FDA Questions (Vicki Younger)

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Message: 21

> > Date: Sun, 2 Nov 2003 08:36:08 +1100

> > From: " Vicki Younger " <vicki@r...>

> >Subject: RE: One more...need INCI name..

> >

> >Isn't the CTFA who says what is and what isn't permitted in

cosmetic

> >labelling, since they would appear to the be the governing body

more

> >concerned with cosmetics? Or is it an association only, with no

direct

> >input into labelling regulations?

I believe The FDA is the governing body in this matter. Typically, Trade

Associations pool their resources to LOBBY governing bodies for policies they

want implemented/retracted.

Doesn't the FDA become involved in cosmetics only when cosmetics

> >manufacturers are making a therapeutic claim, and therefore their

product

> >can be considered a drug?

> >

> >Or am I not understanding this correctly?

> >

> > > You are following FDA labeling regulations when you use INCI

names.

> > > INCI names can come from any number of differernt editions of

the

> > > CTFA's Cosmetic Ingredient Dictionary or the International

Cosmetic

> > > Ingredient Dictionary.

> >

> >My understanding is that FDA doesn't become involved in cosmetics

unless

> >there are " drug " claims associated with the product. If I have

this wrong,

The FDA has authority over all cosmetic labelling. The issue of whether a

product makes health claims is one of classification. If a (cosmetic) product

makes health claims, it is classified as both a cosmetic and a drug, and would

have to meet the requirements of both classifications. The following is an

excerpt from The FDA's website:

FDA is only able to regulate cosmetics after products are released to the

marketplace. Neither cosmetic products nor cosmetic ingredients are reviewed or

approved by FDA before they are sold to the public.

FDA cannot require companies to do safety testing of their cosmetic products

before marketing. If, however, the safety of a cosmetic product has not been

substantiated, the product's label must read " WARNING: The safety of this

product has not been determined. "

FDA does not have the authority to require manufacturers to register their

cosmetic establishments, file data on ingredients, or report cosmetic-related

injuries. To keep abreast of such information, FDA maintains a voluntary data

collection program. Cosmetic companies that wish to participate in the program

forward data to FDA.

Recalls are voluntary actions taken by the cosmetic industry to call back

products that present a hazard or that are somehow defective. FDA is not

permitted to require recalls of cosmetics but does monitor companies that

conduct a product recall. If FDA wishes to remove a cosmetic product from the

market, it must first prove in a court of law that the product may be injurious

to users, improperly labeled, or otherwise violates the law.

FDA collects cosmetic product samples as part of its plant inspections, import

inspections, and follow-ups to complaints of adverse reactions. The agency does

not, however, function as a private testing laboratory. FDA is prohibited from

recommending private laboratories to consumers for sample analysis. Consumers

may consult their local phone directory for testing laboratories.

FDA can inspect cosmetics manufacturing facilities, collect samples for

examination, and take action through the Department of Justice to remove

adulterated and misbranded cosmetics from the market. Domestic and foreign

manufacturers must follow the same regulations. Foreign products that appear to

be adulterated or misbranded may be refused entry into the United States.

For more information, visit their page on Cosmetics, which will have updated

information: http://www.cfsan.fda.gov/~dms/cos-pol.html.

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