COSMETICS VS DRUGS:
The FD&C Act defines the term “cosmetics” 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)). However FD&C Act defines
“drugs” as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of
disease...and articles (other than food) intended to affect the structure or any function of the body of man
or other animals." (FD&C Act, Section 201(g)).
Therefore “cosmeceuticals” (term used by industry) are those cosmetic products who provide medicinal
benefits but are used for beautification purposes and these products are required to comply with FDA
regulations under Drug Regulations (U.S Federal Drug Authority (FDA), 2018) . For instance, a makeup
primer that claims to conceal wrinkles would be considered a cosmetic but a serum that removes or
reduces the size of wrinkles would be regulated as a drug. FDA regulations for cosmetics are very less (or
none in some cases) from those for drugs. For instance cosmetics can be marketed and sold without FDA
approval without listing it with FDA if the manufacturer itself ensures the safety of the product ingredients
and back them with appropriate claims. The obligatory labeling requirements for cosmetics are much
simpler than drugs (U.S Federal Drug Authority (FDA), 2018).
On contrary anti-aging products are usually formulated with ultraviolet (UV) filters which protect from
UVA & UVB rays which are the main cause of skin damage, hence FDA considers all sunscreens as drugs,
and defines the range of filters that may be marketed as active ingredients in anti-aging products. Any
filter not recognized with FDA will be considered illegal and cannot be marketed.
FDA is very stringent on drug regulations and had previously issued various warning letters to Lancôme
for claiming that its products "re-bundle collagen," "can stimulate cell regeneration" and "stimulate the
production of youth proteins."
As a result over-the-counter (OTC) drugs can only be marketed in following ways
1. New Drug Application (NDA) (FD&C Act, Section 201(p)) or an Abbreviated New Drug Application
(ANDA) approved by FDA (FD&C Act, Section 505(a))
2. OTC drug monographs identifying active ingredients and declaring the intended uses for which
FDA has found them to be Generally Recognized as Safe and Effective (GRASE).
Products such as acne creams, sunscreens and antiperspirants etc. that are usually considered cosmetics
but are drugs are usually regulated under monograph and requires no further clearance. But as of yet FDA
hasn’t designed a monograph for anti-aging products and these products are subject to the NDA or ANDA
requirement only. Few of the other requirements from FDA includes compulsory registration and listing
of all the products with the regulator along with the labeling statements with a compulsory Drug Facts
Chart. (U.S Federal Drug Authority (FDA), 2018)
Companies like Vingt Hui exporting anti-aging products to United States must be increasingly aware of
FDA regulations. FDA inspector at port receives import alerts and advices from FDA to check and inspect
products and/or detain based on previous or potential violations by the exporting companies. FDA has an
import alert on products that identify themselves as “skin care products labeled as anti-aging creams" and
renowned firms such as Estee Lauder, Clarins, and Chanel etc. After the withdrawal of IA 66-38 by FDA it
is now possible for skin care or cosmetic products that claim anti-aging properties to be imported.
However companies should remain cautious while claiming any benefits which may change the structure
or function of the body to avoid being recognized as drugs by FDA. Also all marketing communications
either through product packaging or through company’s websites must be seen through conservative lens
and ensure compliance with FDA.