Legal Definitions - two-controlled-studies standard

The two-controlled-studies standard is a specific requirement set by the Federal Trade Commission (FTC) for manufacturers of over-the-counter (OTC) painkillers. This standard dictates that before a company can advertise that its painkiller is superior to another brand—for example, by claiming it works better or causes fewer side effects—it must first substantiate these claims with evidence from two separate, well-designed, and scientifically controlled studies. This rule helps ensure that advertising claims about these widely used products are truthful and not misleading to consumers.

Here are some examples of how this standard applies:

• Imagine a pharmaceutical company developing a new ibuprofen product called "RapidRelief." The company believes its unique formulation allows the painkiller to start working significantly faster than the leading competitor. To advertise "RapidRelief: Starts working 20 minutes faster than Brand X!" on television and in magazines, the manufacturer would be required by the FTC to conduct two distinct, scientifically controlled studies. Each study would need to objectively measure and confirm that RapidRelief consistently provides pain relief more quickly than Brand X. Without these two independent studies, the FTC would prohibit the company from making such a comparative claim in its advertising.

• Consider a generic acetaminophen manufacturer that wants to promote its product, "GentleEase," by claiming it causes less stomach upset compared to the most popular brand of acetaminophen. To legally use the slogan "GentleEase: The acetaminophen with fewer side effects for your stomach" in its marketing campaigns, the company must first complete two separate, rigorous clinical trials. These trials would need to compare the incidence and severity of gastrointestinal side effects between GentleEase and the leading brand, providing robust scientific data to support the claim of reduced stomach irritation. If only one study existed, or if the studies were not scientifically controlled, the advertising claim would not meet the FTC's standard.

• Suppose a company introduces a new children's liquid pain reliever, "KidComfort," and wants to advertise that it reduces fever more effectively than a competitor's similar product. To make the claim "KidComfort: More effective at lowering your child's fever than Brand Y" in its promotional materials, the manufacturer would need to conduct two separate, well-controlled studies. These studies would compare the fever-reducing efficacy of KidComfort against Brand Y in a pediatric population, providing clear, consistent scientific evidence to substantiate the claim of superior performance. If the company could only provide one study, or if the studies lacked proper scientific controls, the FTC would prevent them from making that specific advertising claim.