Hi there permagon-ga,
I have some good news for you - the importing process may be simpler
than you expected.
First of all, hair removal cream typically is classified as a cosmetic
(there's different FDA regulation for cosmetic, drug, soap, etc)
The Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their
intended use, as "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" [FD&C Act, sec. 201(i)].
Although the agency can take action to get unsafe products off the
market, cosmetic don't go through FDA approval before they are
marketed.
(as mentioned on the last paragraph of this article:
http://www.fda.gov/fdac/features/2004/304_summer.html)
To summarize:
"Cosmetic firms are encouraged to register their establishments and
file Cosmetic Product Ingredienet 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, and a registration number is not
required for importing cosmetics into the United States."
"FDA does not have a premarket approval system for cosmetic products
or ingredients, with the important exception of color additives. "
However, cosmetic products imported into the USA are subject to the
same laws and regulations as those produced in the USA. This means
"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)." So, although the FDA does not review or approve
cosmetics, or their ingredients, you are legally obligated to ensure
the safety of the product and put a warning statement of products for
one that has not had extensive safety testing.
http://www.cfsan.fda.gov/~dms/cos-imp.html
You do need the items to be labeled with the ingredients at the time
of import, otherwise the product will be subject to import refusal.
Detailed information on how to properly label the product can be found here:
http://www.cfsan.fda.gov/~dms/cos-lbl.html
As far as making claims about the quality and functionality of the
product, that falls under the regulation of the Federal Trade
Commission. This means, you don't need specific "permission/approval"
for your claim but you must ensure that your claim is not false or
misleading.
"The same general standards apply to advertising regardless of the
media used. The FTC requires that all objective product claims --
whether express or implied -- be adequately substantiated by the
advertiser prior to their dissemination to the public. Failure to
adequately substantiate a claim prior to its dissemination is an
unfair or deceptive act or practice. See Pfizer, Inc., 81 F.T.C. 23
(1974) and FTC Policy Statement Regarding Advertising Substantiation
Program.
The doctrine emerged in the mid-1970s. After Pfizer, the FTC commenced
a campaign to put all major advertisers under advertising
substantiation orders. "
For details on what a claim is, and whether it's false, please visit
the following site and scroll about a fifth of the way down until you
see "False and Misleading Advertising"
http://www.venable.com/publications.cfm?action=view&publication_id=912&publication_type_id=2
So, in terms of FDA approval and permission for product claim, the
cost and time involved is nothing as they are not required. However,
you do need to know the ingredients, ensure they are safe, and label
the product properly in English. Of course, this depends on the
nature of the company and your relationship with them.
I also recommend that you look at the FDA page for Cosmetics:
http://www.cfsan.fda.gov/~dms/cos-toc.html
The FDA specifically recommends that importers take a look at the
Information for Industry page:
http://www.cfsan.fda.gov/~dms/cos-ind.html
I hope this has helped and please feel free to ask for any clarification.
Cheers,
Tox-ga |
