Cosmetics Compliance – USA

The U.S. cosmetics market

The United States of America is the largest beauty and personal care market with revenues of nearly $78 billion in 2020 and an expected annual  growth rate of  4.3% (Statista).

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.

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 EU, the consumer is protected against risks, sometimes even without his or her consent. European legislation is generally considered to be rather heavy-handed and prescriptive due to the concept of consumer protection. A logical consequence is that the responsibility of protecting consumers from products that are unsafe or that promote unfair commercial practices mainly falls into the hands of the authorities (the European Commission, the European Parliament, the Competent Authorities of each member state) and of the EU Responsible Person. In other words, consumers are not responsible for anything related to the normal or reasonably foreseeable use of products. However, the expected downside is that European consumers have limited legal recourse against companies when problems arise.

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 European Union’s risk management policies — and one that clearly distinguishes the EU’s approach from that of the US — is what’s called the precautionary principle.

Hard-coded in Article 191 of the Treaty on the Functioning of the European Union, this principle, in the words of the European Commission, “aims at ensuring a higher level of human health protection through preventative” decision-making. This reference to the precautionary principle is also reported in Recital 36 and Articles 15 and 16 of the European Cosmetics Regulation. In layperson’s terms, this principle states that when there is substantial and credible evidence of danger to human health, protective action should be taken despite continuing scientific uncertainty. By contrast, 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.

In conclusion, the US and the EU have extremely different legal frameworks for regulating cosmetic products. However, the mere fact that US legislation is not prescriptive and only bans six ingredients and restricts only three others [21 CFR 700.11-27 & 250.250], while in Europe, multiple pieces of legislation prohibit more than 1,500 substances and restrict a few hundred more, it 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.

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.

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. As mentioned above, specific state regulations may also apply. Federal Regulation is organized as follows:

In the USA, cosmetic products (as understood in the EU) fall into three product categories:

  1. 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.

  2. 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.

  3. Soaps: The FDA defines “soap” according to two conditions:
    • 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 these alkali-fatty acid compounds, and
    • the product is labeled, sold, and represented solely as soap [21 CFR 701.20].

How does it work?

The regulatory process performed by BIORIUS consists of a formula review, a toxicological risk assessment, and a label review following the above-mentioned regulations to evaluate the safety and compliance of the product.

The process is thus divided into four phases: the formula review, the risk assessment, the label review, and the Voluntary Cosmetic Registration Program. (BIORIUS recommends registering the product since it provides protection in the event of any issues.)

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)

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 
    1. Local toxicity (skin, eyes, etc.)
      Evaluation of the irritation and sensitization potential of the finish product
    2. 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

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

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.

Other U.S.A. Specific Services

Any questions?

© Copyright - 2008 – 2021 BIORIUS