FDA Reader
Simplifying Food Regulation


FDA Reader: Simplifying Food Regulation

Posts tagged nutrient facts
Food Labeling Errors That Can Cost You Your Business
3 Food Labeling Mistakes blog post image.png

Food Labeling Errors That Can Cost You Your Business*

*and how to avoid them

Designing a food label can be a daunting task for an entrepreneur bringing a new product to market. Even after you check the boxes for nutrition facts, product claims, and display requirements, you still have to make it work with your packaging design. But if you don’t have time to make sure your label is 100% compliant with every last regulation, then at least avoid the following mistakes — they could cost you your business.

1. Undisclosed Allergens

Many FDA food recalls are related to undeclared allergens. This typically is the result of two easily-avoidable mistakes: (1) the ingredients listing on the package doesn’t match the product in the packaging and (2) The allergens in the product are not displayed prominently to the consumer.

How to Avoid This Mistake: Make sure your ingredients list is complete and that you are identifying any of the Big 8 allergens using an Allergen statement, such as “contains peanuts”.

Who Cares? The FDA, the person you made sick. 

Likelihood of Discovery: High. Food allergies are common and undeclared allergens tend to get discovered when a consumer has an allergic reaction to the product, despite having checked the label first.

What it will cost you: Because of the potentially life threatening nature of an allergic reaction to food, food manufacturers typically conduct an immediate, voluntary recall of all effected products.

2. Unauthorized Health Claims

There are clearly defined rules when it comes to the types of claims you can make about a food product’s effect on the consumer’s health. The easiest way to guarantee the wrath of the FDA and a swift food recall is to make an-unauthorized health claim or drug claim. This means making a claim about how the product or one of its ingredients affects your body or provides some sort of therapeutic affect. It is unlawful to make this type of claim on the product label itself but also on marketing materials (e.g. the company website), even if you have scientific evidence to back it up.

While the FDA has approved a small number of Authorized health claims approved for use, there are only twelve of them, plus a handful of weakly phrased qualified health claims.

How to Avoid This Mistake: Do not make any unauthorized claim about your product’s effect on the body or treatment of any ailment. Make sure any claims related to nutrition or the benefits of specific ingredients align with the regulation

Who Cares? The FDA. Here’s why: let’s say you claim that the high levels of antioxidants in your popular snack bar has been shown to support immune health in cancer patients. If cancer patients forsake treatment measures in favor of your snack bar, this could have negative public health outcomes. Major retailers will also pull these products from their shelves if they don’t discover this error before they place their order.

Likelihood of Discovery: High. Claims are typically printed prominently to get the consumer’s attention. This also means getting the attention of regulators and savvy consumers.

What it will cost you: All of the products and materials containing the unauthorized claim, possibility of brand damage and the possibility of expensive lawsuits from customers who suffered damages due to this claim..

3. No Standard of Identity (or a misleading one)

FDA labeling requirements clearly require most packaged foods to declare what the product is. This is why a Tostito’s label must clarify that the product is Tortilla Chips and Nutella must describe itself as Hazelnut Spread. While there is a great deal of controversy and open questions surrounding naming conventions for milk-alternatives and meat-alternatives, this isn’t the case for most products.

How to Avoid This Mistake: Include the common name for your product on the front label.

Who Cares? Major retailers who don’t want to be held accountable for carrying a product which could be construed as misleading.

Likelihood of Discovery: Medium-High. It may not be discovered initially, but eventually someone will notice. Typically, a failure to disclose a product’s Standard of Identity doesn’t have negative health implications for the consumer, it’s just mildly confusing, an infraction which rates lower on the FDA’s list of priorities. It’s more likely that a wholesale purchaser or retailer will find issue with this labeling error than the FDA.

What it will cost you: Mainstream retailers may refuse to carry the product until this issue is remedied.

4. Undeclared Ingredients

Even when there’s no allergen implications, the discovery of an undeclared ingredient in a product can bring public outrage to a boil and even lead to a food scare. Quite simply, consumers don’t like finding out that they have been lied to, particularly about what’s in their food.

How to Avoid This Mistake: Work with trusty suppliers and conduct supplier verification activities so you can have confidence in the ingredients you purchase. Make sure that your food labels and ingredients reflect changes made to the product formula.

Who Cares? Your most loyal customers; Twitter.

Likelihood of Discovery: Low-Medium. Using the final few rolls of old food labels after a slight change in product formulation will likely go unnoticed. The deliberate, ongoing failure to accurately convey ingredient composition is more common than we know. Large-scale food fraud can go undetected for years before being uncovered and technology is sometimes altogether incapable of detecting when ingredients are replaced with a cheaper alternative.

What it will cost you: The ongoing failure to accurately declare ingredient composition could result in lawsuits, fines, and total destruction of your brand.

Nutrient Content Claims

What You Need to Know:

A Nutrient Content Claim is a claim that characterizes the level of a nutrient in the food. 

This is different than information listed in the Nutrition Information Panel. Any claims made about nutrition outside of the Nutrition Information Panel would be considered Nutrient Content Claims. Some basic requirements:

  • You can't make claims that could be misleading in any way.

  • Terms like "low-fat" or "sugar-free" have specific nutritional thresholds.

  • Most terms related to nutrition content claims are regulated (and the guidelines are below). If a nutrient content claim is not regulated then it does not mean you are allowed to make that claim.

What You Need to Do:

  • Comply with the guidelines below.

  • Make sure your label is aligned with formatting guidelines in §101.13. (I have not listed these in detail)

  • Keep records to verify any nutrient content claims that you make (including test results)

Types of Nutrient Content Claims:

Implied Nutrient Claim

Describes the food or ingredient in a manner that suggests that a nutrient is present or absent in a certain amount. An implied nutrient claim may also suggest that the food may be useful in maintaining a healthy diet.

  • "high in oat bran"

Expressed Nutrient Claim

An expressed nutrient claim is a direct statement about the level of nutrients in a food.

  • "low sodium"

  • "high protein"

  • "contains 100 calories"

High Content Disclosures

Foods that contain an extremely high amount of one or more nutrients per serving must disclose this on the product label. The threshold is:

  • >13g fat per serving

  • 4.0g of saturated fat

  • 60mg of cholesterol

  • 480mg of sodium

  • These products must have the following statement: "See nutrition information for ___ content" (insert the applicable ingredient). This must be displayed clearly in bold type and no smaller than the "Net Quantity of Contents claim" on the packaging.

  • This requirement does not apply to the following types of foods:

    • infant foods or foods for children under 2 yrs

    • meal products (defined in §101.13 (l))

    • main dish products (defined in §101.13 (m))

See Subpart A 101.13 (h)

Nutrient Level Statements

You may make a statement about the amount or percentage of a nutrient in a serving. For example "less than 3g of fat per serving". Some conditions apply:

  • If the statement characterizes the level of the nutrient as low, but the amount is not actually low, then this must be clarified. For example, if you wanted to say "only 10g of fat per serving" then you would have to additionally state "not a low fat food". This is because 10g of fat is not a low amount of fat for a single serving.

  • Similar to above, if a statement characterizes the level of an ingredient as high but the amount is not actually high, then this must be clarified. For example, You wanted to say, "Contains at least 25mg of protein per serving", then you would have to additionally state "not a significant source of protein" because 25mg is not a significant amount of protein.

  • If the quantity is not characterized in any way (by using a word like "only", then you may simply state the quantity of the nutrient in the food without any disclaimer. For example, "150 calories" or "4g of fat"

Source Subpart A 101.13 (i)

Relative Claims

Relative claims are claims that compare the nutrient level to another reference food. These claims are allowed to use terms such as "light" "reduced" "fewer" "less" and "more". Some considerations when making relative claims:

  • For claims making "less" "fewer" or "more" claims, you may compare the product to the same product (i.e. potato chips to potato chips) or to different product that is part of the same category (i.e. orange juice as a reference for vitamin C tablets).

  • You can also compare to a similar product produced by another brand. If you are comparing to another brand, that brand must be widely available.

  • For claims using the words "light" "added" "reduced" "extra" "plus" "fortified" or "enriched", you must compare similar food products (i.e. your orange juice to another orange juice product)

  • For claims using the word "light" or any other claims, the referenced food must represent the general category of products in that claim. In other words, if you are comparing to a specific brand of lemonade, the brand you are comparing to should be nutritionally representative of lemonades overall.

  • The claim include a comparison of the nutrient amounts in both products in quantitative, clear and concise language.

  • You cannot make a relative claim for lower levels of a nutrient in your product if the referenced product itself meets the requirement for a "low" claim (i.e. 3g of fat or less per serving).

Vitamin and Mineral Claims

You may make claims about vitamin or mineral contents that reference the reference daily intake (RDI) without any special disclaimers. For example "Contains 100% Vitamin C " is allowed.

If you wish to make a claim for a vitamin or mineral content for which there is no reference daily intake (i.e. recommended daily value), you may do so. 


  • Nutrient content claims must be less than 2x the size of the statement of identity (common name of the product) and must be in a prominent and clear type.

Specific Nutrient Content Claim Requirements

Calorie Content Claims (i.e. "Calorie-free" "low calorie")

You may make nutrient content claims about the calorie contents of food.

"Calorie Free" Claims

 For terms such as "calorie free", no calories" "zero calories",

  • The foods must contain less than 5 calories per typical serving amount.

  • If the food naturally meets this condition without any special processing, then this must be described. For example "cider vinegar, a calorie-free-food"

"Low Calorie" Claims

For the terms "low calorie" "few calories" or "low source of calories",

  • The food must have a serving size of >30grams and has fewer than 40 calories per serving. The reasoning here is that you can't make the portion size very small and then claim the product has "low calories per serving".

  • If the food naturally meets this condition without any special processing, then this must be described. For example "celery, a low-calorie-food"

"Reduced Calorie" Claims

For the terms "reduced calorie" or "fewer calories" or "lower calories",

  • The food must contains at least 25% fewer calories than the reference food (this is a relative claim)

  • This claim cannot be made if the referenced product meets the definition for "low calorie"

Sugar Content Claims

Use of the terms "sugar free" "no sugar" "zero sugar" is allowed if:

  • The product contains less than 0.5g of sugar per serving

  • The product contains no ingredient that is a sugar or contains sugars, unless this is explained in the ingredients section

  • It either is labeled as "low calorie"/"reduced calorie" or "not a reduced calorie food"/"not for weight control". The rationale here is that consumers expect sugar-free foods to be low calorie, so this must be specified.

"No Added Sugar" Claims

"No Added Sugar" claims are allowed if:

  • No sugars have been added in processing or production.

  • No ingredients contains added sugars (such as jam or fruit juice)

  • The food it resembles and which it is substituting as a "no added sugar alternative" typically contains added sugars.

  • The product bears a statement that the food is not "low calorie" or calorie reduced" unless the product meets that requirements. Again, the rationale here is that consumers expect added-sugar-free foods to be low calorie, so this must be clarified if it is not true.

"Reduced Sugar" "Lower Sugar" Claims

  • The food must contains at least 25% less sugar than the reference food (this is a relative claim)

Fiber Content Claims

If you make a fiber claim, then you must also disclose the level of fat in a serving, unless the product meets the definition of a low fat food (see below)

See Subpart A -- 101.54 (d) for more details

Specific Wording Requirements

"Low" or "Free" Claims:

  • You may only use the terms "low" or "free" (i.e. "fat free" or "low sodium") when you have specifically processed the food to lower the amount of that nutrient or you not included that nutrient in the formulation of the food

    • A claim of "low sodium potato chips" may be achieved by not adding salt to the chips, since potato chips typically contain salt

    • A claim of "Fat-free peanut butter" may be achieved by a process that removes fat from the peanut butter.

    • If the product inherently lacks a nutrient and it has not been specifically processed to remove that nutrient, then you must clarify that the claim refers to all foods of that type and not simply to your particular product.

See Subpart A 101.13 (e)

"High" or "Rich in" Claims:

You may use these terms if the food contains 20% or more of the Daily-Recommended-Value (DRV) in the amount that is typically consumed.

If the product is a "meal product" containing multiple foods, then you must identify which food is the subject of this claim (i.e. the serving of cauliflower in this product is high in vitamin C)

See Subpart A -- 101.54 (b) for more details

"Good Source" or "Contains"or "Provides" Claims

You may use the terms "good source" "contains" or "provides" if the food contains 10-19% of the Daily-Recommended-Value (DRV) in the amount that is typically consumed.

If the product is a "meal product" containing multiple foods, then you must identify which food is the subject of this claim (i.e. the serving of yams in this product is a 'good source' of fiber)

See Subpart A -- 101.54 (c) for more details

"More" or "Added" or "Extra" Claims

Relative Claims that contain the words "more", "fortified", "enriched", "added", "extra", and "plus" may be used to describe the following:

  • protein content

  • vitamins or mineral content

  • dietary fiber content

  • potassium

The product of the claim must have >10% more of the recommended intake than the referenced product in the claim. All other requirements for relative claims apply (see above).

See Subpart A -- 101.54 (e)

"High Potency" Claims

When Used to Describe Vitamins & Minerals:This claim may be used to describe vitamins and minerals where the product contains 100% or more of the recommended daily intake for that vitamin or mineral.

 For example "Contains botanical X with high-potency vitamin C")

When Used to Describe a Product: "High Potency" claims may be used to describe a product if it contains 100% or more of the daily intake for 2/3 of the vitamins and minerals listed in the RDI which are present at 2% or more in the product.

See Subpart A -- 101.54 (f)

"Light" or "Lite" Claims

These claims may be made if one of the following criteria are met:

The food gets 50% or more of its calories from fat and its fat content is reduced by 50% or more as compared to a similarly reference food (see relative claims).


The food derives less than 50% of its calories from fat and the number of calories is reduced by 1/3 when compared to a reference food (see relative claims).


The food's fat content is reduced by 50% or more when compared to a referenced food (see relative claims).

See Subpart A -- 101.56

"Antioxidant" Claims

You may make a claim about the antioxidant nutrients present in a food insofar as:

  • A recommended daily intake (RDI) has been established for each of the nutrients that are the basis for the claim.

  • The nutrients subject to the claim have recognized, scientific antioxidant activity.

  • The level of each nutrient in the claim must be high enough to qualify for either a "more" "good source of" or "high" claim.

  • The specific nutrients which are the basis for the antioxidant claim must be referenced where the claim is made and again where that specific nutrient is listed.

See Subpart A -- 101.54 (g)


Your product may be subject to additional regulations if you produce one of the following foods.

  • dietary supplements

  • infant foods

  • imitation foods

  • Medical foods

  • "meal products"

  • "main dish products"

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.