DLG Naturals, Inc.
FDA issued a warning letter to DLG Naturals, Inc. (Janesville, WI) after inspecting their facility and reviewing their website in 2022, finding that four products — Nilotica East African Shea Butter, Kalahari Melon Seed Oil, Baobab Oil, and Kigelia Africana Fruit Extract — were being marketed with disease-treatment and structure/function claims that rendered them unapproved new drugs under the FD&C Act. The website claims referenced anti-cancer, anti-inflammatory, eczema, psoriasis, rheumatism, and other therapeutic uses without FDA approval. FDA also flagged falsified Certificates of Analysis and mislabeled cosmetic product lots. The company was required to respond within 15 working days with corrective actions, and FDA warned that failure to comply could result in seizure and/or injunction.
Flagged claims (6)
KMS Oil dates back to the time of the ancient Egyptians with a long history of providing nutrients and healing properties to the skin. In many countries, this was traditionally used as a skin treatment for sores, acne and leg ulcers.
A cosmetic industry leader of beta-sitosterol, it has been shown to have properties that are anti-inflammatory, anti-cancer, and anti-bacterial. It is non-sensitizing, non-irritating, and full of vitamins and fatty acids beneficial for…eczema, psoriasis, and burns.
The butter will rejuvenate skin cells with its content of amyrin and lupeol triterpenes. Studies show its unique combination of unsaponifiables contain UV-B absorbing properties that equal an SPF value of about 3-4.
Kigafirm is a targeted extract of Kigelia Africana fruit that maximizes firming and anti-inflammatory activity.
Kigelia Africana has been traditionally used for breast firming in central Africa and is said to have aphrodisiac properties. Its traditional medicinal applications include the treatment of various skin related disease such as eczema, fungal infections, psoriasis and boils.
Nilotica Shea is attributed to a number of additional functions, including alleviating rheumatism, reduction of dermatitis, strong anti-aging action, a natural emollient, and other benefits.
Required actions (3)
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within 15 working days of receiving this letter.
You should take prompt action to address the violations cited in this letter. Failure to promptly address these violations may result in enforcement action without further notice, including, without limitation, seizure and/or injunction.
We request that your response explains how you intend to address this issue to prevent recurrence.
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