Title
BFAD 2004 Cosmetic Claims Guidelines
Law
Bfad Bureau Circular No. 05, S. 2004
Decision Date
Apr 6, 2004
The Bureau of Food and Drugs (BFAD) updates and consolidates permissible claims for cosmetic products, providing clear guidelines for classification, labeling, and advertising to ensure compliance with established definitions and standards.
A

Definition and Scope of Cosmetic Product

  • Cosmetic product: Substance or preparation intended for contact with external human body parts (epidermis, hair, nails, lips, external genital organs), teeth, and oral mucous membranes.
  • Purpose: Cleaning, perfuming, changing appearance, correcting body odors, protecting or maintaining good condition.
  • Differentiation from medicinal context:
    • Cosmetics produce temporary effects, mainly improve appearance, used regularly for maintenance, aimed at grooming and enhancement.
    • Medicinal products produce permanent/drastic effects, have healing or curative aspects, used restrictively, aimed at disease treatment or cure.

Approval of Cosmetics Label Claims

  • Based on:
    • Definition of cosmetics
    • The actual formulation or preparation
    • Substantial evidence, technical justification, or clinical testing

Permissible Cosmetic Claims

  • Claims allowed if supported by product formulation without invoking therapeutic claims:
    • Hair Treatment
    • Skin Treatment
    • Nail Treatment/Cuticle Treatment
    • Aromatherapy
    • Revitalize/Revitalizing
    • Nourishes/Nourishing skin or hair
    • Makes hair healthy
    • Lightening, whitening (skin and teeth only)
    • Restores elasticity
    • Hair bleaching/hair lightening
    • Exfoliation, exfoliates
    • Water-proof

Claims Requiring Technical Justification

  • Allowed with submission of appropriate technical evidence and BFAD approval:
    • Hypoallergenic
    • Clinically tested, dermatologically-approved/tested, ophthalmologically-tested
    • Mild, extra mild, gentle (for baby/infant products)
    • Noncomedogenic
    • Non-irritating, for sensitive skin
    • Strengthens hair
    • Prevents dandruff/Anti-dandruff
    • All SPF levels
    • Penetrates deeply
    • Antibacterial
    • Antiseptic (for oral and skin preparations)
    • Helps repair hair/split ends
    • Anti-wrinkle/Anti-ageing/Helps prevent formation of wrinkles
    • Helps prevent stretchmarks
    • Removes or sheds dead skin cells
    • Exfoliates (chemical)
    • Management of acne-prone skin
    • Anti-hair loss (without reference to hair regrowth)
    • Rejuvenate/Regenerate
    • Anti-stress (for skin and hair only)
    • Contouring/Slimming/Cellulite control (without reference to weight loss)
    • Firming
    • "No tears" baby shampoo

Evaluation of Non-Listed Claims

  • Claims not included in the permitted lists will be subject to evaluation based on technical evidence submitted to support the claimed action, benefit, or advantage.

Applicability and Supersession

  • The list of claims is non-exhaustive; new product forms and categories to be assessed against the cosmetics definition.
  • Previous BFAD issuances inconsistent with this circular (B.C. No.10 s. 2002, B.M. No. 8 s. 2000, B.C. No. 23 s. 1999, B.M. No. 21 s. 1995) are superseded, repealed, or modified accordingly.
  • The circular took effect immediately upon adoption on April 6, 2004.

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