Nutritional Supplements and Their Labeling Requirements
The supplement market is a booming industry. According to researchers at the Department of Health and Human Services offices, approximately three out of four Americans use at least one dietary supplement product on a regular basis. Uniform labeling and packaging requirements help consumers make informed and safe decisions. Before you start shopping for a new dietary product, take the time to learn about labeling and packaging requirements. Armed with this information, you will be a smarter, savvier, shopper who is better prepared to find the right products to support your nutritional needs.
General Supplement Labeling Requirements
In the United States, supplement labels are regulated by the Federal Drug Administration. Section 201(ff) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) defines a dietary supplement as a product intended for food consumption and to act as a supplement to other food items. They may contain one or more of the following ingredients:
- Vitamins or minerals
- Amino acids
- Botanicals or herbs
- Other supplemental ingredients such as metabolites, extracts or concentrates
The FDA provides recommendations and guidance on what products are considered nutritional or dietary supplements as well as what information must be included on supplement labels, how it should be presented and where it should be located. As a general rule, all supplement product labels should have a principal display panel and an information panel.
Key Information on Supplements Labels
There are five main pieces of information that are required on all nutritional supplement labels. Combined, they provide valuable insight into the product.
Statement of Identity
This is simply a listing of the product's name. It should be placed prominently on the label and in a manner that makes it easy to read and understand.
Net Quantity of Contents
This tells shoppers how much total product is in the package. It may be a number of pills, packets or, as is the case for those choosing the Thrive experience, transdermal patches.
Nutritional information must be provided for all dietary supplements. This takes the form of a "Supplement Facts" panel that looks like the nutritional label you would generally find on a food product. These panels contain valuable information about exact units of each vitamin, mineral or other nutritional supplement provided in the product. Each item should be listed individually and be clearly marked with a standard unit of measurement. Where there is a recommended daily intake amount of a specific nutrient, the contents in a standard dose may be listed as a percentage of that amount.
All supplement ingredients must be disclosed on the label. As with many health products and medications, these are often broken down into active and inactive lists.
The business name and location for supplements manufacturers, packers or distributors must also be placed in an easily identifiable location on the label.
Other Labeling Information
There are a few other considerations in nutritional labeling. One of those concerns what are called new dietary ingredients. The FDA requires that manufacturers submit a premarket notification for any product containing dietary ingredients that were not approved and marketed in the United States prior to October 15, 1994. Any products that contain iron are also subject to strict requirements. Among them is the need for a warning label that reads "WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately."
Claims about products or their ingredients are also closely regulated. Any product claims must be clearly stated and supported on levels. This includes claims such as "no added sugar," "low in calories" or "high potency." Supplement manufacturers are not allowed to make health claims that have not been investigated and substantiated by the FDA. A health claim could be that a supplement prevents or reduces the risk of a certain disease. Organic products and claims about that status are overseen by the USDA's National Organic Program.
Supplements are increasingly popular as Americans take more personal control over their health and wellness. Labeling requirements are designed to increase safety and help consumers make informed decisions about which products are best suited to meet their needs.