Reading labels for hair loss and thinning

Most categories on this site require reading a regulation carefully to work out what the regulator thinks. Not this one. In this category FDA wrote its opinion down in plain English, decades ago, and almost nobody quotes it.

The sentence worth knowing

The regulation covering over-the-counter products sold for external use as hair growers or for hair loss prevention begins by listing what has been marketed for the purpose: “Amino acids, aminobenzoic acid, ascorbic acid, benzoic acid, biotin and all other B-vitamins, dexpanthenol, estradiol and other topical hormones, jojoba oil, lanolin, nucleic acids, polysorbate 20, polysorbate 60, sulfanilamide”, a sulfur preparation, and then “tetracaine hydrochloride, urea, and wheat germ oil”.

Then it says what it thinks of them:

“There is a lack of adequate data to establish general recognition of the safety and effectiveness of these or any other ingredients intended for OTC external use as a hair grower or for hair loss prevention. Based on evidence currently available, all labeling claims for OTC hair grower and hair loss prevention drug products for external use are either false, misleading, or unsupported by scientific data.”

False, misleading, or unsupported by scientific data. That is the regulator’s own wording about an entire product category, and it is still in force.

Note the scope carefully, because it is easy to overstate. This is about topical products sold for hair growth. It does not cover swallowing something, and it does not cover cosmetics that make no growth claim. What it does cover is most of the shelf.

The exception, and what makes it one

Topical minoxidil is not in that category, because it went the other route.

FDA “approved the sale of topical minoxidil as an over-the-counter (“OTC”) drug available without a prescription” in February 1996, as a new drug rather than under a monograph. It has an approved indication, a studied concentration, a known mechanism and a documented side effect profile, and it requires child-resistant packaging above 14 mg per package.

So the shelf contains one thing that cleared a drug approval and a great many things the regulator has described as making unsupported claims. That distinction is invisible from the front of the pack, where everything says the same words about thickness and fullness. Minoxidil has the detail.

Where the vitamins actually sit

Biotin is the most sold ingredient in this category and it is named in that regulation by name. Rubbing it on your head is covered by the sentence above.

Swallowing it is a separate question with a separate answer, and it has a complication most people have never heard of: high-dose biotin interferes with the immunoassays used to measure thyroid function, so a supplement taken for hair can produce a thyroid result that looks like disease. That is on the biotin page and it is the reason it belongs here rather than in a footnote.

Caffeine and the various peptides are marketed on laboratory findings rather than on clinical outcomes, and the gap between those two is the whole subject of this site.

The cause nobody sells a product for

The narrative review on textured hair records that infrequent washing and prolonged protective styling raise the risk of traction alopecia, which is hair loss caused by sustained pull on the follicle.

Traction alopecia is mechanical. No ingredient prevents it and no shampoo reverses it. It is caused by how hair is worn, it is largely preventable, and caught early it is largely reversible. That makes it the most treatable common cause of hair loss on this page and the one with no product attached, which is a fair summary of where the money in this category goes.

The same logic applies to breakage, which is not hair loss at all but looks like it in a mirror. Hair breaking mid-shaft leaves the follicle intact, and the fix is mechanical and conditioning rather than pharmacological, which is covered in the cluster on curly and coily hair.

What to do with a shelf

Read the front for a drug active, and read the back for everything else. If a product contains an approved active it will say so in a drug facts panel, because it has to. If it does not, then whatever it is claiming sits in the category the regulation describes.

That is not a reason to throw a product away. Conditioning agents make hair look thicker and behave better, and that is a real benefit honestly obtained. It is a reason not to expect regrowth from them.