FDA Releases Economically Motivated Adulteration (Food Fraud) Webpage

FDA released their Economically Motivated Adulteration (Food Fraud) webpage.  It is hard to estimate the degree to which food fraud occurs.  Food fraud is more than an economic issue in that it can impact food safety and nutrition.

https://www.fda.gov/food/compliance-enforcement-food/economically-motivated-adulteration-food-fraud
Economically Motivated Adulteration (Food Fraud)

Economically motivated adulteration (EMA) occurs when someone intentionally leaves out, takes out, or substitutes a valuable ingredient or part of a food. EMA also occurs when someone adds a substance to a food to make it appear better or of greater value. For example, when manufacturers add a cheaper vegetable oil to an expensive olive oil but sell the product as 100% olive oil, they are cheating their customers. We refer to this type of EMA as food fraud.

Food fraud is a common type of EMA that the FDA deals with, but EMA also occurs with other products, including animal food and cosmetics. Some types of EMA are also misbranding violations.

Estimating how frequently food fraud occurs or its exact economic impact can be hard because food fraud is designed to avoid detection. Outside estimates by experts have found that food fraud affects 1% of the global food industry at a cost of about $10-$15 billion a year, although some more recent expert estimates put the cost as high as $40 billion a year.

EMA isn’t just an economic issue, though. Depending on what is added, substituted, or left out, food fraud can lead to health issues, some major, and even death. Some examples include lead poisoning from adulterated spices and allergic reactions to a hidden, substituted ingredient that contains even just one food allergen.

We work on several fronts to protect consumers from the potential health risks and economic harm from food fraud.

Examples of Food Fraud

• Honey and Maple Syrup: Even though their labels represented their food as a pure product, some unscrupulous companies have previously mixed honey or maple syrup with cheaper sweeteners such as corn syrup, rice syrup, sugar beet syrups, or cane sugar. This lowered the cost of production, but consumers still paid the full price of a pure honey or maple syrup product with the additional profit going to the companies.
• Olive Oil: Similar to honey and maple syrup, some companies have previously diluted more expensive extra-virgin olive oil with less expensive vegetable oil but sold the mix as pure olive oil at a higher price.
• Seafood: Seafood fraud often happens when someone substitutes a less expensive species of fish for a more expensive species, such as selling less expensive snappers (Lutjanus spp.) or rockfish (Sebastes spp.) for more expensive red snapper (Lutjanus campechanus) in a food. See our Seafood Species Substitution and Economic Fraud page for more information. Another example is when a seller adds ice to frozen seafood to make it heavier before selling it by weight.
• Juice: When manufacturers sell a mixture of citric acid, sweetener, and water as “100%” lemon juice or mix grape juice into their “100%” pomegranate juice, the consumer harm is mostly economic. However, when a company mixes expired, contaminated juice stored in dirty conditions with fresh juice in order to hide the low quality of the expired filthy juice, the resulting juice can possibly harm the person drinking it.
• Spices: One type of spice fraud occurs when an expensive spice (such as saffron) is bulked up with other non-spice plant material (such as plant stems). Another type of fraud is using dyes to give spices a certain color, especially when the color strongly impacts the perception of quality. Lead-based dyes and other industrial dyes that can cause adverse health problems such as cancer have been found in spices such as chili powder, turmeric, and cumin.

Past Examples

• Infant Formula: One way that scientists can estimate how much protein is in a food is by looking at how much nitrogen is present. In 2008, manufacturers in China added melamine (a synthetic chemical often used in plastics that has a high nitrogen content) to infant formula to make it seem like their products had enough protein. This led to kidney failure in babies, and news reports indicated the fraud caused over 300,000 illnesses, 50,000 hospitalizations, and at least 6 deaths.
• Pine Nuts: During 2008 to 2012, some people reported a bitter metallic taste (“pine mouth External Link Disclaimer”) that sometimes lasted for weeks after they ate pine nuts. After an international investigation, it appeared that some manufacturers substituted a non-food species of pine nuts in place of more expensive edible pine nut species.

How We Fight Food Fraud
Before the FDA existed, people could add unsafe preservatives, colors, or other chemicals to the food they sold, such as adding chalk to milk or red lead to cheese. The work that Dr. Harvey Wiley’s “Poison Squad” did to test how this affected human health eventually led to the creation of the FDA. Today, we combat EMA in a variety of ways.

Laws and Regulations
There are a number of different laws and regulations that we use to make sure that the food you buy is actually the food declared on the label and is safe to eat.

• The Federal Food, Drug, and Cosmetic Act (FD&C Act): Section 402(b) of this act (21 U.S.C. 342(b) ) provides common adulteration charges for EMA. For example, a food is adulterated if a valuable ingredient of the food is left out or taken out. Section 403 of this act (21 U.S.C 343) covers when a food is considered misbranded. For example, food is misbranded if its labeling is false or misleading or if it is sold under the name of a different food.
• FDA Food Safety Modernization Act (FSMA): Food fraud can lead to food safety hazards. FSMA and its implementing regulations require companies to put preventive controls in place to guard against hazards intentionally introduced for the purpose of economic gain in both human food and animal food. The FSMA rules covering these hazards are separate from the Mitigation Strategies to Protect Food Against Intentional Adulteration rule, which covers intentional acts meant to cause wide-scale public health harm, such as acts of terrorism focused on the food supply.
• Labeling Regulations: We enforce regulations on how manufacturers may label their products. One example is 21 CFR 101.30, which requires companies to put the percent of juice on the label of any drink that contains fruit or vegetable juice and covers what kind of beverages can be labeled as 100% juice.
• Standard of Identity Regulation: When you buy something labeled as cheddar cheese, you expect it to be cheddar cheese, not some other kind of cheese. In order to promote honesty and fair dealing for consumers, we have established standards of identity regulations that lay out what a product must contain if it is represented as a certain food. See 21 CFR 130 (general), 21 CFR 133 (cheese), 21 CFR 146 (juices), and 21 CFR 168 (sweeteners and syrups) for examples.

Monitoring for Food Fraud

• Detecting food fraud requires constant adaptation because people change the ways they commit fraud in response to past regulatory actions and available detection techniques. Here are some of the ways we regularly work to monitor the food market for the EMA:
• Detecting Food Fraud: To spot trends and instances of food fraud, we gather information from a variety of sources such as consumer or industry complaints, news articles, science publications and presentations, databases, other governments, academia, and subject matter experts. We detect food fraud through FDA inspections and regularly create and test new tools for detecting food fraud.
• We can also detect food fraud through routine or targeted sampling assignments. For example, in 2016 and 2017, we sampled imported palm oil for the presence of Sudan dyes. Sudan dyes are red industrial dyes that can cause cancer and are illegal to use in food. We found these dyes in about 16% of the tested oil and refused to allow these products into the United States. We also put violative manufacturers and products on an import alert to prevent future potentially illegal products from entering the U.S.
• Confirming Food Fraud Through Testing: To check whether food fraud has occurred, we develop a variety of methods for identifying what makes a food unique. Food analytical chemistry, which looks at everything from the basic chemical composition of foods to the chemical identity of added components, plays a significant role. Methods used in biology, such as DNA sequencing, can also play a role. For example, building a DNA library that has the DNA barcode for fish species or a similar one for plants has greatly helped with identifying when species substitution is happening.
• Collaborating with Other Regulatory Partners: To help identify new instances of food fraud and new ways to combat it, we often exchange information on EMA with other federal agencies such as the National Oceanic and Atmospheric Administration and the Department of Justice. We also collaborate with international regulatory bodies to detect and combat food fraud related to imported products.

Enforcement and Legal Consequences
When we discover food fraud, we seek to remove the food product from the market and to prevent fraudulent products from being sold to consumers in the future. We use a variety of tools including recalls, seizures, injunctions, import refusals, and import alerts. For example, we have issued import alerts to prevent products from companies with a history of food fraud from entering the United States. In certain cases, we may also work with the Department of Justice to bring cases against fraudsters, which have led to criminal and civil penalties.
Some examples of the legal consequences include:

• Concealing poor quality fruit juice: In 2021, a court-ordered consent decree barred Valley Processing from operating until it implemented various food safety processes. In addition to finding high levels of arsenic and patulin in the company’s juices, an FDA inspection found they had stored contaminated grape juice for a long time in dirty conditions and then blended it together with newer batches of grape juice to hide the bad quality of the old juice and make the old juice appear of better or greater value than it was. This juice was sold to school lunch programs.
• Foreign crab sold as U.S. crab: In 2019 and 2020, a father and son who ran Casey's Seafood were sentenced to prison for repackaging foreign crab meat as blue crab caught in the U.S. In another similar case, the owner of Capt. Neill’s Seafood was sentenced to prison and fined $250,000 in 2020 while the company was put on probation and fined $500,000.
• Fake Parmesan cheese: In 2016, the president of Castle Cheese was sentenced to three years’ probation, a $5,000 fine, and 200 hours of community service. The company had been adding cellulose (wood pulp) and cheddar to grated parmesan that they sold as 100% parmesan cheese.

For more information about criminal prosecutions of food fraud, please see the FDA’s Office of Criminal Investigations.

Guidance Documents

Here are some of the guidance documents the FDA has published related to food fraud.

General

• Compliance Policy Guide: CPG Sec 555.875 Water in Food Products (Ingredient or Adulterant)
• Compliance Policy Guide: CPG Sec 560.200 Country of Origin Labeling (U.S. Customs and Border Protection regulations require repackaged imports to include the English name of the country of origin.)

Dairy

• Compliance Policy Guide: CPG Sec. 527.100 Butter - Adulteration Involving Insufficient Fat Content

Fruit

• Compliance Policy Guide: CPG Sec 550.625 Oranges - Artificial Coloring

Honey

• Guidance for Industry: Proper Labeling of Honey and Honey Products (03/2018)

Seafood

• Compliance Policy Guide: CPG Sec 540.750 - Use of The Seafood List to Determine Acceptable Seafood Names
• Guidance for Industry: The Seafood List (The FDA’s Guide to Acceptable Market Names for Seafood Sold in Interstate Commerce)
• Guidance for Industry: 1991 Letter to Seafood Manufacturers Regarding the Fraudulent Practice of Including Glaze (ice) as Part of the Weight of Frozen Seafood

Spices

• Compliance Policy Guide: CPG Sec. 525.250 Cloves - Adulteration with Stems