What must labeling claims in marketing applications be supported by?

Labeling claims in marketing applications must be supported by clinical data because this type of data provides robust evidence regarding the safety and efficacy of a product for its intended use. Regulatory authorities, such as the FDA, require that any claims made about a product’s benefits or performance are substantiated by scientific evidence derived from well-designed clinical studies. This ensures that the claims are not only credible but also protect public health by ensuring that marketed products meet established standards.

While competitive market analysis can offer insights into market position and consumer trends, it does not directly validate the claims made about a product's performance or safety. Similarly, consumer testimonials may provide anecdotal support but lack the rigorous scientific foundation needed to substantiate claims in a regulatory context. A cost-benefit analysis, while important for understanding the economic implications of a product, also does not serve to verify the accuracy of labeling claims. Therefore, clinical data stands out as the necessary support for marketing claims in regulatory submissions.