# Aquanova AG · 66-41 · GERMANY — FDA import alert red lists: firms subject to detention without physical examination

For Aquanova AG · 66-41 · GERMANY, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is GERMANY; product is Nanofy Curcumin with Vitamin D3 | Nanofy Curcumin with Vitamin D3 | Nanofy Curcumin with Vitamin D3 | Nanofy Curcumin with Vitamin D3 | Nanofy Curcumin with Vitamin D3; product code is 41 E - - 99 Meal Replacements (Not labeled for treatment of disease) | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 54 A - - 99 Vitamin, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C; date published is 04/14/2020; address is Birkenweg 8-10 , Darmstadt, Hesse GERMANY, verified against its source on 2026-09-16.

- **Firm:** Aquanova AG _(verified: appears in the quote below)_
- **Import alert:** 66-41
- **Import alert name:** Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- **Country:** GERMANY _(verified: appears in the quote below)_
- **Address:** Birkenweg 8-10 , Darmstadt, Hesse GERMANY _(verified: appears in the quote below)_
- **Date published:** 04/14/2020 _(verified: appears in the quote below)_
- **Product code:** 41 E - - 99 Meal Replacements (Not labeled for treatment of disease) | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 54 A - - 99 Vitamin, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. _(verified: each item appears in the quote below)_
- **Product:** Nanofy Curcumin with Vitamin D3 | Nanofy Curcumin with Vitamin D3 | Nanofy Curcumin with Vitamin D3 | Nanofy Curcumin with Vitamin D3 | Nanofy Curcumin with Vitamin D3 _(verified: each item appears in the quote below)_
- **FDA 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)]. | 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)]. | 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)]. | 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)]. | 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)]. _(verified: each item appears in the quote below)_

## What the source says

> Aquanova AG Date Published : 04/14/2020 Birkenweg 8-10 , Darmstadt, Hesse GERMANY 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)].

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_190.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).