FDA Reader
Simplifying Food Regulation


FDA Reader: Simplifying Food Regulation

Posts tagged nutritional label
Exemption from Nutrition Labeling Requirements

Small Business Exemptions:

Businesses/products that fulfill the criteria below may be exempt from the requirements for Nutritional Labeling described in Subpart A 101.9

Exemption Possibility #1: 

A business who makes sales to a consumer (can be a retailer) who:

- Conducts no more than $500,000 in annual gross sales of all products OR

- Conducts no more than $50,000 in annual gross sales of food products.

The food products exempt from labeling must not make any nutrition claims in the product or advertisement of it.

Exemption Possibility #2: 

Low Volume Exemption: A business with fewer than 100 full time employees and fewer than 100,000 units sold in the US (for the preceding 12 months) may be exempt from certain labeling requirements.

The exempt food labels or product advertising may not provide any nutrition information or make a nutrient content claim or health claim.

Source 101.9 (j) Labeling Exemptions

How to Register a Small Business Labeling Exemption:

If the exempt business is not an importer and sells fewer than 10,000 units annually, there is no requirement for registering the exemption.

If the business does not meet the above criteria, then you must file for the exemption each year. You can do this online  or by submitting this form by mail/fax

Foods that are Exempt From Labeling Requirements:

The following foods are exempt from labeling requirements. There is no registration filing required associated with the food-based exemptions below.

  • Raw fruits

  • Vegetables

  • Fish

  • Dietary Supplements (they are regulated under §101.36)

  • Certain egg cartons

  • Infant Formula and foods for children up to 4 yrs of age (modified requirements apply)

  • Foods that contain insignificant amounts of all nutrients required to be in a nutrition panel (i.e. coffee beans, tea leaves, spices, flavor extracts, food colors,)

  • Packaged single-ingredient meat products that are FDA-regulated (i.e. deer, bison, rabbit, quail, wild turkey, ostrich)

  • Foods in small packages that have a total surface area of <12 sq inches

  • Foods served or delivered for immediate consumption

  • Food that is served in bulk containers at a retail establishment. The retail establishment must include the ingredients listing on a card or sign, if not on the bulk container itself.

  • Foods that are prepared inside a retail establishment and only sold in that establishment (i.e. foods processed and sold onsite by independent delis, bakeries, or salad bars)

  • Ingredients that are added to a food for an effect in processing but are present in the finished product at insignificant levels.

  • Some products that are being transported to another facility where they will be processed, packed, or labeled.

Nutrition Facts Labeling

The Scoop: There are very specific requirements for expressing nutrition information on food packaging. Use an online label generator.

What You Need to Know

  • The FDA regulates nutritional information panels, their formats, and requirements.

  • Nearly all packaged products require nutrition information although exemptions do exist

  • You can calculate the nutrition contents of a food using an online nutrition calculator or via a lab analysis of a food sample.

  • The requirements for nutrition labels may vary depending on:

    • Food package size

    • Claims made about the product, its ingredients, and health benefits

New Rule on Nutrition Information Panels

Key Changes in Nutrition Information

In 2016, the FDA updated the requirements for nutrition information panels on foods. The changes include

  • Changing the "Serving Size" to reflect how much someone customarily eats, not how much someone should eat

  • Calories are now in larger and bolder type

  • "Added Sugars" are now required to be included on the label

  • Listings of Vitamin D and Potassium are required

  • Actual amounts must be present for

  • Removal of the "Calories from fat" label requirement

  • Removal of the requirement for Vitamin C and Vitamin A

When Do New Labeling Requirements Take Effect?

Businesses with >$10 million in Annual Food Sales: January 1st 2020 

Businesses with <$10 million in Annual Food Sales: January 1st, 2021.

Components of a Nutrition Information Label:

Serving Size

The serving size must closely equate to the amount that is customarily eaten. This must be expressed in common household measures (i.e. cups, oz, tsp) and include the equivalent metric quantity in parentheses.

Nutrient Components:

The nutrition information label must include some mandatory components (i.e. calories, fat) and may include other voluntary components (vitamin A). No other declarations of nutrition information is allowed on the label, other than those listed below:

Mandatory Nutrient Components

  • Calories

  • "Fat" or "Total Fat"

    • Saturated Fat

    • Trans Fat

    • "Cholesterol"

    • "Sodium"

    • "Total Carbohydrate"

      • "Dietary Fiber"

      • "Total Sugars"

      • "Added Sugars"

      • "Protein

Voluntary Nutrient Components

  • "Calories from saturated fat"

  • "Fluoride"

  • "Soluble Fiber"

  • "Insoluble Fiber"

  • "Sugar Alcohol"

There are specific requirements for how these nutritional elements be described, particularly when there is a small amount of them. This information can be found in 101.9 (c)

Vitamins, Minerals and Macronutrients

The following vitamins and minerals are required on the nutritional label "Supplemental Facts" section. They must be measured in terms of percentage of daily value and weight.

The minimum requirement is listed below (must be listed in this order):

  • Vitamin D,

  • Calcium

  • Iron

  • Potassium

When additional vitamins and minerals are listed, the following order should be preserved:

Vitamins (listed in order)

  • Vitamin A

  • Vitamin C

  • Vitamin D

  • Vitamin E

  • Vitamin K

  • Thiamin

  • Riboflavin

  • Niacin

  • Vitamin B6

  • Folate

  • Vitamin B12

  • Biotin

  • Pantothenic Acid

  • Choline

Macronutrients & Minerals (In order)

  • Calcium

  • Iron

  • Phosphorus

  • Iodine

  • Magnesium

  • Zinc

  • Selenium

  • Copper

  • Manganese

  • Chromium

  • Molybdenum

  • Chloride

  • Potassium

Vitamins and minerals must appear in the label if:

  • They appear in a serving of the product

  • When they are added as a nutrient supplement

  • When a claim is made about them

However, non-required vitamins and minerals  may be excluded if:

  • Neither the nutrient nor component are referred to on the label or advertising of the product

  • If they appear in the product solely for technological purposes

Note that other vitamins and minerals may be required or permitted on the label of standardized foods (i.e. foods that have a specific definition under the FDA Standards of Identity).S

How to Make an FDA Compliant Nutrition Information Label


FDA Aligned Nutritional Label (New Rule)

  1. Have a final product: It is important that you are producing your product consistently and with the same ingredients so that the nutritional label you generate is accurate.

  2. Determine the nutritional contents of your product: You can do this in one of several ways:

    • Conduct your own nutritional analysis using an online nutrition calculator. Google it or try Spark Recipes (This may not be the best one, it's the first one I found)

    • Have your product tested by a laboratory (EMSL is a nationwide provider that can do nutritional analysis)

    • Note: If the FDA tests your product due to a complaint or concern, they will conduct a nutritional analysis on 12 samples from 12 different cases.

  3. Build a nutritional panel and align with the formatting guidelines:

    • The lab or online calculator may generate one for you automatically. If so, confirm it is aligned with the new nutritional facts rule (the easy way to tell is that the "calories" section is in a larger font). It should align with all of the standards listed above.

    • If you'd like to design your own, consider the image below for guidance.

Update your nutritional panel every time you make a change to the recipe or the ingredients: Additionally, you may have to change the nutritional panel if you decide to make a health claim in your advertising or on the product label.

Looking for Something Else?

Information about labeling "variety packs" and separately packaged foods sold in one box is available in section  101.9 (11) (h)