FDA regulates both finished dietary supplement products and dietary ingredients. Generally, manufacturers do not need to register their products with FDA or get FDA approval before producing or selling dietary supplements. However, manufacturers must make sure that product label information is truthful and not misleading.

Under FDA regulations all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with testing, quality control, and dietary supplement distribution in the U.S., must comply with the Dietary Supplement Current Good Manufacturing Practices (cGMPs) for quality control.

We prepare:

  • Qualified Health Claim Petitions
  • Structure-Function Claim Notifications and substantiation files
  • New Dietary Ingredient Notifications
  • We also assist clients in the regulatory approval of medical foods

New Dietary Ingredients Notification Process

A dietary ingredient is a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any of the above dietary ingredients.

The term "new dietary ingredient" means a dietary ingredient that was not marketed in the United States in a dietary supplement before October 15, 1994.

If you want to market a "new dietary ingredient" in a dietary supplement, you must be sure that the substance is considered to be a "dietary ingredient."

The Federal Food, Drug, and Cosmetic Act (the act) requires that manufacturers and distributors who wish to market dietary supplements that contain "new dietary ingredients" notify the Food and Drug Administration about these ingredients. Generally, the notification must include information that is the basis on which manufacturers/distributors have concluded that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling.

If you are unsure whether a dietary ingredient is a "new dietary ingredient" under the act you may still submit a notification to us. Regardless of whether you are required to submit a premarket notification, it is your responsibility to ensure that a dietary ingredient used in a dietary supplement is safe.

MEDERA can provide a Free Assessment of how these regulations apply to your particular product. Simply contact us to provide information about your product(s). To receive our free white paper on marketing a healthcare product in U.S., please click here.