What are topical formulations?
Definition
Topical
formulations are formulations made to be applied onto skin. Topical
formulations include pharmaceuticals, skin care, and cosmetic products.
Products can be formulated in various consistencies including creams, lotions,
and serums. Product base can consist of oil, water, oil-in-water emulsion, and
water-in-oil emulsion.
Discussion
Pharmaceuticals
are characterized by at least one active ingredient whose percentage and
medicinal indication or claim have to be specified on the product label.
Pharmaceuticals
are formulations that were approved by governmental authorities such as
the US Food and Drug Admunistration (FDA) to treat, cure, or care for specific
ailments.
Cosmetics—including
skin care products and cosmeceuticals—cannot claim any medicinal virtue
on
their label. http://vm.cfsan.fda.gov/~dms/cos-217.html
A
cosmetic product may be marketed as such even if it contains ingredients similar
to a pharmaceutical product provided that the ingredients are not individually
restricted
as drugs or otherwise limited for use below a certain concentration.
Even
when similar in its ingredients to a pharmaceutical product, a cosmetic product
cannot claim medicinal virtue without FDA approval
“If the fix is not by a drug than the problem is not a disease”:
Even
if tested in scientifically-sound experiments and found to improve an ailment,
a cosmetic
product cannot claim medicinal virtue without FDA approval
“If the problem is not a disease than the fix is not a drug”:
A
cosmetic product does
not require FDA approval to claim to improve a non-medicinal problem.
A cosmetic product does not require an FDA
approval to be appllied as such (a non-medicine) to a medicinal problem, even
if the cosmetic product is similar in its ingredients to a pharmaceutical
product
that is designed to cure that medicinal problem.
Ingredients
that are restricted by the FDA in their quantitiy of use for a certain purpose
may be used in larger quantities for other purposes as long as the ingredient
itself is not restricted as a drug.
Disclaimer
The preceding text and statements are not legal or medical advice nor are
they intended to reflect the ideas of or represent the Food and Drug Administration.
The sole purpose is to stimulate a discussion and point out issues of concern
in this field.