Introduction
In this blog we will be taking a look at what the legal requirements are to start a cosmetic brand in the USA. We will identify the regulatory body when it comes to regulating cosmetics on the US market. We will discuss brand liability and the legal definition of a cosmetic product. Then we will look at all the legal requirements brands must adhere to be be compliant according to US regulation. We will also stipulate steps brands should take even where they are not legal requirements they increase a brands credibility reinforcing high quality brand management putting the safety of the consumer first as well as protecting the brand against potential legal action.
Brand liability
Liability always rests with the brand who put the product on the market, therefore it is always the responsibility of the brand to ensure the products they are putting on the market are safe for use as directed.
What is a cosmetic
First it is important to understand what a cosmetic is under US regulation. As defined in section 201(i) of the FD&C Act, a cosmetic is a product, except soap, intended to be applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance. (FDA, 2024). Anything claiming to make physiological changes such as healing claims is considered to be a drug where a separate set of regulations must be adhered to.
The Food and Drugs Administration is regulatory body responsible for for regulating cosmetics on the market. Cosmetic brands must adhere to any regulations set by the FDA.
Labelling
According to section 301 of the FD&C Act the marketing of cosmetics that are adulterated or misbranded as well as their adulteration or misbranding while in interstate commerce are prohibited.
A cosmetic is considered misbranded if:
Labelling is false or misleading
The label does not state the name and address of the manufacturer, packer, or distributor
The net quantity of contents
The required information is not stated prominently, with conspicuousness and in terms that it is read and understood by consumers under customary conditions of purchase and use
The container or its fill is misleading
When labelling your cosmetics, the writing must be fully legible and of a reasonable and readable font, written in the English language. They must also contain directions for safe use, warnings, the name and place of business, and net quantity of contents.
A more detailed guide of labelling requirements can be found on the FDA website
Registration
In the US cosmetics do not require registration drugs however do, it is therefore important that the product you are formulating falls under the scope of a cosmetic product and not a drug. The main thing to remember is as soon as you start claiming your product can achieve physiological changes such as healing skin conditions such as eczema or acne it moves into the realm of a drug. To avoid this ensure that all marketing and label claims adhere to the cosmetic standard as stipulated above.
Colourants
The US do have regulations pertaining to the use of colourants in cosmetics. There are two types of approval: those that can be used without batch certification and those that must have batch certification. Click here to find out more about this.
To find out what colour additives are exempt from batch certifications and which colour additives require batch certification. In the far right column detailed are uses and restrictions, it will tell you where on the body specific colourants are able to be used. Use the guide to help you determine where on the body the colourant is allowed to be used, as a rule of thumb unless it explicitly states it is allowed for use in the eye area it means it is not permitted.
Ingredient Safety
It is the responsibility of the brand putting products on the market to ensure that their products are safe for use as directed. This means ensuring you are using ingredients according to their regulatory limits. To find out the regulatory limits of ingredients search the ingredient on the cosmetic ingredient review (CIR) to find out what is the safe usage amount according to the specific cosmetic product you are wanting to make. When searching specific ingredients try not to be too rigid in your search try and search all part of the name always use INCI names and not common names. As a rule of thumb if you cannot find the ingredient you are looking for on the CIR this generally means there are no safety concerns associated with that particular ingredient and it is safe to use in any amount. Click here to conduct your searches.
To find what you are looking for click on all the reports the latest publication as well are past publications skip to the discussion / summary or conclusion and there you will find the regulatory limit for safe use. These documents are around 100 pages long, it is not necessary to read them all the way through to find the information you need. Click control or command ‘F’ and type in conclusion /summary / discussion so you can skip to the section that will have the information you need.
Product liability insurance
Whilst getting product liability insurance is not a legal requirement. It is a very very good idea to get it. As cosmetics companies are ultimately responsible for the products they put on the market, this means you could be liable for any damage or injury sustained by the consumer. This can become expensive very quickly, therefore it is a good idea to get insurance to ensure you are covered on this front. Furthermore, consider getting an insurance plan that includes public liability cover, this ensures you are also covered when selling your products at market stalls should you wish to go down this route. Reputable market or craft organisers will require you to have public liability insurance before they can offer you a vending spot.
Recall Procedure
If you have a product on the market you must have a recall procedure in place. For this reason it is imperative that you put batch codes on each product. So in the event you need to recall products, consumers know which batch codes to look out for. The batch code must change with every new batch.
Testing
The US does not legally require you to test your products, however as stated above as the brand you are legally responsible for whatever products you put on the market. For this reason I highly recommend you get your products tested to ensure the quality and efficacy of them. Make sure your products undergo stability testing so you can be certain that the shelf life you are claiming your product has actually does have this shelf life. Also before putting your products onto the market undergo preservative efficacy testing (PET) testing, this will ensure the preservative you have chosen for your formula is compatible with your formula and adequately protects your product from microbial contamination. Additionally any claims you make about your product will need to have clinical evidence to back it up, be careful any claims you do make are not physiological claims as this then makes your product a drug and not a cosmetic for which there are a different set of regulations you will need to adhere to.
Formulating from home
There are no laws prohibiting you from creating and selling formulas from your home, this is perfectly legal. However it is important to observe good manufacturing practice to ensure your cosmetics are being formulated under safe and sanitary conditions. In order to comply (mandatory but no certification required) with Good Manufacturing Practice and Microbial Quality Management, manufacturers of cosmetics have to define and follow specific cleaning, sanitation and control procedures to keep all apparatus and materials appropriately clean and free of pathologic microorganisms. Procedures also include microbiological control of raw materials, bulk and finished products, packaging material, personnel, equipment and preparation and storage rooms (European Commission, 2012).
Conclusion
In this blog we have identified the regulatory body for cosmetics in the US, we have also identified the responsibilities and liabilities of a brand. We discussed all the legal requirements necessary for a brand to follow in order to be complaint with US regulation. We have also listed further recommendations brand should follow to ensure highest standard of quality and reduce the likelihood of legal action being taken against the brand as stipulated above even if they are not legal requirements if anything does go wrong liability falls to the brand. We have also taken a look at how to adhere to safety limits for ingredients and discussed good manufacturing practice. I hope you have found this blog informative and helpful.
References
Cosmetic Ingredient Review. (2024). Find Ingredient Reviews and Documents. Accessed [16/01/2024]. Available at: https://cir-safety.org/ingredients
European Commission. (2012). The SCCS’S notes of guidance for the testing of cosmetic substances and their safety evaluation 8th revision. Date Accessed [13/11/2023]. Available at: https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_s_006.pdf
Food and Drug Administration. (2024). Cosmetics Labelling Guide. Accessed [16/01/2024]. Available at: https://www.fda.gov/cosmetics/cosmetics-labeling-regulations/cosmetics-labeling-guide
Food and Drug Administration. (2024). Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices. Accessed [16/01/2024]. Available at: https://www.fda.gov/industry/color-additive-inventories/summary-color-additives-use-united-states-foods-drugs-cosmetics-and-medical-devices#ftnote6
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