Biotanico, Inc.

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

Refusal charges, in plain English

• HEALTH C2 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 FIRM2 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 INGRE2 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).

• NUTRIT LBL2 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.

• PLANT PART2 refused lines

  PLANT PART

• UNAPPROVED2 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.

Questions about Biotanico, Inc.

Is Biotanico, Inc. on an FDA import alert?

Yes. As of October 26, 2026, Biotanico, Inc. is on the red list of FDA Import Alert 99-39, “Imported foods that appear to be misbranded”, for clear skin formula (tablets); FDA published the listing on October 12, 2023.

Has FDA refused shipments from Biotanico, Inc.?

Yes. FDA refused 2 shipment lines from Biotanico, Inc. on December 19, 2023. The most recent, on December 19, 2023, was herbals & botanicals (not teas), n.e.c., charged as LIST INGRE (ingredients not listed).

Why did FDA refuse Biotanico, Inc.'s shipments?

The most frequent charges are HEALTH C (unauthorized nutrient content or health claim, 2 lines) and LACKS FIRM (manufacturer name and address missing, 2 lines).

When was Biotanico, Inc. last inspected by FDA?

FDA's most recent inspection of Biotanico, Inc. with a final classification is dated November 15, 2017 and was classified VAI (Voluntary Action Indicated).

What is Biotanico, Inc.'s FEI number?

Biotanico, Inc.'s FDA Establishment Identifier (FEI) is 3007289534.

Can shipments from Biotanico, Inc. still enter the U.S.?

Shipments of clear skin formula (tablets) from Biotanico, Inc. 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).