Japan Bio Science Laboratory Co Ltd

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

Refusal charges, in plain English

• 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.

• 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.

• NCONTACT1 refused line

  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 LBL1 refused line

  Nutrition information missing from label

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

Questions about Japan Bio Science Laboratory Co Ltd

Is Japan Bio Science Laboratory Co Ltd on an FDA import alert?

Yes. As of October 26, 2026, Japan Bio Science Laboratory Co Ltd is on the red list of FDA Import Alert 99-39, “Imported foods that appear to be misbranded”, for organic ashitaba aojiru; FDA published the listing on June 11, 2019.

Has FDA refused shipments from Japan Bio Science Laboratory Co Ltd?

Yes. FDA refused 2 shipment lines from Japan Bio Science Laboratory Co Ltd between March 29, 2019 and April 4, 2019. The most recent, on April 4, 2019, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as UNAPPROVED (unapproved new drug).

Why did FDA refuse Japan Bio Science Laboratory Co Ltd's shipments?

The most frequent charges are UNAPPROVED (unapproved new drug, 2 lines) and LABELING (fair packaging and labeling act, 1 line).

What is Japan Bio Science Laboratory Co Ltd's FEI number?

Japan Bio Science Laboratory Co Ltd's FDA Establishment Identifier (FEI) is 3003704128.

Can shipments from Japan Bio Science Laboratory Co Ltd still enter the U.S.?

Shipments of organic ashitaba aojiru from Japan Bio Science Laboratory Co Ltd 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).