under some level of uncertainty. Also,
as is the case with food additives, FDA’s
decision on a color additive petition
cannot weigh in any possible benefits of
the color additive and is based only on
the safety of the intended use. It is also
important to note that safety decisions
are made based on all relevant scientific
information available at the time. As
such, the agency can and will reconsider
decisions if new information raises significant questions related to the safety
of that color additive.
If FDA decides that a petition establishes that the proposed use of a color
additive is safe, the agency will proceed
with granting the petition by issuing a
final rule in the Federal Register, amending the color additive regulations to list
the color additive for that use. If FDA
determines that the petition fails to
establish that the petitioned use of the
color additive is safe, the agency has the
authority and obligation to deny the
petition. FDA will notify the petitioner
when a petition is going to be denied.
The petitioner then can withdraw the
petition without prejudice to any future
filing of a petition for that color additive. If a petition is denied, FDA will
publish an order denying the petition in
the Federal Register.
Any person adversely affected by a
final rule listing a color additive or an
order denying a color additive petition
has the option of filing an objection
within 30 days of the action. A final
rule for a color additive petition becomes effective the day after the 30-day
period for submitting objections ends,
providing no objections to the final
rule are received. The FD&C Act pro-
vides that, as soon as practicable after
a 30-day period for filing objections
has passed, FDA must publish a notice
either specifying the parts of the rule
stayed by the filing of objections, or if
no objections have been filed, stating
that in a notice confirming the effective
date of the color additive listing. If ob-
jections are received, FDA will evaluate
the merits of the objections and issue
an order on them, which is subject to
judicial review. Any person who files
an objection may also request a hearing
or may waive the right to a hearing. If
a person waives the right to a hearing
and is adversely affected by FDA’s final
order on the objection, the person may
seek judicial review in the U.S. Court
of Appeals in the circuit in which the
person resides or has a place of business.
Any person who files a timely objection
and requests a hearing will be granted
a hearing by FDA if the person raises
relevant and material issues in the objec-
For FDA to protect public health,
the FD&C Act provides numerous enforcement tools to address adulterated
and misbranded products. To ensure
compliance with the color additive
regulations, FDA routinely samples and
analyzes both domestically produced
and imported regulated products in
interstate commerce. Telltale signs of
color additive violations include product label declarations of color additives
that are not permitted in the U.S.,
such as ponceau 4R or carmoisine,
or no declaration of a color additive
when the product obviously contains
added color. Another common violation is declaration of a certifiable color
additive by its common dye name, E
number or Color Index (C.I.) number
instead of the name of its certified
form, for example, tartrazine, E102 or
C.I. 19140 instead of FD&C Yellow No.
5, which is not only misbranding but
also may be adulteration if the color
additive does not come from a certified
batch. In addition, the color additives
FD&C Yellow No. 5, cochineal extract
and carmine are specifically required to
be declared on food labels because they
may be allergens or sensitizers. When
such violations are found, FDA will
take necessary enforcement action. For
products with violations, FDA may issue warning letters or seek seizure, injunction or criminal prosecution. FDA
also may request a recall or issue a letter
to inform the responsible company of
the violation and request action to correct the violation. For violations involving imported products, the products are
denied entry and the companies and
products may be placed on an FDA
import alert. To prevent a color additive
violation, if a company is proposing the
use of a color additive in an FDA-regulated product and is unsure about its
regulatory status, the company should
consult with FDA. n
Andrew J. Zajac is the director of the Division of
Petition Review in FDA’s Office of Food Additive Safety,
College Park, MD.
Julie N. Barrows, Ph.D., leads the Color Technology Team in FDA’s Office of Cosmetics and Colors,
College Park, MD.
2. Barrows, JN et al. “History of U.S. Regulation
of Color Additives and Colorants,” in Food Additives and Packaging, eds. V Komolprasert and P
Turowski (Washington, DC: American Chemical
3. Color Additive Amendments of 1960, Pub. L.
No. 86–618, 74 Stat. 397.
4. Doell, DL et al. 2016. “Exposure Estimate for
FD&C Colour Additives for the US Population.”
Food Add Contam: Part A 33( 5):782–797.
5. Food Additives Amendment of 1958, Pub. L.
No. 85–929, 72 Stat. 1784.
7. Federal Food and Drug Act of 1906, Pub. L.
No. 59–384, 34 Stat. 768.
8. Federal Food, Drug, and Cosmetic Act ( 21
U.S.C. 321, 342, 351, 361, 379e).
9. Federal Food, Drug, and Cosmetic Act of
1938, Pub. L. No. 75–717, 52 Stat. 1040.
10. Medical Device Amendments of 1976, Pub.
L. No. 94–295, 90 Stat. 539.
11. Nutrition, Labeling and Education Act of
1990, Pub. L. No. 101–535, 104 Stat. 2353.
12. Title 21, Code of Federal Regulations, Parts
70, 71, 73, 74 and 82.
13. U.S. Department of Agriculture. 1907. Dyes,
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