Aquanova AG · 66-41 · GERMANY

Product code, Product and FDA notes

41 E - - 99 Meal Replacements (Not labeled for treatment of disease) Date Published: 04/14/2020 Desc: Nanofy Curcumin with Vitamin D3 Notes: The product appears to be a drug, as per Section 201(g)(1) of the Act, 21 U.S.C.321(g)(1), and is intended for use in the cure, mitigation, treatment or prevention of disease. The product appears to be a drug, as per Section 201(g)(1)(B), lacking adequate directions for use [Misbranded, Section 502(f)(1)]. The product appears to not be GRAS and effective for its intended uses; therefore, it is a "new drug", as per Section 201(p) of the Act [21U.S.C.§321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA, as per Section 505(a) of the Act [21 U.S.C.§355(a)]. 41 Y - - 99 Dietary Conventional Foods, N.E.C. Date Published: 04/14/2020 Desc: Nanofy Curcumin with Vitamin D3 Notes: The product appears to be a drug, as per Section 201(g)(1) of the Act, 21 U.S.C.321(g)(1), and is intended for use in the cure, mitigation, treatment or prevention of disease. The product appears to be a drug, as per Section 201(g)(1)(B), lacking adequate directions for use [Misbranded, Section 502(f)(1)]. The product appears to not be GRAS and effective for its intended uses; therefore, it is a "new drug", as per Section 201(p) of the Act [21U.S.C.§321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA, as per Section 505(a) of the Act [21 U.S.C.§355(a)]. 54 A - - 99 Vitamin, N.E.C. Date Published: 04/14/2020 Desc: Nanofy Curcumin with Vitamin D3 Notes: The product appears to be a drug, as per Section 201(g)(1) of the Act, 21 U.S.C.321(g)(1), and is intended for use in the cure, mitigation, treatment or prevention of disease. The product appears to be a drug, as per Section 201(g)(1)(B), lacking adequate directions for use [Misbranded, Section 502(f)(1)]. The product appears to not be GRAS and effective for its intended uses; therefore, it is a "new drug", as per Section 201(p) of the Act [21U.S.C.§321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA, as per Section 505(a) of the Act [21 U.S.C.§355(a)]. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 04/14/2020 Desc: Nanofy Curcumin with Vitamin D3 Notes: The product appears to be a drug, as per Section 201(g)(1) of the Act, 21 U.S.C.321(g)(1), and is intended for use in the cure, mitigation, treatment or prevention of disease. The product appears to be a drug, as per Section 201(g)(1)(B), lacking adequate directions for use [Misbranded, Section 502(f)(1)]. The product appears to not be GRAS and effective for its intended uses; therefore, it is a "new drug", as per Section 201(p) of the Act [21U.S.C.§321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA, as per Section 505(a) of the Act [21 U.S.C.§355(a)]. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 04/14/2020 Desc: Nanofy Curcumin with Vitamin D3 Notes: The product appears to be a drug, as per Section 201(g)(1) of the Act, 21 U.S.C.321(g)(1), and is intended for use in the cure, mitigation, treatment or prevention of disease. The product appears to be a drug, as per Section 201(g)(1)(B), lacking adequate directions for use [Misbranded, Section 502(f)(1)]. The product appears to not be GRAS and effective for its intended uses; therefore, it is a "new drug", as per Section 201(p) of the Act [21U.S.C.§321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA, as per Section 505(a) of the Act [21 U.S.C.§355(a)].