Cosmetics and Bath Products Regulations: FDA Rules and Compliance

The Critical Distinction: Cosmetics vs. Drugs

The FDA's first question: Is your product a cosmetic or a drug?

This distinction determines everything about your compliance requirements.

What the FDA Considers a Cosmetic

Definition: A product intended to be rubbed, poured, sprinkled, or sprayed on the body for cleansing, beautifying, promoting attractiveness, or altering appearance.

Examples of cosmetics:

• • Soaps (bar soaps, body washes used for cleansing only)
• • Bath bombs (used for appearance/fragrance, not medicinal)
• • Body lotion (for moisturizing/appearance)
• • Face cream (for appearance)
• • Lip balm (for appearance, not medicinal)
• • Perfume, body spray
• • Makeup, nail polish

What the FDA Considers a Drug

Definition: A product intended to treat, prevent, cure, or mitigate disease or alter body function.

Examples of drug claims:

• • "Moisturizes and reduces wrinkles" (anti-aging claim = drug)
• • "Treats acne" (therapeutic claim = drug)
• • "Reduces eczema symptoms" (disease claim = drug)
• • "Relieves dry skin" (therapeutic claim = drug)
• • "Heals wounds" (therapeutic claim = drug)
• • "Reduces inflammation" (therapeutic claim = drug)

Why This Matters

Cosmetics: Regulated lightly. Must be labeled properly. Can't make false claims. But no pre-market approval needed.

Drugs: Heavily regulated. Require pre-market FDA approval. Need clinical testing. Much more expensive and complex.

Most handmade cosmetics makers want to stay in the cosmetics category. It's cheaper and simpler.

FDA Regulations for Cosmetics

1. Ingredient Disclosure and "Cosmetic Facility Registration"

Requirement: If you manufacture cosmetics, you must register your facility with the FDA and report the cosmetic ingredients you use.

Cost: Free

Where: FDA Cosmetics Registration & Listing

Important: Some handmade makers skip this, but it's required if you manufacture cosmetics. The penalty for non-compliance can be product seizure.

2. Prohibited and Restricted Ingredients

The FDA maintains a list of prohibited and restricted cosmetic ingredients. You cannot use certain chemicals at all; others can only be used in limited concentrations.

Commonly prohibited ingredients:

• • Mercury (some skin-lightening creams)
• • Lead acetate (some hair dyes)
• • Chloroform
• • Urethan

Good news for most makers: Most common cosmetics ingredients (oils, butters, essential oils, clays, etc.) are allowed. But check the FDA Cosmetic Ingredients List if you're using anything unusual.

3. Proper Labeling Requirements

Every cosmetic product must have a label that includes:

• • Product name
• • Complete ingredient list in descending order by weight (using INCI—International Nomenclature of Cosmetic Ingredients)
• • Net quantity of contents (ounces, grams)
• • Manufacturer/distributor name and address
• • Warnings (if applicable, e.g., "For external use only")
• • Allergen warnings (for fragrance allergens if known)

4. Claims You Can and Cannot Make

This is where most handmade cosmetics makers get in trouble. You must avoid making therapeutic/drug claims.

Rule of thumb: If your claim involves disease treatment, prevention, or body function alteration, it's a drug claim. Stick to appearance and cleansing claims.

Special Product Categories

Soaps

Important distinction: Traditional bar soaps (made with lye via cold-process or hot-process) are classified as cosmetics by the FDA, not drugs, even though they're used for cleansing.

Requirements: Label with ingredients, manufacturer name, warning ("For external use only" optional), net weight. No pre-market approval needed.

Important caveat: If you make liquid soap, body wash, or medicated soap claiming to treat skin conditions, it becomes a drug.

Bath Bombs

Classification: Cosmetics (used for cleansing, appearance, fragrance)

Requirements: Proper labeling with INCI names for all ingredients. Cannot claim therapeutic effects.

Watch out: If your bath bomb description says "relaxing," "stress-relief," or "healing," you're venturing into drug territory.

Lotions, Creams, Body Butters

Classification: Cosmetics (for moisturizing appearance, not treating conditions)

Allowed: "Moisturizes," "nourishes," "improves appearance"

Not allowed: "Heals," "treats," "cures," "relieves" any skin condition

Hair Products

Most hair products are cosmetics (shampoo, conditioner, styling products)

Exception: Anti-dandruff or anti-lice products are drugs (require FDA approval)

For handmade makers: Stick to styling, conditioning, nourishing claims. Avoid anti-dandruff claims.

Cosmetics Compliance Checklist

What About Etsy and Shopify?

Etsy's Rules: Etsy allows cosmetics sales but requires compliance with local and FDA regulations. They prohibit drug claims but allow cosmetics claims.

What Etsy cracks down on:

• • Drug claims (treat, cure, heal, etc.)
• • Unsubstantiated health claims
• • Claims that require FDA approval
• • Selling products with prohibited ingredients

Bottom line: Make sure your Etsy product descriptions use only cosmetics claims, not drug claims. Etsy sellers who make drug claims get suspended.

Testing and Substantiation

FDA Requirement: You must be able to substantiate any claims you make about your products.

What this means: If you claim "moisturizes skin," you should have evidence (scientific studies, testing) supporting that claim.

For handmade makers: You don't need expensive testing for basic cosmetics claims. General knowledge about your ingredients (e.g., shea butter moisturizes) is sufficient. But for specific claims, have documentation.