Owner, operator, or agent in charge of domestic and foreign facilities engaged in manufacturing, processing, packing, or holding of food and dietary supplement for human or animal consumption in the US are required to register with FDA, unless such facility is exempt from the requirement to register by the regulation.
Examples of facilities exempt from registration requirement are:
- Home Based business – a domestic or foreign home based business that meets customary expectations for a private residence that is also used to manufacture, process, pack, or hold food need not be registered.
- Personal consumption: If you are producing food products for personal consumption and not for distribution or sale, you are exempt from FDA registration.
- Farms – Facilities that produce, harvest, pack, or hold raw agricultural commodities are exempt from registration. There are certain exceptions to this exemption.
- Retail Food Establishments – Facilities that sell food products directly to consumers are generally exempt from FDA food facility registration, for e.g., grocery stores, supermarkets, restaurants, food trucks, etc
- Restaurants & Bars – Facilities that prepare and serve food for directly to consumers for immediate consumption are exempt from FDA registration.
- Nonprofit food establishments
- Fishing Vessels – Fishing Vessels engaged in the harvesting and transportation of raw seafood are exempt from registration. There are certain exceptions to this exemption.
- Some foreign facilities, where food from such facility undergoes further processing by another facility outside US are exempt from FDA registratioln.
- Facilities regulated exclusively by USDA.
Facilities looking to register with FDA can reach out to Liberty Management Group Ltd. for assistance. We can help you with registration & other FDA regulations.
Namrata
Regulatory Consultant
support@libertymanagement.us