Can a face cream contain hormones?

The question turns up most around products marketed for menopausal skin, where the pitch is often that the skin is short of something and the jar can supply it. The regulation has an unusually direct answer, and an unusually broad one.

What the rule says about the ingredients

The regulation names them: “Estrogens, progesterone, pregnenolone, and pregnenolone acetate have been present as ingredients in OTC drug products marketed for topical use as hormone creams.”

Its finding about all of them is one sentence: “there is a lack of adequate data to establish effectiveness for any OTC drug use of these ingredients”.

The consequence is that such a product “is regarded as a new drug within the meaning of section 201(p) of the act, for which an approved application or abbreviated application under section 505 of the act and part 314 of this chapter is required for marketing”. Without that approval it is also misbranded.

The part that catches people out

Most regulations describe substances. This one also describes a word.

It continues that any statement “indicating that “hormones” are present in the product, or any statement that features or emphasizes the presence of a hormone ingredient in the product, will be considered to be a therapeutic claim for the product, or a claim that the product will affect the structure or function of the body”.

So the trigger is not only what is in the jar. A cosmetic that leans on the word has made a drug claim by leaning on it, and the regulation says the intended use “may be inferred from the product’s labeling, promotional material, advertising, and any other relevant factor”.

That is a wider net than most people assume a label rule can cast, and it is the reason marketing copy in this category tends to talk around the subject rather than about it.

The exception

One, and it is narrow: “This section does not apply to hydrocortisone and hydrocortisone acetate labeled, represented, or promoted for OTC topical use in accordance with part 348 of this chapter”.

Hydrocortisone is a corticosteroid and therefore a hormone in the regulation’s own broad sense, and it has its own monograph. Everything else in the category is outside.

What this does not tell you

It says nothing about whether hormonal changes affect skin, which is a clinical question this page does not touch, and nothing about prescription treatments, which run through a different route entirely.

What it settles is narrower and still useful when you are holding a jar: an ordinary over-the-counter cream is not a legal route for delivering a hormone, and a label that gestures at one has said more than it may have meant to.

For the general shape of this problem, where the claim rather than the ingredient decides which rules apply, see drug or cosmetic: which claims are regulated.