El Mana

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

Refusal charges, in plain English

• POISONOUS1 refused line

  Poisonous or deleterious substance

  The product appeared to bear or contain a poisonous or deleterious substance which may render it injurious to health.

• 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.

• UNSAFE ADD1 refused line

  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.

Questions about El Mana

Is El Mana on an FDA import alert?

Yes. As of October 25, 2026, El Mana is on the red list of FDA Import Alert 54-16, “Foods/supplements with active pharmaceutical ingredient”, for nettle powder (ortiga); FDA published the listing on December 10, 2021.

Has FDA refused shipments from El Mana?

Yes. FDA refused 1 shipment line from El Mana on November 19, 2021. The most recent, on November 19, 2021, was herbals & botanicals (not teas), n.e.c., charged as UNSAFE ADD (food additive unsafe under section 409).

Why did FDA refuse El Mana's shipments?

The most frequent charges are POISONOUS (poisonous or deleterious substance, 1 line) and UNAPPROVED (unapproved new drug, 1 line).

What is El Mana's FEI number?

El Mana's FDA Establishment Identifier (FEI) is 3005898719.

Can shipments from El Mana still enter the U.S.?

Shipments of nettle powder (ortiga) from El Mana can be detained without physical examination under Import Alert 54-16; 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).