Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Warning Letters Related to Cosmetics

Warning Letters Related to Cosmetics Home
          Cosmetics
          Cosmetics Compliance & Enforcement
          Warning Letters Related to Cosmetics
          Warning Letters Cite Cosmetics as Adulterated Due to Microbial ContaminationWarning Letters Related to Cosmetics Warning Letters Cite Cosmetics as Adulterated Due to Microbial Contamination
  
  	
    Share
    Post
    Linkedin

    Email
    PrintUnder the Federal Food, Drug, and Cosmetic Act, it is illegal to market an adulterated cosmetic in interstate commerce [21 U.S.C. 331(a)]. Under the law, one of the ways in which a cosmetic can become adulterated is if "it contains a poisonous or deleterious substance that may render the product injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual" [21 U.S.C. 361(a)]. Such a "poisonous or deleterious substance" may include microbial contamination.

FDA issued Warning Letters to the following firms, citing cosmetic products as adulterated due to microbial contamination posing a potential health risk for the uses recommended in the labeling:

Color Art, Inc. dba Solid Ink September 18, 2019
	Dynamic Color September 18, 2019
	Intenze Products Inc. September 18, 2019
	Gilchrist & Soames, Inc. March 16, 2016
	Gemdo Cosmetics Inc. April 16, 2015
	Vienna Beauty Products May 17, 2012
	Carrington Labs December 5, 2005
	The Master's Miracle June 9, 2005Untitled Letter

FDA uses untitled letters for violations that do not meet the threshold of regulatory significance for a warning letter and to request correction of these violations. Unlike a warning letter, an untitled letter does not include a statement that warns the individual or firm that failure to promptly correct the violation may result in enforcement action.

FDA issued an untitled letter to the following firm addressing microbial contamination of cosmetic products:

Juice Beauty, Inc. April 16, 2015Resources For You

Import Alert #53-17: Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination

                                                                                  Content current as of:
      03/01/2022
              
              
Regulated Product(s)
		 CosmeticsTopic(s)
			  Investigation & EnforcementWarning Letters Related to Cosmetics
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop