Dietary Supplements

As defined by Congress, 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.

Although dietary supplements are regulated by the U.S. Food and Drug Administration (FDA) as foods, they are regulated differently from other foods and from drugs.

If you are exporting dietary supplements into the United States, it is important to find out if your formulation has been sold in the U.S. before October 15, 1994.  If so, your formulation will be presumed safe by the FDA, based on their history of use by humans. Techlink International will search the FDA database for you.

For a new dietary ingredient (one not sold as a dietary supplement before 1994), the manufacturer must notify the FDA of its intent to market a dietary supplement containing the new dietary ingredient, and provide information on how it was determined that reasonable evidence exists for safe human use of the product. The FDA can either refuse to allow new ingredients into or remove existing ingredients from the marketplace for safety reasons. TechLink International can assist you in submitting new ingredients for approval.

The types of claims that can be made on the labels of dietary supplements and drugs differ. Drug manufacturers may claim that their product will diagnose, cure, mitigate, treat, or prevent a disease. Such claims may not legally be made for dietary supplements.

The label of a dietary supplement or food product may contain one of three types of claims: A health claim, nutrient content claim, or structure/function claim.

The label of a dietary supplement product is required to be truthful and not misleading. If the label does not meet this requirement, the FDA may remove the product from the marketplace or take other appropriate actions.

The same regulations apply to websites and any other types of advertising.

Techlink has helped hundreds of companies meet FDA regulatory compliance to sell their dietary supplements in the U.S.

Contact us for more information.