Unwrapping the Regulations for Soap Labeling

When it comes to creating and selling homemade soap understanding the regulatory landscape is crucial. This blog post will delve into the key distinctions between homemade soap and cosmetics or drugs, according to the U.S. Food and Drug Administration (FDA) regulations. Focusing on definitions and labeling requirements found within 21 Code of Federal Regulations § 701.20.  But first....

The foundation of current FDA regulations lies in the Pure Food and Drug Act of 1906, signed by President Roosevelt. This landmark legislation was enacted due to widespread public concern over, contaminated or mislabeled food products, medications with false or misleading claims, and the presence of dangerous substances in food and drugs.

The 1906 Act established the federal government's authority to regulate the safety and purity of food and drugs, marking a significant step towards consumer protection.  The FDA has evolved significantly since 1906, with numerous amendments and new regulations enacted over the decades to address emerging public health concerns and scientific advancements.

The Federal Food, Drug, and Cosmetic Act of 1938 was a significant amendment to the original 1906 law.  This act was passed in response to the tragic incident where a legally marketed toxic elixir killed 107 people, including many children.  The 1938 Act significantly overhauled the public health system by requiring evidence of safety for new drugs. It established standards for food and granted the FDA authority to conduct factory inspections.  Numerous amendments have further strengthened FDA regulations over the decades.  These amendments reflect the ongoing evolution of FDA regulations to address emerging public health concerns and scientific advancements.

And now back to how this applies to soap.

The FDA defines soap as the product of a chemical reaction between fats and oils with an alkaline substance, typically lye. This process, known as saponification, transforms the fats and oils into soap molecules.

1. What it’s made of:

To be regulated as “soap,” the product must be composed mainly of the “alkali salts of fatty acids,” that is, the material you get when you combine fats or oils with an alkali, such as lye.

To be regulated as “soap,” those “alkali salts of fatty acids” must be the only material that results in the product’s cleaning action. If the product contains synthetic detergents, it’s a cosmetic, not a soap. You still can use the word “soap” on the label.

To be regulated as soap, it must be labeled and marketed only for use as soap. If it is intended for purposes such as moisturizing the skin, making the user smell nice, or deodorizing the user’s body, it’s a cosmetic. 

Or, if the product is intended to treat or prevent disease, such as by killing germs, or treating skin conditions, such as acne or eczema, it’s a drug. You still can use the word “soap” on the label.

You can read the entire regulation if you need help sleeping. 21 CFR § 701.20.”

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-G/part-701/subpart-C/section-701.20

Primary Purpose:

Primarily intended for cleansing the skin.

Regulatory Status:

Generally Recognized As Safe (GRAS) when manufactured under Good Manufacturing Practices (GMPs).  The US Consumer Product Safety Commission (CPSC) regulates true soaps that are made primarily of fats and alkalis and that are manufactured for consumer use. 

Labeling Requirements:

Ingredient Listing: Not typically required.

Net Weight: Must be clearly displayed.

Cautions or Warnings: Required if applicable (e.g., "For external use only").

The FDA defines cosmetics as "articles intended to be rubbed, poured, sprinkled, sprayed, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance."

This broad definition encompasses a wide range of products, including:

Skincare: Moisturizers, cleansers, serums, sunscreens, shaving products, exfoliants.

Haircare: Shampoos, conditioners, styling products

Makeup: Foundation, lipstick, eyeshadow, mascara

Fragrances: Perfumes, colognes, body sprays

Beyond cleansing, they can moisturize, exfoliate, treat, and color.

Subject to FDA regulations, including safety and labeling requirements.

Ingredient List: Required to be listed in descending order of predominance.

Net Weight/Volume: Must be clearly displayed.

Warnings and Cautions: Required if applicable (e.g., "Keep out of reach of children").

Other Requirements: May vary depending on the specific product type (e.g., sunscreen SPF claims).

Many items called “soaps” on the market today are in fact not actual soap; they are cleansers, detergents, or other types of products regulated as either a cosmetic or a drug by the Food and Drug Administration (FDA).  The primary distinction lies in the intended use and formulation.

Soap: Primarily for cleansing, typically made through saponification, and generally exempt from extensive FDA regulations.

Cosmetics: Have a broader range of intended uses beyond cleansing, may contain various ingredients beyond those used in soap, and are subject to FDA regulations regarding safety and labeling.

While generally safe, it's crucial to adhere to proper soap-making techniques and ensure the lye is completely neutralized during the saponification process.

Formulators must ensure the safety of their cosmetic products by conducting appropriate safety assessments and adhering to Good Manufacturing Practices (GMPs).

Accurate and complete labeling is essential for both soap and cosmetic products to comply with FDA regulations and provide consumers with necessary information. Which may include an address.   

The regulations for soaps labeled "for children" are primarily overseen by the Consumer Product Safety Commission (CPSC) in the United States.

Soaps primarily intended for children 12 years old and younger are considered "children's products."   These products must undergo lead testing by a third-party, CPSC-accepted laboratory.  Manufacturers must issue a Children's Product Certificate (CPC), verifying compliance.   

No specific labeling requirements exist solely for children's soaps.  However, general safety guidelines and labeling requirements for all soaps still apply.

Focus on Safety: The primary concern is ensuring the safety of children.

Lead Testing: Lead testing is crucial for children's soaps to minimize potential health risks.   

Cautionary Labeling: Appropriate warning labels are essential for any soap that may pose a hazard.

The FDA in the United States also has specific regulations regarding soaps used for pets.

General Grooming Aids: If the pet soap is intended solely for cleansing or beautifying animals (e.g., making fur soft and shiny), it's generally NOT regulated by the FDA.   

However, if the pet soap claims to cure, mitigate, treat, or prevent disease in animals, affect the structure or function of the animal's body, or have any therapeutic purpose, &/or contains pesticides (like flea and tick treatments)....

-Then it's considered an "animal drug" and IS subject to FDA regulations. This means it requires approval from the FDA's Center for Veterinary Medicine before it can be sold.   

Now, let's delve into an exciting regulation about ingredients: 21 CFR 701.1(b).

The labeling of a cosmetic which contains two or more ingredients may be misleading by reason (among other reasons) of the designation of such cosmetic in such labeling by a name which includes or suggests the name of one or more but not all such ingredients, even though the names of all such ingredients are stated elsewhere in the labeling.--21CFR:701.1(b)

This regulation eloquently states that if a product contains multiple ingredients, it cannot be  misleadingly labeled with a name that only suggests one or some of those ingredients.

"Goat Milk Soap" ---if it also contains coconut oil, olive oil, etc.

"Goat Milk & Coconut Oil Soap" or

 "Handmade Soap with Goat Milk"

Accurate labeling builds trust with customers. They deserve to know exactly what they're purchasing.

Non-compliance can lead to regulatory actions, including fines or even product removal from the market.

Always include a complete list of ingredients on the label.

Use clear and concise language that accurately reflects the product's composition.

Refrain from using terms that suggest the presence of only certain ingredients when others are also present.

Explore alternative names that accurately describe the soap while still highlighting key ingredients.

"Goat Milk & Coconut Oil Soap" or

 "Handmade Soap with Goat Milk & Coconut Oil."

Understanding the regulatory differences between homemade soap and cosmetics is crucial for anyone involved in creating and selling homemade products for all ages. By adhering to relevant regulations, ensuring product safety and prioritizing accurate labeling, manufacturers can build trust with consumers and avoid potential legal issues.

The US Consumer Product Safety Commission regulates true soaps (not cosmetics or drugs) that are made primarily of fats and alkalis and that are manufactured for consumer use. To that end, the CPSC has NO specific labeling requirements for true soaps not primarily intended for use by children age 12 and under.

JD

Side Note: This blog post focuses on the labeling process for soap. It does not delve into the specific properties of any soap itself, as those would fall under the purview of the FDA as cosmetics or drugs.

This blog post aims to inform it's readers about saponification and labeling requirements, highlighting the care and craftsmanship involved in creating this natural and luxurious product, goat milk soap.

This blog post provides general information and should not be considered legal advice. It's crucial to consult with legal counsel or a regulatory experts for specific guidance regarding products and labeling.