For centuries, ingredients in food have served a variety of useful functions. Our ancestors used salt to preserve meats and fish, added herbs and spices to improve the flavor of foods, preserved fruit with sugar, and pickled vegetables in vinegar solutions. Many ingredients help ensure the availability of flavorful, nutritious, safe, convenient, and affordable foods that meet consumer expectations year-round.

Ingredients are added to foods for a variety of functions, such as:

• Maintain or Improve Safety and Freshness: Preservatives slow product spoilage caused by mold, air, bacteria, fungi or yeast. In addition to maintaining the quality of the food, they help control contamination that can cause foodborne illness, including life-threatening botulism. One group of preservatives -- antioxidants -- prevents fats and oils and the foods containing them from becoming rancid or developing an off-flavor. They also prevent cut fresh fruits such as apples from turning brown when exposed to air.
• Improve or Maintain Nutritional Value: Nutrients such as vitamins and minerals are added to many foods to make up for those lacking in a person's diet or lost in processing, or to enhance the nutritional quality of a food.
• Improve Taste and Texture: Spices, natural and artificial flavors, and sweeteners are added to enhance the taste of foods. Emulsifiers, stabilizers and thickeners give foods the texture and consistency consumers expect. Leavening agents allow baked goods to rise during baking. Some additives help control the acidity and alkalinity of foods, while other ingredients help maintain the taste and appeal of foods with reduced fat content.

In general, all ingredients must be declared on food labels, unless there is an exemption. Food manufacturers are responsible for marketing safe foods, including ensuring the safety and regulatory status of the ingredients they use in foods before they are available to consumers. The FDA evaluates and regulates ingredients added to food to help ensure they are used safely.

The safety of food additives and ingredients that are generally recognized as safe (GRAS) must be supported by science that demonstrates its use meets the FDA’s safety standard. Specifically, the information must demonstrate that there is a reasonable certainty of no harm to consumers when an ingredient is proposed or intended for use in food. Because of inherent limitations of science, the FDA can never be absolutely certain of the absence of any risk from the use of any ingredient.

The FDA has several programs as part of its oversight over food ingredients and to aid the food industry in complying with the law. As part of the FDA’s programs, the food industry provides information about an ingredient’s safety in the appropriate submission to the agency.

Our scientists continue to keep up to date as new research is published and to evaluate whether the new information changes our position on the safety of a food ingredient. When we identify new data and information that indicates that the use of an authorized substance is no longer safe, we take action, which may include revoking authorizations for certain uses and informing consumers.

Food manufacturers are required to list all ingredients in the food, unless ingredients are subject to an exemption from this requirement such as incidental additives. On a product label, the ingredients are listed in descending order of predominance by weight, with the ingredients used in the greatest amount first, followed by those in smaller amounts. The label must list the names of any FDA-certified color additives (for example, FD&C Blue No. 1 or the abbreviated name, Blue 1), but some ingredients can be listed collectively as "flavors," "spices," "artificial flavoring," or in the case of color additives exempt from certification, "artificial colors", without naming each one.

Food ingredients must meet the same safety standard regardless of whether they are naturally or artificially derived.

The following table lists the types of common food ingredients, why they are used, and some examples of the names that can be found on product labels. Some additives are used for more than one purpose.

What are color additives and why are they used in food?

A color additive is any substance that imparts color to a food, drug, cosmetic, or to the human body. Color additives include both synthetic substances and substances derived from natural sources. Color additives may be used in food to enhance natural colors, add color to colorless and ‘fun’ foods such as cake decorations, and help identify flavors (such as purple for grape flavor or yellow for lemon). Color additives are sometimes called food dyes.

Are color additives safe to eat?

Yes, color additives are safe when they are used in accordance with with FDA regulations. When the FDA approves the use of a color additive in food, our regulations specify:

• the types of foods in which it can be used,
• any maximum amounts allowed to be used, and
• how the color additive should be identified on the food label.

Do all color additives need to be approved by the FDA before they can be used in foods?

Yes. Under the Federal Food, Drug, and Cosmetic Act, all color additives and new uses for listed color additives must be approved by the FDA before they may be used in foods. A full listing of all approved color additives is available in the Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices.

What criteria does the FDA review when evaluating the safety of a color additive?

When evaluating the safety of a new color additive or a new use for a listed color additive, the FDA considers several factors. These include the short and long-term effects of consumption, composition and properties, manufacturing process, stability, likely amount of consumption/exposure, and the availability of analytical methods for determining its purity and the amount in food.

Synthetic color additives, also known as certified colors, are required to undergo batch certification, a process in which the FDA analyzes a representative sample of each batch of the color additive to ensure it meets the required identity and specifications before it can be used. Prior to certifying a batch, the FDA analyzes the chemical composition.

There are nine certified color additives approved by the FDA for use in food:

• FD&C Blue No. 1
  • Confections, beverages, cereals, frozen dairy desserts, popsicles, frostings & icings
• FD&C Blue No. 2
  • Baked goods, cereals, snack foods, ice cream, confections, and yogurt
• FD&C Green No. 3
  • Cereal, ice cream, sherbet, drink mixers, and baked goods

• Orange B
  • Only approved for use in hot dog and sausage casings
• Citrus Red No. 2
  • Only approved for use to color orange peels
• FD&C Red No. 3
  • Confections, beverages, cereals, ice cream cones, frozen dairy desserts, popsicles, frostings & icings
• FD&C Red No. 40
  • Cereal, beverages, gelatins, puddings, dairy products, and confections
• FD&C Yellow No. 5
  • Confections, cereals, snack foods, beverages, condiments, baked goods, and yogurt
• FD&C Yellow No. 6
  • Cereals, snack foods, baked goods, gelatins, beverages, dessert powders, crackers, and sauces

What is the difference between a certified and an exempt color additive?

”Exempt” colors include pigments from natural sources such as vegetables, minerals, or animals. Examples include annatto extract (yellow), dehydrated beets (bluish-red to brown), caramel (yellow to tan), beta-carotene (yellow to orange) and grape skin extract (red, green). Although exempt color additives are not subject to batch certification requirements, they are still color additives and FDA must approve them before they can be used in foods.

Certified color additives are synthetic colorings that are used widely for intense, uniform color, and because they blend easily to create a variety of hues. These additives are classified as certified because they are required to undergo certification every time a new batch is manufactured.

How do I know whether color additives are in my food?

The FDA requires food manufacturers to list all ingredients on the label, with the ingredients used in the greatest amount first, followed in descending order by those in smaller amounts. The label must list the names of any FDA-certified color additive (e.g., FD&C Blue No. 1 or the abbreviated name, Blue 1). With the exception of carmine/cochineal extract, color additives exempt from certification can be listed collectively as “artificial colors,” “artificial color added,” “color added,” or equally informative terms, without naming each one. Because of potential allergic reactions in some people, carmine/cochineal extract are required to be identified by name on food labels.

Do color additives affect the behavior of children?

The FDA has reviewed and will continue to examine the effects of color additives on children’s behavior. The totality of scientific evidence indicates that most children have no adverse effects when consuming foods containing color additives, but some evidence suggests that certain children may be sensitive to them. The FDA will continue to evaluate emerging science to ensure the safety of color additives approved for use. Parents who wish to limit the amount of color additives in their children’s diet may check the food ingredient list on labels. Parents should also discuss any concerns with their family physician.

Should my family avoid color additives?

Color additives are safe when they are used in accordance with FDA regulations. If you choose to limit your intake of color additives or to avoid them altogether, you can identify whether they are in a product by reading the ingredients on the nutrition label.

If a problem were to arise with a color additive, what would the FDA do?

The FDA continually monitors reports of problems that may be related to color additives and takes action when necessary. The FDA can issue a warning letter to the manufacturer, detain products before they are shipped to stores, issue import alerts, or even seize products that are found to be unsafe or to contain color additives that are prohibited, misused, or not properly identified as ingredients. The FDA may also revoke or amend its regulations of current authorized uses as needed.

Color additives give the red tint to your fruit punch and the green hue to your mint-flavored toothpaste. They are dyes, pigments, or other substances that can impart color when added or applied to a food, drug, cosmetic, or the human body. They can be found in a range of consumer products—from cough syrup and eyeliner to contact lenses and cereal.

So how safe are they? "Color additives are very safe when used properly," says Linda Katz, M.D., M.P.H., Director of the Office of Cosmetics and Colors in FDA's Center for Food Safety and Applied Nutrition (CFSAN). "There is no such thing as absolute safety of any substance. In the case of a new color additive, FDA determines if there is 'a reasonable certainty of no harm' under the color additive's proposed conditions of use." Here are more facts you should know about color additive safety.

FDA regulates color additives used in the United States. This includes those used in food (and dietary supplements), drugs, cosmetics, and medical devices. These color additives (except coal-tar hair dyes) are subject by law to approval by the agency and must be used only in compliance with the approved uses, specifications, and restrictions. In the approval process, FDA evaluates safety data to ensure that a color additive is safe for its intended purposes. Color additives that FDA has found to cause cancer in animals or humans may not be used in FDA-regulated products marketed in the United States.

Two main categories make up FDA's list of permitted color additives. In addition to undergoing approval, some color additives are known as "certifiable." Certifiable color additives are man-made, derived primarily from petroleum and coal sources. The manufacturer submits a sample from the batch for which it is requesting certification, and FDA tests the sample to determine whether it meets the color additive's requirements for composition and purity. If it does, FDA "certifies" the batch and issues a certification lot number. Only then can that batch be used legally in FDA-regulated products.

Certified color additives have special names consisting of a prefix, such as FD&C, D&C, or Ext. D&C; a color; and a number. An example is FD&C Yellow No. 6, often found in cereals, ice cream, and baked goods. Sometimes a color additive is identified by a shortened form of its name, consisting of just the color and number, such as Yellow 6.

Other color additives, in the second main category, are "exempt" from batch certification. These are obtained largely from plant, animal, or mineral sources. Examples include caramel color and grape color extract. They are not subject to batch certification requirements, but they are still artificial color additives and must comply with regulatory requirements. Both types of color additives are subject to rigorous safety standards.

Approval of a color additive for one intended use does not mean approval for other uses. For example, no color additives have been approved for injection into the skin—even though tattoo parlors often claim that the pigments in their inks are "FDA-approved." Likewise, no color additives are approved for permanent makeup (a form of tattooing). And henna is approved for use on the hair, but not the skin.

Reactions to color additives are rare. It is possible, but rare, to have an allergic-type reaction to a color additive. For example, FD&C Yellow No. 5 may cause itching and hives in some people. This color additive is widely found in beverages, desserts, processed vegetables, drugs, makeup, and other products. FDA requires all products containing FD&C Yellow No. 5 to identify it on their labels so that consumers who are sensitive to the dye can avoid it. On medicine labels, this certified color additive is also identified by its uncertified name, "tartrazine."

FDA can take action against companies if there are violations. In the absence of a voluntary action such as a product recall, FDA can issue warning letters, detentions, and import alerts for products that are found to be unsafe or to contain color additives that are prohibited, misused, or not properly identified as ingredients. FDA can also seize such products. Color additive violations are a common reason for detaining imported cosmetic products that are offered for entry into the United States. Color additives in foods and cosmetics marketed abroad are not subject to the same safeguards as those marketed in the United States.

FDA monitors reports of problems related to color additives. Report adverse reactions to color additives to your local FDA Consumer Complaint Coordinator.

Or, report problems to CFSAN's Adverse Event Reporting System (CAERS) by phone at 301-436-2405 or email at CAERS@cfsan.fda.gov.

This article appears on FDA's Consumer Update page, which features the latest on all FDA-regulated products.

Date Posted: December 10, 2007

People have been using food additives for thousands of years. Today more than 3000 substances are used as food additives. Salt, sugar, and corn syrup are by far the most widely used additives in food in this country.

History of Food Additives

In prehistoric times, cavemen may have smoked meats to make them taste better. In coastal regions, early man probably soaked foods, including meat and poultry, in seawater for better flavor and for preservation. The spice trade between Asia, the Middle East, and Europe flourished because the public demanded the flavors that spices added to foods. Early explorers went in search of salt and spices, and wealthy Romans were kidnapped for ransom of salt and spices. Our ancestors discovered that large amounts of sugar helped preserve fruits.

What is a food additive?

"Food additive" is defined by the Food and Drug Administration (FDA) as any substance that—directly or indirectly—becomes a component or otherwise affects the characteristics of any food. This definition includes any substance used in the production, processing, treatment, packaging, transportation or storage of food.

Additives are used to maintain or improve safety, freshness, nutritional value taste, texture and appearance. The use of food additives has become more prominent in recent years due to the increased production of prepared, processed, and convenience foods.

What is a “direct” food additive?

According to the FDA, “Direct food additives are those that are added to a food for a specific purpose in that food.” For example, using phosphates in meat and poultry products to retain moisture and protect the flavor.

What is an “indirect” food additive?

“Indirect food additives are those that become part of the food in trace amounts due to its packaging, storage or other handling,” according to the FDA. For instance, minute amounts of packaging substances may find their way into foods during storage. Food packaging manufacturers must prove to the FDA that all materials coming in contact with food are safe before they are permitted for use in such a manner.

What is a color additive?

FDA defines a color additive as any dye, pigment, or substance which—when added or applied to a food, drug, or cosmetic, or to the human body—is capable (alone or through reactions with other substances) of imparting color. FDA is responsible for regulating all color additives to ensure that foods containing color additives are safe to eat, contain only approved ingredients, and are accurately labeled.

Color additives are used in foods for many reasons: 1) to offset color loss due to exposure to light, air, temperature extremes, moisture, and storage conditions; 2) to correct natural variations in color; 3) to enhance colors that occur naturally; and 4) to provide color to colorless and "fun" foods. Without color additives, colas wouldn't be brown, margarine wouldn't be yellow, and mint ice cream wouldn't be green. Color additives are now recognized as an important part of practically all processed foods we eat.

How are additives approved for use in foods?

Today, food and color additives are more strictly studied, regulated, and monitored than at any other time in history. FDA has the primary legal responsibility for determining their safe use. To market a new food or color additive (or before using an additive already approved for one use in another manner not yet approved), a manufacturer or other sponsor must first petition FDA for its approval. These petitions must provide evidence that the substance is safe for the ways in which it will be used. As a result of recent legislation, since 1999, indirect additives have been approved via a premarket notification process requiring the same data as was previously required by petition.

Who monitors the safety of food additives?

Before any substance can be added to food, its safety must be assessed in a stringent approval process. The Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) shares responsibility with FDA for the safety of food additives used in meat, poultry, and egg products. All additives are initially evaluated for safety by FDA.

When an additive is proposed for use in a meat, poultry, or egg product, its safety, technical function, and conditions of use must also be evaluated by the Risk, Innovations and Management Staff of FSIS, as provided in the Federal Meat Inspection Act, the Poultry Products Inspection Act, the Egg Products Inspection Act, and related regulations.

Although FDA has overriding authority regarding additive safety, FSIS may apply even stricter standards that take into account the unique characteristics of meat, poultry, and egg products. Several years ago, for instance, permission was sought to use sorbic acid in meat salads. Although sorbic acid was an approved food additive, permission for use in meat salad was denied because such usage could mask spoilage caused by organisms that cause foodborne illness.

Additives are never given permanent approval. FDA and FSIS continually review the safety of approved additives, based on the best scientific knowledge, to determine if approvals should be modified or withdrawn.

Why are food additives regulated?

During the early part of the first century in America, people lived off the land. They grew their own foods or bought them from someone they knew and trusted. There was no need for food safety laws. As the country grew and became more industrialized, the number of people who produced their own foods decreased drastically. Therefore, the nation depended on the newly emerging food industry to produce and distribute its food. Unfortunately, during the 1850's, there was much dishonesty concerning adding substances to foods.

The first efforts to pass laws to govern foods were state laws (1850 and beyond). These laws were difficult to enforce. The first major Federal law governing food was the 1906 Federal Food and Drug Act. It set the framework for the regulation of foods and stated that it was illegal to sell misbranded or adulterated foods and drugs in interstate commerce. It listed chemicals that were illegal to add to foods, such as borax or formaldehyde. The law was weak in that there was no method of enforcement and no punishment.

In 1938, the Federal Food and Drug Act was revised to account for changes in medical science and food technology, and was renamed the Federal Food, Drug, and Cosmetic Act. Among the many provisions of the law was a requirement for truthful labeling of additives.

When did food additives regulations begin?

The 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act provided for the first specific regulations of food additives. Approval of new food additives was required before they could be marketed, and the responsibility for proving their safety was placed on the manufacturer.

To use or market a substance to be used as a food additive, a company must first file a petition with the FDA outlining the tests that prove the substance to be safe under the proposed conditions of use. If it is approved as safe under the proposed conditions of use, FDA prescribes in its regulations, the types of foods it may be used in, and how it may be used.

Are any additives exempt from the approval process?

The Food Additives Amendment exempted two groups of food additives from FDA's testing and approval process. One is the list of substances known as "generally recognized as safe" (GRAS). This group includes a variety of substances, from commonly used flavorings and spices to phosphates and carrageenan. These substances are considered harmless under prescribed conditions of use. Past extensive use of these substances has produced no known harmful effects.

The other group of additives known as "substances with prior sanction" was approved by USDA and FDA for use in foods prior to the passage of the 1958 Food Additives Amendment. Examples of these types of substances include potassium nitrite and sodium nitrite. Additives can be removed from the lists if tests indicate the substances are not safe for human consumption.

When were color additives addressed?

The 1960 Color Additives Amendment brought all colors, natural and synthetic, under the Food, Drug, and Cosmetic Act. Color additives may not be used to deceive consumers or to conceal blemishes or inferiorities in food products. Colors used in foods, drugs, and cosmetics must be approved by the FDA before they can be marketed.

The Food Additives Amendment and the Color Additives Amendments include the Delaney Clause, which prohibits the approval of an additive "if it is found to induce cancer when ingested by" people or animals, or "if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in" people or animals. Any substance found to cause cancer is regulated under the general safety provisions of these laws, as well as by the Delaney Clause.

What are labeling requirements for additives?

The statutes and regulations to enforce the statutes require certain information on labels of meat and poultry products so consumers will have complete information about a product. In all cases, ingredients must be listed on the product label in the ingredients statement in order by weight, from the greatest amount to the least.

Substances such as spices and spice extractives may be declared as "natural flavors," "flavors," or "natural flavoring" on meat and poultry labels without naming each one. This is because they are used primarily for their flavor contribution and not their nutritional contribution.

Substances such as dried meat, poultry stock, meat extracts, or hydrolyzed protein must be listed on the label by their common or usual name because their primary purpose is not flavor. They may be used as flavor enhancers, binders, or emulsifiers. They must be labeled using the species of origin of the additive, for example, dried beef, chicken stock, pork extract, or hydrolyzed wheat protein.

Color additives must be declared by their common or usual names on labels (for example, FD&C Yellow 5 or annatto extract), not collectively as colorings. These labeling requirements help consumers make choices about the foods they eat.

The USDA Meat and Poultry Hotline receives many questions about natural flavorings listed on meat and poultry labels. Below are answers to some of the most frequently asked questions.

What substances or ingredients can be listed as "natural flavor," "flavor," or "flavorings" rather than by a specific common or usual name?

Spices (e.g., black pepper, basil, and ginger), spice extracts, essential oils, oleoresins, onion powder, garlic powder, celery powder, onion juice, and garlic juice are all ingredients that may be declared on labeling as "natural flavor," "flavor," or "flavoring." Spices, oleoresins, essential oils, and spice extracts are listed in the Food and Drug Administration regulations.

Can the terms "dried meat or poultry stocks," "dried broth," "meat extracts," and "dried beef plasma" be listed on meat and poultry labels as "natural flavorings"?

No. Substances derived from animal sources must be identified as to the species of origin on the label and be consistent with the definition established by Federal regulation. For example, the listing on the label would read "dried chicken stock," "lamb extract," or "dried beef plasma."

If "meat extract" is added to a processed meat product for flavoring, can it be listed as "flavoring" in the ingredient statement or will it be identified as a "meat product"?

"Meat extract" cannot be identified as "flavoring" in the ingredients statement. "Meat extract is defined as a meat product by Federal regulations and must always be identified by its common or usual name.

How will I know if there is monosodium glutamate (MSG) in a processed meat or poultry product?

MSG is classified as a flavor enhancer by Federal regulation. When it is added to a product, it must be identified as "monosodium glutamate" on the label.

Are MSG and hydrolyzed protein related?

Yes. MSG is the sodium salt of glutamic acid. Glutamic acid is an amino acid, one of the building blocks of protein. It is found in virtually all food and, in abundance, in food that is high in protein, including meat, poultry, cheeses, and fish.

Hydrolyzed proteins, used by the food industry to enhance flavor, are simply proteins that have been chemically broken apart into amino acids. The chemical breakdown of proteins may result in the formation of free glutamate that joins with free sodium to form MSG. In this case, the presence of MSG does not need to be disclosed on labeling. Labeling is required when MSG is added as a direct ingredient.

Can hydrolyzed animal or vegetable protein be identified as "natural flavoring" on the label?

No. FSIS regulation requires that animal or vegetable proteins must be specifically identified in the ingredient statement on the labels. The source of the protein must also be disclosed. On the label, you will read "hydrolyzed wheat protein" or "hydrolyzed milk protein," not just hydrolyzed protein.

What Federal regulation defines what can be listed as a natural flavoring on the meat and poultry label?

On March 1, 1990, FSIS published the final rule, Ingredients That May Be Designated as Natural Flavors, Natural Flavorings, Flavors, or Flavorings When Used in Meat or Poultry Products. The rule did the following:

• Defined the ingredients, i.e., spices, spice extractives, and essential oils, that may be declared as "natural flavors" or "flavors" on meat and poultry labels.
• Required more specific listing of certain ingredients. Substances such as dried beef stock, autolyzed yeast, and hydrolyzed proteins must be listed on the label by their common or usual names because their purpose is not just for flavor. They are flavor enhancers, emulsifiers, stabilizers, and binders.
• Required that the specific source of hydrolyzed protein be indicated on the label, for example, "hydrolyzed soy protein" or "hydrolyzed whey protein."

What is azodicarbonamide (ADA)?

Azodicarbonamide (ADA) is a chemical substance approved for use as a whitening agent in cereal flour and as a dough conditioner in bread baking.

On what basis did FDA approve the use of ADA?

FDA approved the use of ADA as a food additive in cereal flour and as a dough conditioner based on a comprehensive review of safety studies, including multi-year feeding studies.

What has FDA done to continue to ensure the safe use of ADA in foods?

FDA has continued to evaluate the safe use of ADA in foods. In 2016, the agency conducted a comprehensive exposure assessment of semicarbazide (SEM) – a breakdown chemical that forms from ADA during bread making. This assessment was based on (1) the amount of SEM from the use of ADA from the analysis of over 250 representative bread and bread products, and (2) data from two different sets of food consumption data: a) the combined 2009-2012 National Health and Nutrition Examination Survey (NHANES) 2-day dietary intake survey; and b) the 2007-2010 NPD Group, Inc. National Eating Trends-Nutrient Intake Database (NPD NET-NID) 10-14 day data using the proprietary Foods Analysis and Residue Evaluation-National Eating Trends (FARE-NET) program.

Based on this information, FDA developed exposure estimates for SEM for the U.S. population aged 2 years or more and children aged 2-5 years. Children aged 2-5 years were chosen because they would be expected to have the highest exposure to SEM per body weight. This exposure assessment was presented at the 251st National Meeting of the American Chemical Society, on March 15, 2016.

What about studies that show breakdown products of ADA, specifically semicarbazide, to be a carcinogen?

During bread making, ADA completely breaks down to form other chemicals, one of which is SEM. At high levels, SEM has been shown to increase the incident of tumors when fed to female mice, but not to male mice or either gender of rat. These studies were conducted in rodents at levels of SEM that far exceed estimates of human exposure from the consumption of ADA-treated flour or bread products.

Does FDA recommend consumers change their diets?

Based on the science, FDA is not recommending that consumers change their diets because of exposure to ADA/SEM. FDA considers ADA a safe food additive when used for the purposes and at the levels specified in the FDA regulations.

How do I know whether bread products contain ADA?

ADA, like all ingredients intentionally added to food, must be listed on the ingredient label. Consumers are able to identify the addition of ADA by looking for “azodicarbonamide” on the label.

Is ADA necessary to make bread?

No. The use of ADA as a whitening agent and dough conditioner is not necessary to make bread and there are alternative ingredients approved for use available.

Does ADA have other uses?

Yes, ADA is also authorized for use as a blowing agent in sealing caps for food containers such as ketchup bottles. In 2005, the European Food Safety Authority (EFSA) assessed the risk from the use of ADA as a blowing agent and concluded that it is not of concern for human health given the levels that have been found in foods packaged in glass jars and bottles. However, EFSA had also noted that exposure to SEM should be limited where possible, and the European Union banned this use of ADA.

What is benzene?

Benzene is a chemical that is released into the air from emissions from automobiles and burning coal and oil. It is also used in the manufacture of a wide range of industrial products, including chemicals, dyes, detergents, and some plastics.

Why is benzene a concern?

Benzene is a carcinogen that can cause cancer in humans. It has caused cancer in workers exposed to high levels from workplace air. Based on results from a Center for Food Safety and Applied Nutrition (CFSAN) survey of almost 200 samples of soft drinks and other beverages tested for benzene conducted from 2005 through May 2007, a small number of products sampled contained more than 5 parts per billion (ppb) of benzene. The manufacturers have reformulated products, if still manufactured, which were identified in the survey as containing greater than 5 ppb benzene. CFSAN tested samples of these reformulated products and found that benzene levels were less than 1.5 ppb. The US Environmental Protection Agency (EPA) has established a maximum allowable level (MCL) for benzene in drinking water of 5 ppb. FDA has adopted EPA’s MCL for drinking water as an allowable level for bottled water.

Do the levels of benzene in beverages pose a risk to public health?

The results of CFSAN's survey indicate that the levels of benzene found in beverages to date do not pose a safety concern for consumers. Almost all samples analyzed in our survey contained either no benzene or levels below 5 ppb. Furthermore, benzene levels in hundreds of samples tested by national and international government agencies and the beverage industry are consistent with those found in our survey.

How does benzene get into beverages?

Benzene can form at very low levels (ppb level) in some beverages that contain both benzoate salts and ascorbic acid (vitamin C) or erythorbic acid (a closely related substance (isomer) also known as d-ascorbic acid). Exposure to heat and light can stimulate the formation of benzene in some beverages that contain benzoate salts and ascorbic acid (vitamin C). Sodium or potassium benzoate may be added to beverages to inhibit the growth of bacteria, yeasts, and molds. Benzoate salts also are naturally present in some fruits and their juices, such as cranberries, for example. Vitamin C may be present naturally in beverages or added to prevent spoilage or to provide additional nutrients.

What steps are being taken to reduce or eliminate benzene in beverages?

FDA is working with the beverage industry to minimize benzene formation in products. For example, FDA has met with industry to determine the factors contributing to benzene formation. FDA has directly contacted those firms whose products were tested and found to contain more than 5 ppb benzene in our survey. Manufacturers have reformulated products to ensure benzene levels are minimized or eliminated. The International Council of Beverages Associations and the American Beverage Association have developed guidance for all beverage manufacturers on ways to minimize benzene formation. FDA will continue its testing program for benzene in soft drinks and other beverages to monitor levels and will inform the public and manufacturers as new data become available.

How was the problem identified?

FDA first became aware that benzene was present in some soft drinks in 1990. At that time, the soft drink industry informed the agency that benzene could form at low levels in some beverages that contained both benzoate salts and ascorbic acid. FDA and the beverage industry initiated research at that time to identify factors contributing to benzene formation. This research found that elevated temperature and light can stimulate benzene formation in the presence of benzoate salts and ascorbic acid. As a result of these findings, many manufacturers reformulated their products to reduce or eliminate benzene formation.

In November 2005, FDA received reports that benzene had been detected at low levels in some soft drinks containing benzoate salts and ascorbic acid. CFSAN immediately initiated a survey of benzene levels in soft drinks and other beverages. The vast majority of the beverages sampled to date (including those containing both benzoate salts and ascorbic acid) contained either no detectable benzene or levels well below the 5 ppb EPA MCL for benzene in drinking water.

How many and what products were found to have excessive levels of benzene?

To date, FDA has tested almost 200 soft drink and other beverages in the CFSAN survey. Benzene above 5 ppb was found in a total of ten products. Benzene above 5 ppb was found in nine of the beverage products that contain both added benzoate salts and ascorbic acid. FDA also found benzene above 5 ppb in one cranberry juice beverage with added ascorbic acid but no added benzoates (cranberries contain natural benzoates). The manufacturers have reformulated products, if still manufactured, which were identified in the survey as containing greater than 5 ppb benzene. CFSAN tested samples of these reformulated products and found that benzene levels were less than 1.5 ppb.

What about results for benzene in beverages reported in FDA's Total Diet Study (TDS)?

FDA's TDS is an ongoing FDA program that determines levels of various contaminants and nutrients in a broad variety of foods. As was previously reported by the press, FDA's TDS results from 1995 to 2001 included benzene levels in some beverages that were elevated compared with results from CFSAN's surveyand other recent domestic and international studies. In 2006, the FDA conducted an evaluation¹ of the reliability of the TDS benzene results. This evaluation concluded that the TDS procedure used to analyze benzene levels can generate benzene in beverages containing benzoate preservatives. There was also evidence of a source of benzene contamination in the TDS laboratory. Although the FDA evaluation focused on benzene in beverages, these findings also raise questions about the reliability of the method for benzene in solid foods. Because the TDS benzene results appeared to be unreliable, FDA scientists recommend that the benzene data be viewed with great caution while FDA considers removing TDS benzene data from the TDS website. There is no evidence of problems with other TDS data.

FDA acknowledges the interest that many consumers have in the safe use of Bisphenol A (BPA) in food packaging. FDA has performed extensive research and reviewed hundreds of studies about BPA’s safety. We reassure consumers that current approved uses of BPA in food containers and packaging are safe. FDA continues to monitor the scientific literature for new research that helps enhance our understanding of BPA, and will consider new data as it continues to ensure the safe use of BPA in food packaging. Here, FDA experts answer some key questions about the agency's regulation of BPA.

What is BPA?

BPA is a chemical component present in polycarbonate plastic used in the manufacture of certain beverage containers and many food and beverage can liners. BPA-based plastic bottles are generally clear and tough. In cans, BPA-based liners form a barrier between the food and the can surface that prevents corrosion of the can and migration of metal into the food. People are exposed to low levels of BPA because very small amounts may migrate from the food packaging into foods or beverages.

Is BPA safe?

Yes. Based on FDA's ongoing safety review of scientific evidence, the available information continues to support the safety of BPA for the currently approved uses in food containers and packaging. People are exposed to low levels of BPA because, like many packaging components, very small amounts of BPA may migrate from the food packaging into foods or beverages. Studies pursued by FDA's National Center for Toxicological Research (NCTR) have shown no effects of BPA from low-dose exposure.

How does FDA evaluate the safety of food contact substances?

The FDA regulates all food packaging materials, including BPA, from which components can reasonably be expected to migrate into a food. The agency's safety evaluations focus on three factors. These include the cumulative exposure to food contact substances that migrate into foods and beverages, the nature of the packaging components, and the safe levels of exposure.

Why is there such interest in BPA?

Some exploratory scientific studies have appeared in the public literature that have raised questions about the safety of ingesting the low levels of BPA that can migrate into food from food contact materials. To address these questions the National Toxicology Program (NTP), partnering with FDA's NCTR, has been carrying out in-depth studies to answer key questions and clarify uncertainties about BPA.

Has FDA taken any regulatory actions regarding BPA?

FDA's regulations authorize FDA to amend its food additive regulations to reflect when certain uses of an additive have been abandoned. In 2012 and 2013, FDA granted two petitions requesting that FDA amend its food additive regulations to no longer provide for the use of certain BPA-based materials in baby bottles, sippy cups, and infant formula packaging because these uses have been abandoned. An amendment of the food additive regulations based on abandonment is not based on safety, but is based on the fact that the regulatory authorization is no longer necessary for the specific use of the food additive because that use has been permanently and completely abandoned.

How current is FDA's BPA evaluation?

In the fall of 2014, FDA experts from across the agency, specializing in toxicology, analytical chemistry, endocrinology, epidemiology, and other fields, completed a four-year review of more than 300 scientific studies. The FDA review has not found any information in the evaluated studies to prompt a revision of FDA’s safety assessment of BPA in food packaging at this time. The studies reviewed were published or available from November 1, 2009 to July 23, 2013.

How can you tell if a container has BPA?

A resin code of 7 appearing on plastic containers indicates that the container may be made of a BPA-containing plastic.

What's next?

FDA continues to review the available information and studies on BPA, including the newly released draft NTP report (CLARITY-BPA), and will update its assessment of BPA and take additional action if warranted. FDA will also continue to consult with other expert agencies in the federal government, including the National Institutes of Health (and the National Toxicology Program), the Environmental Protection Agency, the Consumer Product Safety Commission, and the Centers for Disease Control and Prevention. And FDA will continue to participate in discussions with our international regulatory and public health counterparts who are also engaged in assessing the safety of BPA.

What is 4-methylimidazole (4-MEI)?

4-methylimidazole (4-MEI) is a chemical compound that is not directly added to food; rather it is formed as a byproduct in some foods and beverages during the normal cooking process. For example, 4-MEI may form when coffee beans are roasted and when meats are roasted or grilled. 4-MEI also forms as a trace impurity during the manufacturing of certain types of caramel coloring (known as Class III and Class IV caramel coloring) that are used to color cola-type beverages and other foods.

Is there a risk from eating foods that contain 4-MEI?

Based on the available information, FDA has no reason to believe that there is any immediate or short-term danger presented by 4-MEI at the levels expected in food from the use of caramel coloring.

What about studies that show 4-MEI to be a carcinogen?

In 2007, the National Toxicology Program (NTP) issued a report summarizing the results of toxicological testing conducted on 4-MEI in rats and mice. A 2-year study in rats was inconclusive regarding carcinogenicity, but a 2-year mouse study showed an increased incidence of certain lung tumors. These NTP studies were conducted in rodents at levels of 4-MEI that far exceed current estimates of human exposure to 4-MEI from the consumption of Class III and Class IV caramel coloring in food products such as colas.

How do I know whether food products contain caramel coloring?

Foods containing added colors must list them either by name or as “artificial colors” in the ingredients statement on the food label. Because there are other artificial colors, the presence of “artificial colors” on a food label does not necessarily mean that caramel coloring is contained in the food. Also, the presence of “caramel coloring” on a food label does not necessarily mean that the food contains 4-MEI, because the term “caramel coloring” also may be used to describe Class I and Class II caramel coloring. Class I and Class II caramel coloring do not contain 4-MEI.

What is FDA doing about the presence of 4-MEI in caramel coloring?

To ensure that the use of caramel coloring in food continues to be safe, FDA is currently reviewing all available data on the safety of 4-MEI and is reassessing potential consumer exposure to 4-MEI from the use of Class III and Class IV caramel coloring in food products. This safety analysis will help FDA determine what, if any, regulatory action needs to be taken. Such actions could include setting a limit on the amount of 4-MEI that can be present in caramel coloring. However, in the interim, FDA is not recommending that consumers change their diets because of concerns about 4-MEI.

Can 4-MEI be eliminated from food products?

Eliminating 4-MEI in food is virtually impossible. However, in the case of caramel coloring, companies can take steps to reduce its formation during the manufacturing process. In fact, several companies have already reduced the amount.

What is the position of international food regulatory agencies on 4-MEI?

The European Food Safety Authority (EFSA) assessed the risk to 4-MEI from the use of caramel colors in 2011 and concluded that human exposure to 4-MEI in Europe was well below the threshold level reflected in the NTP study. In 2012, EFSA re-evaluated the consumer exposure to 4-MEI from the use of caramel colors, and reaffirmed its 2011 conclusion. EFSA also noted that 4-MEI does not appear to cause DNA mutations (genotoxicity) and that the type of tumors observed in the mice from the NTP study can occur spontaneously in these animals. For these reasons, EFSA concluded that they had no concerns about Europeans being exposed to 4-MEI from the use of caramel coloring in food.

FDA receives many inquiries and comments from the public about the chemistry of high fructose corn syrup (HFCS) in relation to other sweeteners such as table sugar and honey, and whether HFCS is safe to eat.

Where does HFCS come from?

HFCS is derived from corn starch. Starch itself is a chain of glucose (a simple sugar) molecules joined together.
When corn starch is broken down into individual glucose molecules, the end product is corn syrup, which is essentially 100% glucose.

To make HFCS, enzymes are added to corn syrup in order to convert some of the glucose to another simple sugar called fructose, also called “fruit sugar” because it occurs naturally in fruits and berries.

HFCS is ‘high’ in fructose compared to the pure glucose that is in corn syrup. Different formulations of HFCS contain different amounts of fructose.

How much fructose is in HFCS?

The most common forms of HFCS contain either 42 percent or 55 percent fructose, as described in the Code of Federal Regulations (21 CFR 184.1866), and these are referred to in the industry as HFCS 42 and HFCS 55. The rest of the HFCS is glucose and water. HFCS 42 is mainly used in processed foods, cereals, baked goods, and some beverages. HFCS 55 is used primarily in soft drinks.

Sucrose (sugar), the most well-known sweetener, is made by crystallizing sugar cane or beet juice. Sucrose is also made up of the same two simple sugars, glucose and fructose, joined together to form a single molecule containing one glucose molecule and one fructose molecule, an exact one-to-one ratio.

The proportion of fructose to glucose in both HFCS 42 and HFCS 55 is similar to that of sucrose. The primary differences between sucrose and the common forms of HFCS are:

• HFCS contains water.
• In sucrose, a chemical bond joins the glucose and fructose. Once one eats, stomach acid and gut enzymes rapidly break down this chemical bond.
• In HFCS, no chemical bond joins the glucose and fructose.

Other nutritive sweeteners can vary in their fructose content (by “nutritive,” we mean that the sweetener contains calories). Honey is a common nutritive sweetener with an approximately one-to-one ratio of fructose to glucose. Fruit and nectar-based sweeteners may have more fructose than glucose, especially those that come from apples and pears.

Is HFCS less safe than other sweeteners?

FDA receives many inquiries asking about the safety of HFCS, often referring to studies about how humans metabolize fructose or fructose-containing sweeteners. These studies are based on the observation that there are some differences between how we metabolize fructose and other simple sugars.

We are not aware of any evidence, including the studies mentioned above, that there is a difference in safety between foods containing HFCS 42 or HFCS 55 and foods containing similar amounts of other nutritive sweeteners with approximately equal glucose and fructose content, such as sucrose, honey, or other traditional sweeteners. The 2010 Dietary Guidelines for Americans recommend that everyone limit consumption of all added sugars, including HFCS and sucrose. FDA participated in the development of the Dietary Guidelines and fully supports this recommendation.

What is melamine?

Melamine is a chemical that has many industrial uses. In the United States, it is approved for use in the manufacturing of some cooking utensils, plates, plastic products, paper, paperboard, and industrial coatings, among other things. In addition, although it is not registered as a fertilizer in the U.S., melamine has been used as a fertilizer in some parts of the world.

Melamine may be used in the manufacturing of packaging for food products, but is not FDA-approved for direct addition to human food or animal feeds marketed in the U.S.

I recently read that plastic tableware from China contained high levels of melamine. Can the melamine from these products get into foods and drinks?

The Taiwan Consumers' Foundation recently tested plastic tableware made in China and found that it contained melamine at a level of 20,000 parts per billion. This type of tableware is manufactured with a substance called melamine-formaldehyde resin. It forms molecular structures that are molded, with heat, to form the shape of the tableware. A small amount of the melamine used to make the tableware is "left over" from this chemical reaction and remains in the plastic. This left-over melamine can migrate very slowly out of the plastic into food that comes into contact with the tableware.

If melamine from plastic tableware can get into foods and drinks, does it make the foods or drinks harmful to health?

It has been found that melamine does not migrate from melamine-formaldehyde tableware into most foods. The only measured migration, in tests, was from some samples (three out of 19 commercially available plates and cups) into acidic foods, under exaggerated conditions (that is, the food was held in the tableware at 160 oF for two hours). When adjusted for actual-use conditions (cold orange juice held in the tableware for about 15 minutes), the migration would be less than 10 parts of melamine per billion parts of juice.

This is 250 times lower than the level of melamine (alone or even in combination with related compounds – analogues – known to increase its toxicity) that FDA has concluded is acceptable in foods other than infant formula (2,500 parts per billion); in other words, well below the risk level. In addition, such highly acidic foods make up only about 10% of the total diet, so the dietary level of melamine in these scenarios would be less than one part per billion.

However, when highly acidic foods are heated to extreme temperatures (e.g.,160 ° F or higher), the amount of melamine that migrates out of the plastic can increase. Foods and drinks should not be heated on melamine-based dinnerware in microwave ovens. Only ceramic or other cookware which specifies that the cookware is microwave-safe should be used. The food may then be served on melamine-based tableware.

Should I stop using plastic tableware?

Foods and drinks may be served on plastic tableware. Plastic tableware that does not specify that it’s microwave-safe should not be used to heat foods and drinks.

How did FDA decide what level of melamine in food doesn’t pose a risk to health?

A safety and risk assessment estimates the risk that specific substances have on human health, based on the best scientific data available at the time. FDA has done this type of assessment to identify the risk posed by melamine and its analogues in foods (Interim Safety and Risk Assessment of Melamine and Its Analogues in Food for Humans).

The risk assessment was conducted by scientists from FDA’s Center for Food Safety and Applied Nutrition and FDA’s Center for Veterinary Medicine, and included a review of the scientific literature on melamine toxicity. Animal studies also provided valuable information for this work. The assessment underwent peer review by a group of experts identified by an independent contractor.

What problems can melamine cause if people eat or drink food contaminated with it?

Products with melamine contamination above the levels noted in FDA’s risk assessment may put people at risk of conditions such as kidney stones and kidney failure, and of death. Signs of melamine poisoning may include irritability, blood in urine, little or no urine, signs of kidney infection, and / or high blood pressure.

What is MSG?

Monosodium glutamate (MSG) is the sodium salt of the common amino acid glutamic acid. Glutamic acid is naturally present in our bodies, and in many foods and food additives.

How is it made?

MSG occurs naturally in many foods, such as tomatoes and cheeses. People around the world have eaten glutamate-rich foods throughout history. For example, a historical dish in the Asian community is a glutamate-rich seaweed broth. In 1908, a Japanese professor named Kikunae Ikeda was able to extract glutamate from this broth and determined that glutamate provided the savory taste to the soup. Professor Ikeda then filed a patent to produce MSG and commercial production started the following year.

Today, instead of extracting and crystallizing MSG from seaweed broth, MSG is produced by the fermentation of starch, sugar beets, sugar cane or molasses. This fermentation process is similar to that used to make yogurt, vinegar and wine.

Is MSG safe to eat?

FDA considers the addition of MSG to foods to be “generally recognized as safe” (GRAS). Although many people identify themselves as sensitive to MSG, in studies with such individuals given MSG or a placebo, scientists have not been able to consistently trigger reactions.

Does “glutamate” in a product mean it contains gluten?

No—glutamate or glutamic acid have nothing to do with gluten. A person with Celiac disease may react to the wheat that may be present in soy sauce, but not to the MSG in the product.

What’s the difference between MSG and glutamate in food?

The glutamate in MSG is chemically indistinguishable from glutamate present in food proteins. Our bodies ultimately metabolize both sources of glutamate in the same way. An average adult consumes approximately 13 grams of glutamate each day from the protein in food, while intake of added MSG is estimates at around 0.55 grams per day.

How can I know if there is MSG in my food?

FDA requires that foods containing added MSG list it in the ingredient panel on the packaging as monosodium glutamate. However, MSG occurs naturally in ingredients such as hydrolyzed vegetable protein, autolyzed yeast, hydrolyzed yeast, yeast extract, soy extracts, and protein isolate, as well as in tomatoes and cheeses. While FDA requires that these products be listed on the ingredient panel, the agency does not require the label to also specify that they naturally contain MSG. However, foods with any ingredient that naturally contains MSG cannot claim “No MSG” or “No added MSG” on their packaging. MSG also cannot be listed as “spices and flavoring.”

Has FDA received any adverse event reports associated with MSG?

Over the years, FDA has received reports of symptoms such as headache and nausea after eating foods containing MSG. However, we were never able to confirm that the MSG caused the reported effects.

These adverse event reports helped trigger FDA to ask the independent scientific group Federation of American Societies for Experimental Biology (FASEB) to examine the safety of MSG in the 1990s. FASEB’s report concluded that MSG is safe. The FASEB report identified some short-term, transient, and generally mild symptoms, such as headache, numbness, flushing, tingling, palpitations, and drowsiness that may occur in some sensitive individuals who consume 3 grams or more of MSG without food. However, a typical serving of a food with added MSG contains less than 0.5 grams of MSG. Consuming more than 3 grams of MSG without food at one time is unlikely.

Over 70% of dietary sodium comes from eating packaged and prepared foods. Most Americans eat too much sodium. According to the Dietary Guidelines for Americans, diets higher in sodium are associated with an increased risk of developing high blood pressure.

The Nutrition Facts label is a handy tool you can use every day to see the amount of sodium in packaged foods and beverages and make informed dietary choices.

High-intensity sweeteners are commonly used as sugar substitutes or sugar alternatives because they are many times sweeter than sugar but contribute only a few to no calories when added to foods. High-intensity sweeteners, like all other ingredients added to food in the United States, must be safe for consumption.

What are high-intensity sweeteners?

High-intensity sweeteners are ingredients used to sweeten and enhance the flavor of foods. Because high-intensity sweeteners are many times sweeter than table sugar (sucrose), smaller amounts of high-intensity sweeteners are needed to achieve the same level of sweetness as sugar in food. People may choose to use high-intensity sweeteners in place of sugar for a number of reasons, including that they do not contribute calories or only contribute a few calories to the diet. High-intensity sweeteners also generally will not raise blood sugar levels.

How does FDA regulate the use of high-intensity sweeteners in food?

A high intensity sweetener is regulated as a food additive, unless its use as a sweetener is generally recognized as safe (GRAS). The use of a food additive must undergo premarket review and approval by FDA before it can be used in food. In contrast, use of a GRAS substance does not require premarket approval. Rather, the basis for a GRAS determination based on scientific procedures is that experts qualified by scientific training and experience to evaluate its safety conclude, based on publically available information, that the substance is safe under the conditions of its intended use. A company can make an independent GRAS determination for a substance with or without notifying FDA. Regardless of whether a substance is approved for use as a food additive or its use is determined to be GRAS, scientists must determine that it meets the safety standard of reasonable certainty of no harm under the intended conditions of its use. This standard of safety is defined in FDA’s regulations.

Which high-intensity sweeteners are permitted for use in food?

Six high-intensity sweeteners are FDA-approved as food additives in the United States: saccharin, aspartame, acesulfame potassium (Ace-K), sucralose, neotame, and advantame.

GRAS notices have been submitted to FDA for two types of high-intensity sweeteners (certain steviol glycosides obtained from the leaves of the stevia plant (Stevia rebaudiana (Bertoni) Bertoni) and extracts obtained from Siraitia grosvenorii Swingle fruit, also known as Luo Han Guo or monk fruit).

In what foods are high-intensity sweeteners typically found? High-intensity sweeteners are widely used in foods and beverages marketed as "sugar-free" or "diet," including baked goods, soft drinks, powdered drink mixes, candy, puddings, canned foods, jams and jellies, dairy products, and scores of other foods and beverages.

How do I know if high-intensity sweeteners are used in a particular food product?

Consumers can identify the presence of high-intensity sweeteners by name in the ingredient list on food product labels.

Are high-intensity sweeteners safe to eat?

Based on the available scientific evidence, the agency has concluded that the high-intensity sweeteners approved by FDA are safe for the general population under certain conditions of use. For certain highly-purified steviol glycosides and extracts obtained from monk fruit, FDA has not questioned the notifiers’ GRAS determinations under the intended conditions of use described in the GRAS notices submitted to FDA.

Are there any high-intensity sweeteners that should be avoided by some people?

Consumers with phenylketonuria (PKU), a rare genetic disorder, have a difficult time metabolizing phenylalanine, a component of aspartame, and should avoid or restrict aspartame consumption. Sensitive consumers can avoid food products containing aspartame by looking at the label of such products, which must include a statement to inform phenylketonurics that the product contains phenylalanine.

How much high-intensity sweetener is safe to eat?

During premarket review, FDA established an acceptable daily intake (ADI) level for each of the five high-intensity sweeteners approved as food additives. An ADI is the amount of a substance that is considered safe to consume each day over the course of a person’s lifetime. For each of these sweeteners, FDA determined that the estimated daily intake even for a high consumer of the substance would not exceed the ADI. Generally, an additive does not present safety concerns if the estimated daily intake is less than the ADI.

In the case of steviol glycosides, an ADI was established by the Joint Food and Agricultural Organization/World Health Organization Expert Committee on Food Additives (JECFA). An ADI has not been specified for monk fruit.

What should I do if I think I am having a reaction to high-intensity sweeteners?

If you believe that you are having an adverse reaction caused by consuming a high-intensity sweetener, stop consuming it and discuss your concerns with your health care provider.

Are there any high-intensity sweeteners that are currently prohibited by FDA for use in the United States but are used in other countries?

Yes. Cyclamatesand its salts (such as calcium cyclamate, sodium cyclamate, magnesium cyclamate, and potassium cyclamate) are currently prohibited from use in the United States. Whole-leaf and crude stevia extracts are subject to an Import Alert and are also not permitted for use as sweeteners. (Note: These forms of stevia are different from certain highly purified steviol glycosides obtained from stevia leaves, which have been the subjects of GRAS notices; FDA has not objected to the use as sweeteners of these highly refined substances.)

Are there other sugar substitutes that are not high-intensity sweeteners?

Yes. Sugar alcohols, another class of sweeteners, can be used as sugar substitutes. Examples include sorbitol, xylitol, lactitol, mannitol, erythritol, and maltitol. The sweetness of sugar alcohols varies from 25% to 100% as sweet as sugar. Sugar alcohols are slightly lower in calories than sugar and do not promote tooth decay or cause a sudden increase in blood glucose. They are used primarily to sweeten sugar-free candies, cookies, and chewing gums.

Vitamin D is a fat-soluble vitamin that is essential for human health. It comes in many forms. The two major forms are vitamin D₂ and vitamin D₃. Vitamin D without a subscript represents either vitamin D₂ or vitamin D₃ or both. The major function of vitamin D is to help with the absorption of calcium and phosphorus in the small intestine. Vitamin D deficiency can lead to abnormalities in bone metabolism, such as rickets in children or osteomalacia in adults. Excess intake of vitamin D can also be harmful, elevating calcium levels in the blood (hypercalcemia). Vitamin D is a food additive added to food as an optional ingredient.

Under the law, the FDA may approve the use of a food additive only after conducting a scientific safety review of the information provided in the petition to ensure that use of ingredients added to foods are safe for the general population. In this case, the FDA evaluated the projected human dietary exposure to vitamin D from foods and dietary supplements, safety data, and other relevant information and found these uses of vitamin D to be safe.

In July 2016, FDA approved an increase to the amount of vitamin D that may be added as an optional ingredient to milk, and approved the addition of vitamin D to beverages made from edible plants intended as milk alternatives, such as beverages made from soy, almond, and coconut, and edible plant-based yogurt alternatives. Vitamin D was already authorized for use in soy beverages, but today’s approval increases the authorized amount for such beverages that are intended as milk alternatives.

The approval, which amends existing food additive regulations, will allow manufacturers to voluntarily add up to 84 IU/100g of vitamin D3 to milk, 84 IU/100g of vitamin D2 to plant-based beverages intended as milk alternatives, and 89 IU/100g of vitamin D2 to plant-based yogurt alternatives.

Many foods or beverages are flavored—but how can you tell where those flavors come from?

For example, if you’re digging into a bowl of cereal that has the word “maple” on the package, and even images of maple leaves, you may think you’re eating a product that contains maple syrup. But not so fast—the taste may come from added flavors.

The same goes for the lemon drink you’ve made from a package picturing fresh lemons. You probably think it was made with lemons, but it may be flavored with natural or artificial lemon flavor.

Why?

Current regulations allow use of terms like “maple,” “maple-flavored,” or “artificially maple-flavored” on the food label without having any maple syrup in the product, as long as it contains maple flavoring. This flavoring could come from a number of sources, including sap or bark from the maple tree. Or it could come from the herb fenugreek, which can impart a maple-like flavor.

The same is true of other products, such as those with fruit flavors. The ingredient label will list the fruit or fruit juice if present in the food.

Likewise, a lemon-flavored food or drink doesn’t necessarily have to contain lemons or lemon juice. However, this food has to be properly labeled if the source of the flavor is not from lemons. For example, if the flavor comes from an artificial source or a source other than lemon, the product’s name must reflect artificial lemon flavor. And if a strawberry shortcake is made with artificial strawberry flavoring, it must be called artificial strawberry-flavored shortcake.

Not everyone cares if the food actually includes a certain ingredient, as long as the flavor tastes right to them. But, says Douglas Balentine, Ph.D., director of FDA’s Office of Nutrition and Food Labeling, if you don’t want a substitute source of the flavor you’re seeking—if, say, you want real maple syrup in your food—the information you need will be in the ingredient list on the food package.

What to Look for on the Ingredient List

Look for a specific mention of the original flavor source on the ingredient list. Some tips:

• If you want a maple food that is made with maple syrup, look for the words “maple syrup” in the ingredient list. In addition, the firm may voluntarily declare “made with 100% maple syrup” elsewhere on the label.
• In some situations, you may see the term “natural flavor” in the ingredient list. If the maple flavor comes from a natural maple flavor, you may see “natural maple flavor” or “natural flavor” in the ingredient list.
• If you want a product made or flavored with the actual fruit, look for the name of the fruit (“grapefruit”) or the name of a juice made from the fruit (“grapefruit juice”) in the ingredient list.

There are some exceptions. So, a product labeled as a butter product—for instance, “butter cookies”—has to be 100 percent butter to include the term. If the food contains both butter and shortening, an appropriate name would be “butter-flavored.”

And if you want real chocolate, look for “chocolate” in the ingredient list.

According to Felicia Billingslea, director of the FDA’s Food Labeling and Standards Staff, there is also a caveat involving the use of cocoa as an ingredient. “Consumers have long recognized that products like chocolate pudding, cake, and cookies may be made with cocoa,” she says. As long as “cocoa” is listed in the ingredient list, the name of the food can include the term “chocolate in certain situations.”

Finally, if the name of the food is accompanied by terms such as “artificial flavors,” or “natural and artificial flavors,” it is a signal that the original source of the flavor may not have been used in the food.

Where Does the FDA Come In?

The FDA monitors food products to ensure that what is written on the package is not misleading or inaccurate and it can, when necessary, take action against the food company. Domestically, warning letters can be followed by enforcement actions such as seizures. Imported foods can be detained until the importer can correct the label.

“Ultimately we want consumers to be able to make informed choices about their foods, and FDA’s job is to make sure consumers know what they’re getting,” says Balentine.