Transcript PCPC-US-Claims-Labeling-2015

Farah K. Ahmed
Associate General Counsel
Chair, Marketing/Advertising, Sunscreen,
Natural/Organic Committees
Personal Care Products Council
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.
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…”
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 ...”
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/VoluntaryCosm
eticsRegistrationProgramVCRP/default.htm)
• Adverse Event Reporting
(http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm241820.htm)
• Recalls are voluntary
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.
Intended Use
Cosmetic?
Drug?
Combination Cosmetic/Drug?
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.
Product Classification
(Examples)
Cosmetics
Drugs
Face powders and Foundations
Shampoos
Bubble baths
Makeup remover
Mascara
Colognes and Perfumes
Lipstick
Nail polish
Deodorants
Shaving cream
Moisturizers
Acne Products
Anti-aging Products
Anti-Caries Toothpaste
Antiperspirants
Anti-dandruff Shampoos
Antimicrobial Body and Hand Washes
Hormone Products
Oral Healthcare (Plaque and Gingivitis)
Skin Bleaching and Lightening
Skin Protectants
Sunscreens
And many more ……
So What Information is Required on a
Cosmetic Product Label?
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.
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)
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
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
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)
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)
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)
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)
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)
More info on cosmetic labeling
• FDA website
http://www.fda.gov/Cosmetics/CosmeticLabelin
gLabelClaims/default.htm
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?
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.
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
Cosmetic Product Labeling