Healthylab Mexicana, S.A. de C.V.

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

Refusal charges, in plain English

• NUTRIT LBL5 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.

• FALSE4 refused lines

  False or misleading labeling

  The labeling appeared to be false or misleading in some particular.

• UNSAFE COL4 refused lines

  Color additive unsafe under section 721

  The product appeared to be, or to contain, a color additive that is unsafe within the meaning of section 721(a) of the FD&C Act, the section that governs which color additives may be used and how.

• COLOR LBLG2 refused lines

  Artificial coloring not declared

  The product appeared to contain an artificial coloring without labeling that states that fact.

• 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.

• 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.

• UNAPPROVED1 refused line

  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.

Questions about Healthylab Mexicana, S.A. de C.V.

Is Healthylab Mexicana, S.A. de C.V. on an FDA import alert?

Yes. As of October 26, 2026, Healthylab Mexicana, S.A. de C.V. is on the red list of FDA Import Alert 45-02, “Foods with illegal or undeclared colors”, for obix-tea 15c dietary supplement; FDA published the listing on March 30, 2018.

Has FDA refused shipments from Healthylab Mexicana, S.A. de C.V.?

Yes. FDA refused 11 shipment lines from Healthylab Mexicana, S.A. de C.V. between January 9, 2018 and July 18, 2019. The most recent, on July 18, 2019, was herbals & botanicals (not teas), n.e.c., charged as UNSAFE COL (color additive unsafe under section 721).

Why did FDA refuse Healthylab Mexicana, S.A. de C.V.'s shipments?

The most frequent charges are NUTRIT LBL (nutrition information missing from label, 5 lines) and FALSE (false or misleading labeling, 4 lines).

What is Healthylab Mexicana, S.A. de C.V.'s FEI number?

Healthylab Mexicana, S.A. de C.V.'s FDA Establishment Identifier (FEI) is 3012133601.

Can shipments from Healthylab Mexicana, S.A. de C.V. still enter the U.S.?

Shipments of obix-tea 15c dietary supplement from Healthylab Mexicana, S.A. de C.V. can be detained without physical examination under Import Alert 45-02; 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).