Current Issues in the Safety and Labeling of Cosmetics

Current Issues in the Safety and Labeling of Cosmetics


Hello. I’m Dr. Linda Katz, Director of FDA’s
Office of Cosmetics and Colors. I’m here to talk to you about how cosmetics are regulated
in the United States. I’ll discuss the laws and regulations
that apply to cosmetics, how FDA monitors cosmetic safety and oversees compliance
with these laws and regulations, and how FDA works with partners
in the international arena, including some of the challenges
we face while ensuring the safety
of cosmetics in this country. First, let me define
what we mean by cosmetics. Cosmetics include a wide variety
of products that most consumers — men, women, and children —
use every day. Recent industry reports estimate
United States sales of cosmetics to be approximately $17.5 billion
in 2010. FDA regulates cosmetics
under the authority of the Federal Food, Drug,
and Cosmetic Act, or the FD&C Act. This law defines cosmetics
by their intended use as articles intended
for cleansing, beautifying, promoting attractiveness,
or altering the appearance. The law specifically excludes soap
from the definition of cosmetics. Soap, however,
is defined very narrowly as products consisting primarily
of alkaline salts of fatty acids. However, most facial and bath bars
do not meet this definition and are therefore regulated
as cosmetics. But not all products that consumers
think of as personal-care products are cosmetics under the law. Some are drugs, usually sold as over-the-counter drugs
in the United States. The FD&C Act defines drugs as articles intended for the use in the diagnosis, cure, mitigation,
treatment, or prevention of disease or to affect the structure
or any function of the body of man or other animals. For example, dandruff and acne
treatments are drugs under the law. So are sunscreens, because they are
intended to prevent conditions such as sunburn and skin cancer. So, under the FD&C Act, many personal-care products
are regulated as cosmetics, some are regulated as drugs, some are both cosmetics and drugs,
and some are neither. Here are some examples. A cleanser is a cosmetic, but an antimicrobial cleanser that is
intended to help prevent disease is also a drug because of
that additional intended use. Shampoos intended just for
cleaning hair are cosmetics, but a shampoo that is also intended
for treating dandruff is both a cosmetic and a drug. Similarly, toothpastes that are
intended not only to clean the teeth, but also to help prevent tooth decay, are both cosmetics and drugs. If a product meets the definition
of a drug, it must comply with the requirements
for drugs, even if it is also a cosmetic. Non-prescription drugs are commonly
called “over the counter,” or OTC, drugs. This slide shows
some of the differences in the way the laws treat OTC drugs
and cosmetics. OTC drugs have to conform
to regulations for their specific drug categories. These regulations
are called monographs. If the OTC drugs don’t conform
to the monograph, they must undergo pre-market
approval before they can be marketed
in the United States. There are no monographs
for cosmetics, and they do not need
pre-market approval. Drugs are evaluated by FDA for safety
and efficacy before marketing. Cosmetics are not. There are regulations
with specific requirements for good manufacturing practice,
or GMP, for drugs, but for cosmetics, there are only
voluntary GMP guidelines. Drug manufacturers must register
their establishments and list their products with FDA, but this is not required
for cosmetics, and serious adverse events
associated with drugs must be reported to FDA. Adverse-event reporting
is not required for cosmetics. So, what are the requirements
to market cosmetics? Under the FD&C Act, they must not be
adulterated or misbranded. FDA’s authority over cosmetics
is post-market. We can take action against
adulterated or misbranded cosmetics that are on the market. Let’s look at what we mean by adulterated and misbranded
cosmetics. Under the law, a cosmetic can
become adulterated in several ways. For example,
a cosmetic is adulterated if it is harmful or injurious
to consumers under labeled
or customary conditions of use. A problem might arise
from the formulation itself, from its container,
or from contamination. A cosmetic can also become
adulterated if it is manufactured or held
under insanitary conditions. Finally, cosmetics are adulterated if they contain a color additive that
is not approved for the intended use. The law makes one exception. Coal-tar hair dyes
are not considered adulterated as long as they are labeled
with a specific caution statement and instructions
for performing a skin test. I’ll talk about color additives
in greater detail later in this presentation. The term “misbranding”
applies to labeling and packaging. A cosmetic is misbranded if its
labeling is false or misleading or if required information
is missing or presented improperly. It’s also misbranded
if its container is deceptive. For example, if the container
makes it look as if it holds more of the product
than it really does. Some products must comply with the 1970 Poison Prevention
Packaging Act, requiring child-resistant packaging. Examples of products
that must comply with this law are primers and glue removers used
with artificial nails because of the serious risk
of poisoning if children ingest them. If these products don’t meet this
requirement, they are misbranded. You can find the regulations
for cosmetics in the Code of Federal Regulation, or
CFR, Title 21, parts 700 through 740. These regulations cover
the topics listed here and are available
on FDA’s cosmetic website. Let’s take a look at the requirements
for cosmetic labeling. This is a complex subject, and FDA has provided
a number of resources on our FDA cosmetics website. I encourage you to visit our website to learn more about the specific
requirements for cosmetic labeling. Certain information must appear
on cosmetic labeling. Labeling information
must be in English or in Spanish
for marketing in Puerto Rico. If you are also labeling
with a second language, make sure that all required
information is in both languages. It must include statement of identity indicating the nature
and use of the product. State net quantity of contents in terms of weight, measure,
numerical count, or a combination of numerical count
and weight or measure. You must use U.S. units —
ounces, for example. You may also provide metric units
if you choose, which can be included
in parentheses. State the name
and place of business. This may be the manufacturer,
packer, or distributor. If the name and address
are not those of the manufacturer, you must include
a distributor statement. This means that the label must say
“manufactured for” or “distributed by.” Material facts are another important
part of cosmetic labeling. Failure to reveal material facts is one form of misleading labeling and therefore makes a product
misbranded. An example would be directions
for safe use. Warning and caution statements
must be prominent and conspicuous. The FD&C Act and related regulations specify warning
and caution statements related to specific products. In addition, cosmetics
that may be hazardous to consumers must also bear appropriate
label warnings. An example of a hazardous product
is a flammable cosmetic. Finally, there is
the ingredient declaration, the listing of all the ingredients
in the product. Let’s take a closer look at this one, since it often raises questions from people marketing cosmetics
internationally. FDA requires an ingredient
declaration under the authority of the Fair
Packaging and Labeling Act, or FPLA. By regulation,
all ingredients must be listed in descending order of predominance down to those present at levels of 1%. Ingredients present at lower levels do not have to follow
order of predominance. Fragrance or flavor can be used instead of listing
each individual component of your fragrance or flavor. The requirement
for an ingredient declaration applies
only to consumer commodities — that is, products marketed
to consumers on a retail basis, whether in stores, in person,
or by mail order. This requirement does not apply to products marketed
only to professionals, free samples, gifts,
or hotel amenities. However, labeling a product
as “professional use only” does not exempt you
from this requirement if the products are, in reality,
being marketed on a retail basis to consumers. Manufacturers sometimes ask how they should identify the names
of the ingredients in their products. The regulations list a hierarchy
of several permitted sources. First, there are some names that have been established
by FDA by regulation. If your ingredient is not listed
in that group, the next source
are authoritative compendia, including the International
Cosmetic Ingredient Dictionary, published by the Personal Care
Products Council, or PCPC. The U.S. Pharmacopeia,
the USP’s National Formulary, the U.S. Homeopathic Pharmacopeia,
and the Merck Index. If you can’t find your ingredient
in any of those sources, the next alternative
is to use a common or usual name understood by consumers in English. As a last choice, you may use
a chemical or technical name, such as those listed
by the International Union of Pure and Applied Chemistry. Trade names, however,
are not acceptable. Here are some more things to know
about the ingredient declaration, especially in the international arena. The PCPC International
Cosmetic Ingredient Dictionary is the basis
of the International Nomenclature for Cosmetic Ingredients and lists
more than 17,500 ingredients as of its 13th edition in 2010. A common question
that we receive is, “What do you do
if you want to market your product in the European Union or E.U., or another country that has different
nomenclature requirements?” FDA permits dual nomenclature
for certain types of ingredients. For color additives, you can list
the name of the color additive as it appears in its
listing regulation in the CFR, followed by the Color Index,
or CI number, in parentheses. You can identify
a botanical ingredient by its common
or usual English name, followed by the genus/species name, as required in the E.U.,
in parentheses. In the United States, color cosmetics
that have the same formulation, except for variations
in the color additives used in them, may use the term “may contain” to include that they may or may not
contain particular color additives. The equivalent in the E.U.
is the plus or minus sign. You can use the plus or minus sign
in parentheses, in addition to “may contain,”
but not in place of it. The source and quality of ingredients are not required
in the ingredient declaration. For example,
you do not need to indicate that an ingredient is from an animal
or botanical source. FDA does not regulate
the terms “organic” and “natural.” If you want to label your products
as made with organic ingredients, check with the U.S.
Department of Agriculture, which regulates the use of this term
for agricultural products. In addition, FDA does not certify
products or ingredients as conforming
to religious requirements, such as kosher or halal. To learn more about
cosmetic labeling requirements, please visit our website. On the website you will find
the Cosmetic Labeling Manual, and we especially encourage you to read the section titled
“Cosmetic Labeling Guide.” Let’s move on to a new subject —
color additives. U.S. requirements for their use
are very strict. First, what is a color additive? Under the FD&C Act, a color additive is any substance
that imparts color to a food, drug, cosmetic,
or medical device. The definition includes black, white,
intermediate grays. It may form after reacting
with the skin, as in the case with dihydroxyacetone
used in sunless tanning products. It may even have other functions
in a product, as in the case of titanium dioxide
and zinc oxide in sunscreens. You can find the requirements
for color additives in Title 21 of the Code of Federal Regulations,
parts 70 and 71. These regulations provide definitions,
general uses and restrictions, and pre-market approval
requirements. They also divide color additives
into two categories — those subject to batch certification, and those exempt
from batch certification, which I will describe further
in a moment. All color additives for use
in FDA-regulated products must undergo pre-market approval. Once approved, the color additive is listed in a regulation
called a “listing regulation,” that states its permitted uses,
specifications, and restrictions, as well as labeling requirements. It’s important to make sure
each color additive you use is permitted for the intended use, and that it complies
with all the requirements in its listing regulation. Misuse of color additives
will make your product adulterated. Let’s take a closer look at the two
categories of color additives. One group, those colors
subject to batch certification, are also referred to as “certifiable.” This group includes synthetic
organic, or “coal tar,” colors. They are subject to an additional step besides being approved
and listed in a regulation. Each manufactured batch
of these colors must be certified as meeting
composition and purity by FDA’s color certification labs before it can be used
in FDA-regulated products. Certifiable colors are subject
to a user fee, in which fees are calculated
by pounds certified. You can recognize these color
additives by their names, which consist of a prefix,
such as FD&C or D&C, a color, and a number. A common example
is FD&C Yellow No. 5, the certified form of tartrazine. Uncertified tartrazine is not permitted
in place of FD&C Yellow No. 5. The same holds true for all color additives
subject to certification. If a certifiable color additive
is not from a certified batch, don’t use it. The other group, those from mineral,
animal, or botanical sources, are exempt from batch certification
by FDA. Instead, manufacturers
are responsible for making sure these color additives meet the specifications stated
in their listing regulations. Let’s discuss registration, a topic that we receive
many questions about from our international partners, including “Must I register?”
“How do I register?” and “What’s involved?” First, as we stated earlier, you don’t have to register
your cosmetic establishment or file cosmetic formulations
with FDA. Registration is required for drugs,
not cosmetics. However, FDA maintains the Voluntary
Cosmetic Registration Program, or VCRP, and we encourage you to take part. The VCRP is a way for industry
to report post-marketing data to FDA. This information assists FDA in monitoring and ensuring
cosmetic safety. The information also assists industry
efforts to evaluate cosmetic safety. FDA provides frequency of use data
from the VCRP to the Cosmetic Ingredient Review,
or CIR, Expert Panel to assist in its safety evaluations. The CIR is an independent,
industry-funded panel of medical and scientific experts
that meets quarterly to conduct safety assessments
of cosmetic ingredients and publishes its findings
in peer-review journals. FDA participates in CIR
in a non-voting capacity. Since December 2005, cosmetic firms have been able
to participate in the VCRP electronically, accessing the system
from our website. There are two parts to the VCRP — establishment registration and filing of product formulations
and ingredients. Both are voluntary. Despite the word “voluntary”
in the name, FDA often receives inquiries
from importers who have been told that
the cosmetic registration is required before they can import products
into the United States. This is not true. Imported cosmetics may be detained because they do not comply with the laws and regulations
that apply to them. They will not be detained
for not participating in the VCRP. The subject of imports leads us
to the next topic — international issues. This is a growing area of FDA activity
for many reasons. As a result of the increasing imports
and exports over the past 10 years and the opening of world borders, FDA’s activity on the international
scene has increased and has many over-arching goals. In particular, FDA works to… facilitate international trade
and promote mutual understanding, facilitate exchange of scientific
and regulatory knowledge with foreign government officials
to the extent permitted by law, accept equivalent standards,
compliance activities, and enforcement programs
of other countries if such programs meet FDA’s level
of public-health protection, and maintain the high level
of public-health protection afforded by U.S. law. FDA is particularly active
in two organized efforts at international harmonization. The first is the ISO Technical
Committee on cosmetics, or ISO-217. This committee reviews
draft international standards and new work proposals. The committee’s working groups show
the scope of its activities — microbiological standards and limits packaging, labeling, and marking, analytical methods, terminology, good manufacturing practice (GMP), sunscreens, and nanomaterials. We also work with our regulatory
partners in Canada, the European Union, and Japan in the International Cooperation
on Cosmetics Regulation, or ICCR. This process currently involves industry trade association partners
as well. In the future, it may be expanded to include
additional countries or jurisdictions, as well as other stakeholders. Topics under discussion at ICCR
include, for example, cosmetic labeling, alternatives to animal testing,
nanotechnology, trace contaminants, and sunscreens, which are regulated as cosmetics
in some countries but as drugs in the United States. To learn more about FDA’s
international activities, please visit our website. Whether domestic or imported, cosmetics must meet the same
standards for safety and labeling. Let’s look at FDA’s compliance
and enforcement activities. Although imported
and domestic cosmetics must meet the same
regulatory standards, there’s an important difference
between FDA’s legal authority over domestic and imported
cosmetics. For cosmetics manufactured
domestically, FDA needs to show that the product
is adulterated or misbranded. Imported cosmetics, however, can be detained upon entry if they simply appear to be
adulterated or misbranded. FDA’s compliance program
for cosmetics covers both imported
and domestic products. This compliance program reflects
risk-based enforcement priorities. This means that we consider
potential health consequences when determining
enforcement priorities. These are our risk-based
enforcement priorities — oral-care products, especially low
or no-alcohol mouthwash, which has been associated
with infection due to microbial contamination, eye-area cosmetics,
contamination leading to infection, skin-care products,
including wet wipes for infants, certain hair-care products,
such as relaxers or straighteners, unapproved color additives, and products containing
certain cattle material, because of concerns about
bovine spongiform encephalopathy, also known as BSE
or mad cow disease. What kind of information do we use to monitor and evaluate
cosmetic safety? We look at a number of sources — our database
of adverse event reports that contains information
provided primarily by consumers, but also by healthcare providers, historical recall data
and inspectional findings, data from the VCRP, FDA research and other published
scientific literature, data provided
by other government agencies, such as
the National Toxicology Program, conclusions of the CIR Expert Panel, conclusions
of other authoritative bodies, such as the Institute of Medicine, and information submitted to FDA by the cosmetic industry
or other parties. FDA has a number of tools to use
in its enforcement efforts. We can issue a Warning Letter, which informs a firm
that we are aware of violations and that corrective action is needed. We can target
our establishment inspections and import sampling programs to focus on areas
of greatest concern. Seizure is a legal term
for an action taken through the courts to keep a product off the market. We can detain an imported product
upon entry if it appears to be adulterated
or misbranded, and we can refuse entry
when the violation is confirmed. Injunction is a legal action
to keep a firm or individual from engaging in illegal activity. And, if necessary, FDA can prosecute
firms and individuals in court. FDA has issued Warning Letters
citing therapeutic claims made for products marketed
as cosmetics, inadequate manufacturing conditions,
illegal use of color additives, and microbial contamination. These Warning Letters are posted
on our website. Sometimes in the news, you may hear
that FDA has “ordered” a recall. But the law does not give FDA
the authority to recall cosmetics. Cosmetic recalls are voluntary actions
that companies take to remove a problem product
from the market. FDA works with companies to make
sure recalls are effective. There are three categories of recalls, based on the level of risk
to consumers. Class I recalls involve products with a clear or irreversible
adverse health consequence or death, where the item is dangerous
or defective. Class II recalls involve products that can result in temporary or medically reversible
adverse health consequences. With Class III recalls, the product is unlikely to cause
adverse health effects. I mentioned earlier
that imports may be detained if they appear to be adulterated
or misbranded. Violations that commonly result
in import refusals include drugs and medical devices
marketed improperly as cosmetics, labeling violations,
color additive violations, contaminants,
and insanitary conditions. In addition, products may be refused
entry into this country if their sale is prohibited or restricted in the country
from which they were exported, a practice known
as “product dumping.” FDA issues Import Alerts to help
inspectors target their efforts. Products listed in Import Alerts are subject to detention
without physical examination. In general,
Import Alerts for cosmetics focus on products containing
unapproved color additives, ingredients that are poisonous
or deleterious, labeling violations, and filth or insanitary conditions. In addition, several Import Alerts
for other product categories may affect imported cosmetics. These include Import Alerts
for amniotic fluid, bulk high-risk bovine tissue
from BSE countries, skin-care products
with anti-aging claims appropriate for drugs
rather than for cosmetics, other unapproved new drugs,
and dentifrice products. Those are toothpastes
which contain diethylene glycol. Resources on FDA’s compliance and
enforcement authority and activities, including imports, are available to you on our website. Looking forward, what are some
of the challenges FDA faces in ensuring the safety of cosmetics
on the market? For one thing, manufacturing
is increasingly global. U.S. manufacturers export cosmetics, and U.S. consumers purchase
cosmetics from around the world. This requires a greater FDA presence
in the international arena and more work
with our international partners. One area of concern is alternatives
to animal testing. FDA does not require animal testing
of cosmetics. We advise manufacturers to do
whatever testing is necessary to ensure product safety, gaining the most useful information
from the fewest animals, and using
the most humane methods possible. We also are working
with other agencies in this country and with our international partners on developing and validating
alternatives to animal testing. Another challenge is the growth
in sophisticated technology and complex ingredients. This may take the form
of nanotechnology, or the growing use
of so-called “actives” that may actually be drugs
under the law. Examples include
human-tissue extracts, recombinant, or human, peptides, and other ingredients
that may actually be used as active ingredients in drugs, such as certain prostanoids
and hormones. And what about botanicals? The FD&C Act requires cosmetics
to be safe, no matter what may be
the source of their ingredients. The fact that an ingredient comes
from a plant doesn’t make it safe. The safety of U.S. consumers
is FDA’s first concern. In this presentation,
we have given you a brief overview of U.S. requirements for the safety
and labeling of cosmetics, as well as some current challenges
in cosmetic safety and the international market. We encourage you
to visit our website, for more in-depth resources
on FDA authority over cosmetics, as well as your responsibilities
under U.S. law when you market cosmetics
in this country. Our website also provides
important safety information on a number of cosmetic products
and ingredients. If you still have questions, you can
contact us by phone or by e-mail. We’ll do our best to respond to your
questions promptly and thoroughly. Thank you for joining us today.

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