Title
Permissible Cosmetic Claims on Exfoliating Products
Law
Bfad Bureau Circular No. 23, S. 1999
Decision Date
Nov 24, 1999
The Bureau of Food and Drugs clarifies permissible claims for cosmetic preparations, specifically allowing terms like "exfoliate" and "exfoliant," provided that adequate evidence supports their efficacy in promoting skin renewal and treating acne.

Questions (BFAD BUREAU CIRCULAR NO. 23, S. 1999)

It clarifies and guides BFAD personnel and clients on the permissible use of the words and claims “exfoliate” and “exfoliant” for cosmetic preparations, including how these terms will be evaluated in labeling.

They are fundamentally astringents intended to encourage desquamation (shedding) of the stratum corneum of the skin.

Examples include witch hazel, salicylic acid, and alpha hydroxy acids (AHAs).

They are described as prepared for oily skin and intended in place of astringents in cleansing regimens for acne-prone persons.

Acceptable claims include: (1) Exfoliants; (2) Exfoliate; (3) Remove or shed-off dead skin surface cells; (4) Uncover new skin that looks cleaner, fresher and finer; (5) Accelerate the natural renewal of skin cells; (6) Aid in the treatment of acne by alleviating comedones.

BFAD requires submission of substantive evidence and/or the submission of the cosmetic preparation’s formulation to substantiate the claim.

No. It says claims or similar claims to those listed are considered acceptable with the required evidence/formulation submission; other words or phrases not included will be evaluated based on technical evidence.

BFAD will evaluate them based on the technical evidence submitted to substantiate the action, benefit, or advantage the words/phrases depict.

“Exfoliate” is one of the explicitly acceptable claims for cosmetic preparations, subject to the requirement of substantive evidence and/or the formulation.

Since “anti-aging exfoliation” is not in the listed acceptable claims, BFAD will evaluate it based on the technical evidence submitted to substantiate the action/benefit claimed.

It permits: “Aid in the treatment of acne by alleviating comedones.”

It provides the scientific/functional basis for what “exfoliant/exfoliate” means, which supports the requirement that labeling claims must be substantiated by evidence tied to the described mechanism.

It indicates submission of substantive evidence and/or the formulation of the cosmetic preparation.

They must not rely solely on allowable wording; they must ensure they can substantiate the claim and be ready to provide evidence and/or formulation details during BFAD evaluation.


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