Month: May 2023

Understanding MoCRA: A Guide to the Modernized Cosmetics Regulation Act of 2022

In the ever-evolving world of cosmetics, ensuring consumer safety and regulatory compliance is of paramount importance. Recognizing the need for modernization, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has ushered in significant changes to the regulatory landscape governing cosmetic products in the United States. Aimed at enhancing safety, transparency, and oversight, MoCRA replaces outdated regulations from 1938 and introduces a range of new requirements that impact manufacturers and importers alike. In this blog, we will delve into the key updates brought about by MoCRA, providing valuable insights to beauty manufacturers and importers regarding compliance and industry best practices.

 

Under MoCRA, cosmetic facilities must register with the US Food and Drug Administration (FDA) and renew their registrations every two years. The registration requirement applies to establishments involved in manufacturing or processing cosmetic products distributed in the United States. Existing facilities have until December 29, 2023, to complete their registrations, while new facilities must register within 60 days of commencing manufacturing operations. It is crucial for facilities to initiate the registration process early to account for any unforeseen issues or potential delays from the FDA.

 

The FDA holds the authority to suspend a facility’s registration if it determines that a product manufactured or processed by the facility poses a reasonable probability of causing severe adverse health consequences or death. Moreover, if the agency believes that other products in the facility may be similarly affected due to an inability to isolate the failure or a pervasive failure concern, registration suspension is also applicable. In such cases, the facility is prohibited from selling or distributing cosmetics products in the United States.

Additionally, responsible persons, such as manufacturers, distributors, or packers whose names appear on the label, are required to list each cosmetic product with the FDA. This step promotes transparency and facilitates efficient monitoring of products in the market.

 

The Voluntary Cosmetic Regulations Program (VRCP), which allowed voluntary submission of product information to the FDA, is no longer accepting submissions. MoCRA mandates a more extensive volume of submissions, necessitating the development of a new program by the FDA to handle facility registrations and product listings. This change enables the FDA to manage regulatory oversight effectively, ensuring greater transparency and safety within the industry.

 

MoCRA places a strong emphasis on consumer safety by mandating cosmetic manufacturers to submit safety information about their products to the FDA. This includes reporting any adverse reactions experienced by consumers and disclosing information regarding potentially harmful ingredients used in the products. The FDA utilizes this data to evaluate product safety and take appropriate actions to protect consumers.

 

Furthermore, manufacturers must adhere to Good Manufacturing Practices (GMPs), which encompass guidelines ensuring the quality and safety of cosmetic products. Compliance with GMPs involves using clean equipment, proper handling and storage of ingredients, and implementing robust quality control measures.

 

Another crucial aspect of MoCRA is the requirement for cosmetic manufacturers to disclose the full list of ingredients used in their products on the product label. This shift from previous regulations, which allowed vague terms like “fragrance,” provides consumers with enhanced transparency, enabling them to make informed decisions about the products they use.

Under MoCRA, certain exemptions are granted to cosmetic/drug and cosmetic/device combination products, relieving them from specific requirements including compliance with Good Manufacturing Practices (GMPs), adverse event reporting, registration and listing obligations, safety substantiation, and recordkeeping. These exemptions do not extend to facilities involved in the manufacturing of both combination products and cosmetics.

 

Small businesses are exempt from GMP and registration and listing requirements. A small business is defined as having average gross annual sales in the U.S. for the previous three-year period of less than $1,000,000, adjusted for inflation. It is important to note that the small business exemption does not apply if the business manufactures products that come into contact with the eyes, are injected, are intended for internal use, or alter appearance for more than twenty-four hours.

 

The Modernization of Cosmetics Regulation Act (MoCRA) represents a crucial leap forward in the regulation of cosmetics in the United States. With its emphasis on safety, transparency, and compliance, MoCRA ensures that the beauty industry aligns with evolving consumer expectations. Manufacturers and importers must familiarize themselves with the updated requirements to ensure they meet the standards set forth by MoCRA.


At Future Forwarding, our expertise in supply chain management and deep understanding of regulatory compliance can help you stay on top of these complex requirements. By leveraging our industry knowledge and network, we ensure that you can effectively navigate the regulatory landscape, maintain compliance, and streamline your operations. With our reliable support, shippers can focus on core business while confidently meeting the obligations imposed by MoCRA. To find out more, reach out to Future Forwarding today.

Staying Compliant With CPSC

The U.S. Consumer Product Safety Commission (CPSC) is an independent agency of the federal government that was created in 1972 through the Consumer Product Safety Act. It’s responsible for protecting consumers from unreasonable risks of injury or death from thousands of types of consumer products. The Commission’s work to ensure the safety of consumer products is central to its mission.

The CPSC’s role in trade compliance is significant. It works closely with U.S. Customs and Border Protection (CBP) to identify and examine imported products that may not comply with U.S. safety standards. This collaboration is crucial to prevent non-compliant products from entering the U.S. market.

The CPSC’s role in trade compliance includes:

  1. Product Regulation: The CPSC has jurisdiction over about 15,000 types of consumer products, from toys to toasters. They establish safety standards for these products, and it’s illegal to import products that do not meet these standards.

  2. Enforcement: The CPSC enforces compliance with these standards. They can take various enforcement actions, including issuing recalls for products already on the market and stopping non-compliant products at the border before they enter the U.S. market.

  3. Inspection: The CPSC inspects products at ports of entry into the U.S. If inspectors suspect a product may be non-compliant, they can detain it for further inspection and testing.

  4. Recalls: If a product is found to be unsafe after it has entered the market, the CPSC has the power to issue recalls. They can also negotiate voluntary recalls with companies.

  5. Penalties: Companies that fail to comply with CPSC regulations can face significant penalties. This includes civil penalties, criminal penalties, and even imprisonment in some cases.

  6. Education: The CPSC also works to educate businesses about U.S. safety standards and their responsibilities under the law. They provide guidance and support to help businesses comply.

  7. International Cooperation: The CPSC cooperates with product safety agencies in other countries to promote worldwide consumer product safety.

For businesses involved in manufacturing, importing, or selling consumer products, understanding the CPSC’s role and regulations is essential for trade compliance. Failure to comply with these regulations can result in significant penalties and damage to a company’s reputation. 

 

Importers have specific responsibilities to ensure that the products they bring into the United States comply with CPSC regulations. Here are the main steps an importer should take:

 

  1. Understand CPSC Regulations: The first step is understanding which CPSC regulations apply to your products. The CPSC regulates about 15,000 types of consumer products, and each may have specific safety standards that it must meet.

 

  1. Product Testing and Certification: Most products under the jurisdiction of CPSC must be tested by a CPSC-accepted laboratory to certify compliance with applicable safety regulations. Once tested, a written certificate of compliance, also known as a Children’s Product Certificate (CPC) for children’s products or a General Certificate of Conformity (GCC) for non-children’s products, must accompany the product from the manufacturer to the distributor or retailer.

 

  1. Labeling and Tracking Information: Certain products must include specific labeling information. For example, children’s products must have permanent, distinguishing marks (tracking label) that provide information like the manufacturer’s name, the location and date of production, and detailed information on the manufacturing process.

 

  1. Report Potential Safety Issues: If you learn of a potential safety defect or hazard related to your product, you are legally obligated to report this to the CPSC. This includes situations where the product has been recalled in another country.

 

  1. Cooperate with Recalls: If a product you import is subject to a recall, you must cooperate with the CPSC and take steps to notify consumers, remove the product from store shelves, and provide remedies to consumers, which can include a repair, replacement, or refund.

 

  1. Stay Updated: The CPSC regularly updates its regulations and standards. It’s important to stay up-to-date with these changes to ensure continued compliance.

 

These are general guidelines, and the specific steps may vary depending on the type of product and the applicable regulations. The CPSC has a regulatory robot that can help with simple questions. However, compliance can be complex, so it’s best to have an expert on your side. Future Forwarding is proud to have a team of experts ready to keep your cargo moving and compliant. We’re also on the forefront of new technologies and innovative thinking to improve efficiency.

In that vein, CPSC is launching an e-filing pilot program. If you’d like to participate, contact Corporate Compliance Manager Shannon Whitt at 404-608-0060 ext 127.

Export Control Classification Numbers

Export Control Classification Numbers (ECCN) are important in international trade as they determine the level of control that the US government places on the export of certain goods and technologies. ECCNs are codes used to classify products and technologies based on their level of sensitivity and potential for military or terrorist use. 

 

This classification system helps to regulate the export of certain goods to foreign countries and ensures that national security interests are protected.

 

Finding ECCN numbers for your products is essential if you intend to export them. The first step is to determine if your product or technology is subject to export control regulations. This can be done by reviewing the US Commerce Control List (CCL), which identifies controlled items and their corresponding ECCNs.

 

Once you have identified the product or technology, the next step is to determine its ECCN. This can be done using several methods, including:

 

  1. Self-Classification: Review the ECCN list and determine which category your product falls under. This method requires a good understanding of the ECCN classification system and may require consultation with an export compliance professional.
  2. Online ECCN Search Tools: The US government provides several online resources for finding ECCNs. The Bureau of Industry and Security (BIS) website has a searchable database that provides ECCN information for controlled items.
  3. Consultation with the Manufacturer: The manufacturer of the product or technology can provide the ECCN number. They should have already classified the product or technology and can provide the necessary information.

 

It is essential to ensure that the correct ECCN is assigned to your product or technology before exporting it. Failure to comply with export regulations can result in significant penalties, including fines and imprisonment. Additionally, incorrect classification can lead to delays in the export process, which can impact your business’s bottom line and customer satisfaction.

 

Finding ECCN numbers is an important step in exporting controlled products and technologies. The US government has a regulatory system in place to control the export of sensitive goods and technologies. It is the responsibility of the exporter to ensure that their products are properly classified before being exported. By utilizing the available resources and tools, exporters can ensure that their products comply with regulations and are shipped smoothly and efficiently. At Future Forwarding, we are dedicated to helping our customers navigate the complex world of international trade and customs regulations. Our team of experts has the knowledge and expertise to help you determine the correct ECCN for your products and technologies, ensuring that your exports are compliant with all relevant regulations. Reach out and see how we can help you keep your cargo compliant and moving. 

 

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