Farah K. Ahmed Associate General Counsel

1. Farah K. Ahmed Associate General Counsel Chair, Marketing/Advertising, Sunscreen, Natural/Organic Committees Personal Care Products Council

2. Who primarily regulates cosmetics? • Food and Drug Administration (FDA) • Congress passes laws (mainly: Food, Drug and Cosmetic Act)  FDA enforces/develops regulations under these laws. • FDA  Center for Food Safety and Applied Nutrition (CFSAN)  Office of Cosmetics • FDA  Center for Drug Evaluation and Research (CDER)  Office of Nonprescription Drugs • Federal Trade Commission (FTC) also has a stake in the game.

3. Cosmetic “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance…”

4. Drug “articles intended ... for use in the ... treatment ... or prevention of disease ...” and “articles ... intended to affect the structure or any function of the body ...”

5. Premarket Approval vs. Post-Market Surveillance • Post-market surveillance • Marketplace, customs, complaints, etc. • Premarket approval for colors only. • Voluntary Cosmetic Reporting Program (http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/VoluntaryCosmeticsRegistrationProgramVCRP/default.htm) • Adverse Event Reporting (http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm241820.htm) • Recalls are voluntary

6. A Cosmetic is Misbranded if: • Its labeling is false or misleading (keep in mind intended use). • It does not bear the labeling information required by regulation. • The container is made or filled in a deceptive manner.

7. Intended Use Cosmetic? Drug? Combination Cosmetic/Drug?

8. Combination Cosmetic/Drug Articles intended to cleanse, beautify or promote attractiveness as well as treat or prevent disease or otherwise affect the structure or any function of the human body.

9. Product Classification(Examples)

10. So What Information is Required on a Cosmetic Product Label?

11. FDCA Requires Cosmetic products shall be labeled with the following information: • Net Quantity of Contents. • Name and Place of Business, Manufacturer, Packer, or Distributor. • Warning Statements. • Directions for Use.

12. LABELING REQUIREMENTS FOR COSMETIC PRODUCTS Statement of Identity (21 CFR 701.11) Name and Place of Business of Manufacturer, Packer, or Distributor (21 CFR 701.12) Declaration of Net Quantity of Contents (21 CFR 701.13) Warning Statements (21 CFR 740) Adequate Directions for Use Where Appropriate Designation of Ingredients (21 CFR 701.3)

13. FPLA Authorizes Fair Package Labeling Act Authorizes FDA to issue regulations establishing labeling requirements for: • Statement of Identity • Declaration of Ingredients • Net Quantity of Contents • Name and Place of Business, Manufacturer, Packer, or Distributor

14. Statement of Identity (21 CFR 701.11) Identifies the Product to the Consumer. Must appear on inner AND outer container. One of the following terms must be used for the statement of identity: • a common or usual name; or • a descriptive name; or • a fanciful name when the nature of the cosmetic is obvious to the consumer; or • an illustration or vignette representing the intended use of the cosmetic product. Shampoo

15. Name and Place of Business of Manufacturer, Packer, or Distributor (21 CFR 701.12) Must appear on both the inner AND outer containers of a cosmetic product. • as appropriate, should be qualified with a phrase such as “Distributed by,” or “Manufactured for.” • cannot use a post office box as address. • street address may be omitted if it can be found in a current city directory or telephone directory. ABC Cosmetics Company Chicago, Il USA (Back of Container)

16. Declaration of Net Quantity of Contents (21 CFR 701.13) • must appear conspicuously on the principal display panel (PDP) of the outer and inner container • must be in terms of weight, mass, measure, numerical count, or a combination of numerical count and weight or measure. • must be expressed in “English” units and SI metric system. • must be on the bottom 30% of the PDP in lines generally parallel to the base. 8 fl oz (236 mL)

17. Warning Statements (21 CFR 740) • Required when they may be necessary to prevent a health hazard. • must be prominent and conspicuous, and in a bold type size of at least 1/16" with "contrasting background.” • required if a cosmetic ingredients have not been adequately substantiated for safety. • specific warning statement established by regulation for a particular class of products. • must appear on both the inner and outer containers of a cosmetic product (unless otherwise specified by regulation). Warning: Flammable. Keep away from flame. For external use only. Keep out of eyes. In case of contact with eyes, flush with water. Contact a physician if swallowed. For children under 6, use only with adult supervision. (Back of Container)

18. Adequate Directions for Use Where Appropriate • Not Required by regulation. • To ensure consumer has adequate directions for using the product as intended. • Helps to ensure safe and effective use of the product. Directions: Wet hair, apply 1 cap full of shampoo and massage until lather forms. Rinse thoroughly and pat dry with a towel. Complete drying with a towel or blow-dryer. For best results, use twice a week. (Back of Container)

19. Designation of Ingredients (21 CFR 701.3) Required only on the outer container of a cosmetic product (on “any appropriate information panel”) • Applies only to products sold at retail for use by the consumer. Does not apply to: • Products sold to beauty salons for professional use by cosmetologists • Gifts or free samples • Testers or demonstration containers • Theatrical makeup for professional use only • names must be selected according to the regulations established by FDA to require uniform nomenclature for ingredient labeling. Ingredients:Water, Ammonium Laureth Sulfate, Ammonium Lauryl Sulfate, Sodium Lauroyl Sarcosinate, Glycol Distearate, Sodium Sulfate, Fragrance, DMDM Hydantoin, Disodium Phosphate, Sodium Phosphate, Lauryl Alcohol, PEG-600, Sodium Chloride, Polyquaternium-10 and Blue 1. (Back of Container)

20. More info on cosmetic labeling • FDA website http://www.fda.gov/Cosmetics/CosmeticLabelingLabelClaims/default.htm

21. A Note About Claim Substantiation • All claims (e.g., reduce wrinkles, hypoallergenic, natural, organic) are required to be adequately substantiated • Level of substantiation required depends on the claim • Be aware of comparative claims – superiority or parity • Be aware of implied claims • Puffery is ok, but is it really puffery?

22. A Note About Soap To meet the definition of soap in FDA’s regulations, a product has to meet three conditions:  • What it’s made of: To be regulated as “soap,” the product must be composed mainly of the “alkali salts of fatty acids,” that is, the material you get when you combine fats or oils with an alkali, such as lye. • What ingredients cause its cleaning action: To be regulated as “soap,” those “alkali salts of fatty acids” must be the only material that results in the product’s cleaning action. If the product contains synthetic detergents, it’s a cosmetic, not a soap. You still can use the word “soap” on the label. 

23. A Note About Soap (cont.) • How it's intended to be used: To be regulated as soap, it must be labeled and marketed only for use as soap. If it is intended for purposes such as moisturizing the skin, making the user smell nice, or deodorizing the user’s body, it’s a cosmetic. Or, if the product is intended to treat or prevent disease, such as by killing germs, or treating skin conditions, such as acne or eczema, it’s a drug. You still can use the word “soap” on the label. • You can read the entire regulation at 21 FR 701.20.  • If your product meets the regulatory definition of soap, it’s regulated by the Consumer Product Safety Commission (CPSC), not by FDA

24. Cosmetic Product Labeling