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A Look Behind the Label: How Food Manufacturers Prevent Allergen Cross-Contact

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In an earlier post, we explored food allergy labeling laws and why many food products include “may contain” statements. To better understand the extent to which these foods may in fact contain allergens, we’re going closer to the source: food manufacturers.

On nearly all matters concerning food safety, including allergen control, FDA-regulated food manufacturers follow the Food Safety Modernization Act (FSMA).

Signed into law in 2011, FSMA introduced significant reforms to the nation’s food safety laws. For the first time, food manufacturers were required to develop and maintain a written “food safety plan.” FSMA also gave the FDA discretionary authority to approve or reject these food safety plans, giving auditors considerable interpretive power over which food safety plans would pass muster.

In 2015, the FDA published a final rule on Preventive Controls for Human Foods. This regulation is one of the key parts of FSMA and mandates that companies perform a Hazard Analysis and develop Risk-Based Preventive Controls (often referred to as “HARPC”).  The regulation requires manufacturers to identify and implement controls for any “reasonably foreseeable” food safety hazard–which includes the top eight most common allergens (tree nuts, peanuts, shellfish, finfish, soy, milk, egg, and wheat). Accordingly, if any of these allergens could end up in the final food product, manufacturers must implement preventive controls, defined as “written procedures the facility must have and implement to control allergen cross-contact.” Notably, allergen testing is currently discretionary, not required.

So how tough are these food safety plans on food allergens?

According to food safety expert Dr. Scott Brooks, pretty tough. “While FSMA is not prescriptive, food safety plans must stand up to scrutiny from FDA inspectors. The FDA has published industry guidance to help ensure FSMA compliance, and those in the industry know that it’s important to follow the FDA’s guidance documents.” While not finalized, the FDA draft guidance document on HARPC advises implementing controls to prevent cross-contact, and other measures including product sequencing and sanitation controls.

Most larger companies invest considerable resources into food allergen management, according to food safety expert Dr. Bert Popping. Indeed, “large manufacturers often test foods for trace allergens and have allergen management controls in place.” Dr. Popping notes however that “a number of typically small and medium-sized companies have no allergen management in place, and accordingly will often issue precautionary statements like ‘may contain’ for legal reasons, without performing any risk assessment.”

Further guidance on HARPC will be important for advancing safety measures around allergen control at food manufacturers. Until then, we may have to settle for “may.”

- Abi and the Allergy Amulet Team

 

This piece was written by the Allergy Amulet team and reviewed by Dr. Bert Popping and Dr. Scott Brooks for accuracy. 

Dr. Bert Popping is the managing director of FOCOS, a food consulting group based in Germany. Dr. Popping has over 20 years of experience in the food industry, and has authored over 50 publications on topics including food authenticity, food analysis, validation, and regulatory assessments.

Dr. Scott Brooks is a food safety consultant and founder of River Run Consulting. He is the former Senior VP of Quality & Food Safety, Scientific and Regulatory Affairs at Kraft Foods, and prior to that was the VP of Global Food Safety, Scientific & Regulatory Affairs, and Quality Policy at PepsiCo.

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Do Waitstaff Create a False Sense of Security?

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I’m often asked whether a consumer device that tests for unwanted ingredients in foods will give those with food allergies a false sense of security when dining out. My response is usually the same: do waitstaff give the food allergic a false sense of security when assuring customers their food is safe?

From personal experience as a waitress, and as someone with food allergies, I can assure you, it happens.

Roughly a decade ago, I waitressed at a restaurant in Midtown Manhattan. It was a fast-paced work environment that demanded recall of dozens of orders and seating positions at any given time. The restaurant was located a few blocks north of Madison Square Garden, so we’d routinely get flooded with hungry patrons before and after performances. During my tenure waiting tables, I grew accustomed to the frequency with which waitstaff made mistakes—and it’s often. A few times a week I would mix up orders, fail to put in special requests, and was once lambasted for accidentally serving a woman regular coke instead of diet. I never made that mistake again.

But there’s a difference between mixing up soft drink orders and forgetting to inform the kitchen of a food allergy. Despite their best efforts and intentions, waitstaff don’t always get it right—even when it comes to food allergies. Many waiters don’t know that pesto usually contains pine nuts, that marzipan is almond paste, or that peanuts and nutmeg are not tree nuts. According to a recent CDC report, restaurants were found responsible for nearly half of all food allergy fatalities over a thirteen-year period. That same report found that less than half of all restaurant managers, and only one third of servers, receive any formal training on food allergies. Legislation is also lagging. Today, only six states (Illinois, Massachusetts, Maryland, Michigan, Rhode Island, and Virginia) and two cities (NYC and St. Paul, MN) have passed laws to increase food allergy safety and awareness in restaurants. We’ve clearly got a long way to go.

I’ve also had my fair share of personal experiences with misinformed waitstaff. This past year alone, waitresses at two different restaurants assured me that my dish was allergen-free when, in fact, it was not. One of the more memorable incidents occurred when I was ten. Our family went to a fancy restaurant near our home for my mom’s 40th birthday. I typically wasn’t allowed desserts at restaurants, but my parents decided to make an exception. We informed the waitress of my food allergies, who then confirmed with the chef that the dessert was safe. After sheepishly taking a small bite, the waitress came barreling out of the kitchen towards the table: there was marzipan in the icing (they hadn’t checked with the pastry chef until after it was delivered to our table). Fortunately, I spit the cake out and the reaction did not rise to the level of anaphylaxis.

Dining out has and will always present challenges for the food allergic, and living in a bubble isn’t a realistic option: I don’t know one adult with food allergies that doesn’t dine out at restaurants or eat foods prepared by others. Right now, the food allergy community relies on the word of the kitchen and waitstaff—the first and only line of defense to prevent a reaction; then there’s epinephrine if things go wrong. Little progress has been made in the way of management tools for preventing allergic reactions in past decades, but fortunately, that’s starting to change. We’re finally seeing a surge of start-up activity in the food allergy space, with different products and apps designed to help the food allergic population better manage their allergies. After all, dining out shouldn’t feel like a game of Russian roulette!

Consumer devices that test foods for unwanted ingredients are intended as a supplement, not a substitute, to the standard precautionary measures those with food allergies would otherwise take when dining out or eating foods prepared by others. For example, I’m still going to tell the waitstaff I have food allergies; I’m still going to take a small bite before diving into my dish; I’m still going to avoid Thai restaurants, desserts, and pesto; and I’ll continue to have my epinephrine on hand. But an additional layer of assurance would be a vast improvement on the status quo.

Having been on both sides of the table, I know this much is true: waitstaff make mistakes, and it only takes one to trigger anaphylaxis. We food allergic folks need all the tools and reassurances we can get.

- Abi and the Allergy Amulet Team

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Why the Thigh?

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Most people that carry epinephrine to treat serious allergic reactions will tell you they were given strict instructions to inject the needle into their outer thigh. They may also tell you that the needle can be injected over clothing, if necessary.

For years I carried epinephrine because I received weekly seasonal allergy injections. Today I carry epinephrine for my food-allergic child. For a long time I didn’t know why I was advised to inject the needle into my thigh. My hunch is that most people don’t know why either.

Several years ago, the Journal of Allergy and Clinical Immunology published a study measuring epinephrine absorption in children with a history of anaphylaxis. The participants were randomly assigned to receive a single injection of epinephrine either subcutaneously (under the skin) or intramuscularly (in muscle).

Among children that received epinephrine subcutaneously, epinephrine absorption was considerably slower than for those that received the injection intramuscularly. 

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A few years later, the same clinical journal published this study. Their goal was to measure epinephrine absorption in adults intramuscularly versus subcutaneously, but also evaluate absorption differences between two different intramuscular sites: the thigh and the upper arm.

The results of this latter study (below) support the recommendation that epinephrine should be administered in the outer thigh. Greater blood flow in the thigh was considered the likely reason why the absorption rate was higher relative to the upper arm. 

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Failure to timely administer epinephrine during an allergic reaction is the leading cause of fatalities among the food allergic, which is why it’s so important to carry epinephrine if you have a food allergy. These findings further underscore the importance of administering the needle into the thigh, as delayed epinephrine absorption could have serious implications during life-threatening episodes of anaphylaxis.

So now you know, folks! Raise your epinephrine high to the sky, then swing it firmly into the thigh!

- Meg and the Allergy Amulet Team 

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What To Expect When You’re Expecting…An Oral Food Challenge

My daughter, moments after finishing her first oral food challenge.

My daughter, moments after finishing her first oral food challenge.

This topic is pretty fresh in my mind as my daughter underwent an oral food challenge to macadamia nuts last week. In case you’re not familiar with an oral food challenge (OFC), or haven’t experienced one yet, let us fill you in.

Today, oral food challenges are considered the gold standard for food allergy diagnosis in children and adults alike. Skin prick and blood tests aid in diagnosis, but they are prone to error—false positives are not uncommon. You can read more about food allergy diagnosis methods in our blog Food Allergies Today: An Expert Q & A.

There are typically three reasons why you might do an oral food challenge:

1. You or your child tested positively for a food allergy but have never actually eaten the food.

2. You or your child tested positively for a food allergy and have eaten the food before with no symptoms.

3. To see if you or your child has outgrown a known food allergy.

An oral food challenge is usually held at your allergist’s office over a few-hour period. The allergist administers tiny amounts of the potential allergen in gradually increasing doses over a set period of time (usually 3-6 hours). In my experience, the whole challenge start to finish lasts around 4 hours. Once the full serving is administered, the doctor will typically observe the patient for a couple hours to monitor for signs or symptoms of an allergic reaction. If symptoms occur at any point during an OFC, the challenge stops and symptoms are treated immediately.

Importantly, not everyone is a good candidate for an OFC. According to allergist Dr. Jordan Scott, “when asthma is flaring or when patients are ill, we don’t challenge.”

Let’s talk about what to expect. First, block off the day, because even if the OFC is expected to last only a few hours, the experience can be emotionally draining and stressful. Being prepared and understanding the purpose and procedure is incredibly important! Below you’ll find a list of things to prepare ahead of time so you can tackle the challenge head on. 

Ask your allergist what he/she needs you to bring. He may ask you to provide the food for the challenge, or his office may provide the food (we’ve done both). If you’re providing the food, make sure you’ve done your homework to ensure it’s not processed in a shared facility or processed on a shared line with something else you’re allergic to. For example, when we challenged sesame a couple years ago, we ensured the hummus we brought wasn’t processed in a shared facility with nuts: my daughter’s other allergen. We didn’t want cross-contact playing a factor.

Ask your allergist what you should stop doing. Ask your allergist what medicines you need to stop taking before the challenge. Our allergist requires that we stop giving our daughter her daily antihistamines for seasonal allergies a few days before the challenge, as that could mask reaction symptoms during the OFC. Additionally, she cannot take any asthma medicine that day. However, if asthma symptoms start flaring, there’s a chance they’ll want to play it safe and reschedule your challenge anyway—clear communication with your allergist is key!

Bring lots of activities for entertainment. If the trial is for a child, I’ve found that new activities, games, and library books always help to hold their attention longer. Having a favorite stuffed “friend” or something that the child associates with comfort is helpful too. If you’re an adult, a good book and your favorite digital gadgets will probably suffice!

Pack safe snacks. If the challenge goes well, you may be at the allergist’s office for several hours. However, the tiny doses of food your allergist administers aren’t likely to fill you up ☺. We like to bring some of our daughter’s favorite tried and true snacks that we know are safe (another way to avoid bringing cross-contact into the equation!). Since the challenge is at an allergist’s office, and there will likely be patients in the near vicinity with food allergies, it’s an added bonus if you can bring foods that are free from the most common allergens: peanuts, tree nuts, fish, shellfish, wheat, egg, milk, and soy. I also bring disinfectant wipes in case the food spills so that I can clean it up properly for the next allergic patient. Good food allergy etiquette is important!

Bring your emergency medications. While this may seem unnecessary (hello, you’re at the allergist’s office ☺), it’s important. There’s always a small chance of a delayed reaction, and if that happens on the way home, you’ll want to have your epinephrine and antihistamines at the ready.

Stay calm. If you’re a parent accompanying a child to an OFC, it helps to remain calm if your child experiences an allergic reaction. “If a reaction occurs, it is important for parents to remain calm because children can pick up on the anxiety and feed on that,” allergist Dr. John Lee advises. If your child experiences a reaction, Dr. Lee also suggests that parents avoid calling it a “failed challenge” in front of their child, noting that “this can make a child feel as if they’ve somehow failed, or done something wrong.”

Leave the siblings at home. If the food challenge is for your child, it’s smart to leave any siblings at home so you can stay focused—especially in the event of an allergic reaction. Best-case scenario, your child doesn’t have a reaction and it ends up being quality time with your babe. If you’re an adult, you’ll still want to bring someone with you for support and to make sure you get home safely.

Set a course of action/next steps. Once the challenge is complete, talk to your allergist about next steps. If the challenge went well, make sure you know how to proceed with exposure to the food moving forward. If it didn’t, they may recommend future testing/follow up, and possibly strict avoidance of the food.

I hope you find these tips helpful! After experiencing my daughter’s first oral food challenge, I felt far better equipped to take on the second. In case you’re wondering, she passed her OFC to macadamia nuts! This is one nutritious food we can add back into her diet. Hooray!

If you’re interested in discussing oral food challenges further, let me know. We’ve been through several, so I know the ropes pretty well!

- Meg and the Allergy Amulet Team 

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Navigating Food Allergies as a Foreigner the SMART Way

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I was born with numerous food allergies. Growing up in the ‘60s and ‘70s with life-threatening food allergies was incredibly rare, as were the means to managing them. On several occasions, I had to rely on self-induced vomiting for a remedy (epinephrine auto-injectors wouldn’t come onto the market until my early twenties). Thankfully, I grew out of most of my allergies by the time I was a teen, although I remain severely allergic to peanuts, pistachios, and other legumes to varying degrees. After a couple decades managing my allergies, I’d grown pretty adept at navigating the food-allergic life. Then I moved to Southeast Asia.

I flew to Singapore in January 1985, armed with zero knowledge of Southeast Asia or its food (this was well before Google would have informed me that Southeast Asian food includes lots of nuts and legumes). By that time, thankfully, I carried an EpiPen with me, although I had never actually used one.

My first years in Asia were a learning experience in many ways; some of the most “memorable” lessons came from managing my food allergies. To paraphrase Kelly Clarkson: what didn’t kill me made me (slightly) smarter.

For those food-allergic travellers out there, below are five tips that I hope will help you on your journeys.

1.  Study ahead of time

For my kick-off lunch in Asia, I went to a Chinese restaurant with the rest of my team and several clients. The first dish was a cold duck salad, which sounded safe enough. I confidently dug in my chopsticks and took a couple bites. Big mistake. I would soon learn that one of the main ingredients in the dish was chopped peanuts. I stopped eating and found my way back to my hotel. Three days later, after an EpiPen and several bouts of vomiting, I was finally able to get off my hotel room floor. Not a great way to start my Asian adventures.

If I had bothered to do some basic research on the culture’s signature dishes and ingredients ahead of time (and maybe even studied the language), I could have saved myself a lot of trouble. With all the information available on the web nowadays, restaurant research is relatively easy. Find an item on a menu that seems safe and double check with the waitstaff at the restaurant. A chef card translated into the country’s native language always comes in handy too!

2. Medications like epinephrine and antihistamines should always remain close at hand

I remember grabbing a drink one night at a hotel bar with a good friend. I finished my beer before he did (not an uncommon event!), and being the joker that I am, figured I would swap our beer glasses when he turned his head so I could get another swig of beer. Once my lips came into contact with the glass, I knew I was in trouble. He had been eating peanuts! I immediately ran upstairs to my hotel room. Thankfully, I had epinephrine on hand and was able to stave off a more severe reaction.

I now carry medicine with me at all times, in my briefcase, my other briefcase, and my carry-on. I cannot stress how important it is to keep emergency medications on your person. It has saved me on numerous occasions. Traffic can be horrendous in many Asian cities, and I have yet to find any pharmacy in the region that sells antihistamines, let alone an epinephrine auto-injector!

3. Ask questions

When I came to Asia, I was often afraid to ask about ingredients or request that a dish be prepared without certain ingredients. This led to several instances of unnecessary allergic reactions. In hindsight, I should have worried more about my throat (which closes when I eat peanuts) than saving face, which is a big concern in Asia. At times, of course, waiters or friends may not know what goes into specific dishes. In such cases, or anytime you are in doubt, don’t eat it!

There can also be language barriers to overcome. For many servers, English is not their first language. As such, I have found that I need to be very specific with my questions—instead of asking about legumes, I ask about peas, beans, bean sprouts, bean curd, and bean paste—use local terms as much as possible!

4. Remember the hidden ingredients

Over the years I’ve had several food experiences that resulted in urgent visits to the doctor and/or hospital due to anaphylactic reactions. Often, these visits were because I ate a seemingly safe dish that had a sauce or spread containing nuts or legumes.  

Once at a hawker centre, I ordered a seemingly safe plate of satay. Being much wiser after having spent a few years in the region, I avoided the peanut dipping sauce. Unfortunately, despite only eating the skewered meat, I experienced an allergic reaction. I later learned that the satay chef had used peanut oil to baste the meat, and while peanut oil is nowhere near as deadly for me as peanuts, I still had a reaction.

In another instance, I ordered a basic chicken sandwich only to discover after taking a bite that it contained a pesto sauce made with pistachios. I also remember eating Indian food and wondering why I kept getting sick afterward. Eventually, I found out that papadum (which is served with many meals) is often made with ground lentil or chickpea flour. Thai green curry can include green beans, and some chili crab is made with peanuts.

In sum, there’s more than meets the eye for many food items in Southeast Asia. Those “hidden” ingredients? They are often the most dangerous ones.

5. Tell others

When travelling, especially with a group, I often kept quiet about my allergies as I did not want to inconvenience others. This occasionally backfired when I ended up having a reaction. I soon realized that telling the people you know is essential when living with a food allergy—in the case of a severe reaction, they may need to assist in administering your medications.

Often, I’ve found that friends and family are more than willing to omit certain ingredients or make special arrangements to accommodate allergies. I have also found that many restaurants—and even some hawkers—are quite willing to accommodate my special requests such as noodles without bean sprouts or fried rice without peas.

In summary, when travelling abroad, remember that food is a major part of every culture and that you can enjoy it as long as you are SMART about it: Study ahead of time, keep Medication close at hand, Ask questions, Remember the hidden ingredients, and Tell others.

- Nels Friets

 

Nels is the Co-Founder & Vice Chairman of tryb Capital, a Singapore-based financial investment group that invests in emerging financial technology solutions. Nels is also an investor in Allergy Amulet with the Bulldog Innovation Group, a network of Yale alumni investors.

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