Introducing a New Dietary Ingredient
To The Market?

Discovering a new ingredient for a dietary supplement can be exciting. Not only is there a possibility of the ingredient helping consumers, but being the first to market could mean great success for your product line.

However, before you introduce a new ingredient to the market, there are some things you need to know. Namely, you MJST comply with FDA regulations regarding new dietary ingredients. Here’s How…

First, You Must Submit To The FDA a Pre-Market Notification if You:

  • Intend to market a new dietary ingredient
  • Intend to market a supplement containing that ingredient
  • Are a distributor intending to market a new dietary ingredient
  • Are a distributor who intends to market a supplement containing it

This Pre-Market Notification Must Contain

  • Your name and complete address
  • The name of the new ingredient. If it’s an herb or botanical, you must include its Latin name.
  • A description of the dietary supplement that will contain the new ingredient.
  • Descriptions should include the level of the ingredients in the product
  • Conditions of use of the product or suggested in the labeling.
  • If no conditions of use are recommended, ordinary conditions of use and history/evidence of safety showing it is expected to be safe.
  • Published materials and references on the ingredient (translated to English if necessary)
  • The signature of the person responsible for the content of the notification.

Of course, there can be pitfalls when submitting for a new ingredient. It’s why it’s always wise to consult with an FDA compliance attorney before submitting any forms to the FDA.

Bustos Law Group can handle all your compliance issues including new ingredient pre-market notification forms.

Don’t let paperwork prevent you from being first to market with your great new idea. Contact Bustos Law Group today for a free consultation.