What the term denotes
Skin Care, in this catalog, is an organisational heading used by the supplier to group items. It is a filing label. It is not a statement that anything under it does anything, is intended for anything, or has been evaluated for anything.
The name is not a claim
A grouping label that names an area of the body reads, at a glance, like a statement of purpose. It is not one. Nothing under this heading is offered as having any effect, and the heading itself should not be read as implying one.
Research use only
Everything grouped under this heading in our catalog is designated research use only. That designation marks material as intended for laboratory research and explicitly not for diagnostic or therapeutic use. It describes intended use — it is not a statement about quality, and it does not create a category of permitted use in people.
Where the regulatory line sits
Under US law the distinction between a cosmetic and a drug turns substantially on intended use as evidenced by claims. Material designated research use only sits outside both frameworks as supplied. FDA publishes where those boundaries are, and the FTC publishes what it expects of health-related advertising claims.
Documentation to expect
A certificate of analysis for the lot, stated composition, container details and storage conditions.
Authoritative sources
US government publications, linked for reference. None of these evaluate, approve or endorse anything in this catalog.
- FDA — Cosmetics ↗
FDA's cosmetics pages, including where the line sits between a cosmetic and a drug claim.
- FTC — Health Products Compliance Guidance ↗
What the Federal Trade Commission expects of anyone making a health-related claim in advertising.
- 21 CFR Part 809 (eCFR) ↗
The federal regulation containing the research-use-only labelling provision for in vitro diagnostic products.
- FDA — Unapproved Drugs ↗
FDA's explanation of what it means for a product to be unapproved, and how it treats them.
Frequently asked questions
- Does the Skin Care category mean these items are for skin?
- No. It is an organisational heading a supplier uses to group a list. It is not an indication, not a claim, and not a statement that anything under it has been evaluated for any purpose.
- What does research use only mean in this category?
- That the material is designated for laboratory research and not for diagnostic or therapeutic use. That designation applies regardless of which heading an item is filed under.
- What separates a cosmetic from a drug in US law?
- Largely intended use as evidenced by the claims made. FDA publishes guidance on where that boundary sits, and the same formulation described differently can fall on different sides of it.