A dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. The “dietary ingredients” in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites.
Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, powders or bars.
A “new dietary ingredient” is one that was not sold in the U.S. in a dietary supplement before October 15, 1994. Manufacturers and distributors are responsible for determining if a dietary ingredient is “new”.
Dietary supplements do not need approval from FDA before they are marketed.
Domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are required to register with U.S. Food and Drug Administration (U.S. FDA).
A foreign company or registrant must provide the name, address, and phone number of its U.S. Agent such as ITB HOLDINGS LLC.
The U.S. Food and Drug Administration will not confirm a registration, provide an FDA Registration Number, or provide confirmation of a registration renewal until ITB HOLDINGS LLC confirms it has agreed to serve as U.S. Agent.
Dietary Supplements Facility Registrations cannot be completed without a DUNS Number (Data Universal Numbering System, abbreviated as DUNS or D-U-N-S), which is issued by Dun & Bradstreet, Inc.
Below are specific countries DUNS Number links:
FDA regulates both finished dietary supplement products and dietary ingredients. Consumer survey on dietary supplements revealed that 77 percent of Americans use them.
The agency takes action against any adulterated or misbranded dietary supplement product after it reaches the market.
Dietary supplements imported into the United States must be safe and contain no prohibited ingredients, and all labeling and packaging must be informative and truthful.
All health claims must undergo review by the FDA through a petition process.
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.”
Qualified health claims (QHCs) are supported by scientific evidence, but do not meet the more rigorous “significant scientific agreement” standard required for an authorized health claim.
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.
Information that must be on a dietary supplement label includes: a descriptive name of the product stating that it is a “supplement;” the name and place of business of the manufacturer, packer, or distributor; a complete list of ingredients; and the net contents of the product. In addition, each dietary supplement (except for some small volume products or those produced by eligible small businesses) must have nutrition labeling in the form of a “Supplement Facts” panel. This label must identify each dietary ingredient contained in the product.
- Essential fatty acids (EFAs)
- Branched-chain amino acids (BCAA)
- Fish Oil
- Omega-3 Fatty Acids
- Weight Loss Conjugated Linoleic Acid (CLA)
- Coenzyme Q10 (CoQ10)
- Alpha-Lipoic Acid
- Green Coffee
Then, it must be registered with the United States Food and Drug Administration.
Also, make sure your labels are compliant before you export your products to the U.S.