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Unit_22_-_FDA_Requirements_for_Food_Labe - Unit 22 FDA...

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22. 1 Unit 22 - FDA Requirements for Food Labeling There are a variety of regulations that require certain types of information to be provided to consumers through labeling of packaged products. While it is beyond the scope of this course to cover all these regulations, we will take a closer look at a category that you are all familiar with: food. Labeling on foods is regulated in the US by the Food and Drug Administration. As is the case for most legal requirements in the US, there is federal law that, in essence, sets the standards. It then sets regulations promulgated by regulatory agencies that provide the details of the requirements. These regulations are published in the Code of Federal Regulations, or CFR, which is available online at http://www.gpoaccess.gov/cfr/ (as well as in print form). For food labeling, the regulations reside in Title 21, Part 101, which is generally written as 21CFR101 , and is titled “Food Labeling.” The regulation has 165 printed pages, so we are obviously not going to have time to cover it in detail! Regulations are also subject to change. The way the process works is that a notice of the proposed change is printed in the Federal Register. A set time is allocated for public comments. Next, the agency reviews the comments and publishes a response along with the perhaps modified change in regulations, which goes into effect after a set time period. The very first thing addressed in 21CFR101 is the definition of, and requirements for, the “principal display panel” – or PDP of a packaged food. And we quickly find out just how complex reading a regulation can be the actual title of this section is “ § 101.1 Principal display panel of package form food.” So what is a “package form food”? T he language tells us this is “food in package form” – which, in more common language, is packaged food! If this is enough to make you want to give up on even trying to understand food labeling requirements, fortunately the FDA also recognizes that wading through the regulatory language is daunting, so they have published some things to help. One such document is the Food Labeling Guide, published as a “Guidance for Industry.” Various agencies publish these guidance documents to help companies (that are trying their best to comply with the relevant regulations) understand exactly what they are supposed to do. This particular guidance document can be found at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/F oodLabelingNutrition/FoodLabelingGuide/default.htm While the recommendations in these guidance documents are not legally binding (other approaches that meet the regulations can be used), most companies find it best to follow them unless there is some compelling reason not to do so.
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