We are once
again coming up on a busy time of year, one where many of you will be doing
craft shows and a considerable amount more retail! It’s also a time of year
when many of you will sell more body care than all other items combined! This
is the perfect time to give you an overview on proper product labeling and send
you to the right places for more information regarding this process!
First, ALL cosmetics must be properly labeled
per the FDA. The FDA is regulated by Center for Food Safety and Applied Nutrition
(CFSAN). CFSAN is responsible for assuring that not only are all cosmetics are
safe but also that they are properly labeled. Being a small business does not
exempt you from the same rules as the big boys.
If you are making Cold Process Soap (or hot process, true
liquid soap but in general those made only using a lye solution and fats) you
are exempt from product labeling through FDA guidelines but I would still
recommend it for peace of mind. What if you used peanut oil and a customer with
a peanut allergy used that product? Exactly! Soap labeling which is governed by
the CPSC, the Consumer Product Safety Commission: http://www.cpsc.gov/
Over the years there has been a lot of debate in the world of hand crafted soaps
and cosmetics. Melt & Pour soaps typically are considered a cosmetic as
they are made using chemical surfactant ingredients and are not considered true
soap. I received confirmation on what IS needed on a soap label and what truly
defines it as soap directly from the CPSC. This is copied and pasted from a
response they emailed to me:
The Consumer Product Safety Commission (CPSC) regulates true
soaps that are made primarily of fats and alkalis and that are manufactured for
consumer use. The CPSC has no specific labeling requirements for such soaps.
However, if the product meets the definition of a hazardous substance, under
the Federal Hazardous Substances Act (FHSA) it may require cautionary labeling
as specified under the statute.
Section 2(p)(1) of the FHSA, 15 U.S.C. § 1261(p)(1),
requires that hazardous substances bear certain cautionary statements on their
labels. These statements include: signal words; affirmative statements of the
principal hazard(s) associated with a hazardous substance: the common or usual
name, or chemical name of the hazardous substance; the name and place of
business of the manufacturer, packer, distributor, or seller; statements of
precautionary measure to follow; instructions when appropriate, for special
handling and storage; the statement “Keep out of the reach of children” or its
practical equivalent; and, when appropriate, first aid instructions.
A product is determined to be a hazardous substance if the
substance or a mixture of substances is toxic, corrosive, an irritant, a strong
sensitizer, is flammable or combustible, or generates pressure through
decomposition, heat or other means, and if the substance or mixture of substances
may cause substantial personal injury or substantial illness during customary
or reasonably foreseeable handling or use, including reasonably foreseeable
ingestion by children. A determination that a product is toxic may be based on
the results of animal tests or on human experience.
It is the responsibility of a manufacturer or importer of a
product to determine whether its product meets the definition of a hazardous
substance and, if so, to fulfill its obligations under the FHSA for appropriate
precautionary labeling. The U.S. Consumer Product Safety Commission
does not perform pre-market clearance for household products containing
hazardous substances nor does it certify those products.
The Food, Drug and Cosmetic Act specifically excludes soap because
soap is not defined in the act. In administering the act, the Food & Drug
Administration interprets the term “soap” to apply only to articles that meet
the following conditions:
1)
The bulk of the nonvolatile matter in the product consists of an alkali salt
of fatty acids and the detergent properties of the article are due to the
alkali-fatty acid compounds; and
2)
The product is labeled, sold and represented only as soap.
The interpretation goes on to state that products intended
to cleanse the body and which are not “soap” as defined above are considered
“cosmetics” regulated by FDA.
If your product meets the definition above (1 & 2) then
it would be subject to the Federal Hazardous Substances Act. If the product
meets the definition of a hazardous substance it is required to be labeled for
the hazards it presents to the consumer during reasonable and foreseeable use.
Cosmetic
labeling requires quite a bit of information. I strongly suggest that anyone
making cosmetics of any kind familiarize themselves with the FDA website. There
is a vast amount of information which is all current and lists all of the
information necessary to be sure you are making a product that fits into the
scope of the law. Their website is http://www.fda.gov
The following information
must appear on the principal display panel:
- An identity statement, indicating the nature and use
of the product, by means of either the common or usual name, a descriptive
name, a fanciful name understood by the public, or an illustration [21 CFR 701.11].
- An accurate statement of the
net quantity of contents, in terms of weight, measure, numerical count or a
combination of numerical count and weight or measure [21 CFR 701.13].
The following information
must appear on an information panel:
- Name and place of business. This may be the manufacturer,
packer, or distributor. This includes the street address, city, state, and
ZIP Code. You may omit the street address if it is listed in a current
phone directory or city directory [21 CFR 701.12(a)].
- Distributor statement. If the name and address are not
those of the manufacturer, the label must say "Manufactured
for..." or "Distributed by...," or similar wording
expressing the facts [21 CFR 701.12(c)].
- Material facts. Failure to reveal material
facts is one form of misleading labeling and therefore makes a product
misbranded [21 CFR 1.21]. An example is directions for safe use,
if a product could be unsafe if used incorrectly.
- Warning and caution statements. These must be prominent and
conspicuous. The FD&C Act and related regulations specify warning and
caution statements related to specific products [21 CFR part 700]. In addition,
cosmetics that may be hazardous to consumers must bear appropriate label
warnings [21 CFR 740.1]. An example of such hazardous products
is flammable cosmetics.
- Ingredients. If the product is sold on a
retail basis to consumers, even it it is labeled "For professional
use only" or words to that effect, the ingredients must appear on an
information panel, in descending order of predominance. [21 CFR 701.3]. Remember, if the
product is also a drug, its labeling must comply with the regulations for
both OTC drug and cosmetic ingredient labeling, as stated above. To learn
more, see "Ingredient
Names," "Color
Additives and Cosmetics," "Fragrances
in Cosmetics," and "'Trade Secret'
Ingredients."
Cosmetics produced or
distributed for retail sale to consumers for their personal care are required
to bear an ingredient declaration (21 CFR 701.3). Cosmetics not customarily
distributed for retail sale, e.g., hair preparations or make-up products used
by professionals on customers at their establishments and skin cleansing or
emollient creams used by persons at their places of work, are exempt from this
requirement provided these products are not also sold to consumers at professional
establishments or workplaces for their consumption at home.
The ingredient declaration
must be conspicuous so that it is likely to be read at the time of purchase. It
may appear on any information panel of the package, i.e., the folding carton,
box wrapping if the immediate container is so packaged, and may also appear on
a firmly affixed tag, tape or card. The letters must not be less than 1/16 of
an inch in height (21 CFR 701.3 (b)). If the total package surface available to bear
labeling is less than 12 square inches, the letters must not be less than 1/32
of an inch in height (21 CFR 701.3(p)). Off-package ingredient labeling is permitted if
the cosmetic is held in tightly compartmented trays or racks, it is not
enclosed in a folding carton, and the package surface area is less than 12
square inches (21 CFR 701.3(i)).
The ingredients must be
declared in descending order of predominance. Color additives (21 CFR 701.3(f)(3)) and ingredients
present at one percent or less (21 CFR 701.3(f)(2)) may be declared
without regard for predominance. The ingredients must be identified by the
names established or adopted by regulation (21 CFR 701.3(c)); those accepted by the
FDA as exempt from public disclosure may be stated as "and other
ingredients" (21 CFR 701.3(a)).
Cosmetics which are also
drugs must first identify the drug ingredient(s) as "active
ingredient(s)" before listing the cosmetic ingredients (21 CFR 701.3(d)).
All label statements
required by regulation must be in the English language and must be placed on
the label or labeling with such prominence and conspicuousness that they are
readily noticed and understood by consumers under customary conditions of
purchase (21 CFR 701.2).
It is my recommendation
that anyone making cosmetic products take the time to browse these pages for
more information with regards to proper cosmetic labeling. Just being a small
business does not exempt you from the law. The FDA fines small businesses as
well as larger ones. The information contained within their website is
informative and easy to follow.
http://www.fda.gov/Cosmetics/Labeling/Regulations/ucm126444.htm
is the link to the entire FDA Cosmetics Labeling Guide. This is a MUST read for
anyone making anything cosmetic. It includes the following: (this is
hyperlinked right to the FDA site.)
Cosmetic Labeling Guide
Available in PDF
(279KB)
The Cosmetics Labeling
Guide provides step-by-step help with cosmetic labeling, with examples and
answers to questions manufacturers often ask about labeling requirements
under U.S. laws and related regulations.
On this page:
Read the Cosmetics Labeling Guide fully. I can
answer questions for you through our online chat, email or phone if there is
something you can’t find or don’t understand as well. Bitter Creek and Bitter
Creek South are committed to making sure you have the proper understanding when
it comes to properly labeling your products!
Happy Cosmetics Making!
Flicker!
