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
how can i get an NDC number for a dietary supplement for insurance refund ?
Dear Tom,
NDC number denotes National Drug Code, which is only for drugs, you cannot apply and NDC Number for a dietary supplement. Please visit https://www.fdahelp.us/fda-labeler-code.html to know more about NDC Labeler code assignment https://www.fdahelp.us/fda-labeler-code.html
how can i get fda approval for coconut oil supplement ?
FDA is not approving dietary supplements, if this is not a new dietary ingredient, you can start marketing after make sure, your labels are in compliance with FDA regulations, issue prior notice, comply with GMP etc..
after completing FDA registration, can i get a registration certificate as a proof of FDA registration ?
Sure, LMG will issue free FDA registration certificate as a proof of FDA registration to the industry. you can complete our online form for fda food facility registration at https://www.fdahelp.us/food-form.html
how much is your fees for FDA registration for a food facility ?
LMG fees for US FDA registration and US FDA Agent service is USD 349/year.
how much is the FDA fees for dietary supplement registration ?
there is no FDA fees for Dietary supplement facility registration, LMG fees for US FDA Agent service and FDA dietary supplement facility registration is USD 349/year for a foreign facility.
I am planning to market coconut products (including chocolate coated coconut candy ) in the USA, the manufacturer is in Sri Lanka. who need to get the FDA approval ? the Sri Lanka manufacturer or my company in the USA ? Do i need to get fda approval for each product or the company ?
Food products does not require FDA approval, instead you need to register your manufacturing / processing facilities with FDA. If the importer is having a warehouse, the warehouse must register with fda as a holding facility. if you are storing the product at your home, you cannot register your home as a facility with FDA.
is there a list of FDA approved dietary ingredients or list of dietary ingredients not allowed ?
There is no approved dietary ingredient list, but there is an advisory list of dietary ingredients which FDA recommend not to use.