Shellfish is considered one of the most common food allergens in the U.S., with Food Allergy Research and Education (FARE) estimating that 2% of the country’s population is affected.
With this percentage representing over 6 million people and the majority being allergic to crustaceans, crustacean shellfish has become known as one of the ‘Big 9 Allergens’ in the U.S., a term used for foods that comprise the majority of allergic reactions. If these nine allergens are present in packaged food or dietary supplements, they are subject to food labeling requirements. There are significant consequences for failing to have allergen declarations present on labels. Businesses must know how to implement allergen labels correctly and employ effective “allergen management procedures.”
Below, we cover everything you need to know about allergen labeling requirements in the USA, relevant food safety legislation, and the dangers and risks of food allergens within food businesses.
LiberEat supports Food Business Operators (FBOs) by providing reliable and efficient allergen error detection, helping to prevent recalls and protect consumer health. To find out more, check this out.
What are the Differences between Mollusk and Crustacean Shellfish?
To understand what a crustacean shellfish allergy is, it’s essential to understand the distinct types of shellfish and how they are different.
Shellfish is a broad term for invertebrates living in water with a shell or shell-like exterior. It is categorized into two groups:
Crustaceans and Mollusks.
- Crustaceans are aquatic invertebrates with jointed legs, no backbone, and a hard shell. They include animals such as shrimp, prawns, crabs, and lobsters.
- Mollusks, on the other hand, are also known as bivalves. They are soft-bodied animals with two shells surrounding them, which are valves that can open and close. Examples include oysters, clams, and scallops.
While the UK considers both crustaceans and mollusks to be two of their 14 main allergens, mollusks aren’t classified as one of the top 9 food allergens by the Food & Drug Administration in the United States due to crustacean shellfish allergies being more prevalent – findings from a 2019 study estimated that adult mollusk allergy rates were 1.6%, while crustacean allergy rates were at 2.4%.
Symptoms of a Crustacean Shellfish Allergy
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.
The symptoms of a crustacean shellfish allergy are similar to many other food allergy, such as:
- Headaches, nausea, diarrhea, and vomiting
- Skin rashes
- Symptoms affecting the eyes and nose, such as itching or a runny nose and eyes.
Anaphylaxis may occur in cases of a severe allergic reaction. Those experiencing anaphylaxis may notice that they start feeling dizzy or confused, have a fast and weak pulse, have pale, clammy skin, constricted airways, and/or difficulty breathing caused by the swelling of their throat or tongue. This can be fatal due to blocked airways leading to cardiac or respiratory arrest.
If someone is going into anaphylactic shock, the Mayo Clinic advises the following steps:
- Call 911 or your local emergency number.
- Ask if they need help administering an Epinephrine Autoinjector if they have one. This is normally injected into the thigh, though the FDA has recently approved EpiPen nasal sprays.
- Ensure they are lying face up and still. If vomiting or bleeding from the mouth occurs, they will need to lie on their side to prevent choking.
- Cover the person with a blanket and loosen tight clothing.
- Apply CPR until paramedics arrive If there are no signs of breathing, coughing, or movement. Aim for 100 chest presses per minute.
Food labeling requirements for Crustacean Shellfish
In the U.S., crustacean shellfish, along with the majority of the big nine allergens, is regulated by the Food and Drug Administration (FDA). In 2004, the first 8 major allergens were introduced under the Food Allergen Labeling and Consumer Protection Act (FALCPA), while a 9th allergen, Sesame, was introduced on January 1st, 2023, under the Food Allergy Safety, Treatment, Education, and Research Act (the FASTER act).
Under these acts, food labels must contain the food source name of any of the big nine allergens if present in the food. If the common name of an ingredient containing a major allergen already contains the food source name, then this requirement is already met, such as ‘buttermilk’ containing the name of the major allergen ‘milk’.
In instances where this isn’t the case, the common name must be present in parentheses after the ingredient, such as ‘lecithin (soy)’, or appear immediately after the ingredients in a ‘contains’ statement, such as ‘Contains eggs, sesame, and milk’.
Failure to correctly declare allergens in labeling will result in a product recall. According to the FDA regulatory procedures manual, this is undertaken for products that “present a risk of injury or gross deception or are otherwise defective. ” The manufacturer typically does this voluntarily, albeit requested by the FDA, following the guidance issued by code 21 CFR 7.
If a company fails to respond to the FDA request for a voluntary product recall, a mandatory recall can be issued under Section 423 of the Food Drugs and Cosmetic Act, added by Section 206 of the Food Safety Modernization Act. This was introduced on January 4th, 2011.
Recalls can be incredibly expensive for businesses due to the cost and manpower needed to retrieve affected products and the allocation of resources needed for any PR activities and legal expenses. High-profile cases may also result in reputational damage, which some businesses may never recover from. For an extensive look at everything you need to know about food recalls, visit our dedicated page.
Correct knowledge and implementation of allergen safety processes and food law are crucial, and we recommend anyone eager to learn more about U.S. allergens take a look at our ‘Top 9 Allergens Hub. ‘ For businesses looking to take a proactive approach to allergen management, don’t hesitate to contact us to learn more about how LiberEat’s Allergen Detection technology can help your business.
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. Give yourself peace of mind, and contact us to learn more about how LiberEat can help protect your business.