Natural Vitality · 99-39 · AUSTRALIA

Product code, Product and FDA notes

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. 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.