A Guide on FDA Packaging And Labeling Requirements

Posted December 28, 2022 FDA Food Packaging Labeling Requirement

Are you an American manufacturer working in the food or another industry? Your labeling needs to follow laws that significantly affect your packaging. So you can make the right decisions and offer the information these laws bound you with. We have some top US FDA packaging requirements you need to comply with.

You can read about food and general laws that the FDA or Food and Drug Administration imposes on manufacturers. We will cover industries like food, electronic devices, and general labeling.

General Labeling Requirements

Certain general requirements make labeling super important for any manufacturer or packaging firm. The laws are clear about how you should mention different information on your package labeling.

  • You should ensure your name’s present on every container you send to your customers.
  • Also, you should mention user instructions when you use and store the products.
  • It is a must to ensure all of your labels follow the specific information you must convey to them. A responsible person must check them before they are used on the containers.
  • As a brand, you are responsible for avoiding any mix-up of specific labels and using certain ones by others.
  • Responsible individuals must keep in mind that they should keep the labeling area safe from any label mix-up. In addition, they should clear any chance of a label mix-up before the labeling process starts.
  • Ensure that you waste all the extra labeling tags and that they never reach the labeling area at any time.
  • You must store packaging material, inserts, or containers in an area that does not cause any labeling mix-ups.

In short, you cannot get away if you do not follow the best practices. A company that does not pay attention and budget to avoid label mix-ups will have compliance issues.

Radiation Guidelines in Food and Packaging

Radiations in food packaging can make an impact on your food; the FDA has set laws for it, like

Packaging will be considered radiation if it has the following:

  • If your x-ray tubes create x-radiation if a source has a voltage of 500.
  • Your product should contain information about your X-ray tubes’ maximum radiation emission.
  • If it carries radiation, your packaging should contain information consumers need about the radiation source.

Some Food Packaging Guidelines

There are laws about putting labels on your food packaging. For instance, you can have a label on the front or principal display panels. You should also mention the food’s name and give an identity statement.

Other mandatory information must exist here like it should carry the manufacturer’s name and address. Ensure you also offer your packer or distributor’s information here, like their name and address.

FDA Food Packaging and Labeling Requirements

Offer the company name and address if the city directory does not have the address. Your city, town, and state should also be mentioned there. You should also give your ZIP code on the packaging.

These FDA food labeling requirements make it easy for your customers to understand why food packaging needs attention and vigilance.

What Are FDA Food Packaging Label Requirements?

Your labels should carry certain information and follow the guidelines. Some elements they should have are

  • It should carry the contents’ net quantity
  • Make sure your packaging labels list all ingredients the product has.
  • You should always offer nutrition information for your food product.
  • Adding the manufacturer’s name to the label is a must as well.
  • You can mention your sub-ingredients following the ingredients’ common name.
  • Using short names of ingredients is allowed.
  • Ensure your net quantity appears in a red box in the principal display panel.

These tips show FDA food packaging guidance that you should follow entirely.

Nutrition Labeling

Your food products must contain nutritional facts about them with a certain hierarchy. For instance, they should have information like nutrients in a particular order. For example, they must start with calories and end with potassium.

Other rules apply to your product packaging like you can mention Fluoride next to Sodium. These points are an FDA food label guide for packaging companies and firms.

Device Labeling Guidelines

A brand must ensure that they test all the labels before their use on the product packaging. Ensure that you check all expiration dates on these labels. The company should provide a system for any changes in labeling.

It is better to avoid any labeling over an existing label. Make sure you mention your product’s sterile part in the labeling process. Your customers should know what part of your product is sterile. Instructions about avoiding contaminations in the device may be mentioned on it.

You may need the expiry date mentioned on the device if any of the parts have limited-time use capability.

FDA Food Packaging Requirements For Nutrients

Allergens are one of the biggest concerns for regulatory authorities in many countries. The FDA is strict about this aspect and makes things easy for customers in this section.

Poultry, alcoholic beverages, and meats are not part of labeling restrictions regarding allergens. It is essential to mention all the allergens that a product may contain.

Celiac disease is one of the most common allergies in the United States. And this is why the American government is taking stringent steps to avoid any gluten consumption mishaps by such patients. Gluten-free labeling laws make sure such mishaps do not occur. Here are some points to keep in mind for better compliance.

  • Only the product that does not contain gluten will be labeled gluten-free and vice versa.
  • If your product mentions and claims not to use gluten without meeting the requirements, it will be considered an act of misbranding.
  • You can not claim your product to be gluten-free if it does contain refined grains with this ingredient.
  • A product can not claim to be gluten-free if it carries more than 20 ppm of gluten.

These rules must be strictly followed as they can cause serious health conditions for individuals with celiac disease.

FDA Packaging Guidelines For Drugs

FDA also takes care of compliance with their drug packaging and labeling guidelines. Their rules state that your packaging should be precise to offer quick information about your product. Make sure that your packaging delivers information that healthcare practitioners can understand.

Also, it should have relevant terms for such professionals and the industry. Moreover, it should talk about scientific evidence perfectly.

The Usage and Indications Section For Drugs

Ensure your medicine packaging contains information about who can use them and when. These indications must go with the results of any studies conducted over groups for use. The labeling may have a certain broader group who may use them.

You should update the product’s information about a certain drug when new updates are available. This way, you can communicate the latest usage and indications of any drug containing labels. Also, you should specify if a medicine will work for a particular disease and what it will do against it.

For instance, a medicine can be for specific prevention or maybe for treatment. So, your drug label should contain this information accurately. Also, ensure you offer any information about subgroups that can use the medicines. The label can have certain limitations only if an FDA expert is concerned about the drug or if there is any risk of issues with the product.

Mention any conditions in which you should use the drug. You can mention a limitation of use in such conditions.

If a drug is for pediatric patients (young kids) may be for only their population. The drugs can be used for both adults and young kids. Also, adults who may have efficacy can use the product. If the medicine is effective for a certain pediatric group, your consumers may use it for other subgroups in the same group.

So, it would be best if you mentioned age groups with drug use.

These are the most common FDA packaging and labeling requirements you should meet in the concerned industries to ensure you comply with the laws.


Where can a consumer find the FDA food labeling guide?

You can find everything about food labeling on the FDA website. They have guidelines for every industry that make their resources comprehensive and accurate for every professional packaging and labeling need.

Why is food labeling important?

Food labeling helps consumers learn about the product and helps them make decisions to choose the most appropriate products for them. In addition, such packaging essentials allow them to look for the products that go with their health and any health issues. For instance, you can not consume gluten if you have celiac disease. So, food packaging and labeling mention this ingredient in packaging to ensure that patients do not accidentally consume this ingredient.

Why do you think the FDA requires some products to have an “as prepared” label?

Mentioning such information on your food packaging allows customers to make educated decisions about their consumption. Such information will enable them to learn about different aspects of the product’s ingredients.

Let Your Packaging and Labeling Be in Compliance With FDA

The Packaging Hub ensures you get packaging and labeling compliant with the American Food and Drug Authority. These US FDA packaging requirements ensure customers get the best products with the best information.

This information is essential for them to make educated and correct decisions about the products they choose and use. And we help you get the proper packaging and labeling your customers will love to rely on.

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Steve Harsh
Steve Harsh, a packaging and printing expert who has been working in the field for over a decade. It has been my privilege to write on this topic, which I have been doing for years to help people learn about this essential field that helps millions achieve their business goals.

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