Fit for Human Consumption: Regulations Surrounding the Food Industry


The food industry is a tightly regulated one, as producers and manufacturers supply products that could conceivably cause harm to the people who buy them. There are times when food producers, often inadvertently, may fail to comply with regulations. These situations can lead to recalls of their products. There may be legal repercussions too, as the federal government may take enforcement action against them. They may also need to defend against a product liability lawsuit by consumers who claim they have been injured. One recent recall illustrates some of the problems the food industry occasionally faces.

Recent Daily Harvest Recall Illustrates Potential Dangers

Daily Harvest is a company that markets and sells on-demand fresh vegan products. In June 2022, the company announced a safety recall of its French Lentil + Leek Crumbles product. The recall affected 28,000 units of the product that were distributed in mid-June throughout the country. Since Daily Harvest sells predominantly online, the products had a wide distribution.

Nearly 500 people reported being sickened after consuming the product. These customers experienced severe liver and gastrointestinal issues. Some reported extreme pain and needed hospitalization for their illnesses. The company drew criticism for the way it handled the recall, with some claiming Daily Harvest used the recall to further market the product.

The FDA’s preliminary investigation may have zeroed in on the tara flour used in the product as the source of the contamination. The company itself believes the tara flour was the problem.

The Food and Drug Administration Extensively Regulates the Food Industry

There are numerous regulations aimed at preventing incidents like this. The Food and Drug Administration is the federal regulator responsible for the food industry. The FDA both writes and enforces rules governing the industry. So long as the food produced crosses state lines, federal law controls it. FDA regulations for the food industry are found in Title 21 of the Code of Federal Regulations.

Here are some of the regulations that govern the food industry:

  • Food processors cannot sell adulterated food that contains any substance injurious to human health or that is unsafe.
  • Food manufacturers and sellers cannot market any misbranded products.
  • Any companies that manufacture, process, pack, or hold food for human or animal consumption in the U.S. must register with the FDA.
  • Food processing firms must register with their states and follow their states’ laws (in addition to FDA regulations).
  • Food manufacturers must allow themselves to be inspected by the federal government and cooperate with its inspectors.
  • Food processors must have and follow “Good Manufacturing Practices.”
  • Companies must assess the safety of the raw ingredients used in manufacturing their products.

These are just some of the many regulations that govern the food industry. There are thousands of pages of federal rules and interpretations. In addition, the FDA is continuously amending its rules and issuing new interpretations of them.

Penalties for Violating FDA Rules and Regulations

Food manufacturers must be aware of these regulations because the FDA has broad enforcement powers. The agency may do the following when it spots violations:

  • Recommend criminal prosecution against those who violate the rules that can result in a misdemeanor conviction and jail time;
  • Impose fines of up to $500,000;
  • Seek an injunction to order the company to refrain from future violations; and/or
  • Remove goods or products from the market.

The FDA has field inspectors who visit companies and collect samples. These inspections could lead to a recommendation of enforcement actions. The FDA may also then issue a public warning letter to a company.

Food Manufacturers Can Also Face Lawsuits

Plaintiff’s attorneys try to act as their own attorneys general to enforce food regulations. They are waiting to pounce on food manufacturers in court at the slightest suggestion that something is at issue with their products. Some lawyers will focus on cases where there are injuries. Others seem to focus on the more comical, such as Subway’s “Footlong” sandwiches not really measuring 12 inches. Either way, food companies must defend themselves in these lawsuits at great cost.

The plaintiff’s bar aggressively and opportunistically seeks out plaintiffs in the immediate aftermath of announcements of food recalls. In some cases, there will have been no documented injuries, and they will come up empty. In other cases, food producers will be subjected to costly litigation that can last for years. Even if their product was not defective, producers will need to spend large amounts of money to defend the cases filed against them.

The legal standard in these cases is whether the producer sold a defective product. There are three different types of defects that could lead to legal liability:

  • Design defects
  • Manufacturing defects
  • Marketing defects

In food product lawsuits, the most common claim alleged is that something went wrong in the manufacturing process that made the product unreasonably dangerous. In other cases, plaintiffs will allege the company knew of the potential problems and failed to warn the public about them.

After the Daily Harvest product recall described above was announced publicly, the company was almost instantaneously hit with lawsuits filed by people who alleged they were sickened by the recalled products. One plaintiff claimed they needed to have their gallbladder removed after becoming violently ill from the product. Given the circumstances of the recall, the company may have a difficult time defending against the allegations. Many if not most defendants in these types of cases will at least make some effort to settle the lawsuits before they go to court.

The one certainty about food industry regulations is that food manufacturers need an experienced attorney with extensive knowledge of the industry to help them navigate those regulations. Companies, with the help of experienced legal counsel, need to stay in front of new developments and proactively deal with legal challenges when something goes wrong.