Why is Regulatory Compliance Important?

In the realm of labeling your soap or cosmetic products, it is to forget the big picture.  Especially why are these regulations in place and why is so important to comply with them.  In a recent posting called Why is Regulatory Compliance Important? , Marie Gale explains why it is so important.

Anti-Aging, Rejuvenating, and Repairing Claims

Did you know about the FDA's Import Alert 66-38 titled "Skin Care Products Labeled as Anti-Aging Creams" of 1988?  It clearly states that exaggerated 'anti-aging' claims could cause a product to be unapproved new drug.  This alert was the basis for understanding restrictions on cosmetics claims like anti-aging, rejuvenating and repairing.  At the end of 2017, the import alert was withdrawn. What to learn more about this topic?  Marie Gale, who wrote a book on Soap and Cosmetic Labeling and currently writes news, updates about labeling, gmp, and regulations on her site on www.mariegale.com, wrote an article called Anti-Aging Rejuvenating and Repairing Claims.

Healing Claims for Ingredients

Did you know if indicate that product ingredient can heal, you are making the same claim for the product itself, it becomes an unapproved new drug? Well, it is true.  And you do not need to get in trouble with the FDA.  Learn more about this subject in a blog post from Marie Gale called Healing Claims for Ingredients.

Why No One is Too Small to Follow the Labeling Rules & Cosmetics Regulations

So you are thinking of taking your hobby of making soap and other bath and body products and selling them?  Well, I do not want to scare you but you may want to read this posting ModeronSoapmaking called Why No One is Too Small to Follow the Labeling Rules & Cosmetic Regulations.  It is important to know why you need to be complainant to the regulations before you start selling your products.

Understanding FDA Cosmetic vs. Drug Claims

Now that you want to turn your hobby into a business and sell your products, you will have to understand the rules of making claims about your product is very important.  The rules and regulations for selling bath and body products fall are created by the FDA (Food and Drug Administration) and are put into place for the safety of the consumer. According to The Soap Queen, soap and cosmetics should not make claims that could confuse your product as a drug.  And the FDA regulates and defines cosmetics, drugs and soap differently.  I can be tricky to understand these definitions and what type of claims are appropriate for each one of them.  In a recent post called Understanding FDA Cosmetic vs. Drugs, The Soap Queen explains what you need to know.  So I would suggest reading this post before you start selling your products.

Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)

Are you just getting into the hobby of making your own soap? Are you confused whether soap is a cosmetic, drug or both? Well to answer some of your questions, the In a July 2002, the FDA posted on their website an article titled, Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) in July 2002. For those who have knowledge or more information to share, please let us know your experience.

FDA (U.S. Food & Drug Administration) Guidelines and Regulations for Soap

Soap is in a different category than cosmetics (body care products). The FDA says soap is exempt from the provisions for cosmetics must but you must go by the FDA's definition of soap. To be classified as soap, you can not make any cosmetic claims about your soap on the soap label. If you say the soap is moisturizing, that is a claim for cosmetics and your soap is now a cosmetic. You now must follow the guidelines and regulations for cosmetics. Basically what soap does is clean and that is the only claim you can make about your soap. See below highligted words for the FDA's defintion of a cosmetic.

Statements below are directly quoted from the FDA website: http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074201.htm

And what if it's "soap"?
Soap is a category that needs special explanation. That's because the regulatory definition of "soap" is different from the way in which people commonly use the word. Products that meet the definition of "soap" are exempt from the provisions of the FD&C Act because -- even though Section 201(i)(1) of the act includes "articles...for cleansing" in the definition of a cosmetic -- Section 201(i)(2) excludes soap from the definition of a cosmetic.”

How FDA defines "soap"

Not every product marketed as soap meets FDA's definition of the term. FDA interprets the term "soap" to apply only when --

• 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 [21 CFR 701.20].

If a cleanser does not meet all of these criteria...

If a product intended to cleanse the human body does not meet all the criteria for soap, as listed above, it is either a cosmetic or a drug. For example:

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.
If a product --

• is intended solely for cleansing the human body and

• has the characteristics consumers generally associate with soap,

• does not consist primarily of alkali salts of fatty acids,

it may be identified in labeling as soap, but it is regulated as a cosmetic.

How does the law define a cosmetic?

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.

Source: http://www.naturalskinandbodycare.com/2009/11/is-your-soap-cosmetic-or-soap.html

FDA Labeling Guidelines for Soap

The Federal Food, Drug and Cosmetic Act of 1938 was signed by FDR amidst a burgeoning public outcry for consumer protection from quack cures and cosmetic products that caused harm rather than cure or enhance the user. The act was designed to protect the public from products that made unsubstantiated or fraudulent claims, or that caused harm due to inclusion of harmful ingredients. The act covered the broad scope of both what is consumed or ingested as food and those ingredients that are used to treat, cure or enhance cosmetically.

Though this new law made it illegal for manufacturers to include ingredients in products that could be harmful to an unsuspecting public yet it wasn't until it was amended to include - the Pesticide Amendment of 1954, the Food Additives Amendment of 1958, and the Color Additive Amendments of 1960 – that the law became specific in nature requiring manufacturers to use only ingredients (which included additives and color) in manufacturing that prior research revealed to be safe for public consumption.

However, it wasn’t until The Fair Packaging Act of 1967 that strict labeling guidelines became standard manufacturing practice which required manufacturers to own up to ingredients used in the manufacturing and processing of their products - and to this end to be accountable to a certain standard and disclosure to the public who bought their products. What this act did more than anything else was to usher in the era of ‘truth in labeling’ that held manufacturers responsible for ensuring that the products that they brought to the marketplace was safe for consumers by assuring that ingredients used in products were tested and deemed safe, that the manufacturing process did not expose product ingredients to contaminants and that required a listing of all ingredients along with company contact information on all items that was used for food, drug and cosmetic purposes.

Plain soap is not a Cosmetic or Drug

Manufacturers who create soaps are still held responsible for creating a safe product. Soap that makes no claims to do anything than its intended purpose, that is, as a cleansing agent is not a cosmetic under FDA guidelines and is not subject to the rigorous labeling guidelines of cosmetics. Instead it is regulated by the US Consumer Product Safety Commission, an independent federal regulatory agency which is charged with protecting the public against unreasonable risks of injuries and deaths associated with consumer products. The Federal Hazardous Products Acts gives jurisdiction to CPSC for regulating "...all noncosmetic, nondrug substances used in the home."

Soaps that are Cosmetics or Drugs

However, there are exceptions to this. Once a manufacturer uses verbiage which claims that the soap has a special use other than that which it is intended for - such as claiming that the soap has special moisturizing properties or that it treats or cures a certain skin condition, then the soap as per labeling is not just plain soap anymore but is now a cosmetic or even a drug and subject to the regulatory guidelines of cosmetics and drugs. In addition, what sets plain soap apart from cosmetic soaps is how they have to be labeled. A soap that claims it has special properties that will enhance or alter the molecular structure of the user has to be labeled with ingredients listed in International Nomenclature of Cosmetic Ingredients format. International Nomenclature of Cosmetic Ingredients AKA INCI, is a special naming convention which classifies ingredients used in cosmetic and body care manufacturing based on scientific, Latin or English names.

The Fair Packaging Act of 1967, sets specific guidelines for labeling products which states that all products should have the basic components listed below- Please note that if you are making regular soap which has no other claim than as a cleansing product then these guidelines apply to you:

This statement is taken from the Federal Trade Commission's Website

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)."

Links to Resources: http://www.cfsan.fda.gov/~dms/cos-lbl.html

Federal Trade Commission website with link to the Fair Packaging Act which directs how manufacturers should label consumer commodities: http://www.ftc.gov/os/statutes/fpla/outline.html

FDA Regulatory requirements for labeling of cosmetics marketed in the United States: http://www.cfsan.fda.gov/~dms/cos-lab1.html

US Food and Drug Administration

The U.S. Consumer Product Safety Commission is charged with protecting the public from unreasonable risks of serious injury or death from more than 15,000 types of consumer products under the agency's jurisdiction. http://www.cpsc.gov/

OSHUN Supply INCI listing of common names and INCI names of ingredients used in soap and cosmetic product manufacturing: http://www.oshun.ca/inci.html

Source: Permission to reprint by Winsome Tapper, Soapmaking Editor, http://www.bellaonline.com/site/soapmaking

Listing Ingredient Tips From Wholesale Supplies Plus

Listing ingredients on a cosmetic label is not hard but it can be confusing. All of the information presented here can be found at the FDA's Cosmetic Website.

Ingredients on a cosmetic label must be listed in order of predominance using correct INCI terminology. A few key tips for labeling a cosmetic:

Color additives of any concentration are listed after the listing of ingredients that are not color additives (ie: can go at the end of the label). Ingredients present not exceeding 1% can be listed in any order after the listing of ingredients over 1%

Fragrance is listed on the label with the word "fragrance oil". Fragrance that is added at 1% or more needs to be listed in the correct order on the label. If you are using a premade base, you may need to contact the manufacturer for where to properly list fragrance on the ingredient listing. It should not be added last on the label.

Essential oils can be stated as "fragrance" or by the appropriate botanical name. They should not be listed as the general words "essential oils".

If you are interested in further reading outside of the FDA website. I highly recommend the book:

Soap & Cosmetic Labeling How to Follow the Rules and Regs Explained in Plain English.

Author: Marie Gale

Wishing You Much Success!
Debbie May
www.WholesaleSuppliesPlus.com

Source: http://wholesalesuppliesplus.blogspot.com/2007/10/listing-ingredients.html

Labeling Melt & Pour Soaps

There many questions about labeling soap especially melt and pour soap. In this article, Labeling Melt & Pour Soaps by Debbie May of Wholesale Supplies Plus states:

"Melt and Pour Soap (MP Soap) is a commercially produced compound formulated for the purpose of cleansing the body. Natural vegetable oils are saponified and used as a base for the MP Soap. Additives are commonly added to the base to improve clarity, lather and craftability.

The Food and Drug Association (FDA) states that if a product is predominately comprised of fatty acids and alkalis for the purpose of cleansing the body, it does not meet the requirement of a cosmetic and does not need to be labeled as a cosmetic.

This means that instead of the FDA soap falls under the watch of the US Consumer Product Safety Commission. They require the following on the label:

Identifying statement indicating the word "Soap"
Net Weight of Product
Name and Place of Business

If you make the claim that your MP Soap has special moisturizing properties or has specific benefits such as exfoliating, then it does fall in the FDA definition of a cosmetic and must be labeled as a cosmetic. In this case they require the following on the label:

Identifying statement indicating the word "Soap"
Net Weight of Product
Name and Place of Business
Directions for Safe Use
Warning and Caution Statements
Ingredients

The FDA Cosmetic Website has additional information for your reference."

Another great reference would be Marie Gale's book about labeling.