1. “A Cosmetic By Any Other Name”— Situations When Marketed Cosmetics Products are Considered Drugs

The FDA regulates drugs and cosmetics differently, with the latter being subject to significantly less regulatory requirements. Cosmetic manufacturers can sometimes violate the law by marketing a cosmetic product with a drug claim or marketing a drug product as a cosmetic, failing to comply with regulatory requirements for drugs. When determining whether a product is a “cosmetic” or a “drug”, the U.S. Food and Drug Administration (“FDA”) examines the “intended use” of the product.

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), cosmetics are defined 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.”¹ Products recognized as cosmetics under the law include skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, hair colors and deodorants. In contrast, drugs are defined as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”²

FDA determines the “intended use” of a product by analyzing the claims stated on the product’s labeling, its advertisements, and in other promotional materials. FDA also looks to consumer perception and use of certain ingredients that have well-established therapeutic uses to determine whether a product is a “drug” or “cosmetic”.

In some instances, a product can be considered both a drug and a cosmetic. This occurs when a product has two intended uses. For example, a moisturizer with sun protection factor (SPF) claims is considered both a drug and a cosmetic. The moisturizer is a cosmetic because its use is to beautify skin while the SPF component is a drug because its use it to protect the skin from ultraviolet A and B rays. As a result, the product must comply with both cosmetic and drug regulatory requirements.

It is important for cosmetic manufacturers to understand the distinction between cosmetic and drug claims. Furthermore, it is critical for these companies to consider the claims on their products’ labeling, advertising (including on the Internet), and any other promotional materials. This is especially the case when they are marketing sunscreen products that are regulated differently by the FDA than they are in Europe by European authorities.

2. There are Two Sheriffs in Town—Cosmetic Product Labels are Subject to Both FDA and FTC Requirements

The FDA and the Federal Trade Commission (FTC) are both authorized by federal laws to regulate product labeling. Pursuant to the FD&C Act, FDA has the authority to regulate cosmetic labeling claims while the FTC has the authority to regulate advertising claims of cosmetic products under the Federal Trade Commission Act (“FTC Act”).

Although the FD&C Act does not require cosmetic product labeling to be reviewed or approved by the FDA, the FDA can take enforcement actions against companies whose cosmetic products are misbranded. As mentioned earlier, this generally occurs when a cosmetic product is marketed with “drug” claims such as treating or preventing a disease. FDA often issues warning letters to these companies, stating that these marketed cosmetic products are “new drugs” that need prior approval from FDA to market these products as drugs.

The FTC regulates the advertising claims of cosmetic products, and requires that these claims be truth and not misleading. The FTC generally issues administrative complaints to companies that engage in deceptive advertising. The FTC often issues complaints to cosmetic companies after FDA has issued warning letters to these companies.

Cosmetic manufacturers should be aware of both FDA and FTC’s regulations and enforcement actions (e.g., warning letters, seizures, and injunctions) related to cosmetics, and develop compliance programs to ensure their labeling and advertising claims align with both agencies’ regulations.

3. Be Aware of State Requirements Related to Cosmetic Products

In addition to the FDA and FTC regulations, almost every state has laws and regulations that apply to cosmetic products. Most of these states have their own Food, Drug, and Cosmetic Act that closely mirrors the federal FD&C Act. Some states such as Florida and Louisiana have additional requirements for cosmetic manufacturers such as facility registration, product registration, licensing/permitting, and/or inspections. For example, Florida requires in-state cosmetic manufacturers to obtain a cosmetic manufacturer permit from the state.

In 2005, California passed the California Safe Cosmetic Act. This law applies to all cosmetic products sold in California. This Act requires cosmetic manufacturer, packer, and/or distributor named on the product label to provide to the California Safe Cosmetics Program (CSCP) a list of all cosmetic products that contain any ingredients known or suspected to cause cancer or developmental or other reproductive harm.

Cosmetic manufacturers should be aware of the applicable state requirements for their products in additional to the federal regulatory requirements.

4. What’s New About Talc

Recently, FDA released a white paper titled IWGACP Scientific Opinions on Testing Methods for Asbestos in Cosmetic Products Containing Talc (including Talc Intended for Use in Cosmetics). The white paper outlined scientific opinions on the testing of talc-containing cosmetic products for asbestos. The IWGACP white paper follows the February 2020 FDA public meeting on asbestos testing.

Any cosmetic manufacturing using talc as an ingredient should be aware of FDA’s recent guidance on product testing.

5. Proposed Legislation Could Change the Makeup of the Current Cosmetics Regulations

Since the passage of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) in 1938, FDA’s oversight of cosmetics has generally remained unchanged.

Last summer, Senators Dianne Feinstein (D-Cal.) and Susan Collins (R-Me.) reintroduced the Personal Care Safety Act (S. 2100). This bill would substantially expand FDA’s authority over cosmetics. Under the proposed legislation, FDA could issue mandatory recalls in certain instances that involve cosmetic products that would likely cause serious adverse health consequences and the companies has refused to voluntarily recall these products. As of now, the FDA lacks this authority. The bill also would require companies to register with FDA and disclose the ingredients they use in their products. Additionally, under the proposed bill, companies must report serious adverse events including death and inpatient hospitalization to FDA within 15 days. Furthermore, companies must report an annual summary of all adverse events including nonserious adverse events such as rashes.

This legislation would require FDA to promulgate regulations for cosmetic good manufacturing practices. FDA would also be allowed to seize counterfeit cosmetic products. Lastly, similar to drugs and medical devices, the bill would authorize FDA to collect user fees from manufacturers.

Currently, there has been no action since the introduction of the bill and we do not expect passage of the bill this year. Nevertheless, there continues to be some support for this proposed legislation and we will continue to monitor for changes.

FOOTNOTES

1. See FDCA §201(i); 21 U.S.C. §321(i).

2. See FDCA §201(g)(1); 21 U.S.C. §321(g)(1).