Contains Nonbinding Recommendations 
Guidance for Industry: Colored Sea Salt 
Additional copies are available from: 
Office of Food Additive Safety, HFS-200 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive 
College Park, MD 20740 
(Tel) 240-402-1200 
http://www.fda.gov/ForIndustry/ColorAdditives/GuidanceComplianceRegulatoryInformation/ucm153033.htm 
You may submit written comments regarding this guidance at any time.  Submit written 
comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852.  All comments should be 
identified with the title of the guidance document.  
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
September2015 
1  Contains Nonbinding Recommendations 
 
Table of Contents 
 
I.  Introduction 
 
II.  Discussion
2 
  Contains Nonbinding Recommendations 
 
1
Guidance for Industry: Colored Sea Salt
 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
we) on this topic.  It does not establish any rights for any person and is not binding on FDA or 
the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
responsible for this guidance as listed on the title page. 
 
 
I.  Introduction  
 
This guidance document is intended for manufacturers of colored sea salt products.  This 
document describes the regulatory requirements for the use of color additives to color sea salt. 
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe our current thinking on a topic and should be 
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  
The use of the word should in FDA guidances means that something is suggested or 
recommended, but not required. 
 
II. Discussion 
 
Colored sea salt products containing added charcoal or red clay are sometimes referred to as 
Hawaiian Sea Salt.  These colored sea salt products are being marketed to consumers and 
industry for food use in the United States.   
 
Under section 201(t) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
321(t)), a color additive is a dye, pigment, or other substance made by a process of synthesis or 
similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final 
change of identity, from a vegetable, animal, mineral, or other source, and when added or applied 
to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or 
through reaction to another substance) of imparting color thereto.2  When substances such as 
charcoal and red clay are added to sea salt, these substances meet the statutory definition of a 
color additive under the FD&C Act because these substances impart color to the salt.  
 
                                                            
1 This guidance has been prepared by the Office of Food Additive Safety, Division of Petition Review in the Center 
for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.  
2 See also 21 CFR 70.3(f). 
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  Contains Nonbinding Recommendations 
Section 721(a) of the FD&C Act (21 U.S.C. 379e(a)) defines conditions under which a color 
additive is deemed unsafe.  A color additive used in or on a food will be deemed unsafe unless: 
(1) there is a regulation listing such color additive; (2) the regulation allows that particular use; 
and (3) the color additive and its use conform to the regulation.  Neither charcoal nor red clay is 
listed for safe use by FDA under section 721(a) of the FD&C Act.  In addition, charcoal and red 
clay are not otherwise exempt from such listing.  Furthermore, neither charcoal nor red clay is 
listed in FDAs regulations for use in coloring food, including sea salt (see section 721(b) of the 
FD&C Act (21 U.S.C. 379e(b)).3  Therefore, any food that contains these color additives is 
adulterated under section 402(c) of the FD&C Act (21 U.S.C. 342(c)).  The introduction or 
delivery for introduction into interstate commerce of any food that is adulterated is a prohibited 
act.4  FDA can take enforcement action against an adulterated food product, consistent with our 
priorities and resources.  
Manufacturers of sea salt that intend to add color additives that are not currently approved for 
food use to their products, such as charcoal or red clay, must first obtain approval for the use of 
these substances through the color additive petition process.  Color additive petitions must be 
submitted to FDAs Office of Food Additive Safety, HFS-200, 5001 Campus Drive, College 
Park, MD 20740.  The information required for color additive petitions is outlined in 21 CFR 
71.1.  There are guidance documents available on our website that address the administrative, 
chemistry, toxicological, and environmental information that should be included in support of a 
color additive petition.5   
3 Charcoal was provisionally listed as a color additive for use in food in 1960, but because no evidence was
submitted that scientific investigations were under way to establish safety, the provisional listing was terminated by 
FDA in 1964 (see 29 FR 17089; December 15, 1964). 
4 Section 301(a) of the FD&C Act (21 U.S.C. 331(a)). 
5 http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/default.htm. 
4