Hype vs. Science: Drugs, Claims, and Crafty Marketing

Deciphering cosmetics claims and marketing can be tricky. Is that new serum you're eyeing a new, miracle wonder serum? Is the labelling accurate or misleading? Has the brand accidentally turned it into a drug just by using the wrong words on the label? Who protects consumers?


North American Cosmetics Regulations

According to Health Canada, a cosmetic is defined as: 

“Any substance used to clean, improve or change the complexion, skin, hair, nails or teeth. Cosmetics include beauty preparations (make-up, perfume, skin cream, nail polish) and grooming aids (soap, shampoo, shaving cream, deodorant).”

The Federal Food, Drug, and Cosmetic 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)].

In Canada, a product is legally classified as a drug if it makes claims to modify body functions or to prevent/treat disease. In the USA, drugs are "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)]. In both countries, getting a product to the market that is classified as a drug is an extensive process with much higher standards for safety, manufacturing, testing, and labeling.

It is mandatory for cosmetics products to be registered prior to being sold on the Canadian market. However, Health Canada does not regulate cosmetics. Instead, Canadian Ad Standards acts as a watchdog to ensure cosmetics are not marketed with false or misleading claims. Registration of cosmetic products in the USA is voluntary. There is no approval process prior to release, but the FDA will issue warnings – and it is illegal for companies to make unapproved drug claims. 

It may surprise many people to learn that cosmetics are not required to be tested for safety, even if they contain (allowable) substances that could be classified as drugs in some contexts. While a large majority of companies are ethical beauty brands, there are situations where crafty marketing can blur the lines between cosmetics and drugs. 

 

Cosmetic Prohibited and/or Restricted Use: 3 Examples

  • Retinoic acid (trentoin) and hydrocortisone are two examples of ingredients that can only be used as drugs. They are prohibited for use in cosmetics (though they may be available over the counter).
  • Salicylic acid and Allantoin are two examples of ingredients that might be marketed as either a drug or a cosmetic, depending on the preparation and the particular claims made. They have restrictions for use.

Salicylic Acid (for topical use):

  • A beta hydroxy acid effective for treating acne, dandruff, and other skin conditions through enhanced exfoliation and other mechanisms. It also acts as a preservative.
  • Requires a physician’s prescription if it is a concentration >20% or if the pH of the final product is <3 (note that particular preparation is suggested for plantar warts, not face peels).
  • If sold over the counter, salicylic acid is considered a drug if:
    • It is marketed with phrases such as: active ingredient, reduces acne, improves scars, prevents acne, treats acne, kills acne bacteria (phrases that claim it modifies body function or treats disease). Stating claims like these makes it a drug regardless of what concentration is used in the formula.
    • If >2% concentration is used.
  • If sold over the counter at <2% concentration, salicylic acid can be considered a cosmetic ingredient (or a preservative in the solution), provided the claims used to market it do not imply any drug effects like treating acne.

 Allantoin:

  • Classified as an over-the-counter skin protectant drug with wound-healing effects. If a marketing claim declares it as an active ingredient, it makes the product a drug (i.e., for “minor scrapes and burns” or “relief of poison ivy and insect bites”).
  • If you make no claims, it remains a cosmetics ingredient. It is generally recognized as safe and included in innumerable products that do not market it with a drug claim.

 

 

Active Ingredients

 active ingredients

For a drug, the “active Ingredient” is the actual ingredient that makes the product work. It has a drug monograph and will have been registered with a DIN or NPN (drug identity number or natural product number).

When it comes to cosmetics, the term “active ingredient” is used as a marketing term for something believed to have a true effect on your appearance. While it might be true, if you market the results as actively altering the biology of the skin, then you are identifying it as a drug. This is where marketing terminology and semantic finesse happens.

We prefer to use words like “Functional” to highlight those effects that are intended to be non-passive in the quest for enhancing your appearance.

Unfortunately, a lot of exciting botanical ingredients don’t actually produce effects in real, human tissue, despite what the results showed in the lab. However, there are “workhorse” ingredients that have widespread use throughout the cosmetics industry. Substances like retinol, vitamin C, alpha/beta hydroxy acids, niacinamide, hyaluronic acid, peptides, and Coenzyme Q10 are used extensively. This is because they are coveted by consumers and generally understood to have desirable effects on appearance.

When we find nature-based, functional ingredients that have evidence of effectiveness we always work to incorporate. This is what we call a Performance Botanical. 


There are also trendy, exotic sounding ingredients that result in label appeal and consumer excitement, such as: Microencapsulated Amazonian Orchid Stem Cells (we made that one up). That’s why all of this “claims” and “drug vs. cosmetics” stuff matters. If we market a product as a life-changing Fountain of Youth Serum and say it eliminates all signs of aging, while charging $600/ounce, we hope that the FDA and Canadian Ad Standards would take us to task over the lack of proof and the use of misleading advertising. [Full disclosure: we do have our eyes on some Japanese orchid stem cells, but will be marketing ethically and appropriately, as is our corporate responsibility].

Words matter.

 

Unregulated Terms

Cosmeceutical: no legal meaning or accepted definition. Marketing term.

Hypoallergenic/Safe for Sensitive Skin: When made, usually a brand has had some type of testing performed (unfortunately the type of testing is not standardized). Allergies can happen to any person at any time and from any substance – some more than others. Clear labeling is one of the most important ways to market your product as hypoallergenic and non-irritating. And choosing ingredients that are non-irritating definitely matters.

Dermatologist Tested/Approved: This means a dermatologist was somehow involved at some point. It could mean that they merely read the ingredient list. It could mean that they received samples. It might mean that they had a detailed role in product development.

Free From:” this unregulated, umbrella term is problematic because when a brand advertises a product as “free from” ___(something), it implies that other products that do contain the ingredient are somehow less safe. Marketing a sirloin steak as “gluten free” is silly. Marketing a face oil as “water-free” is useless. Selling something as “preservative free” is dangerous if preservatives were necessary for safety. Be cautious when you see a long list of “free from” ingredients. They are designed to distract you. 

All-Natural, Chemical Free, Toxin Free Skincare, etc. These classifications are also without much meaning or regulation. There are some industry watchdogs and certification programs that exist that do create some standardization (i.e. for organic cosmetics or for cruelty free skincare products), but enforceability and legal standing rarely exists. Some words like “toxin-free” just become umbrella phrases that marketers use to tell consumers their product is “clean” - but remember, nothing is truly non-toxic or chemical free from a science standpoint.

It is important to recognize and acknowledge the traditional medicine practices that have existed for thousands of years, and that traditional wisdom has played an incredible role in both cosmetic and medical science.

 

What is a Claim?
Claims are made by companies in their advertising materials (packaging, web page, social media). Claims may be about the ingredients, the product, the intended results, or endorsements. Making cosmetics claims and avoiding statements that cause your product to be identified as a drug can be challenging. Claims must be true and verifiable. Some are easy to substantiate,  some are unregulated (i.e. hypoallergenic, dermatologist tested, sustainable skincare) and some require cautious wordsmithing:

Semantic Finesse:

Improves the look of fine lines, evens tone, reduces the appearance of dark spots.

Stimulates cell growth, improves micro circulation, suppresses melanin. 

Improves the appearance of marks left by acne.

Heals acne, reduces scars.

Smooths and improves the texture of the skin.

Breaks down fat deposits and reduces cellulite.

 

See the difference?

Cosmetics Claims focus on the results and how things look.

Drug claims focus on the mechanism of action and underlying physiology.

To go from being an ordinary skincare brand to becoming one of the best ethical beauty brands, the approach taken for making and substantiating product claims is critical. 

 

Claims Testing

As a brand gains customers and begins to generate revenue, the next step is to work on establishing evidence that their products do what is intended. Back to the salicylic acid example. If a brand develops a cream that contains salicylic acid, a consumer might expect that it would help acne. While the assumption may be correct, the actual product could fall short of meeting expectations. What if the brand added herbal extracts that de-activate salicylic acid? What if they used comedogenic oils that results in clogged pores and increased acne?

Hypoallergenic: the best way to claim that a product is hypoallergenic requires repeat insult patch testing over a period of multiple exposures in multiple subjects. However, any person could still have a reaction to tested products.

 

Consumer use testing: Surveys administered by an independent lab to a cohort of people using the product under usual conditions. The results are subjective (ie. 95% of women surveyed felt their skin was softer…)

 

Objective Measurements: The depth of wrinkles, color/number of pigmented lesions, number of clogged pores, bacterial studies, skin elasticity, trans epidermal water loss.

 

Data transparency is a corporate responsibility. We caution consumers to read with a critical eye (check out our previous article about greenwashing). It is important for brands to go one step further than just substantiating a claim without providing details of how they did it.

If a brand claims “hypoallergenic and dermatologist tested” wouldn’t you like to know if there was a patch test performed on 5 people for a 24-hour period versus repeatedly on the same 50 people over 6 weeks? The latter is a much more valid measurement for allergenic potential.

 

If a brand claims “90% of consumers report a reduction in the appearance of age spots” wouldn’t you want to know if this represented 9/10 women or 90/100 women? Or if they were 25 years old or 55?

 

As a brand does more testing, their marketing claims can be strengthened because they have produced verifiable results. However, this process doesn’t come with a low price tag, and it can take a long time before Indie Startup Brands can get going and afford it. Some of the tests above cost over $25 000 per product to perform!

Consumer expectations also need to be realistic. It’s absolutely possible that a face product will have results that do things things like improve texture and even tone. But if it sounds too good to be true, it probably is. If you want to become wrinkle free or completely eliminate dark spots you’re going to need to spend some time under a laser beam or scalpel.

So… how do we as brands tell you as consumers about our products and what to expect from them?

At bareLUXE™, our main marketing gimmick is transparency. We tell you exactly what we are doing and why.

We take simple ingredients and elevate them into more effective products. bareLUXE CoreComplex™ Blends contain primarily organic carrier oils. Carrier oils have many skin benefits and contain antioxidants and exciting phytochemicals, but they are not going to produce dramatic changes to your appearance. They're lovely but quite passive.

  • Our Elevated Face Oils all start with one of our proprietary CoreComplex Oil Blends as a base. Then we add Performance Botanicals that will have a more visible effect on the appearance of your skin than just carrier oils alone.

We really love using Bakuchiol as an excellent example of how Green Beauty can be elevated.

The Babchi Seed (psoralea corylifolia) can be used to produce a carrier oil or plant extract using traditional, natural extraction methods. When this approach is taken, there is no way to know how much of the effective ingredient (Bakuchiol) is present in the solution.

Pure Bakuchiol can be isolated and extracted (from the seeds) using a very scientific process called monomolecular extraction. The Bakuchiol produced is natural and pure, but the methods used to produce it are not considered natural. There is a growing body of evidence supporting Bakuchiol as a retinol alternative. 


We are committed to educating our consumers about our products and why we choose the ingredients we use.