mdi ConsultantsSince the issuance of 2013 revised FDA Guidance “Cosmetic Good Manufacturing (GMP) Guidelines/Inspection Checklist”, FDA enforcement of cosmetic manufactures has been steadily on the rise.
FDA has always used warning letters as an effective compliance mechanism to let companies know that they have violated the laws and to tell them what corrective action they need to take. Over the years, FDA has issued a number of warning letters directed to cosmetic establishments. These were mainly related to unauthorized drug claims made for products marketed as cosmetics, improper marketing of medical devices as cosmetics and safety violations due to illegal use of color additives. The latest FDA warning letter trend highlights problems with microbial contamination of cosmetic products.
Under the Federal Food, Drug, and Cosmetic Act, it is illegal to market an adulterated cosmetic in interstate commerce. One of the ways in which a cosmetic can become adulterated is if it contains a poisonous or deleterious substance, i.e. microbial contamination, that poses a potential health risk for the uses recommended in the product labeling.
In the recent March 16, 2016 warning letter issued to Gilchrist & Soames, Inc., FDA stated that during inspection of the Gilchrist & Soames cosmetic manufacturing facility in Plainfield, Indiana, FDA investigators collected samples of various shower gels, shampoos, lotions and conditioners manufactured and distributed to the hotel industry, retail and charitable organizations. Further testing at the FDA laboratories found significant microbial contamination of the “Gilchrist & Soames Spa Therapy Conditioning Shampoo,” Shower Gel,” “Pelican Hill Shower Gel,” and “Essential Elements Shampoo”. All collected samples contained the pathogen Pseudomonas aeruginosa which is highly resistant to antibacterial agents such as quaternary ammonium compounds, penicillin, and many broad-spectrum antibiotics. P. aeruginosa is among the most virulent opportunistic pathogens and can cause severe and life-threatening infections. This pathogen can survive in topical and eye-area cosmetics and has been implicated in significant eye infections which may lead to corneal ulcers and blindness.
In the warning letter, FDA cited a number of insanitary practices that investigators observed at the manufacturing plant such as lack of appropriate maintenance and timely cleaning of the production equipment and lack of microbiological testing for the raw materials, in-process materials and finished products. While FDA acknowledged that Gilchrist & Soames voluntarily recalled several products due to microbiological contamination, the Agency indicated that due to the extent of microbial contamination, the manufacturer needs to develop a comprehensive remediation plan to correct and prevent future contamination issues and ensure product safety.
In another warning letter issued to a contract cosmetic manufacturer Gemdo Cosmetics (Valencia, CA) on April 16, 2015, FDA cited contamination of the Juice Beauty Illuminating Eye Shadow products with the ocular pathogen, Bacillus cereus. This pathogen is known to cause a rapid inflammation of the eye which is resistant to treatment. Significant loss of vision, and often loss of the eye itself, can occur within 24 to 48 hours after exposure to B cereus. Particularly, Bacillus cereus contaminated eye- shadow products may cause users to develop bacterial conjunctivitis, keratitis and periorbital cellulitis. Once again, FDA observed a number of insanitary conditions at this cosmetic manufacturing establishment suggesting that manufacturing operation or conditions at this facility have likely contributed to the contamination and adulteration of the cosmetic products. FDA requested the manufacturer develops a comprehensive remediation plan to correct and prevent future contamination issues and ensure product safety.
It is important to note the product owner for the Juice Beauty Illuminating Eye Shadow, Juice Beauty Inc. (San Rafael, CA) has also received an Untitled Letter from US FDA dated April 16, 2015 for the same microbial contamination violation. 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. However, an untitled letter is still an important indicator of company’s non-compliance and all cited violations must be corrected within the FDA indicated timeline. In the untitled letter to Juice Beauty Inc. FDA explained that although the firm may contract out certain cosmetic manufacturing operations, it cannot, contract out its ultimate responsibility to ensure that the cosmetics it places into commerce are not adulterated.
In all warning letters, FDA recommended the manufacturers refer to the adulteration reduction guidelines provided in the Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for cosmetics available at: Warning Letters Cite Cosmetics as Adulterated Due to Microbial Contamination.
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