Good manufacturing practices (GMP) refer to the procedures in place within a company to ensure that products meet certain quality standards throughout all stages of production, packaging, storage, and shipment. GMP is crucial to avoid adulteration or misbranding of cosmetic products.
The new US law on cosmetic products, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), imposes several new requirements on cosmetic manufacturers, producers, and brand owners. Currently, manufacturers of cosmetic products sold in the United States are recommended to follow GMP principles. However, MoCRA requires the FDA to codify GMP for the first time:
- FDA shall publish a proposal regulation on GMP by December 29, 2024.
- FDA shall publish the final rulemaking on GMP by December 29, 2025.
Awareness of GMP development is essential as brands will have to ensure their partners and suppliers meet the new requirements.
The law indicates that the FDA should consider international standards in developing GMP for the United States, such as ISO 22716:2007, to which companies must adhere to sell cosmetic products in the European Union. The FDA will likely use it as the foundation of US GMP. Thus, following ISO 22716:2007 ensures that you are on the right track of compliance in the United States. Additionally, the FDA shall take into account the size and scope of cosmetics manufacturers to not impose undue economic burdens on small businesses.
- The FDA intends to engage with stakeholders and interested parties in developing GMP regulations, and Obelis USA aims to be part of it. With 35 years of international experience, we have collaborated with regulatory bodies and institutions to shape compliance in the EU and beyond.
On top of GMP, MoCRA establishes many requirements for cosmetic manufacturers, including the following:
- Facility registration
- Product listing
- Safety substantiation
- Adverse events evaluation and recording
- Severe adverse events reporting
If you appoint Obelis USA as your US Agent, we will assist you with the above and ensure you meet all regulatory requirements for selling cosmetic products in the United States.
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