Understanding Supplement Labeling Regulations

In the United States, the FDA regulates supplement labels under the Dietary Supplement Health and Education Act (DSHEA). Labels must include product name, quantity, nutrition labeling, ingredient list, and the name and address of the manufacturer or distributor.

Supplement labels must have a Supplement Facts panel. It should list serving size, amount, and percent daily value of each nutrient. Other required elements include net contents, identity statement, and a disclaimer if health claims are made.

The ingredients must be listed in descending order of predominance by weight. This includes active ingredients in a proprietary blend and other ingredients such as fillers, artificial colors, or flavorings.

It's essential to declare any major allergens contained in the supplement, as per the Food Allergen Labeling and Consumer Protection Act. These include milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans.

While not pre-approved by the FDA, any claims on the label must be truthful and not misleading. Evidence to support claims should be available upon request. 'Structure/function' claims must be accompanied by a disclaimer.

Labels should reflect that the product was made following Current Good Manufacturing Practices (CGMPs). This ensures supplements meet quality standards and are free from contaminants or inaccuracies in strength and composition.

Use clear, legible fonts and high-contrast colors for readability. The layout must facilitate easy identification of the product's purpose, directions for use, and health-related information, enhancing consumer understanding and compliance.