The FD&C Act defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance." Examples of cosmetics include:  

• Skin moisturizers, creams, serums and powders   

• Moisturizers, including cleansers with moisturizing claims  

• Perfumes  

• Lipsticks, lip balm  

• Fingernail polishes  

• Eye and facial makeup  

• Tattoo ink  

• Shampoos and conditioners  

• Permanent waves  

• Hair coloring, hair spray, hair gel   

• Handwash/bodywash  

• Baby products/baby wipes  

• Shaving cream  

• Beard products (oil, etc.)  

• Certain devices that perform cosmetic functions, e.g., micro needling tools, dermabrasion or exfoliation products, gua sha and face rollers, blemish kits, and makeup sponges and other applicators  

• Deodorants 

• Any substance intended for use as a component of a cosmetic product 

Certain traditional soap products aren't considered cosmetics under the FD&C Act. However, most “soap" and other cleanser products are still considered cosmetics (or even drugs). For example, any “soap" product that moisturizes skin, includes deodorant, or makes the user “smell nice" would be considered a cosmetic under the FD&C Act and would be subject to this policy. Marketplace sellers should assume that soap products are subject to this policy.    

Products intended as “grooming aids" for animals are not cosmetics regulated by FDA. Cosmetics can be viewed by the US Food and Drug Administration (FDA) to be drugs or medical devices if they are intended to treat or cure a disease or for to affect the structure or function of the body.     

 No. However, cosmetics are regulated by the FDA. For example, the FDA regulates the types of ingredients allowed in cosmetics and the types of claims that can be made about an ingredient and/or a product. The FDA also regulates the manufacturing of cosmetics and requires the products be registered and listed with the FDA. 

Yes. Cosmetics must meet specific requirements related to manufacturing, cosmetic labeling, safety reporting and registration and listing with the FDA. Only cosmetics that meet all requirements under the FD&C Act may be sold on Walmart Marketplace. Some of these requirements came into effect on December 29, 2023, others will be phased in over time.  

• Labeling  

An identity statement indicating the nature and use of the product and an accurate statement of the net quantity of contents must appear on the principal display panel. Cosmetic packaging also must contain an information panel with:   

1. The name and place of business of the manufacturer, packer, or distributor 

2. Distributor statement

3. Material facts or important directions 

4. Warning and caution statements 

5. All ingredients listed in descending order of amounts used in the product 
   

If the cosmetic product also contains OTC drug ingredients, its labeling must comply with the regulations for both OTC drug and cosmetic ingredient labeling as well as Walmart’s policy for OTC Drugs. 

• Registration and Listing  

Any person who owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the U.S. must register each facility with the FDA and renew such registration every two years. The entity whose name and identifying information appears on the product label must provide to the FDA each year certain “listing" information about each cosmetic product manufactured for U.S. distribution.

• Manufacturing 

By the end of 2025, cosmetics will be required to be manufactured in accordance with Good Manufacturing Practices (GMPs). Cosmetic GMP regulations will establish quality requirements and standards for the manufacturing, packaging, labeling and storing of cosmetic products.

• Adverse Event Reporting  

Manufacturers, packers or distributors of cosmetic products whose name appears on the label of the cosmetic product must (1) report serious adverse events to the FDA within 15 days of receiving relevant information related to the serious adverse event, and (2) maintain records of adverse events. A serious adverse event is an adverse event resulting in death, a life-threatening experience, inpatient hospitalization, persistent/significant disability or incapacity, congenital anomaly or birth defect, infection, or significant disfigurement, e.g., serious and persistent rashes, second- or third-degree burns, significant hair loss or persistent and significant alteration of appearance.

• Safety Substantiation 

Manufacturers, packers or distributors of cosmetic products whose name appears on the label of the cosmetic product must ensure that the safety of each cosmetic product is supported by “adequate substantiation." Adequate substantiation of safety can be determined through tests, studies, research, analyses or other evidence considered by experts with qualified training.  

•  Small Business Exemptions

  • Certain businesses that are considered a “small business" are exempted from some of the facility registration, product listing and CGMP manufacturing requirements. A “small business" is an owner or operator of a cosmetics manufacturing facility with average gross annual sales of less than $1 million (inflation adjusted) for the previous three-year period, except if they are engaged in manufacturing or processing certain higher risk cosmetic products, including: Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual  

  • Cosmetic products that are injected 

  • Cosmetic products that are intended for internal use 

  • Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer isn't part of such conditions of use that are customary or usual