Paolo Giacomoni, PhD, Insight Analysis Consulting02.01.24
Between October and early December 2023, 326 cosmetic products were recalled from the market. The total sum of recalled products for 2023 exceeded 6,600. Quite a humongous number, isn’t it?
The vast majority of the recalled cosmetic products contained the banned allergenic fragrance butylphenyl methylpropional. Many other products contained forbidden ingredients such as hydroquinone or clobetasol propionate or lead. Some products were even contaminated by bacteria. But whatever the reason, they’re all worrisome for a product category promoting skin health and beauty!
How can we explain why so many products violate simple rules of safety? Should we imply that cosmetics companies are unable to follow the basic rules of the US FDA and are deprived of the basic knowledge of microbiology and biochemistry? Or should we conclude that in many brands there is a relaxation in the oversight of biologists and biochemists on the preparation of products? Are we witnessing the scientist’s shrinking role in the production process?
If such a decision had been taken by the other major distributors in the cosmetic arena, that might explain the lack of the scientific oversight on the preparation and manufacturing of the products, with negative consequences on their quality and on their advertising credibility. Don’t forget, a couple of years ago, a major brand was sued for marketing a product that did not contain live probiotics as advertised…Indeed, to no surprise of every attentive microbiologist, the added preservatives had killed all the probiotics!
And the FDA insists that “The firm should notify customers as well as the FDA that a recall is underway” and invites consumers to keep authorities such as the FDA informed when they feel or notice that something is wrong with a product.
When a product is contaminated with bacteria, one should not blame the preservatives. Rather, one must ask the production engineers to look for sites of contamination in the assembly line, from mixing vats to vial fillers. The preservatives used in cosmetic products are there to avoid the contaminations borne by the fingers of the consumer into the jar. Preservatives are not meant to have a universally broad spectrum and are only selected to inhibit the growth of the most frequently encountered microorganisms, such as, for instance, Aspergillus brasiliensis (fungus), Candida albicans (yeast), Escherichia coli (bacterium of the gastro-intestinal tract, Gram negative), Staphilococcus aureus (bacterium of the respiratory tract, Gram positive) and Pseudomonas aeruginosa (bacterium of the skin flora, Gram negative). One could also try and test preservatives for their possible adhesion to the walls of the jar. If this happens, they would be actually removed from the emulsion and trapped away from the bulk of the product. They would therefore be hindered from interacting with the very microorganisms they are expected to kill.
Of course, some products are meant to contain probiotics. These microorganisms are thought or proven to have positive effects on some skin conditions and added to skin care products in the same way as nutritional probiotics are used in yogurt. The oxymoronic approach is to prepare products containing probiotics as well as preservatives. The more sophisticated and difficult approach would be to search for preservatives able to hinder the growth of common contaminants while allowing the probiotic to survive. The commonsense approach is to use not probiotics but their metabolites, the so-called postbiotics, that are able to perform the same action of the beneficial microorganisms without requiring the addition of billions of bacteria in the jar. Another reasonable way would be to use the so-called prebiotics, the nutritional ingredients that favor the growth of the friendly commensal flora while hindering the growth of unwanted, harmful microorganisms.
When a preferred brand is recalled, consumers start asking questions about management’s savviness…and change brands.
Paolo Giacomoni, PhD
Insight Analysis Consulting
paologiac@gmail.com
516-769-6904
Paolo Giacomoni acts as an independent consultant to the skin care industry. He served as Executive Director of Research at Estée Lauder and was Head of the Department of Biology with L’Oréal. He has built a record of achievements through research on DNA damage and metabolic impairment induced by UV radiation as well as on the positive effects of vitamins and antioxidants. He has authored more than 100 peer-reviewed publications and has more than 20 patents. He is presently Head of R&D with L.RAPHAEL—The science of beauty—Geneva, Switzerland.
The vast majority of the recalled cosmetic products contained the banned allergenic fragrance butylphenyl methylpropional. Many other products contained forbidden ingredients such as hydroquinone or clobetasol propionate or lead. Some products were even contaminated by bacteria. But whatever the reason, they’re all worrisome for a product category promoting skin health and beauty!
How can we explain why so many products violate simple rules of safety? Should we imply that cosmetics companies are unable to follow the basic rules of the US FDA and are deprived of the basic knowledge of microbiology and biochemistry? Or should we conclude that in many brands there is a relaxation in the oversight of biologists and biochemists on the preparation of products? Are we witnessing the scientist’s shrinking role in the production process?
A Poor Decision?
Or, are we suffering the consequences of the generalization of the wicked decision of one multinational CEO in the late 1990s? Having noticed the R&D department’s burgeoning budget, he decided to make drastic cuts to R&D to make it less “powerful.”If such a decision had been taken by the other major distributors in the cosmetic arena, that might explain the lack of the scientific oversight on the preparation and manufacturing of the products, with negative consequences on their quality and on their advertising credibility. Don’t forget, a couple of years ago, a major brand was sued for marketing a product that did not contain live probiotics as advertised…Indeed, to no surprise of every attentive microbiologist, the added preservatives had killed all the probiotics!
Recalls & FDA: What Is the Law?
What is a recall? The FDA states the following “A recall is a firm’s removal or correction of a marketed product that FDA considers to be in violation of the laws we administer and against which we would initiate legal action, such as seizure.”And the FDA insists that “The firm should notify customers as well as the FDA that a recall is underway” and invites consumers to keep authorities such as the FDA informed when they feel or notice that something is wrong with a product.
What Should Consumers Do?
In May 2018, the FDA advised health professionals and consumers to avoid using products that have been recalled by Shadow Holdings as they might be contaminated with bacteria within the Burkholderia cepacia complex, also commonly called Bcc. At that time, the recommendation by the FDA was that if a consumer had a reaction when using any cosmetic, they should stop using the product. Next, consumers were advised to contact a doctor or other healthcare provider for medical advice. Finally, tell FDA. Problems related to any cosmetic can be reported by contacting FDA’s MedWatch reporting system.Recall Lessons
When a product is recalled because it contains a forbidden ingredient, one would expect that the chemist and the marketing executive responsible for that product be held responsible and accountable with the consequent sanctions. If a product is recalled because the emulsion has “fallen apart,” before blaming the chemist, one must explore the distribution route and the possible exposure of the delivering trucks to the extreme summer temperatures of Texas and New Mexico, for instance, and start envisioning the use of refrigerated trucks.When a product is contaminated with bacteria, one should not blame the preservatives. Rather, one must ask the production engineers to look for sites of contamination in the assembly line, from mixing vats to vial fillers. The preservatives used in cosmetic products are there to avoid the contaminations borne by the fingers of the consumer into the jar. Preservatives are not meant to have a universally broad spectrum and are only selected to inhibit the growth of the most frequently encountered microorganisms, such as, for instance, Aspergillus brasiliensis (fungus), Candida albicans (yeast), Escherichia coli (bacterium of the gastro-intestinal tract, Gram negative), Staphilococcus aureus (bacterium of the respiratory tract, Gram positive) and Pseudomonas aeruginosa (bacterium of the skin flora, Gram negative). One could also try and test preservatives for their possible adhesion to the walls of the jar. If this happens, they would be actually removed from the emulsion and trapped away from the bulk of the product. They would therefore be hindered from interacting with the very microorganisms they are expected to kill.
Of course, some products are meant to contain probiotics. These microorganisms are thought or proven to have positive effects on some skin conditions and added to skin care products in the same way as nutritional probiotics are used in yogurt. The oxymoronic approach is to prepare products containing probiotics as well as preservatives. The more sophisticated and difficult approach would be to search for preservatives able to hinder the growth of common contaminants while allowing the probiotic to survive. The commonsense approach is to use not probiotics but their metabolites, the so-called postbiotics, that are able to perform the same action of the beneficial microorganisms without requiring the addition of billions of bacteria in the jar. Another reasonable way would be to use the so-called prebiotics, the nutritional ingredients that favor the growth of the friendly commensal flora while hindering the growth of unwanted, harmful microorganisms.
When a preferred brand is recalled, consumers start asking questions about management’s savviness…and change brands.
Paolo Giacomoni, PhD
Insight Analysis Consulting
paologiac@gmail.com
516-769-6904
Paolo Giacomoni acts as an independent consultant to the skin care industry. He served as Executive Director of Research at Estée Lauder and was Head of the Department of Biology with L’Oréal. He has built a record of achievements through research on DNA damage and metabolic impairment induced by UV radiation as well as on the positive effects of vitamins and antioxidants. He has authored more than 100 peer-reviewed publications and has more than 20 patents. He is presently Head of R&D with L.RAPHAEL—The science of beauty—Geneva, Switzerland.