Navigating Compliance: FDA approval vs. CE marking for beauty products
In the modern world, product safety issues, especially medical devices and food, are at the forefront. That is why manufacturers wishing to enter the markets of the United States and the European Union countries are required to obtain appropriate permits and certifications. In the United States, the main regulatory body is the Food and Drug Administration (FDA), while for Europe, the CE marking is considered the key symbol of conformity. Both processes have similar goals, but they differ in structure and requirements.
The FDA (Food and Drug Administration) is a federal agency of the U.S. Department of Health and Human Services responsible for monitoring the safety and effectiveness of medicines, medical devices, food, cosmetics, and other product categories. Obtaining FDA approval confirms that the product meets strict safety standards and can be sold in the United States. Without such certification, access to the American market is impossible.
On the other hand, the CE marking (Conformité Européenne) indicates that the product complies with EU legislation and can be freely sold within the European Economic Area (EEA). It is mandatory for a range of products, including medical devices, electronics, toys, and equipment. Obtaining a CE mark does not require centralized approval, as is the case with the FDA, but involves passing a conformity assessment and complying with EU directives and regulations.
Such procedures are necessary not only to comply with formal requirements, but also to strengthen consumer confidence, ensure transparency, and protect public health. Both the FDA and CE require manufacturers to provide detailed documentation, clinical data, test results, and internal quality control. It is important to understand that even the slightest inconsistencies can lead to a refusal of certification.
Let us look at which types of products are subject to mandatory certification, how the processes of obtaining approval from the FDA and CE marking differ, what stages need to be passed and what difficulties may arise on the way to entering the international market.
First of all, products used in cosmetology, such as Botox, fillers and biorevitalizants, are subject to strict certification to ensure their safety and effectiveness. Botox, for example, is a drug that requires FDA approval before being used in medical practice, including cosmetic procedures. This approval ensures that the product has passed clinical trials and meets high safety standards. Fillers used to correct wrinkles and bulky skin defects must also be certified by the relevant regulatory authorities.
The processes of obtaining approval from the FDA (US Food and Drug Administration) and obtaining the CE marking (Conformité Européenne) have important differences due to legislative and regulatory peculiarities in the USA and Europe. One of the main differences is the approach to regulation. In the United States, the FDA regulates a wide range of products, including medicines, medical devices, and cosmetics, setting strict requirements for product safety, efficacy, and quality. To receive approval from the FDA, manufacturers are required to conduct clinical trials and provide results that prove the safety and effectiveness of their product. This process can be lengthy and expensive, as the FDA often requires numerous studies and the provision of sound evidence.
In Europe, the process of obtaining a CE mark is different, although it requires confirmation of safety and product compliance with established standards. However, unlike the FDA, there is no single centralized authority in the EU that would check every product. Instead, manufacturers can work with accredited notified bodies that carry out the necessary inspections and tests. The CE marking confirms that the product complies with EU directives, and after receiving this marking, the product can be freely sold on the European market. However, the process of obtaining a CE mark does not always require as in-depth clinical trials as in the United States, which sometimes makes this path less expensive.
Thus, the main differences between the approval processes from the FDA and CE labeling are in the approach to regulation and safety verification. While the FDA sets strict requirements and conducts thorough inspections, in Europe the focus is on compliance with directives and working with notified bodies, which can speed up and simplify the certification process.
Korean manufacturers of cosmetic and medical products such as botulinum toxins and fillers are also actively entering the international market. One of the most striking examples is Hugel, whose botulinum toxin, previously known under the Botulax brand, were renamed Letybo on the international market. Getting approval from the FDA for Letybo was an important event in Korea, which was actively reported in the local news. Nabota botulinum toxin is also known, which entered the US market under the brand name Jeuveau, and its manufacturer, has also received FDA approval. At the same time, botulinum toxin Botulax is in the process of obtaining approval from the FDA, which is likely to expand the presence of Korean products in the American market in the near future.
In the field of fillers, Korean companies have also made significant strides in obtaining permits for their products. Juvelook and Juvelook Volume boosters, as well as the popular Juvederm filler, have received approval from the FDA, which allowed them to be freely sold on the American market. Other products’ companies, such as LG Chem (Yvoire), have already applied for permits, indicating the continued trend of Korean manufacturers to seek to expand their presence in the global cosmetology industry.
To date, such well-known products as Botulax, Juvelook, Rejuran, Hyaron, Juvederm, The Chaeum, VOM, Youthfill and J-cain cream have successfully received CE markings. These products are used in aesthetic medicine and dermatology, from botulinum toxins to biorevitalizants and anesthetic creams.
