- 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
ITB HOLDINGS LLC provides the following services to domestic and foreign companies that are manufacturers, exporters, warehouses, importers, or distributors:
■ Foreign Supplier Verification Program
■ U.S. Agent Service
■ Prior Notice
■ Label Design
Unlike drugs, supplements are not intended to treat, diagnose, prevent, or cure diseases. That means supplements should not make claims, such as “reduces pain” or “treats heart disease.”
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).
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.
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.
All Food Facilities must renew their registration between October 1 and December 31, 2022.
- Company Registration
- U.S. Agent Service
Prior Notice, Label Review or Update, FSVP (Foreign Supplier Verification) Importer Service, are available upon request.