Friday, July 27, 2012

Wonderful Wild World of Wood Wicks!

When you think of summer, you think of campfires, when you think of winter you think of fireplaces. They both have one thing in common, the great crackling sound from the fire! Did you know that Bitter Creek offers a wick that is made of 100% natural organic wood! Here is some information on our amazing Wood Wicks!

This candle is made using EZ Soy™ Wax
18 oz apothecary jar
Sweet Potato Pecan Pie
#5 Two Wicks
(5/8") Wood Wicks
Orange Diamond Dye Chips
Candle has been burning 5.5 hours with no trimming.
Wood Wicks
*Wood Wicks require a special wick clip (tab) sold separately!
• 100% natural grown. 100% organic. No chemical treatments
• Fast burn pool formation for superior hot throw.
• No straightening. 100% rigid in manufacturing.
• Crackling wood fire sound while wood wick is burning.
• Does not require trimming.
• No mushrooms. Little to no debris. Minimal carbon buildup.
• When sized properly no smoking during burn cycle.
• Little to no afterglow sooting.
• Less overheating at End of Life with wood wick clip.
• Clip keeps flame at safety height, 3/8” above bottom.
• Works in Containers, Pillars, and Votives.
• Efficiently burns all waxes; Paraffin, Soy, Mottling, Palm etc.
• Wood wicks are sized from ¼” to 1” wide.
• Soy and Soy blends may require 2 wicks.
• One clip fits all wood wick sizes and thicknesses.
• Large flat area on bottom of clip for easy use of Wick Stickums.
• Clip is tin coated steel which inhibits rust and discoloration.
• Widths and height come in 1/8” increments for exact sizing.
• Ideal wick height when pouring is 1/8”-1/4” above wax surface.
• 100% grown, manufactured, and sold in the USA.
Sounds too good to be true, doesn't it? It's not! These wicks are amazing!!! They burn clean, are very low maintenance, burn hot enough to achieve perfect melt pools and optimize scent throw and at the same time don't burn too hot at all! Every candle we've wicked with these has been simply impressive!! 

Before choosing to carry this line of wicks, we tried every wood wick we could find. They were NOT impressive. There was limited sizing, they were so thick they were difficult to trim after burning and more impossible to cut to size. They drown out in every wax and none burned even close to right. In a nutshell, if you tried the wicks we did, you are probably afraid to try again. Don't be. These are not the same wicks. These have been engineered by one of the best in the industry to be one of a kind. They burn amazing!
Our wood wicks are compatible with most waxes. We offer a chart that will give you a basic idea of where to start when wicking with them in your wax (I've pasted this to the bottom of this page for your convenience) I have added some pictures of the wicks in jars so you can see how great they burn! The best part is they really crackle and it's loud enough to hear unlike some of the big brands!

For anyone wanting to make a basic Wood Wick Candle to start, here is a list of supplies and directions for you! 

Ez Soy Wax
8 oz Smooth Side Jelly Jar
Lid for Jelly Jar

Caution Labels
Blank Candle Labels

Dyes (The only dye we do not recommend are liquids in this wax)
Fragrance Oil
Wood Wicks
Wood Wick Tab

Wick Stickum

  • To make the Wood Wick Jelly Jar Candle first be sure your jar is clean of debris.
  • Place the two #3 Wood Wicks in the Special Wood Wick Tab
  • Place a Wick Stickum on the bottom of the tab and adhere to the Jelly Jar
  • Follow these instructions for heating the wax, scenting, coloring and pouring it:
    HeatEZ Soy™ to 175-180*. Add your dye and blend well, then add your fragrance and blend well.
    Allow the wax to cool to about 105* and start stirring. When the wax reaches a slushy stage, it looks similar to an Icee starting to warm up, pour the wax into room temperature jars. The actual pour temp of the wax is about 95* but because it is not completely fluid at this point, an internal temp is hard to achieve. Pouring hotter will result in more frosting and tops that are not completely smooth
  • Trim the wicks and place lids on the jars and allow to "cure for at least 48 hours before burning. Some scents may take up to two full weeks to cure.
  • Don't forget to place a warning label on the bottom of the jar and make a label for the front with your company logo! :)
We recommend using chip, block, powder or flake dyes with soy waxes. Liquid dyes can cause excessive frosting due to the solvents in them. If your tops are not smooth, try pouring a touch cooler. If they are lumpy try a bit warmer. It does take some trial and error testing to determine the exact right pour temp for you.

Wood Wicked 3 1/2" Diameter Candle Burning:

Wood Wick conversion measurements:

#2 width 0.250" - 1/4"
#3 width 0.375" - 3/8"
#4 width 0.500" - 1/2"
#5 width 0.625" - 5/8"
#6 width 0.750" - 3/4"
#7 width 0.875" - 7/8"
#8 width 1.000" - 1"

Candle Diameter
Single Pour
Soft Wax
2" Diameter Candle
#2 (2 Wicks)
3" Diameter Candle
#3 (2 Wicks)
#2 (2 Wicks)
3.5" Diameter Candle
#4 (2 Wicks)
#3 (2 Wicks)
#3 (2 Wicks)
4" Diameter Candle
#5 (2 Wicks)
#4 (2 Wicks)
#4 (2 Wicks)
5" Diameter Candle
#3 (2 Wicks)
#7 (2 Wicks)
#3 (2 Wicks)
#6 (2 Wicks)
#6 (2 Wicks)

*All Wood Wicks are sold in 6" lengths.
*Wood Wicks require a special wick clip (tab). These can be found in this category with the wood wicks as well as with the Wick Tabs.
*Please keep in mind these are only suggestions on where to begin your testing. All applications should be individually tested for proper sizing.

chemicals were used in the forests or processing/manufacturing of the wood wicks. Are our wood wicks Certified Organic? No. "Certification" in the organics industry is a complex process that the tree growers, mill, wick manufacturer and Bitter Creek would have to go through costing a huge sum of money. The Certification Process is a piece of paper that states what we already do, make an organic wick. We do not plan to make this a "Certified Organic" product anytime in the future unless the cost is significantly lowered. But you have our word, they ARE an Organic Product, they are just not certified.

Wood Wick Candles are beautiful and sound amazing but smell amazing too! Give the wood wicks a try on your next order. They unique sound and look will set you apart from your competition giving you an edge!

Happy Candlemaking!

Monday, July 16, 2012

Labeling your products!

I am a member of a number of online resources/groups/blogs etc. and lately I have noticed a large increase in the number of questions regarding what needs to be labeled on a cosmetic, soap etc. and what claims can be and can not be made regarding these products.

The FDA guidelines often read with such gray area that I myself find it confusing and often frustrating to read through even after almost 15 years experience in the business!. With the busy holiday season just around the corner, this seemed like a super time to go back over the FDA website to help our customers understand what is needed in body care labeling.

Good manufacturing practices are essential when creating and packaging Cosmetics & Soaps. Often times the gray area I talked about above comes from knowing the difference. Is it soap? Is it a cosmetic? Is it a drug or maybe it's a combination hybrid?! This has been very confusing over the years and this should help clarify this, or that is my hope at least.

True soap is NOT included in regulations by the FDA but rather the Consumer Product Safety Commission: Over the years this has been a STRONG debate in the world of hand crafted soaps and cosmetics. I actually recently got 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.

I stand by my long time belief that "MOST" melt and pour soap is still considered a cosmetic and thus requires labeling per the FDA guidelines.
If you look at a list of standard ingredients for melt and pour soap, you find that they are primarily comprised of detergents and other chemical ingredients and not fats (vegetable oils, animal fats like lard etc.) and alkalis (potassium or sodium hydroxide) or the product of mixing a fat and an alkali like sodium cocoate = soap created by the combination of sodium hydroxide and coconut oil. This is a list of a pretty basic melt and pour soap:
Glycerin, Propylene Glycol, Sodium Stearate, Sodium Laureth Sulfate, Sorbitol, Cocos Nucifera (Coconut) Oil, Sodium Myristate, Triethanolamine, Sodium Laurate, Sodium Cocoate, Water.
To me that isn't true soap and thus should be labeled as a cosmetic as it is not primarily a fat and alkali base. In this particular melt and pour, the top ingredients, Glycerin and Propylene Glycol are neither a fat OR an alkali.

Although true soap does not require by law ingredients declaration, I personally find it a good practice to always label what is in your product. People often have allergies or are sensitive to a certain ingredient and this way, you are protecting them and yourself by letting them know in advance what is in your product.

Most cosmetics out there ARE NOT correctly labeled. This includes the big guys. I find this page really defines it but it is imperative that as a cosmetics manufacturer you read the entire section on the FDA website. They will gladly answer questions if you should have them. They get many questions so please be patient waiting for a response. Bottom line, be careful & use good manufacturing practices and above all READ the Cosmetics section on the FDA website before you label or sell your products. This is the link to the entire Cosmetics section of their site.

Here are some basics with regards to labeling cosmetics in the United States. 

Summary of  Regulatory Requirements for Labeling of Cosmetics Marketed in the United States

From the Cosmetic Labeling Manual
October 1991; updated June 18, 2009
Cosmetics marketed in the United States, whether manufactured here or imported from abroad, must be in compliance with the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), Fair Packaging and Labeling Act (FP&L Act), and the regulations published under the authority of these laws.
The regulations published by the Food and Drug Administration (FDA) are all codified in Title 21, Code of Federal Regulations (21 CFR). The regulations applicable to cosmetics are stated at 21 CFR, parts 700 to 740 (21 CFR 700 to 740). The color additive regulations applicable to cosmetics are found at 21 CFR 73, 74, 81 and 82.
The FD&C Act defines cosmetics as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions. Included in this definition are products such as skin creams, lotions, perfumes, lipsticks, fingernail polishes, eye and facial make-up preparations, shampoos, permanent waves, hair colors, toothpastes, deodorants, and any material intended for use as a component of a cosmetic product. Soap products consisting primarily of an alkali salt of fatty acid and making no label claim other than cleansing of the human body are not considered cosmetics under the law.

Cosmetics That Are Also Drugs

Products that are cosmetics but are also intended to treat or prevent disease, or affect the structure or functions of the human body, are considered also drugs and must comply with both the drug and cosmetic provisions of the law. Examples of products which are drugs as well as cosmetics are anticaries toothpastes (e.g., "fluoride" toothpastes), suntanning preparations intended to protect against sunburn, antiperspirants that are also deodorants, and antidandruff shampoos.
Most currently marketed cosmetics which are also drugs are over-the-counter drugs. Several are new drugs for which safety and effectiveness had to be proved to the agency before they could be marketed. A new drug is a drug which is not generally recognized by experts as safe and effective under the conditions of intended use or which has become so recognized but has not been used to a material extent or for a material time under such conditions.
The regulatory requirements for drugs are more extensive than the requirements applicable to cosmetics. For example, the FD&C Act requires that drug manufacturers register every year with the FDA and update their lists of all manufactured drugs twice annually. Additionally, drugs must be manufactured in accordance with current good manufacturing practice regulations as codified at 21 CFR 210 and 211.
For additional information, refer to Is It a Cosmetic, a Drug, or Both? (Or Is It Soap)?

Adulterated or Misbranded Cosmetics

The FD&C Act prohibits the distribution of cosmetics which are adulterated or misbranded. A cosmetic is considered adulterated if it contains a substance which may make the product harmful to consumers under customary conditions of use; if it contains a filthy, putrid, or decomposed substance; if it is manufactured or held under insanitary conditions whereby it may have become contaminated with filth, or may have become harmful to consumers; or if it is not a hair dye and it contains a non-permitted color additive. Coal-tar hair dyes bearing on the label the caution statement prescribed by law and that give "patch-test" instructions are exempted from the adulteration provision even if they are irritating to the skin or are otherwise harmful to the human body. Eyelash and eyebrow dyes are not included in this exemption. All dyes used in eyelash and eyebrow dye products must be approved by the FDA for such use.
A cosmetic is misbranded if its labeling is false or misleading, if it does not bear the required labeling information, or if the container is made or filled in a deceptive manner. For additional information, see Key Legal Concepts: "Interstate Commerce," "Adulterated," and "Misbranded."

Cosmetic Labeling

The cosmetics distributed in the United States must comply with the labeling regulations published by the FDA under the authority of the FD&C Act and the FP&L Act. Labeling means all labels and other written, printed or graphic matter on or accompanying a product. The label statements required under the authority of the FD&C Act must appear on the inside as well as any outside container or wrapper. FP&L Act requirements, e.g., ingredient labeling and statement of the net quantity of contents on the principal display panel, only apply to the label of the outer container. The labeling requirements are codified at 21 CFR 701 and 740. Cosmetics bearing false or misleading label statements or otherwise not labeled in accordance with these requirements may be considered misbranded and may be subject to regulatory action.
The principal display panel, i.e., the part of the label most likely displayed or examined under customary conditions of display for sale (21 CFR 701.10), must state the name of the product, identify by descriptive name or illustration the nature or use of the product, and bear an accurate statement of the net quantity of contents of the cosmetic in the package in terms of weight, measure, numerical count, or a combination of numerical count and weight or measure. The declaration must be distinct, placed in the bottom area of the panel in line generally parallel to the base on which the package rests, and in a type size commensurate with the size of the container as prescribed by regulation. The net quantity of contents statement of a solid, semisolid or viscous cosmetic must be in terms of the avoirdupois pound and ounce, and a statement of liquid measure must be in terms of the U.S. gallon of 231 cubic inches and the quart, pint, and fluid ounce subdivisions thereof. If the net quantity of contents is one pound or one pint or more, it must be expressed in ounces, followed in parenthesis () by a declaration of the largest whole units (i.e., pounds and ounces or quarts and pints and ounces). The net quantity of contents may additionally be stated in terms of the metric system of weights or measures.
The name and place of business of the firm marketing the product must be stated on an information panel of the label (21 CFR 701.12). The address must state the street address, city, state, and zip code. If a firm is listed in a current city or telephone directory, the street address may be omitted. If the distributor is not the manufacturer or packer, this fact must be stated on the label by the qualifying phrase "Manufactured for ......" or "Distributed by ......" or similar, appropriate wording.
The Tariff Act of 1930 requires that all imported articles state on the label the English name of the country of origin.

Declaration of Ingredients

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).

Label Warnings

Cosmetics which may be hazardous to consumers when misused must bear appropriate label warnings and adequate directions for safe use. The statements must be prominent and conspicuous. Some cosmetics must bear label warnings or cautions prescribed by regulation (21 CFR 740). Cosmetics in self-pressurized containers (aerosol products), feminine deodorant sprays, and children's bubble bath products are examples of products requiring such statements.
Although the FD&C Act does not require that cosmetic manufacturers or marketers test their products for safety, the FDA strongly urges cosmetic manufacturers to conduct whatever toxicological or other tests are appropriate to substantiate the safety of their cosmetics. If the safety of a cosmetic is not adequately substantiated, the product may be considered misbranded and may be subject to regulatory action unless the label bears the following statement: Warning--The safety of this product has not been determined. Sec. 21 CFR 740.10.

Tamper-Resistant Packaging

Liquid oral hygiene products (e.g., mouthwashes, fresheners) and all cosmetic vaginal products (e.g., douches, tablets) must be packaged in tamper-resistant packages when sold at retail. A package is considered tamper resistant if it has an indicator or barrier to entry (e.g., shrink or tape seal, sealed carton, tube or pouch, aerosol container) which, if breached or missing, alerts a consumer that tampering has occurred. The indicator must be distinctive by design (breakable cap, blister) or appearance (logo, vignette, other illustration) to preclude substitution. The tamper-resistant feature may involve the immediate or outer container or both. The package must also bear a prominently placed statement alerting the consumer to the tamper-resistant feature. This statement must remain unaffected if the tamper-resistant feature is breached or missing. Sec. 21 CFR 700.25.

Law Enforcement Authority

For enforcement of the law, the FDA may conduct examinations and investigations of products, inspect establishments in which products are manufactured or held, and seize adulterated (harmful) or misbranded (incorrectly or deceptively labeled or filled) cosmetics. Adulterated or misbranded foreign products may be refused entry into the United States. To prevent further shipment of an adulterated or misbranded product, the agency may request a federal district court to issue a restraining order against the manufacturer or distributor of the violative cosmetic. The FDA may also initiate criminal action against a person violating the law. Examples of products seized in recent years are nail preparations containing methyl methacrylate or formaldehyde, various eyebrow and eyelash dye products containing prohibited coal-tar dyes, and products contaminated with harmful microorganisms. For further information, see FDA Authority Over Cosmetics.
Further questions regarding regulatory requirements for marketing cosmetics should be directed to the Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Cosmetics and Colors (HFS-100), 5100 Paint Branch Parkway, College Park, MD 20740, (240) 402-1130. Questions regarding requirements for marketing products which are also drugs should also be addressed to FDA's Center for Drug Evaluation and Research.

Cosmetic claims are a big thing as well. This outlines more what you can and can not say about your product. THIS IS VERY IMPORTANT! This is copied and pasted directly from the FDA website page:

Cosmetic Labeling & Label Claims

April 25, 2006; updated January 23, 2012
The following information is a brief introduction to cosmetic labeling requirements. For a more thorough explanation of cosmetic labeling regulations, see FDA's Cosmetic Labeling Manual and the cosmetic labeling regulations themselves (21 CFR parts 701 and 740). Firms also may wish to discuss their labeling needs with a consultant.
Proper labeling is an important aspect of putting a cosmetic product on the market. FDA regulates cosmetic labeling under the authority of both the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). These laws and their related regulations are intended to protect consumers from health hazards and deceptive practices, and to help consumers make informed decisions regarding product purchase.
It is illegal to introduce a misbranded cosmetic into interstate commerce, and such products are subject to regulatory action. Some of the ways a cosmetic can become misbranded are
  • its labeling is false or misleading
  • its label fails to provide required information
  • its required label information is not properly displayed
  • its labeling violates requirements of the Poison Prevention Packaging Act of 1970 [FD&C Act, sec. 602; 21 U.S.C. 362]

Does FDA pre-approve cosmetic product labeling?

No. Neither the FD&C Act nor the FPLA requires cosmetic labeling to undergo pre-market approval by FDA. It is the manufacturer's and/or distributor's responsibility to ensure that products are labeled properly. Failure to comply with labeling requirements results in a misbranded product.

Some labeling terms you should know

Before proceeding with a discussion of labeling requirements, it is helpful to know what some labeling terms mean:
  • Labeling. This term refers to all labels and other written, printed, or graphic matter on or accompanying a product [FD&C Act, sec. 201(m); 21 U.S.C. 321(m)].
  • Principal Display Panel (PDP). This is the part of the label most likely displayed or examined under customary conditions of display for sale [21 CFR 701.10].
  • Information Panel. Generally, this term refers to a panel other than the PDP that can accommodate label information where the consumer is likely to see it. Since the information must be prominent and conspicuous [21 CFR 701.2(a)(2)], the bottom of the package is generally not acceptable for placement of required information, such as the cosmetic ingredient declaration.

Is it permitted to label cosmetics "FDA Approved"?

No. As part of the prohibition against false or misleading information, no cosmetic may be labeled or advertised with statements suggesting that FDA has approved the product. This applies even if the establishment is registered or the product is on file with FDA's Voluntary Cosmetic Registration Program (VCRP) (see 21 CFR 710.8 and 720.9, which prohibit the use of participation in the VCRP to suggest official approval). False or misleading statements on labeling make a cosmetic misbranded [FD&C Act, sec. 602; 21 U.S.C. 362].

What about therapeutic claims?

Promoting a product with claims that it treats or prevents disease or otherwise affects the structure or any function of the body will cause the product to be considered a drug under the FD&C Act, section 201(g). FDA has an Import Alert in effect for cosmetics labeled with drug claims. For more information on drug claims, see Is It a Drug, a Cosmetic, or Both? (Or Is It Soap?).

How should products be labeled if they are both drugs and cosmetics?

If a product is an over-the-counter (OTC) drug as well as a cosmetic, its labeling must comply with the regulations for both OTC drug and cosmetic ingredient labeling [21 CFR 701.3(d)]. The drug ingredients must appear according to the OTC drug labeling requirements [21 CFR 201.66(c)(2) and (d)] and the cosmetic ingredients must appear separately, in order of decreasing predominance [21 CFR 201.66(c)(8) and (d)]. Contact FDA's Center for Drug Evaluation and Research (CDER) for further information on drug labeling.

What languages are acceptable?

All required labeling information must be in English. The only exception to this rule is for products distributed solely in a U.S. territory where a different language is predominant, such as Puerto Rico. If the label or labeling contains any representation in a foreign language, all label information required under the FD&C Act must also appear in that language [21 CFR 701.2(b)].

What labeling information is 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. [21 CFR 701.12].
  • Distributor statement. If the name and address are not those of the manufacturer, the label must say "Manufactured for..." or "Distributed by..." [21 CFR 701.12].
  • 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 740]. In addition, cosmetics that may be hazardous to consumers must bear appropriate label warnings [21 CFR 740.1]. Flammable cosmetics are an example.
  • Ingredients. If the product is marketed 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]. As an alternative, when cosmetics are distributed on a mail-order basis, the package mailed to the consumer may contain readily visible instructions for locating the ingredient declaration, such as in a product catalog (currently interpreted as including a website), or instructions for requesting a copy of the ingredient declaration. Mail-order distributors must respond promptly to such requests [21 CFR 701.3(r)]. Remember, if the product is also an OTC drug, its labeling must comply with the regulations for both OTC drug and cosmetic ingredient labeling, as stated above.
In a nutshell I really hope this has helped you understand better the need for accurate labeling regardless of what you are making. It is important and it's the law!

Happy Cosmetics, Soap and Candle Making!