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U.S. FDA Labeling Regulations

The U.S. Federal Food, Drug and Cosmetic Act (FFDCA) defines “labeling” as all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article. The term ‘accompanying’ is interpreted liberally to mean more than physical association with the food product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instructions, websites, etc.

Labeling mistakes result in more than 22% of all detentions in the United States. Registrar Corp helps companies modify their food, medical device, cosmetic or drug labeling to comply with U.S. FDA regulations. Registrar Corp will revise your graphic label and provide a report that details the regulations, compliance guides, warning letters, import alerts, and other guidance documents that necessitated the revisions. Having your labeling reviewed by Registrar Corp can prevent costly errors. To learn how this service would be beneficial for your particular product, simply click on your product type below:

 

Food, Beverage & Supplement Labeling and Ingredients Review

The Nutrition Labeling and Education Act (NLEA), which amended the FFDCA requires most foods to bear specific nutrition and ingredient labeling and requires food, beverage, and dietary supplement labels that bear nutrient content claims and certain health messages to comply with specific requirements. Furthermore, the Dietary Supplement Health and Education Act (DSHEA) amended the FFDCA, in part, by defining “dietary supplements,” adding specific labeling requirements for dietary supplements, and providing for optional labeling statements. Registrar Corp helps companies modify their food, beverage, or dietary supplement labeling to comply with these and other U.S. FDA regulations. To learn how U.S. FDA food, beverage, and dietary supplement labeling regulations apply to your products, simply click the Notice of FDA Action shown on the left.

 

Medical Device Label Reviews and Graphic Design

The U.S. FDA has many labeling-related requirements to help assure that medical devices are used safely and effectively, including, but not limited to, provisions on misbranding in Section 502 of the FFDCA. Such labeling requirements may address adequate instructions for use, servicing instructions, adequate warnings against uses that may be dangerous to health or information that may be necessary for the protection of users. Registrar Corp helps companies modify their medical device labeling to comply with these and other U.S. FDA regulations. To learn how U.S. FDA medical device labeling regulations apply to your products, simply click the Notice of FDA Action shown on the left.

 

Cosmetic Labeling and Ingredient Review

The FFDCA prohibits the distribution of cosmetic products which are adulterated or misbranded. A cosmetic product is considered adulterated if it contains a substance which may make the product harmful to consumers under customary conditions of use or if its labeling claims are false or misleading, if it does not bear the required labeling information, or if the container is made or filled in a deceptive manner. Furthermore, some U.S. States, such as California, have additional labeling requirements. Registrar Corp helps companies modify their cosmetic labeling to help avoid charges of adulteration and misbranding as well as comply with U.S. FDA and State regulations. To learn how cosmetic labeling regulations apply to your products, simply click the Notice of FDA Action shown on the left.

 

Drug Labeling and Ingredient Reviews

The U.S. FDA now requires that drug labels be indexed using Extensible Markup Language (XML) in Structured Product Labeling (SPL) format. Registrar Corp can help modify your drug labeling to comply with U.S. FDA regulations. Registrar Corp provides revised graphic files ready to be printed or edited, and a report that details the regulations, compliance guides, warning letters, import alerts, and other guidance documents from the U.S. FDA. To learn how U.S. FDA drug labeling regulations apply to your products, simply click the Notice of FDA Action shown on the left.





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