Rey GmbH · 99-39 · AUSTRIA

Product code, Product and FDA notes

29 B - T 99 Carbonated Soft Drink, N.E.C., Packaged Food (Not Commercially Sterile) Date Published: 10/02/2015 Desc: MitoChon Energy Drink Notes: *** Charges: 403(i)(2), 403(q)(5)(F), 403(y). The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403(i)(2) of Federal Food, Drug and Cosmetic Act (the Act) in that it is fabricated from two or more ingredients, but the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR 101.36. Specifically: In the "other" section of the product's ingredient list, the product lists "Trade Secret Stabilization Process" and "Solubilized in water from the Austrian Alps." While these may be true statements, the former is not appropriate to list in the ingredients section of the product and the latter is not the common or usual name for "water." Additionally, ingredients such as NADH, Q10H2, Pyridoxal- 5'-PO43, and Vitamin B2 RSP must be spelled out or listed by their common and usual names. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403 (q)(5)(F) of the Act in that your "Supplement Facts" panel is not in an appropriate format as required by 21 CFR 101.36. The article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of section 403 (y) [21 U.S.C. § 343(y)] of the Act. The label fails to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 [21 U.S.C. § 379aa-1] of the Act, may receive a report of a serious adverse event with such dietary supplement.***