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FDA Reader: Simplifying Food Regulation

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Food Labeling Errors That Can Cost You Your Business
 
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Food Labeling Errors That Can Cost You Your Business*

*and how to avoid them

Designing a food label can be a daunting task for an entrepreneur bringing a new product to market. Even after you check the boxes for nutrition facts, product claims, and display requirements, you still have to make it work with your packaging design. But if you don’t have time to make sure your label is 100% compliant with every last regulation, then at least avoid the following mistakes — they could cost you your business.

1. Undisclosed Allergens

Many FDA food recalls are related to undeclared allergens. This typically is the result of two easily-avoidable mistakes: (1) the ingredients listing on the package doesn’t match the product in the packaging and (2) The allergens in the product are not displayed prominently to the consumer.

How to Avoid This Mistake: Make sure your ingredients list is complete and that you are identifying any of the Big 8 allergens using an Allergen statement, such as “contains peanuts”.

Who Cares? The FDA, the person you made sick. 

Likelihood of Discovery: High. Food allergies are common and undeclared allergens tend to get discovered when a consumer has an allergic reaction to the product, despite having checked the label first.

What it will cost you: Because of the potentially life threatening nature of an allergic reaction to food, food manufacturers typically conduct an immediate, voluntary recall of all effected products.


2. Unauthorized Health Claims

There are clearly defined rules when it comes to the types of claims you can make about a food product’s effect on the consumer’s health. The easiest way to guarantee the wrath of the FDA and a swift food recall is to make an-unauthorized health claim or drug claim. This means making a claim about how the product or one of its ingredients affects your body or provides some sort of therapeutic affect. It is unlawful to make this type of claim on the product label itself but also on marketing materials (e.g. the company website), even if you have scientific evidence to back it up.

While the FDA has approved a small number of Authorized health claims approved for use, there are only twelve of them, plus a handful of weakly phrased qualified health claims.

How to Avoid This Mistake: Do not make any unauthorized claim about your product’s effect on the body or treatment of any ailment. Make sure any claims related to nutrition or the benefits of specific ingredients align with the regulation

Who Cares? The FDA. Here’s why: let’s say you claim that the high levels of antioxidants in your popular snack bar has been shown to support immune health in cancer patients. If cancer patients forsake treatment measures in favor of your snack bar, this could have negative public health outcomes. Major retailers will also pull these products from their shelves if they don’t discover this error before they place their order.

Likelihood of Discovery: High. Claims are typically printed prominently to get the consumer’s attention. This also means getting the attention of regulators and savvy consumers.

What it will cost you: All of the products and materials containing the unauthorized claim, possibility of brand damage and the possibility of expensive lawsuits from customers who suffered damages due to this claim..

3. No Standard of Identity (or a misleading one)

FDA labeling requirements clearly require most packaged foods to declare what the product is. This is why a Tostito’s label must clarify that the product is Tortilla Chips and Nutella must describe itself as Hazelnut Spread. While there is a great deal of controversy and open questions surrounding naming conventions for milk-alternatives and meat-alternatives, this isn’t the case for most products.

How to Avoid This Mistake: Include the common name for your product on the front label.

Who Cares? Major retailers who don’t want to be held accountable for carrying a product which could be construed as misleading.

Likelihood of Discovery: Medium-High. It may not be discovered initially, but eventually someone will notice. Typically, a failure to disclose a product’s Standard of Identity doesn’t have negative health implications for the consumer, it’s just mildly confusing, an infraction which rates lower on the FDA’s list of priorities. It’s more likely that a wholesale purchaser or retailer will find issue with this labeling error than the FDA.

What it will cost you: Mainstream retailers may refuse to carry the product until this issue is remedied.

4. Undeclared Ingredients

Even when there’s no allergen implications, the discovery of an undeclared ingredient in a product can bring public outrage to a boil and even lead to a food scare. Quite simply, consumers don’t like finding out that they have been lied to, particularly about what’s in their food.

How to Avoid This Mistake: Work with trusty suppliers and conduct supplier verification activities so you can have confidence in the ingredients you purchase. Make sure that your food labels and ingredients reflect changes made to the product formula.

Who Cares? Your most loyal customers; Twitter.

Likelihood of Discovery: Low-Medium. Using the final few rolls of old food labels after a slight change in product formulation will likely go unnoticed. The deliberate, ongoing failure to accurately convey ingredient composition is more common than we know. Large-scale food fraud can go undetected for years before being uncovered and technology is sometimes altogether incapable of detecting when ingredients are replaced with a cheaper alternative.

What it will cost you: The ongoing failure to accurately declare ingredient composition could result in lawsuits, fines, and total destruction of your brand.


 
Introduction to Participatory Guarantee Systems
 
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What is a Participatory Guarantee System (PGS)?

A participatory guarantee system is an alternative method for regulating standards of food production. A PGS can be easily understood by contrasting it with the traditional 3rd party certification system.  In that model, a food producer (e.g. a farm) aligns with a set of standards that have been defined by a government or private certification scheme. The farm’s implementation of these standards is enforced via an occasional audit which is conducted by a representative of the auditing firm.

Participatory Guarantee Systems were inspired by the early organic food producers of the 1970s and 80s who wanted to implement the standards of food production which we now recognize as principles of the organic movement. These pioneers in the sustainable foods movement developed their own standards and implemented a system of self governance based on participation, trust, and transparency. This framework is the model for the participatory guarantee system.

A participatory guarantee system (PGS) is a ‘locally focused quality assurance systems that certify producers based on the active participation of stakeholders and are built on a foundation of trust, social networks, and knowledge exchange’
— International Federation of Organic Agriculture Movements (IFOAM)

Participatory Guarantee Systems are not currently recognized as certification tools in the EU or the United States. However, PGS are recognized as comparable to 3rd party certification schemes in several Latin American countries and they are being assessed as a potentially viable alternative to 3rd party certifications.

Example: How to Form a Participatory Guarantee System

Let’s suppose a group of farmers in California wants to create a set of farming standards based on sustainable water-use practices. Unfortunately, there are no certifications available which align with their vision so the farmers decide to form a Participatory Guarantee System called "Water Smart Farming". Here's how it works:

1. A group is formed of stakeholders in this system. The stakeholders includes local farmers, the buyers of their produce, and members of a local non-profit which manages local water resources. All of these groups are incentivized to see that the standards of the PGS are upheld.

2. The group writes a set of standards that the farmers will be held to. This includes "rules" which govern water usage and promote sustainable irrigation practices. This is what the farmers are agreeing to uphold and enforce among other members.

3. The group creates a framework for how the PGS will make decisions. This framework also describes when and how the group will convene and how the group will fulfill the roles of the PGS (e.g. inspecting farms, reviewing records.) This structure may be adopted from other successful PGS.

4. The group defines how they will conduct "quality assurance" -- in other words, how the group will make sure the system is being followed. This will entail site inspections to evaluate irrigation practices and water usage. Quality Assurance also entails meetings where the farmers can discuss their experiences and methods for improving. Typically, members of the PGS are rotated between two groups: one "visit group" conducts inspections and the other "evaluation group" evaluates inspection data. This aims to ensure fairness and minimize mistakes that could be made by one evaluator.

5. Participating farmers follow the application procedure that the group has created. They begin by evaluating how well their water-usage practices align with the standards of the PGS. If the application is approved, then a farm visit is scheduled.

6. Farmers who are in good standing with the PGS may label their product with the "Water Smart Farming" logo. This illustrates that the products were farmed according to the standards of the PGS. Membership with this PGS may also offer other perks provided by various stakeholders in the system: the local government will market products farmed by members of the PGS; a sustainability-conscious distributor will carry products created by member farmers; a local retailer agrees to only sell products created by member farmers.

Comparing Participatory Guarantee Systems and 3rd Party Certification 
Subject Area Participatory Guarantee System 3rd Party Certification System
Enforcement party Stakeholders A private auditing firm (or government agency)
Enforcement mechanism Continuous evaluation of materials, sites and practices through site visits and meetings Infrequent, scored audits
Consequence of repeated failure to achieve standards Removal from the PGS an dthe los of associated benefits (marketing and sales opportunities) Loss of certification
Themes Total transparency and universal accessibility of documentation.

Stakeholder participation in decision making and enforcement of standards
Confidentiality between food producer and auditing firm.

The food producers are non-participants in the creation of standards and the auditing process.

 

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3rd Party Certification System and an Increasingly Self-Regulated Food Industry
 
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Introduction

My work as a consultant often entails teaching food manufacturers about 3rd party audits and supporting them to achieve certification so they can expand their sales opportunities. The story is often the same — my client has wholesale buyers lined up for their product, but the buyer won’t ink the deal until a 3rd party audit result is provided. While some clients can afford invest in the consulting fees and facility upgrades to meet achieve the private certification standards, other cannot make this investment. Their sales opportunities and growth will suffer until they can achieve that shiny gold star, the 3rd party certification.

This piece offers two claims about how the rising importance of private certification impacts the food industry. Under each heading, I explore some of the benefits and drawbacks experienced by various actors in the food industry, including food manufacturers, public health regulators, and consumers.


The private certification system has become the dominant mechanism by which food businesses are deemed sufficiently safe and high quality to be sold in mainstream markets.

At one time a government inspection report was a valuable indicator of a food manufacturer’s food safety and quality performance. Recently, the authority of these documents has declined while an audit report from a private certification body is a trusted symbol.

Pros: 

  1. 3rd party certifications are internationally accepted. Certification schemes transcend jurisdictional and national boundaries, creating global recognized standards of food safety and quality. This means that a food retailer with a catalog of international suppliers can verify the quality of their suppliers’ products without having to understand the food regulations of the country of origin. Instead, they simply ask their suppliers to align with one of the top certification schemes. This is an enormous convenience for wholesale buyers, who can trust 3rd party certification as a uniform standard of product quality, regardless of  the country of origin. 

  2. A food manufacturer can request and pass a 3rd party audit on their own schedule. If a beverage manufacturer is confronted with a huge sales opportunity that requires a 3rd party audit, they could feasibly schedule the audit, pass the audit and present that documentation to their retail partner in a matter of weeks. On the other hand, a food manufacturer may only be inspected by the FDA every few years. A well-established food producer may not have a government-issued inspection report when a prospective buyer requests it, or else the inspection report may be old enough that the buyer refuses to accept it.

Cons: 

  1. The central role of the 3rd Party Certification System creates a pay-to-play system. Procuring an expensive certification from one of several private certification schemes is a de facto requirement for selling food in mainstream markets. Whether supplying food to a major supermarket, a hospital, a university cafeteria, or a specialty outlet such as QVC or an airline caterer, these buyers will uniformly require 3rd party certification from their suppliers. A food manufacturer which is unable or unwilling to pay-to-play sacrifices the opportunity to participate in these major markets.

  2. A food manufacturer whose operations meet FDA requirements may still have to spend tens of thousands of dollars to achieve the exalted standards of the 3rd party certification scheme. Achieving 3rd party certification comes at a cost. While the audit itself may cost several thousands of dollars (by contrast, FDA registration and inspections are free), preparing for an audit will easily cost cost tens of thousands of dollars in consulting fees and facility upgrades.  This disproportionately hurts small-to-medium food producers and translates to higher food costs for consumers.

The dominance of the 3rd Party Certification System is contributing to a self-regulated food industry

Pros of Industry Self-Regulation: 

  1. The FDA cannot possibly keep up with the task of protecting the nation’s food supply. Despite a wealth of corrupt incentives, private-sector oversight generally supports the preservation of public health.  

  2. The standards set by 3rd party certification schemes typically exceed the standards published by government health agencies (e.g. the FDA). In turn, higher standards can translate to better consumer protection mechanisms and public health outcomes. 

  3. The private sector is a more effective enforcer of food availability than the government. For example, despite the clear illegality of CBD as a food ingredient, the FDA is entirely incapable of keeping CBD-containing items off of shelves. However, when Whole Foods implemented a no-CBD policy in September 2018, the products vanished from all store shelves.

Cons of Industry Self-Regulation:

  1. Industry self-regulation creates corrupt incentives (Ahem, financial collapse of 2009).

  2. Certification bodies (auditing firms) are supposed to be the referees, but their incentives are misaligned. When a certification body audits a food business, they are paid for that audit. If the firm passes the initial certifying audit, then a subsequent yearly audit is required for that food business to maintain certification with the scheme. By providing a passing score to an audit, a certification body nearly guarantees future income from subsequent audits — after all, why would a food business switch auditing firms if their current auditor is giving them passing grades?

    At the same time, the certification bodies have a negative incentive for providing a failing audit score — A food manufacturer would likely pursue the same audit from a different firm in hopes of finding a more lenient auditor who will provide a passing score.

  3. Individual certification schemes also face corrupt incentives — namely to stoke public uncertainty about the food supply and to build a massive food-safety-complex which further entrenches the necessity of private certification schemes and consultants.

    One way food certification schemes preserve their place in the food-safety-complex is by continuously updating their standards. The rhetoric here typically emphasizes the changing science of food safety and need for industry to align with these findings. The schemes don’t disclose the actual impact of these changes in terms of public health because they don’t have to —  both retailers and consumers are quick to accept any marginal improvement in our food supply. But, while a new food safety standard will be heralded as a landmark contribution to improved public health, the actual change might only take a tiny fraction of the food supply from “very safe” to “very very safe”.

    The impact on the food industry is less murky: food manufacturers have no choice but to upgrade their operations so that they can maintain their certification and their place on supermarket shelves. This may require hiring an “official” consultant dispatched by the certification scheme or additional audits to confirm that the latest standards have been faithfully implemented. These costs — easily tens of thousands of dollars per manufacturer — filter back up to the certification scheme.

    “Upgrading” their standards is the easiest way for a certification scheme to inject capital into their business and preserve their continued existence in the food industry. And over time a convenient macro-trend emerges: the standards of private and public regulations continue to diverge — with the private certification schemes requiring a much higher set of food safety and quality standards than the government.

    All else aside, when confronted with the choice between “more safe” and “less safe”, the consumer will always demand “more safe”. But it’s impossible to compare the two frameworks without a consensus about what is safe food?  Would you add a dollar to the price of yogurt if it meant reducing the chances of sickness from 1 in 10 million to 1 in 100 million?  The self-regulated food industry may have already made this choice for you. You’ll pay the extra dollar for the extra-safe yogurt because the supermarket refused to carry the “less safe” brand which only offers a 99.99999% assurance of product safety. Is this a valuable protection of public health or a sign that self-regulation in the food industry has gone too far?


 
 

Glossary of Terms:

Certification Scheme - The companies that write and maintain private certification standards (e.g. BRC, SQF)

Certification Body - the auditing firm which actually conduct the audit. An auditing firm may serve as a certification body for multiple certification schemes so that they can provide the type of certification that their client is seeking.

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How to Pass Quality Assurance and Get Your Product Into Major Retailers
 
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It’s More Than Winning Over the Buyers

What is Quality Assurance?

At a food retailer, the QA team is responsible for maintaining the quality and safety of products sold by that retailer. In the case of a supermarket, this would include products sourced from suppliers, products made through contracted manufacturers, and even ready-to-eat food prepared at the onsite deli. The QA Team conducts quality inspections, handles food recalls, and conducts supplier verification.

The Quality Assurance team may be the reason your food product doesn't make it into major retailers and distribution chains. This would happen if you are unable to prove that you are following industry-standard practices. For this reason, it's important to understand what your purchaser's QA Team is looking for and how to work with them so that you can get your product onto retailer shelves and grow your sales.

Even after a major buyer has pledged to place an order, there’s another hurdle before you can start selling your products to a new retailer: The Quality Assurance (QA) Team.

The QA team’s job is to uphold quality standards and protect the company’s reputation. They evaluate hundreds of prospective (and current) suppliers to determine whether their products meet the company’s quality and safety standards.

They are the gatekeeper for all new products and if the product doesn’t pass quality assurance, then the retailer won’t risk carrying that product.

Don’t let this frighten you. The QA team has no incentive to arbitrarily reject new suppliers and they are often willing to work with new suppliers to help them pass QA and get their products onboard.

Before we go into strategies for working with QA teams, let’s review how the process typically works.

How QA Teams Approve Suppliers

After the buying team expresses interest carrying a new product, the QA team steps in to conduct some due diligence about the supplier.

The QA team will typically email the prospective supplier requesting information, such as a third party audit result or records showing your company’s food safety practices.

After, there may be some back-and-forth with your contact on the QA team. This depends on your company’s ability to provide the requested documents and demonstrate the safety and quality of your product.

Finally, the QA team will either give your products a “pass” or they will delay the company’s purchase of your products until you can achieve specific requirements.

With this in mind, having a positive relationship with your a prospective buyer’s QA team can mean the difference between winning a huge account or not. To stay in their good graces, consider the following tips:

  1. Before asking a question or requesting a piece of material from the QA team, check and see if it’s available on the company’s supplier facing website.

  2. Avoid asking them to explain food safety concepts or regulation to you. Instead, look it up on FDAreader.com or, if we’ve failed you, then google it.

  3. Fill out all forms and documents as completely as possible and provide all requested documents.

  4. Collate your submissions a minimum number of attachments and present it in the most straightforward possible manner. Your QA contact reviews thousands of these documents per month and will appreciate your efforts towards clarity.

  5. Be honest. The QA team doesn’t demand perfect manufacturing programs as a prerequisite for approval and they appreciate when suppliers are honest about their process.

What the Quality Assurance Team is Looking For

QA teams want a supplier who presents them with a straightforward case about “why our product’s safety and quality is not worth worrying about.”

The most compelling evidence is a third party audit result— which reads like a physical exam for your company’s food safety practices. In the absence of that, a thoughtfully compiled and organized set of food safety policies and records can signal that your business is serious about food safety. Ultimately, the QA team will describe their needs — and it’s important to listen. Dozens of times, I’ve been able to get my clients’ products into new retailers despite their inability to meet the “official” supplier qualifications. All I did was follow the instructions we were given, provide the documents that we were able to come up with, and present it in an easy-to-read format.

Honesty is the Answer (Even When the Truth is Imperfect)

When confronted with a shortcoming in my clients’ food safety practices I have found that honesty is the answer. Specifically, I candidly explain the current state of that food safety issue and how the supplier is working to fix it. The following anecdote from my consulting career illustrates how this has worked in my favor:

One time, a distributor hired me to fix some trouble they were having with a nationwide supermarket chain. The supermarket had already been selling the distributor’s product for almost a year but the distributor was ignoring all of QA team’s emails. Eventually, the supermarket’s buying team threatened to halt all business with the distributor unless they responded to the QA team’s requests, and so the distributor hired me as a consultant to sort it all out. I quickly put together a basic food safety plan— a set documents showing how the distributor managed food safety across their operation— and sent it off to the supermarket’s QA team.  

The QA manager who was reviewing the documents noticed a problem and called me. He explained that, while the warehouse operation looked safe enough, the distributor didn’t have any evidence that the actual foods they were buying were safely manufactured. In other words, he pointed out that the distributor hadn’t done any supplier verification. He was 100% right and this could have been a deal breaker for working with the distributor.

I took a deep breath and told him the truth— that the distributor hadn’t verified the safety of any of the foods in their catalog prior to hiring me that week. I had just begun sending out requests to the distributor’s suppliers a few days before. So far only one supplier of ninety had responded. I sent the QA manager an overview of how I was beginning to implement a supplier verification program on behalf of the distributor. I also shared the records showing we had collected information from and approved one supplier. Then I waited.

To my surprise, the QA manager was grateful for the honesty and he approved the distributor to continue supplying the supermarket. We were able to organize a timeline by which the distributor would verify all of their suppliers over the course of several months and communicate this to the supermarket.

In my experience, displaying honesty— even about imperfections in my client’s food safety program— actually instilled a greater confidence in the program overall. QA teams are constantly being lied to (I’m sure they don’t like it) and they are quick to acknowledge that even the best suppliers have imperfect programs.

So how should you approach working with a new purchaser and their QA team?

  • Figure out exactly what they want and don’t waste their time

  • Be honest about where you can and and can’t meet their expectations

  • Present your documents in an organized fashion.


How to Understand a Food Recall

How to Understand a Food Recall

Outgoing FDA Commissioner Gottlieb released his 2nd letter concerning the legal fate of Cannabidiol (CBD) in the last 6 months

You are probably overreacting when it comes to food recalls. When an FDA food recall is issued, most people interpret it to mean “that food isn’t safe. I should stop buying it in grocery stores and eating it in restaurants.”  This is an understandable and cautious reaction, but it is completely unnecessary. Coupled with media-fueled fear mongering, it can lead to “food scares” which can shatter industries and wipe out small businesses and farms which played no part in causing the recall. Here are a few things to consider when you hear about an FDA food recall.

The Scope of a Food Recall is Much Smaller Than You Think:

When a recall notice is recalled, it typically refers to a single batch of product created in one factory under a single brand. The batch details are listed in the recall notice released by the FDA, although the media won’t likely include this detail when they report it. Let’s use the recent recall of Pilsbury Unbleached All-Purpose Flour(5lb) as an example: only lots 8 292 and 8 293 of Pilsbury Unbleached All-Purpose Flour(5lb) were suspected of being unsafe and therefore were recalled.

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With that in mind, consider the following:

  • It’s probably unsafe to eat Pilsbury Unbleached All-Purpose Flour(5lb) labeled with lot code 292-8 or 292-9. That’s it.

On the other hand:

  • It’s safe to eat all other lots of Pilsbury Unbleached All-Purpose Flour 5lb

  • It’s safe to eat any other type of Pilsbury flour (there’s probably no safer time, in fact)

  • It’s safe to eat any other Pilsbury product

  • It’s safe to eat all other brands of flour

Unfortunately, most people who read the news will gloss over the details and simply stop buying flour or pilsbury products for a few months. The impact of this “food scare” may be sufficient to shutter smaller producers who, unlike Pilsbury ,may not be able to weather the dip in sales until public confidence is restored.

How “Food Scares” Occur

Of the Last 25 FDA Food Recalls (2019):

  • 14 were due to labeling errors.

  • 9 were due to the possible presence of illness-causing bacteria

  • 2 were related to the possibility of a foreign object in the food (soft plastic in one case, unknown in the other)

It’s rare that an entire group of foods (e.g. cantaloupe) is recalled. When this does occur, it’s in response to a widespread foodborne illness outbreak. The general nature of the recall is a reflection that investigators are still working to figure out the exact source of the problem. This type of urgent warning is always temporary, although the reverberations may harm those industries for years.

Let’s say that hospitals in three midwestern states have seen an unusual spike in Salmonella cases. Epidemiologists would use patient tests to see the if cases are related and also interview the patients to see what they had been eating. Eventually, they will be able to identify the commonalities in cases and determine use statistical analysis to determine that cantaloupe, for example, was the food to have caused the outbreak. 

Normally, epidemiologists would continue investigating and, by understanding where the victims shopped and ate, be able to trace the supply chain to a particular processing plant. Rarely, illnesses are reported at a faster rate than epidemiologists can trace the problem. If an atypical number of hospitalizations related to salmonella continue to be reported with cantaloupe as the likely culprit, public health officials may be forced to go public with whatever information they have collected at that time —  if only to stop the spread of illness. 

At worst, this will be a food-wide recall, which may recommend consumers in those midwestern states to discard and avoid eating all cantaloupe for fear that it is contaminated with salmonella. This sort of alert can be effective in curbing new cases of the illness outbreak, but it also prompts sensational media reports. This can create a “food scare”, where consumers who are not necessarily exposed to that risk (i.e. outside of those midwestern states where the danger has been identified) forsake cantaloupe in the misguided notion that they are preserving their safety. This can cause financial hardship for cantaloupe farmers globally and tarnish the reputation of the entire industry for years.

Ultimately, the epidemiologists will trace the illness to a farm or processing center and the scope of the recall will be narrowed to only concern the cantaloupe which is bears some risk to the consumer. But the resulting food scare may sink those small farmers who can’t weather the lasting decline in sales. They are unfortunate, collateral damage caused by a negligent food processor, sensational reporting, and misguided consumers.

Most Recalled Foods Are Still Safe to Eat

Most recalled food items won’t actually make you sick. In fact, 56% of the FDA food recalls so far this year were based on labeling errors. Here are two common scenarios where a labeling error would lead to a recall:

In one scenario, the manufacturer accidentally put coffee ice cream in the container labeled Strawberry Ice Cream. Here, a recall is required because the nutrition label and ingredients list — which are heavily regulated—  don’t match the product inside the packaging. From the perspective of the FDA, this is no different than a manufacturer lying about the ingredients in their product, so a recall is typically initiated.

A second common cause of recalls is due to “undeclared allergens”. This means that the manufacturer failed to state a major allergen that their product contains. For example, Bachman pretzels recently recalled a batch of their product for failing to state that it “Contains Milk”.  For the small group of people who are allergic to milk, this failure to disclose the allergen in the product could trigger an allergic reaction. This recall is important because someone with a milk allergy wouldn’t typically avoid pretzels and so the allergen declaration is a critical measure of consumer safety. For most people however, the presence of an undeclared milk allergen would not pose a health hazard.

You Are Unlikely To Get Sick Even If You Consume A Recalled Food

The complexity of our food systems and scope of supply chains present a statistical unlikelihood that you will become sick from a product implicated in a reported food recall. The following hypothetical aims to illustrate this point:

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5 Things We Learned From the FDA Update on CBD Foods

5 Things We Learned From the FDA Update on CBD

Outgoing FDA Commissioner Gottlieb released his 2nd letter concerning the legal fate of Cannabidiol (CBD) in the last 6 months

Outgoing FDA Commissioner Gottlieb released his 2nd letter concerning the legal fate of Cannabidiol (CBD) in the last 6 months

Earlier this year I wrote an article in response to FDA Commissioner Scott Gottlieb’s update on the regulatory status of CBD. As I explained, despite the passage of the 2018 Farm Bill (which legalized hemp as an agricultural commodity) CBD is still illegal as a food ingredient under FDA regulation.

Alarmed by the widespread misinterpretation of the 2018 Farm Bill and the FDA regulations concerning CBD,  the outgoing FDA commissioner released another statement on April 2nd, 2019.

Here’s what we learned:

  1. The FDA Is Targeting CBD Products Which Make Drug Claims

The FDA appears most concerned with CBD-product manufacturers who make claims about the ability of CBD to cure or treat disease (aka ‘drug claims’). They have issued warning letters to several brands of CBD foods, including Relievus, Nutra Pure, and PotNetwork for illegally stating the therapeutic affects of CBD without sufficient evidence and the required FDA approval. These companies have made unsubstantiated claims related to CBDs ability to treat addiction, alzheimer’s disease, tumors, cancer, among other ailments.

The imminent concern of the FDA is this: a consumer reads those drug claims and purchases a CBD product to treat a serious health ailment. If this individual chooses to treat their disease with CBD over a drug whose effectiveness has been endorsed by the FDA, that individual’s health might deteriorate. 

Gottlieb vowed that the FDA will continue to go after companies making these illegal drug claims on CBD products.


2. Expect Enforcement of Most CBD Foods to be Minimal


If you read the statement closely, you’ll find great news for the majority of CBD food producers.

As it relates to CBD products which do not contain egregious drug-claims, the FDA described their enforcement in milder terms. The agency offered a tepid commitment to “monitor the marketplace and take enforcement action as needed to protect the public health”. CBD products which do not make drug claims and which contain reasonable doses of CBD are not a major public health concern. It appears that the FDA will not invest resources in taking down the manufacturers and retailers of CBD food products, for now at least.

3. The FDA Still Isn’t Convinced CBD is Safe

Gottlieb outlined some concerns related to CBD in his statement. When CBD was successfully trailed as an active ingredient in the epilepsy drug Epidiolex, it was administered in specific dosages under medical supervision and marketed with FDA labeling. Because scientists currently don’t understand the effects of high consumption levels or the cumulative effects of CBD over time, the risk assessment of CBD as a food ingredient remains incomplete. The commissioner also noted a possibility of liver damage resulting from ongoing CBD usage, which needs to be explored further.


4. The FDA is Clarifying their Current Stance and Seeking Possible Paths Towards Legal CBD in Food

In a nod to the opacity of their own regulation, the FDA has promised to update their website with plain-language explanations of CBD regulation and an FAQ section. They also outlined two steps towards considering the lawful marketing and sales of CBD products: the creation of an internal agency group tasked with exploring regulatory pathways to legality and an upcoming public hearing to gather stakeholder input about cannabis-derived products.

The agency also re-affirmed their commitment to building a transparent regulatory framework surrounding CBD and cannabis-derived products. While the FDA regulations are mind-numbingly convoluted and the legal nuances of CBD outshine most prospective food ingredients under FDA consideration, I am hopeful that their efforts can provide clarity on this popular issue.

5. The FDA Won’t Undermine Its Own Policies to Legalize CBD

As stated in my previous article, there are many reasons why the FDA currently assesses CBD as unfit to be a food ingredient. In his statement, Gottlieb reaffirmed that CBD would have to comply with all facets of regulation — including the FD&C Act and the standards set for new dietary ingredients and food additives— before they give CBD the green light. While the allocation of agency resources may expedite this process, CBD will have to fit into the regulatory framework of the FDA and not visa versa.

Conclusion


It appears that CBD is on the pathway towards legal acceptance as a food ingredient. Despite political pressures, the process may take a year or more as it navigates the standard regulatory path for a innovative food ingredient.

The short term viability of CBD food products may hinge on the willingness of major retailers to carry CBD-containing products, which are still illegal. As of February 2019, Whole Foods included CBD on their list of banned ingredients while the FDA commissioner criticized CVS and Walgreens for continuing to carry CBD products.

 
Why is the FDA Picking a Fight with Plant-Milk?
Oat Milk post image no text.png

The only thing harder than developing and selling an innovative food product is figuring out a legal name for it. The FDA has long sought to protect consumers from imitation products and false advertising by implementing Standards of Identity which define parameters for what we can call certain types of foods. 

These protections ensure that our milk is not diluted with cheap fillers and that a package of imitation crab clearly describes what is doing the imitating. The FDA’s stated goal is for a consumer to glance at a product on a shelf and know exactly what they’re buying. 

But when it comes to innovative products, things get tricky. If you pulled everything off the shelf labeled “milk” in your local supermarket, you’d likely end up with equal parts rice, almond, oats, and soy extracts as true dairy milk. The dairy lobby is not happy about this.

Is it clear that oat milk did not come from a cow? Most likely, yes. The plant-based-milk industry is adamant about this and is quick to remind us of the absurd image in which a dairy worker milks a lactating almond. Nothing is unclear about plant-based-milks, they contend. In a 2013 ruling supporting the alt-milk industry, Judge Samuel Conti expressed that the hypothetical consumer confused by the terms “almond milk” and “soymilk” also probably thinks ebooks are made of paper. According to his decision, the notion that this consumer exists “stretches the bounds of credulity.

On the other hand, is it possible that consumers of oat milk assume it has similar nutritional properties as dairy milk? Yes. At least I assumed so, until now. 

This is the crux of the FDA’s argument for why oat milk is a misleading product name — that a mother would substitute her child’s dairy milk with a “milk” product that, unbeknownst to her,  has a substantially diminished nutritional profile. As a result, her child could come become under-nourished and at risk for chronic disease —  which the FDA was specifically created to eradicate.

Continuing with the agency’s reasoning, this wouldn’t have happened if the product weren’t labeled as milk. An “Oat Non-Dairy Beverage” has no presumed nutritional profile, and this is why it’s a safer name to put on the label.

As it turns out oat milk has substantially less protein, calcium and iron than dairy milk, although oat milk producers often fortify their products with vitamins and minerals to make them more nutritionally robust.

Stroll down a supermarket aisle and you’ll notice the risk-averse brands who opt for more conservative, descriptive names for their products. They’ll do anything they can to offset the clunkiness of these monikers, from maximizing the word “Oat” to the largest legally allowable size to cluttering the panel with reminders that it is Certified Organic and Gluten-Free.

Some companies have shrewdly labeled their products as “soymik” or “almondmilk”, (spelled deliberately as a single word) and argue that this frees them from various provisions governing “milk” products. And the plant-based milk industry is fighting back on multiple fronts. The Good Food Initiative highlights the labeling restrictions as a constitutional violation of free speech and sees the FDA as perpetuating consumer confusion by “picking winners”. 

It’s true that powerful food lobbies have continually sought to manipulate the FDA to boost sales and deter new entrants to the market — in 2018 fourteen senators voted to prohibit the FDA from studying the use of the term “milk”. And as the controversy about plant-based milks transforms into one about food product marketing, the FDA regulation is ill-equipped to provide consistent answers.

The conflict between plant-based-milks and the FDA is premised on the fact that plant-milks don’t fit the Standard of Identity for “milk”. But the Standards of Identity were written to prevent food manufacturers from trickery on the production line, not to police food naming conventions. It’s no surprise that innovative products foods are so hard to name.

Why Is Oat Milk Everywhere?

The widespread presence of oat milk on supermarket shelves is hardly an indicator of the FDA’s stance on the product’s legality. The agency takes a notoriously reactive stance and will often observe regulation-defying-products for months or years before intervening (e.g. CBD, which is plainly illegal as a food ingredient yet seemingly everywhere as a food ingredient).

According to commissioner Scott Gottlieb, the FDA is working to overhaul the standard of identities for product categories — such as milk and cheese—  whose names have been adopted by innovative plant-based foods. This seems prudent and long overdue, but in the mean time, are plant-based milks really worth going after? 

Perhaps. These regulatory outcomes will set a precedent for an impending food category that expects to be even tougher to regulate and more disruptive than plant-based milks: meat-alternatives. Although “clean meats” such as Impossible and Beyond Burger currently make up less than <1% of domestic meat sales, they are gaining traction in the $90 billion dollar global meat industry. Both the USDA and FDA face an onslaught of regulation-defying food products that are perfectly safe to eat but just don’t fit the framework. Who would have guessed that the hardest part of creating vegan bacon would be deciding what to call it?


 
How the FDA Regulates Nutraceuticals
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What Exactly Are Nutraceuticals?

According to the industry, nutraceuticals are ‘pharmaceutical grade’ nutrients that are consumed for a health benefit. In reality, they are vitamins, minerals, herbs, and extracts.

But you won’t find the word “nutraceutical” in federal law. The only place it appears on the FDA website is in the names of companies that have received warning letters for violating the FDA regulations.

According to the FDA regulations, most nutraceuticals would be categorized as “dietary supplements”. These are extracts, concentrates or combinations of vitamins, minerals, botanicals, herbs, or dietary substances  “for use by man to supplement the diet by increasing the total dietary intake.”

When is a Nutraceutical a Drug?

One of the primary indicators between dietary supplements and drugs relates to health claims. Whereas a dietary supplement is meant to provide nutrients, a drug is designed to treat illness or disease.

So, in order to maintain classification as a dietary supplement (and avoid the FDA’s strict drug approval process), Nutraceuticals must maintain that they are not intended to treat, diagnose, prevent, or cure diseases. So, no label claims about treating pain, or preventing cancer.

How Are Nutraceuticals Regulated?

Producers of nutraceuticals classified as dietary supplements are required to register their facility with the FDA. Much like foods, producers of nutraceuticals are expected to comply with Current Good Manufacturing Practices -- these outline facility standards, employee practices, and sanitation requirements, to ensure that the product is produced in a safe manner.

Labeling standards for dietary supplements are lumped together with those for foods. However, there are unique expectations for how dietary supplements are marketed and what claims they can make.

For the complete set of regulations on producing dietary supplements, check out the guided question set in 21 CFR 111


 
Corrections vs. Corrective Actions in Food Processing
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What You Need to Know

Correction

A correction means taking action in a timely manner to identify and correct a minor and isolated problem that does not directly impact product safety.

Examples of corrections include:

  • Re-cleaning the production line if it appears dirty after the first clean.

  • An employee is asked to leave the production area and put on the proper attire before re-entering the production area.

  • The temperature of a walk-in refrigerator is adjusted because it is a time of high traffic and the temperature is approaching the critical limit.

Corrections occur in the moment and don't require any documentation

Corrective Action

A corrective action is a procedure that must be taken if a corrective action is not properly implemented. This must be documented and the record should describe:

  • What occurred

  • How the problem was corrected

  • How it will be avoided in the future

  • What was done with the product in question

Examples where corrective action is required include:

  • A sample of canned salsa is tested and the pH exceeds the requirement of <4.3.

  • A refrigerator is found to have exceeded the temperature requirement of ≤41ºF for several hours.

  • The producer of bottled juice realizes that during the last production run, numerous bottles were not properly sealed by the capping machine, possibly due to defective packaging.

For more about corrective actions, see our full guide


Correction or Corrective Action?

The following examples illustrate how an operator may choose between a correction and a corrective action


Scenario Type of Action Required Why Recommended Action
Cookies on a conveyer oven are finished in 8 minutes instead of the required 10 minute cook time Corrective Action The cook step is (presumably) a preventive control used to kill bacteria present in raw cookie dough. Because the product failed to achieve the 10 minute cook time, then the preventive control has failed and a corrective action is required. 1. Adjust the belt temperature to reseet to 10 minute cook time.
2. Test to confirm the belt speed has increased the cook time to 10 minutes.
3. Re-cook the cookies for an additional 2 minutes (or discard)
4. Record this on a corrective action form.
Cookies on a conveyer oven are completed in 12 minutes instead of the required 10 minute cook time Correction Since the product was overcooked, it still achieved the preventive control that requires a >10 minute cook time. Adjust the belt speed to reduce the cook time to 10 minutes. Consider testing the overcooked product for quality
Sheet pans are observed to be unclean immediately after being run through the dishwasher Correction This is a minor problem that poses no risk to the safety of the food if it is corrected. Re-run the dishes through the dishwasher and confirm they are clean.
The dispenser for dishwasher sanitizer chemical is discovered to be empty after a day of production Corrective Action It is possible that many utensils and dishes were used in production without having been sanitized. This directly impacts food safety of product that was produced and so corrective action should be taken. 1. Refill the sanitizer chemical in the dish machine and confirm it is being applied during the cycle.
2. Assess why the sanitizer ran out and whether chemical levels should be checked more frequently to avoid this problem recurring.
3. Evaluate the food that contacted the un-sanitized utensils/dishes and determine whether it should be discarded, re-worked or served. If the food cannot be proven to be safe then it should be discarded.
 
CBD and FDA Food Regulation

What You Need to Know about CBD and the FDA

The FDA Regulation on CBD is not as lenient as the widespread presence of CBD would lead you to believe

The FDA Regulation on CBD is not as lenient as the widespread presence of CBD would lead you to believe

This article provides a background on the FDA's current regulation of CBD. To learn about more recent updates, see 5 Things we Learned from the FDA Update on CBD Foods

CBD is a Drug Ingredient, Not a Food Ingredient or a Dietary Supplement

CBD (Cannabidiol) is an active ingredient in an FDA-approved drug (Epidiolex) which was subject to the rigorous drug-approval process. According to FDA regulation, substances which are active ingredients in a drug cannot be introduced as ingredients into food or marketed as dietary substances.

Even if the FDA hasn't yet approved the drug yet, its active ingredients are typically disallowed as food or dietary supplement ingredients insofar drug trials are underway and publicly known.

This is the crux of the FDA's argument for disallowing CBD in food products prior to the June 2018 approval of Epidiolex, a CBD-based epilepsy drug. In 2017, the FDA sent warning letters to producers of CBD-infused food and cosmetic products, arguing that the use of CBD was illegal because publicly known drug trials for Epidiolex were already underway.

CBD Dietary Supplements are easy to come by

CBD Dietary Supplements are easy to come by

There is an exception to the rule: if the substance in question was marketed as a dietary supplement or conventional food ingredient before it became an drug ingredient, then it may continue to be used as a food ingredient. In the case of CBD, the FDA has determined that there isn’t sufficient evidence of it’s historic use as a food ingredient.

Still, in late 2018, the FDA acknowledged that they have the authority to approve the use of a pharmaceutical ingredient in a food or dietary supplement. And according to the commissioner’s statement in December 2018, they are currently deciding whether to pursue this as it relates to CBD (and THC too). What would compel the FDA to allow CBD in FDA-regulated foods? At this point, it’s unclear.

Bottom Line: It is unlawful to sell any food or dietary supplement containing CBD if that product enters interstate commerce.

CBD-Containing Cosmetics are Actually Drugs — even if they don’t make any claims

The difference between a cosmetic and a drug is whether the product "affects the structure or function of the body." Simply, if the product causes any sort of physiological change that is beyond "cleansing, beautifying, promoting attractiveness, or altering the appearance", then it is considered a drug.

For example anti-perspirant is considered an over-the-counter drug because its effects are not merely cosmetic: anti-perspirant causes a physiological change -- it blocks our pores-- which prevents the wearer from sweating.) While deodorant would be considered a cosmetic (it’s merely perfume), sunscreen is considered a drug.

Of course CBD has a physiological effect on the body —it’s the active ingredient in the FDA-approved prescription drug Epidiolex — so any product containing CBD would be classified as a drug. Even if you argued that the CBD served a cosmetic purpose or made no claims about the effects of CBD, it has a well known therapeutic use and this would classify it as a drug.

Does this mean CBD-containing Cosmetics are illegal?

Yes. Unless the FDA changes how they regulate CBD specifically, any producer of a CBD-containing cosmetic would need to submit a New Drug Application and receive pre-market approval from the FDA.

Still, CBD-containing cosmetics are widely available both online and in retail locations nationwide. It’s unclear when and how the FDA will crack down on the illegal sale of these drugs. Typically, they go after brands who make false claims about their drug’s ability to treat or cure a disease. CBD brands who list the therapeutic effects of CBD or directly state its ability to alleviate certain symptoms will no doubt be the first to receive an FDA warning letter.

How will retailers react? We’ll have to wait and see.

FAQ - CBD and FDA Regulation

Does it matter that the CBD is hemp-derived?

No. Regardless of the origin of the CBD, substances which are active ingredients in a drug cannot introduced as ingredients into food or marketed as dietary substances.

What if my CBD/THC product doesn't enter interstate commerce?

If a food product's packaging and ingredients (including the CBD) were sourced entirely in-state and your product is sold in-state, then the product may not be considered as participating in inter-state commerce.

In this case, the product would not be subject to FDA regulation. (Learn more in our article Does the FDA Regulate My Food Business?)

However, this doesn't mean you're in the clear -- check with your state and local health authorities to confirm there's no local law that automatically adopts FDA regulation at the local level or expressly prohibits CBD as a food ingredient.

Why are some companies allowed to sell CBD in foods?

They're not. Many food companies are operating in violation of FDA regulation. The FDA has sent warning letters to food products which contain CBD or cannabis-derived ingredients. However, due to the reactive nature of the FDA and a large array of responsibilities, not all of these companies have been approached.

The FDA regulates all types of new ingredients that are added to food. Whenever any sort of new compound (either a dietary supplement or something that wasn't considered "food") is added to a food, the FDA must first approve that new dietary ingredient.

Can hemp be used as a food ingredient if it doesn't contain CBD or THC?

Yes. There are hemp products that do not contain CBD or THC, such as hemp-seed-derived food ingredients. Three of these products have been added to the list of "generally recognized as safe (GRAS)" ingredients. They are:

1. Hulled hemp seed

2. Hemp seed protein powder

3. Hemp seed oil

The reasoning is that they do not contain CBD or THC. If these food ingredients are manufactured in a way that is consistent with FDA regulations, then they are allowed as ingredients in FDA-regulated foods.

Is CBD GRAS? (Generally Recognized as Safe)

No. While other hemp products (see above) are considered GRAS, cannabidiol (CBD) is not one of them.

If you’d like to check whether a specific ingredient is allowable in food, consider searching this database of .


More About CBD

 
What You Need to Know Before Joining an Incubator Kitchen

As incubator kitchens (commonly known as "shared-kitchens" or "commissary kitchens") pop up at an unprecedented rate, little attention has been paid to the regulation of these multiple tenant food processing facilities.

In this presentation to the Central Atlantic States Association of Food and Drug Officials, Ned Klein explains the regulatory landscape surrounding this business model and how food businesses and shared kitchen operators alike can protect themselves.

Bottom Line: FSMA has a severe impact on shared kitchens operate. For more about FSMA and food businesses, check out our detailed FSMA Guide

 
Understanding E. Coli in a Food Processing Context

What is E. Coli?

The Escherichia Coli bacteria shown under a microscope

The Escherichia Coli bacteria shown under a microscope

We all know that E. coli is a threat to human health that is transmitted by food. But what foods specifically? How is it controlled and how can we protect ourselves from it as eaters and food producers?

The Basics:

Escherichia coli is a bacteria that produces a toxin called “Shiga”, that can cause food borne illness and even death.

Associated Foods:

  • Raw ground beef

  • Raw seed sprouts

  • Raw milk

  • Unpasteurized juice

  • Foods contaminated by fecal matter

Transmission: 

Human-to-Human or via contaminated food.

Incubation Period: 

Usually 3-4 days after exposure, but it can range from 1-9 days.

Symptoms:

  • None (it can be asymptomatic)

  • Diarrhea

  • Bloody Diarrhea

  • Kidney failure

Control Measures (i.e. how we stop it)

  • Cooking food to 155º for 15 seconds will kill E. coli.

  • No bare hand contact with ready-to-eat (RTE) foods

  • Strong employee health policies (i.e. no sick employees handling food)

  • Hand washing

  • Prevention of cross-contamination

  • Pasteurization or treatment of juice

The Bottom Line:

E Coli is a dangerous bacteria that can be transmitted via food and cause tremendous harm. At the same time, it’s something we can control quite easily and, if you are taking appropriate precautions, should not be something to worry about.

If you have more questions about how to control E. coli, ask in the comments section below.


 
What is a "Kill Step" in Food Safety?

What does a “Kill Step” or "Lethality Step" mean in Food Safety?

When I was first managing a commissary producing 10,000 meals per day, our engineer was always talking about the “kill step.” I never knew what he was talking about but I have since realized it is one of the most important steps in food safety.

Most efforts we take in food safety are related to harmful bacteria. And most efforts are related to minimizing (but not stopping) the growth of harmful bacteria.

A strategy that minimizes bacteria growth is refrigeration. Most bacteria can’t reproduce quickly in cold, but they still reproduce, albeit at a slow rate. This is the reason that perishable food doesn't last indefinitely in the fridge. Of course, without refrigeration, bacteria grows quickly at room temperature and we intuitively know this is bad (i.e.leftover chicken left out overnight).

The most important thing to remember is this: if you leave food on the counter overnight and then put it back in the fridge, it won’t kill the bacteria that grew while it was sitting out, it’ll just slow down the growth process from the moment you put it back in the fridge.

This graph should help illustrate what I mean:

Food Safety Chicken Bacteria pt 1.jpg

What's Happening in this Graph?

1. You have chicken leftovers in the fridge. There is some bacteria in the leftovers, but it is still safe to eat. You can also see that bacteria growth is slow during these periods because of the cold.

2. You accidentally leave the leftovers on the counter overnight. Eek! We can see by the steepness of the line that bacteria count is growing RAPIDLY during this time, because bacteria are happy and reproduce quickly at room temperature.

3. In the morning, you see that you left the leftovers out all night. At this point, the bacteria level is unsafe to eat, but you put them back into the fridge anyway. While this slows down the growth rate of the bacteria, there is still an unsafe amount of bacteria in the chicken. Remember the refrigeration slows down bacteria growth rates, but it does not kill existing bacteria. So why did you put it back into the fridge? (keep reading!).

4. At lunch, you throw the chicken into the microwave and nuke it for 4 minutes, remembering that you left it out all night on the counter. This, my friend, is the kill step. Cooking (in this case, chicken) to 165º F doesn't slow bacteria growth, it actually kills all of the bacteria that already grew on the chicken.  At 165º only 1 in 100,000 Salmonella bacteria will survive. We call this a "Log 5" reduction because it reduces the count by 5 zeros. In effect, it "resets the clock" and makes the food safe to eat again. we see on the graph that the bacteria count plummets to almost nothing.

5. The leftovers are so goddamn hot that you went to write a blog post and forgot all about lunch for an hour. During this time, the leftovers cooled down to about room temperature, which triggered rapid bacteria growth. However, because you killed almost all of the salmonella bacteria in the leftovers, the total bacteria count remains low, despite exponential growth rates. It's still safe to eat even though it sat out at room temperature. This is fairly intuitive.

6. You remember the food and eat your (lukewarm) lunch. It tastes good and you didn't expose yourself to any food safety risk.

 

What Did We Learn?

  • Cooking/Reheating food ("The kill step") drastically reduces harmful levels of bacteria and makes it safe to eat.

  • Slow bacteria growth doesn't necessarily mean the food is safe to eat (as in step #3). Putting food with unsafe levels of bacteria in the refrigerator won't kill the pre-existing bacteria.

  • Fast bacteria growth doesn't necessarily mean food is unsafe to eat, as in Step #6. Think about your elementary school lunchbox (not refrigerated!). It's OK to have rapid bacteria growth for short amounts of time IF you're starting with a low bacteria count OR if there's a kill step after.

OK, So What is a Kill Step?

Here are some examples of "Kill Steps" used to reduce bacteria counts in food production:

  • Cooking

  • Use of chemicals: For example, using anti-microbial produce wash reduces bacteria counts in vegetables that will be served raw.

  • Pasteurization: heating something up without meaningfully changing it's composition to kill bacteria

  • Freezing: The majority of fish intended for raw consumption is frozen for a period of 7 days to kill harmful parasites. Note that freezing isn’t effective as a kill step against bacteria.

It's important to remember that different microorganisms have different tolerances for specific treatments. Another way of saying this is: what would kill a human may not kill a cockroach (and visa versa in some cases).  Freezing kills specific parasites present in raw fish, but it doesn't kill Listeria Monocytogenes, it just slows down the growth rate. Depending on the food being manufactured, multiple kill steps may be used to address different hazards in the production process.

What Happens When You Don't Use a Kill Step

Almost all food production operations use a kill step. The reason is because we don't know the preexisting microorganism counts when we receive a product in our facility. For example, we don't know whether the vegetables that we serve raw had safe or unsafe levels of E. Coli in them when they were purchased from our supplier.  Even if our process implies good food handling practices and low bacteria growth, we still may be putting our customers at risk because our supplier did not take precautions. This graph explains the risk we take on when we don't have a kill step:

Bacteria Growth with no Kill Step.jpg

It's impossible to know the level of bacteria growth in a purchased ingredient without conducting expensive lab tests. What we can do is choose reputable suppliers, take the temperature of incoming deliveries to confirm they weren't mishandled in transport, and include a kill step in our production process. By including a kill step in our process, we are not relying on our suppliers to have a 0.00% error rate.

Bacteria Growth with A Kill Step.jpg

In order to eliminate that risk, we include a kill step so we know our food is safe to deliver to customers, even if we received unsafe products from a supplier.

So What's the Kill Step in My Process?

Before you pick a kill step, you need to be aware of what specific microorganisms are found in the foods you produce. The good news is that specific types of harmful bacteria only exist in specific food groups, so if you make raspberry jam, you don't need to worry about bacteria that lives in shellfish. You can look up what types of bacteria exist in the food you produce in this FDA Training Manual on page 485-486.

Once you know what the hazards exist in your process, you can investigate what is an appropriate kill step and implement it.

Do you use a kill step in your production? Comment below

 
My $250,000 Lesson in Food Safety

I had been managing a 20k square foot food manufacturing facility for 8 days when we were inspected and shut down by the local health department.

I was terrified when the inspectors arrived. What were they looking for? What would they discover that I was unaware of? This is a fear that many restaurant owners and food producers are familiar with.

I made 3 mistakes that closed our business for 4 days and cost the company $250k, excluding lost revenue.

Mistake #1: Everything is OK Because This is How We’ve Always Done It

My predecessor had twenty years experience managing food establishments. When I took over, I trusted everything was operating according to the regulations and maintained the same standard. Employees washed their hands, wore gloves, and we had a team of porters cleaning the space every night. No report of food poisoning was ever traced back to our operations.

So everything is OK, right? [winces and pushes these concerns into the back of your mind]

Mistake #2: It Is Not Our Responsibility

The fruit flies that settled on our ceiling hadn’t come from our space. They had been living in the building-wide compost bins, which was situated outside of our space, albeit directly under our kitchen. We had fly traps in place and we had written the building 2 emails about the problem already.

Food producers tell me the same thing about their suppliers: “It’s their responsibility to make sure there is no safety risk in the chicken/flour/produce/glassware they sell us.”

Really?! Would you bet a quarter million dollars and your business’ reputation on it?

Mistake #3: Food Safety is Complicated and Something I Can Ignore Until We Get Bigger

Ugh. I am really talented at avoiding things that seem daunting. Plus, food safety regulations are really long and boring.

So I covered my eyes and ears and sang to myself at the top of my lungs. I told myself I’d fix the problems when we had more resources and when we were big enough to matter.

Have you ever told yourself any of these things?

THERE IS GOOD NEWS: you don’t need to know everything about food safety to ace 3rd party audits, and scale operations to millions of dollars in sales. In fact, most food establishments only need to control 1-3 hazards.

I will teach you to achieve food safety excellence without changing your operations, incurring huge costs, or taking up your time.

What part of food safety worries you? Post in the comments.

Digital vs. Paper Record keeping in a Food Processing Environment

I am often asked by food producers whether they should convert their record-keeping to a digital entry process. I always respond by asking them why do you want to do this?

It seems like a natural change, that adopting digital record keeping in food production is a natural transition as an operation matures.  Actually, digital logs aren’t always better than paper logs.

I implemented a fleet of iPads and digital logs in my own commissary, only to return to pen-and-paper record keeping when I struggled with accountability and completeness.

record keeping paper or digital Blog Post Thumbnail (1).png

Digital Logs:

Pros

  • Can be accessed via tablet in the production space.

  • Updates can be rolled out seamlessly (i.e. sent to the iPad remotely).

  • Past records are accessible anywhere: simply print out a copy.

Cons

  • Technology inevitably gets complicated. iPads must be charged, housed, sterilized, and updated.

  • Missing entries are more difficult to see when records are housed digitally

  • They are easy to fabricate

  • Requires a substantial setup and training to implement

  • Often requires proprietary or expensive software

  • Expensive hardware


Paper Logs:

Pros:

  • They’re stupid simple.

  • They are harder to fabricate and missing entries are easy to spot

  • Simple technology means zero training

  • They are cheap to implement (printer access + clipboards + pencils)

Cons:

  • Paper records can get lost and are lost forever.

  • They require manual updating: printing new sheets and setting them around the production facility.

  • Requires a paper filing system for storage.

So Where Should I start?

Here’s my advice: start with paper logs. They’re easy to implement and will get you into the habit of record keeping. You will probably change the format of your record keeping materials a lot in the beginning: paper will support this. Once you get comfortable with this and missing entries ease to become a problem, you may consider transferring to digital.

The real benefits of digital record keeping goes beyond eliminating paper copies: seamless integration of technology (bluetooth thermometers! WIFI enabled scales!) will bring an unprecedented level of professionalism and ease to your production process. But to start, I recommend keeping it as simple as possible: pencil and paper.


 
3 Reasons You Should Conduct Supplier Visits

Supplier visits are a wonderful thing to procrastinate on if you’re a food manufacturer or restaurant owner. There’s barely enough time to get through your own production, so why lose a day to go visit one of your suppliers? Here are 3 reasons your business will benefit from a field trip upstream:

  1. Your customers care about product quality

  2. You are legally compelled to conduct supplier visits

  3. You will learn how to improve your business

 

1.  Your Customers Care About Product Quality

Your customers demand the highest quality products from you. This means consistency of product, zero risk of food borne illness, and a product that tastes perfect every time. As a food producer, your sole focus is to get an "A+" on this every single day in your own facility. But can you guarantee the same of each of your suppliers?

Here is a simple and yet difficult truth to swallow: when you take custody of purchased ingredients/packaging/goods, you are responsible for them. For example, if you produce chocolate bars and your customers gets sick because of salmonella-infected sugar that was mishandled by your supplier (not you!) then your product will be recalled. Perhaps theirs will too, but that hardly matters when your production is halted and your brand reputation is at stake.

Here is a less extreme example: a supplier visit might show you that one of your suppliers is taking risks that you don't feel comfortable with. Whether it's a less-than-clean facility or lax attitudes about food safety basics, this may open a conversation with them about raising their food safety standards or losing your business.

2.  You Are Legally Compelled to Conduct Supplier Visits

Ahh, the Food Safety and Modernization Act (FSMA). All food manufacturers except exempt facilities (i.e. small timers and very low risk operations) must have a Supplier Verification Plan. In short, you have to prove that you are doing your due diligence when it comes to vetting your suppliers, beyond picking the vendor with the lowest prices.

Fortunatelythe standard for "Supplier Verification" plans is fairly low from a regulatory standpoint because FSMA is new and everyone is still catching up. It doesn't necessarily require supplier visits, but this is actually one of the easiest ways to comply with FSMA without having to write out long, complicated food safety documents. Just visit the supplier and record that you conducted a visit, who you visited, and when.

 

3.  You Will Learn How to Improve Your Business

Supplier visits are a great way to learn about how to improve your operations. Chances are that your supplier is a more advanced operation than yours and that they've solved a lot of the problems that you haven't solved yet.

When I was managing a commissary, I visited one of our suppliers with the expectation of learning very little. I was completely wrong. Even though their product was completely different from ours: (them: raw chopped vegetables, us: gourmet hot meals) I saw what my facility was going to look like when we scaled 10x.

The quality assurance manager toured me around the facility and answered every question I had. It was an hour of free consulting that my company would have paid thousands of dollars for. He also sent me home with a flash-drive of  documentation and their recent audit results that I used to cut costs in my own operation and prepare for our next inspection.

Every business wants to increase their output by 10x but very few of us truly understand what that looks like. How many hires does that require? How will the layout of your facility change? Visiting your suppliers will show you what's happening in the big leagues and illuminate the path to getting there.

How to Conduct a Supplier Visit

  1. Get in touch with your contact and ask if there's a time that works for you to come by and visit. Your suppliers will be very familiar with this request and probably have a process in place.

  2. Show up on time and be respectful of their time. Remember, someone is taking time from their production role to tour you around, so be considerate and thankful.

  3. Be a sponge

    • Ask if you can take photos. If so, photograph anything and everything. You may not think much of their eyewash stations now, but you'll be happy to revisit photos of theirs when it comes time to install your own.

    • Take notes. First, confirm it's OK to bring your note-taking apparatus into the facility. If so, scribble like your memory is fading. Otherwise, you'll forget all of it.

    • Ask questions. The goal here is twofold: First, it's a great way to learn about how to improve your own operations. Second, it's a great insight into their food safety awareness and culture.

    • Ask for documents. Request their food safety plan, audit results, log entries, everything. This isn't an unreasonable request: it's part of your due diligence. They'll probably only give you some of it, but this is priceless. Wouldn't it be helpful to have the scoresheet used by the auditor that's going to decide whether your product should be allowed on Whole Foods shelves? Bring a flash drive so you can accept digital copies.

  4. Act on your findings. If you are aware that your supplier is creating a food safety hazard and you pass that risk along to your customer without doing anything about it (i.e. changing suppliers) you could go to jail. Yeah.

  5. Send a thank you note. Anyone in the business long enough knows that supplier relationships are critical. A simple 3 sentence email will suffice and you'll be happy to have the contact.

As busy as you undoubtedly are with your own business, supplier visits are a critical part of your commitment to food safety. If nothing else, the field trip will show you how to host visitors in your own facility because it's only a matter of time before someone wants to walk through your space and see your records. Are you ready?

Have you conducted a supplier visit? Whats' the most surprising thing you saw? Let us know in the comments section below.


 
 

This Article is For You if…

∆ You purchase ingredients or packaging from another company


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