- 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
You must register your facility if you are the owner, operator, or agent in charge of either a domestic or foreign facility engaged in the manufacturing or processing, packing, or holding of dietary supplements for consumption in the United States, unless your facility qualifies for one of the exemptions.
If you are an owner, operator, or agent in charge of a domestic facility, you must register your facility whether or not the dietary supplements from the facility enters interstate commerce.
A corporation may be authorized to register a facility on behalf of an owner, operator, or agent in charge of that facility.
Facility means any establishment or structure under ownership at one general physical location, that manufactures or processes, packs, or holds dietary supplements for consumption in the United States.
Holding facilities include warehouses, more than 100,000 of which are registered with the FDA, but not yet Amazon.com Inc’s fulfillment centers.
FDA wants to regulate fulfillment centers as food facilities. However, Amazon.com Inc begs to differ. Amazon.com Inc claims to be a retail company, which would exempt its fulfillment centers from registration. The FDA contends that Amazon.com Inc is not selling food and dietary supplements directly to customers, and therefore, is distinct from a grocery store. That is not preventing the FDA from inspecting these fulfillment centers and issuing Warning Letters.
The private residence of an individual is not a facility. Nonbottled water drinking water collection and distribution establishments and their structures are not facilities.
Foreign companies exporting to the United States must identify a United States Agent such as ITB HOLDINGS LLC, during the registration process.
Your company’s business activities in the United States cannot be conducted through the designated U.S. Agent for the purpose of FDA Registration.
ITB HOLDINGS LLC helps businesses comply with U.S. FDA regulations. We make the process very easy. Get the best service your business deserves.
The United States Food and Drug Administration will not issue a registration number until ITB HOLDINGS LLC has confirmed that it has agreed to act as U.S. Agent for a foreign company.
All Food Facilities must renew their registration between October 1 and December 31, 2024.
FDA has canceled Food Facility Registrations that did not provide a valid Unique Facility Identifier (UFI) as part of their FDA Registration. If your registration was invalidated, your company was removed from the registration and listing database.
At this time, the FDA recognizes the DUNS Number as an acceptable UFI for registrations. The DUNS number is assigned and managed by Dun & Bradstreet (D&B) Inc. DUNS numbers can be obtained or confirmed by visiting D&B’s website.
Click, pay, provide the required information, to get started. ITB HOLDINGS LLC will register your facility, as U.S. Agent.
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.
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.”
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.
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).
- Company Registration
- U.S. Agent Service
The Dietary Supplements Market size is projected to reach $220.8 billion by 2027.
Dietary supplements recommendations can be found everywhere on commercials, through social media influencers, and from neighbors, friends, and family.
- More than one-third of Americans take supplements.
- Multivitamin or mineral supplements make up 40% of all vitamin sales.
- The most common supplement contains fish oil, omega 3, DHA, or EPA fatty acids.
- About 30% of adults age 65 and older take 4 or more supplements of any kind.
Dietary supplements are ingested in form of tablets, capsules, soft gels, gel caps, powders, bars, gummies, and liquids. Common supplements include:
- Vitamins (such as multivitamins or individual vitamins like vitamin D and biotin).
- Minerals (such as calcium, magnesium, and iron).
- Botanicals or herbs (such as echinacea and ginger).
- Botanical compounds (such as caffeine and curcumin).
- Amino acids (such as tryptophan and glutamine).
- Live microbials (commonly referred to as “probiotics”).
The FDA does not have the authority to approve dietary supplements for safety and effectiveness, or to approve their labeling, before the supplements are sold to the public. However, the FDA reviews product labels and other labeling information, including websites, to ensure products are appropriately labeled and that they do not include claims that may render the products drugs (claims to treat, diagnose, cure, or prevent diseases).
Under the FD&C Act, it is the responsibility of dietary supplement companies to ensure their products meet the safety standards for dietary supplements and are not otherwise in violation of the law.