Cosmetic Imports
June 22, 2001; Updated December 13, 2006 and October 29, 2009
Cosmetic products imported into the United States are subject
to the same laws and regulations as those produced in the United
States. They must be safe for their intended uses and contain no
prohibited ingredients, and all
labeling and packaging must be informative and truthful,
with the labeling information in English (or Spanish in Puerto
Rico). All
color additives must be approved by FDA; many cannot be used
unless certified in FDA's own laboratories. If the product has
an intended use that causes it to be considered a
drug, it must
comply with the requirements for drugs, including establishment
registration and drug listing.
FDA encourages cosmetic firms to register their
establishments and file Cosmetic Product Ingredient Statements
with FDA's
Voluntary Cosmetic Registration Program (VCRP). However,
firms importing products considered to be solely cosmetics in
the United States are not required to register with FDA. The
VCRP can only accept Cosmetic Product Ingredient Statements for
cosmetics that are already on the market in the United States. A
registration number is not required for importing cosmetics into
the United States.
Among the most common reasons for
import refusals of cosmetics are labeling violations, the
illegal use of color additives, and the presence of poisonous or
deleterious substances, such as pathogenic microorganisms. FDA
has several
Import Alerts for cosmetics that do not comply with U.S.
laws and regulations governing cosmetics and color additives. In
addition, two of FDA's Import Alerts for drugs address
cosmetic-type products marketed with therapeutic claims that
cause them to be considered unapproved new drugs under the law:
one for certain skin care products labeled as anti-aging creams
and another for various unapproved new drugs promoted in the
U.S. Another addresses bulk shipments of high-risk bovine tissue
from BSE (bovine spongiform encephalopathy) countries. FDA urges
cosmetic importers to consult our
Information for Cosmetic Manufacturers, Packagers, and
Distributors and
Import Surveillance for further resources.
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