Reference Source

Natural Vitality · 99-39 · AUSTRALIA

For Natural Vitality · 99-39 · AUSTRALIA, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is AUSTRALIA; product is Body Brilliance | Male Testo Dietary Supplement; 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; date published is 06/09/2017; address is 11 Aldinga St , Brendale, Queensland AUSTRALIA, verified against its source on 2026-09-16.

Firm
Natural Vitality verified
Import alert
99-39
Import alert name
Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
Country
AUSTRALIA verified
Address
11 Aldinga St , Brendale, Queensland AUSTRALIA verified
Date published
06/09/2017 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. each item verified
Product
Body Brilliance | Male Testo Dietary Supplement each item verified
FDA notes
The articles appear to be misbranded within the meaning of Section 403(y) of the Act in that the 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 articles appear to be misbranded within the meaning of Section 403(s)(2)(C) of the Act because the labels fail to identify the part of the plant from which the botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 21 101.36(d)(1). The products appear to be misbranded within the meaning of Section 403(q)(5)(F) of the Act in that the labels have a Nutrition Facts panel, however its statement of identity declares it as a dietary supplement. [21 CFR 101.36]. The articles appear to be misbranded within the meaning of Section 403(u) of the Act in that they purport to contain ginseng, but the purported ginseng ingredient is not from a plant classified with the genus Panax. Section 403(u) of the Act, provides that the term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax. Specifically, the Male Testo and Body Brilliance products contain an ingredient identified as Siberian Ginseng and/or Siberian Ginseng powder on the firm's website https://bodyism.com/us/ and declare Eleutherococcus senticosus root extract (commonly known as Siberian ginseng) on the physical product label. Those ingredients may not be declared under a name that includes the term "ginseng" because it is not from the genus Panax. | The articles appear to be misbranded within the meaning of Section 403(y) of the Act in that the 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 articles appear to be misbranded within the meaning of Section 403(s)(2)(C) of the Act because the labels fail to identify the part of the plant from which the botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 21 101.36(d)(1). The products appear to be misbranded within the meaning of Section 403(q)(5)(F) of the Act in that the labels have a Nutrition Facts panel, however its statement of identity declares it as a dietary supplement. [21 CFR 101.36]. The articles appear to be misbranded within the meaning of Section 403(u) of the Act in that they purport to contain ginseng, but the purported ginseng ingredient is not from a plant classified with the genus Panax. Section 403(u) of the Act, provides that the term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax. Specifically, the Male Testo and Body Brilliance products contain an ingredient identified as Siberian Ginseng and/or Siberian Ginseng powder on the firm's website https://bodyism.com/us/ and declare Eleutherococcus senticosus root extract (commonly known as Siberian ginseng) on the physical product label. Those ingredients may not be declared under a name that includes the term "ginseng" because it is not from the genus Panax. 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

Natural Vitality Date Published : 06/09/2017 11 Aldinga St , Brendale, Queensland AUSTRALIA 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 06/09/2017 Desc: Body Brilliance Notes: The articles appear to be misbranded within the meaning of Section 403(y) of the Act in that the 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 articles appear to be misbranded within the meaning of Section 403(s)(2)(C) of the Act because the labels fail to identify the part of the plant from which the botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 21 101.36(d)(1). The products appear to be misbranded within the meaning of Section 403(q)(5)(F) of the Act in that the labels have a Nutrition Facts panel, however its statement of identity declares it as a dietary supplement. [21 CFR 101.36]. The articles appear to be misbranded within the meaning of Section 403(u) of the Act in that they purport to contain ginseng, but the purported ginseng ingredient is not from a plant classified with the genus Panax. Section 403(u) of the Act, provides that the term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax. Specifically, the Male Testo and Body Brilliance products contain an ingredient identified as Siberian Ginseng and/or Siberian Ginseng powder on the firm's website https://bodyism.com/us/ and declare Eleutherococcus senticosus root extract (commonly known as Siberian ginseng) on the physical product label. Those ingredients may not be declared under a name that includes the term "ginseng" because it is not from the genus Panax. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 06/09/2017 Desc: Male Testo Dietary Supplement Notes: The articles appear to be misbranded within the meaning of Section 403(y) of the Act in that the 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 articles appear to be misbranded within the meaning of Section 403(s)(2)(C) of the Act because the labels fail to identify the part of the plant from which the botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1) and 21 101.36(d)(1). The products appear to be misbranded within the meaning of Section 403(q)(5)(F) of the Act in that the labels have a Nutrition Facts panel, however its statement of identity declares it as a dietary supplement. [21 CFR 101.36]. The articles appear to be misbranded within the meaning of Section 403(u) of the Act in that they purport to contain ginseng, but the purported ginseng ingredient is not from a plant classified with the genus Panax. Section 403(u) of the Act, provides that the term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax. Specifically, the Male Testo and Body Brilliance products contain an ingredient identified as Siberian Ginseng and/or Siberian Ginseng powder on the firm's website https://bodyism.com/us/ and declare Eleutherococcus senticosus root extract (commonly known as Siberian ginseng) on the physical product label. Those ingredients may not be declared under a name that includes the term "ginseng" because it is not from the genus Panax.

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

Source

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