DLG Naturals, Inc.

Warning LetterClosed

Mary Jo Knueppel Chief Executive Officer DLG Naturals, Inc. 2949 Venture Drive, Suite 100 Janesville , WI 53546-8502 United StatesFEI 3008391301Issued Apr 28, 2022Office of Human and Animal Food Operations – West Division 1

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3008391301.

Violations0

Issue DateApr 28, 2022

Product TypeDrugs

StatusClosed

Closeout LetterJul 21, 2023

Letter Details

Firm: DLG Naturals, Inc.
Location: Mary Jo Knueppel Chief Executive Officer DLG Naturals, Inc. 2949 Venture Drive, Suite 100 Janesville , WI 53546-8502 United States
FEI Number: 3008391301
Country: United States
Issue Date: April 28, 2022
Issuing Office: Office of Human and Animal Food Operations – West Division 1
Product Type: Drugs
Status: Closed
Closeout Letter: July 21, 2023

Summary

DLG Naturals, Inc. was cited for selling four botanical products—Nilotica East African Shea Butter, Kalahari Melon Seed Oil, Baobab Oil, and Kigelia Africana Fruit Extract—as unapproved new drugs in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. The company made disease treatment and body function claims on its website (such as therapeutic properties for Baobab Oil) that caused these products to qualify as drugs under FDA definition, yet they lacked required FDA approval before being marketed and sold. The violations were identified during a facility inspection in September-October 2021 and confirmed through a subsequent review of the company's website in March 2022.

DLG Naturals, Inc. FDA Warning Letter, April 28, 2022