In connection with the registration of cosmetics products, the Bureau of Food and Drugs (BFAD), issues this circular concerning a consolidation and update of permissible cosmetics claims.  Previous issuances by BFAD include B.C. No. 10 s. 2002, B.M. No. 8 s. 2000, B.C. No. 23 s. 1999, B.M. No. 21 s. 1995 governing acceptable cosmetics claims.  Such pronouncements are for the guidance of clients and BFAD staff. Inspite of these issuances, inquiries regarding classification (whether food, drug or cosmetics) are brought to the attention of this Office.  We advise our clients that before registration or conceptualization of labels, claims and advertising, they should make sure that such products should be in consonance with the definition of cosmetics.

1. The BFAD would classify whether or not products are cosmetics based on:

- Republic Act 3720 as amended
- Label Text
- Product intended use
- Claims and ingredients
- Definition of cosmetics

2. Definition and Scope of Cosmetic product

A " COSMETIC product" shall mean any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and mucous membrane of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, and/or correcting body odors and/or protecting or keeping them in good condition.

As an illustration, the following are the words used in cosmetic context as differentiated from medicinal context:

The cosmetic context has the typical attributes of:

.   Temporary action
.   Improvement in appearance of the skin, nails, hair and teeth
.   To be used regularly to maintain its effect
.   The effect is aimed at grooming and enhancing the appearance of the skin, nails, hair and teeth

The medicinal context has the typical attributes of:

.   Permanent or drastic effects after completion of treatment
.   Healing or curative aspects
.   To be used restrictively because of potency of treatment
.   The effect is aimed at treatment or cure of a disease condition

3. Cosmetics label claims shall be approved based on:

>   Definition of cosmetics products
>   The cosmetic formulation or preparation itself
>   Substantial evidence /technical justification or clinical test

4. The following are examples of permissible cosmetic claims which can be used in said products where the formulation or preparation itself can support the action, benefit and/or advantage that it describes as long as therapeutic claim is not invoked:

a.  Hair Treatment
b.  Skin Treatment
c.  Nail Treatment/cuticle treatment
d.  Aromatherapy
e.  Revitalize/Revitalizing
f.  Nourishes/nourishing skin or hair
g.  Makes hair healthy
h.  Lightening, whitening (skin and teeth only)
i.  Restores elasticity
j.  Hair bleaching /hair lightening
k.  Exfoliation, exfoliates
l.  Water-proof

5. The following are examples of claims that will require technical justification.  Provided that appropriate evidence is submitted and approved by BFAD, the following words and phrases are allowed for use in cosmetics products

a.  Hypoallergenic
b.  Clinically tested; dermatologically-approved/tested, ophthalmologically-tested
c.  Mild, extra mild, gentle (for baby/infant products)
d.  Noncomedogenic
e.  Non-irritating, for sensitive skin
f.  Strengthens hair
g.  Prevents dandruff/Anti-dandruff
h.  All SPF levels
i.  Penetrates deeply
j.  Antibacterial
k.  Antiseptic (for oral and skin preparations)
l.  Helps repair hair/split ends
m.  Anti-wrinkle/anti-ageing/helps prevents formation of wrinkles
n.  Helps prevents stretchmarks
o.  Removes, sheds off dead skin cells
p.  Exfoliates (chemical)
q.  Management of acne-prone skin
r.  Anti-hair loss (without reference to hair regrowth)
s.  Rejuvenate/regenerate
t.  Anti-stress (for skin and hair only)
u.  Contouring/slimming/cellulite control (without reference to weight loss)
v.  Firming
w.  "No tears" baby shampoo

6. Words and phrases not included in the foregoing lists will be reviewed and evaluated on the basis of technical evidence that will be submitted to support the action, benefit, advantage that such words or phrases will describe.

7. This list is non-exhaustive, new product forms and categories should be considered against the definition of cosmetics.

All Circulars, Memorandums and other issuances (B.C. No.10 s. 2002, B.M. No. 8 s. 2000, B.C. No. 23 s. 1999, B.M. No. 21 s. 1995) regarding cosmetic claims, inconsistent with the provision of this Bureau Circular are hereby superseded, repealed and modified accordingly.

This Bureau Circular shall take effect immediately.

Adopted: 06 April 2004


(SGD.) PROF. LETICIA BARBARA B. GUTIERREZ, MS
Director