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The FDA Just Banned 7 Artificial Flavors Used in Candy, Ice Cream, Carbonated Drinks, and More

The FDA Just Banned 7 Artificial Flavors Used in Candy, Ice Cream, Carbonated Drinks, and More


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There's a major health risk associated with them, according to new research.

Last week, the Food and Drug Administration officially banned the use of seven different food additives after both food safety experts and environmentalists presented research suggesting that these substances caused cancer in laboratory animals. One of the flavors had already been removed from the FDA's approved list because it's no longer used by many manufacturers.

On most labels that you'd find in the grocery store, these ingredients are listed simply as "artificial flavors" rather than by their specific names. The six artificial additives linked to cancer—benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine, respectively—are typically added to products to simulate natural mint, citrus, and cinnamon flavors.

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According to Laura MacCleery, policy director for the Center for Science in the Public Interest, these flavorings are most often found in baked goods, candy, carbonated drinks and beverages, chewing gum, and ice cream. MacCleery said that the FDA first received a petition to ban these additives back in 2016 before a few health advocacy organizations sued the federal agency for a response.

The flavors in question were first approved for use in 1964, according to CNN, but the United States Department of Health and Human Services' National Toxicology Program were the ones to test the additives for cancer. Two different species of animals were found to contract cancer from the artificial flavors, the report says.

More on foods that can cause you harm:

In their official announcement, the FDA notes that these flavorings are used "in very small amounts" within the U.S., concluding that they don't "pose a risk to public health under the conditions of their intended use." The national agency, however, is required by law to ban any food additive that has been shown to cause cancer in humans, or animals, in any dose, CNN reports.

Those manufacturers who still use the six additives in their products will have two years to find replacements, the FDA says—hopefully, they'll incorporate natural mint, citrus, and cinnamon instead.


Eating with Your Eyes: The Chemistry of Food Colorings

Would you drink black water? Clear Pepsi? How about using pink butter or green ketchup? Believe it or not, these products actually existed, and not that long ago either. But there is a reason these food fads did not last. Consumers prefer that the color of food matches its flavor.

The link between color and taste is logical. Since oranges are orange, we expect orange-colored drinks to be orange-flavored. Red drinks should taste like cherries, and purple drinks should taste like grapes. If a food is multicolored, it could be moldy and should not be eaten, unless you are eating blue cheese—which gets its distinct flavor from mold!

An astonishing amount of the foods we eat is processed. These foods are altered from their natural states to make them safe, say, to remove harmful bacteria, or to make them appealing and to prolong their shelf life. About 70% of the diet of the average U.S. resident is from processed foods. Much of what we eat would not look appealing if it was not colored. Think of food coloring as cosmetics for your food. Without coloring, hot dogs would be gray. Yum!


The Truth on Artificial Sweeteners

No getting around it, we Americans have a sweet tooth. Most of us eat the equivalent of 20 teaspoons of sugar a day. True, you're probably not sucking on sugar cubes throughout the day, but you are probably downing more than your fair share of sugary cereals, snacks, sodas, ice cream .. and the list goes on and on.

For the average person, there's nothing wrong with sugar per se, unless all the sweet foods in your daily diet are keeping you from eating and drinking the nutritious foods you need. But for people who are trying to lose weight, or have to watch their blood sugar because of diabetes, too much sugar can be a problem. That's where artificial sweeteners can come in handy. These low-calorie sweeteners, reports the International Food Information Council, are safe to use, provide sweetness without calories, and provide a choice of sweet foods.

A 1998 survey conducted by the Calorie Control Council reported that 144 million American adults routinely eat and drink low-calorie, sugar-free products such as desserts and artificially sweetened sodas. The FDA has approved five artificial sweeteners:

Continued

  • Acesulfame potassium (Sunett)
  • Aspartame (NutraSweet or Equal)
  • Sucralose (Splenda)
  • D-Tagatose (Sugaree)
  • Saccharin (Sweet 'N Low)

You may be surprised to see saccharin on that list. Discovered in 1879, saccharin -- which is 300 times sweeter than sugar -- was used during World War I and World War II to make up for sugar shortages and rationing. In the 1970s, the FDA was going to ban saccharin based on the reports of a Canadian study that showed that saccharin was causing bladder cancer in rats. A public outcry kept saccharin on the shelves (there were no other sugar substitutes at that time), but with a warning label that read, "Use of this product may be hazardous to your health. This product contains saccharin which has been determined to cause cancer in laboratory animals."

That warning label is no longer needed, says Ruth Kava, PhD, RD, director of nutrition for the American Council on Science and Health. Further research has shown that male rats have a particular pH factor that predisposes them to bladder cancer. What may be true for male rats does not necessarily hold true for humans (or even for female rats) hence, no more warning labels for saccharin. "A lot of things that cause harm in animals don't always cause harm in humans," she says.

Continued

Like saccharin, aspartame is another sweetener that -- though thoroughly tested by the FDA and deemed safe for the general population -- has had its share of critics who blame the sweetener for causing everything from brain tumors to chronic fatigue syndrome. Not so, says Kava. The only people for whom aspartame is a medical problem are those with the genetic condition known as phenylkenoturia (PKU), a disorder of amino acid metabolism. Those with PKU need to keep the levels of phenylalanine in the blood low to prevent intellectual disability as well as neurological, behavioral, and dermatological problems. Since phenylalanine is one of the two amino acids in aspartame, people who suffer from PKU are advised not to use it.

Some people can be sensitive to sweeteners and experience symptoms such as headaches and upset stomach, but otherwise, there is no credible information that aspartame -- or any other artificial sweetener -- causes brain tumors, or any other illness, says registered dietitian Wendy Vida, with HealthPLACE, the health and wellness division of Highmark Blue Cross Blue Shield in Pittsburgh.

Continued

Kava says that since sweeteners are so much sweeter than sugar, a very small amount is needed to achieve the same sweetness one gets from sugar. "If used normally, the amounts you take in are so minuscule as to be of no concern at all."

Another sweetener receiving much publicity of late is stevia, an herbal sweetening ingredient used in food and beverages by South American natives for many centuries and in Japan since the mid-1970s. According to Ray Sahelian, MD, author of The Stevia Cookbook, stevia has shown no significant side effects after more than 20 years of use in Japan. "There are no indications at this point from any source that stevia has shown toxicity in humans," says Sahelian, though he agrees that further research is warranted.

Because stevia is not FDA-approved, it can not be sold as an artificial sweetener however, it can be -- and is -- sold as a dietary supplement. Because these supplements are not regulated as well as those that have received FDA approval, and therefore have no guarantee of purity, Kava is leery about the use of stevia. "This is a product that's just asking for good research studies," she says. "We just don't know enough yet."

Continued

Though there are any number of people quick to point out what they believe are the dangers of artificial sweeteners, others think that they may actually have beneficial properties -- apart from reducing calorie intake and managing diabetes. Researchers at the Oklahoma Medical Research Foundation, for example, have found in several preliminary studies that aspartame is "especially effective in relieving pain associated with osteoarthritis, multiple sclerosis, and sickle cell anemia."

Whether artificial sweeteners are shown in the future to have therapeutic effects remains to be seen, says Kava. For now, though, their main purpose is to help people reduce caloric intake and/or control diabetes. If you don't need to watch your calories or your blood sugar, there is no real reason to use the sweeteners unless you just happen to like the taste, says Kava. "But if you need to control your sugar and caloric intake, artificial sweeteners are a safe, effective way to do that."

Sources

SOURCES: International Food Information Council Calorie Control Council FDA Ruth Kava, PhD, RD, director of nutrition, American Council on Science and Health Wendy Vida, RD, HealthPLACE, Highmark Blue Cross Blue Shield, Pittsburgh Ray Sahelian, MD, author, The Stevia Cookbook Oklahoma Medical Research Foundation.


Partially Hydrogenated Vegetable Oil

What It Is: A manufactured fat created by forcing hydrogen gas into vegetable fats under extremely high pressure, an unintended effect of which is the creation of trans fatty acids. Food processors like this fat because of its low cost and long shelf life.

Found In: A large portion of margarines, pastries, frozen foods, cakes, cookies, crackers, soups, fast food items and nondairy creamers

What You Need to Know: Though trans fat has been shown to contribute to heart disease more so than saturated fat (it's in a number of these 30 Worst Foods For Your Heart), its artery-clogging effects extend beyond your heart. Reduced blood flow can impact everything from brain function to sexual function. While most health organizations recommend keeping trans fat consumption as low as possible, a loophole in the FDA's labeling requirements allows processors to add as much as 0.49 gram per serving and still claim zero in their nutrition facts. Sneaky!

There is some good news, though. The Food and Drug Administration (FDA) finally banned partially hydrogenated oils from packaged food products. Unfortunately, that doesn't mean you'll never see a trans fat ever again. Restaurants can still use artificial trans fats in their food as of now, but the World Health Organization has a plan to eliminate these fats from the global food supply.


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Are Artificial Flavours And Colors In Food Safe For Us And Our Children?

Flavourings are used in a variety of different foods such as soft drinks, chewing gum, confections, ice creams, baked goods, puddings, gelatins and other desserts, just to name a few. Most of these flavourings are considered fairly safe when used in modest amounts. There are also “flavour enhancers” which are substances used that seem to bring out or improve the flavours of the food. Salt is most likely the most common, though monosodium glutamate (MSG) is used quite frequently. Malitol is another example of a flavouring agent.

Here is a list of some of the natural flavourings:

NATURAL FLAVOURINGS

Vanilla Licorice Cocoa Garlic

Kola nut Mustard Cassia Clove

Fenugreek Peppermint Anise Lemon oil

Fennel Orange oil Ginger Other fruit oils

Most labeling on packages will not specify whether the flavourings used are artifical or natural they usually just state “natural” or “artificial flavouring.” It is important that the labels are read carefully especially if we want to avoid the many chemicals used in artificial flavouring.

Why are artificial flavorings such a concern?

The natural flavorings themselves are not a concern. The problem is that most labeling on packages does not specify whether the flavorings used are artificial or natural they usually just state “natural” or “artificial flavoring.” It is important that the labels are read carefully if we want to avoid the many chemicals used in artificial flavoring as a lot of these can have very harmful effects on the body and the brain, especially young children.

Here is a list of some chemicals found in artificial flavourings:

  • Amyl alcohol Isoamyl alcohol and acid
  • Amyl salts Linalol
  • Benzaldehyde Linalyl salts
  • Benzyl acetate Nonyl alcohol
  • Benzyl alcohol Nonyl salts
  • Butyl acetate and salts Octyl alcohol and salts
  • Diacetyl Phenethyl alcohol and salts
  • Ethyl acetate Pinenes
  • Ethyl butyrate Propyl alcohol and salts
  • Ethyl formate Rhodinol
  • Formic acid Salicylaldehyde
  • Geraniol Valeric acid
  • Geramyl acids

Here is a list of common foods contain colourings and flavourings:

  • Alcoholic beverages Ices Sauces
  • Baked goods Icings Seasonings
  • Candy Jams Shortening
  • Cereals Jellies Soda pop
  • Cordials Liquors Soups
  • Desserts Maple syrup Spices
  • Gelatins Margarine Syrups
  • Gum Meats Yogurts
  • Ice cream Puddings

Why are the added colours in food a concern?

Current colors in use derived for food, drugs and cosmetics (labeled FDC colors by the Food and Drug Administration) include:

  • Citrus Red#2 – withdrawn in 1976, except for use in coloring oranges, because it was shown to cause cancer in animals. It had been widely used in desserts, cereal, and maraschino cherries.
  • Red #3 (erythrosine) – used in cherries, cherry pie, gelatins, ice cream, fruit cocktail, candy, sherbet, pudding, cereals, and baked goods. It is on the safe list, but it has been suggested that this coal-tar derivative is harmful, possibly causing gene mutations, cancers, or changes in brain chemistry. Clear evidence is lacking, so FDC Red #3 stays on the safe list and does not have to be listed on labels except as “artificial color.”
  • Red #40 (Allura Red AC) – took the place of banned Red #2 and is used in foods, drugs, and cosmetics. It may cause cancer in animals.
  • Blue #1 – a coal-tar derivative used in soft drinks, candy, ice cream, cereals, and puddings. It is on the permanent safe list. It is a possible allergen, and it can cause tumors in animals at the site of injection.
  • Blue #2 – used the same way as Blue #1 and is on the permanent FDA list. The World Health Organization rates it in category B – questionable for use in food.
  • Green #3 – this color is used for green foods such as mint jelly, gelatins, candy, frozen desserts, and cereals. It is classified as safe but is a potential allergen and is tumorigenic upon injection.
  • Yellow #5(tartrazine) – this is the most notable color agent, partly because it causes the most immediate allergic reactions in people sensitive to salicylates, such as aspirins (to which it is related), and because, by law, it is the only artificial color that must be listed by name on packaging. Tartrazine is used in yellow-colored foods such as spaghetti, puddings, gelatin, soft drinks, sherbets, ice creams, cereals, and candy. Attempts to ban it have not succeeded. Most people can tolerate some Yellow #5 in foods, but those with sensitivity may develop skin reactions or asthma symptoms (problems are worse in sensitive asthmatics).
  • Yellow #6 – another coal tar color, it is used in many foods, such as candies, baked goods, carbonated beverages, and gelatins. It is considered safe, though there is also some concern about allergy.

So, are any of these poisons safe for use for us or our children? Given the fact that there has been such an increase in the number of kids and adults diagnosed with ADD, ADHD and Behavioural Disorders, and with various cancers, I would argue that we should keep away from any foods that contain any of these added chemicals and colourings as they do not seem to add anything into our lives and wellbeing, and are more of a toxic burden on the body. What do you think?


Are Artificial Flavours And Colors In Food Safe For Us And Our Children?

Flavourings are used in a variety of different foods such as soft drinks, chewing gum, confections, ice creams, baked goods, puddings, gelatins and other desserts, just to name a few. Most of these flavourings are considered fairly safe when used in modest amounts. There are also “flavour enhancers” which are substances used that seem to bring out or improve the flavours of the food. Salt is most likely the most common, though monosodium glutamate (MSG) is used quite frequently. Malitol is another example of a flavouring agent.

Here is a list of some of the natural flavourings:

NATURAL FLAVOURINGS

Vanilla Licorice Cocoa Garlic

Kola nut Mustard Cassia Clove

Fenugreek Peppermint Anise Lemon oil

Fennel Orange oil Ginger Other fruit oils

Most labeling on packages will not specify whether the flavourings used are artifical or natural they usually just state “natural” or “artificial flavouring.” It is important that the labels are read carefully especially if we want to avoid the many chemicals used in artificial flavouring.

Why are artificial flavorings such a concern?

The natural flavorings themselves are not a concern. The problem is that most labeling on packages does not specify whether the flavorings used are artificial or natural they usually just state “natural” or “artificial flavoring.” It is important that the labels are read carefully if we want to avoid the many chemicals used in artificial flavoring as a lot of these can have very harmful effects on the body and the brain, especially young children.

Here is a list of some chemicals found in artificial flavourings:

  • Amyl alcohol Isoamyl alcohol and acid
  • Amyl salts Linalol
  • Benzaldehyde Linalyl salts
  • Benzyl acetate Nonyl alcohol
  • Benzyl alcohol Nonyl salts
  • Butyl acetate and salts Octyl alcohol and salts
  • Diacetyl Phenethyl alcohol and salts
  • Ethyl acetate Pinenes
  • Ethyl butyrate Propyl alcohol and salts
  • Ethyl formate Rhodinol
  • Formic acid Salicylaldehyde
  • Geraniol Valeric acid
  • Geramyl acids

Here is a list of common foods contain colourings and flavourings:

  • Alcoholic beverages Ices Sauces
  • Baked goods Icings Seasonings
  • Candy Jams Shortening
  • Cereals Jellies Soda pop
  • Cordials Liquors Soups
  • Desserts Maple syrup Spices
  • Gelatins Margarine Syrups
  • Gum Meats Yogurts
  • Ice cream Puddings

Why are the added colours in food a concern?

Current colors in use derived for food, drugs and cosmetics (labeled FDC colors by the Food and Drug Administration) include:

  • Citrus Red#2 – withdrawn in 1976, except for use in coloring oranges, because it was shown to cause cancer in animals. It had been widely used in desserts, cereal, and maraschino cherries.
  • Red #3 (erythrosine) – used in cherries, cherry pie, gelatins, ice cream, fruit cocktail, candy, sherbet, pudding, cereals, and baked goods. It is on the safe list, but it has been suggested that this coal-tar derivative is harmful, possibly causing gene mutations, cancers, or changes in brain chemistry. Clear evidence is lacking, so FDC Red #3 stays on the safe list and does not have to be listed on labels except as “artificial color.”
  • Red #40 (Allura Red AC) – took the place of banned Red #2 and is used in foods, drugs, and cosmetics. It may cause cancer in animals.
  • Blue #1 – a coal-tar derivative used in soft drinks, candy, ice cream, cereals, and puddings. It is on the permanent safe list. It is a possible allergen, and it can cause tumors in animals at the site of injection.
  • Blue #2 – used the same way as Blue #1 and is on the permanent FDA list. The World Health Organization rates it in category B – questionable for use in food.
  • Green #3 – this color is used for green foods such as mint jelly, gelatins, candy, frozen desserts, and cereals. It is classified as safe but is a potential allergen and is tumorigenic upon injection.
  • Yellow #5(tartrazine) – this is the most notable color agent, partly because it causes the most immediate allergic reactions in people sensitive to salicylates, such as aspirins (to which it is related), and because, by law, it is the only artificial color that must be listed by name on packaging. Tartrazine is used in yellow-colored foods such as spaghetti, puddings, gelatin, soft drinks, sherbets, ice creams, cereals, and candy. Attempts to ban it have not succeeded. Most people can tolerate some Yellow #5 in foods, but those with sensitivity may develop skin reactions or asthma symptoms (problems are worse in sensitive asthmatics).
  • Yellow #6 – another coal tar color, it is used in many foods, such as candies, baked goods, carbonated beverages, and gelatins. It is considered safe, though there is also some concern about allergy.

So, are any of these poisons safe for use for us or our children? Given the fact that there has been such an increase in the number of kids and adults diagnosed with ADD, ADHD and Behavioural Disorders, and with various cancers, I would argue that we should keep away from any foods that contain any of these added chemicals and colourings as they do not seem to add anything into our lives and wellbeing, and are more of a toxic burden on the body. What do you think?


Six artificial flavors are being ordered out of the food supply

NEW YORK (AP) — Six artificial flavors are being ordered out of the food supply in a dispute over their safety, but good luck to anyone who wants to know which cookies, candies or drinks they're in.

The dispute highlights the complex rules that govern what goes in our food, how much the public knows about it, and a mysterious class of ingredients that has evolved over decades largely outside of public view.

On food packages, hundreds of ingredients are listed simply as natural flavor or artificial flavor. Even in minute amounts, they help make potato chips taste oniony or give fruit candy that twang.

"The food system we have is unimaginable without flavor additives," said Nadia Berenstein, a historian of flavor science based in New York.

The flavors are also at the center of a dispute over how ingredients should be regulated.

The U.S. Food and Drug Administration is giving companies two years to purge their products of six artificial flavors — even though the FDA made clear it believes the ingredients are safe in the trace amounts they are used.

The six artificial flavors in question, with names like methyl eugenol, benzophenone, ethyl acrylate and pyridine, are used to create cinnamon or spicy notes, fruity or minty flavors, or even hints of balsamic vinegar.

The FDA and the Flavor and Extract Manufacturers Association, an industry group, did not respond when asked for examples of products the six ingredients are used in. But they noted in statements that the compounds have natural counterparts in foods like basil, coffee, grapes and peppermint, and that the action does not affect the naturally derived versions.

The FDA said it had to order the artificial versions out of the food supply because of a lawsuit brought by consumer advocacy groups that cited a 60-year-old regulation known as the Delaney clause. The rule prohibits additives shown to have caused cancer in animals, even if tested at doses far higher than what a person would consume.

In a statement, the flavor industry group said the Delaney Clause doesn't allow regulators to assess an ingredient's risk based on modern scientific understanding, but that changing it would require an act of Congress. As far back as 1981, the Government Accountability Office issued a report saying the clause should be re-examined because of its inflexibility.

Christopher Kemp, a professor of cancer biology at the Fred Hutchinson Cancer Research Center, doesn't think the rule is necessarily too strict a threshold. He said animal studies provide the strongest evidence about cancer risk in humans, and that it is better to err on the side of caution.

Erik Olson of the Natural Resources Defense Council, one of the groups that sued over the six ingredients, said it's also unknown what effect they might have when used in combination with other ingredients. And since they're listed only as "artificial flavor," he said people don't know in what concentrations they're used in particular products.

"It's all secret. You can't pick up an ice cream or chewing gum or a baked good and have any idea what chemicals are in there," he said.

Berenstein, the flavor science historian, said the ingredients in flavors don't have to be specified in part because regulators decided long ago that listing the names of compounds on packages might just confuse people. And she stressed that flavors are used in infinitesimal amounts. In 2015, the flavor industry estimates just 40 pounds of one of the now banned artificial ingredients was produced.

But Bernstein said a more robust regulatory system might inspire greater public confidence about flavors.

In a separate but related lawsuit, the FDA is also facing a challenge over its oversight of the universe of ingredients companies can put into foods, including artificial flavors.

New flavors, sweeteners and other ingredients can go through an FDA petition process to be approved as food additives. But another option lets manufacturers deem their own ingredients to be "generally recognized as safe."

There's no clear rule for when ingredients should take one path or the other. The artificial sweetener Splenda is an approved food additive. Another sweetener, stevia, was declared GRAS by manufacturers.

The six artificial flavors in question were approved food additives, along with dozens of other synthetic flavors . The flavor industry group also regularly declares other ingredients like them to be GRAS, without formal review by the FDA.

Critics say GRAS determinations were meant for basic ingredients like salt and vinegar, not highly engineered ingredients. The advocacy groups suing the FDA say the GRAS option has turned into a loophole that lets companies approve all sorts of ingredients without public scrutiny, including artificial flavors.


CFR - Code of Federal Regulations Title 21

The information on this page is current as of April 1 2020.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

Subpart A - General Provisions

Sec. 101.4 Food designation of ingredients.

(a)(1) Ingredients required to be declared on the label or labeling of a food, including foods that comply with standards of identity, except those ingredients exempted by § 101.100, shall be listed by common or usual name in descending order of predominance by weight on either the principal display panel or the information panel in accordance with the provisions of § 101.2, except that ingredients in dietary supplements that are listed in the nutrition label in accordance with § 101.36 need not be repeated in the ingredient list. Paragraph (g) of this section describes the ingredient list on dietary supplement products.

(2) The descending order of predominance requirements of paragraph (a)(1) of this section do not apply to ingredients present in amounts of 2 percent or less by weight when a listing of these ingredients is placed at the end of the ingredient statement following an appropriate quantifying statement, e.g., "Contains _ percent or less of ___" or "Less than _ percent of ___." The blank percentage within the quantifying statement shall be filled in with a threshold level of 2 percent, or, if desired, 1.5 percent, 1.0 percent, or 0.5 percent, as appropriate. No ingredient to which the quantifying phrase applies may be present in an amount greater than the stated threshold.

(b) The name of an ingredient shall be a specific name and not a collective (generic) name, except that:

(1) Spices, flavorings, colorings and chemical preservatives shall be declared according to the provisions of § 101.22.

(2) An ingredient which itself contains two or more ingredients and which has an established common or usual name, conforms to a standard established pursuant to the Meat Inspection or Poultry Products Inspection Acts by the U.S. Department of Agriculture, or conforms to a definition and standard of identity established pursuant to section 401 of the Federal Food, Drug, and Cosmetic Act, shall be designated in the statement of ingredients on the label of such food by either of the following alternatives:

(i) By declaring the established common or usual name of the ingredient followed by a parenthetical listing of all ingredients contained therein in descending order of predominance except that, if the ingredient is a food subject to a definition and standard of identity established in subchapter B of this chapter that has specific labeling provisions for optional ingredients, optional ingredients may be declared within the parenthetical listing in accordance with those provisions.

(ii) By incorporating into the statement of ingredients in descending order of predominance in the finished food, the common or usual name of every component of the ingredient without listing the ingredient itself.

(3) Skim milk, concentrated skim milk, reconstituted skim milk, and nonfat dry milk may be declared as "skim milk" or "nonfat milk".

(4) Milk, concentrated milk, reconstituted milk, and dry whole milk may be declared as "milk".

(5) Bacterial cultures may be declared by the word "cultured" followed by the name of the substrate, e.g., "made from cultured skim milk or cultured buttermilk".

(6) Sweetcream buttermilk, concentrated sweetcream buttermilk, reconstituted sweetcream buttermilk, and dried sweetcream buttermilk may be declared as "buttermilk".

(7) Whey, concentrated whey, reconstituted whey, and dried whey may be declared as "whey".

(8) Cream, reconstituted cream, dried cream, and plastic cream (sometimes known as concentrated milk fat) may be declared as "cream".

(9) Butteroil and anhydrous butterfat may be declared as "butterfat".

(10) Dried whole eggs, frozen whole eggs, and liquid whole eggs may be declared as "eggs".

(11) Dried egg whites, frozen egg whites, and liquid egg whites may be declared as "egg whites".

(12) Dried egg yolks, frozen egg yolks, and liquid egg yolks may be declared as "egg yolks".

(14) Each individual fat and/or oil ingredient of a food intended for human consumption shall be declared by its specific common or usual name (e.g., "beef fat", "cottonseed oil") in its order of predominance in the food except that blends of fats and/or oils may be designated in their order of predominance in the foods as "___ shortening" or "blend of ___ oils", the blank to be filled in with the word "vegetable", "animal", "marine", with or without the terms "fat" or "oils", or combination of these, whichever is applicable if, immediately following the term, the common or usual name of each individual vegetable, animal, or marine fat or oil is given in parentheses, e.g., "vegetable oil shortening (soybean and cottonseed oil)". For products that are blends of fats and/or oils and for foods in which fats and/or oils constitute the predominant ingredient, i.e., in which the combined weight of all fat and/or oil ingredients equals or exceeds the weight of the most predominant ingredient that is not a fat or oil, the listing of the common or usual names of such fats and/or oils in parentheses shall be in descending order of predominance. In all other foods in which a blend of fats and/or oils is used as an ingredient, the listing of the common or usual names in parentheses need not be in descending order of predominance if the manufacturer, because of the use of varying mixtures, is unable to adhere to a constant pattern of fats and/or oils in the product. If the fat or oil is completely hydrogenated, the name shall include the term hydrogenated, or if partially hydrogenated, the name shall include the term partially hydrogenated. If each fat and/or oil in a blend or the blend is completely hydrogenated, the term "hydrogenated" may precede the term(s) describing the blend, e.g., "hydrogenated vegetable oil (soybean, cottonseed, and palm oils)", rather than preceding the name of each individual fat and/or oil if the blend of fats and/or oils is partially hydrogenated, the term "partially hydrogenated" may be used in the same manner. Fat and/or oil ingredients not present in the product may be listed if they may sometimes be used in the product. Such ingredients shall be identified by words indicating that they may not be present, such as "or", "and/or", "contains one or more of the following:", e.g., "vegetable oil shortening (contains one or more of the following: cottonseed oil, palm oil, soybean oil)". No fat or oil ingredient shall be listed unless actually present if the fats and/or oils constitute the predominant ingredient of the product, as defined in this paragraph (b)(14).

(15) When all the ingredients of a wheat flour are declared in an ingredient statement, the principal ingredient of the flour shall be declared by the name(s) specified in §§ 137.105, 137.200, 137.220 and 137.225 of this chapter, i.e., the first ingredient designated in the ingredient list of flour, or bromated flour, or enriched flour, or self-rising flour is "flour", "white flour", "wheat flour", or "plain flour" the first ingredient designated in the ingredient list of durum flour is "durum flour" the first ingredient designated in the ingredient list of whole wheat flour, or bromated whole wheat flour is "whole wheat flour", "graham flour", or "entire wheat flour" and the first ingredient designated in the ingredient list of whole durum wheat flour is "whole durum wheat flour".

(16) Ingredients that act as leavening agents in food may be declared in the ingredient statement by stating the specific common or usual name of each individual leavening agent in parentheses following the collective name "leavening", e.g., "leavening (baking soda, monocalcium phosphate, and calcium carbonate)". The listing of the common or usual name of each individual leavening agent in parentheses shall be in descending order of predominance: Except, That if the manufacturer is unable to adhere to a constant pattern of leavening agents in the product, the listing of individual leavening agents need not be in descending order of predominance. Leavening agents not present in the product may be listed if they are sometimes used in the product. Such ingredients shall be identified by words indicating that they may not be present, such as "or", "and/or", "contains one or more of the following:".

(17) Ingredients that act as yeast nutrients in foods may be declared in the ingredient statement by stating the specific common or usual name of each individual yeast nutrient in parentheses following the collective name "yeast nutrients", e.g., "yeast nutrients (calcium sulfate and ammonium phosphate)". The listing of the common or usual name of each individual yeast nutrient in parentheses shall be in descending order of predominance: Except, That if the manufacturer is unable to adhere to a constant pattern of yeast nutrients in the product, the listing of the common or usual names of individual yeast nutrients need not be in descending order of predominance. Yeast nutrients not present in the product may be listed if they are sometimes used in the product. Such ingredients shall be identified by words indicating that they may not be present, such as "or", "and/or", or "contains one or more of the following:".

(18) Ingredients that act as dough conditioners may be declared in the ingredient statement by stating the specific common or usual name of each individual dough conditioner in parentheses following the collective name "dough conditioner", e.g., "dough conditioners (L-cysteine, ammonium sulfate)". The listing of the common or usual name of each dough conditioner in parentheses shall be in descending order of predominance: Except, That if the manufacturer is unable to adhere to a constant pattern of dough conditioners in the product, the listing of the common or usual names of individual dough conditioners need not be in descending order of predominance. Dough conditioners not present in the product may be listed if they are sometimes used in the product. Such ingredients shall be identified by words indicating that they may not be present, such as "or", "and/or", or "contains one or more of the following:".

(19) Ingredients that act as firming agents in food (e.g., salts of calcium and other safe and suitable salts in canned vegetables) may be declared in the ingredient statement, in order of predominance appropriate for the total of all firming agents in the food, by stating the specific common or usual name of each individual firming agent in descending order of predominance in parentheses following the collective name "firming agents". If the manufacturer is unable to adhere to a constant pattern of firming agents in the food, the listing of the individual firming agents need not be in descending order of predominance. Firming agents not present in the product may be listed if they are sometimes used in the product. Such ingredients shall be identified by words indicating that they may not be present, such as "or", "and/or", "contains one or more of the following:".

(20) For purposes of ingredient labeling, the term sugar shall refer to sucrose, which is obtained from sugar cane or sugar beets in accordance with the provisions of § 184.1854 of this chapter.

(22) Wax and resin ingredients on fresh produce when such produce is held for retail sale, or when held for other than retail sale by packers or repackers shall be declared collectively by the phrase "coated with food-grade animal-based wax, to maintain freshness" or the phrase "coated with food-grade vegetable-, petroleum-, beeswax-, and/or shellac-based wax or resin, to maintain freshness" as appropriate. The terms "food-grade" and "to maintain freshness" are optional. The term lac-resin may be substituted for the term shellac.

(23) When processed seafood products contain fish protein ingredients consisting primarily of the myofibrillar protein fraction from one or more fish species and the manufacturer is unable to adhere to a constant pattern of fish species in the fish protein ingredient, because of seasonal or other limitations of species availability, the common or usual name of each individual fish species need not be listed in descending order of predominance. Fish species not present in the fish protein ingredient may be listed if they are sometimes used in the product. Such ingredients must be identified by words indicating that they may not be present, such as "or", "and/or", or "contains one or more of the following:" Fish protein ingredients may be declared in the ingredient statement by stating the specific common or usual name of each fish species that may be present in parentheses following the collective name "fish protein", e.g., "fish protein (contains one or more of the following: Pollock, cod, and/or pacific whiting)".

(c) When water is added to reconstitute, completely or partially, an ingredient permitted by paragraph (b) of this section to be declared by a class name, the position of the ingredient class name in the ingredient statement shall be determined by the weight of the unreconstituted ingredient plus the weight of the quantity of water added to reconstitute that ingredient, up to the amount of water needed to reconstitute the ingredient to single strength. Any water added in excess of the amount of water needed to reconstitute the ingredient to single strength shall be declared as "water" in the ingredient statement.

(d) When foods characterized on the label as "nondairy" contain a caseinate ingredient, the caseinate ingredient shall be followed by a parenthetical statement identifying its source. For example, if the manufacturer uses the term "nondairy" on a creamer that contains sodium caseinate, it shall include a parenthetical term such as "a milk derivative" after the listing of sodium caseinate in the ingredient list.

(e) If the percentage of an ingredient is included in the statement of ingredients, it shall be shown in parentheses following the name of the ingredient and expressed in terms of percent by weight. Percentage declarations shall be expressed to the nearest 1 percent, except that where ingredients are present at levels of 2 percent or less, they may be grouped together and expressed in accordance with the quantifying guidance set forth in paragraph (a)(2) of this section.

(f) Except as provided in § 101.100, ingredients that must be declared on labeling because there is no label for the food, including foods that comply with standards of identity, shall be listed prominently and conspicuously by common or usual name in the manner prescribed by paragraph (b) of this section.

(g) When present, the ingredient list on dietary supplement products shall be located immediately below the nutrition label, or, if there is insufficient space below the nutrition label, immediately contiguous and to the right of the nutrition label and shall be preceded by the word "Ingredients," unless some ingredients (i.e., sources) are identified within the nutrition label in accordance with § 101.36(d), in which case the ingredients listed outside the nutrition label shall be in a list preceded by the words "Other ingredients." Ingredients in dietary supplements that are not dietary ingredients or that do not contain dietary ingredients, such as excipients, fillers, artificial colors, artificial sweeteners, flavors, or binders, shall be included in the ingredient list.

(h) The common or usual name of ingredients of dietary supplements that are botanicals (including fungi and algae) shall be consistent with the names standardized in Herbs of Commerce, 1992 edition, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the American Herbal Products Association, 8484 Georgia Ave., suite 370, Silver Spring, MD 20910, 301-588-1171, FAX 301-588-1174, e-mail: [email protected], or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. The listing of these names on the label shall be followed by statements of:

(1) The part of the plant (e.g., root, leaves) from which the dietary ingredient is derived (e.g., "Garlic bulb" or "Garlic (bulb)"), except that this designation is not required for algae. The name of the part of the plant shall be expressed in English (e.g., "flower" rather than "flos")

(2) The Latin binomial name of the plant, in parentheses, except that this name is not required when it is available in the reference entitled: Herbs of Commerce for the common or usual name listed on the label, and, when required, the Latin binomial name may be listed before the part of the plant. Any name in Latin form shall be in accordance with internationally accepted rules on nomenclature, such as those found in the International Code of Botanical Nomenclature and shall include the designation of the author or authors who published the Latin name, when a positive identification cannot be made in its absence. The International Code of Botanical Nomenclature (Tokyo Code), 1994 edition, a publication of the International Association for Plant Taxonomy, is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the International Code of Botanical Nomenclature may be obtained from Koeltz Scientific Books, D-61453 Konigstein, Germany, and University Bookstore, Southern Illinois University, Carbondale, IL 62901-4422, 618-536-3321, FAX 618-453-5207, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(3) On labels of single-ingredient dietary supplements that do not include an ingredient list, the identification of the Latin binomial name, when needed, and the part of the plant may be prominently placed on the principal display panel or information panel, or included in the nutrition label.


FDA orders 6 artificial flavors out of foods

NEW YORK (AP) - Six artificial flavors are being ordered out of the food supply in a dispute about their safety, but good luck to anyone who wants to know which cookies, candies or drinks they're in.

The dispute highlights the complex rules that govern what goes in our food, how much the public knows about it and a mysterious class of ingredients that has evolved over decades largely outside of public view.

On food packages, hundreds of ingredients are listed simply as natural flavor or artificial flavor. Even in minute amounts, they help make potato chips taste oniony or give fruit candy that tang.

"The food system we have is unimaginable without flavor additives," said Nadia Berenstein, a historian of flavor science based in New York.

The flavors are also at the center of a dispute about how ingredients should be regulated.

The U.S. Food and Drug Administration is giving companies two years to purge their products of six artificial flavors - even though the FDA made clear it thinks the ingredients are safe in the trace amounts they are used.

The six artificial flavors in question, with names like methyl eugenol, benzophenone, ethyl acrylate and pyridine, are used to create cinnamon or spicy notes, fruity or minty flavors or even hints of balsamic vinegar.

The FDA and the Flavor and Extract Manufacturers Association, an industry group, did not respond when asked for examples of products the six ingredients are used in. But they noted in statements that the compounds have natural counterparts in foods like basil, coffee, grapes and peppermint, and that the action does not affect the naturally derived versions.

The FDA said it had to order the artificial versions out of the food supply because of a lawsuit brought by consumer advocacy groups that cited a 60-year-old regulation known as the Delaney clause. The rule prohibits additives shown to have caused cancer in animals, even if tested at doses far higher than what a person would consume.

In a statement, the flavor industry group said the Delaney Clause doesn't allow regulators to assess an ingredient's risk based on modern scientific understanding, but that changing it would require an act of Congress. As far back as 1981, the Government Accountability Office issued a report saying the clause should be re-examined because of its inflexibility.

Christopher Kemp, a professor of cancer biology at the Fred Hutchinson Cancer Research Center, doesn't think the rule is necessarily too strict a threshold. He said animal studies provide the strongest evidence about cancer risk in humans, and that it is better to err on the side of caution.

Erik Olson of the Natural Resources Defense Council, one of the groups that sued over the six ingredients, said it's also unknown what effect they might have when used in combination with other ingredients. And since they're listed only as "artificial flavor," he said people don't know in what concentrations they're used in particular products.

"It's all secret. You can't pick up an ice cream or chewing gum or a baked good and have any idea what chemicals are in there," he said.

Berenstein, the flavor science historian, said the ingredients in flavors don't have to be specified in part because regulators decided long ago that listing the names of compounds on packages might just confuse people. And she stressed that flavors are used in infinitesimal amounts. In 2015, the flavor industry estimates just 40 pounds of one of the now banned artificial ingredients was produced.

But Bernstein said a more robust regulatory system might inspire greater public confidence about flavors.

In a separate but related lawsuit, the FDA is also facing a challenge over its oversight of the universe of ingredients companies can put into foods, including artificial flavors.

New flavors, sweeteners and other ingredients can go through an FDA petition process to be approved as food additives. But another option lets manufacturers deem their own ingredients to be "generally recognized as safe."

There's no clear rule for when ingredients should take one path or the other. The artificial sweetener Splenda is an approved food additive. Another sweetener, stevia, was declared GRAS by manufacturers.

The six artificial flavors in question were approved food additives, along with dozens of other synthetic flavors . The flavor industry group also regularly declares other ingredients like them to be GRAS, without formal review by the FDA.

Critics say GRAS determinations were meant for basic ingredients like salt and vinegar, not highly engineered ingredients. The advocacy groups suing the FDA say the GRAS option has turned into a loophole that lets companies approve all sorts of ingredients without public scrutiny, including artificial flavors.