Selecting a Route to Market

Unlike foods, including dietary supplements, the safety of a drug is based on a benefit to risk ratio. Benefit is an assessment of the drug s efficacy, balanced against any negatives with respect to a particular indication in a target population (24). Thus, a drug that is deemed safe to treat leukemia may not be safe to treat osteoarthritis. 

Similar to drugs, dietary supplements can make claims to affect the structure or function of the body. However, supplements are specifically prohibited from making disease claims. A dietary supplement bearing structure or function claims is also required to carry the following disclaimer on the product label The FDA has not evaluated this claim. This product is not intended to diagnose, mitigate, treat, cure or prevent disease (19). 

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