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January 31, 2018

How Contaminated Cosmetics Are No Superficial Problem

Ask the FDA?

collection of different cosmetics

Throughout human history, we have maintained a conflicted relationship with our bodies. We don’t just mean the struggle to lose a pound or two, or the issues some of us face with physical dysfunction. It goes so much further than that, as news headlines frequently remind us. But there’s a way in which our bodily dissatisfactions – even to the point of dysmorphia – reveal themselves in much more subtle ways. Ways that, as a society, we often accept and encourage, without ever really looking into why. One of these is the use of cosmetics. Seem superficial? Perhaps, but let’s take a moment to consider questions around contaminated cosmetics as it relates to manufacturing, contamination control and safety for products we apply to the largest organ of our body – the skin.

It’s no secret that we like to use substances and techniques to improve, enhance, or alter our features. Whether it is the medical intervention sought for facial dysmorphologies, the ultra high-tech use of elective lipo-sculpting, or the centuries-old application of cosmetic make-up products, we have long sought to change the way we look to others. In the Christian Bible, a tome not usually referenced in discussions of human beauty and vanity, the book of Kings (9:30) notes that Jezebel, Phoenician princess and original ‘painted woman’ who ultimately met a grizzly fate, was a fan of decorating her eyelids. Further, the book of Esther – the eponymous heroine of which is often regarded as a post-feminist icon – also notes the importance and  ritual of beauty treatments.

Outside of the Judeo-Christian tradition, Queen Nefertiti, ruler of Egypt between 1353 and 1336 BC, famously pioneered the use of kohl to enhance the now iconic look of the eyes for both women and men in that society. Interestingly, according to the American Chemical Society, data exists to suggest that an ingredient in the make-up may have not only increased allure but also decreased the risk of eye infection. Serving as natural anti-bacterials, lead chloride along with laurionite – a lead halide mineral – exhibited protective tendencies, safeguarding the wearer against bacterial infection in a geographical area prone to water-borne contamination. Perhaps those ancient Egyptians were wiser than we think?

That said, and despite its widespread traditional use, not all makeup is protective nor even harmless.

Historically, lead poisoning has been linked with the use of some ingredients commonly used in cosmetics, and even today the incidents of toxicity in personal care products are all too high. According to Poison Control, the National Capital Poison Center, cosmetics and personal care products rank as the #1 substances implicated in the poisoning of children younger than 6 years of age. At 13.3% of all cases – or 138,904 cases in 2016, cosmetics beat out even cleaning compounds, pesticides, and analgesics.(1)

Let’s take a moment to digest that statistic: there are more young children poisoned every year by makeup than by pain medications. Suddenly the problem takes on a whole new complexion.

So what is the landscape of the beauty products industry and how is it regulated?

It’s no secret that a small handful of mega-corporations dominate the modern beauty industries on the global level and, within the U.S., two of the biggest players are L’Oréal and Estée Lauder. And, within the largest national cosmetics market in the world, the U.S. players share in a revenue stream of $62 billion in 2016. Need a context for this figure? According to World Bank data, $62 billion is more than the gross domestic product (GDP) of Jamaica, Botswana, Iceland, and The Bahamas. Combined.(2) So it’s fair to say this industry is comparatively lucrative.

And, as with any industry, with big profits should come big responsibility. However, that may not exactly be the case. So what is the role of governmental oversight in the manufacture of products intended purely for the cosmetics market?

In a previous article, we examined the regulation in the over-the-counter supplement industry and the ways in which nutritional supplements may pose a threat to more than just your bank balance. But is the same true of cosmetics? How far does regulation prevent these ‘beauty products’ from doing more than simply taking a bite out of your disposable income? Let’s take a look…

Take a moment to step back in time to America of the late 30s… It was the final lingering days of the Great Depression, Roosevelt was back in the office for a second presidential term, Benny Goodman was drawing the entertainment crowds, labor relations were undergoing change as unionization swept the nation, and the New Deal was coming to an end. And, in 1938, Senator Royal S. Copeland of New York was the principal author on a new law, the Food, Drug, and Cosmetics Act. This legislation was a direct response to a tragedy in which more than 100 people were poisoned by sulfanilamide, an antibiotic and antibacterial which, when formulated with diethylene glycol, can cause kidney failure.(3) The FDCA replaced the much more constrained Pure Food and Drug Act of 1906 which had come to be regarded by many as solely a ‘truth in labeling’ law. The new legislation defined a cosmetic product is one that is intended ‘to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance.’ This includes, but is not limited to, perfumes, lipsticks, hair colors, toothpastes, moisturizers, and shampoos. With this legislation, increased transparency led to the recognition that some ingredients were manifestly overtly dangerous and others wildly controversial. And although we have moved away from the worst offenders including petro-chemicals, a class of antimicrobial preservatives known as parabens, and sodium lauryl sulfate – an emulsifier that although a GRAS ingredient (generally regarded as safe) may cause skin irritation, especially dermatitis – the problem goes deeper that the inclusion of known controversial ingredients.  Predictably there’s also the question of contamination.

Under section 601 of the Federal Food, Drug, and Cosmetic Act, a product may be classified as adulterated for one of four reasons. These are quoted directly from the agency’s website: (4)

  1. It may be injurious to users under conditions of customary use because it contains, or its container is composed of, a potentially harmful substance.
  2. It contains filth.
  3. It contains a non-permitted, or in some instances non-certified, color additive.
  4. It is manufactured or held under insanitary conditions whereby it may have become injurious to users or contaminated with filth.

There does seem to be a heavy emphasis on contamination by ‘filth’ – in the case of cosmetics, this would mean bacteria, fungal agents, or particulate matter.

But how widespread is this potential contamination risk? According to FDA alerts, taint can be found in products as diverse as mouthwash, body shimmer powder, and tattoo ink.(5) In fact, already this year a hair product, KeraCare Hydrating Detangling Shampoo made by Avlon Industries based in Illinois, was subject to a voluntary recall by the manufacturer due to bacterial infection. In audit samples of the sulfate-free product, Enterobacter cloacae was found to pose a risk to consumers, particularly those with a compromised immune system. Enterobacter is an anaerobic, non-spore forming, gram-negative bacterium that can cause endocarditis and infections of the soft tissue, bones and joints, intra-abdominal area, urinary tract, lower respiratory tract, and of the skin. According to the National Center for Biotechnology Information, a service of the National Institutes of Health (NIH), enterobacter is an opportunistic but multidrug-resistant pathogen that has long been associated with notoriously difficult to contain outbreaks of infection in hospital settings.

And enterobacter has a track record of elevated mortality.

In a study published in 2017 in the Canadian Journal of Infectious Diseases and Medical Microbiology, lead authors Xiaopeng Li and Huan Ye of the Department of Infectious Diseases, Capital Medical University, Beijing detailed a study of 148 patients with carbapenem-resistant Enterobacteriaceae (CRE).(6) Despite medical intervention for bloodstream infections (BSIs) which included intensive care, central venous or urethral catheterization, and courses of antibiotic treatment, 65.4% of the patients died within 30 days of infection.(7)

Clearly, enterobacter is not an infection to be taken lightly.

But, despite its powers to alert and inform, the FDA itself does not have the power to recall tainted products.

As outlined in its own Recall Policy for Cosmetics ‘FDA has no authority under the FD&C Act to order a recall of a cosmetic, although it can request that a firm recall a product.’(8) However, when an alert is issued, the agency does strive to take an active part in monitoring the situation. Collating status reports, conducting audits on the wholesale and retail level, evaluating health hazards, designating hazard classification, and destroying tainted products are all within its remit, as is the power to notify the public via the FDA Enforcement Report, a weekly publication that details recalls with assigned classifications.(9)

So, the state of play for the FDA is that it has to power to notify but not to act. In essence, the agency is fighting the fight with one hand metaphorically tied behind its back. Does this mean that the best we can do is to conduct a review of cGMPs and hope that the FDA is up to speed with its recommendations? Hopefully not. Although on first examination comprehensive, the agency’s Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist was published in 1997 and updated in 2008.(10) Times have certainly changed and it is beginning to look like we should consider the FDA’s position to be a skeleton framework rather than a comprehensive set of guidelines. That said, it is a fairly robust skeleton, covering topics such as records-keeping, equipment safety, prohibited/restricted ingredients, and protocols for internal audits. Optimal conditions for buildings and facilities used for the manufacture, processing, or storage of ingredients and finished goods are outlined, and the proper design and maintenance of equipment is also detailed. Interestingly, the agency’s guidelines also stress the vital importance of personnel training as a route to ensuring that raw materials are handled correctly and that protocols are followed – whether they are laboratory controls, the generation of Hazard and Critical Control Points (HACCP), or the adherence to good manufacturing practices (GMPs).

But there does need to be more. In addition to local and regional standards in contamination control for cosmetics manufacture, the international body, the International Standardization organization (ISO) has stepped in to create a blueprint for product safety. According to a white paper authored by Eize de Boer of SGS, an inspection and certification organization headquartered in Geneva, Switzerland, ISO 22716 was developed as an effort to consolidate and update regulations formed in the European Union and to provide a ‘comprehensive approach for a quality management system tor those engaged in the manufacturing, packaging, testing, storage, and transportation of cosmetic finished products.’(11)

And on a national level, changes are also afoot. In a bi-partisan initiative, two measures have recently come before lawmakers to increase the safety of our cosmetic products. The first, reintroduced by Senator Dianne Feinstein (D-CA) and co-sponsored by Senator Susan Collins (R-ME), is the Personal Care Products Safety Act, and is bolstered by the second initiative, the FDA Cosmetic Safety and Modernization Act, sponsored by Senator Orin Hatch (R-UT). Both bills ‘would require cosmetic manufacturers and distributors to report “serious adverse events” to the FDA within 15 business days of receipt of notice. As defined by both bills, this would include adverse events associated with the use of a cosmetic product, ranging from disfigurement to death [similarly to] the existing mandatory reporting requirement for drugs […], but adverse event reporting is currently voluntary for cosmetics.’(12)

In addition to the mandate to report, cosmetics facilities would need to be registered which would not only leverage revenue in the form of registration fees and taxes but also hold the facility to account in the case of public safety concerns. The Collins-Feinstein bill would require a listing of all ingredients used in manufacture and mandate that the FDA review at least five new ingredients annually using a notice and comment process. It even lists suggestions of the first five candidates for review! And the FDA’s powers would be extended to enable recalls as opposed to simply overseeing them.

But, from our vantage point as contamination control experts, perhaps the critical part of the Collins-Feinstein bill is the requirement that the FDA establish and update its good manufacturing practices. After all, even the most recent update of 2008 has been left behind in terms of new materials and ingredients. This delay in modernizing the cGMPs would surely not be tolerated in similar/cross-over industry silos. In the bio-pharma arena, outdated protocols would undoubtedly cost lives. Perhaps, given the mortality study for our old bacterial foe Enterobacter, it’s time tighten up regulation by acknowledging that the cosmetics industry is not really that different?

Whether you use cosmetics or not, how do you feel about tightening up governmental oversight of the industry? We’d love to know your thoughts!

References:

  1. https://www.poison.org/poison-statistics-national
  2. http://databank.worldbank.org/data/download/GDP.pdf
  3. To read more on this, please refer to our earlier article ‘Compounding Pharmacies: Exploring the Insanitary/Unsanitary Conundrum.
  4. https://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm
  5. https://www.fda.gov/cosmetics/complianceenforcement/recallsalerts/default.htm
  6. https://www.hindawi.com/journals/cjidmm/2017/6212910/
  7. ibid
  8. https://www.fda.gov/Cosmetics/ComplianceEnforcement/RecallsAlerts/ucm173559.htm
  9. https://www.fda.gov/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm2005190.htm
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