FDA Warns Seller Over 'Anti-Cancer' Goji and Cacao Labels

On September 29, 2026, the FDA publicly posted a warning letter, dated July 2, 2026, that it sent to Good Stuff Cacao over disease claims on its food products. The agency determined that marketing ordinary foods with phrases like "Anti-Cancer," "Anti-Diabetic," and "Lowers Risk of Heart Disease" legally converts those pantry items into unapproved new drugs. The letter asked the company to respond in writing and warned that failing to fix the problems may lead to legal action.

Key takeaways:

• The FDA issued a warning letter (dated July 2, 2026; posted September 29, 2026) to Good Stuff Cacao for labeling goji berries, green tea, raw cacao, and honey with drug-level disease claims like "Anti-Cancer" and "Anti-Diabetic".
• Under federal law (FD&C Act section 201(g)(1)(B)), marketing conventional food products to cure, treat, or prevent disease makes them drugs; FDA said these four are unapproved new drugs, and three are also misbranded because they lack adequate directions for lay use.
• The letter is about marketing claims; it cites no contamination and announces no recall.
• Shoppers must distinguish between permitted structure/function claims and unauthorized disease-prevention promises when reading food labels.

What happened

The U.S. Food and Drug Administration (FDA) Human Foods Program issued a formal warning letter (CMS #729744) to Good Stuff Cacao, dated July 2, 2026, and posted it on FDA's warning letters page on September 29, 2026. The letter was addressed to co-owner Barbara J. Mietling in Rock Island, Tennessee. The subject of the action was classified as "New Drug/Misbranded."

According to the letter, the FDA reviewed the company's website, goodstuffcacao.com, in April 2026. The company took orders there for food products, including Goji Berries, Green Tea, Raw Cacao Powder, and Crystallized Raw Honey. During that review, regulators found that product label images on the website featured explicit therapeutic claims.

The agency quoted specific phrases from product label images shown on the website. Goji Berries were labeled with terms such as "Anti-Cancer," "Anti-Diabetic," and "Antimicrobial." The Green Tea label claimed that the product "Lowers Risk of Heart Disease," "Fights Alzheimer's, Parkinson's and More," and "Reduces Anxiety." Raw Cacao Powder featured claims including "Fights Tooth Decay," "Regulate Blood Sugar," and "Lower Blood Pressure," while the Crystallized Raw Honey was labeled as "Antiviral."

Maria S. Knirk, Director of the Office of Enforcement within the Human Foods Program Office of Compliance and Enforcement, signed the warning letter. The document instructed the firm to submit a written response within 15 working days detailing the specific steps taken to correct the violations and prevent their recurrence.

What changed

When a seller markets a food item with claims that it can prevent, mitigate, treat, or cure a disease, the regulatory classification of the product changes under federal law. Section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) defines drugs to include articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Because those label images promised disease benefits, the FDA concluded the items are intended for use as drugs.

Because the FDA found the four foods are not generally recognized as safe and effective for those uses, it called them "new drugs" under section 201(p) of the FD&C Act. With exceptions the letter says do not apply, a new drug cannot be introduced into interstate commerce without prior FDA approval.

Furthermore, the FDA determined that the Goji Berries, Green Tea, and Raw Cacao Powder are misbranded drugs under section 502(f)(1) of the FD&C Act. Under federal regulations, drug labeling must bear adequate directions for use so a layperson can use the product safely for its intended purposes. The agency said those three products are intended to treat one or more diseases that are not amenable to self-diagnosis or treatment without a licensed practitioner's supervision, so adequate directions for a layperson cannot be written. Selling a misbranded drug across state lines violates the Act.

Who is affected

The warning letter specifically names four distinct products offered on the Good Stuff Cacao website:

• Goji Berries
• Green Tea
• Raw Cacao Powder
• Crystallized Raw Honey

The FDA did not disclose whether these products are distributed in physical retail stores, nor did it disclose the total sales volume or the geographic boundaries of past shipments beyond website sales. Furthermore, the agency did not identify any consumer illnesses, adverse reactions, or physical injuries associated with consuming the products.

It is critical to distinguish between a marketing violation and a physical hazard. The FDA did not announce any contamination, chemical adulteration, or safety-testing failures related to the ingredients themselves. Similarly, no recall was announced in the warning letter. The regulatory action is about the claims shown on the website's product label images, not the safety of the foods themselves.

What it means for shoppers

For consumers, seeing words like "Anti-Cancer" or "Regulate Blood Sugar" on a bag of berries or cocoa might look like an objective health summary, but federal labeling standards treat those words differently. When shopping online or browsing specialty grocery aisles, understanding How to Read a Food Label: The Ingredient List, Line by Line is essential for separating real nutritional components from unverified marketing.

Shoppers should understand that the FDA's letter does not state whether goji berries, green tea, cacao, or honey have measurable biological effects on human diseases. Instead, the letter says that selling foods with disease-treatment claims, without FDA drug approval, violates federal law. FDA approves a new drug based on scientific data showing it is safe and effective; these foods never went through that review.

If you currently have these products in your kitchen, the warning letter does not identify a contamination risk requiring disposal. However, shoppers managing chronic medical conditions should never rely on conventional foods, teas, or honey as substitutes for physician-prescribed treatments or evidence-based care plans.

The background

Federal oversight separates label statements into distinct categories: nutrient content claims, structure/function claims, and health claims. Regulators spell out these boundaries in official agency guidance on label claims for conventional foods and dietary supplements. Understanding these definitions helps explain why Good Stuff Cacao crossed into drug regulation territory.

A health claim explicitly links an ingredient or food substance to a reduced risk of a specific disease or health-related condition. Under the Nutrition Labeling and Education Act (NLEA), authorized health claims must meet the Significant Scientific Agreement standard and receive direct FDA authorization by regulation. Alternatively, claims may be based on authoritative statements from scientific bodies under the Food and Drug Administration Modernization Act (FDAMA), or permitted as qualified health claims under agency enforcement discretion when scientific evidence is emerging but not definitive.

In contrast, structure/function claims describe how an ingredient or nutrient affects the normal structure or function of the human body. FDA's own examples include "calcium builds strong bones" and "antioxidants maintain cell integrity." Structure/function claims are not subject to premarket review, but they may not explicitly or implicitly link the effect to a disease.

A bold promise on the front of a package is no shortcut to judging a food, a point we cover in Myth: One Health Score Tells You If a Food Is Good for You. When a food label crosses the line from describing normal physiological support to using words like "Anti-Diabetic" or "Fights Alzheimer's," the FDA treats the product as an unapproved new drug.

What to watch next

The letter gave Good Stuff Cacao 15 working days from receipt to provide a formal written response to the FDA. The company is required to outline the corrective actions it has taken or plans to take to bring its labeling and website into full compliance with the FD&C Act.

The FDA warned that failing to adequately address the matter may result in legal action, including seizure and injunction. The FDA has not disclosed whether Good Stuff Cacao has responded or whether the cited claims have been changed or removed.

Limitations exist regarding what the current evidence establishes. The warning letter does not evaluate clinical evidence for or against cacao, goji berries, green tea, or honey. It finds only that these products were marketed with drug claims without FDA approval.