New Year, New Projects, Labeling Information!

With the start of a new year often comes the start of new projects for those in the candle, soap and cosmetics industry. With these new projects often come a large number of questions with regards to labeling and other requirements. I thought this would be a good time to go over these again so that they are fresh in everyone’s minds in the New Year!

Let me start by saying that no labeling will substitute for good insurance, nor will creating a corporation or an LLC. Product Liability Insurance is a must for people that are selling their product to protect themselves against the high cost of a potential lawsuit. While insurance is not normally needed and very few people are ever sued, why take chances, right? There are many professional organizations like The Handcrafted Soap Makers Guild who offer insurance for their members. Many homeowner’s policies will also cover it. Remember when looking you don’t just need General Liability but also Product Liability. With that out of the way, let’s get talking labels!

When you are making candles, room sprays, incense and melts your labeling will be required to place certain information on the labels to be sure the consumer knows what they are buying. This information can be found here: https://www.ftc.gov/enforcement/rules/rulemaking-regulatory-reform-proceedings/fair-packaging-labeling-act which says:

Rule Summary:

The Fair Packaging and Labeling Act (FPLA or Act), enacted in 1967, directs the Federal Trade Commission and the Food and Drug Administration to issue regulations requiring that all "consumer commodities" be labeled to disclose net contents, identity of commodity, and name and place of business of the product's manufacturer, packer, or distributor. The Act authorizes additional regulations where necessary to prevent consumer deception (or to facilitate value comparisons) with respect to descriptions of ingredients, slack fill of packages, use of "cents-off" or lower price labeling, or characterization of package sizes. The Office of Weights and Measures of the National Institute of Standards and Technology, U.S. Department of Commerce, is authorized to promote to the greatest practicable extent uniformity in State and Federal regulation of the labeling of consumer commodities.

Basic Requirements: The FPLA requires each package of household "consumer commodities" that is included in the coverage of the FPLA to bear a label on which there is:

• a statement identifying the commodity, e.g., detergent, sponges, etc.;
• the name and place of business of the manufacturer, packer, or distributor;
• and the net quantity of contents in terms of weight, measure, or numerical count (measurement must be in both metric and inch/pound units).

Purpose of the Act: The FPLA is designed to facilitate value comparisons and to prevent unfair or deceptive packaging and labeling of many household "consumer commodities."

FDA: The Food and Drug Administration (FDA) administers the FPLA with respect to foods, drugs, cosmetics, and medical devices. The FTC administers the FPLA with respect to other "consumer commodities" that are consumed or expended in the household. Many products that are exempt from the FPLA nevertheless fall within the purview of the Weights and Measures laws of the individual states.

Be sure to always check your states website to determine their specific rules regarding weights and measures. Basically it states that the FTC requires any product manufacturer of a consumable product (something that is used) to list on their label exactly how much product the package contains. This needs to be listed by either unit of measure or by weight or volume, depending on the product. Here are a few examples of random products from my house.

Cat treats: NET WT. 3 OZ (85g)
Screen Cleaner: NET WT. 4 Fl. Oz. (118ml)
Cleaning Wipes: 80 Wipes 6 x 6.5 in. (15.24 x 16.51 cm)

The cat treats are listed by the weight of the product. The screen cleaner spray is listed by liquid (fluid) volume, which is specified by listing the ounces as "fluid" ounces. The wipes are listed as the total number of how many units are in the package, also including the size of each unit.

For a candle, everything is done by weight, so you would want to list the contents of your candle by weight in ounces and then include the weight in grams in parentheses after it, just like on the cat treats example. Don't forget to deduct the weight of the jar or container itself, you only want to list the contents of the actual consumable product inside the container! If you have a digital scale with a tare feature, it is really easy.

You must also list your company name and contact info on the label. Here is exactly what the regulation says:

(1) The commodity shall bear a label specifying the identity of the commodity and the name and place of business of the manufacturer, packer, or distributor;

(2) The net quantity of contents (in terms of weight or mass, measure, or numerical count) shall be separately and accurately stated in a uniform location upon the principal display panel of that label, using the most appropriate units of both the customary inch/pound system of measure, as provided in paragraph (3) of this subsection, and, except as provided in paragraph (3)(A)(ii) or paragraph (6) of this subsection, the SI metric system;

So if you private label your products for others, the labels could list the name and place of business of the distributor instead. Or if for example, say you just produced the candles but sent them out to another company to be packaged in boxes and labeled... then the packager/distributor could put their company info on the label instead of yours.

The best way to get examples of how to do your labels is to look at some from some of the large candle companies, like Yankee. I dug thru my candle box and found a few name brands to give you examples.

McCall's Country Canning lists theirs on the bottom, on their caution label. It says 16 oz. Classic Jar Candle. Burn Time 110 - 130 hrs.

Pilgrims Primitives lists theirs on the caution label also. It says "Approximate Net Wt. 3.75 oz."

L'Occitane lists theirs right on the label on the top of the tin. It says "100 g- Net Wt 3.5 OZ". Then on the bottom caution label it states "Around 20 hours of soft fragrancing for the home."

I also found a pillar candle made by Claire's Garden and it lists the size of the pillar instead of the weight. It says 4" x 4" Burns up to 90 hours.

If you have any questions please read over that FTC link thoroughly, and you can also try contacting them with any questions you're unsure of: https://www.ftc.gov/contact

With cosmetics, the rules are a bit different. 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

Be sure to 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 is committed to making sure you have the proper understanding when it comes to properly labeling your products!

Happy Holidays and have a SAFE New Year!
Flicker!