publications | June 13, 2024

Magic’s in the Makeup: FDA Modernizes Cosmetic Product Labeling Requirements

Footnotes for this article are available at the end of this page.

“Can’t be good for my health,” a song lyric from Gwen Stefani and No Doubt’s early 2000s single, “Magic’s in the Makeup,” comes to mind when we think of the Food and Drug Administration’s possible motives for recent developments with their implementation of the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”).¹Prior to MoCRA, the statutory provisions regulating cosmetics remained relatively unchanged for the previous 84 years. FDA’s implementation of MoCRA, partly through stricter labeling requirements, aims to put in place measures to better ensure that the cosmetics people use every day are safe, wholesome, and have labels that provide the information consumers need to make an informed purchasing decision.²

In this Bulletin, we summarize the label requirements for cosmetics before and after MoCRA, offer our observations on recent developments, and provide an example of the rudimentary elements now required on the label of a cosmetic considering current FDA guidance.

Pre-MoCRA Background

Prior to MoCRA, the Federal Food, Drug, and Cosmetic Act (“FD&C”) and the Fair Packaging and Labeling Act (the “FPLA”) mandated that cosmetic manufacturers, packers, and distributors disclose certain information on the labels of cosmetics.³ Pre-MoCRA, labels of cosmetics had to include:

A list of ingredients in descending order of predominance.⁴
A statement of the product’s identity on the principal display panel.⁵
The name and place of business of the manufacturer, packer, or distributor.⁶
The net quantity of contents of the product.⁷

Post-MoCRA Highlights

With the passage of MoCRA, manufacturers are now statutorily mandated to substantiate the safety of their products and ensure that the cosmetic product is safe. The term “safe” means that the cosmetic product, including any ingredient of the cosmetic product, is not injurious to users under the conditions of use provided on the label.
MoCRA introduces three major requirements for label of cosmetic products.
- First, MoCRA adds a requirement for cosmetic product labels to include contact information (domestic address, phone number, or electronic contact information that may include a website) through which the responsible party can receive adverse event reports. Cosmetic labels must contain contact information by December 29, 2024.
- Second, cosmetic labels must disclose each fragrance allergen present in the product.
  - FDA will determine what constitutes a fragrance allergen through future rulemaking.
  - In the rulemaking process, FDA will consider “international, State, and local requirements for allergen disclosure, including the substance and format of requirements in the European Union, and may establish threshold levels of amounts of substances subject to disclosure.”⁸
  - FDA must issue a notice of this proposed rulemaking by June 29, 2024, and publish a final rule within 180 days after the close of the public comment period.⁹
- Third, for cosmetic products that are intended solely for professional use the label must include a clear and prominent statement indicating that the product is to be administered or used only by licensed professionals. “Professional” is defined as individuals licensed by the state to practice cosmetology, nail care, barbering, or esthetics.

Minimum Label Requirements Post-MoCRA

All label statements must be in the English language and clearly visible and understood by consumers under customary conditions of purchase.¹⁰

On the principal display panel:¹¹
- A statement of the identity of the product.
- A descriptive name or illustration identifying the nature or use of the product.
- The net quantity of contents of the product in terms of weight, measure, numerical count, or combination of the terms.
On the information panel:
- The name and place of business of the manufacturer, packer, or distributor.¹²
  - If the distributor is not the manufacturer or packer, the label must state this fact on the label using the qualified phrase “Manufactured for . . . ” or “Distributed by . . . ” or similar wording.
- Contact information (domestic address, phone number, or electronic contact information that may include a website) of the manufacturer, packer, or distributor for reporting of adverse events (if different than the above).
Anywhere on the label:¹³
- Declaration of ingredients appearing in descending order of predominance.
  - The list of ingredients must be clearly visible, so people are likely to read it when buying the product.
  - The list can be on any information panel of the package, such as the folding carton, immediate box wrapping, or firmly affixed on the tag, tape, or card.
- Fragrance allergen warning (if applicable).
- Professional use only disclaimer (if applicable).

AGG Observations

Companies will likely be required to disclose any fragrance ingredients that FDA considers to be allergens on an individual basis rather than simply listing “fragrance” on cosmetic product labels.
At this time, we do not know what constitutes an allergen under MoCRA, however, until the FDA promulgates its final rule, cosmetic companies can use the EU guidelines as reference to begin identifying fragrance allergens.¹⁴
FDA will maintain its regulation of labeling claims and cosmetic companies will continue to be vulnerable to class action consumer protection lawsuits relating to their marketing claims.
Given the ambiguity surrounding the term “safe,” we can expect increased scrutiny about the composition of cosmetics and litigation to follow.
Brand owners are ultimately accountable for making sure their products are properly labeled and safe when used according to the directions on the label.

To bring it back to Gwen Stefani’s song, we hope these new labeling requirements for cosmetics will help steer consumers in the right direction and make it clear that there is more than just “Magic in the Makeup.”