Are your skin care products cosmetics or drugs, or both?

The U.S. Food & Drug Administration (FDA) Office of Cosmetics has been a tear recently, sending out warning letters to various cosmetic manufacturers, all of involving unapproved drug claims.  So what is a drug claim and why is it important?

The U.S. Federal Food, Drug and Cosmetic Act (FD & C Act) defines cosmetics, according to 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)].

In contrast, the FD & C Act defines a drug partly according to its intended use 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, sec. 201(g)(1)].

Although there are some differences between U.S. and Canadian regulations, there is general agreement that a drug is an article that, in its intended use, affects the biological structure or function of the body in a known manner. These intended uses and the effect of the uses, are laid out in the drug monograph that must be filed with the governing body, and they are defined as “approved” uses of the drug.

A cosmetic may used to alter the physical appearance of the body but it may only do so at a superficial level, without affecting biological function. If a cosmetic is marketed with claims that suggest an effect on the biology of the body, such claims are viewed as “unapproved” uses.

The line between “drug” and “cosmetic” has become increasingly blurred as cosmetic manufacturers use active ingredients that may (or may not) have an effect on the biology of the skin and hair. Compounding the problem is the tendency of marketers of cosmetic products to use florid language to make extravagant claims about what their products can do, ignoring the legal definitions of “drug” and “cosmetic”.  A few examples of unapproved uses for cosmetics, found in the FDA warning letters,  are provided below. In each one, I have underlined the problematic language.

Excerpt from FDA warning letter to La Bella Figura, July 21, 2016:

Daily Elements Defense Facial Oil
“[E]asily absorbed due to its small molecular structure increasing circulation… rebuild cell structure and support new growth…”
“Rosehip CO2 and Pomegranate CO2 seed oils help rebuild collagen.”

Jardin de Fleurs Skin Revitalizer
“Honeysuckle, Jasmine, Rose Damascena and Carrot Seed Hydrosols aid in reducing skin inflammation…”

Excerpt from FDA warning letter to TPR Holdings, LLC, July 22, 2016:

Freeze 24-7 Instant Targeted Wrinkle Treatment
“Gynostemma is a pure plant extract, which acts to help microcirculation, and assists GABA in communicating its muscle relaxation message.”

Excerpt from FDA warning letter to Peter Thomas Roth, LLC, July 22, 2016:

Un-Wrinkle Turbo™ Line Smoothing Toning Lotion
“A blend of 18 neuropeptides and peptides – work to help send signals to skin to help activate anti-aging mechanisms that help the appearance of deep wrinkles and expression lines.”
“Under Benefits: 24 Karat Gold – helps soothe and has been known to provide anti-inflammatory benefits

Mega-Rich™ Intensive Anti-Aging Cellular Eye Crème
“Under Benefits: SYN®-COLL – Peptide that mimics the body’s own mechanism to produce collagen
“Tetrapeptide and Oligopeptide – Peptides that work synergistically to help promote collagen production while helping to stimulate fibroblast cells in the skin

The majority of these claims are found on beauty products that promise a restorative or “anti-aging” effect on the skin, which typically involves tamping down inflammation, boosting collagen production, and having some kind of beneficial effect on skin cell growth. Claims similar to the ones above are rampant in the beauty marketplace. There are so many offenders, it would be impossible for the FDA to catch every single one. However, with the power of social media, it is easier to publicly call out companies for egregious marketing claims.

Besides being unlawful, unapproved drug claims like the ones highlighted above can lead the consumer to believe the product can do much more than it actually can, or that it can be used in place of prescription drugs or medical treatments available from a doctor. In the vast majority of cases, the claims have little scientific evidence to back up the claim, and in the worse cases, the claims are spurious.

With regards to the examples above, there are no ingredients available over the counter that can make skin tissue produce more collagen, which is a structural protein found in the dermis, the layer of tissue below the outermost layer, the epidermis. Likewise, there are no over-the-counter ingredients that are known to stimulate fibroblast cells, rebuild cell structure or affect “microcirculation”.

Claims of fighting inflammation are also commonly found on beauty products. Because inflammation appears to cause so many disorders, researchers are hunting down potential candidates that can help to fight inflammation and there many potential candidates, but for fighting inflammation, at the moment, only a few ingredients that are available are the counter are proven as effective anti-inflammatory agents, and those are the salicylates.

Last few words

Be aware of the difference between a drug and a cosmetic. If you see examples of any of the types of claims show above, read through the ingredients carefully, and know what the active ingredients are and the scientific evidence to back up the claims. Be especially careful when it comes to products containing “natural therapeutic” ingredients, and natural health care products. If in doubt, consult with your dermatologist or doctor, and check the U.S. FDA and Health Canada websites for information.


1.  (a) U.S. Food, Drug and Cosmetic Act:

   (b) Canada Food and Drug Act, and Regulations:

Under the Canadian Food & Drug Act, a drug is defined as  “any substance or mixture of substances manufactured, sold or represented for use in:
the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or the symptoms thereof in man or animal
restoring, correcting or modifying organic functions in man or animal, or
disinfection in premises in which food is manufactured, prepared or kept”;

Under the Canadian Food & Drug Act, a cosmetic is defined as “any substance or mixture of substances, manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth and includes deodorants and perfumes.”

2. U.S. Food and Drug Administration, listing of warning letters addressing drug claims made for products marketed as cosmetics: