Earlier this month, the US Food & Drug Administration updated its website to add several useful overviews and Fact Sheets to help you properly launch, lead, and grow your handmade cosmetics business. While these updates do not change the law, they specifically publicly recognize, for the first time as far as I know, the existence of the handmade or “homemade” cosmetics industry. (Yay!)
Handmade companies and Makers are regulated just like larger companies. The new updates make it easier for small manufacturers and their customers to interpret and apply the law to their unique circumstances. This article provides a high level overview of the updates, with links to where you can find and read them for yourself. I have also included links to our members who offer resources and assistance in specific areas, as well as links to some exclusive resources for our members.
This is a long article and I do not recommend that you read it all at once, especially if you are a newcomer to the cosmetics world. I have organized each of the ten sections in what I think is a logical way, each section building on the ones before it. You can read one section and the accompanying links one at a time, and gradually understand and embrace not just the different laws, but also the concepts behind them.
1. Small Business and Homemade Cosmetics Fact Sheet
FDA website link, released March 19, 2014
Manufacturing in your home. It’s not a violation of FDA law to manufacture cosmetics in your home. (It could be a violation of state law, Florida specifically, so keep that in mind.) The fact that you can sell cosmetics made in your home does not eliminate your responsibility to manufacture products in an environment that will not cause them to become adulterated. Good manufacturing practices are important, no matter where you make your products. (See Item Number 2, below.)
Exclusive Member Resource: How to Apply for a Florida Cosmetics Manufacturing Permit. (Member login required)
Registration. You do not have to register your cosmetics business or your products with FDA, but it is recommended that you do so under FDA's Voluntary Cosmetic Registration Program. While participation is voluntary (at least, for now), registration of your company provides valuable public information, including how many companies in the United States manufacture and sell cosmetics to the public.
Exclusive Member Resource: Introduction to FDA’s Voluntary Cosmetic Registration Program. (Member login required)
“Natural” and “organic” on labels. The same requirements for safety and labeling apply to all cosmetics, no matter what their source. This includes, for example, making sure that all your labeling is truthful and not misleading. FDA has not defined the term “natural” and has not established a regulatory definition for this term in cosmetic labeling. The USDA regulates use of the term “organic” under the National Organic Program. See Item Number 3, below.
Product Testing. FDA cosmetics laws do not require that you test your products in any particular way. While you don't have to follow any specific test, you are responsible for making sure the products you sell are safe. This is a basic rule that applies to anyone selling products to the public, not just cosmetics. For cosmetics, this includes using an appropriate preservative that provides your product with a reasonable shelf life and protects it from nasty bacteria that can compromise its effectiveness and/or safety. You can check with our member, Cindy Jones at Sagescript for more information on product testing.
Exclusive Member Resource: How to Conduct Microbiology Tests on Cosmetics (Member login required)
Name and Address. You must let consumers know where your products are made. Even if you work from home, people have to be able to find you if they have a question about your products. While it stands to reason that people can easily “find” you at your website, the truth is that the regulations have not caught up with technology, and still require that you list your business name and contact information (“name and place of business of the manufacturer, packer, or distributor”) on your product labels — even if that means printing your home address on your label.
As an alternative, you can purchase a local phone book listing. If your business is listed in your local phone book, you can use a PO Box on your labels, and avoid using your home address altogether.
So your choice is clear: spend some money to advertise in your local phone book and avoid listing your home address on your labels, or save some money and list your home address on your labels.
Read the Small Business and Homemade Cosmetics Fact Sheethere.
See also “Soap and Lotions,” released March 24, 2014.
2. Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist
FDA website link, released March 20, 2014
FDA regulations do not require that any particular systems or practices be in place in order for you to legally make and sell cosmetics. That does not mean you can make products however it's convenient for you, however. FDA requires that you have manufacturing processes, and that they be designed to store ingredients and supplies in a clean and safe manner, and to promote the safe and clean manufacturing of the products you sell.
The good news here is that there is no huge list of “dos” and “don'ts” that you have to follow. The bad news here is that there is no huge list of “dos” and “don'ts” that you have to follow. There are few mandates, but the gist of the guidelines is that you maintain a customary set of methods and practices that ensure the safety and cleanliness of your manufacturing area and of your products, wherever and however they are made.
It would be wise for you to comb through the FDA's GMP Guidelines and make sure you have a specific manufacturing system in place. For example, wearing a hair net and gloves in the manufacturing area prevents products from being contaminated as you are making them. Logging in raw materials as they are received keeps track of their age and source. Maintaining samples of batches of product helps keep a record of when something was made so you can track back a particular product if a customer has a question.
Our member, Lela Barker of Lucky Break Consulting, offers a great course on GMP for cosmetics companies, so be sure to check her out if you have questions in this area.
Read FDA's Good Manufacturing Guidelines here.
3. “Organic” Cosmetics
FDA website link, released March 19, 2014
“Organic” is a labeling term that is regulated through the US Department of Agriculture's (USDA's) National Organic Program (NOP). The term “organic” is used to indicate that a food or other agricultural product has been produced through approved methods that integrate cultural, biological, and mechanical practices that foster cycling of resources, promote ecological balance, and conserve biodiversity.
Obviously, cosmetics are not food, and while they may contain agricultural ingredients, they are not agricultural products in and of themselves. This makes use of the term “organic” on cosmetics labels particularly detail-oriented, for while the NOP was not written for cosmetics, it does apply to cosmetics. Use of the term “organic” is regulated by the US Department of Agriculture (USDA) in three main ways: production of organic products, handling of organic products, and labeling of organic products. Third party companies provide organic certification services to organic growers, processors, and handlers.
Generally, you cannot use the term “organic” on cosmetic labels unless you are in compliance with NOP. Specific attention is paid to the principale display panel (generally, the part of the label the consumer sees when looking at a product on a shelf), on which the term “organic” cannot appear unless the product contains a very high proportion of organic ingredients, or is certified organic itself. The product can contain a lower percentage of organic ingredients and properly use the term “organic” in the list of product ingredients.
A full discussion of the ins and outs of organic labeling for cosmetics is beyond the scope of this post, but you can find a very valuable, user-friendly summary of the NOP as it applies to cosmetics companies here (PDF). (You can find a listing of third party certificate companies here. That link is dated 2013, so it may not be complete and some of the companies listed may no longer be certified as I write this post in March 2014.)
California has its own requirements when it comes to using the word “organic” on cosmetic product labels. For more information about this, see the California Organic Products Act of 2003, which prohibits the retail sale of any cosmetic product labeled as “organic” unless it meets the criteria of a minimum of 70% organic content … excluding water. Learn more at the California Organic Program website.
Exclusive Member Resource: Understanding the Organic Certification Process. (Member login required)
4. Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)
FDA website link, released March 20, 2014
Some products are cosmetics. Some products are drugs. Some products are both cosmetics and drugs. If a product is both a cosmetic and a drug, it must comply with both cosmetic and drug laws.
FDA cosmetics laws define a cosmetic is defined 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.” Examples include things like lotion, perfume, lip stick, nail polish, makeup and eye shadow, shampoo, deodorant, hair colors, and bath bombs.
Soap is not defined as a cosmetic, though the distinction is without a huge difference since the best practice is to label a soap the same way you would label a cosmetic (even though you don't have to) since you want to fully disclose ingredients of all kinds to the people who are buying your products. It is important to note that the components of a cosmetic are also defined as cosmetics. For example, a body cream made with olive oil is a cosmetic, and the olive oil itself, when sold separately is also regulated as a cosmetic if it is intended for use as a cosmetic within the scope of the definition above.
For more information about soap and how FDA defines it for regulatory purposes, read the Soap Fact Sheet here.
A drug is defined, in part, as a product “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” If a product claims to cure head aches, grow hair, or relieve symptoms associated with eczema, it will be classified by FDA as a drug and must comply with drug regulations.
On the other hand, a product that helps you feel more cheerful, makes your hair prettier, or smoothes the skin (and nothing more) will not be classified by FDA as a drug and must only comply with cosmetic regulations.
A full discussion of the difference between a drug and a cosmetic, and the overlapping area where a product is both, is beyond the scope of this post. FDA's Fact Sheet on this topic is a must read for all cosmetics manufacturers, so be sure to know it inside and out. This document is one of the most useful FDA resources on the planet. If you make cosmetics, or are thinking about starting a company to do so, you must read and digest this information.
5. Cosmetic Labeling Guide
FDA website link, released March 27, 2014
Once your product is made, it must be labeled properly. By way of a high level overview, this boils down to the following:
– what the product is
– how much product is in the container
– where the product was made or who is distributing or packing it
– all marketing copy must be true and not misleading
– an ingredient declaration so consumers know what is in the product
More information about what names to use to identify specific cosmetic ingredients can be found in the Ingredient Names resource here.
Mislabeled products are ones that are out of compliance in any of these areas.
The labeling requirements also include things like type and font size, placement of particular information, and the order in which ingredients are listed. It sounds like a lot, and it is until you read and understand how all of it fits together.
Just remember that the overall purpose is to make sure consumers get clean cosmetics that are labeled in a way that helps them understand what they are buying for themselves and their families. Essentially, it's no more and no less than you would want to know when buying products for use in your own home.
Read the FDA's Cosmetic Labling Guide here.
6. Fragrances in Cosmetics
FDA website link, released March 24, 2014
If a product containing fragrance is intended to be used as a cosmetic (see definition in Item Number 4, above), then the FDA regulates that product as a cosmetic.
If a product containing fragrance is intended to be used as a drug (see definition in Item Number 4, above), then the FDA regulates that product as a drug (and possibly a cosmetic as well).
If a product containing fragrance is intended to be used as a household product (like a carpet freshener or a dryer sheet), then that product is regulated by the Consumer Product Safety Commission (CPSC).
As you can see, the decide how the fragranced product is regulated, you have to look at the purpose for which the products is intended. What is the consumer buying it for? To be more beautiful? Then it's probably a cosmetic. To cure a stuffy nose? Then it's probably a drug. To make your clothes smell better? Then it's probably regulated the CPSC.
The question of fragrance necessarily raises the issue of use of essential oils in products. Essential oils can be used to add fragrance to a cosmetic.
7. Aromatherapy
FDA website link, released March 24, 2014
The Indie Business Network is pleased to serve a growing number of aromatherapists and people who make products containing essential oils, which are used in the practice of aromatherapy. An ongoing challenge for many of these companies is how the FDA addresses aromatherapy products.
If an aromatherapy product (or product containing essential oils, whether or not it is called an “aromatherapy” product) makes a claim that it can make you feel more beautiful or attractive, then FDA would regulate that product as a cosmetic. But if that same product makes a claim to help with depression, sleep, or smoking cessation, FDA would regulate that product as a drug.
The FDA says it will address these situations on a “case-by-case” basis, which essentially means that the regulations in this area are intentionally broad so the FDA can maintain discretion when assessing the facts of individual situations on their own unique merits. “The devil is in the details,” as is so often the case. You should approach the labeling of your essential oils/aromatherapy products with FDA's regulations in mind.
Read what the FDA says about aromatherapy products here.
8. Salon Professionals: Fact Sheet
FDA website link, released March 19, 2014
A growing number of Indie Business Network members not only make the product they sell, but are also licensed in their states to apply them to clients. Nail technicians, massage therapists, hair dressers, barbers, and more are connecting through our networking avenues to exchange ideas and create new sales opportunities. To the extent these therapists and professional practitioners are regulated, they are regulated by authorities in their local areas and not by FDA. However, the FDA's website does a great job of directing practitioners to information to help them carefully select the products they will use on their clients. This is a handy link for manufactures to know about since therapists who buy their products will be directed there by FDA to get some of their questions answered.
Check out what salon professional are being told about FDA cosmetics regulations here.
9. Temporary Tattoos, Henna/Mehndi, and “Black Henna”
FDA website link, released March 26, 2014
This is important for a growing number of our members (and industry participants in general) who make and sell henna products for hair coloring purposes. For those who don't know, henna is a natural colorant made from a plant. It is approved only for use as a hair dye, and not for direct application to the skin. Though I have personally had henna applied to my skin on several occasions with no problems whatsoever, it is important to know the FDA's regulatory requirements in this regard.
Read about FDA regulation of tattoos and henna products here.
10. Makeup
FDA website link, released March 23, 2014
There are two big issues here, and neither of them are new. First, makeup that claims any sunscreen or sun protection factor (SPF) is regulated as a cosmetic *and* a drug, so unless you have complied with FDA's drug regulations, you cannot legally claim sunscreen and SPF on any product, including makeup.
Exclusive Member Resource: Creating a Niche Sunscreen Brand. (Member login required)
Second, makeup generally includes use of colors which, which rare exception, are regulated by FDA.
See a full list of color additives that are exempt from certification requirements here.
Full links to FDA's color additive regulations can be found here.
Read These Links Yourself!
A post like this can only highlight these very useful resources.
If you are a cosmetics manufacturer, I urge you to print them out and put them in a folder or notebook that you can easily reference and share with your team. Everyone who works closely with you in your business should have a basic working knowledge of the regulatory framework within which you operate. Sharing this information with your employees and helpers can only make your business better.
FDA's Website Continues To Become More Useful and Easier to Navigate
There was a time when FDA's website was difficult to navigate. It was hard to find things, and when you did, it was usually written in lawyer-speak. That has changed significantly. Today, any small cosmetics manufacturer can easily and quickly use the links listed here, and other resources at the cosmetics area of FDA's website, to easily and quickly find answers to questions about how cosmetics must be made, labeled and sold to the public.
The cosmetics industry has been regulated by FDA since the 1930s, and as you know from many blog posts here in the Law and Advocacy Section of our blog, that is not going to change. The good news is that, by these updates, FDA continues to take proactive steps to positively recognize the growing handmade soap and cosmetics industry, and to make the regulatory framework available for all to see and understand. This is good for manufacturers of course, but it's also great for consumers, the media, and the growing industry of Makers and handmade entrepreneurs in general.
I hope this information is useful to you.
Best and success,
Question
Do you make cosmetics? Do you find these updates and links easier to use than the ones you have used in the past? What else would you like to see FDA do to make it easier for you to understand and comply with FDA cosmetics laws? Share your feedback in the comments section below.
