The Core Prohibition: Disease Claims
The most significant restriction on dietary supplement claims is the prohibition against making disease claims. A product claiming to diagnose, cure, mitigate, treat, or prevent any disease is legally classified as a drug and must undergo FDA approval. Supplement manufacturers cannot state or imply their product can, for instance, prevent cancer, cure a cold, or treat diabetes. Making such a claim is illegal and can result in severe penalties.
The Mandatory Disclaimer
Unlike drugs, supplements do not require pre-market FDA approval. Therefore, any "structure/function" claim must include a specific, bolded disclaimer.
The Fine Line: Structure/Function vs. Disease Claims
Distinguishing between a permissible structure/function claim and an impermissible disease claim can be challenging. A structure/function claim describes how a nutrient affects the normal function or structure of the body, such as “Calcium builds strong bones”. A disease claim, conversely, refers to a specific disease or category of diseases, for example, “This product prevents osteoporosis”. Manufacturers must be careful to avoid language that, even if not explicitly naming a disease, implies a disease-related benefit. The FTC actively monitors advertising claims for such implications.
Deceptive Advertising and Misleading Tactics
The Federal Trade Commission (FTC) plays a crucial role in regulating supplement advertising to prevent deceptive practices. The FTC mandates that companies have "competent and reliable scientific evidence" for their claims, typically requiring rigorous human clinical studies. The FTC also specifically prohibits several misleading advertising techniques.
Forbidden Marketing Elements
- Misrepresenting FDA Approval: Supplements cannot claim to be or imply they are “FDA approved”.
- Misleading Endorsements: Testimonials from consumers or experts are prohibited if used to make claims the company cannot scientifically support. Phrases like “results not typical” are insufficient to correct a deceptive testimonial.
- Implying Claims Through Third-Party Information: Using scientific literature or other materials to imply benefits not supported by the product's own evidence is not allowed.
- Vague Qualifiers for Weak Science: Terms such as “preliminary” or “promising” may not be adequate disclaimers for claims based on limited scientific evidence, as consumers might perceive them as stronger support than they are.
Comparison of Permissible and Impermissible Claims
| Claim Type | Permissible Example | Impermissible Example |
|---|---|---|
| Effect on Body System | “Supports a healthy cardiovascular system.” | “Treats high blood pressure.” |
| Symptom Relief | “Alleviates occasional constipation.” | “Cures chronic constipation.” |
| Effect on Levels | “Helps maintain cholesterol levels already within the normal range.” | “Lowers serum cholesterol levels.” |
| Immune System Support | “Supports immune system function.” | “Combats viral infections.” |
| Mental State | “Helps reduce everyday stress and tension.” | “Alleviates depression.” |
| Bone Health | “Calcium builds and maintains strong bones.” | “This product prevents osteoporosis.” |
How to Identify and Avoid Misleading Claims
Consumers can identify potential red flags by carefully examining supplement labels and advertisements. Beyond illegal disease claims, several other indicators can suggest a claim is misleading.
Key Red Flags
- Unrealistic Promises: Claims that seem too good to be true, like rapid weight loss or instant energy boosts, are often deceptive.
- Undefined or Meaningless Terms: Words like “natural” or “pharmaceutical strength” lack legal definitions and do not guarantee quality, safety, or effectiveness.
- Absence of Third-Party Testing: Voluntary testing by organizations like NSF or USP verifies label accuracy and purity, and its absence can be a warning.
- Product vs. Ingredient Studies: Be wary of claims based solely on studies of individual ingredients, as the effect may differ in the final product.
Conclusion
Understanding the regulations governing dietary supplements is key to making informed choices. Supplements are legally barred from making disease claims, a function reserved for approved drugs. Both the FDA and FTC enforce rules to prevent misleading advertising, requiring scientific evidence for claims and prohibiting deceptive practices like unsubstantiated endorsements. Consumers should be critical of unrealistic promises and understand the difference between permissible structure/function claims and prohibited disease claims. For detailed information, consult {Link: Congress.gov https://www.congress.gov/crs-product/R48623}.
