Juicemaster Ltd · 99-39 · UNITED KINGDOM

Product code, Product and FDA notes

54 A - - 01 Vitamin A Date Published: 10/02/2015 Desc: Powergreens food supplement Notes: VIOLATIONS: 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 the presentation of the nutrition information on the labeling does not comply with the requirements of 21 CFR 101.36. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 402(a) (1) because the label bears deleterious substances by containing a Probiotic Mix which includes Anisakis simplex (A. Simplex), a parasitic nematode known to cause infections in humans and Streptococcus faecium (S. Faecium) also known as Enterococcus faecium, an inhabitant of the large bowel and feces in humans; 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 the Act because it fails to declare all probiotic ingredients in the "Probiotic Mix" statement as required by 21 CFR 101.4; 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(s)(2)(A)(ii)(I) of the Act in that it fails to include the quantitative amount by weight per serving size of all the dietary ingredients 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(s)(2)(C) of the Act because it does not list the part of the plant from which the botanical ingredients are derived from as required by 101.4 (h)(2); ; 54 A - - 99 Vitamin, N.E.C. Date Published: 10/02/2015 Desc: Powergreens food supplement Notes: VIOLATIONS: 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 the presentation of the nutrition information on the labeling does not comply with the requirements of 21 CFR 101.36. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 402(a) (1) because the label bears deleterious substances by containing a Probiotic Mix which includes Anisakis simplex (A. Simplex), a parasitic nematode known to cause infections in humans and Streptococcus faecium (S. Faecium) also known as Enterococcus faecium, an inhabitant of the large bowel and feces in humans; 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 the Act because it fails to declare all probiotic ingredients in the "Probiotic Mix" statement as required by 21 CFR 101.4; 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(s)(2)(A)(ii)(I) of the Act in that it fails to include the quantitative amount by weight per serving size of all the dietary ingredients 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(s)(2)(C) of the Act because it does not list the part of the plant from which the botanical ingredients are derived from as required by 101.4 (h)(2); ; 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 10/02/2015 Desc: Powergreens food supplement Notes: VIOLATIONS: 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 the presentation of the nutrition information on the labeling does not comply with the requirements of 21 CFR 101.36. The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of section 402(a) (1) because the label bears deleterious substances by containing a Probiotic Mix which includes Anisakis simplex (A. Simplex), a parasitic nematode known to cause infections in humans and Streptococcus faecium (S. Faecium) also known as Enterococcus faecium, an inhabitant of the large bowel and feces in humans; 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 the Act because it fails to declare all probiotic ingredients in the "Probiotic Mix" statement as required by 21 CFR 101.4; 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(s)(2)(A)(ii)(I) of the Act in that it fails to include the quantitative amount by weight per serving size of all the dietary ingredients 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(s)(2)(C) of the Act because it does not list the part of the plant from which the botanical ingredients are derived from as required by 101.4 (h)(2); ;