The U.S. Food and Drug Administration (FDA) has issued new warning letters highlighting significant public health risks related to improperly canned desserts and unapproved drug claims found in dietary supplements. This announcement, released in June 2025, raises critical concerns that every consumer should be aware of when choosing food and wellness products.
Why the FDA Issued These Warning Letters
The FDA frequently monitors food and supplement manufacturers to ensure that they comply with federal safety and marketing regulations. This latest round of warning letters pertains to two major concerns:
1. Botulism Risk in Canned Desserts
Improperly canned low-acid foods—such as custards, puddings, and other creamy desserts—can harbor Clostridium botulinum, the dangerous bacterium responsible for botulism, a rare but potentially deadly illness. These hazards arise when commercial canning protocols are not strictly followed, particularly with low-acid, shelf-stable foods.
⚠️ Botulism Facts: According to the CDC, botulism can cause breathing difficulty, muscle paralysis, and even death. It is particularly dangerous in infants and older adults.
2. Illegal Drug Claims in Dietary Supplements
Several dietary supplements were found to be marketed with unauthorized drug claims—such as promising to “treat” or “cure” specific diseases—violating the Federal Food, Drug, and Cosmetic Act. Supplements cannot legally be marketed as treatments unless they go through FDA-approved clinical testing and review, like pharmaceuticals.
🧠 Did You Know? The FDA classifies dietary supplements as food, not drugs, under the Dietary Supplement Health and Education Act (DSHEA). Learn more about supplement regulation from the FDA’s official supplement guidance.
Implications for Consumers & Businesses
Understanding the risks highlighted by the FDA can help consumers make safer choices and help manufacturers stay compliant.
⚠️ Health Risks
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Botulism is a medical emergency that can lead to irreversible paralysis or death.
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Supplements with unfounded drug claims may mislead consumers into skipping necessary medical treatment.
⚖️ Regulatory Consequences
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Manufacturers found violating these regulations may face product recalls, civil penalties, or even legal action.
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Repeated or severe violations can lead to product seizures or business shutdowns.
📢 Consumer Awareness
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This warning emphasizes the need for consumers to be able to identify red flags in product labeling.
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It also underscores the importance of buying canned goods and health supplements from reputable, compliant manufacturers.
Safety Measures for Consumers
The FDA advises consumers to take the following precautions when buying and using food or dietary supplements:
✅ Check Labels Carefully
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Look for professionally printed labels.
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Watch out for red-flag phrases like “cures,” “treats all diseases,” or “no side effects,” especially in supplements.
🛒 Be Cautious with Homemade or Small-Batch Canned Goods
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Avoid shelf-stable desserts and other low-acid foods that are not commercially canned or lack evidence of proper canning methods.
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If you’re canning at home, follow the USDA’s home canning guidelines to prevent botulism.
🔎 Stay Informed
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Sign up for recall alerts and safety updates from the FDA Recalls page.
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Report any adverse reactions or issues to the FDA’s MedWatch program.
Frequently Asked Questions (FAQs)
Q: What are the symptoms of botulism?
A: Early symptoms may include blurred vision, difficulty swallowing, muscle weakness, and respiratory issues. Seek immediate medical attention if you suspect botulism.
Q: How do I know if a supplement is making illegal drug claims?
A: Supplements should not make definitive claims about treating or curing medical conditions. These claims are only allowed for FDA-approved drugs. Look for structure/function claims (e.g., “supports heart health”) instead of disease treatment promises.
Q: Are all canned desserts unsafe?
A: No. Commercially produced products from licensed facilities that follow FDA-approved processes are generally safe. Be cautious with homemade or improperly labeled canned desserts.
Q: What can manufacturers do to stay compliant?
A: Follow current Good Manufacturing Practices (cGMPs), consult FDA regulations, and avoid making health claims not supported by clinical evidence or FDA approval.
Conclusion
The FDA’s warning letters serve as a critical reminder for both consumers and manufacturers. For consumers, awareness and vigilance are your best tools when choosing food and dietary products. For businesses, strict compliance with safety regulations and truthful marketing are not optional—they are essential for public trust and legal standing.