FITNESS FACTORY GROUP · 99-39 · UNITED KINGDOM
For FITNESS FACTORY GROUP · 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 Clomadex | TESTAFLEX Hormone Augmentation | Clomadex | TESTAFLEX Hormone Augmentation; product code is 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. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C; date published is 04/07/2017; address is Unit 108, Brunswick Business Park , Tower Street, , Liverpool, UNITED KINGDOM, verified against its source on 2026-09-16.
- Firm
- FITNESS FACTORY GROUP 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
- Unit 108, Brunswick Business Park , Tower Street, , Liverpool, UNITED KINGDOM verified
- Date published
- 04/07/2017 verified
- Product code
- 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. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. each item verified
- Product
- Clomadex | TESTAFLEX Hormone Augmentation | Clomadex | TESTAFLEX Hormone Augmentation each item verified
- FDA notes
- The product appears to be misbranded within the meaning of; 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 product appears to be misbranded within the meaning of; Section 403(y) of the Act in that the product 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 product appears to be misbranded within the meaning of; Section 403(q)(5)(F) of the Act in that the in that the presentation of the nutrition information on the labeling of your products do not comply with 21 CFR 101.36. The product appears to be misbranded within the meaning of; Section 403(r)(6) of the Act in that the product label makes structure function claims but fail to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b). | The product appears to be misbranded within the meaning of; 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 product appears to be misbranded within the meaning of; Section 403(y) of the Act in that the product 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 product appears to be misbranded within the meaning of; Section 403(s)(2)(C) of the Act in that the product label fails to identify the part of the plant (e.g.; root; leaves) from which each botanical dietary ingredient in the product is derived; as required by 21 CFR 101.4(h)(1). The product appears to be misbranded within the meaning of; Section 403(q)(5)(F) of the Act in that the in that the presentation of the nutrition information on the labeling of your products do not comply with 21 CFR 101.36. The product appears to be misbranded within the meaning of; Section 403(r)(6) of the Act in that the product label makes structure function claims but fail to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b). | The product appears to be misbranded within the meaning of; 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 product appears to be misbranded within the meaning of; Section 403(y) of the Act in that the product 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 product appears to be misbranded within the meaning of; Section 403(q)(5)(F) of the Act in that the in that the presentation of the nutrition information on the labeling of your products do not comply with 21 CFR 101.36. The product appears to be misbranded within the meaning of; Section 403(r)(6) of the Act in that the product label makes structure function claims but fail to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b). | The product appears to be misbranded within the meaning of; 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 product appears to be misbranded within the meaning of; Section 403(y) of the Act in that the product 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 product appears to be misbranded within the meaning of; Section 403(s)(2)(C) of the Act in that the product label fails to identify the part of the plant (e.g.; root; leaves) from which each botanical dietary ingredient in the product is derived; as required by 21 CFR 101.4(h)(1). The product appears to be misbranded within the meaning of; Section 403(q)(5)(F) of the Act in that the in that the presentation of the nutrition information on the labeling of your products do not comply with 21 CFR 101.36. The product appears to be misbranded within the meaning of; Section 403(r)(6) of the Act in that the product label makes structure function claims but fail to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b). each item verified
What the source says
FITNESS FACTORY GROUP Date Published : 04/07/2017 Unit 108, Brunswick Business Park , Tower Street, , Liverpool, UNITED KINGDOM 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 04/07/2017 Desc: Clomadex Notes: The product appears to be misbranded within the meaning of; 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 product appears to be misbranded within the meaning of; Section 403(y) of the Act in that the product 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 product appears to be misbranded within the meaning of; Section 403(q)(5)(F) of the Act in that the in that the presentation of the nutrition information on the labeling of your products do not comply with 21 CFR 101.36. The product appears to be misbranded within the meaning of; Section 403(r)(6) of the Act in that the product label makes structure function claims but fail to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b). 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 04/07/2017 Desc: TESTAFLEX Hormone Augmentation Notes: The product appears to be misbranded within the meaning of; 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 product appears to be misbranded within the meaning of; Section 403(y) of the Act in that the product 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 product appears to be misbranded within the meaning of; Section 403(s)(2)(C) of the Act in that the product label fails to identify the part of the plant (e.g.; root; leaves) from which each botanical dietary ingredient in the product is derived; as required by 21 CFR 101.4(h)(1). The product appears to be misbranded within the meaning of; Section 403(q)(5)(F) of the Act in that the in that the presentation of the nutrition information on the labeling of your products do not comply with 21 CFR 101.36. The product appears to be misbranded within the meaning of; Section 403(r)(6) of the Act in that the product label makes structure function claims but fail to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b). 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. Date Published: 04/07/2017 Desc: Clomadex Notes: The product appears to be misbranded within the meaning of; 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 product appears to be misbranded within the meaning of; Section 403(y) of the Act in that the product 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 product appears to be misbranded within the meaning of; Section 403(q)(5)(F) of the Act in that the in that the presentation of the nutrition information on the labeling of your products do not comply with 21 CFR 101.36. The product appears to be misbranded within the meaning of; Section 403(r)(6) of the Act in that the product label makes structure function claims but fail to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b). 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. Date Published: 04/07/2017 Desc: TESTAFLEX Hormone Augmentation Notes: The product appears to be misbranded within the meaning of; 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 product appears to be misbranded within the meaning of; Section 403(y) of the Act in that the product 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 product appears to be misbranded within the meaning of; Section 403(s)(2)(C) of the Act in that the product label fails to identify the part of the plant (e.g.; root; leaves) from which each botanical dietary ingredient in the product is derived; as required by 21 CFR 101.4(h)(1). The product appears to be misbranded within the meaning of; Section 403(q)(5)(F) of the Act in that the in that the presentation of the nutrition information on the labeling of your products do not comply with 21 CFR 101.36. The product appears to be misbranded within the meaning of; Section 403(r)(6) of the Act in that the product label makes structure function claims but fail to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b).
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html
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