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The Statutes & Regulations Covering Soap & Cosmetics

This article applies to the United States.

PART I – WHAT ARE STATUTES AND REGULATIONS?

Federal Statutes or Acts

A statute, also known as an act, is a law passed by a legislative body. In the US, at the federal level, acts are passed by US Congress and then approved by the President. Once approved, the laws that affect the public as a whole (“public laws”) are incorporated into the United States Code (USC). An existing act can be updated or amended by a subsequent act. Federal statutes apply to all states.

The US Code can be found here: https://www.govinfo.gov/app/collection/uscode/. A particular section of the US Code is cited by chapter and section, i.e. 21 USC 361.

Federal Regulations

Most often, an act is somewhat general and gives authority to a branch of the government to create and implement regulations to detail how the act should be implemented.

All regulations go through an extensive process that is governed by various laws and regulations to ensure fairness and public input before they go into effect. Once approved, they are added to the Code of Federal Regulations (CFR). The Code of Federal Regulations applies to all states and can be found here: https://www.ecfr.gov/. A particular section of the CFR is cited by chapter and section, i.e. 21 CFR 701.

States

All US states and territories have their own systems for creating statutes and regulations for their citizens or residents. For the most part, the state systems are very similar to the federal system, although the names may be slightly different. Most state statutes and regulations can be found online.

Preemption

For statutes, preemption is the idea that the statutes of a higher authority will override (“preempt”) the statutes of a lower authority. In our industry, it is most seen where Congress specifically includes a “preemption clause” in a federal Act that says no state can make a law to change the federal law. Where there are disputes regarding preemption or questions about when or how it is applied, it is settled in the courts.

PART II – FEDERAL STATUTES AND REGULATIONS ADDRESSING COSMETIC LABELING

Food Drug and Cosmetic Act

The Food Drug and Cosmetic Act is the primary law covering cosmetics. It was initially passed in 1938 with only a few sections actually applicable to cosmetics:

• Section 331(a) – Prohibiting the introduction of an adulterated or misbranded cosmetic into interstate commerce
• Section 361 – Defining an adulterated cosmetic
• Section 362 - Defining a misbranded cosmetic

Between 1938 and 2020, there were many changes to the FDCA, but only two changes to the part on cosmetics:

• 1960: Changing the definition of adulterated and misbranded cosmetics to include unapproved color additives;
• 1970: Changing the definition of a misbranded cosmetic to include a cosmetic package in non-compliance with child safety packaging and hazardous substance labeling (when required) (referencing the

MoCRA, the Modernization of Cosmetic Regulations Act of 2020 was the first major change to the cosmetic section of the Food Drug and Cosmetic Act. It added eleven new sections and modified the existing sections defining adulterated and misbranded cosmetics.

FDCA Regulations

The regulations that have been issued to implement and detail the FDCA as applied to cosmetics are:

• 21 CFR 700.3: Definitions
• 21 CFR 70: Color Additives
• 21 CFR 73.2030 – 73.2995: Color Additives Exempt from Certification, Cosmetics
• 21 CFR 74.2052 – 74.2711: Color Additives Subject to Certification, Cosmetics
• 21 CFR 740: Cosmetic Product Warning Statements

Except for technical changes (address or contact information) these regulations have not been updated since being issued.

There will be additional regulations issued to implement aspects of MoCRA, but they have not been proposed yet.

Fair Packaging and Labeling Act

The Fair Packaging and Labeling Act was passed in 1966 and set requirements for the labeling of all consumer products sold in the United States. It was updated in 1992 to add the requirement that the net contents contain metric measurements. It is covered in Title 15, Chapter 39 of the US Code.

The FPLA gives the FDA the responsibility for issuing regulations for labeling of food, drugs and cosmetics, and the Federal Trade Commission responsibility for issuing regulations for all other consumer commodities (with a few exceptions).

FPLA Regulations – For Cosmetics

Regulations issued by the FDA in 1974 to implement and detail the labeling of cosmetics in accordance with the FPLA:

• 21 CFR 701: Cosmetic Labeling

This regulation has not been updated since being issued. The change to the law (to require metric measurements) was never incorporated into the regulations. Nonetheless, it is the law and is applicable to cosmetic labeling.

FPLA Regulations – For Non-Cosmetics (Including Soap)

Regulations issued by the FTC to implement and detail the labeling of non-FDA consumer commodities in accordance with the FPLA:

• 16 CFR 500: Regulations under Section 4 of the Fair Packaging and Labeling Act
• 16 CFR 501: Exemptions from Requirements and Prohibitions Under Part 500
• 16 CFR 500: Regulations under Section 5(c) of the Fair Packaging and Labeling Act

Poison Prevention Packaging Act of 1970

The Poison Prevention Packaging Act established special packaging requirements for packaging products that could be hazardous to children (“child-proof packaging”) with some exceptions for special use packaging for elderly or handicapped persons. The Act is covered in Title 15, Chapter 39A of the US Code.

As part of the Act, the Food Drug and Cosmetic Act was amended to add that a cosmetic product that failed to comply with the requirements of the Poison Prevention Packaging Act would be considered misbranded.

The Act gave the Consumer Product Safety Commission responsibility for issuing regulations covering the detailed implementation of the PPPA.

PPPA Regulations

The regulation issued by the CPSC to detail the implementation of the PPPA is:

• 16 CFR 1700: Poison Prevention Packaging

Federal Hazardous Substances Act

The Federal Hazardous Substances Act was initially enacted in 1960 and has been updated numerous times, particularly with the inclusion of provisions for the safety of products for children. It covers hazardous substances that are flammable, toxic, irritants, sensitizers, or corrosive, that could otherwise cause injury, or that could be choking or other hazard to a child. The Act is covered in Title 15, Chapter 30 of the US Code.

The Food Drug and Cosmetic Act defines “misbranded” as not only what is on the package, but what may be omitted from the package. Therefore, if a product is flammable or could otherwise cause harm, failing to disclose the information would make the product misbranded.

For cosmetics, this could apply to products containing sensitizers or that have a high flash point because of high alcohol or low fragrance or essential oils with a low flash point. It would also apply to products marketed to or intended to be used by children, particularly where there is an included or attached toy.

The Act gave the Consumer Product Safety Commission the responsibility of issuing regulations for the implementation of the act. At least one regulation issued by the FDA also applies, even though it was not written as a result of the Hazardous Substances Act.

Hazardous Substances Act Regulations

The regulations that have been issued to implement the Hazardous Substances Act, and detail when and how a hazardous substance must be disclosed are:

• 16 CFR 1500: Hazardous Substances and Articles: Administration and Enforcement Regulations
• 21 CFR 740.1: Establishment of Warning Statements

The regulations that cover products for children, particularly with regard to choking hazards are:

• 16 CFR 1501: Method for Identifying Toys and Other Articles Intended for Use by Children Under 3 Years of Age Which Present Choking, Aspiration, or Ingestion Hazards Because of Small Parts.

PART III – State Regulations Addressing Cosmetics

Because of the preemption clause in the Fair Packaging and Labeling Act, no states have broad labeling requirements for cosmetics that differ from the federal laws and regulations.

There are some states that have regulations covering the registration and/or inspection of cosmetic manufacturing facilities, and/or registration of cosmetic products manufactured within the state. At present, those states are:

• California
• Connecticut
• Florida
• Kentucky (possibly)
• Louisiana
• Nevada (may recognize a small business exemption)
• Ohio
• Pennsylvania

Florida has an exemption for small businesses, with the requirement that a disclaimer statement is added to the label. This may be in violation of the preemption section of the Fair Packaging and Labeling Act, but it has not yet been challenged.

PART IV – ADVERTISING, MARKETING, and BUSINESS PRACTICES

In addition to statutes and regulations that directly address labeling, there are statutes and regulations that address various aspects of commerce, which could also apply to the marketing and presentation of cosmetic products.

Unfair, deceptive, false or misleading

US Code Title 15, Chapter 2, Federal Trade Commission, makes unfair methods of competition and unfair or deceptive practices in or affecting commerce unlawful (15 USC 45) and empowers the Federal Trade Commission to prevent companies or persons from using unfair competition or unfair or deceptive practices. Some of the applicable regulations include:

• 16 CFR 260: Guides for the Use of Environmental Marketing Claims
• 16 CFR 255: Guides Concerning Use of Endorsements and Testimonials in Advertising
• 16 CFR 323: Made in the USA Labeling

There have also been other acts passed by Congress that address specific aspects of marketing, advertising, and other aspects of products in commerce that could be applicable to your advertising and marketing. These are also enforced by the Federal Trade Commission:

• Children Online Privacy Protection Act of 1998 (15 USC 6501-6508)
  Regulations: 16 CFR 312: Children’s Online Privacy Protection Rule
• Telemarketing and Consumer Fraud and Abuse Prevention (15 USC 6101-16108)
  Regulations: 16 CFR 310: Telemarketing Sales Rule
• Controlling the Assault of Non-Solicited Pornography and Marketing (15 USC 7701-7713)
  Regulations: 16 CFR 316: CAN-SPAM Rule

Cause Marketing

While not regulated at a federal level, most states have laws and regulations addressing advertising and marketing that promote sales by stating that some of the sale price or profit will be donated to a charity.

Sweepstakes, Games, and Raffles

Also not regulated at a federal level but certainly regulated at a state level are sweepstakes, games, and raffles. Check with your state before promoting or engaging in promotional activities where a prize is promised.