Treasury Decision 8810 Notice and Opportunity for Hearing Upon Filing of Notice of Lien Temporary and Proposed Regulations Un Form

That is a good question, Niko Nikolaou, and the answer can be very complex.  The U.S. US Food and Drug Administration (FDA) does not “approve” conventional food products such as Olive Oil.  Instead, facilities that manufacturers, processes, packs, or holds food (i.e. olive oil) that may be consumed in the United States by humans or animals must register with FDA as a food facility.  Although some facilities may be excluded from this FDA requirement (such as retail food establishments that sell food products directly to consumers as its primary function), most facilities must comply with this requirement of the Federal Food Drug and Cosmetic Act, as amended by the Bioterrorism Act of 2002 and the FDA Food Safety Modernization Act.  In addition, FDA expects manufacturers to follow current good manufacturing practices (cGMP).  In January 2011, The Food Safety Modernization Act (FSMA) was signed into law. The Act mandates new requirements, many of which will be instituted over the upcoming months by the FDA.FDA  does not have regulations pertaining to the standards for grades of olive oil.  However, the US Department of Agriculture (USDA) has issued revised standards for grades of olive oil in order to incorporate terms consistent with objective criteria for determining quality and purity and to make them  consistent with International Olive Council trade standards.  These standards became effective October 25, 2010 and serve as a basis for the inspection and grading of commodities by the Federal inspection service.  The standards define “U.S. Extra Virgin Olive Oil,” “U.S. Virgin Olive Oil,” “U.S. Olive Oil,” and “U.S. Refined Olive Oil.” These grade standards do not apply to olive oil blends, i.e. olive oil mixed with herbs, spices, fruits, vegetables, or other oils.   Meanwhile, the FDA requires companies that produce certain shelf-stable, aseptically sealed low-acid canned or acidified foods to obtain a Food Canning Establishment (FCE) registration. In addition, manufacturers must file documentation with U.S. FDA for each process used in the production of  foods subject to these requirements. These submissions are known as a "Process Filing” by the FDA and each is assigned a unique "Submission  Identifier" (SID).  Although olive oil itself may be excluded from this requirement, infused oils are typically not excluded from FCE requirements.FDA has extensive labeling requirements for conventional foods, such as olive oil.  FDA has issued scores of regulations that govern many aspects of a food label and mandate certain declarations.  The most common compliance issues on non-U.S. food labels are the manner of nutrition declaration and ingredient labeling.  Conventional foods that are exported to the United States must be compliant with the FDA’s regulations or risk detention or refusal at the portof entry.  I am the Vice President of Registrar Corp, and we have provided assistance to companies with products very similar to yours. Registrar Corp can assist you with your food facility registration, FCE/SID Filing and labeling compliance. Visit http://www.registrarcorp.com/fda... for more information regarding U.S. FDA food labeling requirements. Also, our team of Regulatory Specialists is available 24/7 via Live Help (www.registrarcorp.com/livehelp) if you would like immediate assistance with the labeling for your product.

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