Are you planning to sell your cosmetics in the US ?

USA Cosmetics Compliance – The U.S. Cosmetics Market: the United States of America is the largest beauty and personal care market with expected revenues of $91 billion in 2023 and with an expected annual growth of 2.60%. This is one of the strongest growing markets and is driven by young consumers whose buying habits are impacted by the predominance of social media and e-commerce, especially when it comes to cosmetic products. To tap into this market, it’s vital that you meet the cosmetic regulatory requirements. This resource will navigate you through the process.

On December 29th, 2022, the biggest amendment of the U.S. Cosmetic Regulation since 1938 has been enacted. The publication of the Modernization of Cosmetic Regulation Act (MoCRA) in the USA is expected to have a large impact on the cosmetic industry, while it implies the reinforcement of FDA’s power.

More information on the MoCRA

The US is a free country (the land of the free)

The key words are freedom and responsibility. It is of course forbidden to put a dangerous product in the US market and it is very important to make sure that everything is OK before selling them on the US market. But there is indeed a lot more freedom to demonstrate the safety of an ingredient with an important Toxicological work beforehand.

Biorius, Specialist in US cosmetic safety assessments

As specialists in US cosmetic safety assessments and US cosmetics regulation for more than 15 years, Biorius offers a reliable turnkey solution for verifying and registering cosmetic products in an effective way. This solution, based on in-depth knowledge of the legislation, consists of a team of more than 50 scientific consultants offering a wide range of expertise and sophisticated IT tools and is the fastest and most reliable way to access the US market.

Regulatory context

While they look fairly similar upon first glance, American and European cultures differ in several ways. When it comes to implications for the cosmetics industry, the main differences are as follows:

Consumer Information vs. Consumer Protection

In the US, information is key, and everything must be done to ensure that the consumer makes a well-informed purchase decision. Cosmetics legislation seems to be rather light compared to Europe, and is not prescriptive when it comes to ensuring product safety or substantiating marketing communications. It’s no surprise, then, that consumers are responsible for the decision they make in their own lives. In other words, consumers are considered fully responsible if they damage their own health since proper information was provided regarding the product. The logical consequence of this is that the consumer can sue the responsible company in the event of a problem. The USA is a more litigious society, and a consumer suing a cosmetics brand is not unusual. This happens every day (especially in the form of class-action lawsuits) and the costs resulting from settling these can be devastating for a company.

Precautionary Principle

A key element of the US risk management policies is what’s called the precautionary principle.
The US federal government’s approach to the management of chemical substances sets a very high bar for the proof of harm that must be demonstrated before regulatory action is taken. The burden of proving that a product is unsafe lies with the authorities until an actual safety issue comes up. When such an event takes place, legal recourse by the consumer and/or the authorities then becomes possible, if not likely.
As an example, the US legislation is not prescriptive and only bans six ingredients and restricts only three others [21 CFR 700.11-27 & 250.250], but this should not be interpreted as easy. It’s simply a reminder that the devil is in the details, and the most dangerous traps are the ones that remain invisible.

Any cosmetic marketed within the US market must be compliant with provisions of the Federal Food, Drug and Cosmetic Act, the Fair Packaging and Labeling Act and all regulations published under the authority of these laws (and specific state regulations may also apply).

States

In the United States, regulations vary from state to state. This is especially true in California. There are therefore two types of regulations to consider: federal regulations and state regulations. BIORIUS takes this important fact into consideration when reviewing and ensuring the compliance of cosmetic products in the USA. Biorius can support the complete US Federal regulatory process and the complete US Federal and States regulatory process to check the Cosmetic Regulation in all the US states, California included. California is indeed the State with the most complicated Cosmetic Regulation with:

• California Air Resources Board
• California Safe Cosmetic Program
• Proposition 65
• Volatile Organic Compounds

In the USA, cosmetic products fall into three product categories:

Regular Cosmetics

The FDA defines cosmetics [FD&C Act, sec. 201(i)] 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”.Examples: skin moisturizers, perfumes, lipsticks, fingernail polish, eye makeup and facial cosmetics, cleansing shampoos, permanent waves, hair color and deodorants, as well as any substance intended for use as a component of a cosmetic product.

Over-the-counter products

Over-the-counter products are drug products available without a prescription. OTC drugs are defined by the FDA [FD&C Act, sec. 201(g)(1)]] as “drugs that are safe and effective for use by the general public without seeking treatment by a health professional”.BIORIUS can cover OTCs with existing monographs. The FDA has published monographs (i.e., rules), stating requirements such as which ingredients may be used and for which purpose.

Soaps

The FDA defines “soap” according to two conditions:

• Тhe 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 these alkali-fatty acid compounds, and
• Тhe product is labeled, sold, and represented solely as soap [21 CFR 701.20].

Step 1: Formula Review

Analysis of the cosmetic formulation in order to determine if the restrictions and prohibitions on ingredients and combinations of ingredients are respected.

Considering that there are both federal regulations and state regulations, BIORIUS proposes two types of formula review for the USA, depending on the needs of the cosmetics brand:

1. A federal formula review that does not consider the requirements for each state.
2. A federal and state-level formula review that takes state-level requirements into consideration and is comprehensive.

In both cases, our experts determine the INCI list, warnings and/or specific use instructions and evaluate the presence of colorants.
Upon completion of the evaluation, a formula review report is issued, which highlights the following elements:

• Ingredients
• Percentages of each ingredient
• Restrictions (federal and state level, depending on the type of formula review requested)
• Margins of Safety
• Expert commentary – missing documents, amendments needed
• INCI list (warnings can be added)

Step 2: Risk Assessment

A review of the toxicological profile of each ingredient and of the finished product through the available literature, internal programs and existing databases. This evaluation is systematically performed under the supervision of a toxicologist.

The toxicological risk assessment report, which presents the toxicological profile of the product, is also delivered and is structured as follows:

1. Review of ingredients

   Individual evaluation of the ingredients to ensure their regulatory and toxicological compliance

2. Review of exposure

   Determination of the quantity, frequency, surface of application and retention factor

3. Review of toxicity

   • Local toxicity (skin, eyes, etc.)
     Evaluation of the irritation and sensitization potential of the finish product
   • Systemic toxicity
     Determination of a margin of safety in order to ensure the non-toxicity of the product

4. Toxicologist’s conclusion

   Confirmation of product safety and determination of warnings that must be included on the product’s label

Step 3: Label & Claims Review

Evaluation of the product label (required information, translations, symbols and claims).Corrective actions and remarks provided to proceed with updating the label.

Upon completion of the evaluation, a label review report is issued, which highlights the following elements:

• Required elements and their inclusion on the label (primary packaging, secondary packaging, leaflet)
• Claims substantiation
• Expert commentary – strategic recommendations for updating the labels

Step 4: California

In the United States, regulations vary from state to state. This is especially true in California. There are therefore two types of regulations to consider: federal regulations and state regulations. BIORIUS takes this important fact into consideration when reviewing and ensuring the compliance of cosmetic products in the USA. Biorius can support the complete US Federal regulatory process and the complete US Federal and States regulatory process to check the Cosmetic Regulation in all the US states, California included. California is indeed the State with the most complicated Cosmetic Regulation with:

• California Air Resources Board
• California Safe Cosmetic Program
• Proposition 65
• Volatile Organic Compounds

Step 5: Voluntary Cosmetic Registration Program

Registration is not required prior to selling regular cosmetic products in the USA. Nevertheless, a cosmetics brand must always be able to prove the safety of a product. BIORIUS recommends the Voluntary Cosmetic Registration Program because it provides protection in the event of any issues.

Learn More about the Voluntary Cosmetic Registration Program

If you wish to develop the sales of your cosmetic products in the US, this is something Biorius can help you with. Biorius can indeed support the complete US cosmetics regulation process.

Biorius is:

• Specialized in cosmetic regulations in Europe, the United Kingdom, the United States, and in more than 60 countries.
• Mainly composed of 50 regulatory experts, specialists, toxicologists and scientists (chemists and biologists)
• Reassuring and comfortable: we have more than 1,500 international clients, we have already evaluated more than 100,000 products and we never had any compliance issues (fines, withdrawals of the market, etc.) in 15 years of existence.

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