SC PlantExtrakt · 99-39 · ROMANIA
For SC PlantExtrakt · 99-39 · ROMANIA, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is ROMANIA; product is UTI Relief | Common Fig | Earache Relief | Flu Relief | Silver Birch | Anxiety Relief | Digestive Relief | Allergy Relief | Black Currant | Silver Birch | Allergy Relief | Earache Relief | Anxiety Relief | Flu Relief | Black Currant | UTI Relief | Digestive Relief | Common Fig; product code is 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 03/23/2017; address is Zalaului f.n. , Radaia, Cluj ROMANIA, verified against its source on 2026-09-16.
- Firm
- SC PlantExtrakt verified
- Import alert
- 99-39
- Import alert name
- Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- Country
- ROMANIA verified
- Address
- Zalaului f.n. , Radaia, Cluj ROMANIA verified
- Date published
- 03/23/2017 verified
- Product code
- 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
- Product
- UTI Relief | Common Fig | Earache Relief | Flu Relief | Silver Birch | Anxiety Relief | Digestive Relief | Allergy Relief | Black Currant | Silver Birch | Allergy Relief | Earache Relief | Anxiety Relief | Flu Relief | Black Currant | UTI Relief | Digestive Relief | Common Fig each item verified
- FDA notes
- Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act 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(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor. | The product label is misbranded within the meaning of Section 403(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. | Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act 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(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor. | Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act 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(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor. | The product label is misbranded within the meaning of Section 403(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. | Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act 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(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor. | Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act 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(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor. | Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act 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(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor. | The product label is misbranded within the meaning of Section 403(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. | The product label is misbranded within the meaning of Section 403(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. | Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act 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(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor. | Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act 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(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor. | Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act 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(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor. | Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act 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(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor. | The product label is misbranded within the meaning of Section 403(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. | Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act 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(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor. | Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act 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(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor. | The product label is misbranded within the meaning of Section 403(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. each item verified
What the source says
SC PlantExtrakt Date Published : 03/23/2017 Zalaului f.n. , Radaia, Cluj ROMANIA 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 03/23/2017 Desc: UTI Relief Notes: Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act 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(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 03/23/2017 Desc: Common Fig Notes: The product label is misbranded within the meaning of Section 403(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 03/23/2017 Desc: Earache Relief Notes: Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act 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(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 03/23/2017 Desc: Flu Relief Notes: Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act 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(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 03/23/2017 Desc: Silver Birch Notes: The product label is misbranded within the meaning of Section 403(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 03/23/2017 Desc: Anxiety Relief Notes: Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act 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(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 03/23/2017 Desc: Digestive Relief Notes: Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act 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(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 03/23/2017 Desc: Allergy Relief Notes: Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act 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(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 03/23/2017 Desc: Black Currant Notes: The product label is misbranded within the meaning of Section 403(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 03/23/2017 Desc: Silver Birch Notes: The product label is misbranded within the meaning of Section 403(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 03/23/2017 Desc: Allergy Relief Notes: Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act 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(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 03/23/2017 Desc: Earache Relief Notes: Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act 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(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 03/23/2017 Desc: Anxiety Relief Notes: Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act 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(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 03/23/2017 Desc: Flu Relief Notes: Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act 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(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 03/23/2017 Desc: Black Currant Notes: The product label is misbranded within the meaning of Section 403(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 03/23/2017 Desc: UTI Relief Notes: Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act 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(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 03/23/2017 Desc: Digestive Relief Notes: Section 403(q)(5)(F) of the Act because it fails to bear nutrition information ("Supplements Facts") as required by 21 CFR 101.36. Section 403(q)(1)(A) of the Act because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Section 403(i)(2) of the Act 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(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number. Section 403(e)(1) of the Act in that the product label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The bottle labels do not identify the name and place of business of the manufacturer, packer, or distributor. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 03/23/2017 Desc: Common Fig Notes: The product label is misbranded within the meaning of Section 403(y) of the Act in that the bottle, box, and paper insert labels fail 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. The address must include a street address or the label must bear a domestic phone number.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html
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