1. Are Food Additives Safe?
This presentation will examine what food additives are and whether these ingredients are safe to be in our food.
Kayla Pietig

2. What exactly is a food additive?
Technically a food additive is anything that you add to your food!
Legally…
What exactly is a food additive? Technically a food additive is anything that you add to your food, but legally food additives have a different definition. Let’s take a look…

3. The Legal Definition
Legally, the term refers to "any substance where the intended use of which results or may reasonably be expected to result -- directly or indirectly -- in its becoming a component or otherwise affecting the characteristics of any food." This definition includes any substance used in the production, processing, treatment, packaging, transportation or storage of food.
Legally, the term refers to "any substance where the intended use of which results -- directly or indirectly -- in its becoming a component or otherwise affecting the characteristics of any food." This definition includes any substance used in the production, processing, treatment, packaging, transportation or storage of food.
Basically it is anything we add to our food whether it is to preserve it, add color, or flavor.

4. Can you name a food additive?
Think about this….
Can you name a food additive?
Can you name a food additive?

5. Why do we even use additives?
Uses:
Safety and Freshness
Nutritional Value
Improve Food Quality
We use food additives to preserve safety and freshness of food, to add nutritional value, and to improve food quality.
For safety and freshness- Mold, air, bacteria, fungi or yeast can easily ruin food without additives, which is why we add them to food to give a longer shelf life and to keep the product fresher longer. They can also help prevent fats and oils from becoming rancid and giving the product an off flavor. Another very important use is in the prevention of food borne illnesses and contamination.
For nutritional values- It is very common for a lot of our foods to be fortified to add nutritional components that are lost through processing or are insufficient in the population’s diet. Adding nutrients into our food has helped to prevent vitamin and mineral deficiencies and prevent malnutrition. All products containing extra nutrients can also be found on the label.
With regard to improving food quality- Natural or artificial flavorings, colors, spices, and sweeteners are added to food to give the foods a better flavor, texture, and appearance. Things that help to improve quality would be emulsifiers which add stability and thicken food products. An example of this would be egg yolks which are commonly used as emulsifiers in various products. Additives can also help to preserve the acidity or alkalinity of products to help prevent spoilage.

6. Regulation of food additives
The Food and Drug Administration (FDA) has the primary and legal responsibility for approving food additives as “safe”.
Today food and color additives are more regulated and monitored than anytime in the past.
What does the FDA consider when approving additives?
When evaluating the safety of food additives, the following criteria are examined by the Federal Drug Administration:
1) the composition and properties of the substance
2) the amount that would typically be consumed
3) immediate and long-term health effects and
4) various safety factors.
-The FDA defines a food additive as “safe” when knowledgeable scientist can confirm that a substance is not harmful for its intended uses. The data must reflect safety depending on how it is going to be used, how much will be consumed, and the population who will be consuming the product.
-During the evaluation process by the FDA, the level that should be used is determined by a built in safety margin, and will only allow the use of minimal amounts that would be harmless for human consumption and not cause any negative affects.
-After all the criteria are investigated, the FDA makes their judgment based on the scientific evidence that is available to determine that the additive will cause no negative side-affects.

7. Generally Recognized As Safe (GRAS)
GRAS is a label that the FDA uses to describe various products that are added to our food
Items on the GRAS list are scientifically proven to be safe
If not approved for GRAS the FDA takes action to prevent the distribution of the product
Product must be proven safe for the intended use before they are allowed to be on the market
The Generally Recognized as Safe (or GRAS) term is used by the FDA to describe various products that are added to our food. Items on the GRAS list are scientifically proven to be safe. If the FDA does not approve a product they will then take action to prevent the distribution of that product. Products must be proven safe for the intended use before they are allowed to be placed on the market for consumers to purchase.

8. Food Additive Types: Direct food additives Indirect food additives
There are two different types of food additives: direct and indirect.
A direct food additive is what is added to food for a specific purpose. An example of a direct additive would be gums but not the type that we chew as chewing gum. Gums are added to things such as salad dressings, pie fillings, frozen foods, and even toothpaste! By adding gums to the food it provides more stability, a longer shelf life, and a better mouthfeel and texture. You can find most direct additives on the food label. A direct additive that will be covered later in this presentation is butylated hyrdroxytoluene (BHA).
A indirect food additive is anything that becomes part of the food unintentionally through the packaging, storage, and the handling process. Even though this does not sound safe, the Food and Drug Administration (FDA) requires food manufacturers to prove that any materials that may come into contact with the food to be safe.

9. Color Additives What are color additives used for? Offset color loss
Correct color variations and add enhancements
To make foods more “fun”
The 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.”
Certified colors are human made to add color and create uniformity and will not add any flavor. There are currently 9 certified colors that are approved for use in the United States. Tartrazine is a certified color that will be reviewed in this presentation.
Colors exempt from certification are pigments that are from natural sources such as plants, animals, or minerals. Some examples are dehydrated beets which give a bluish-red to brown color and grape skin extract which give red or green color.

10. Common Additives You May Have Heard About…
Ingredient Type
Purpose
Seen on the Label As
Preservatives
Prevent food spoilage and slow changes in color, texture, and flavor
sodium benzoate, calcium propionate, sodium nitrite, potassium sorbate, BHA, BHT
Flavors and Spices
Add natural and synthetic flavors
Natural flavoring, artificial flavor, spices, Monosodium glutamate (MSG)
Fat Replacers
Provide mouthfeel, flavor, and texture to replace the fat in low-fat or fat-free foods
Olestra, cellulose gel, carrageenan. modified food starch, guar gum, xanthan gum, whey protein concentrate
Stabilizers, thickeners, texturizers
Provide texture and mouthfeel
Gelatin, pectin, guar gum, carrageenan, xanthan gum, whey
This chart contains common products that you might see listed in the ingredient lists of foods you eat. The preservative sodium benzoate may be in foods such as salad dressings, soft drinks, canned tuna, and mixed dried fruit. You can also find the potassium sorbate in cheese, wine, and dried meats. Potassium sorbate and sodium benzoate both inhibit mold and yeast from spoiling food.
-Natural and artificial flavors are found in a number of products like granola bars, flavored juices, and flavored soda pop. Monosodium glutamate or MSG is a common additive that you may have heard of and is common in items such as soup, barbeque sauce, and seasoning mixtures. Both of these additives are used to give our food more flavor.
-Fat replacers replace the fat in some our favorite foods to give us low-fat or fat- free products. Gums are a common fat replacer because they thicken, can give a gel like consistency, and also give products stability. Fat replacers such as xanthan gum is used in fat free salad dressings, sauces, and ice cream. Modified food starch can be used to thicken products that are acidic and would not thicken by using just corn starch. Gravies, sauces, and pie filling are common items that contain modified corn starch as a thickener.
-Stabilizers, thickeners, and texturizers give us that texture that we love when we eat certain foods. Again gums are a common source, along with gelatin and pectin which can be found in jellies, jams, and jello.

11. Commonly Researched Additives
Amaranth
Tartrazine
Butylated Hydroxyanisole (BHA)
Sodium Nitrate and Sodium Nitrite
The next portion of this presentation will discuss four specific additives: Amaranth, Tartrazine, BHA, Sodium Nitrate and Sodium Nitrite

12. Amaranth
Amaranth is a general term that refers to a whole family of herbs
The “Hopi Red Dye” was originally used by the Native American tribe , the Hopi for a deep red dye
Today we know it better as FD&C Red No. 2
Amaranth is a general term that refers to a whole family of herbs.
-The flowers of the 'Hopi Red Dye' amaranth were used by the Hopi Indians as the source of a deep red dye. Today we use it as a color additive to add color to products such as hot dog casing, ice cream, medication, makeup, and pet food.
In the 1970’s data from a Russian study began to raise questions about the additives as a possible cause of brain tumors and thus prompted the “red scare.” The issue then went to the FDA where they performed their own study and came up with inconclusive results. It became a bigger issue after the consumer-oriented Health Research Group petitioned the FDA to ban Amaranth (also known as Red No 2) which then began to get attention from consumers. Once again the FDA’s toxicology committee found the additive to be safe but after reviews they concluded that there may be a relation between malignant tumors in female mice. The additive was then banned from use in the United States to prevent fear in consumers.

13. Amaranth…
A study was conducted to determine the possible carcinogenic affects of the color additive Amaranth
Done with mice
Mice were given a dose of 200 or 1000 mg/kg body weight
Examined the mice gut and feces after given the dose of amaranth
A study published in the Food and Chemical Toxicology journal in 2008 looked at potential carcinogenic affects of amaranth. It was done with mice where amaranth was administered twice at 24 hour intervals orally. The mice received 200 or 1000 milligrams which would be an amount that is less than 1 teaspoon. There was also a control group that was given corn oil and water.
-Researchers then examined the mice’s gut and feces and tested for any damage to the DNA to determine if there was any possible mutations that could cause cancer and if there was any other type of negative consequences from the dosing.

14. Study Results…
This graph shows cell changes to mice as a result of exposure to Amaranth as well as 3 other additives. Located inside the red box, the researchers determined that the incidence of tissue damage in mice given Amaranth was not statistically different from that of the control groups.
-In the control groups, the incidence of tissue damage was low and when the researchers compared food additives to the control group there was an increase in cell division. But overall the results showed when amaranth is given orally in 24 hour intervals the dye did not significantly increase tissue damage in the gut for doses given up to 2000 mg/kg.

15. Is Amaranth Safe?? Study Conclusions…
Supported amaranth as a safe additive
Amaranth is considered a non mutagenic substance
-According to the authors (tsuda et al and Sasakie et al) the observed damage was not from its toxicity, cell death, or accelerated cell growth but maybe from other causes. The results from the study hypothesized that food dye exposure did increase frequency of cell division in the colon and suggest that the additives either blocked the cell cycle for new cell growth and increased the number of dividing cells. But after review of tissue sections from this study it showed that the additive had no effect in any of the organs that were examined. Researchers concluded that oral exposure to amaranth did not induce gene altering effects in the mice.
Amaranth is not considered to be a cause of altering DNA which would potentially cause diseases or cancer. “Carcinogenicity data concerning amaranth are abundant but were inadequately reported or inconclusive. Most studies have indicated a lack of carcinogenic potential but some suggest increased tumor incidence.”

16. Amaranth Amaranth is still used in Canada and Europe today.
Despite research studies that support Amaranth as a safe additive the FDA banned its use in the United States based on the concept that the additive could possibly not be safe!
Amaranth is used in Canada and Europe today, but despite research studies that support this food additive as safe, the FDA’s ban for it’s use is still in effect today in the United States. The ban, imposed in the 1970s, was based on the concept that the additive could possibly be unsafe and was largely a reaction to the public’s scare of the food additive instead of solid research.
-The color additive could make a comeback in the US if a company decided to petition the FDA and provide substantial information of the additive’s safety.

17. Tartrazine
Also known as FD & C Yellow No. 5, C.I. No , and Food Yellow No. 4
Orange/yellow powder that will dissolve in water
Tartrazine is the next food additive that will be covered.
This food additive is a certified food color also know as FD & Cyellow No.5, C.I. No and Food Yellow No. 4. It comes in a orange/yellow powder that will dissolve in water and is used in a variety of food products, cosmetics, and medication to impart it’s orange/yellow color.

18. Tartrazine Study
“Effects of tartrazine on exploratory behavior in a three- generation toxicity study in mice”
Study done with mice
Study Results
The levels of tartrazine that where used in this study did produce a few side-effects on neurobehavior through the generations of mice.
Tanaka, et al. published a study in _2008_____(year) in the _Reproductive Toxicology__ (journal) to examine the safety of tartrazine.
-The study’s purpose was to determine if there were negative behavioral side affects of tartrazine in the parent generation of mice and their offspring. Mice were divided into 4 groups to examine different doses of the color additive. Tartrazine was given to a total of 60 mice at three different doses plus one control group from when they were 5 weeks to 9 weeks old. The tartrazine was mixed and given as an oral tablet.
-After the 9 weeks researchers analyzed the mice's’ function and behavior, specifically looked at how long it would take the mouse to turn over to its feet when it was placed on it’s back, how long it took for the mouse to bring its head up when placed upside down on an incline, placing the mouse on a platform to determine it’s “cliff avoidance”, how the mouse behaved and swam when placed in water, and a test to determine the mouse’s sense of smell by evaluating the exploratory behavior.
The results of the study determined tartrzine did not affect the mice’s food intake or body weight and the litter size and offspring birthweight were also not affected. It was determined that Tartrazine affected the mice's exploratory behavior, but it was most significantly seen in juvenile mice which suggest that it has the most effect through generations. Another finding was that the tartrazine accelerated the mice’s swimming ability, especially with male mice.
Overall, the three dose levels that were used in the study did not have any negative affects on reproduction and only a few affects on behavior. The dose levels had the most significance in male mice which were in the amounts that are greater than the recommended adequate intake. Researchers determined that levels of tartrazine humans consume would not produce any adverse affects.
Another research article that was mentioned in the study above,published in _2007__ (yr) in the _Regulatory Toxicology and Pharmacology___ (journal) concluded that from prior research which tested tartrazine in mice for 2 years reported that the occurrence of tumors and disease was unrelated to tetrazine in the diet. Another finding from this study was that tetrazine was not absorbed by the body and was easily metabolized in the colon and excreted.
Other various studies have also concluded that tartrazine has no carcinogenic affects and does not affect development or reproductive behaviors. Currently tartrazine is considered safe by the FDA.

19. Butylated Hydroxyanisole (BHA)
Carcinogen or Anti-Carcinogen??
Butylated hydroxyanisole (BHA) is used as a preservative because it is antioxidant that stabilizes and preserves freshness, nutrition, flavor and color in both animal and human foods. BHA is currently approved by the FDA as a food additive.
BHA has been hypothesized to cause cancer but it has also been hypothesized to be an anti carcinogen as well. So, what should you believe? Let’s look into the research about this food additive and cancer.
It has been shown to have cancer causing affects in mice when given in large doses but has never been proven to cause cancer in humans. The main area where the cancer was found in research with mice, was in the forestomach, which humans do not have. Additionally, the doses that were given to the mice were more than what the FDA allows to be added in our food.
On the flip-side, research has also shown that BHA can have anti-cancer affects because it inhibits cell to cell communication and therefore could stop the spread of cancer cells.

20. BHA as a Carcinogen BHA as a carcinogen research… Study Results
Study done to determine the relationship between BHA and bladder cancer and cancer of the forestomach in mice
Study to determine BHA carcinogenic affects in Japanese House Shrews
Study Results
Increased cell growth and cancer in the forestomach of mice
Increased cell growth in the lungs
But is it a carcinogen? In a review article published in _1999_____ (year) that looked at information from the International Agency for Research on Cancer (IARC) evaluated BHA and found evidence that it had carcinogenic affects in animals but not in humans. It was found that when given in large doses, cancer and tumors were found in the forestomach of mice. In this study, doses of BHA were given in doses of 98 milligrams and 414 milligrams. When given at the large doses it was found that the incidence of forestomach cancer in mice was 34.6% in males and 29.4% in females, but when given in low doses, mice were found to have no malignant cancer.
-Another study mentioned in the review article by _Amo et al.____(author) published in _1990____ (year) looked at BHA as a carcinogen in Japanese house musk shrews that do not have a forestomach. BHA was given to male and female shrews for 80 weeks and given amounts of 0.5%, 1%, and 2% incorporated into the diet. The shrews that received the high doses died within the first 8 weeks due to gastrointestinal hemorrhaging. The low and middle dose groups had increased cell growth in the lungs, but this study did not contain a control group and was also not confirmed and therefore can not be considered creditable.

21. Anti-Carcinogenic Affects of BHA
When given in large doses BHA may be a possible anticarcinogen
Still needs more research to confirm the claim
No definite answer!
-There are multiple studies that also suggest BHA could be a possible anti- carcinogen.
Studies show that BHA can inhibit carcinogenic affects of other chemicals when given in high doses or extremely small doses. In an article by Williams and Iantopoulos, it was stated, “These studies suggest that low doses of BHA inhibit carcinogenesis (or the development of cancer) when given prior to and during exposures to DNA reactive carcinogens. Anti- carcinogenic activity at low concentrations has been suggested to be due to free radical trapping activity.” But when BHA was given in large amounts, greater than 3% in the diet, it was shown to inhibit carcinogenic affects when given before or during the cancer.
-Overall there needs to be more research done to support this anti-carcinogen conclusion. It has been shown to have anti-cancer affects when given in small or large amounts, but the research is still inconclusive.

22. BHA Carcinogen vs. anti-carcinogen
We do not fully understand how BHA works in both situations!
Still need more research
What can we believe about BHA?
No specific answer
Currently it is an approved additive that has been found to be safe by the FDA
In conclusion, there is not enough scientific information published about the mechanism of BHA that it either causes cancer or helps to eliminate it. Simply put, we do not yet fully understand how BHA works and more research is needed. Researchers estimate that you would have to consume 125 times the recommended estimated daily intake of 0.05 to 0.2mg per kg of body weight for it to be toxic.

23. Sodium Nitrite & Sodium Nitrate
Uses
Found in meat and fish
Food safety?
Used as a tool to prevent food spoilage that causes food born illness
Is sodium nitrite a cause of cancer or other diseases?
Sodium nitrite and nitrate are used as an additive in meats and fish because it is a preservative, it adds color, and prevents from bacterial spoilage. Nitrate itself is considered to be harmless but when it is converted to sodium nitrite, this compound is what begins to cause some concern.
Recent studies have suggested that high consumption of cured meats such as bacon, sausage, and luncheon meats may be linked to colon cancer. In a study by _Linseisen, Jakob, Sabine Rohrmann, et al.____(author) who reviewed various research articles, it was found that consuming g/day of processed meat increased the chances of colon cancer by 49-54%, but the study also stated that age, weight, BMI, socioeconomic status, smoking, alcohol consumption were also key factors.
Despite evidence showing a correlation between the consumption of processed meat and colorectal cancer there is no direct evidence that proves that sodium nitrite is the direct cause of the cancer. There are other factors that play a large role in the possible development of cancer or other diseases. Overall it is recommended to limit your consumption of processed meats and try to incorporate more fresh lean meats into the diet.

24. What do you think?
Is the research supporting the safety of additives trustworthy and reliable?
Given all that you have heard, what do you think? Is the research supporting the safety of additives trustworthy and reliable?

25. Regulation of food additives
Once the additive is found safe and is approved:
1. The FDA issues regulations
2. Consultation with the USDA
3. Continued monitoring of the recently approved additive
As a review, the FDA first studies any food additive to determine if the additive is safe for human consumption. It then regulates the type of food that an additive can be in, how much can be used, and how it should appear on the food label. Since the US Department of Agriculture is in charge of meat safety in the US food system, if a product is going to be in meat or poultry then the FDA works with the USDA to monitor the new product. Once an additive is introduced in the consumer market, federal officials monitor the populations’ consumption of the additive and continue to watch for possibilities of any negative affects. Even after the product is on the market it is still being monitored and studied.

26. What do you think?
Do you think that the FDA current system in approving and monitoring food and color additives is adequate?
Do you think that they need more information, or need to provide more information about food additives on the label?
Do you think the FDA’s current system for approving and monitoring food and color additives is adequate?
Do you think the FDA needs more information or should provide the public with more information about food additives on the food label?

27. How Can Consumers Find Information on Additive Safety?
Find information on what the FDA approves for food additives and which additives are on the GRAS list, visit:
For more information, here are two additional resources that you can use to find more information about additives. To find information about what the FDA approves for food additives and which additives are on the GRAS list visit the FDA’s website at

28. What Does the Research Say?
There is research available that support certain additives as a carcinogenic agent and there are also studies that show some additives are completely safe and could also have anti-cancer affects.
Overall there is a lot of conflicting information about food additives. There is research that supports additives as a cause of cancer and research that says it is safe and even a possible anti-cancer agent. The FDA uses the most up to date and recent testing to determine additive safety. If there is ever a direct cause or proof suggesting that a product is unsafe it will be banned from use. We have to rely on what the most recent studies tell us to determine additive safety.

29. Take Home Message
Food additives have been in use since medieval times as a way to preserve food and prevent spoilage.
Technological advances have allowed us to find new ways to preserve our foods while also adding flavor, color, and creating a desirable mouthfeel.
Food additives are in a majority of products we can consume and are currently regulated by the FDA for product safety.
All additives must be tested for ongoing safety through scientific reviews that give us a better understanding of the additives. Also the technology and methods of testing continue to improve which helps to give even more information about additives and the possible effects that they could cause. Due to the diligence the FDA uses to test, approve and monitor food additives, consumers should feel safe about the foods they eat.