FDA REGISTRATION NUMBER
Food labeling is required for most prepared foods.
Changes to the Nutrition Facts and Supplement Facts Label
■ Changes include increasing the type size for “Calories,” “servings per container,” “Serving size” declaration, bolding the number of calories and the “Serving size” declaration.
■ The footnote is changing and must indicate: “*The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.”
■ “added sugars” now included.
■ Vitamins A and C no longer required.
■ Manufacturers with $10 million or more in annual sales must switch to the new label by January 1, 2020.
■ Manufacturers with less than $10 million in annual food sales have until January 1, 2021 to comply.
■ Manufacturers must declare the actual amount, in addition to percent Daily Value of vitamin D, calcium, iron and potassium. They can voluntarily declare the gram amount for other vitamins and minerals.
Nutrition labeling for raw produce (fruits and vegetables) and fish is voluntary.
Unlike drugs, supplements are not intended to treat, diagnose, prevent, or cure diseases.
Five statements are required:
■ Statement of identity (name of the dietary supplement)
■ Net quantity of contents statement (amount of the dietary supplement)
■ Nutrition labeling
■ Ingredient list
■ Name and place of business of the manufacturer, packer, or distributor.
You must list the street address if it is not listed in a current city directory or telephone book, the city or town, the state, and zip code. You may list the address of the principal place of business in lieu of the actual address.
You are required to use a print or type size that is prominent, conspicuous and easy to read.
■ You must list dietary ingredients without RDIs or DRVs in the "Supplement Facts" panel for dietary supplements. You are not permitted to list these ingredients in the "Nutrition Facts" panel for foods.
■ You may list the source of a dietary ingredient in the "Supplement Facts" panel for dietary supplements. You cannot list the source of a dietary ingredient in the "Nutrition Facts" panel for foods.
■ You must include the part of the plant from which a dietary ingredient is derived in the "Supplement Facts" panel for dietary supplements. You are not permitted to list the part of a plant in the "Nutrition Facts" panel for foods.
■ You are not permitted to list "zero" amounts of nutrients in the "Supplement Facts" panel for dietary supplements. You are required to list "zero" amounts of nutrients in the "Nutrition Facts" panel for food.
■ You may use a type size no smaller than 4.5 point for the "Supplement Facts" panel on the labels of small packages.
■ You may use a tabular format on small packages. You also may present "Supplement Facts" information in a linear (string) fashion if the label will not accommodate the "Supplement Facts" panel in a tabular format.
■ On products for children less than 2 years of age, other than infant formula, you must not declare calories from fat, calories from saturated fat, saturated fat, polyunsaturated fat, monounsaturated fat, and cholesterol.
■ On products for children less than 4 years of age, you may not include % DVs for total fat, saturated fat, cholesterol, total carbohydrate, dietary fiber, vitamin K, selenium, manganese, chromium, molybdenum, chloride, sodium, or potassium.
Dietary supplement containing multiple vitamins
Dietary supplement containing multiple vitamins for children and adults
Multiple vitamins in packets
Dietary supplement containing dietary ingredients with and without RDIs and DRVs
You may find FDA regulations for specific claims in 21 CFR 101, Subpart D (Specific Requirements of Nutrient Content Claims):
■ 101.54(b) "High" claims
■ 101.54(c) "Good Source" claims
■ 101.54(e) "More" claims
■ 101.54(f) "High potency" claims
■ 101.54(g) "Antioxidant" claims
■ 101.56 "Light" or "Lite" claims
■ 101.60 "Calorie or Sugar" claims
■ 101.61 "Sodium or Salt" claims
■ 101.62 "Fat, fatty acids, and cholesterol" claims
■ 101.65 Implied nutrient content claims
■ 101.65(d) "Healthy" claims
■ 101.67 Use of nutrient content claims for butter
Exemptions for small businesses and low-volume products are available only if your products' labels bear no claims or other nutrition information.
Monday - Sunday
3:00 AM - 6:00 PM
Eastern Standard Time
Email responses are provided within hours or 30 minutes, not days.
You can always chat with us, 7 days a week, 3:00 AM - 6:00 PM EST.
Dietary Supplements Facilities
Food Canning Establishments
Medical Devices Establishments
Foreign Supplier Verification Program
Initial Importer Service
FDA Detention Assistance
FDA Compliance Service