Capital O2 Natural Health Company Ltd

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

Refusal charges, in plain English

• UNAPPROVED9 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.

• DIRECTIONS5 refused lines

  DIRECTIONS

• UNSAFE ADD2 refused lines

  Food additive unsafe under section 409

  The product appeared to contain a food additive that is unsafe within the meaning of section 409 of the FD&C Act, the section that governs which food additives may be used and under what conditions.

• DIETARYLBL1 refused line

  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).

• DIRSEXMPT1 refused line

  DIRSEXMPT

• FRNMFGREG1 refused line

  FRNMFGREG

• LABELING1 refused line

  Fair Packaging and Labeling Act

  The package appeared not to meet the Fair Packaging and Labeling Act because of the placement, form, or contents of a required label statement.

• LIST INGRE1 refused line

  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).

Questions about Capital O2 Natural Health Company Ltd

Is Capital O2 Natural Health Company Ltd on an FDA import alert?

Yes. As of October 27, 2026, Capital O2 Natural Health Company Ltd is on the red list of FDA Import Alert 99-45, “Foods that are or contain an unsafe food additive”, for living bitters tonic; FDA published the listing on May 22, 2023.

Has FDA refused shipments from Capital O2 Natural Health Company Ltd?

Yes. FDA refused 17 shipment lines from Capital O2 Natural Health Company Ltd between September 7, 2018 and March 18, 2026. The most recent, on March 18, 2026, was aloe (herbal and botanical (not teas) ii (continued)), charged as UNSAFE ADD (food additive unsafe under section 409).

Why did FDA refuse Capital O2 Natural Health Company Ltd's shipments?

The most frequent charges are UNAPPROVED (unapproved new drug, 9 lines) and DIRECTIONS (directions, 5 lines).

What is Capital O2 Natural Health Company Ltd's FEI number?

Capital O2 Natural Health Company Ltd's FDA Establishment Identifier (FEI) is 3013153905.

Can shipments from Capital O2 Natural Health Company Ltd still enter the U.S.?

Shipments of living bitters tonic from Capital O2 Natural Health Company Ltd can be detained without physical examination under Import Alert 99-45; 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).