Labeling Your Handcrafted Soap & Cosmetics

We are once again coming up on a busy time of year, one where many of you will be doing craft shows and a considerable amount more retail! It’s also a time of year when many of you will sell more body care than all other items combined! This is the perfect time to give you an overview on proper product labeling and send you to the right places for more information regarding this process!

First, ALL cosmetics must be properly labeled per the FDA. The FDA is regulated by Center for Food Safety and Applied Nutrition (CFSAN). CFSAN is responsible for assuring that not only are all cosmetics are safe but also that they are properly labeled. Being a small business does not exempt you from the same rules as the big boys.

If you are making Cold Process Soap (or hot process, true

liquid soap but in general those made only using a lye solution and fats) you are exempt from product labeling through FDA guidelines but I would still recommend it for peace of mind. What if you used peanut oil and a customer with a peanut allergy used that product? Exactly! Soap labeling which is governed by the CPSC, the Consumer Product Safety Commission: http://www.cpsc.gov/ Over the years there has been a lot of debate in the world of hand crafted soaps and cosmetics. Melt & Pour soaps typically are considered a cosmetic as they are made using chemical surfactant ingredients and are not considered true soap. I received confirmation on what IS needed on a soap label and what truly defines it as soap directly from the CPSC. This is copied and pasted from a response they emailed to me:

The Consumer Product Safety Commission (CPSC) regulates true soaps that are made primarily of fats and alkalis and that are manufactured for consumer use. The CPSC has no specific labeling requirements for such soaps. However, if the product meets the definition of a hazardous substance, under the Federal Hazardous Substances Act (FHSA) it may require cautionary labeling as specified under the statute.

Section 2(p)(1) of the FHSA, 15 U.S.C. § 1261(p)(1), requires that hazardous substances bear certain cautionary statements on their labels. These statements include: signal words; affirmative statements of the principal hazard(s) associated with a hazardous substance: the common or usual name, or chemical name of the hazardous substance; the name and place of business of the manufacturer, packer, distributor, or seller; statements of precautionary measure to follow; instructions when appropriate, for special handling and storage; the statement “Keep out of the reach of children” or its practical equivalent; and, when appropriate, first aid instructions.

A product is determined to be a hazardous substance if the substance or a mixture of substances is toxic, corrosive, an irritant, a strong sensitizer, is flammable or combustible, or generates pressure through decomposition, heat or other means, and if the substance or mixture of substances may cause substantial personal injury or substantial illness during customary or reasonably foreseeable handling or use, including reasonably foreseeable ingestion by children. A determination that a product is toxic may be based on the results of animal tests or on human experience.

It is the responsibility of a manufacturer or importer of a product to determine whether its product meets the definition of a hazardous substance and, if so, to fulfill its obligations under the FHSA for appropriate precautionary labeling. The U.S. Consumer Product Safety Commission does not perform pre-market clearance for household products containing hazardous substances nor does it certify those products.

The Food, Drug and Cosmetic Act specifically excludes soap because soap is not defined in the act. In administering the act, the Food & Drug Administration interprets the term “soap” to apply only to articles that meet the following conditions:

1) The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the detergent properties of the article are due to the alkali-fatty acid compounds; and

2) The product is labeled, sold and represented only as soap.

The interpretation goes on to state that products intended to cleanse the body and which are not “soap” as defined above are considered “cosmetics” regulated by FDA.

If your product meets the definition above (1 & 2) then it would be subject to the Federal Hazardous Substances Act. If the product meets the definition of a hazardous substance it is required to be labeled for the hazards it presents to the consumer during reasonable and foreseeable use.

Cosmetic labeling requires quite a bit of information. I strongly suggest that anyone making cosmetics of any kind familiarize themselves with the FDA website. There is a vast amount of information which is all current and lists all of the information necessary to be sure you are making a product that fits into the scope of the law. Their website is http://www.fda.gov

This information must show on the principal display panel of all cosmetic products, this is copied from http://www.fda.gov/Cosmetics/Labeling/Regulations/default.htm#information_required

The following information must appear on the principal display panel:

• An identity statement, indicating the nature and use of the product, by means of either the common or usual name, a descriptive name, a fanciful name understood by the public, or an illustration [21 CFR 701.11].
• An accurate statement of the net quantity of contents, in terms of weight, measure, numerical count or a combination of numerical count and weight or measure [21 CFR 701.13].

The following information must appear on an information panel:

• Name and place of business. This may be the manufacturer, packer, or distributor. This includes the street address, city, state, and ZIP Code. You may omit the street address if it is listed in a current phone directory or city directory [21 CFR 701.12(a)].
• Distributor statement. If the name and address are not those of the manufacturer, the label must say "Manufactured for..." or "Distributed by...," or similar wording expressing the facts [21 CFR 701.12(c)].
• Material facts. Failure to reveal material facts is one form of misleading labeling and therefore makes a product misbranded [21 CFR 1.21]. An example is directions for safe use, if a product could be unsafe if used incorrectly.
• Warning and caution statements. These must be prominent and conspicuous. The FD&C Act and related regulations specify warning and caution statements related to specific products [21 CFR part 700]. In addition, cosmetics that may be hazardous to consumers must bear appropriate label warnings [21 CFR 740.1]. An example of such hazardous products is flammable cosmetics.
• Ingredients. If the product is sold on a retail basis to consumers, even it it is labeled "For professional use only" or words to that effect, the ingredients must appear on an information panel, in descending order of predominance. [21 CFR 701.3]. Remember, if the product is also a drug, its labeling must comply with the regulations for both OTC drug and cosmetic ingredient labeling, as stated above. To learn more, see "Ingredient Names," "Color Additives and Cosmetics," "Fragrances in Cosmetics," and "'Trade Secret' Ingredients."

Declaration of Ingredients http://www.fda.gov/Cosmetics/Labeling/Regulations/ucm126438.htm#Cosmetics

Cosmetics produced or distributed for retail sale to consumers for their personal care are required to bear an ingredient declaration (21 CFR 701.3). Cosmetics not customarily distributed for retail sale, e.g., hair preparations or make-up products used by professionals on customers at their establishments and skin cleansing or emollient creams used by persons at their places of work, are exempt from this requirement provided these products are not also sold to consumers at professional establishments or workplaces for their consumption at home.
The ingredient declaration must be conspicuous so that it is likely to be read at the time of purchase. It may appear on any information panel of the package, i.e., the folding carton, box wrapping if the immediate container is so packaged, and may also appear on a firmly affixed tag, tape or card. The letters must not be less than 1/16 of an inch in height (21 CFR 701.3 (b)). If the total package surface available to bear labeling is less than 12 square inches, the letters must not be less than 1/32 of an inch in height (21 CFR 701.3(p)). Off-package ingredient labeling is permitted if the cosmetic is held in tightly compartmented trays or racks, it is not enclosed in a folding carton, and the package surface area is less than 12 square inches (21 CFR 701.3(i)).
The ingredients must be declared in descending order of predominance. Color additives (21 CFR 701.3(f)(3)) and ingredients present at one percent or less (21 CFR 701.3(f)(2)) may be declared without regard for predominance. The ingredients must be identified by the names established or adopted by regulation (21 CFR 701.3(c)); those accepted by the FDA as exempt from public disclosure may be stated as "and other ingredients" (21 CFR 701.3(a)).
Cosmetics which are also drugs must first identify the drug ingredient(s) as "active ingredient(s)" before listing the cosmetic ingredients (21 CFR 701.3(d)).
All label statements required by regulation must be in the English language and must be placed on the label or labeling with such prominence and conspicuousness that they are readily noticed and understood by consumers under customary conditions of purchase (21 CFR 701.2).
It is my recommendation that anyone making cosmetic products take the time to browse these pages for more information with regards to proper cosmetic labeling. Just being a small business does not exempt you from the law. The FDA fines small businesses as well as larger ones. The information contained within their website is informative and easy to follow.

http://www.fda.gov/Cosmetics/Labeling/Regulations/ucm126444.htm is the link to the entire FDA Cosmetics Labeling Guide. This is a MUST read for anyone making anything cosmetic. It includes the following: (this is hyperlinked right to the FDA site.)

Cosmetic Labeling Guide

Available in PDF (279KB)
The Cosmetics Labeling Guide provides step-by-step help with cosmetic labeling, with examples and answers to questions manufacturers often ask about labeling requirements under U.S. laws and related regulations.
On this page:

• Laws Regulating Cosmetic Labeling
• Legal Definitions of Terms
• Principal Display Panel
• Placement of Information on Labels
• Prominence and Conspicuousness
• Language
• Type Size
• Identity Labeling
• Name and Place of Business
• Net Quantity of Contents Declaration
• Warning Statements
• Ingredient Labeling
• Prominence
• Ingredient Identification
• Order of Declaration
• Fragrances and Flavors
• Trade Secret Ingredients
• Petitioning for Trade Secrecy
• Drug Ingredients
• Color Additives Added for Color Matching
• Incidental Ingredients
• Dissimilar Product Assortments
• Similar Product Assortments
• Branded Shade Lines
• Direct Mail Cosmetics
• Off-Package Ingredient Labeling

 Read the Cosmetics Labeling Guide fully. I can answer questions for you through our online chat, email or phone if there is something you can’t find or don’t understand as well. Bitter Creek and Bitter Creek South are committed to making sure you have the proper understanding when it comes to properly labeling your products!

Happy Cosmetics Making!
Flicker!