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Lip care
All Containers›Shop by use case›Lip care›Cosmetic or drug›Two regimes, and which one you are inShop all lip care →
Cosmetic or drug

Two regimes, and which one you are in

By Dwight Davis, Founder

Updated

On this page5

Almost everything about a lip balm business follows from one determination, and people often make it without realizing a determination was available.

The fork

A cosmetic is something applied to the body for cleansing, beautifying or altering the appearance. A drug is something intended to affect the structure or a function of the body, or to treat or prevent a condition.

Lip balm sits on the line by nature. A tinted balm sold as color is a cosmetic. The same base sold for chapped lips is something else, because 21 CFR 347.3 defines a lip protectant drug product as one that temporarily prevents dryness and helps relieve chapping of the lips, and adds, in the regulation itself, that this is "traditionally called lip balm."

Intended use is what decides, and intended use is established by what you say.

What a cosmetic costs you

Ingredient declaration under INCI, a principal display panel with an identity and a net quantity, and your name and address.

Facility registration and product listing under MoCRA, with small-business exemptions that some makers qualify for.

Safety substantiation, which has no small-business exemption and is the obligation people are most often unaware of.

What a drug costs you

An active ingredient from the monograph list, at a monograph concentration.

A Drug Facts panel in the prescribed format.

Establishment registration with FDA, an NDC labeler code, drug listing for each product, and annual renewal.

Manufacture under cGMP, 21 CFR Parts 210 and 211, which is a pharmaceutical standard and has no exemption based on the size of the business.

That last one is the item that changes what kind of operation you are running. It is not a heavier version of cosmetic compliance; it is a different discipline.

Where makers often actually land

In the wrong one, by accident, because "for dry, chapped lips" is the most natural sentence in the world to put on a lip balm and it is the sentence that moves the product.

Two routes out, and both are deliberate. Formulate to the monograph and accept the drug obligations, or write the label so the product stays a cosmetic. The rest of this section is those two routes.

References

21 CFR 347.3, Definitions. "Lip protectant drug product. A drug product that temporarily prevents dryness and helps relieve chapping of the exposed surfaces of the lips; traditionally called ‘lip balm.’" ecfr.gov
US Food and Drug Administration. Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?). Intended use, established by claims, is what decides. fda.gov
US Food and Drug Administration. Summary of Cosmetics Labeling Requirements. fda.gov
US Food and Drug Administration. Registration & Listing of Cosmetic Product Facilities and Products under MoCRA, including the small-business exemptions and what they do not cover. fda.gov
Written from the federal regulation and FDA guidance named on each page, not from a laboratory or a legal practice. Whether a particular formula and a particular label make a cosmetic or a drug is a determination about your product, and this is not that determination.