By Dr. Susan Lin, MD | MD HAIR | La Cañada Ventures, Inc.
Published on mdhair.com — The Physician Behind MD HAIR Series
You have read the product page three times and you still cannot find the sentence you came for.
Supports the appearance of thicker, fuller-looking hair. You read it again. Appearance. Looking. Two hedges in nine words. And the question forming in your head is entirely reasonable: if this actually did something, wouldn't they just say so?
I want to answer that, because I am the person who chose those words, and I have never enjoyed reading them either.
I am Dr. Susan F. Lin, M.D. — Boston University School of Medicine, board-certified in Obstetrics & Gynecology and in Anti-Aging Medicine, formulating the MD® line at La Cañada Ventures, Inc. since 2008. I have sat in the meeting where someone proposes a cleaner, warmer, more confident sentence, and I have been the person who says no. Sometimes I have been wrong about the marketing and right about the law, and the sentence went out flat and careful and cost us sales.
So here is the honest account: that phrasing is not a hedge, and it is not lawyer-fog sprayed over a weak product. It is a boundary line — the edge of a legal category — and on the other side of it is a claim I am not entitled to make. What follows is where the line runs, why it runs there, and what I would say if it did not exist.
The Line Is Drawn by What a Product Is Intended to Do
In United States law, a product's regulatory identity is set by its intended use, and claims are the primary evidence of intent. A drug is defined as an article intended for the diagnosis, cure, mitigation, treatment or prevention of disease — or an article intended to affect the structure or any function of the body (FD&C Act § 201(g)).
Read the second half slowly. Affecting structure or function is, by itself, enough to make something a drug.
Dietary supplements get out of that through a carve-out written into DSHEA in 1994 (Public Law 103-417). Cosmetics do not. There is no cosmetic equivalent, no application to file, no evidence package that earns a topical product the right to say grows hair. A topical whose intended use is hair growth is not a well-substantiated cosmetic. It is an unapproved drug.
This produces an asymmetry that explains almost every strange sentence in this category, and once you see it you cannot unsee it:
| Product type | May claim structure/function? | Practical ceiling |
|---|---|---|
| Dietary supplement (oral) | Yes, under DSHEA — truthful, substantiated, notified, with the disclaimer | Supports healthy hair |
| Cosmetic (topical) | No — a structure/function claim asserts drug status | Supports the appearance of fuller-looking hair |
| Drug | Yes, and disease claims too | Regrows hair — after review |
MD Nutri Hair™ is a supplement. Our topicals are cosmetics. The two arms of the same protocol operate under different claim rules, which is why our own copy sounds different depending on which product it is describing. That inconsistency is not sloppiness. It is two categories.
What a Structure/Function Claim Actually Is
For the supplement side, the permitted class of statement is narrow and specific. A structure/function claim describes the role of a nutrient or dietary ingredient in affecting the normal structure or function of the human body, or characterises the documented mechanism by which it does so (FDA, Structure/Function Claims). Calcium builds strong bones. Fibre maintains bowel regularity.
Three obligations attach, and all three are real:
- Truthful and not misleading, with substantiation held before the claim is made. The FTC expects competent and reliable scientific evidence appropriate to the claim; stronger claims demand stronger support (FTC guidance).
- Notification to the FDA within 30 days of first marketing the claim. Note what this is: a notification. Not a review, not an authorisation, not permission. Anyone describing it as FDA approval has misread the document.
- The disclaimer, verbatim: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
That last one is where readers get cynical — it reads like a company disowning its own product. It is closer to the opposite. It is the fixed, non-negotiable price of being allowed to make structure/function statements at all, and a supplement that makes such statements without it is not more confident. It is out of compliance.
Where a Structure/Function Claim Becomes a Disease Claim
The boundary between the two is set out in regulation (21 CFR § 101.93(g)), and it is broader than most people expect, because it catches implied disease claims as well as express ones.
A claim crosses into disease territory if it references a specific disease or class of diseases; if it references a characteristic sign or symptom of one; if the product name itself implies a disease; if the formulation includes an ingredient recognised for treating a disease; or if citations, pictures or symbols — a journal reference about treating a condition, an image of a diseased organ — carry the implication that the words avoid.
Applied to hair, the line runs like this:
Permitted for a supplement: supports healthy hair · supports normal hair growth · provides nutrients that contribute to keratin synthesis · supports a healthy scalp environment — each with substantiation and the disclaimer.
Not permitted, at any evidence level, without drug approval: treats androgenetic alopecia · stops hair loss · reverses female pattern baldness · for alopecia areata · corrects hormonal hair loss · treats seborrheic dermatitis.
And note the trap in the last two examples. Naming the cause does not soften a claim — it sharpens it. Supports hair health is a structure/function statement. Supports hair health in women with thyroid disease names a disease and is a disease claim. This is why our articles about hypothyroidism, PCOS and iron deficiency route you to a physician and a laboratory panel rather than to a bottle. Not caution for its own sake. It is the only honest structure available, and it also happens to be the correct clinical advice.
Why the Topicals Get an Even Narrower Sentence
Cosmetics do not get the DSHEA carve-out, so the ceiling drops again.
A cosmetic is defined as an article intended for cleansing, beautifying, promoting attractiveness, or altering the appearance (FD&C Act § 201(i)). Appearance is not a weasel word bolted on by a compliance department. It is the statutory word. It is the whole territory the category occupies.
This is also why 21 CFR § 310.527 matters: over-the-counter drug products labelled for hair growth or prevention of hair loss are not generally recognised as safe and effective. The unapproved-OTC-hair-grower door was closed decades ago. Everything sold outside drug approval in this aisle therefore lives in appearance language — or is non-compliant.
So the anatomy of the sentence you find evasive:
"Supports the appearance of thicker, fuller-looking hair."
- Supports — contributory, not causal. We are not claiming to be the sole or sufficient cause of a change.
- the appearance of — the statutory territory of a cosmetic. Explicitly not a claim about follicular biology.
- looking — signals a visual outcome, not a measured one. No hair was counted.
Every word is doing work, and yes, it reads like a lawyer wrote it, because in a sense one did — legislators in 1938 and 1994.
And the Real Product Is Real
Here is the part the hedging obscures, and it deserves saying clearly. Appearance effects are genuine effects. The hair shaft is dead keratin. Reduce combing friction, lay the cuticle flatter, cut static so fibres separate instead of collapsing, deposit a thin conditioning film — and hair reflects light more evenly and occupies more visible volume. Someone who has been avoiding photographs for a year notices that, and it matters to them. It is not counted density and I will not let it be read as counted density, but cosmetic is not a synonym for cosmetic in the dismissive sense.
What I Would Say If the Line Were Not There
Fair question, so here is the direct answer.
I would still not tell you our products regrow hair, because I do not have a randomised, placebo-controlled trial showing that, and I would not make that claim on the evidence I hold regardless of what any statute permitted.
What I would say — and what the law compresses out of the sentence — is closer to this:
In laboratory studies on human dermal papilla cells, the cells at the base of the follicle, verbascoside induced cell proliferation, prevented testosterone-induced cell death, and reduced the release of pro-inflammatory signals including IL-1α, IL-6, IL-1β and TNF-α (Wisuitiprot et al., 2022). Those were cell studies, not human trials; the authors state that clinical study is still needed; and the verbascoside tested came from Acanthus, not lilac — the same molecule from a different botanical source, not our own material. That is mechanistic rationale for why the ingredient is in the formula. It is not evidence that the finished product regrows hair.
That paragraph is longer, more caveated and less satisfying than regrows hair. It is also true, checkable — the paper is open access — and it is what I actually believe. The nine-word compliant sentence and this paragraph are not in conflict. The paragraph is what the sentence is compressing.
Which is the real argument of this article: the phrase is a ceiling, not a summary. If you want to know what I think, read the mechanism paragraph, read the evidence page, and read the article where I set out exactly what our studies do and do not establish. The label was never going to hold that.
Where This Is Genuinely Frustrating — Including on Our Own Box
I said I would be candid, so three admissions.
First: precise language and persuasive language are different crafts, and I have chosen precise every time. It costs us. A customer comparing our page against a competitor promising regrowth in six weeks is comparing a constrained sentence with an unconstrained one and has no way to tell which is which. The honest brand reads weaker. I know that, I have watched it in our analytics, and I have not changed the policy — but I am not going to pretend the trade is free.
Second: careful phrasing can itself become a technique. Stack enough hedged claims beside a dramatic photograph and the overall impression does the work the words refused to do. The FTC has been clear for years that net impression governs — a page can be non-compliant even where each individual sentence would survive on its own. If our copy ever reads that way to you, tell us; that is a failure of the standard, not an application of it.
Third: our own box asks for the same reading discipline this article teaches. The MD Nutri Hair™ box front reads thicker, fuller, longer looking hair in 30 days. The word looking is doing exactly the legal work described above — it is an appearance claim, and it carries the DSHEA asterisk. Read it precisely, as this article has been asking you to read every label: surface and appearance properties — manageability, how full hair looks, and in my clinical experience a settling of day-to-day shedding — are the kinds of change that can show inside about 30 days, because they do not have to wait for the hair cycle. Density is different. A change in how much hair you actually have cannot be honestly assessed inside 90 days, because a follicle cannot report back faster than it grows — which is why every timeline article on this site holds 90 days as the minimum window for judging density, and why the box's 30-day sentence and the site's 90-day rule are answers to two different questions. If you take one habit from this page, take that one: always ask which question a timeframe is answering.
The Bottom Line
Supports the appearance of is not evasion. It is the outer edge of a legal category.
Cosmetics may claim to cleanse, beautify, promote attractiveness and alter the appearance — and nothing more, because a claim about the structure or function of the body makes a topical product a drug, and there is no route by which a cosmetic can earn that claim. Dietary supplements may make structure/function claims under DSHEA — truthful, substantiated, notified within 30 days, and carrying the mandatory disclaimer — but never disease claims, expressly or by implication. Drugs may say what drugs say, having been reviewed before marketing.
So when you compare two products and one sounds far more confident, the first question is not which works better. It is are these two sentences even allowed to be compared? Often they are not: one brand is inside its category and the other has left it.
We write the constrained sentence. I would rather be precise than persuasive, and I would rather you found the language irritating than found it reassuring and wrong.
Dr. Susan Lin's Clinical Perspective
"In clinic I could say to a patient, plainly, what I thought a treatment would and would not do for her — with all the conditionals a real conversation carries. A label cannot hold that conversation. It is a single sentence, read in three seconds, governed by categories written in 1938 and 1994, and it has to be true for every person who reads it. So the language compresses, and what compresses out is exactly the nuance a physician most wants to keep. My discomfort is not with the constraint — the constraint protects patients from the industry I work in. It is that the constraint penalises the compliant. The brand willing to say anything sounds more certain than the brand telling the truth, and the customer has no way to tell them apart from the page. Which is why I keep writing the long version underneath: the label is the ceiling, the article is the answer."
— Dr. Susan F. Lin, M.D., Physician Formulator, MD HAIR
Mechanism Spotlight: Appearance and Biology Are Two Different Systems — and the Law Follows the Biology
The category line is not arbitrary. It tracks a real boundary in the tissue.
The hair you see is dead keratinised fibre. It has no metabolism, no blood supply, no capacity to repair. Everything a topical can do to it is physical and optical: smoothing lifted cuticle scales so light reflects specularly rather than scattering; reducing inter-fibre friction so strands separate and occupy volume; neutralising static charge; depositing a conditioning film that adds a small amount of diameter. The result — hair that looks fuller — is genuine, immediate, and reverses when you stop. This is the appearance layer, and it is precisely what altering the appearance was written to cover.
Beneath the skin sits the other system. The dermal papilla, a cluster of specialised mesenchymal cells at the base of the follicle, signals to the surrounding matrix keratinocytes and effectively governs the follicle's cycling between anagen, catagen and telogen and the calibre of the shaft it builds. Change what happens there and you have changed structure and function — biology, on a timescale of months, persisting after the intervention ends.
Between the two systems lies the stratum corneum, a dense lipid-and-corneocyte barrier evolved to keep foreign molecules out. Its selectivity is the reason the boundary is meaningful rather than notional: molecules above roughly 500 daltons penetrate intact skin very poorly (Bos & Meinardi, 2000), and delivery is further modulated by vehicle, pH, contact time and stability. A compound that performs beautifully on cultured dermal papilla cells has, in that dish, skipped the barrier entirely.
So the legal line and the biological line sit almost on top of one another. Above the barrier: optics, appearance, cosmetic. Below it: the follicle's own machinery, structure and function, drug. When a product's copy migrates from how your hair looks to what is happening in your follicle, it has crossed both lines at once — and the question is whether the evidence crossed with it.
Recommended Reading
Pillar pages on mdhair.com:
- The Clinical Evidence Behind MD HAIR
- The Lilac & Verbascoside Science
- Drug-Free Hair Loss Treatment — The Complete Guide
- About Dr. Susan Lin, M.D. — The Physician Behind MD®
Related articles in this series:
- Cosmetic, Supplement, or Drug? The Three Categories That Explain Everything — the full map this article's boundary line belongs to
- How Long Does It Take to Regrow Hair? A Realistic Timeline — why 30 days and 90 days are answers to different questions
- Drug-Free and Natural Are Not the Same Word — the other label word that means less than it appears to, and the one that means more
- Anagen, Catagen, Telogen: The Hair Cycle, Properly Explained — the biology that sets the honest assessment window
Our sister site md-factor.com applies the same claim standard across the wider MD® portfolio.
MD HAIR Product Recommendation
None. An article about not overstating claims should not end in a claim.
Instead: take the MD HAIR Quiz. It works through what is actually driving your hair change — hormonal transition, telogen effluvium, nutritional deficiency, androgenetic miniaturisation, or several at once — and several of its outcomes send you to a physician and a laboratory panel rather than to any product of ours. That is deliberate. If what you have is a disease, you need the drug category and a doctor, and no amount of carefully worded appearance language is going to substitute.
If you want to know what our evidence actually is rather than what our labels are permitted to say, the Clinical Evidence page states it at its real weight, including what it does not establish.
A note on authenticity: genuine MD HAIR™ and MD Nutri Hair™ products are sold only through mdhair.com, md-factor.com, and the official La Cañada Ventures, Inc. stores on Amazon and Walmart. Claims made by unauthorised sellers are not ours, are not written to this standard, and are not something we can stand behind.
References
- Federal Food, Drug, and Cosmetic Act § 201(g) (drug) and § 201(i) (cosmetic), 21 U.S.C. § 321. law.cornell.edu
- Dietary Supplement Health and Education Act of 1994, Public Law 103-417 (full text, NIH Office of Dietary Supplements). ods.od.nih.gov
- 21 CFR § 101.93 — Certain types of statements for dietary supplements (notification, disclaimer, and the disease-claim criteria at § 101.93(g)). eCFR
- U.S. Food and Drug Administration. Structure/Function Claims. fda.gov
- U.S. Food and Drug Administration. Small Entity Compliance Guide on Structure/Function Claims (January 2002). fda.gov
- U.S. Food and Drug Administration. Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?). fda.gov
- U.S. Food and Drug Administration. Cosmetics Labeling Claims. fda.gov
- 21 CFR § 310.527 — Drug products containing active ingredients offered over-the-counter for hair growth or for hair loss prevention. eCFR
- U.S. Federal Trade Commission. (2022). Health Products Compliance Guidance. ftc.gov
- U.S. Federal Trade Commission. Guides Concerning the Use of Endorsements and Testimonials in Advertising, 16 CFR Part 255. eCFR
- Wisuitiprot V, Ingkaninan K, Waranuch N, et al. (2022). Effects of Acanthus ebracteatus Vahl. extract and verbascoside on human dermal papilla and murine macrophage. Scientific Reports, 12, 1491. PMID 35087085 · open access
- Bos JD, Meinardi MMHM. (2000). The 500 Dalton rule for the skin penetration of chemical compounds and drugs. Experimental Dermatology, 9(3), 165–169. PMID 10839713
- Dhurat R, Saraogi P. (2009). Hair evaluation methods: merits and demerits. International Journal of Trichology, 1(2), 108–119. PMID 20927232
Dr. Susan F. Lin, M.D. is the physician formulator behind MD HAIR and MD Nutri Hair™, product lines of La Cañada Ventures, Inc. — physician-formulated since 2008 under the MD® mark (U.S. Reg. No. 4,471,494). She trained at Boston University School of Medicine and is board-certified in Obstetrics & Gynecology and in Anti-Aging Medicine (A4M).
MD® products are cosmetics and dietary supplements manufactured in FDA-registered, GMP-compliant facilities — a description of the facility, never of product approval. They are not FDA approved; no cosmetic or dietary supplement is. Individual results vary. MD Nutri Hair™ is a dietary supplement. These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
MD Nutri Hair™ is for adults only, one capsule daily. Per the product label: do not take if you are pregnant or breast feeding. Because there are no clinical data in pregnant or breastfeeding women, we do not advocate using MD HAIR products during pregnancy or lactation.
This article is for educational purposes, describes United States claim rules in general terms, and is neither medical nor legal advice. Consult your own physician for personalized guidance.
Explore more in The Physician Behind MD HAIR series at mdhair.com/pages/dr-susan-lin