Cheevalome

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

Refusal charges, in plain English

• 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 Cheevalome

Is Cheevalome on an FDA import alert?

Yes. As of October 25, 2026, Cheevalome is on the red list of FDA Import Alert 54-15, “Supplements and ingredients containing kratom”, for mitragyna speciosa (kratom capsules); FDA published the listing on November 26, 2024.

Has FDA refused shipments from Cheevalome?

Yes. FDA refused 1 shipment line from Cheevalome on October 30, 2024. The most recent, on October 30, 2024, was kratom (herbal and botanicals, not teas ii), charged as UNAPPROVED (unapproved new drug).

Why did FDA refuse Cheevalome's shipments?

The most frequent charge is UNAPPROVED (unapproved new drug, 1 line).

What is Cheevalome's FEI number?

Cheevalome's FDA Establishment Identifier (FEI) is 3032397308.

Can shipments from Cheevalome still enter the U.S.?

Shipments of mitragyna speciosa (kratom capsules) from Cheevalome can be detained without physical examination under Import Alert 54-15; 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).