Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Your DLG Naturals products “Nilotica East African Shea Butter,” “Kalahari Melon Seed Oil,” “Baobab Oil,” (hereinafter referred to as “DLG Naturals products”) as well as Zuplex Botanicals’ “Kigelia Africana Fruit Extract” (also marketed as “Kigafirm”) products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), [21 U.S.C. 355(a) and 331(d)].
Passage 2Based on our review of your website, your DLG Naturals products and Zuplex Botanicals’ “Kigelia Africana Fruit Extract” products are drugs under section 201(g)(1) of the FD&C Act [21 U.S.C. 321(g)(1)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the body.
Passage 3A 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.
Passage 4KMS 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.
Passage 5The 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.
Passage 6Nilotica 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.
Passage 7Kigafirm is a targeted extract of Kigelia Africana fruit that maximizes firming and anti-inflammatory activity.
Passage 8Kigelia 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.
Passage 9Your DLG Naturals products and Zuplex Botanicals’ “Kigelia Africana Fruit Extract” product are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act [21 U.S.C. 321(p)].
Passage 10We note your firm has provided Certificates of Analysis (COAs) when no testing has been performed. Our investigators documented one instance where you provided a COA to your customer indicating a mold count of less than **(b)(4)** CFU/g; however, test results for the lot indicated a mold count of 720 CFU/g.
Passage 11Our investigators documented cosmetic products stored in containers either unlabeled or with incorrect lot numbers.