Labeling of Nutritional Products & Dietary Supplements

A food labeling guide has been set for the industry by the Office of Nutritional Products, Labeling and Dietary Supplements in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration. This guide is updated frequently and it is essentially up to the manufacturer to stay current with the regulatory updates found in the Federal Register.
Nutritional product is a broad term of what some may use interchangeably with a dietary supplement, a conventional food with a health claim or a medical food. Most regulated food and supplement products fall under these categories. There is ample information provided by the FDA relating to the labeling, safety and regulation of these products. There has been a recent effort by the FDA to regulate dietary supplements and health claims on conventional foods. This is in effect to establish safe manufacturing processes and ensure that concise health information is communicated to consumers.

Background

• The labeling of dietary supplements is somewhat different from the labeling laws and regulations of conventional foods. Conventional foods are referred to by the FDA as "prepared foods, such as breads, cereals, canned and frozen foods, snacks, desserts, drinks, etc," which must contain a food label. Nutrition labeling for raw produce and fish is voluntary. The term "dietary supplement" was defined by congress as a product taken orally to supplement the diet and must contain a "dietary ingredient," which may be a combination of "vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites." A dietary supplement can be seen in forms such as capsules, powders, liquids and bars. In 1994, the Dietary Supplement Health and Education Act (DSHEA) was an amendment to the previously followed Federal Food, Drug, and Cosmetic Act for regulation. Dietary supplements containing a "dietary ingredient" would no longer need FDA approval before marketing. The manufacturer would be responsible for product safety and product claims. However, once a dietary supplement is on the market, the FDA works with the Federal Trade Commission to monitor the safety and advertising of dietary supplements.

Current Regulations

• The most current regulation of dietary supplements was issued by the U.S. Food and Drug Administration. The final rule requires current good manufacturing practices (cGMPs) of dietary supplements. The rule applies to all domestic and foreign producers of dietary supplements. This will ensure that quality standards are met and products are processed consistently. By June 2010 all producers, small and large, of dietary supplements will be required to follow proper procedures to meet current good manufacturing practices. A voluntary testing program that verifies the quality, purity, and potency of dietary supplements has been put in place by U.S. Pharmacopeia. This voluntary program also ensures cGMPs are followed. The USP stamp can be displayed on the label of the dietary supplement utilizing this program.

Dietary Supplement Labels

• There are certain requirements set by the U.S. Food and Drug Administration that must be present on the label of a dietary supplement. The label must state that the product is a supplement, along with a descriptive name for the product. The business name and address of the manufacturer, packer or distributor must be present. The label must contain a complete list of ingredients and net contents. The "Supplement Facts Panel" must contain a list of each dietary ingredient in the product.

Health Claims

• All health and nutrient claims on conventional labels must meet the definition set by the FDA. Such as, for a product label claiming low-sodium, the product must contain less than 140 mg of sodium per serving.
  Health claims on dietary supplements must not claim to cure or treat a disease. They can display an effect the supplement has on maintaining the bodies' normal function. When a supplement claims to promote health, it must use a disclaimer as set by the FDA stated as, "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent disease."

Warnings

• The bottom line is that the FDA, along with other regulatory agencies, are doing their best to monitor food and supplement labeling. However, it is also recommended that the consumer be aware and take precautions when shopping for dietary supplements. Be ware of labeling claims that sound too good to be true, be cautious when the percent daily value (%DV) for certain vitamins and minerals well exceed 100 percent, and look for a reputable name brand. When you are confused about a product label, be sure to consult with a health care provider.