Aquanova AG

6 records, newest first. Each line links to the FDA page it came from.

Refusal charges, in plain English

• UNAPPROVED4 refused lines

  Unapproved new drug

  The product appeared to be a new drug within the meaning of section 201(p) of the FD&C Act without an approved New Drug Application. FDA can apply this charge to a food or supplement whose labeling presents it for drug uses.

• DIETARYLBL3 refused lines

  Not identified as a dietary supplement

  The label appeared not to identify the product with the term "dietary supplement" (which may be modified with the name of an ingredient).

• HEALTH C3 refused lines

  Unauthorized nutrient content or health claim

  The label or labeling appeared to carry a nutrient content claim or health claim that is not authorized.

• LACKS FIRM3 refused lines

  Manufacturer name and address missing

  The packaged product's label appeared not to show the name and place of business of the manufacturer, packer, or distributor.

• LIST INGRE3 refused lines

  Ingredients not listed

  The product is made from two or more ingredients and the label appeared not to list the common or usual name of each one (or, for a juice beverage, the percentage of juice).

• NCONTACT3 refused lines

  No U.S. adverse event contact on supplement label

  The dietary supplement label appeared not to show a U.S. address or phone number through which a serious adverse event can be reported.

• NUTRIT LBL3 refused lines

  Nutrition information missing from label

  The label or labeling appeared not to carry the nutrition information that U.S. law requires for the food.

• DIETARYING2 refused lines

  Dietary ingredients not listed

  The dietary supplement label appeared not to list each dietary ingredient and its quantity, or the total quantity of a proprietary blend.

Questions about Aquanova AG

Is Aquanova AG on an FDA import alert?

Yes. As of October 25, 2026, Aquanova AG is on the red list of FDA Import Alert 99-39, “Imported foods that appear to be misbranded”, for nanofy; FDA published the listing on August 21, 2023.

Has FDA refused shipments from Aquanova AG?

Yes. FDA refused 4 shipment lines from Aquanova AG between May 19, 2020 and July 8, 2021. The most recent, on July 8, 2021, was meal replacements (not labeled for treatment of disease), charged as UNAPPROVED (unapproved new drug).

Why did FDA refuse Aquanova AG's shipments?

The most frequent charges are UNAPPROVED (unapproved new drug, 4 lines) and DIETARYLBL (not identified as a dietary supplement, 3 lines).

When was Aquanova AG last inspected by FDA?

FDA's most recent inspection of Aquanova AG with a final classification is dated February 11, 2013 and was classified NAI (No Action Indicated).

What is Aquanova AG's FEI number?

Aquanova AG's FDA Establishment Identifier (FEI) is 3003641717.

Can shipments from Aquanova AG still enter the U.S.?

Shipments of nanofy from Aquanova AG can be detained without physical examination under Import Alert 99-39; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).