Red Dye No 3 and other dyes, are they safe?

Red Dyes in Food, are they safe? Should they be banned?

Red Dye # 40 has been linked unofficially to some behavioral problems with young children.
Red dye No. 40 is found in hundreds of foods, including Twizzlers, Doritos, Twinkies, chocolate cake mix, vanilla frosting and crosissants.
This is a great site about red dyes and the history of what is going on with dyes in general.

Click here to read more.

Note: This is an older article and oddly enough when I researched red dye 3, I could not find any new info as far as it being banned. The FDA apparently tried to ban it at one point and failed.

Red No. 3 and Other Colorful Controversies
by Dale Blumenthal

The lure of red cherries in canned fruit cocktail is legendary in many
American families. Siblings fight over them, parents use them to bribe or
treat their children, and even adults count the cherries spooned into their
dessert. But, the days of the fruit cocktail cherry colored by FD&C Red No. 3
may be numbered. Because large amounts of the color have been shown to cause
cancer in rats, FDA recently ended certain uses of FD&C Red No. 3 and plans to
end the remaining uses. The cherries in 21st century fruit cocktail could
well be light brown.

Color has long been recognized as important in consumer acceptance of nearly
every food, medication and cosmetic product. Even the hue of the containers
can make the difference between a best seller and a “no-sale-er.”

A research project in the 1970s, reported in the October 1973 issue of
Marketing, illustrated just how big the impact of color can be on the
acceptance of food items in particular. Research volunteers were served a
meal of steak, peas and French fries. They ate part of the meal under special
lighting that concealed the fact that the colors of the food had been
altered. When, under normal lighting, the test group discovered that their
steaks were blue, peas red, and french fries green, some participants became
ill at the sight of the unnaturally colored food they had been eating.

Color Safety

Food once was colored only with natural dyes. Beets, peppers, grape skins,
saffron, and even brilliantly scarlet extracts prepared from dried bodies of
cochineal insects lent their distinctive colors to the cook’s creativity.

By the 19th century, colors derived from other chemicals came into use–with
sometimes serious health consequences (see “Additives for Eye Appeal” in the
July-August 1973 issue of FDA Consumer). Lead chromate and copper sulfate
began to be used to tint candy and pickles. Arsenic and other poisonous
impurities were added when mixing up new color additives. Dyes made from
coal-tar and petroleum derivatives also appeared in foods, drugs and cosmetics.

How, then, can a consumer be sure that the bright primary colors and the
subtle shadings that color many consumer products today are safe to eat, use
in drugs, put on skin or hair, or–as with colored contact lenses–stick in
the eyes? A monitoring process–directed by FDA and refined over several
decades–ensures that this is so.

FDA began a comprehensive assessment of the safety of color additives with the
passage of the Pure Food and Drugs Act of 1906. The country had changed from
an agricultural to an industrial nation. No longer did most Americans live on
farms and produce their own food. Instead, much of the food a nation of city
dwellers ate was processed, chemically preserved, and marketed by large firms
competing for consumers’ attention.

It was a time of triumph for synthetic dyes, followed by concern on the part
of public health officials about the safety of these dyes. Harvey Wiley,
chief of USDA’s Bureau of Chemistry, challenged the ease with which
manufacturers added chemicals to food. Food safety became Wiley’s special
cause, and he was instrumental in bringing about passage of the first federal
Food and Drugs Act in 1906.

This landmark food law prohibited the use of any color additive in foods if
the color would deceive the consumer, conceal inferiority or damage, or
otherwise result in misbranding and adulteration. However, Wiley believed
that the use of color additives in food required further investigation. He
hired an outside consultant, dye expert Bernard Hesse, Ph.D., to study the

After reviewing 80 of the most commonly used colors, many of which had never
been tested before, Hesse recommended only seven color additives as safe for
use in food. His recommendation was announced in a 1907 regulation, Food
Inspection Decision 76, which also introduced a system for voluntary
certification of synthetic food colors.

Pre-Market Approval

The Federal Food, Drug, and Cosmetic Act of 1938 elaborated on the earlier
regulations by providing for the listing and mandatory certification of
synthetic color additives used in foods, drugs and cosmetics. During the
1950s, a safety concern associated with the improper use of FDC’s Orange No. 1
prompted additional safety studies on color additives used in food, including
FDC’s Red No. 3.

Then, in 1960, Congress amended the Food, Drug, and Cosmetic Act of 1938 to
set up a pre-market approval system for new color additives and to require
demonstration of the safety of color additives already in use.

Approved color additives were divided into two groups: those requiring FDA’s
certification (synthetic dyes made mostly from coal tar and petroleum
derivatives) and those exempt from FDA’s certification (substances derived
from vegetable, animal or mineral products). Each batch of a synthetic color
is tested by the manufacturer and a sample submitted to FDA for certification
according to specifications in the Code of Federal Regulations. Colors exempt
from batch certification must also meet specifications in the CFR.

The 1960 amendments placed the color additives already in use on a provisional
list to permit their continued use while the manufacturers developed the
necessary data for a petition to support the listing of the color additive.

Many of the color additives requiring certification come in two forms:
straight colors and lakes. Straight colors in many cases are water-soluble
dyes. Certain straight colors are used to make “lakes” or water-insoluble
forms of the color additive. Lakes are used in products in which leaching or
“bleeding” of color would pose problems, such as in cookie fillings, coated
tablets, candies, chewing gum, and lipsticks. The agency is currently
planning a proposal regarding the regulation of lakes.

Manufacturers seeking approval for new color additives or for those on the
provisional list were required to submit a petition to FDA with scientific
data demonstrating that a specific color was safe for its intended uses. If
the agency approved the petition, the color was placed on a “permanent”
listing. Colors can be approved for use in food, drugs, and cosmetics (FDC),
in drugs and cosmetics only , or specifically for external drug and
cosmetic use .

To date, of the original 200 provisionally listed color additives, 90 have
been listed as safe and the rest have either been withdrawn by industry or
delisted by FDA.

FD&C Red No. 3

FDA terminated the provisional listings for FD&C Red No. 3 on Jan. 29, 1990,
at the conclusion of its review of the 200 straight colors on the 1960
provisional list. Commonly called erythrosine, FD&C Red No. 3 is a tint that
imparts a watermelon-red color and was one of the original seven colors on
Hesse’s list.

The provisionally listed uses that were recently terminated include use of the
straight color in cosmetics and externally applied drugs and all uses of the
lakes of FD&C Red No. 3.

The case of FDC Red No. 3, however, presents what one individual familiar
with color regulation calls a “regulatory inconsistency.” Although the
provisional uses (about one-third of its uses) are now banned, FDC Red No. 3
is still permanently listed for use in ingested drugs and food, such as baked
goods, cherries, dairy products, desserts, dietary supplements, food
seasonings, jellies, jams, and vegetable products.

This paradox came about because of improvements in scientific methods and the
timing of the petitioner’s submission for permanently listing the food and
ingested drug uses. After the 1960 provisional listings, studies were
performed on FDC Red No. 3. Results did not show any safety concerns, and in
response to a petition by the Certified Color Manufacturers Association
(CCMA), FDC Red No. 3 was permanently listed for use in ingested drugs and
foods in June 1969.

Cosmetic and externally applied drug uses of the color remained provisionally
listed while studies on skin exposure were conducted. Meanwhile, FDA expanded
its safety requirements in 1977 to include more extensive studies on
provisionally listed color additives. Based upon the results of new studies
on FDC Red No. 3, conducted by the International Research Development
Corporation and completed in 1982, the agency concluded that FDC Red No. 3
causes thyroid cancer in male rats.

The Cosmetic, Toiletry and Fragrance Association and CCMA argued that no
direct cancer-causing effect was seen in animals given the color in the low
levels used in consumer goods. FDA, however, decided that the evidence of
thyroid tumors in rats was clear, and that the additional research cited by
industry did not establish that an indirect mechanism--such as a hormonal
effect triggered by the dye--caused the tumors, rather than the dye itself.
Thus, FDA denied the manufacturers' petition for further permanent listings of
the color. Based on data from the studies, the agency estimated that the
lifetime risk of thyroid tumors in humans was at most 1 in 100,000.

Like FDC Red No. 3, FDC Blue No. 1 and FDC Yellow No. 5 were also
permanently listed for food and ingested drug uses in 1969. When FDA reviewed
new, more extensive studies on FDC Blue No. 1 and FDC Yellow No. 5, the
agency found that these two color additives did not cause cancer in animal
studies. (But, since FDC Yellow No. 5 causes allergic reactions in some
people, FDA requires its listing on food labels.)

As experts note, while the provisional listings for straight colors have
ended, advances in science will require continual monitoring of the safety of
color additives.

Delaney Dilemma

The decision to ban the provisional uses of FDC Red No. 3 is based on the
Delaney Clause of the 1960 Color Additive Amendments. Under that clause, FDA
cannot approve color additives shown to induce cancer in humans or animals in
any amount.

Many government officials, however, believe that the inflexibility of the
Delaney Clause should be replaced by a standard that allows for what may be an
insignificant cancer risk. Advances in technology and the ability to detect
minute quantities of cancer-causing chemicals in foods may make the risk
standard of the Delaney Clause unnecessarily stringent in some cases. In
announcing the decision to terminate the provisional uses of FD&C Red No. 3,
Health and Human Services Secretary Louis W. Sullivan, M.D., said that the
decision to ban the uses of Red No. 3 was not based on risk but on the legal
mandate of the Delaney Clause.

In 1986, FDA took a different approach in approving four cosmetic dyes for
which cancer risk was trivial. The agency based its approval of Orange
No. 17, FDC Red No. 19, and Red Nos. 8 and 9 on the legal maxim "de
minimis non curat lex," meaning that the law does not concern itself with
trifles. A government review panel had assessed the worst-case risks for
externally applied drug and cosmetic uses for D&C Orange No. 17 as 1 in 19
billion (that is, exposure to external cosmetics containing FDC Orange No. 17
may cause at most one additional case of cancer in 19 billion people over a
70-year lifetime of exposure) and for FDC Red No. 19 as 1 in 9 million. The
maximum possible cancer risk for D&C Red Nos. 8 and 9 was evaluated as 1 in 60

The next year, however, the U.S. Court of Appeals for the District of Columbia
held that the Delaney Clause does not contain an exemption for cancer-causing
color additives with only trivial risks. Thus, the court ordered FDA to ban
the colors listed under the de minimis principle.

In the past two Congresses, Senator Edward Kennedy of Massachusetts and
Congressman Henry Waxman of California have introduced legislation concerning
pesticides that others in government would extend to other
additives--including colors--as well. The proposed legislation would
substitute a "negligible risk" standard for the "zero-risk" standard (such as
described in the Delaney Clause) to the regulation of pesticides. The bills
define "negligible risk" as causing at most one additional case of cancer in 1
million people over a 70-year lifetime of exposure to the compound.

President Bush endorsed the negligible risk standard for pesticides in his
October 1989 Food Safety Plan. A joint press statement issued that same day
by HHS Secretary Sullivan, USDA Secretary Yeutter, and EPA Administrator
Reilly noted that while the president's plan specifically addresses pesticide
residues, the principle of negligible risk is one that naturally applies to
other additives to the food supply.

Small Risks

The ban of the provisionally listed uses of FDC Red No. 3 applies to new
manufacture and production of affected products. Because any health risks
posed by Red No. 3 are extremely small, FDA concluded that consumers may
continue to use existing supplies of products that already contain that color.

Following the mandate of the Delaney Clause, FDA will now reconsider the
permanently listed uses of the straight form of FDC Red No. 3. The procedure
for banning a permanently listed dye, however, is more complex than that for
terminating the provisional uses and requires time for public comment.

Though in the future, new definitions of acceptable risk spawned by new
technologies may replace the Delaney definition, for now FDA must operate
under this meaning and say to consumers that because of the risks, certain
uses of FD&C Red No. 3 can no longer be allowed.

Dale Blumenthal is a staff writer for FDA Consumer.

Lists Available

For complete lists of color additives approved for use in food, drugs and
cosmetics--including the year approved, uses and restrictions--write to:
Division of Colors and Cosmetics
FDA (HFF-442)
200 C Street, S.W.
Washington, D.C. 20204

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