Dietary Supplement Label Requirements

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Dietary supplement label requirements. In our industry one of the most important components of any successful labeling and package design effort is fda compliance. 21 cfr 101 36 b 1 i how does supplement facts differ from. Or dietary substance used to.

Most important is that fda requires a supplements facts panel on all dietary supplement products. The initial nutrition labeling requirements for dietary supplements were promulgated by the food and drug administration fda in 1999. Without it your supplement cannot be sold in the us.

When a nutritional supplement provides 225 or more calories per serving requirements include a specified amount and quality of protein a maximum amount of fat a minimum amount of linoleic and n 3 linolenic acids with a ratio of linoleic acid to n 3 linolenic acid between 4 1 and 10 1 and a specified amount of various vitamins and mineral. First what is a dietary supplement. Almost two decades later on may 27 2016 fda published a final rule revising the nutrition labeling requirements for foods and dietary supplements.

More recent regulations require manufacturers to observe good manufacturing practices gmps established for this industry including ingredient testing. The dietary supplement health and education act of 1994 the dshea amended the act in part by defining dietary supplements adding specific labeling requirements for dietary supplements and. 1 the statement of identity name of the dietary supplement 2 the net quantity of contents statement amount of the dietary supplement 3 the nutrition labeling.

According to the fda website the federal food drug and cosmetic act defines a dietary ingredient as a vitamin. To ensure your current labels are compliant here are the requirements for marketing and labeling dietary supplements. Congress established the dietary supplement health and education act dshea in 1994 to create a regulatory framework to address the safety and labeling of dietary supplements.

Indeed ensuring that all information concerning that particular dietary supplement is in compliance with fda labeling requirements may be difficult and often very onerous. Fda labeling is one of the most important regulatory requirements for dietary supplements in that it provides the consumer the necessary information on the product. So what are the dietary supplement label requirements for fda compliance.