FDA Reader
Simplifying Food Regulation


FDA Reader: Simplifying Food Regulation

Posts tagged FSMA Requirement
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"

Food Defense and Intentional Adulteration

What You Need to Know:

  • "Intentional Adulteration" refers to the risk of someone deliberately contaminating a food product with aim of causing harm.

  • The Intentional Adulteration Rule was implemented to address bio-terrorism threats committed against food companies to contaminate the US food supply.

  • It applies to some, but not all food businesses (see "Applicability" below)

  • You can fulfill the requirements for a Food Defense Plan using our template


Does the  Final Rule on Intentional Adulteration  Apply to you?

Does the Final Rule on Intentional Adulteration Apply to you?

If you are a business under FDA regulation with >$10m/year in sales, then you most likely are required to comply with the Intentional Adulteration Rule.

Check the exemptions below and, if they do not apply to your businesses, see "What You Need to Do?"

Exemptions from the Intentional Adulteration Rule:

See if one of the following exemptions applies to your business or check out the applicability flowchart below

Does the Intentional Adulteration Rule Apply to My Business?

  • Food businesses that are not regulated by the FDA and aren't required to register as a food facility.

  • Small food businesses that produce, distribute, or hold less than $10 million dollars in product retail value per year, averaged over the last 3 years.

  • Food businesses that exclusively produce one of the following:

    • Licensed alcoholic beverage producers

    • Animal-food producers

    • Food which is packed, re-packed, or re-labeled food in a way that the container around the food remains intact.

    • Food businesses that only hold food, such as a distributor (unless the food is held in large liquid storage tanks).

    • Certain foods packaged on farms (See 21 CFR 121.5)

The FDA offers a flow chart to determine if the Rule on Intentional Adulteration applies to your food business.

Compliance Timeline:

Large Businesses (>500 Employees): July 26th, 2019

Small Businesses (< 500 employees): July 27th, 2020

What You Need To Do:

Access our Free Food Defense Plan Template

If you are required to follow the Intentional Adulteration Rule, then you must develop a Food Defense Plan. This plan documents that you have developed and implemented the following activities:

  1. Conduct a "vulnerability assessment" to identify where your business is vulnerable

  2. Develop "mitigation strategies" for addressing food defense threats.

  3. Monitor your mitigation activities to make sure they're working

  4. Develop corrective actions for when things go wrong

  5. Conduct verification checks

  6. Maintain records

  7. Re-analyze your food defense as necessary

1. Conduct A Vulnerability Assessment

This is a written assessment of what areas your facility and product might be at risk to a threat of intentional adulteration. You should evaluate the following:

  • The potential impact if your product was contaminated

  • The degree of access available to your product

  • The ability of an attacker to contaminate your product

  • The possibility of an inside attacker.

The easiest way to conduct a vulnerability assessment, is to use our Food Defense Plan Template and modify it to suit your business' needs.

Source 21 CFR 121.130

2. Develop Mitigation Strategies

If you identify a vulnerability in your business, then you must address it. Your mitigation strategies could include:

  • Upgrading security around your facility (i.e. adding fencing, upgrading locks, reducing access)

  • Developing a way to record and manage visitors in your facility.

  • Minimizing access to sensitive areas to only the people who require that access.

  • Changing how you store in-process product

  • Upgrading your packaging to minimize opportunity for contamination.

This section must include a written explanation of how your strategy specifically minimizes the risk(s) that you identified in your vulnerability assessment.

3. Monitor Your Mitigation Strategies

You must monitor your food defense efforts to verify that they're effective.

Some of your mitigation strategies may be a simple structural fix (i.e. fencing the facility grounds) while others may require ongoing management (implementing a visitor-access policy).

The strategies that require ongoing maintenance should be monitored to ensure that they are effective. For example, if you implement a visitor-access policy for your facility, then a supervisor should occasionally monitor that guests are wearing the required badge and that the sign-in document that you developed is actually being used.

How often must I monitor my mitigation strategies?

This is your choice. You should monitor your practices which support food defense enough to ensure that they're being performed effectively.

Do I need to keep records of my monitoring?

Yes. All of your monitoring efforts should be recorded. You can do this by keeping "exception records" where the only records kept are to document when the strategy is not working.

4. Develop Corrective Actions For When Things Go Wrong

You must have written corrective action procedures that will guide you in what to do if one of your mitigation strategies fails.

For example, let's pretend your visitor-access policy requires all guests to be checked-in and wear a badge in the processing space. When you develop that food defense strategy, you should also create a corrective-action to answer the question "What do we do if there is an unauthorized person in the production space?". Your corrective action could be registering the visitor and reviewing security footage prior to releasing the product that was being processed.

If something goes wrong in your food defense procedures, you must document that a corrective action was taken and how the problem was solved. Store this in your records.

Additionally, if take a corrective action to address a failure then you must also take action to ensure that the same failure does not recur.

5. Conduct Verification Checks

You must conduct verification activities to confirm that your mitigation strategies are being carried out effectively. This is a "double check" to make sure everything is happening according to plan.

Specifically, you must verify that monitoring is effective and that your corrective actions were taken appropriately. This verification can take the form of a manager reviewing the records that were taken during a given time-period and signing off on them.

A manager may conduct verification on the facility's visitor-access policy by reviewing the visitor registration sheet each week to ensure that it is being used.

How often must I conduct verification checks?

This is up to you. Verification should occur often enough that you can make adjustments if something is found to be wrong. For example, records are typically verified before the relevant product leaves the facility. This way, the product can be inspected or reconsidered if the verification reveals something improper occurred.

Do verification activities need to be written?

Yes. However, it does not need to be a separate form. A manager can verify a document by signature and date showing that the document was reviewed and that verification occurred.

6. Keep Records

Your Food Defense Plan must be written and on file. Additionally, you should keep records of the following for at least 2 years:

  • Monitoring records

  • Corrective Action records

  • Verification Records

  • Any documents related to the food defense plan

  • When your food defense plan was changed or updated

Your records should meet the requirements outlined in Part 117 Subpart F: Record keeping

7. Reanalyze Your Food Defense As Necessary

You must reanalyze your food safety plan:

  • Every 3 years at minimum

  • Whenever a change is made that might expose a new vulnerability or increase your risk of intentional adulteration.

  • If the FDA identifies new vulnerabilities that they deem relevant to your business.

If your business makes a change that requires an adjustment to your food safety plan, you have 90 days to update your plan and implement the new strategies.