Deadline to List Calories on Restaurant Menus Quickly Approaching

As of May 5, 2017, chain restaurants with 20 or more locations are required to provide nutrition labeling of “standard” menu items. Restaurant owners should, if they haven’t already, start preparing for the compliance deadline. In addition to restaurants, this requirement also applies to food facilities in entertainment venues, such as movie theaters and amusement parks, take-out food establishments, bakeries, convenience stores, grocery stores and supermarkets.

These menu labeling requirements were published on December 1, 2014 as a final rule by the Food and Drug Administration (“FDA”), as required under the Affordable Care Act. If you are a small business owner these new rules will have a significant impact on your operations. What it means is that calorie counts will have to be displayed for popcorn at a theater, food from a salad bar, hot dogs from a convenience store and takeout pizza. In addition, vending-machine operators with at least 20 locations also will be required to post calorie counts.

Calorie information also will be required for some alcoholic beverages served in bars and restaurants. This would apply to beverages listed on menus and menu boards, however, this would not apply to mixed drinks ordered at the bar. Craft brewers should take notice. Even if the rules may not directly affect beer manufacturers, those that sell their brews to chain retailers may be forced to supply calorie counts or take their products elsewhere.

While the purpose behind these rules are to combat obesity in America, where over one-third of meals are consumed outside the home, the effect is to burden retailers with significant compliance costs. Retailers are now faced with the choice of passing this additional cost onto the consumer or eliminating certain products from their menus. While not an easy decision for businesses to make, non-compliance can lead to legal action by the FDA.

The rule’s requirements for determining caloric content and labeling menus are highly detailed and complicated. Therefore, if your small business needs assistance in complying with the rule, please contact us at Morsel Law.

Worldwide Olive Oil Shortage

Buyers beware: this could mean an increase in food fraud as criminals attempt to cash in on record high prices. Olive Oil accounts for more than 10% of all incidents of food fraud worldwide. Fraudsters in the past have been caught passing off cheaper oils from Turkey and Tunisia as higher priced Italian oil.

Other schemes have been identified where importers were blending cheaper oils, such as hazelnut, soy, corn, walnut or palm oil, and passing the products off as 100% pure olive oil. This is especially concerning when nut-oils are substituted which can lead to major problems for those with food allergies.

For more, you can view the article.

If you have questions about food fraud, please contact our attorneys at Morsel Law.

President Signs Mandatory GMO Labeling Law: What You Need to Know

Last week President Obama signed the National Bioengineered Food Disclosure Standard into federal law. The law mandates disclosure of genetically modified organisms (“GMO”) on food labels. The law directs the U.S. Department of Agriculture (“USDA”) to establish, within two years, a nationwide mandatory disclosure standard for bioengineered foods and the labeling procedures. This means that the law itself does not define the standard, but instead gives the USDA significant discretion to define and implement the required disclosure.

Below are some things manufacturers should know about the law:

  • Preemption of State Laws. The new law specifically preempts all state and local labeling requirements applicable to genetically engineered (“GE”) foods that do not mirror the language in the law. This would even apply to state laws already passed, including Vermont where mandatory GMO labeling went into effect in July.
  • Defining Bioengineered Food. The law defines bioengineered food as food that contains genetic material “that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques” and “for which the modification could not otherwise be obtained through conventional breeding or found in nature.” This definition could be interpreted as quite restrictive, so it will be important to watch the rule-making process to see how the law is interpreted.
  • Labeling Requirements. The law does not specify GMO labeling standards, this is left up to the USDA to determine. However, the law does state the methods to disclose GMOs in food, such as text on the packaging, a USDA-created symbol, or an electronic or digital link (such as a QR code) selected by the manufacturer. Small food manufacturers are provided the additional flexibility to disclose GMO ingredients either by listing a toll free number or link to website containing the disclosure on their labels. The purpose of the law was to disclose GMO ingredients on food labels so consumers searching grocery store aisles could make informed decisions, but law effectively fails to achieve its purpose because “disclosure” can be a link to somewhere else, not on the label itself.
  • You Aren’t What You Eat. Meat from animals that consume bioengineered food are exempt from disclosure. Specifically, the law prohibits the USDA from considering any food primarily derived from an animal because “the animal consumed feed produced from, containing, or consisting of a bioengineered substance.” So, for example, you go into a store to buy some beef for a family barbecue and, because of your concern about the safety of GE foods, you want to purchase a GMO free product. You’re aware that most cows slated for consumption are fed a diet containing mostly corn, a majority of which is bioengineered. The label doesn’t disclose GMO ingredients, so you think you’re safe. Think again. Even if the cow eats nothing else but bioengineered corn its entire life, the meat is not considered GE under the new law. Thus, Congress is betting that consumers will be uniformed about the provisions in the law and think their meat is non-GMO, even if its arguably not.

Food Recalls: Does Your Insurance Policy Cover “Reasonable Probability” of Contamination?

Many food businesses, after conducting a risk assessment, will purchase some form of recall insurance (commonly referred to as product contamination insurance). These recall policies typically provide coverage for “actual” contamination, meaning for coverage to kick in the consumption or use of the product must have resulted in bodily injury and/or property damage. To date, recalls were voluntary and initiated by the company. However, earlier this year the final rules were issued under the Food Safety Modernization Act (FSMA), which provide FDA with the authority to mandate recalls for food products if there is a “reasonable probability” that the food product is adulterated or misbranded and the use and/or exposure to the product would cause serious health consequences or death.

The FDA’s mandatory recall authority under FSMA may put food businesses at risk because many insurance policies don’t provide coverage for government recalls without an “actual” contamination. The direct and indirect costs associated with these recalls can be substantial. It is important to know if your damages are covered by your policy and, if so, to what extent.

While many insurers have yet to address FSMA, some insurers have altered their basic form or issue an endorsement for “government recall”.  However, not all “government recall” clauses are created equal, so careful attention should be spent when reviewing or negotiating the policy to ensure proper coverage, especially since every business is different and are faced with different risks.

In order to better understand their insurance requirements, businesses should perform a comprehensive risk analysis. The risk analysis should not only include the business’s products and operations, but also the operations of their suppliers’ and an analysis of the quality of the ingredients included in the business’s final products. Often overlooked in the analysis process is the risks assumed in purchase and sale agreements and vendor contracts. Businesses should review these agreements to identify and determine which risks can and/or should be insured. Many contracts in the food industry are written in favor of the buyer, so in the event of a recall, the seller (policyholder) is responsible for associated costs. The effects of a recall to a seller without proper coverage could be devastating.

When discussing recall coverage with your broker, the following are a list ofitems you may want to address:

  • Direct Product Damage – Many policies cover the contaminated product in the field or warehouse, but some only cover product in the field.
  • Publicity – Publicity coverage is not always included in a basic policy, but when it is the most important feature of this coverage is that it can result from “an actual or alleged contamination, where the Named Insured’s Product(s) and the Named Insured must be specifically named.” If a business supplies an ingredient used by a buyer in a finished product and the buyer’s product is recalled (in most cases only the finished product is identified in the recall), then is this scenario the policy won’t provide coverage.
  • Lost Gross Profit/Extra Expense (LGP) – If the policyholder loses an account due to a recall event, this pays for a year or more of LGP. For many food businesses, a large account could represent a significant portion of their total revenue. Extra Expenses may arise when it is necessary to engage another processor and new processing costs exceed the businesses normal processing costs.
  • Rehabilitation Expenses – This coverage pays for the rehabilitation of the brand in the marketplace. Many businesses overlook the importance of obtaining this coverage because one food safety incident can destroy a brand that a business has spent years building.
  • Crisis Response/Consultant Expenses – Coverage for these expenses can be very important and largely address the costs involving specialized attorneys and public relations/crisis response specialists.

If you have questions about coverage under your insurance policy, please contact our attorneys at Morsel Law.

Entrepreneurs Beware: Violating Food Safety Laws Can Land You in Jail

I frequently receive calls from food startups who want to know the best way to protect their business from their competition. Specifically they’re concerned about theft of their recipes, intellectual property and key employees. After listening to their concerns, I then pose a question to them: what steps have you taken to protect your business from a food safety incident? More often than not there is silence on the other end of the phone. What I attempt to explain to them is that, regardless of all their other legal concerns, without a comprehensive food safety program in place their business will be worthless. Some listen, others don’t. But many of these entrepreneurs don’t realize is that, while they may think they’re in the food business, they’re actually in the food safety business.

The food industry is unlike any other. When a software company’s product is defective or a financial services company provides poor advice the worst thing that may happen is customers lose money. But unlike these industries, when a food business introduces an adulterated product into commerce consumers may become seriously ill, possibly resulting in death. Now I get many startups are “bootstrapping” their business and capital is tight, so careful decisions must be made where to spend and where to cut corners. While you may want everyone of your witty and artfully crafted slogans trademarked, if by doing so you’re foregoing having your product labels reviewed for FDA compliance or engaging a food safety professional to assist in designing and implementing good manufacturing principals, then you’re setting yourself up for failure.

If you don’t believe me, let’s take a look at a few recent examples. A licensed maple syrup producer decided to expand his business by using the apples picked from his farm to make and sell cider. This all seemed harmless until the cider was linked to an E.coli outbreak that sickened four people, including two children. The court found that the owner failed to follow good manufacturing processes and he was convicted of selling adulterated food, sentencing him to 14 to 48 months in prison.

In another incident, a woman plead no-contest to charges that she sold adulterated and misbranded food at several Michigan farmers markets. She sold various pickled products directly to consumers, which under Michigan law requires certain processes to take place during the production cycle to prevent the risk of botulism. Additionally, under federal law all food processors who make low acid and acidified foods must register their establishment. Here, the woman produced the products out of her home kitchen, not a registered facility, and she apparently didn’t even know there are laws regarding the manufacturing of food products which are intended to protect consumer health. These mistakes cost her not only $3,100 in fines and 11 months of probation, but her business.

For food startup businesses, making sure your products and food safety procedures are in compliance up front will save you countless headaches, and potentially money, down the road.  If there is on piece of parting advice I can give food entrepreneurs out there it’s this: you will make many mistakes running your business, but most likely the business will continue to survive and you’ll learn from these mistakes; however, it only takes one food safety incident to destroy a business. If you don’t believe me, take a look at Blue Bell ice cream and Chipotle. Whether their businesses will survive these outbreaks or not remains unclear.

Salad Grown Locally: Investment Opportunity or False Hope

All food is local…that is unless you live in Chicago and want a salad in the middle of January. In this case the lettuce in your salad (and the majority of the other ingredients) is most likely grown in Mexico or California and shipped to your local grocery store. However, a few entrepreneurs are trying to change the produce supply chain by growing green, leafy vegetables on a commercial scale in some unlikely places.

As reported in articles last week by Wall Street Journal and Eater.com, rooftop greenhouse facilities have sprouted up in cities across the United States, including New York City and Chicago. These businesses seek to provide consumers with fresh produce that is available in stores within a few hours of harvest, reducing the amount of waste due to spoilage. They also aim to price their products comparably to existing brands since their transportation costs are significantly less as shipping is usually only a short trip across town. Reducing transportation use would also result in a positive environmental impact, which is another one of their goals.

Some urban farms have caught the attention of investors who have contributed millions of dollars in hope of success. But apparently, not all urban farms are created equal.  Some, including BrightFarms Inc. and FarmedHere LLC, have cancelled plans to open farms or shut down operations after only a few months in business. However others, like Gotham Greens Farms LLC (which has raised $30 million from investors) and AeroFarms LLC (which has raised $70 million in corporate and project financing), appear to be on track for success.

While it is not clear whether these business models will prove to be long-term successes, potential investors should be familiar with the potential roadblocks that can make or break urban farming businesses. First (and foremost) is cost. Rooftop greenhouses are extremely expensive, upwards of 20% more than a traditional greenhouse. Also, permitting times will increase because “farming” is normally not a permitted use in urban centers and would require a zoning variance. In addition to local laws, growers may be subject to the recently published Produce Safety rule promulgated under the Food Safety Modernization Act, which establishes science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables. It is important businesses prepare for the implementation of, and the steps required for their business to comply with, the Produce Safety rule.

Investing in agriculture, just as with any other type of investment, requires competent and thorough due diligence. While the investment may look good on paper, investors should remember the saying made famous by President Ronald Reagan: “trust, but verify.”

Food Importers Required to Verify Foreign Suppliers

As I’m sure those of you in the food import business are aware, FDA finalized its rule on Foreign Supplier Verification Programs (“FSVP”) for Importers of Food for Humans and Animals. The rule requires that importers implement a FSVP to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, and to ensure that the supplier’s food is not adulterated and not misbranded with respect to allergen labeling.

If you import food into the U.S. you must comply with the requirements under the rule or face regulatory action. The following is an overview of rule and what your business can do to comply its requirements.

What Importers Are Affected:  The rule applies to all importers of food into the U.S. An “importer” is the U.S. owner or consignee of food that is being offered for import or, if there is no such owner or consignee, the U.S. representative or agent of the foreign owner or consignee at the time of entry.

What Food Is Covered: The FSVP Rule applies to all food that is imported or offered for import into the United States. Certain foods are not covered by FSVP, including (1) juice and fish that complies with FDA’s Hazard Analysis and Critical Control Point (“HACCP”) regulations; (2) food for research or evaluation; (3) food for personal consumption; (4) alcoholic beverages; (5) food that is imported for processes and future export; (6) low-acid canned foods; and (7) certain meat, poultry, and egg products that are regulated by the U.S. Department of Agriculture at the time of import. The rule also sets forth modified requirements for importers of dietary supplements and dietary supplement components, very small importers, and importers of food from certain small foreign suppliers.

Importer Requirements Under Rule: Each importer must develop an FSVP that ensures “foreign suppliers” are producing food in a way that provides the same level of protection as what is required under the Preventive Controls Rules and the Produce Safety Rule (if applicable) and ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling. A “foreign supplier” is an entity that manufactures, processes or grows food, or raises animals that are exported to the U.S. without further manufacturing or processing.

What Must Be Included:  An FSVP must be developed by a “qualified individual” who must perform the various activities and be able to read and understand the language of any records that must be reviewed. In developing an FSVP, an importer is required to conduct and document the following activities:

  • Hazard Analysis: An importer must complete a written hazard analysis that identifies potential hazards for each food and each supplier, including biological, chemical (including radiological) and physical hazards.
  • Risk Evaluation: An importer must evaluate the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance. Factors that importer’s must consider in the evaluation can include the foreign supplier’s procedures, processes and practices related to food safety, and any information that FDA may have regarding the foreign supplier’s compliance. The importer can also rely on another entity to perform the risk evaluation under certain circumstances.
  • Verification Activities: Based upon the evaluation of risk conducted, the importer must establish and follow written procedures to ensure that it only imports from approved foreign suppliers. Appropriate supplier verification activities may include annual on-site audits of the supplier’s facility, sampling and testing, or a review of the supplier’s relevant food safety records. The importer can also rely on another entity to determine and perform appropriate supplier verification activities under certain circumstances.
  • Supply Chains: The final rule also adds flexibility and recognizes the reality of modern distribution chains by not requiring an importer to conduct supplier verification (or evaluate the risk posed by a food and the foreign supplier’s performance) when the hazard requiring a control in a food will be controlled by a subsequent entity in the distribution chain in the United States. For example, if an importer’s customer will control the hazard, the importer can rely on its customer to provide written assurance that the food will be processed for food safety and must disclose that the food has not been processed to control the identified hazard. If the hazard will be controlled by a subsequent entity in the distribution chain, the rule requires disclosure that the food has not been processed to control the identified hazard as well as a series of written assurances starting with assurances from the customer to the importer and continuing the obligation to provide written assurance of processing for food safety throughout the distribution chain. The rule provides flexibility for an importer to establish, document and implement an alternative system that ensures adequate control, at a later distribution step, of the hazards in a food product distributed by a manufacturing/processing facility.
  • Conduct Corrective Actions: If something goes wrong and an importer determines that its foreign supplier has not used safe processes and procedures, the importer must take immediate corrective action. The appropriate action will depend on the circumstances, but can include discontinuing use of the foreign supplier until the cause of noncompliance, adulteration or misbranding has been adequately addressed.

The risks evaluated as part of an FSVP must be promptly reevaluated upon the discovery of new information. Additionally, an FSVP must be reassessed for each food and each foreign supplier at least once every three years. Based on the results of any such FSVP reassessment, an importer must promptly adjust its supplier verification activities if necessary.

What is the Deadline to Comply:  Importers must comply with the rule by the latest of the following dates:

  • 18 months after publication of the final rule;
  • For the importation of food from a supplier that is subject to the preventive controls or produce safety rules, six months after the foreign supplier is required to meet the relevant regulations;
  • For an importer that is itself a manufacturer or processor subject to the supply-chain program provisions in the preventive controls regulations, the date by which it has to comply with those provisions.

It is important for companies to determine whether they are subject to FSVP requirements, and, if so, to begin taking steps to ensure compliance. If you are unsure of whether your company is subject to, or if you need assistance complying with, the FSVP rule please contact our attorneys at Morsel Law.

KIND Petitions FDA: Should Investors Lose Confidence in General Counsel?

In a previous article I discussed how important it is for food businesses to conduct an in-depth label review prior to launching new products. Specifically, I addressed the FDA Warning Letter issued to KIND LLC and pointed out how costly labeling mistakes can be, especially when the risk could have easily been mitigated. In their response to FDA, KIND agreed to correct most of the technical errors noted in the letter; however, when it comes to changing their view of what foods are allowed to label themselves as “healthy” they don’t agree with what they refer to as “outdated” regulations.

In a citizen petition letter (“Petition Letter”) sent to FDA last week, KIND’s general counsel, Justin Mervis, notes that under current regulations “whether or not a food can be labeled “healthy” is based on specific nutrient levels in the food rather than its overall nutrition quality.” KIND then goes on to claim that new scientific evidence no longer supports this view and that, accordingly, FDA amend 21 C.F.R. 101.65(d)(2) in regards to nutritional content claims so that manufacturers may use the term “healthy” without regard to the total fat or saturated fat, if the source of such fat comes from fruits, vegetables, nuts, seeds, legumes, whole grains or seafood, provided that “such foods are used in their whole form or have been processed in such a way that did not materially degrade their nutritional value.”

While the Petition Letter makes several other recommendations, the majority of the Petition Letter is devoted to the argument that there is a disconnect between the Dietary Guidelines and what claims manufacturers are permitted to state on their labels. KIND argues that manufacturers should be permitted to make claims on their products labels (e.g., “nuts are part of a healthy diet”) that are consistent with federal dietary recommendations and current scientific evidence. As such, KIND goes on to request the FDA “undertake rulemaking to define a “dietary guidance statement” as a statement in food labeling about the usefulness of a food, or a category of foods, in maintaining healthy dietary practices.” The requested rule would permit claims on food labels to communicate that certain foods are useful in creating a diet that is consistent with current dietary recommendations, so long as those claims are not misleading.

While it isn’t a secret that food regulations, in some part, have become “outdated”, what makes KIND’s petition interesting is it comes after being caught violating the same regulations they are petitioning to amend. The real question is whether KIND knew their product labels were non-compliant when released into the marketplace or did they make a business decision to move forward with non-compliant labels in order to promote their “healthy” marketing campaign. While the saying “it’s better to ask for forgiveness then to ask for permission” may apply in certain situations, it’s probably not the best strategy when it comes to breaking federal law.

The role of the general counsel is to advise executive leaders on the state of the law, how certain laws affect their business and to provide pertinent information and/or legal advice to such leaders so they have the ability to make informed decisions. The general counsel is not required to be an expert in the industry in which their client operates (although it certainly helps); however, they should know the limits of their expertise and, when appropriate, bring in outside assistance with such expertise. If they don’t know their limits, or can’t identify potential legal issues outside their expertise, then their departure should be swift. After all what good is legal counsel if leaders are not able to rely on their advice?

It isn’t clear whether KIND made the decision to market their products with non-compliant labels, but if they did the general counsel shouldn’t take the blame. However, it took KIND six months to file their Petition Letter which leads me to believe the labeling violations occurred not because of a strategic business decision, but due to the lack of regulatory expertise and oversight from the general counsel’s office. If my presumption is correct, investors should demand answers and push for changes in the executive suite. These violations have resulted in significant expense revising labels, advertising and websites, in addition to substantial legal fees incurred responding to the Warning Letter and submitting the Petition Letter, and most recently defending consumer lawsuits. While attorneys play a significant role in advising businesses, legal fees cannot be entirely avoided; however, they can be efficiently managed. It is up to KIND’s investors to decide whether their capital in this situation was well-spent.

Creating Sustainable Jobs Through Aquaculture

Many cities and states have experienced economic difficulties at one point or another. Some overcame adversity, while others continue to struggle. Those who were successful when faced with the realities of a declining tax base and bleak economic picture turned to open-minded leaders who understood that “business as usual” wasn’t going to right the ship. These leaders all accepted the concept that if you expect to grow and thrive then you need to continually reinvent yourself .

Think of Boston in the late 1970’s through early 1980’s which relied heavily on manufacturing jobs, the city lost close to half of its population from all-time highs. Now, thirty years later, Boston is a leader in technology, education and medicine. Or take Pittsburgh back in the early 1980’s where the steel industry was collapsing and unemployment exceeded 17 percent. Many area leaders responded with denial and people held out hope the steel mills would reopen. But that didn’t happen, instead mill owners began demolishing plants and selling the steel for scrap. In the middle of the crisis, leaders emerged from the surrounding communities and joined forces to guide greater Pittsburgh into the technology center it is today.

So what does all of this have to do with aquaculture? Well, as the country increasing searches for locally sourced food, supplies for fresh seafood are in high demand. But not every state has the natural resources available to fulfill this growing need and consumers are left to the mercy of large distributors. Michigan, however, is in position not only to meet this demand, but to become a leader in this industry. The state has the longest freshwater coastline in the U.S. and the second longest coast line in the U.S. next to Alaska. But not everyone is open to new ideas and innovation.

Recently, a bill was introduced that would prohibit any commercial fishing operations on the Great Lakes surrounding Michigan. The reasoning behind the bill is to protect the natural resources of the state (i.e., fish waste causes pollution). Well, yeah, that’s why it’s called “waste”! But with a strong regulatory structure and academic community in Michigan, surely aquaculture can be studied and carried out in a responsible and environmentally friendly way. Just as farmers are stewards of the land, owners of aquaculture operations care deeply about the water. I’m sure nobody wants to see the Great Lakes return to the conditions that plagued them during the twentieth century, nobody more than aquaculture farmers that rely on these waters for their livelihood.

Michigan’s jump into aquaculture isn’t about “growing fish for the expensive restaurants in Chicago”, as Sen. Rick Jones of Grand Ledge has put it. It’s about bringing Michigan into the future and using it’s resources responsibly to reinvent itself and create jobs. Michigan is already a dominant force in agriculture and is home to one of the nation’s premier agricultural schools in Michigan State University. There is no reason why Michigan can’t follow the same path with aquaculture, but it takes leaders with vision and openness to new ideas. Not only will aquaculture farms result in direct jobs, but indirect jobs such as manufacturing of fish products and transportation of the products to market.

If we are to take something away from the experiences of cities mentioned above, it is important to point out that Pittsburgh, referred to as the “Steel City”, now relies on less than 20% of its economic output from steel. I’m not comparing Pittsburgh with the entire State of Michigan (or even Detroit for that matter), because the economics of a city are quite different from that of an entire state. However, in a state that historically has relied heavily on the automotive industry as a driver of economic growth, Michigan’s leaders should take note. While Michigan, outside of a few distressed metropolitan areas (i.e., Detroit, Pontiac, Flint), is not experiencing an economic crisis, people aren’t exactly tripping over each other to relocate to the state either, with an estimated population growth rate near zero. This is why, more than ever, all options should be on the table. While it’s easier to say “no” to new ideas, especially ones that may upset some constituents, successful leaders make decisions regardless if the decisions are unpopular. After all it’s not about making the popular decision, it’s about doing what is right for the economic success of Michigan.

FDA Issues Another Blow to Maker of Just Mayo

Earlier this year, Hampton Creek Inc., the maker of Just Mayo, was sued by Unilever, the maker of Hellman’s mayonnaise, and accused of false advertising for calling its egg-less spread “mayo”. Even though experts thought the claims were strong, the case was eventually dropped due to the negative publicity Unilever received which painted it as a corporate bully. As mentioned in an earlier article, a class-action lawsuit was filed against Hampton Creek in Florida state court asserting similar claims, but this time by consumers who claim they were misled into thinking Just Mayo’s product was actually mayonnaise.

Well, unfortunately for Hampton Creek, the third time isn’t a charm. This time the feds are knocking on their door. On August 12th, FDA issued a warning letter to Hampton Creek citing various violations of the Federal Food, Drug and Cosmetic Act (the “FDC Act”) by their Just Mayo and Just Mayo Sriracha products. The warning letter specifically notes that both products make “cholesterol free” nutrient content claims on their labels (and website), but don’t include a statement that discloses the level of total fat in a serving of the product in immediate proximity to the cholesterol claims, which is a violation of the applicable regulations. The letter also notes both products make unauthorized health claims on their labels (and website) by implying that the products can reduce the risk of heart disease due to the absence of cholesterol. Under federal regulations (see 21 C.F.R. 101.14(a)(4)), a food is disqualified from making health claims if the food contains more than 13 grams of total fat per 50 grams. Both Just Mayo and Just Mayo Sriracha contain 36 grams of fat per 50 grams.

But the biggest blow is one that will set up plaintiffs for successful consumer protection lawsuits. Just like the accusations made by Unilever and the Florida consumer in their complaints, the FDA notes that because neither the Just Mayo and Just Mayo Sriracha products contain eggs, they don’t meet the definition of “mayonnaise” under the regulations (see 21 C.F.R. 169.140(c)), and thus are misbranded under the FDC Act. While the FDA goes on to list several additional labeling violations in the warning letter, this could be the most detrimental to Hampton Creek’s core business.

Many recent lawsuits have relied on FDA warning letters as evidence to support a claim that a manufacturer violated state and/or federal law and, in many instances, the plaintiffs have been successful. Food manufacturers should ensure they thoroughly understand FDA regulations before labeling their products. This is not only to avoid a false advertising lawsuit, but also to avoid misbranding. It’s a prohibited act to distribute misbranded products and manufacturers can be subject to FDA enforcement and/or private party lawsuits.

Whether the lawsuits against Hampton Creek could have been avoided is difficult to determine. However, what I can say for certain is this warning letter is sure to bring additional lawsuits. So I hope for Hampton Creek’s sake they take the time to focus their attention internally and resolve the issues that could have easily been avoided by conducting a thorough regulatory review.

As mentioned above, food companies may minimize the chances of their products facing a legal challenge by consulting with an attorney familiar with FDA regulations. If you need assistance navigating or complying with the laws affecting your food or beverage businesses, please feel free to contact our attorneys at Morsel Law.