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Who Defines Dermocosmetics? - Part Ⅲ

Regulatory Fog and Trust Crisis: How Can Dermocosmetics Win the Right to Define Themselves?

As boundaries between skincare products and medical systems increasingly blur, regulatory uncertainty has become a core obstacle to the global expansion of dermocosmetics.

The report points out that the term "dermocosmetics" has not yet been officially adopted by the FDA or EU Cosmetic Regulation (EC), and its legal status resembles the ambiguously defined industry term "cosmeceutical".

In other words, dermocosmetics are neither strictly cosmetics nor fully classified as pharmaceuticals. Such vague classification makes many brands tend to exaggerate the "medical professionalism" in their promotion without bearing the same legal responsibility as drugs.

Brian Freedman from Evolved By Nature pointed out that once efficacy claims cross a therapeutic red line, brands may face legal risks of illegal drug promotion. He emphasized the urgent need for clear definitional standards to delineate responsibility boundaries between dermocosmetics, conventional skincare, and medical products. Otherwise, misusing terms such as "clinical-grade", "prescription-strength", or "dermatologist-level" will erode consumer trust in truly scientifically supported products in the long run.

Regulatory gaps not only create a space for brand promotion and operation, but also mean cross-border development must address fragmented challenges like formula compliance, label scrutiny, and ingredient restrictions. Kelly A. Dobos stated, "Dermocosmetics often feature more complex formulations and stronger efficacy claims than traditional skincare products, so in terms of formula compliance, data submission, and efficacy verification systems, they must exceed traditional standards." She stresses that dermocosmetics are not equivalent to "cosmeceuticals" or "performance skincare", and such confusion is very dangerous at the regulatory level. She called on the industry to establish a unified terminology system, clarify which products can use the term "dermocosmetics", and promote the establishment of a third-party certification system to stabilize consumer awareness and market expectations.

Who Defines Dermocosmetics? - Part Ⅲ 1

The report also urges the industry action on the following three key tasks:

  • Establish a clear definitional framework for dermocosmetics
  • Advance international regulatory harmonization and standardization
  • Promote independent third-party certification mechanisms to verify efficacy testing, safety validation, and label compliance

The rise of dermocosmetics represents a profound industry transformation driven by science and evolving consumer cognition. It is challenging traditional skincare value system and reshaping the logic of formula development, ingredient selection and efficacy verification. Crucially, it also reminds us that "medical credibility" cannot rely on conceptual packaging, but must be based on clinical pathways, data support, and tangible results.

From formulas to regulations, from consumer education to industry self-discipline, the future of dermocosmetics remains undefined. But this debate over what constitutes dermocosmetic has become an undeniable issue in the contemporary beauty industry.

Who Defines Dermocosmetics? - Part Ⅱ
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