Making Natural Soap: FDA Soap Regulation

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September 3, 2013 by thesoapalchemist

Soap Regulation

Anyone interested in making soap should familiarize themselves with regulations concerning the cosmetic industry. You may wonder why it’s important to know about cosmetic regulation when you’re only making soap. The truth is, many of the soaps being sold on the internet and at craft fairs around the country are in violation of federal law because of claims made that take the soap from a mere cleansing bar, to a cosmetic or drug product.

The FDA is responsible for enforcing The Food and Drug Act, a lengthy set of requirements that govern cosmetic formulation, manufacture, labeling, claims and more. Soap is exempt from regulation, and overseen by the Consumer Product Safety Commission, as long as:

The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product’s detergent properties are due to the alkali-fatty acid compounds, and
The product is labeled, sold, and represented solely as soap

(http://www.fda.gov/cosmetics/guidancecomplianceregulatoryinformation/ucm074201.htm)

The problem is that many soap crafters like to shout from the roof tops about their natural soaps’ ability to not only cleanse skin, but moisturize and condition skin, create smooth supple skin, heal eczema and rosacea, improve acne, erase wrinkles, and more. Any of these claims, even when truthful, move your soaps out of the “just soap” arena, and into the big world of FDA Cosmetic and/or Drug Regulation. The following except from http://fda.gov can help you to determine if you are selling a cosmetic or drug.

“If a product –

consists of detergents or
primarily of alkali salts of fatty acids and
is intended not only for cleansing but also for other cosmetic uses, such as beautifying or moisturizing,

it is regulated as a cosmetic.

If a product –

consists of detergents or
primarily of alkali salts of fatty acids and
is intended not only for cleansing but also to cure, treat, or prevent disease or to affect the structure or any function of the human body,

it is regulated as a drug.”

Source:  http://www.fda.gov/cosmetics/guidancecomplianceregulatoryinformation/ucm074201.html

It is therefore, imperative to analyze the claims you make regarding your soaps in order to determine which category they fall under.

Just what is a claim?

Many soap crafters are unaware of what the FDA regards as a “claim.” Claims can be made on labeling, for example a bar soap bearing a label with  “Janie’s Acne Soap” on it. Claims can be made on a website, in a description of your products. “Our soaps are naturally conditioning, moisturizing, and excellent for dry skin.” Claims can be about the ingredients, and not necessarily the finished product, for example, “Tea tree oil is a powerful anti-acne agent. We blend Tea Tree oil with oil-absorbing clay to create this bar of wonderful soap…” Claims can even be made by posting testimonials on your website, “I just love Janie’s Acne Soap. I used to have terrible acne, but it started to clear up, as soon as I used this miracle bar!”

Our advice is to tread carefully. Don’t make claims that can’t be backed up with proof. If you do make claims, be sure you have supporting evidence that they are accurate. And, be certain you are following labeling guidelines that correspond to the category of product you are making. If your soaps are cosmetics, be sure your labels follow all applicable cosmetic labeling regulations. Consult the FDA website, for more on labeling requirements.

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