Dietary supplements are regulated by FDA as special foods.
A dietary supplement is a product, taken by mouth, that contains a dietary ingredient intended to supplement the human diet. The DSHEA defines an ingredient, as dietary ingredient if it is one or a combination of the following substances; vitamins, minerals, herbs, amino acids, enzymes, extracts, or concentrates.
Under the DSHEA, it is the responsibility of the manufacturer of a dietary supplement to ensure that their product is safe before marketing in US.
FDA considers any dietary ingredient to be a New Dietary Ingredient if it was not marketed in the US as a dietary supplement before October 15, 1994. Such an ingredient cannot be used legally in a dietary supplement until the manufacturer or distributor submits an NDI (New Ingredient Notification) to FDA, at least 75 days before marketing this dietary supplement. An NDI includes details of what the dietary ingredient is and the history of its use or other evidence establishing that it can reasonably be expected to be safe.
For marketing dietary supplements in US, all dietary supplement facilities must beFDA registered and ensure that the product labels are compliant with FDA regulations. Foreign facilities are also required to designate a US Agent for FDA communications.
FDA has detailed labeling requirements specific to dietary supplements. Supplements are not permitted to make claims implying their use for the purpose of treating, diagnosing, preventing, or curing diseases.
Foreign dietary supplement facilities must also file a Prior Notice with FDA before their shipment enters US. Failure to issue a Prior Notice will result in detainment of shipment.
Liberty Management Group LTD is one of the leading FDA consulting group in the USA. LMG provides assistance with Registration, US Agent Service, Prior Notice, Label Review and many more FDA regulations.
Namrata
FDA Regulatory Consultant
support@libertymanagement.us
Published on: January 16, 2019