Good Stuff Cacao

WARNING LETTER Good Stuff Cacao MARCS-CMS 729744 — July 02, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email with Confirmation of Receipt Product: Food & Beverages Recipient: Recipient Name Ms. Barbara J. Mietling Recipient Title Co-Owner Good Stuff Cacao 631 Hideaway Ln Rock Island , TN 38581-4246 United States (b)(6), (b)(7)(C) Issuing Office: Human Foods Program United States WARNING LETTER July 2, 2026 CMS # 729744 Dear Ms. Mietling: The United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://goodstuffcacao.com in April 2026 and determined that you take orders there for your Goji Berries, Green Tea, Raw Cacao Powder, and Crystalized Raw Honey products. The claims on your website, https://goodstuffcacao.com, establish that these products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov. Examples of some of the claims that provide evidence that your products are intended for use as drugs include: On your website for Goji Berries, https://goodstuffcacao.com/products/goji-berry?_pos=1&_sid=4b101b33a&_ss=r, an image of your product label includes the following statements: "Anti-Cancer" "Anti-Diabetic" "Antimicrobial" On your website for Green Tea, https://goodstuffcacao.com/products/green-tea?_pos=1&_sid=ac5debabb&_ss=r, an image of your product label includes the following statements: "Lowers Risk of Heart Disease" "Fights Alzheimer's, Parkinson's and More" "Reduces Anxiety" On your website for Raw Cacao Powder, https://goodstuffcacao.com/products/raw-cacao-powder?_pos=1&_sid=f79053364&_ss=r, an image of your product label includes the following statements: "Fights Tooth Decay" "Regulate Blood Sugar" "Lower Blood Pressure" On your website for Crystallized Raw Honey, https://goodstuffcacao.com/products/crystalized-raw-honey?_pos=1&_sid=519622a80&_ss=r, an image of your product label includes the following statement: "Antiviral" Your Goji Berries, Green Tea, Raw Cacao Powder, and Crystalized Raw Honey 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 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 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. Misbranded Drugs A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 C.F.R. § 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. §353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner. Your Goji Berries, Green Tea, and Raw Cacao Powder are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, your Goji Berries, Green Tea, and Raw Cacao Powder fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. § 331(a)]. This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your 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. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction. Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. Please send your reply to the Food and Drug Administration via email to HFP-OCE-Labeling@fda.hhs.gov, copying Simone E. Hollis, Compliance Officer, at Simone.Hollis@fda.hhs.gov. If sending a response by mail, address to Food and Drug Administration Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Critical Foods and Dietary Supplement Enforcement HFS-608, 5001 Campus Drive, College Park, MD 20740. If you have any questions regarding any issues in this letter, please contact HFP-OCE-Labeling@fda.hhs.gov, copying Simone E. Hollis at Simone.Hollis@fda.hhs.gov, and include reference #729744 on any submissions and within the subject line of any email correspondence to the agency. Sincerely, /S/ Maria S. Knirk, JD, MBA Director, Office of Enforcement Office of Compliance and Enforcement Human Foods Program Content current as of: 09/29/2026 Regulated Product(s) Food & Beverages