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This month, we celebrate the 20th anniversary of the codification of the final rules that overhauled the U.S. Food and Drug Administration’s (FDA) nutrition labeling requirements for food in the United States. Passage of the Nutrition Labeling and Education Act (NLEA) gave FDA authority to require specific nutritional information be declared on most food sold in the United States. FDA’s ubiquitous Nutrition Facts Chart was born and all manifestations of it written into the Code of Federal Regulations (CFR). NLEA also led to the codification of the FDA requirements for making nutrient content and health claims on food. These FDA’s rules forever changed the way food would be labeled and marketed in the United States.

FDA labeling rules are complex. An entire part of the CFR (Part 101) is dedicated to the required labeling elements, including the statement of identity, net quantity statement, ingredient declarations, format of the nutrition chart and the information found therein, manufacturer/distributor/packer declaration, and requirements for claims. The nutrition facts chart itself is regulated in a tangled web of requirements that stipulate when simplified, tabular, linear, side-by-side formats can be used. Additional regulations govern when footnotes may be excluded, when certain nutrient values may be omitted, where the chart may be placed, and when the chart may be omitted altogether!

Additional requirements may be found in Compliance Policy Guides and Guidance Documents. Some claims used on food labeling lack legal definitions, or are subject to “proposed rules” that have been languishing in regulatory limbo for years (e.g., “gluten-free,” “non-GMO,” refrigeration statements). Navigating this regulatory landscape can present a challenge for food companies.

Food products whose labels do not comply with FDA regulations may be deemed misbranded and risk detention and outright refusal by the agency. FDA recently announced, “Labeling problems accounted for 68 percent of food recalls, including 34 percent of recalls due to undeclared major food allergens.”[1] FDA Detentions are expensive and disrupt a company’s supply chain, often resulting in a loss of customers and financial revenue. Class action lawsuits against food companies for misleading nutrition claims are also on the rise. Even large companies such as Heinz, PepsiCo, and ConAgra have not been immune.

Companies may avoid an expensive lawsuit or costly detentions by ensuring their product labels comply with FDA regulations. Registrar Corp assists clients in navigating the tangled web of FDA regulatory compliance. Registrar Corp’s label review service provides detailed analysis of product labeling to ensure that each label incorporates the numerous regulations that govern the format and content of food labels.
If you have any question about food labeling requirements or any FDA regulation, please contact Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or call us at +1-757-244-0177.

 


[1] “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food.” Office of Federal Register, 4 Jan. 2013. Web. 8 Jan. 2013. <http://www.ofr.gov/OFRUpload/OFRData/2013-00125_PI.pdf>.

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Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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