2. NON- PERMISSIBLE COSMETICS CLAIMS BY ANIS TALIB NATIONAL PHARMACEUTICAL CONTROL BUREAU

3. INTRODUCTION  The Non-Permissible Claims List is designed to help the cosmetic industry to comply with the Malaysian cosmetic regulatory requirements and other applicable legislation and regulations namely the Sale of Drugs Act 1952.  The list is intended to provide examples covering the most common range of cosmetic claims and is NOT an exclusive or exhaustive listing.

4. DEFINITION  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 the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition.

5.  The definition specifies six (6) functions pertaining to cosmetic products, namely: 1. to clean 2. to perfume 3. to change the appearance 4. to correct body odours 5. to protect 6. to keep in good condition.  Skin, hair, teeth and includes soaps, toilet preparations, antiperspirants, deodorants and perfumes.

6. CHARACTERICTICS OF COSMETICS VS DRUGS  The cosmetic context has the typical characteristics of: 1. Temporary action 2. Improvement of the appearance of the skin 3. To be used regularly to maintain the effect 4. The effect is aimed at grooming and enhancing the appearance of the skin texture.

7.  The medicinal context has the typical characteristics of : 1. Permanent or drastic effect after completion of a treatment 2. Healing or curative aspects 3. To be used restrictively because of the potency of the treatment. 4. The effect is aimed at treatment of or relieving a disease condition

8. IS IT COSMETIC ?  Products are determined to be either cosmetics or therapeutic goods based on the following factors: It conforms to the definition of a cosmetic It must possess at least one of the stated purposes It is not EXCLUSIVELY intended to protect from disease.

9. IS IT COSMETIC ? 4. The balance of claims must tend towards cosmetic 5. The ingredients and its level used must adhere to the list of permitted/restricted ingredients 6. Its complies generally with the remainder of the Regulations, labeling etc.

10. ACCEPTABLE VS UNACCEPTABLE CLAIMS 1. 1. A claim can be a word, a sentence, a paragraph or simply an implication 2.A cosmetic cannot have a specific claim for alleviating, treating, curing or preventing a disease or symptoms of a pathological condition.

11. 3.The Non-Permissible Claims List contains claims that are clearly unacceptable for a cosmetic. 4.The examples in the List should only be used as a guide and are not to be taken as the final authority

12. NON-PERMISSIBLE CLAIMS FOR COSMETICS PRODUCTS SubjectNon-Permissible Claims for Cosmetic Products Active Ingredient  medicinal (therapeutic ) ingredients Ageing  eliminate age spots  de-pigmentation  bleaching of the skin  eliminate aging  eliminate aging process  stop aging  stop aging process  reverse aging  reverse aging process  prevent aging  prevent aging process

13. NON-PERMISSIBLE CLAIMS FOR COSMETICS PRODUCTS SubjectNon-Permissible Claims for Cosmetic Products Astringent  removes toxins Acne, pimple, blackheads, comedones  Acne, pimple, blackheads, comedones  stop acne  heal acne  prevent acne  stop pimple  heal pimple  prevent pimple  stop blackhead  heal blackhead  prevent blackhead  stop comedone  heal comedone  prevent comedone

14. NON-PERMISSIBLE CLAIMS FOR COSMETICS PRODUCTS SubjectNon-Permissible Claims for Cosmetic Products Dentifrice  abscess  antiseptic action  gumboil  gingivitis  inflammation of gums  mouth ulcers  periodontitis  pyorrhoea  periodontal disease  sensitivity  stomatitis  thrush

15. NON-PERMISSIBLE CLAIMS FOR COSMETICS PRODUCTS SubjectNon-Permissible Claims for Cosmetic Products Contour creams  weight loss  removal of cellulite  removes fat  reduce swelling (oedema)  control swelling (oedema)

16. NON-PERMISSIBLE CLAIMS FOR COSMETICS PRODUCTS SubjectNon-Permissible Claims for Cosmetic Products Hair  eliminate dandruff  control dandruff  eliminate seborrheic dermatitis  alopecia  stop hair loss  cure hair loss  stop baldness  cure baldness  replace hair  restore hair cells

17. NON-PERMISSIBLE CLAIMS FOR COSMETICS PRODUCTS SubjectNon-Permissible Claims for Cosmetic Products Skin-(Cleansers, Soap)  antibacterial  antimicrobial  antiseptic  disinfectant  germicide  fungicide  virucide  kills pathogens  heal cuts  heal wounds  treat infection  treat jock itch

18. NON-PERMISSIBLE CLAIMS FOR COSMETICS PRODUCTS SubjectNon-Permissible Claims for Cosmetic Products Healthy  restores health (refers to general health) Nails  growth Perfumes (fragrances, colognes, toilet water)  any implication of hormonal attraction Relax  relax muscles (muscle relaxant)

19. NON-PERMISSIBLE CLAIMS FOR COSMETICS PRODUCTS SubjectNon-Permissible Claims for Cosmetic Products Mouthwash  antiviral  antiseptic  germicide  kills pathogens  antibacterial  Antimicrobial Skin - (Facial Peels)  remove scars  remove permanent markings

20. NON-PERMISSIBLE CLAIMS FOR COSMETICS PRODUCTS SubjectNon-Permissible Claims for Cosmetic Products Skin - (Moisturisers)  numbing  pain  analgesic effect  abrasions  bites  insect bites  cuts  nicks  inflammed skin  rashes

21. NON-PERMISSIBLE CLAIMS FOR COSMETICS PRODUCTS SubjectNon-Permissible Claims for Cosmetic Products Sun, suntan products, after-sun treatments, sun protection, tanning accelerators  reference to allowing you to stay out in the sun x times longer Therapy, treatment  reference to disease control (treatment) (healing)  medicated (therapeutic) treatment for infections (burns) Vitamins  any reference to the therapeutic effects of vitamins

22. NON-PERMISSIBLE CLAIMS FOR COSMETICS PRODUCTS SubjectNon-Permissible Claims for Cosmetic Products Wrinkles  eliminate wrinkles  stop wrinkles  reverse wrinkles  prevent wrinkles Anti-perspiration  stop sweating  eliminate sweating  stop perpiration  eliminate perpiration

23. EXAMPLE 1 : Type of acceptable and unacceptable claims for aging & wrinkle products Acceptable ClaimsUnacceptable Claims - Helps prevent signs/ appearance the look of aging/ premature aging - Effectively repair the visible signs of the skin’s aging process - Reduce fine lines - Minimize fine lines - Reduce the signs of aging - Slows appearance/the look of aging/premature aging - Slows signs/the look of aging/premature aging - Protect against the visible signs of aging - Fades dark spots - Cover up age spots - Hide age spots  Refer to the List

24. EXAMPLE 2 : Type of acceptable and unacceptable claims for acne, pimple, blackheads, comedones products. Acceptable ClaimsUnacceptable Claims -Cleaner for acne-prone skin -Hides acne, pimple, comedones, blackheads -Cover acne, pimple, comedones, blackheads -Removes oil  Refer to the List

25. EXAMPLE 3 : Type of acceptable and unacceptable claims for hair care products Acceptable ClaimsUnacceptable Claims -Removes (washes) (cleans) loose dandruff flakes from the hair -Add body to hair -Help make hair look thicker (fuller) -Revitalise the appearance of hair, restore beauty (lustre) (sheen) to the hair -Promote lustre -Helps to maintain hair density -Helps prolong the hair’s lifespan and to preserves the hair capital. -Keep the scalp clean and balance.  Refer to the List

26. EXAMPLE 4 : Type of acceptable and unacceptable claims for contour creams products. SubjectNon-Permissible Claims Examples of Acceptable ClaimsExamples of Unacceptable Claims  Contour Creams -Weight Loss -Removal of cellulite -Removes fat -Removes swelling (oedema) - Control swelling (oedeme) -This product can help to reduce the appearance of the orange peel effect, also called cellulite, and improve the tone and softness of the skin. -The silhouette slims down progressively. -Skin tissues are unclogged, body contours are refined and the result is a beautifully “reshaped”. -This product can eliminate/remove cellulite (or reference to permanent removal of cellulite) and prevent the recurrence of fat deposits in the sub dermal fat layer of the body. -Any reference to weight loss. -Skin tissues are permanently restructured to give a beautifully “reshaped” figure.

27. EXAMPLE 5 Types of acceptable and unacceptable claims for sun, suntan products. Acceptable claimsUnacceptable claims -Gives skin a bronze (suntanned) colour (appearance) -Gives you up to 6 times more sun protection than wearing nothing at all.

28. EXAMPLE 6 Types of acceptable and unacceptable claims for skin (moisturizers) Acceptable claimsUnacceptable claims -To provide relief to dry skin. -Moisturizes and protects for soft, supple body skin, resulting in younger and healthier – looking skin.  o provide relief and soothes irritated skin.