The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) regulate dietary supplements, but these products do not undergo the same pre-market approval process for safety or efficacy as prescription drugs. This means consumers must be vigilant about label content. Certain claims are prohibited, particularly those implying a product can cure diseases or exaggerating benefits, as are testimonials directly on the label.
Prohibited Medical Claims
Dietary supplements are intended to supplement the diet, not to treat, cure, mitigate, or prevent disease. Any claim that suggests a supplement can achieve these outcomes is a drug claim and is prohibited unless the product is approved as a drug.
Examples of Illegal Disease Claims
- Statements claiming to cure or treat specific conditions like arthritis or hypertension.
- Using symbols that imply a benefit for diseases, such as a heart symbol for heart disease.
- Phrases suggesting a product can resolve a medical condition.
- Claims comparing a supplement's effectiveness to that of a prescribed drug.
Unsubstantiated and Misleading Information
Beyond disease claims, other deceptive statements are also prohibited. These often make exaggerated promises lacking scientific support.
Types of Misleading Statements
- Vague or exaggerated terms: Phrases like "proven to work miracles" or unsubstantiated "clinically proven" claims are considered misleading.
- False guarantees: Promising "guaranteed results" or asserting a product is "100% safe" is prohibited.
- False 'Natural' claims: Implying safety solely because a product is "natural" is not allowed.
Prohibited Labeling Elements
The FDA provides guidance on what should not be included directly on the Supplement Facts panel or product label to ensure clarity and factual information.
Testimonials
Individual user testimonials about a product's effectiveness should not be on the product label. They are permissible in marketing materials but not on the packaging itself.
Confusing Scientific Jargon
Supplement labels should be easily understood by consumers. Excessive or confusing scientific terminology, like certain 'nanocluster' claims, is prohibited if it is misleading and implies an unverified level of scientific validity.
Comparison of Prohibited vs. Permitted Claims
Distinguishing between allowed and disallowed claims is vital. The table below highlights the differences.
| Feature | Permitted Claim (Structure/Function Claim) | Prohibited Claim (Drug Claim) |
|---|---|---|
| Purpose | Describes the role of a nutrient in affecting the body's structure or function. | States or implies the product can treat, cure, or prevent a specific disease. |
| Example (Bones) | "Calcium builds strong bones". | "Treats osteoporosis". |
| Example (Immune) | "Supports immune health". | "Prevents the common cold". |
| Example (Energy) | "Helps support energy metabolism." | "Cures chronic fatigue." |
| Required Disclaimer | Must include the statement: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease". | Requires FDA approval to market the product as a drug. |
Why Are These Items Prohibited?
These regulations aim to protect consumers. Supplements don't undergo pre-market testing like drugs, so the FDA relies on manufacturers for safety and accurate labeling. Prohibiting misleading claims prevents false promises that could harm health or lead people to avoid necessary medical treatment. For example, claiming a supplement shrinks tumors would cause the FDA to regulate it as an unapproved drug. Understanding these rules helps consumers identify deceptive marketing.
Conclusion
Being a knowledgeable consumer of dietary supplements means understanding which elements are prohibited on labels. Illegal disease claims, exaggerated benefits, unverified testimonials, and confusing scientific terms are red flags. Look for products with clear, factual labels that comply with regulations, including the required disclaimer for structure/function claims, to make safe and informed choices.
Additional Resources
For more detailed information on dietary supplement regulations and labeling guidelines, refer to the official FDA Dietary Supplement Labeling Guide.
