390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | USA
+1 855-510-2240
Supplements
DIETARY SUPPLEMENTS

Before you export any dietary supplements to the United States, register your company with the U.S. Food and Drug Administration, to avoid the detention of your shipment.

DIETARY SUPPLEMENT FACILITY REGISTRATION

ITB HOLDINGS LLC provides the following services to domestic and foreign companies that are manufacturers, exporters, warehouses, importers, or distributors:

Supplement Facility Registration

■ Foreign Supplier Verification Program

■ U.S. Agent Service

■ Prior Notice

■ Label Review

■ Label Design

Most Food Facility Registrations are completed within 72 hours after your payment is received. Same Day Service is also available, when needed and requested.

WHAT A DIETARY SUPPLEMENT IS

A dietary supplement is a product that :

is intended to supplement the diet
contains one or more dietary ingredients (including vitamins; minerals; herbs or other botanicals; amino acids; and other substances) or their constituents
is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and
is labeled on the front panel as being a dietary supplement.

HEALTH CLAIMS

A product sold as a dietary supplement and promoted on its label or in labeling as a treatment, prevention or cure for a specific disease or condition would be considered an unapproved illegal drug.

CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS

All domestic and foreign companies that manufacture, package, label or hold dietary supplement, 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.

CGMP regulations address appropriate personal hygienic practices, design and construction of a food plant and maintenance of plant grounds, plant equipment, sanitary operations, facility sanitation, and production and process controls during the production of food.

Product Complaint involving serious illness or injury

The manufacturer, packer, or distributor whose name appears on the label of a dietary supplement, is required to submit to FDA, all serious adverse event reports associated with use of the dietary supplement in the United States.

“Serious adverse events” result in death, a life-threatening experience, an inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect, or require medical or surgical intervention to prevent such serious outcomes (based on reasonable medical judgment).

Biennial Registration Renewal

All Food Facilities must renew their registration between October 1 and December 31, 2020.