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More than a quarter of a century since Albert Kligman, M.D., Ph.D., introduced the term “cosmeceutical,” the existence of this group of compounds has never been officially or legally recognized, leaving this category of products largely unregulated.1 The United States Food and Drug Administration (USFDA) classifies personal care products as a drug, cosmetic, or both [e.g., antidandruff shampoos or moisturizers with sun protection factor (SPF)]. Cosmeceutical products, which are personal care products that may actually yield a biologic impact, fall between the cracks of these incomplete designations.

Most manufacturers of cosmeceutical formulations have established the clinical merit of their products despite the lack of official oversight, but some doubt is inevitable given the regulatory loophole, particularly when companies make extraordinary claims. Manufacturers typically test main ingredients and finished products in small in vivo trials, but rarely if ever publish results in the peer-reviewed literature.

Even though cosmeceuticals are not regulated by the FDA, there are standards and guidelines for good practices in many cases. Manufacturers that try to skirt this self-policing system risk a greater likelihood that their product(s) will not succeed. It is important for practitioners and consumers alike to be familiar with these standards. That is, claims made on cosmeceutical products routinely use the same terms or expressions none of which are made patently clear but are somewhat consistently used across manufacturers. Given the absence of regulatory oversight of these products, this chapter will read between the lines and explain the language used in cosmeceutical marketing claims. These terms and expressions are defined below, and further described according to the typical data used to support their marketing.



No standard definition has been established for “allergen-free” either, and no testing is required of companies. More often than not, “allergen-free” indicates that the product includes no fragrances on the European Union’s “List of Substances Which Cosmetic Products Must Not Contain Except Subject to Restrictions and Conditions Laid Down” or other compounds typically identified as allergens. Some manufacturers use human repeated insult patch testing (HRIPT) for allergy testing.


Each manufacturer defines this term in its own way, often using it liberally, as no standard definition of hypoallergenicity has been established. HRIPT of about 100 to 200 subjects and cumulative irritation testing (smaller panel) are the common methods of evaluation. Occasionally, photoreactivity testing is conducted, depending on the product type.


When a product lacks common fragrance ingredients, particularly those most often linked to allergic sensitivity, or a traditional fragrance intended to impart scent to a product, its manufacturer can label the formulation as fragrance-free. However, the appearance of the expression “fragrance-free” on a product does not necessarily mean that a fragrance is not included. Companies sometimes include fragrance subcomponents or botanicals to ...

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