Naturelle LLC

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

Refusal charges, in plain English

• UNSAFE ADD6 refused lines

  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.

• UNAPPROVED4 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.

• DIRSEXMPT2 refused lines

  DIRSEXMPT

Questions about Naturelle LLC

Is Naturelle LLC on an FDA import alert?

Yes. As of October 26, 2026, Naturelle LLC is on the red list of FDA Import Alert 99-45, “Foods that are or contain an unsafe food additive”, for dabur chyawanprash; FDA published the listing on November 27, 2023.

Has FDA refused shipments from Naturelle LLC?

Yes. FDA refused 6 shipment lines from Naturelle LLC between December 18, 2023 and July 18, 2025. The most recent, on July 18, 2025, was herbals & botanicals (not teas), n.e.c., charged as UNSAFE ADD (food additive unsafe under section 409).

Why did FDA refuse Naturelle LLC's shipments?

The most frequent charges are UNSAFE ADD (food additive unsafe under section 409, 6 lines) and UNAPPROVED (unapproved new drug, 4 lines).

When was Naturelle LLC last inspected by FDA?

FDA's most recent inspection of Naturelle LLC with a final classification is dated March 17, 2019 and was classified VAI (Voluntary Action Indicated).

What is Naturelle LLC's FEI number?

Naturelle LLC's FDA Establishment Identifier (FEI) is 3009907395.

Can shipments from Naturelle LLC still enter the U.S.?

Shipments of dabur chyawanprash from Naturelle LLC can be detained without physical examination under Import Alert 99-45; 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).