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WARNING LETTER

DLG Naturals, Inc. MARCS-CMS 622277 —


Delivery Method:
VIA UPS
Product:
Drugs
Food & Beverages

Recipient:
Recipient Name
Mary Jo Knueppel
Recipient Title
Chief Executive Officer
DLG Naturals, Inc.

2949 Venture Drive, Suite 100
Janesville, WI 53546-8502
United States

Issuing Office:
Office of Human and Animal Food Operations – West Division 1

United States


April 28, 2022

WARNING LETTER

Refer to CMS 622277

Dear Ms. Knueppel:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your manufacturing facility located at 2949 Venture Drive, Suite 130, Janesville, Wisconsin, on September 23, September 28, and October 6, 2021. We also reviewed your website at the Internet address www.dlgnaturals.com in March 2022 and have determined that you take orders there for the DLG Naturals, Inc. products “Nilotica East African Shea Butter,” “Kalahari Melon Seed Oil,” “Baobab Oil,” and Zuplex (PTY) Ltd.’s (hereinafter “Zuplex Botanicals”) “Kigelia Africana Fruit Extract.”

Your 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)]. As explained further below, introducing, or delivering these products for introduction into interstate commerce violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Unapproved New Drugs

Based 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.

Examples of some of the claims observed on your website www.dlgnaturals.com that provide evidence that your products are intended for use as drugs include, but may not be limited to, the following:

On the website www.dlgnaturals.com:

• From your “Baobab Oil” product webpage: “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.”

• From your “Kalahari Melon Seed Oil” product webpage: “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.”

• From your “Nilotica East African Shea Butter” product webpage:
    o “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.”
    o “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.”

• From your “Kigelia Africana Fruit Extract” product webpage:
    o “Kigafirm is a targeted extract of Kigelia Africana fruit that maximizes firming and anti-inflammatory activity.”
    o “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.”

Your 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)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 505(a) and 301(d) of the FD&C Act [21 U.S.C. 355(a) and 301(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. No approved applications are in effect for your products.

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. 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.

In addition to the above violations, we offer the following comments:

• We 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. We acknowledge that you voluntarily recalled product; however, we request that your response explains how you intend to address this issue to prevent recurrence.

• Our investigators documented cosmetic products stored in containers either unlabeled or with incorrect lot numbers. If lot-by-lot testing of your cosmetic ingredients occurs to ensure they are not adulterated, appropriate quality control operations should be employed to ensure lots are correctly identified. It is unclear whether corrective actions promised during the inspection have since been implemented.

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. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days of receiving this letter, state the reason for the delay and the timeframe within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made. If you believe your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

Please send your written response to Dianna Sonnenburg, Compliance Officer, U.S. Food and Drug Administration, at 250 Marquette Avenue, Suite 600, Minneapolis, Minnesota, 55401. If you have any questions regarding any issues in this letter, please contact Ms. Sonnenburg at Dianna.Sonnenburg@fda.hhs.gov.

Sincerely,
/S/

Michael Dutcher, DVM
District Director, Minneapolis District
Program Division Director, Office of Human
    and Animal Food Operations – West Division 1

 
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