified
Date published
06/05/2018 verified
Product code
54 A - - 99 Vitamin, N.E.C. | 54 A - - 99 Vitamin, N.E.C. | 54 B - - 99 Mineral N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
Product
Geosilica Silica Supplement | Recover Muscle and Nerves Minerals | Geosilica Silica Supplement | Geosilica Silica Supplement | Recover Muscle and Nerves Minerals 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 sections: Section 403(e)(2) of the Act [21 U.S.C.§ 343(e)(2)] in that the metric declaration of the net quantity of content statement is on an information panel of the outer package rather than the principal display panel (PDP). The declaration of the net quantity of contents on the bottle is located on the PDP but not in the bottom 30 percent of the label as required by 21 CFR 101.7(f). Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.36. 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) may receive a report of a serious adverse event with such dietary supplement. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(r)(6) of the Act [21 U.S.C. §343(r)(6)] because the label makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b). | 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 sections: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] and section 1453(a)(2) of the Fair Packaging and Labeling Act [15 U.S.C. §1453(a)(2)] in that the metric declaration of the net quantity of content statement is on an information panel rather than the principal display panel. Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product labels fail to bear the common or usual name of the food on the principal display panel as required by 21 CFR 101.3(a). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 Section 403(i)(2) charge because the ingredients are not declared in accordance with 21 CFR 101.4. | 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 sections: Section 403(e)(2) of the Act [21 U.S.C.§ 343(e)(2)] in that the metric declaration of the net quantity of content statement is on an information panel of the outer package rather than the principal display panel (PDP). The declaration of the net quantity of contents on the bottle is located on the PDP but not in the bottom 30 percent of the label as required by 21 CFR 101.7(f). Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.36. 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) may receive a report of a serious adverse event with such dietary supplement. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(r)(6) of the Act [21 U.S.C. §343(r)(6)] because the label makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b). | 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 sections: Section 403(e)(2) of the Act [21 U.S.C.§ 343(e)(2)] in that the metric declaration of the net quantity of content statement is on an information panel of the outer package rather than the principal display panel (PDP). The declaration of the net quantity of contents on the bottle is located on the PDP but not in the bottom 30 percent of the label as required by 21 CFR 101.7(f). Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.36. 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) may receive a report of a serious adverse event with such dietary supplement. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(r)(6) of the Act [21 U.S.C. §343(r)(6)] because the label makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b). | 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 sections: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] and section 1453(a)(2) of the Fair Packaging and Labeling Act [15 U.S.C. §1453(a)(2)] in that the metric declaration of the net quantity of content statement is on an information panel rather than the principal display panel. Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product labels fail to bear the common or usual name of the food on the principal display panel as required by 21 CFR 101.3(a). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 Section 403(i)(2) charge because the ingredients are not declared in accordance with 21 CFR 101.4. 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

GeoSilica Iceland Date Published : 06/05/2018 Granasbraut 506 , Reykjanesba, ICELAND 54 A - - 99 Vitamin, N.E.C. Date Published: 06/05/2018 Desc: Geosilica Silica Supplement 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 sections: Section 403(e)(2) of the Act [21 U.S.C.§ 343(e)(2)] in that the metric declaration of the net quantity of content statement is on an information panel of the outer package rather than the principal display panel (PDP). The declaration of the net quantity of contents on the bottle is located on the PDP but not in the bottom 30 percent of the label as required by 21 CFR 101.7(f). Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.36. 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) may receive a report of a serious adverse event with such dietary supplement. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(r)(6) of the Act [21 U.S.C. §343(r)(6)] because the label makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b). 54 A - - 99 Vitamin, N.E.C. Date Published: 06/05/2018 Desc: Recover Muscle and Nerves Minerals 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 sections: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] and section 1453(a)(2) of the Fair Packaging and Labeling Act [15 U.S.C. §1453(a)(2)] in that the metric declaration of the net quantity of content statement is on an information panel rather than the principal display panel. Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product labels fail to bear the common or usual name of the food on the principal display panel as required by 21 CFR 101.3(a). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 Section 403(i)(2) charge because the ingredients are not declared in accordance with 21 CFR 101.4. 54 B - - 99 Mineral N.E.C. Date Published: 06/05/2018 Desc: Geosilica Silica Supplement 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 sections: Section 403(e)(2) of the Act [21 U.S.C.§ 343(e)(2)] in that the metric declaration of the net quantity of content statement is on an information panel of the outer package rather than the principal display panel (PDP). The declaration of the net quantity of contents on the bottle is located on the PDP but not in the bottom 30 percent of the label as required by 21 CFR 101.7(f). Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.36. 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) may receive a report of a serious adverse event with such dietary supplement. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(r)(6) of the Act [21 U.S.C. §343(r)(6)] because the label makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b). 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 06/05/2018 Desc: Geosilica Silica Supplement 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 sections: Section 403(e)(2) of the Act [21 U.S.C.§ 343(e)(2)] in that the metric declaration of the net quantity of content statement is on an information panel of the outer package rather than the principal display panel (PDP). The declaration of the net quantity of contents on the bottle is located on the PDP but not in the bottom 30 percent of the label as required by 21 CFR 101.7(f). Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)] in that the nutrition information is not in an appropriate format as defined in 21 CFR 101.36. 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) may receive a report of a serious adverse event with such dietary supplement. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Section 403(r)(6) of the Act [21 U.S.C. §343(r)(6)] because the label makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b). 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 06/05/2018 Desc: Recover Muscle and Nerves Minerals 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 sections: Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)] and section 1453(a)(2) of the Fair Packaging and Labeling Act [15 U.S.C. §1453(a)(2)] in that the metric declaration of the net quantity of content statement is on an information panel rather than the principal display panel. Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] in that the product labels fail to bear the common or usual name of the food on the principal display panel as required by 21 CFR 101.3(a). Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not as defined in 21 CFR 101.9 Section 403(i)(2) charge because the ingredients are not declared in accordance with 21 CFR 101.4.

accessdata.fda.gov, retrieved 2026-09-15

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