Dietary Supplement Notifications

A Dietary Supplement is intended to provide nutrients, such as vitamins, minerals, fatty acids or amino acids that are missing or are not consumed in sufficient quantity in a person's diet. Some countries define dietary supplements as foods, while in others they are defined as drugs. Dietary supplements are regulated as foods, not as drugs. While pharmaceutical companies are required to obtain FDA approval proving the safety or effectiveness of their products prior to their entry into the market, dietary supplements, like food, do not need to be pre-approved by FDA before they can enter the market. However, it is mandatory that you submit a notification to FDA of your product within 30 days of first marketing your product. 

We have solutions for every type of client. If you are simply starting up or contemplating a new venture and would like to know the regulations, laws, timeframes and possible pitfalls, talk to us. If you are a multi-national firm that has completed this process hundreds of times before, we can help you as well. The ever-changing laws surrounding consumer goods such as Food, Dietary Supplements, Drugs and Cosmetics requires people that stay on top of all of the changes and proactively counsel with clients to ensure top profitability and lowest amount of downtime.

FDA Imports.com, LLC is a full-service regulatory consulting firm with consultants and affiliated attorneys with substantial experience in the field of dietary supplements. Let us show you “the way through” and show you how well the process can work when you have the right people backing up all decision-making.