What Regulatory Experts Want You to Know About Writing Cosmetic Claims
Writing claims is one of my favorite parts of the product development process but it’s also the part that I tend to have the most beef with. Oh the things that brands will say about their products sometimes really grinds my gears. I get it: you want to be competitive, you want your product to be this shiny, cool thing for your consumer. But here’s the reality: claims are one of the most common reasons brands run into trouble—whether it’s with regulatory bodies or even competitors.
But how do you handle this delicate balance? We know that majority of consumers look for claims when deciding to buy a beauty product, so we can’t just ignore them all together. But we also shouldn’t put our brand at risk for legal consequences.
In order to master this delicate balance, we first need to understand the ins and outs of the regulation so that we can build up our claim writing skills with a good solid foundation under us.
Table of Contents
What is a Cosmetic Claim
Claims include any written or verbal information on your product.
This includes the following, but not limited too:
Primary and secondary packaging
Website copy
Before and after images
Social media (including UGC and affiliate content)
Videos and commercials
Printed marketing materials
Blog posts and other written media
Paid testimonials
Claims will become the backbone of your marketing strategy and help you communicate what your product does, how it works and why someone should buy it. This could include information on the aesthetic properties (ex. this formula gives a matte skin feel), the functional benefits (ex. blurs the appearance of wrinkles) or even value-based information (ex. cruelty-free).
Types of Beauty Claims
When writing information about your product, you will likely be making a variety of claims. It is important to understand the different categories of claims so that you can better understand how you go about backing up each one sufficiently.
Performance Claims: Focus on the visible effects of the product. Example: "Improves the appearance of fine lines and wrinkles."
Ingredient Claims: Highlight key ingredients and their benefits. Example: "Contains hyaluronic acid that hydrates the skin."
Value Based Claims: Includes claims around the brand or formula's values such as "vegan," "free from artificial fragrance," “all natural” or "Non-GMO."
Aesthetic Claims: Relates to the sensory experience around the product such as the texture, scent, or color. Example: "Leaves skin feeling silky smooth."
Who Regulates Cosmetic Claims
Both the FDA and FTC regulate claims in here the U.S. While you don't have to have claims approved through either regulatory body, you must ensure two main things:
Language must be compliant
Claim must be truthful and backed by proper substantiation
Failing to follow the above could make your brand a target for legal action, including warning letters, recalls and lawsuits. And while you may think your brand is flying under the radar and will never get in trouble, trust me it is just a matter of time.
FDA Definition of a Cosmetic vs. a Drug
Understanding how the FDA views cosmetics in the eye of the regulation is critical to understanding how to write in a compliant way.
Definition of a cosmetic:
"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)].
Definition of a drug:
"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)].
When writing a claim you need to ensure that your word choices don't push your product into the "drug" category. In general, we want to avoid language that implies the following:
Structure-Function: This type of language implies that the product can alter either the structure or the function of the skin. Example: "increases collagen," "boosts cellular energy," “calms inflammation"
Therapeutic Effect: This includes language suggesting the product is intended to treat, cure, or prevent a condition. Example: "treats eczema," "cures acne," "reduces dandruff”
Understanding which skin/hair/oral problems are considered diseases by the FDA is also important. Certain conditions are only allowed to be treated via OTC or Rx formulations and not cosmetic formulas. Even if you are using a cosmetic ingredient in a formula that shows a reduction in acne, it doesn’t mean you can talk about it. This is because acne is considered a disease and requires the use of pharmaceutical actives at specific levels as well as specific registration, labeling and formulation requirements per the regulation.
Even if you never launch an OTC formulation, you should still familiarize yourself with the topical OTC monographs so you don’t unintentionally imply that your cosmetic product is a drug.
The main topical OTC/Rx categories include sunscreen, cavities, other oral diseases (sensitivity, gingivitis, etc.), topical antibiotics, topical antiseptics and hand sanitizers, topical antifungals, acne, antiperspirant, topical analgesics, skin protection, seborrheic dermatitis/dandruff, and hair growth.
You can find all OTC monographs at the link here: https://dps.fda.gov/omuf/monographsearch
Examples of Non-Compliant Language
I want to highlight some examples of non-compliant language so that you understand what the above information looks like in real life.
Example One
High Risk: Our exfoliating toner helps to prevent acne breakouts for clearer looking skin.
Why this is non-compliant: Acne is a skin disease which would imply your cosmetic product is treating a disease.
Lower Risk: Our exfoliating toner reduces the appearance of blemishes for clearer looking skin.
Example Two
High Risk: Provides an anti-inflammatory effect that reduces skin redness and irritation.
Why this is non-compliant: Saying a cosmetic has an anti-inflammatory effect implies a therapeutic action is happening which falls outside of the definition of a cosmetic.
Lower Risk: Reduces the appearance of redness and provides more comfortable feeling skin.
Example Three
High Risk: Boosts the production of collagen which works to eliminate wrinkles.
Why this is non-compliant: This claim is implying that your cosmetic formula has an effect on the function (protein production) and structure (collagen) of the skin which falls outside of the definition of a cosmetic. This claim is also overpromising results (eliminate wrinkles) which is not something a cosmetic formula can do.
Lower Risk: Reduces the appearance of wrinkles for firmer, more youthful looking skin.
Example Four
High Risk: Uses Nanohydroxyapatite at the optimal concentrations of 10% to provide the same cavity protection as fluoride.
Why this is non-compliant: hydroxyapatite is a cosmetic ingredient and has not been approved by the FDA for cavity protection. Implying this ingredient works on this disease means you are selling a misbranded drug product.
Lower Risk: Powered by 10% nanohydroxyapatite to support your teeth’s natural restorative process for a strong and healthy smile.
Tips for Writing Compliantly
Focus on the Visible Effects
Since you can’t imply your product works on the structure or function of the skin, it is a safer bet to focus on the visible effects. This could include things like smoothing, firming, brightening, radiance, complexion, etc.
Remember the definition calls out: cleansing, beautifying, promoting attractiveness, or altering the appearance
Sticking to effects that imply the above is going to be lower risk. You still need to have proper data to back up what you are saying, but that’s a topic for another day.
You may have noticed in my lower risk examples above I used the word appearance a lot. This is because cosmetics are allowed to “alter the appearance" of the skin per the definition. When we talk about changes that occur with the skin such as wrinkles, dark spots, redness or blemish reduction- adding appearance before the thing we changed lowers the risk. Without the word "appearance" (or the look of) you are implying more of a structure-function benefit, which we mentioned above is not compliant for cosmetics.
Watch your Verb Usage
Some verbs can imply either a structure function or therapeutic effect. While there are the more obvious ones like saying your product heals, treats or cures, there are also some verbs that may be less obvious.
In general it is best to avoid “absolute” verbage and wording.
Saying things like erases, eliminates, repairs, rebuilds, regenerates, stimulates, eliminates, corrects and prevents are still high risk verbs to use for a cosmetic formula.
Even verbs like soothes, calms, boosts, and protects could be non-compliant if you are implying a therapeutic or structure-function effect with the rest of the sentence.
Getting creative with your word usage is a key skill to learn for claim writing- you need to learn how to keep your risk low and avoid non-compliant language while still trying to imply a specific benefit that the consumer will understand.
Sticking to soft verbs or adding in adjectives and adverbs almost always will lower your risk.
We already talked about adding in the word “appearance” but words like visibly, improves the look of, helps, minimizes, enhances, conditions, hydrates, revitalizes, refreshes, and supports are typically lower risk alternatives.
Stay Away from Skin Structure
I see claims around boosting cellular energy, improving collagen production, and strengthening the skin barrier a lot. Talking about the skin’s structure and how your product alters it, is non-compliant and falls outside of the definition of a cosmetic.
In general, calling out and referencing specific skin physiology is high risk and non-compliant.
For example: certain proteins or enzymes (collagen, elastin, melanin, tyrosinase, etc.), ECM or dermal matrix, DNA/DNA repair, cells, cellular energy, fibroblasts, cellular turnover, sebaceous gland, stem cell, and blood vessels.
Keep your language general around the skin’s appearance and focus on the surface level improvements.
Common Misconceptions
"If a competitor is making the claim, I can too."
Honestly if I had a dollar for every time I have heard this one, I’d be retired by now. It sucks seeing a competitor making an extremely high risk claim. You feel like you need to one up them or at least be on a level playing field. It feels unfair that you are trying to follow the rules but others aren’t. But that doesn’t mean that the claim is complaint. It just means that the company is taking a risk. They are risking being caught.
Through out my career, I have seen a plethora of warning letters and lawsuits, and 9x out of ten whatever claim was being called out was not worth making in the end. The time, money and resources it will take to update the issue could send your brand in a downward spiral. Plus the negative PR that comes around lawsuits and warning letters can make consumers trust you less.
Focus on what you can say about your formula and say it really well.
"Small brands aren’t on the FDA's radar"
If you think your brand is too small for the FDA to find out about, think again. I always like to say that if your customers can find out about you, so can the FDA. Just because you are a small brand, doesn’t mean you are exempt from regulation around claims.
No matter the size, you should be following the rules.
"Claims on social media don’t need to follow the same rules”
It doesn’t matter if the claim is on your website or TikTok, it is still a claim and the rules still apply.
If you are paying influencers, affiliates, or other content creators to make posts on your behalf they also need to follow the rules. When I worked for a brand, this one came back to bite us big time. We had customers saying things like our products treated cancer and the FDA came down on us for selling misbranded drug products.
Educating, monitoring and reviewing any UGC or paid content is critical to ensuring your brand stays compliant across all platform and content types.
"If I use disclaimers, I can make high-risk claims."
Oh I love seeing the good ole "this product is not intended to diagnose, treat, cure, or prevent any disease" at the bottom of a webpage that is filled with non-compliant language. That disclaimer is doing absolutely nothing to protect you from the high risk claims you are making. Disclaimers shouldn’t be used as a substitute for compliance.
Final Thoughts
Writing compliant cosmetic claims requires a deep understanding of regulatory guidelines, creative language skills, and a commitment to transparency and integrity. By avoiding common misconceptions and focusing on truthful and complaint language you can safeguard your brand from regulatory action.
Stay informed with FDA and FTC news and updates, including warning letters
Have a claims review process in place and stay proactive
Consult a professional if you need help and guidance (The team at BeautySci Studios brings over half a decade of experience in writing claims and can review your product’s claims for compliance).
Remember, compliance isn’t just about avoiding penalties—it’s about creating a foundation of credibility and authenticity that sets your brand apart in a competitive market.
