Why You Should Always Test Your Products Before Marketing

When considering cosmetic safety testing, such as routine bacteria and fungal counts and preservative challenge testing, many cosmetic manufacturers and formulators wonder why it is necessary to test their products if they are putting well known preservatives in them and testing may not seem cost effective for the business. Occasionally, the FDA will inspect companies to make sure that the products they are creating are free from microbial contamination and safe for use. Some cosmetic companies fail to follow the guidelines set by the FDA and experience problems that could have been easily prevented by regular testing, acceptable sanitation practices, and good documentation. When the FDA finds that a company has failed to follow its guidelines, the consequences can be expensive and damaging to the public image of the company and, therefore, much less cost effective than running the necessary tests. Below is a list of 4 cases where regular testing would have benefited the companies involved and could have prevented the warning letters from the FDA.

1. May 2012

A small skincare company in Dayton, Ohio that specializes in body butters and lotions, received a warning letter from the FDA. After undergoing inspection, it was found that a specific beauty product the skincare company produced was contaminated with bacteria known to be a health hazard. This triggered an inspection of their facilities which revealed that the company's biggest problem was sanitation. Records showed that some equipment hadn't been cleaned in twenty years. “Regular cleaning” of their production floor occurred once a year. When their products were tested and contamination was reported, they were asked for their testing documentation. They had incomplete documentation and, in some cases, none at all. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm313452.htm.

Solution: Regular testing by an experienced lab with good documentation and more regular, thorough sanitation practices by the cosmetic skincare company.

2. December 2005

The FDA sent a warning letter to a cosmetic manufacturer in Irving, Texas regarding an inspection conducted in late August of that year. This company manufactured a mouthwash that was found to be contaminated when several lots of the hazardous product had already been distributed. Upon further inspection, their filling hoses were found to have the same microorganism that had contaminated the mouthwash. Their employees had failed to follow sanitation guidelines regarding cleaning the facilities. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2005/ucm075727.htm.

Solution: Regular plate count testing with a reputable laboratory such as Microchem Laboratory could have revealed the contamination, allowing this company to recognize the problem and locate the source prior to the FDA's involvement.

3. April 2009

A large, well known company based out of Ohio experienced major issues at one of their cosmetic manufacturing facilities that were addressed by the FDA. The main issues surrounded the sanitation of the equipment used to manufacture and fill their cosmetic products which resulted in some of them becoming contaminated. Many of the cosmetic and personal care products were manufactured and held in unsanitary conditions. The holding tanks were inspected and found to have high numbers of microbes in them and the parts were not taken apart and cleaned adequately. The cosmetic company was required to issue quality notices to the public due to the growth of several microorganisms found in their holding tanks after sanitation. The FDA found that the facility did not review and make necessary changes to their procedures on regular cleaning and maintenance even after discovering that their cleaning methods were ineffective. End-product testing did not reveal any of these organisms; however, there was still the potential due to the product being stored in the tanks with the contaminants. The company insisted that their preservative was killing the microbes found in the production machinery. The FDA argued that, though this may be the case, the preservatives are meant to prevent the growth and spread of any bacteria or fungi that may be introduced into the product post-production and does not make up for a lack of good sanitary practices. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm161902.htm.

Solution: While this company was adding necessary preservatives to their products, it could have benefited from a testing laboratory that would provide them with regular batch testing to ensure that products were not leaving the facility with microbial contamination.

4. June 2005

The FDA found many issues with a small cosmetics company in Maple Grove, Minnesota, which included problems with mislabeling and misrepresenting the product and its uses. This skincare company was warned about certain microbiological issues that its product suffered. Many of their skincare products that were inspected by the FDA revealed that the products contained levels of bacteria and fungi that were above what is considered a safe level for consumers. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2005/ucm075440.htm.

Solution: Regular bacteria and fungal plate count testing by scientists with knowledge of the acceptable levels of microorganisms for cosmetics could have this benefited this company and prevented many of the issues discovered by the FDA.

All of these warning letters could have been avoided with proper sanitary procedures and the use of a good testing laboratory to verify that their cosmetic products were free from microorganisms upon manufacture and to test for their preservative efficacy. The benefits of microbiological testing will, by far, exceed the drawbacks and cost of such testing. By testing their products with a quality laboratory, such as Microchem Laboratory, a company can be sure that the tests are conducted with the benefits of the cosmetics company always in mind.