Setting the Record Straight:
FDA Inspects MONAT Facilities

Truth About MONAT

  • FDA conducted an inspection of MONAT’s facilities in Miami, Florida, for six days over the period of March 12 through 20.  An agency inspector and a toxicologist conducted a thorough audit of our facilities, manufacturing processes, formulas, labeling and packaging materials, finished and unfinished products, and certain manufacturing records.  They also took samples of finished products and raw materials.
  • At the conclusion of the inspection, the FDA representatives informed the Company that they found no violations or other matters of significant concern.  They left a list of five  minor observations, none relating to formulas or product ingredients.
  • FDA representatives informed us that the samples they took would be analyzed by the agency, and that we could expect to receive their results in six weeks or so.  They added that they saw no “red flags” on any ingredient the company uses.
  • In that context, and in general, it is important to note that FDA does not approve cosmetic products.  Nor does it certify the safety, efficacy or quality of any cosmetic products.  No FDA approval or certification of MONAT’s products was given or implied in the inspection, and none should be implied from our report of the inspection.
  • Although, as with all cosmetics marketed in the U.S., MONAT’s product are not approved or certified by FDA, MONAT is committed to compliance with FDA requirements for all our products, and we are confident that they are safe, effective and highly beneficial to our consumers.