If These Claims Are Illegal, Why Are They Everywhere?
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The uncomfortable truth about medical claims in handmade skincare — and why responsible small businesses are getting tired of pretending this isn’t happening
I am going to say something that may ruffle a few feathers.
As a small business owner who has spent a considerable amount of time trying to understand cosmetic regulations, labeling requirements, advertising rules and the line between a cosmetic claim and a drug claim, there is something that has become increasingly frustrating:
Blatant medical claims in the handmade skincare industry are everywhere.
Scroll through social media long enough and you’ll find them.
Visit enough vendor events and you’ll hear them.
Browse handmade skincare websites and you’ll see them.
Products advertised as treating eczema. Healing psoriasis. Helping rosacea. Treating acne. Relieving inflammation. Healing wounds. Treating pain. Fixing hormonal problems. Treating anxiety. Helping insomnia.
Sometimes the medical condition is practically the product name.
And eventually, those of us who are deliberately trying to operate responsibly start asking a very reasonable question:
If these claims aren’t permitted for ordinary cosmetics, why doesn’t the FDA do something about them?
The answer is more complicated — and frankly more frustrating — than many consumers realize.
First, Let’s Get Something Straight: Handmade Does Not Mean Exempt
There seems to be a persistent idea in the handmade community that being a tiny business somehow creates a regulatory bubble around you.
It doesn’t.
Being handmade doesn’t exempt a business from federal law.
Selling at farmers markets doesn’t exempt a business.
Operating from a small workshop doesn’t exempt a business.
Being “all natural” doesn’t exempt a business.
Having a disclaimer at the bottom of a website doesn’t magically erase the claims appearing above it.
And having good intentions certainly doesn’t change the regulatory classification of a product.
The FDA specifically publishes guidance for small and homemade cosmetic businesses. https://www.fda.gov/cosmetics/resources-industry-cosmetics/small-businesses-homemade-cosmetics-fact-sheet According to FDA, businesses that manufacture or market cosmetics have a legal responsibility for the safety and labeling of their products.
FDA also makes an important distinction:
A product intended simply to cleanse, moisturize, beautify or alter appearance may fall within the cosmetic category.
But when a product is intended to treat or prevent disease or affect the structure or function of the body, https://www.fda.gov/cosmetics/cosmetics-laws-regulations/cosmetics-us-law it may be regulated as a drug — or as both a cosmetic and a drug.
That distinction doesn’t suddenly disappear because somebody made the product in batches of 24 instead of 24,000.
“But It Contains Natural Ingredients”
That isn’t the loophole people seem to think it is either.
Beef tallow can be natural.
Calendula can be natural.
Essential oils can be natural.
Herbs can be natural.
Honey can be natural.
None of that automatically gives a business permission to advertise a product as treating a disease.
FDA even points out in its guidance for small cosmetic businesses that choosing ingredients considered “natural” or “organic” does not guarantee that a product is safe.
More importantly, the regulatory issue surrounding medical claims isn’t simply what is inside the jar. It is what you are claiming that jar will do.
That distinction matters tremendously.
So Why Are These Products Still Being Sold?
Here’s the part I think many consumers — and apparently quite a few business owners — misunderstand.
FDA does not sit at a desk approving every cosmetic label, website and Facebook post before the public sees it.
Cosmetic labeling generally does not receive FDA pre-approval before a product goes onto the market.
And FDA actually acknowledges the consequence of that system.
According to FDA's own information about cosmetic labeling claims , cosmetic products and ingredients generally do not undergo FDS premarket approval, with the notable exception of color additives. FDA also explains that consumers may therefore encounter cosmetics on the market carrying claims that go beyond what the law permits.
Think about what that means.
Seeing a product for sale is not evidence that its claims are legal.
A product existing on a website for two years doesn’t mean FDA reviewed it.
A Facebook advertisement running successfully doesn’t mean somebody approved the wording.
A product sitting on a shelf doesn’t mean its claims passed regulatory review.
And a business saying, “We’ve been selling it this way for years and nobody has ever said anything,” certainly doesn’t mean the claims are compliant.
Sometimes it simply means nobody has stopped them yet.
Those are two very different things.
Why Doesn’t FDA Catch Everybody?
Because there are an enormous number of products on the market and enforcement is not an automatic pre-market process for cosmetics.
FDA says factors that can influence whether a cosmetic establishment is inspected include the products involved, consumer or trade complaints, a company’s compliance history, FDA surveillance and compliance initiatives, and agency resources.
FDA explains that https://www.fda.gov/cosmetics/cosmetics-compliance-enforcement/inspection-cosmetics can also include the types of products involved, consumer or trade complaints, a company's compliance initiatives, and agency resources.
In other words, enforcement is inherently selective and risk-based.
That helps explain something that otherwise looks completely contradictory:
A claim can potentially violate federal requirements and still remain publicly visible.
Lack of immediate enforcement is not approval.
Silence is not permission.
And getting away with something is not the same thing as being compliant.
And Yes, FDA Really Does Take Action Over These Claims
This isn’t some hypothetical technicality that regulatory nerds argue about.
There are actual FDA enforcement actions involving exactly this issue.
In July 2026, FDA issued a warning letter involving topical making disease and treatment claims products with labeling such as an eczema and psoriasis “stopper,” acne-related treatment language, rosacea claims and “joint & muscle repair” claims.
FDA determined that the claims demonstrated intended drug uses and that the products at issue were unapproved new drugs.
Read that again.
These weren’t prescription bottles masquerading as moisturizer.
They included balms and topical skincare products making disease or body-function claims.
This is precisely why language matters.
A maker can personally believe with every fiber of their being that an ingredient helped their eczema.
A customer can sincerely tell them that a balm changed their life.
Neither experience automatically transforms a cosmetic into an FDA-compliant eczema treatment.
“But My Customers Say It Healed Their Eczema”
This is another area where things get uncomfortable.
A testimonial isn’t necessarily a regulatory escape hatch.
The Federal Trade Commission regulates advertising, and its health-products compliance guidance explains that advertisers cannot simply use customer testimonials to communicate claims that would otherwise require substantiation.
In other words:
You generally cannot make an impermissible or inadequately substantiated claim simply by putting quotation marks around it and attributing it to a customer.
“My customer said it, not me” is not the brilliant legal workaround social media sometimes makes it appear to be.
The FTC looks at both express and implied advertising claims and at the overall message consumers reasonably take away from an advertisement.
That means businesses should be thinking beyond individual words.
What is the advertisement actually communicating?
What would a reasonable customer believe this product is supposed to do?
That matters.
And No, A Disclaimer Doesn’t Magically Fix Everything
We’ve all seen it.
A page spends six paragraphs telling you how a product can help a particular medical condition and then ends with something resembling:
These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent disease.
There is a problem with treating that sentence like a magic eraser.
If the entire advertisement communicates a therapeutic message, a disclaimer at the bottom doesn’t necessarily undo the overall impression created by the rest of the advertisement.
The FTC's health-product advertising guidance guidance specifically addresses the importance of the net impression consumers receive from advertising.
You can’t scream “THIS TREATS ECZEMA” for an entire advertisement and then whisper “not intended to treat anything” at the bottom and assume the contradiction disappears.
That isn’t responsible marketing.
It’s wordplay.
Here Is Where This Becomes Infuriating for Responsible Small Businesses
This is the part I don’t think gets discussed enough.
Imagine two handmade skincare companies standing beside each other at a market.
Company A has spent time researching regulations.
They’ve reviewed their labels.
They’ve changed product descriptions.
They’ve removed questionable language.
They’ve deliberately avoided disease claims.
They may even have rewritten perfectly compelling marketing because they realized it crossed a regulatory boundary.
Their product description says something like:
“Richly moisturizes and conditions dry-feeling skin.”
Company B puts a jar on the table and essentially says:
“Treats eczema, psoriasis and rosacea naturally.”
Now put yourself in the customer’s shoes.
Which one sounds more powerful?
Of course the second one does.
One company is promising moisturized skin.
The other appears to be promising relief from diagnosed medical conditions.
And therein lies the problem.
Responsible compliance can actually make the responsible business look less confident in its own products.
That should bother people.
Because businesses willing to make the biggest claims can create an enormous marketing advantage over businesses deliberately staying within appropriate boundaries.
And I am tired of pretending that isn’t happening.
This Is Not Small Business Versus Big Government
I own a small business.
I love small businesses.
I want more people to build things, create products, pursue entrepreneurship and bring genuinely innovative handmade goods to the marketplace.
This isn’t about wanting regulators to destroy small businesses.
And it certainly isn’t about cheering when another entrepreneur gets into trouble.
It’s about wanting small businesses to act like businesses.
When you accept someone’s money, manufacture products they put on their body and advertise those products publicly, you have taken on responsibilities.
Learning the rules is one of them.
You don’t have to like every regulation.
You can think some regulations are excessive.
You can advocate for changing them.
But “I didn’t know” and “everybody else does it” aren’t business strategies.
Natural Skincare Deserves Better Than Snake-Oil Marketing
This may be the part that ruffles the most feathers.
I believe reckless medical claims actually hurt the natural skincare industry.
There are beautifully formulated handmade products on the market.
There are extraordinarily knowledgeable small makers.
There are traditional ingredients worth rediscovering.
There are consumers who genuinely prefer simple formulations and thoughtfully sourced ingredients.
And there are products people absolutely love using.
We don’t need to pretend a jar of skincare is practicing medicine in order for it to have value.
When businesses turn every botanical into a miracle treatment and every customer experience into proof of medical efficacy, they don’t strengthen this industry.
They undermine its credibility.
Consumers become understandably skeptical.
Responsible makers get lumped together with irresponsible ones.
And legitimate conversations about traditional ingredients, formulation and skincare get drowned out by increasingly outrageous promises.
Natural does not have to mean anti-science.
Handmade does not have to mean unregulated.
Traditional does not have to mean irresponsible.
And responsible marketing does not mean you don’t believe in your products.
We Have Changed Our Own Marketing Because of This
At Naturally Lathered Tallow Co., this isn’t something we preach from a distance.
We have changed wording.
We have reconsidered claims.
We have had conversations internally about what we should and shouldn’t say.
There are times when stronger language would unquestionably make a product easier to market.
We don’t always use it.
Not because we don’t believe in what we make.
Not because customers haven’t shared incredible experiences with our products.
But because there is a difference between sharing someone’s experience and turning that experience into a medical promise to the next customer.
That line matters to us.
Sometimes responsible business ownership means choosing the less sensational sentence.
Sometimes it means saying “supports soft, moisturized skin” when the internet is screaming much bigger promises.
And yes — sometimes watching competitors make those promises anyway is incredibly frustrating.
So Should FDA Be Doing More?
I think consumers deserve a marketplace where the rules don’t appear optional simply because enforcement hasn’t caught up yet.
I also think responsible businesses deserve a marketplace where following those rules isn’t effectively punished by allowing more aggressive competitors to make claims compliant businesses intentionally avoid.
FDA clearly does enforce these requirements.
The warning letters exist.
Inspections happen.
Regulatory actions happen.
But FDA also openly acknowledges the realities of market surveillance, public-health priorities and limited resources.
That leaves a substantial amount of responsibility exactly where it should have been all along:
with the business making the claim.
The question shouldn’t be:
“Can I get away with saying this?”
It should be:
“Can I responsibly stand behind saying this?”
Those are very different standards.
To Other Handmade Skincare Businesses: We Can Do Better
I’m not writing this because I think Naturally Lathered Tallow Co. is perfect.
We aren’t.
Regulations are complicated. Guidance changes. Formulations evolve. Labels get revised. Businesses learn.
We will undoubtedly continue learning too.
There is a tremendous difference, however, between making an honest mistake and building a marketing strategy around medical promises your product isn’t legally positioned to make.
If you’re selling skincare, learn the distinction between cosmetics and drugs.
Learn what your claims communicate.
Review your website.
Review your labels.
Review your social media.
Review the testimonials you’re using as marketing.
And when you’re unsure, research it.
Being small isn’t an excuse for being careless.
It is an opportunity to prove that small businesses can hold themselves to incredibly high standards.
And To Consumers: Ask Better Questions
When you see a skincare product promising to cure, heal, treat or prevent a medical condition, don’t automatically assume the claim must be legitimate because the advertisement exists.
Ask questions.
What exactly is being promised?
Is this being sold as skincare or as treatment for a disease?
Is there credible evidence behind the claim?
Is the business selling a cosmetic while advertising it like medicine?
And perhaps most importantly:
Is someone selling you a thoughtfully formulated product — or selling you hope?
There is a difference.
Our Products Don’t Need Medical Promises To Be Worth Making
We started Naturally Lathered Tallow Co. because we believe traditional ingredients can be used thoughtfully in modern products.
We believe in hand-rendered tallow.
We believe in careful formulation.
We believe in knowing what goes into the products we sell.
And we believe a small business can be passionate about natural skincare without pretending its products are pharmaceuticals.
That’s part of what Rooted in Tradition • Made for Modern Life means to us.
Tradition deserves respect.
Science deserves respect.
Our customers deserve respect.
And so do the rules that help consumers understand what they’re actually buying.
So yes, it frustrates me when I see blatant medical claims casually thrown around the handmade skincare industry.
It frustrates me because businesses trying to operate responsibly notice.
It frustrates me because consumers may not know the difference.
And it frustrates me because this industry does not need exaggerated medical promises to succeed.
We can make exceptional products without making promises we have no business making.
And perhaps it’s time more of us started saying so.
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If you'd like to understand where the regulatory line actually falls, read our companion article: