Color Additives
A color additive is a dye, pigment, or other substance made by a process of synthesis or that is extracted, isolated, or otherwise derived from a vegetable, animal, mineral, or other source and that, when added or applied to a food is capable of imparting color to it.[1] The FDA is responsible for determining the safety of color additives based on its own independent analysis, as well as the scientific data submitted to it by the company proposing to introduce the additive into the food supply.[2] The FDA defined “safe” in the context of color additives to mean “that there is convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive.”[3] In addition, the FDA passed a specific regulation noting that if the information from qualified scientists suggests the possibility that a color additive has induced cancer when ingested, “no regulation may issue which
BOX 5.1
GRAS and Caffeine
In the 1970s, the Select Committee on GRAS substances analyzed caffeine as a commercially added food ingredient (but not caffeine that naturally occurs in food such as coffee and tea). In 1978, the committee concluded that:
“A. While no evidence in the available information on caffeine demonstrates a hazard to the public when it is used in cola type beverages at levels that are now current and in the manner now practiced, uncertainties exist requiring that additional studies be conducted.
B. It is inappropriate to include caffeine among the substances generally recognized as safe (GRAS). At current levels of consumption of cola-type beverages, the dose of caffeine can approximate that known to induce such pharmacological effects as central nervous system stimulation.”8
The FDA lists caffeine as GRAS “when used in cola-type beverages in accordance with good manufacturing practices,”b at “0.02%” of the product, or in concentrations no greater than 200 parts per million.0 However, food manufacturers started adding much larger amounts of caffeine to beverages such as alcoholic drinks and energy drinks, and additionally began adding caffeine to various foods, such as waffles, gum, and snack foods.d This addition of caffeine is not required to be disclosed on the food label so companies can add caffeine without notifying consumers of its existence in the product or of the amount of caffeine included. Some beverage companies voluntarily disclose the amount of caffeine in their products.8
Although the Alcohol and Tobacco Tax and Trade Bureau regulates the labeling of alcoholic beverages, the FDA has the authority to evaluate the safety of ingredients added to alcoholic beverages.' In 2009,g the FDA sent letters to the manufacturers of caffeinated alcoholic beverages noting that the GRAS regulation “does not confer GRAS status to the use of caffeine in ... alcoholic beverages or at higher use levels” and that the agency did not sanction this use.h The FDA requested companies to provide data and information supporting the conclusion that their company's' use of caffeine in an alcoholic beverage was GRAS or sanctioned by the FDA. In 2010, four companies were still producing caffeinated alcoholic beverages. The FDA sent official Warning Letters to these companies and all four stated that they had ceased production or shipment of the products! (See Chapter 6 for further discussion of the FDA's authority to address food labeling violations, including its use of Warning Letters.)
In 2013, the FDA notified food manufacturers that it would investigate the safety of additional caffeine in food products (such as waffles and syrup) and particularly its effects on children and adolescents.k The agency noted that it was prepared to go through the regulatory process but sought industry's “voluntary restraint.” In the wake of this announcement, one company announced that it would discontinue production of its caffeinated gum; the FDA commended the company and has taken no formal action on caffeine labeling or its GRAS status since then.m
In addition to the public health concerns over mixing alcohol with caffeine, consuming extreme levels of caffeine on its own has health consequences. Energy drinks containing several times the amount of caffeine in cola-type products are sold nationally.11 A study by HHS revealed that emergency room visits involving energy drinks alone or mixed with other substances increased tenfold from 2005 to 2009.° Eleven percent of these visits involved youth
1
aged 12-17 years, and the vast majority of these (75%) were due to energy drink consumption alone. The American Academy of Pediatrics' position is that caffeine and energy drinks “have no place in the diet of children and adolescents,” and the American Medical Association supports banning the marketing of energy drinks to youth under the age of 18 years.p
In July 2013, the United States Senate Committee on Commerce, Science and Transportation held a hearing on the potential health risks associated with the consumption of energy drinks by children and teenagers; thereafter, Senators Edward J. Markey (Massachusetts), John D. Rockefeller (West Virginia), Richard J. Durbin (Illinois), and Richard Blumenthal (Connecticut) followed up with reports and letters." The Senators wrote letters to energy drink manufacturers urging them to commit to voluntary measures not to market their products to youth. Several of the big energy drink companies have refused to abide by the Senators' requests to limit marketing to adolescents/ These products remain legal for youth to purchase (except in one county in New York State), so the First Amendment stands as a barrier to government prohibitions on related marketing practices (see Chapter Seven). State and local governments could ban the sale, as opposed to the marketing, of energy drinks to youth pursuant to their police power, as discussed in Chapter 9.
aFood and Drug Administration. Database of Select Committee on GRAS Substances (SCOGS) Reviews. Caffeine. 1978. http://www.accessdata.fda.gov/scripts/fcn/fcnDetailNavigation. cfm?rpt=scogsListing&id=42
bGood Manufacturing Practices are the FDA's descriptions of the methods, equipment, facilities, and controls for producing processed food (and dietary supplements) to ensure proper quality, packaging and labeling.
c21 CFR 182.1180.
dFood and Drug Administration. For Consumers. FDA to Investigate Added Caffeine. May 3, 2013. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm350570.htm
eJ. L. Pomeranz, C. Munsell, and J. L. Harris. Energy Drinks: An Emerging Public Health Hazard for Youth. Journal of Public Health Policy. 2013;34(2):254-271.
fAlcohol and Tobacco Tax and Trade Bureau. Alcohol Beverages with Added Caffeine. August 21, 2014. http://www.ttb.gov/main_pages/caffeine-added.shtml
gFDA to Examine the Safety of Caffeinated Alcoholic Beverages. November 13, 2009. http://www. fda.gov/ForConsumers/ConsumerUpdates/ucm190364.htm
hFood and Drug Administration. Food. Background Information: Caffeinated Alcoholic Beverages. Nov 13, 2009.Caffeinated Alcoholic Beverages Sample Letter #1
Caffeinated Alcoholic Beverages Sample Letter #2
Caffeinated Alcoholic Beverages Sample Letter #3 http://www.fda.gov/Food/ IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm233591.htm
iFood and Drug Administration. Food. Caffeinated Alcoholic Beverages. November 17, 2010.
http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm190366.
htm
jFood and Drug Administration. News & Events. Update on Caffeinated Alcoholic Beverages. November 24, 2010. http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm234900.htm
kFood and Drug Administration. For Consumers. FDA to Investigate Added Caffeine. May 3, 2013. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm350570.htm [4]
nJ. L. Pomeranz, C. Munsell, J. L. Harris. Energy Drinks: An Emerging Public Health Hazard for Youth. Journal of Public Health Policy. 2013;34(2):254-271.
oSubstance Abuse and Mental Health Services Administration. Center for Behavioral Health Statistics and Quality. The DAWN Report: Emergency Department Visits Involving Energy Drinks. November 22, 2011. Rockville, Maryland.
pStaff of Senator Edward J. Markey (D-MA) in coordination with the staff of Senators Richard J. Durbin (D-IL), and Richard Blumenthal (D-CT). Buzz Kill: A Survey of Popular Energy Drinks Finds Majority of the Market Unwilling to Make Commitments to Protect Adolescents. January 2015. http://www.markey.senate.gov/imo/media/doc/2014-12-30-Report_BuzzKill_EnergyDrinks_ ScreenV.pdf
qStaff of Senator Edward J. Markey (D-MA) in coordination with the staff of Senators Richard J. Durbin (D-IL), and Richard Blumenthal (D-CT). Buzz Kill: A Survey of Popular Energy Drinks Finds Majority of the Market Unwilling to Make Commitments to Protect Adolescents. January 2015. http://www.markey.senate.gov/imo/media/doc/2014-12-30-Report_BuzzKill_EnergyDrinks_ ScreenV.pdf
rStaff of Senator Edward J. Markey (D-MA) in coordination with the staff of Senators Richard J. Durbin (D-IL), and Richard Blumenthal (D-CT). Buzz Kill: A Survey of Popular Energy Drinks Finds Majority of the Market Unwilling to Make Commitments to Protect Adolescents. January 2015. http://www.markey.senate.gov/imo/media/doc/2014-12-30-Report_BuzzKill_EnergyDrinks_ ScreenV.pdf
permits its use.”[5] The FDA may also confine its approval of color additives to certain foods.
Food companies seeking to introduce a new color additive for use in food must submit a petition for certification to the FDA or request an exemption from certification from the agency. Certifiable color additives are those that are synthetically made and are primarily derived from petroleum and coal sources.[6] Companies must submit a batch of the proposed synthetic color additive to the FDA. Examples of synthetic color additives approved for use in food include FD&C Blue No. 1, FD&C Red No. 40, and FD&C Yellow No. 5.[7] The category of color additives that are exempt from the certification process are those that are primarily derived from plant, animal, or mineral sources. Caramel color and annatto extract are examples of this second category approved for use in food.[8] Although they are not subject to certification requirements and companies do not need to submit batches to the FDA, companies must still comply with regulatory requirements. For example, grape color extract, derived from Concord grapes, must comply with specifications regarding pesticide residues, and arsenic and lead levels, and is only approved for use in coloring “nonbeverage food.”[9] The FDA requires that food packaging disclose the presence of color additives. Any color additive, whether subject to, or exempt from certification is considered an “artificial color” or “artificial coloring” by the FDA.[10] Food manufacturers must list the full or abbreviated name of any FDA-certified color additive, such as FD&C Blue No. 1 or Blue 1. For noncertified color additives, manufacturers may state “Artificial Color,” “Artificial Color Added,” or “Color Added.”[11]-[12]
- [1] 21 CFR 70.3(f).
- [2] Food and Drug Administration. Overview of Food Ingredients, Additives & Colors. April 2010.http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm094211.htm
- [3] 21 CFR 70.3(i).
- [4] Food and Drug Administration. For Consumers. FDA to Investigate Added Caffeine. May 3, 2013.http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm350570.htm mFood and Drug Administration. Food. Added Caffeine in Gum. http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm396885.htm
- [5] 21 CFR 70.50.
- [6] Food and Drug Administration. For Consumers. How Safe are Color Additives? December10, 2007. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048951.htm
- [7] U.S. Government Printing Office. Electronic Code of Federal Regulations. Title 21, ChapterI, Subchapter A, Part 74. e-CFR Data is current as of December 23, 2014. http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&sid=3f6c9146ba54b1b84f17046e27197926&tpl=/ecfrbrowse/Title21/21cfr74_main_02.tpl
- [8] Food and Drug Administration. For Industry. Color Additive Status List. List 4. December2009. http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm106626.htm
- [9] 21 CFR 73.169.
- [10] 21 CFR 101.22(a)(4).
- [11] 21 CFR 101.22(k).
- [12] Food and Drug Administration. Overview of Food Ingredients, Additives & Colors. April 2010. http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ ucm094211.htm
