Translating Data into Claims and Interpreting Regulations: Science vs. Marketing

The term substantial evidence, coined by the US Food and Drug Administration (FDA) as part of the Federal Food, Drug and Cosmetic Act, applies mostly to new drug development, but also to products that are already approved. Although it is practically applied to drugs, it is important for the personal care industry to understand its rationale, especially since cosmetic products are becoming more sophisticated. Moreover, the same approach might be used when a claim issue regarding a personal care product arises and the FDA must make a judgment.

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