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What Are the Current FDA Labeling Requirements and What Happens If I Am Not Compliant?

March 24, 2022

Basics of FDA Labeling Requirements

When you look at the enormous amount of regulation surrounding nutrition labeling and FDA label requirements – the simplified version is 132 pages long – the thought of navigating all those food labeling requirements can be daunting to say the least. But, in the simplest terms possible, the labeling requirements describe 1) what information you must put on a food or beverage label, 2) what information you may put on a food or beverage label, and 3) details about how that information must be expressed or displayed.

The information that must be included on FDA labeling for foods or beverages includes six basic elements:

The name of the food (e.g., nut mix)
The “Net Quantity of Contents” statement, or how much of your product is in the package (e.g., 8 oz (227g))
A Nutrition Facts panel
An Ingredient Statement (that is, a list of everything that is in the food or beverage)
An Allergen Statement (that is, a list of any of the major allergens that the food contains)
The name and address of the manufacturer, distributor, or packer.

Depending on your food, FDA labeling requirements may also necessitate a warning – for instance, if the package is pressurized (like non-stick cooking spray) or needs to be cooked before eating.

There are also food labeling regulations regarding information that you may put on a label, but which is not legally required to be on the label. Usually, this involves “claims”, or statements about the food’s benefits or specific characteristics. This can include information like health or nutrition claims (e.g., good source of calcium), or characteristics like “gluten-free”.

The details about how all that information is expressed tend to be where things get more complicated. For the information that must be on FDA labeling, these details can include (but are not limited to) …

Which side of the package each piece of information is on
How small the font size can be,
Which words you can use to describe the name of the food,
How to round the numbers in your FDA nutrition label.
… and much, much more.

Regarding the information that may be included on food labeling, FDA labeling requirements are very particular about the wording that you need to follow and the criteria you need to meet when using claims. For example:

Claims about nutrient levels (e.g., “high in vitamin D”) correspond to specific ranges of the % Daily Values of those nutrients.
Claims linking an ingredient or nutrient to a disease may require a carefully worded disclaimer on the package.
In foods labeled “gluten-free”, the amount gluten must be below a specific, testable level.
…and much more.

Fortunately, there are some helpful resources available, like the FDA Food Labeling Guide (available at https://www.fda.gov/media/81606/download). Keep in mind that, when using these and other resources, FDA labeling requirements are constantly changing – use the most up-to-date version, and check all your findings against the current version of the Code of Federal Regulations (CFR) (available at https://www.ecfr.gov/cgi-bin/ECFR?page=browse).

What Happens If You Aren’t Compliant

If the information you provide on the label is incorrect or misleading, or if it doesn’t follow the FDA labeling requirements about how that information is expressed, your product will be considered “misbranded”. The FDA usually determines this from an inspection, from a consumer or competitor complaint alleging that your food is misbranded, or from a notification by the manufacturer themselves.

If the product is indeed misbranded, the FDA is authorized to take one of several different actions, depending on how much of a risk the misbranding presents to consumers. In non-urgent cases, the FDA may issue an “Untitled Letter” letting you know that there is a problem with the product so that you can correct it. More serious violations will result in a “Warning Letter”, which also allows you to correct the problem but also serves as a warning that the FDA plans to step in if you do not correct it soon. “Warning Letters” are posted publicly on the FDA’s website as well. If the misbranding is serious enough to cause harm to the consumer – often because of an allergen in the food that was not included in the allergen statement – the FDA can call for an injunction (where food is not allowed to go to market) or a recall (where food already on the market gets removed). If this happens multiple times, your registration can be revoked, essentially removing your right to sell food. In of these cases, the FDA will also investigate the root of the problem, to prevent it from happening in the future.

How RL Food Testing Laboratory Can Help

RL Food Testing Laboratory is eager to help you meet FDA labeling requirements and help you provide accurate label information to your valued customers! While we don’t work with package design (such as label placement) or with claims, we do offer valuable services including food testing and creating FDA-compliant nutrition labels, ingredient statements, and allergen statements.


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