Natural Elixirs Sdn Bhd

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

Refusal charges, in plain English

• UNAPPROVED3 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.

• FALSE2 refused lines

  False or misleading labeling

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

• 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.

Questions about Natural Elixirs Sdn Bhd

Is Natural Elixirs Sdn Bhd on an FDA import alert?

Yes. As of October 26, 2026, Natural Elixirs Sdn Bhd is on the red list of FDA Import Alert 54-16, “Foods/supplements with active pharmaceutical ingredient”, for ultra detox capsules; FDA published the listing on November 27, 2018.

Has FDA refused shipments from Natural Elixirs Sdn Bhd?

Yes. FDA refused 3 shipment lines from Natural Elixirs Sdn Bhd between July 31, 2018 and October 1, 2018. The most recent, on October 1, 2018, was senna (herbal & botanicals, not teas), charged as UNAPPROVED (unapproved new drug).

Why did FDA refuse Natural Elixirs Sdn Bhd's shipments?

The most frequent charges are UNAPPROVED (unapproved new drug, 3 lines) and FALSE (false or misleading labeling, 2 lines).

What is Natural Elixirs Sdn Bhd's FEI number?

Natural Elixirs Sdn Bhd's FDA Establishment Identifier (FEI) is 3014376401.

Can shipments from Natural Elixirs Sdn Bhd still enter the U.S.?

Shipments of ultra detox capsules from Natural Elixirs Sdn Bhd 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).