Peanut Allergen | The U.S. Big Nine Allergens

Peanuts are one of the most commonly known allergenic foods and are a concern for businesses due to the increasing prevalence of allergies. 

The American Academy of Allergy, Asthma, and Immunology (AAAAI) estimates that 1-2% of the U.S. population suffers from peanut allergies. Studies have noted that this percentage has grown exponentially in recent decades.

Even a tiny percentage of the U.S. population equates to millions of food-hypersensitive consumers that businesses must legally accommodate with clear allergen information. In this article, learn everything you need to know about peanut allergies and the relevant food labeling requirements. 

What causes peanut allergies?

Please Note: LiberEat’s content is not intended to be a substitute for professional medical advice. You should always take precautions and use appropriate judgment concerning food allergies to protect yourself and others under your care.

A peanut allergy is caused by the body’s immune system mistakenly identifying specific peanut proteins as harmful foreign substances known as antigens. In response, the immune system releases a protein that protects the body (an antibody) known as Immunoglobulin E. The antibody releases a chemical known as histamine, which has the side-effect of causing typical allergic reaction symptoms such as:

  • Itchy skin and hives
  • Stomach cramps, nausea, and diarrhea
  • Wheezing 
  • Pale and clammy skin

All food allergies can result in anaphylaxis, a potentially fatal reaction that can cause a rapid drop in blood pressure and difficulty breathing due to swelling of the tongue, lips, and throat. More information about anaphylaxis can be found here. 

In the U.S., recent years have brought consumers medical options to alleviate food allergy symptoms. The FDA has approved a powder for oral immunotherapy treatment to minimize the risk of allergic reactions for those with peanut allergies. A news release regarding the drug is available on their website. 



What is a major food allergen, according to the FDA?

Peanuts were categorized as a ‘major allergen’ in 2004 as part of the Food Allergen Labeling and Consumer Protection Act (FALCPA). 

A ninth major allergen, Sesame, was introduced under the Food Allergy Safety, Treatment, Education, and Research Act (FASTER Act) on January 1st, 2023. This group, collectively known as the ‘Big Nine’ or the ‘Nine Major/Main’ allergens, contains the following:

  1. Cows’ Milk
  2. Egg (Chicken eggs specifically)
  3. Fish
  4. Crustacean shellfish
  5. Tree nuts
  6. Wheat
  7. Peanuts
  8. Soybeans
  9. Sesame

Under the two pieces of food law, manufacturers and retailers are legally required to declare the major allergens under FDA jurisdiction if they are present in dietary supplements or packaged food. This is done by clearly identifying the food source on food labels.

Some common names of ingredients already contain the nine major allergens’ source name (e.g., buttermilk contains “milk,” for example), but for other ingredients, the source name can be declared in two different ways: in parenthesis, following the name of the ingredient in the ingredients list, or in a “contains” statement, following the entire ingredients list. Examples can be seen on the FDA website.

Particular meat, egg, and poultry products are exempt from FALCPA labeling requirements as they are regulated by the Food Safety and Inspection Service (FSIS), an agency of the United States Department of Agriculture. However, it is still recommended that allergen statements be provided on food packaging. The FSIS website has a helpful FAQ that details its relationship with the FDA and allergen labels.

As with many oils, peanut oil goes through a refinement process that removes the majority of allergenic proteins. As a result, many of those with a peanut allergy may not have a peanut oil allergy. Highly refined oils are exempt from allergen labeling requirements, though it’s possible for small amounts of proteins to persist. It is advised to see an allergist and make your judgment regarding foods with peanut oil.

What is a food recall, and how does it affect my business?

Failure to comply with labeling requirements detailed in food safety legislation such as FALCPA can have serious consequences for your business. The most common is food recalls, issued by the FDA for products that present a health risk, are grossly deceptive, or are defective. 

While requested by the FDA, recalls are typically done voluntarily by the manufacturer following guidance supplied by 21 CFR 7. If the manufacturer fails to comply with the voluntary recall notice, the FDA has the power to issue a mandatory recall under section 423 of the Food Drugs and Cosmetic Act, which was added to the FD&C Act by section 206 of the Food Safety Modernization Act on January 4th, 2011. Mandatory recalls are rare, as most businesses will undergo this process voluntarily once made aware of the error leading to the need for a recall.  

Businesses can experience a myriad of issues stemming from undergoing a product recall. When a food recall occurs, the operation must utilize many company resources to focus on removing the affected products from the market. Regulatory bodies, consumers, and relevant businesses in the supply chain will need to be notified, and staff will be involved in increased PR activities as they interact with affected consumers and try to minimize reputational damage. 

Depending on the consequences of the undeclared allergens (e.g., if consumer fatalities occurred), brand reputation may not recover or take years to do so. The media will likely notice recalls, as the FDA lists recalls on its website and social media. 

The Role of Food Safety Technology in Managing Allergen Data

There is more pressure than ever to provide clear allergen information for consumers. Failure to do so can lead to devastating consequences, such as expensive product recalls and criminal penalties. 

LiberEat’s platform automatically detects errors in allergen data across supplier specifications and packaging labels. It provides food businesses with real-time alerts and helps them comply with FALCPA and the Food Safety Modernization Act (FSMA).

At LiberEat, we understand that many food businesses aim to implement the best allergen management processes. However, manual data entry and checking methods often leave room for human error and challenging allergen detection. Additionally, food safety teams face overwhelming misinformation about food safety requirements, further complicating compliance efforts.

To learn more, please see our  U.S. Big Nine Allergens Information Hub, which contains all the information you need on allergens and relevant legislation. 

We provide a revolutionary approach to food safety with our food safety technology, protecting businesses against allergens to offer peace of mind to your food safety teams.  

LiberEat Allergen Detection Software

LiberEat’s food safety software helps prevent errors in allergen data on supplier specifications, website and app data, food packaging, and menus. This can help protect your customers from the major allergens—find out more about these with our allergen information hub.

Correctly managing and reviewing your allergen data is essential for keeping you and your customers safe. 

Errors in allergen data can cause potentially devastating allergic reactions and expensive product recalls. For your peace of mind, contact us to learn more about how LiberEat can help protect your business.