Natural Does Not Mean Safe—The Dirt on Clean Beauty Products ,

Courtney Blair Rubin, MD, MBE1; Bruce Brod, MD1
Author Affiliations Article Information
1Department of Dermatology, University of Pennsylvania, Philadelphia.
JAMA Dermatol. Published online September 25, 2019. doi:10.1001/jamadermatol.2019.2724

Natural Does Not Mean Safe
Clean beauty, also known as natural skin care, is having a moment. From 2017 to 2018, the natural skin care market grew by 23% to 1.6 billion dollars, accounting for over 25% of the 5.6 billion dollars of annual skin care sales in 2018.1 Staunch warnings from influencers such as Gwyneth Paltrow, whose blog Goop warns readers “Do you want antifreeze (propylene glycol) in your moisturizer? We’re going to guess no,”2 have ignited fear in consumers who are now hungry for skincare that is safe and nontoxic. However, the US Food and Drug Administration (FDA) has failed to define clean and natural, leaving these labels open to interpretation by nondermatologist retailers, bloggers, and celebrities who have set out to define clean beauty for themselves. While the clean beauty movement has demonized hundreds of compounds, in this Viewpoint, we argue that an arbitrary designation of clean or natural does not necessarily make products safer for consumers.

Many of the ingredients that have been denounced by clean beauty evangelists seem to be selected haphazardly as companies attempt to “greenwash” their products to make them more attractive to conscientious shoppers. In July 2018, for example, Whole Foods released its updated list of unacceptable ingredients, which lists over 400 compounds they feel are unfit for their line of premium body care.3 Their list of banned ingredients includes petrolatum, which dermatologists have consistently recommended to patients with skin barrier disruption owing to its nonallergenicity, superior qualities as a humectant, and economical cost that makes it accessible to patients of all backgrounds. The Campaign for Safe Cosmetics advocates for consumers to avoid a multitude of ingredients including parabens,4 which the American Contact Dermatitis Society named 2019 nonallergen of the year.5 Parabens are some of the least allergenic preservatives available, with rates of contact sensitization between 0.5% to 1.4%—rates that have been stable since the 1990s.6 The Environmental Working Group’s (EWG) safe skin database warns consumers against exposure to chemical sunscreen ingredients,7 though a recent editorial in JAMA8 explains that although there is evidence of systemic absorption of sunscreen ingredients, we do not yet have data to link this systemic absorption with toxic or adverse effects, and that sunscreens remain critical in our defense against keratinocytic skin cancers.

Additionally, many so-called natural products contain high concentrations of botanical extracts that are a leading cause of both irritant and allergic contact dermatitis and photosensitization.9 In a study done by the University of Ferrara, 6.22% of topical herbal product users reported 1 or more adverse cutaneous reactions, with a prevalence higher in women than men.10 While Goop states that “the worst offenders are preservatives that release formaldehyde, a known human carcinogen and potent skin irritant and allergen,”11 large-scale studies across Europe and the United States investigating the rates of contact dermatitis to common preservatives show that the preservatives most frequently implicated in contact sensitization are isothiazolinones, including methylchoroisothiazolinone and methylisothiazolinone, which are not formaldehyde releasers.12,13 With a sensitization rate greater than 4%, isothiazolinones are the most common cause of contact dermatitis to preservatives in Europe.12 Alternative preservatives with lower rates of contact sensitization include formaldehyde and formaldehyde releasers, parabens, and iodopropynyl butylcarbamate. The prevalence of contact allergy to formaldehyde ranges from 1% in Europe to 7% in the United States, while the prevalence of contact allergy to formaldehyde releasers such as quaternium-15, diazolidinyl urea, imidazolidinyl urea, 1,3-dimethylol-5,5-dimethylhydantoin, and 2-bromo-2-nitropropane-1,3-diol (bronopol) ranges from less than 1% in Europe to between 0.5% and 2% in the United States. Contact sensitization rates for iodopropynyl butylcarbamate have been reported to range from 1.2% to 4.2%.6,12 The natural skin care movement’s intolerance of parabens and other safer preservatives has unintended consequences, such as the use of more allergenic preservatives such a methylisothiazolinone. This unwarranted avoidance of low-allergen and safe preservatives and increased use of botanicals has been associated with a new epidemic of contact dermatitis, which is responsible for high medical bills, time away from work and family, and a diminished quality of life.13,14

In general, it seems that sulfates, parabens, formaldehyde releasers, chemical sunscreens, fragrance, butylated hydroxytoluene, phthalates, and propylene glycol are skin care components that are consistently banned by the natural skin care movement. While it is imperative for patients with contact dermatitis to avoid any ingredients they are sensitized to, many of the strongest voices in the clean beauty movement suggest avoiding ingredients owing to a theoretical risk of endocrine disruption and cancer, despite the fact that a causative relationship between these disease states and the concentration of these ingredients in cosmetic products has not been proven scientifically.5 In the same way that the antivaccine movement often fails to acknowledge the success of vaccines in promoting population health, it is easy to forget that the use of safe preservatives such as parabens and formaldehyde releasers is necessary to prevent severe infections and complications such as the Pseudomonas-induced corneal ulcers reported in the 1970s from inadequately preserved mascara.15,16

At this point in time, there seems to be discordance between what dermatologists know about the science of the skin and what is being disseminated to consumers through the clean beauty movement. The EWG’s safe skin database scores thousands of products based on the putative toxicity of their ingredients,17 but these claims are not always uniformly agreed on by a broad consensus of experts, and can cause confusion to consumers. For example, the EWG has assigned a hazard score of 5 (moderate hazard) to the common ingredient PEG-2 soyamine, despite acknowledging that, “data available: none.”18 Although the EWG remains a powerful force driving the clean beauty dialogue, their method for assessing risk does not seem to be data driven. The EWG also profits from participating in affiliate programs where they receive a percentage of the sale when a consumer makes a purchase through their website, which may be a notable conflict of interest. The Cosmetic Ingredient Review (CIR), on the other hand, is an alternative resource, which consists of experts in a number of disciplines including dermatology and toxicology. Claims made by the CIR are backed by scientific evidence that is visible to readers. After extensive review of the evidence, they determined that propylene glycol, parabens, sulfates, and many other ingredients demonized by the clean beauty movement were nontoxic and noncarcinogenic.19

Dermatologists need to be educated on the science of skin care ingredients so that when patients inevitably ask us about natural skin care, we can explain that natural is a marketing term that does not necessarily mean safer or more effective. Misinformation may lead to higher rates of contact dermatitis, substantial financial investment into natural products encouraged by companies with a clear financial conflict of interest, and unnecessary avoidance of safe and necessary skin care ingredients. Additionally, we urge the FDA to consider defining clean and natural to prevent consumer misconceptions about what these terms mean. Finally, both consumers and physicians should demand that the clean beauty movement back up their claims with evidence.

Back to topArticle Information
Corresponding Author: Bruce Brod, MD, MBE, Department of Dermatology, University of Pennsylvania, 3600 Spruce St, 2 Maloney Building, Philadelphia, PA 19104 (bruce.brod@uphs.upenn.edu).

Published Online: September 25, 2019. doi:10.1001/jamadermatol.2019.2724

Conflict of Interest Disclosures: None reported.

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Comment
3 Comments for this articleEXPAND ALL
September 28, 2019
Natural vs Synthetic
Joe DiNardo, MS in toxicology | Retired personal care toxicologist, formulator and regulatory person with 43+ yrs experience
Although I agree with the title of the article, I have to disagree with most of the information presented, regardless if the source of the information is from a company or the authors. First, goop should really be named “goof” … many of the words that come from the owner’s mouth are incorrect like propylene glycol is anti-freeze … that would be ethylene glycol. And it was dermatologist that gave propylene glycol a “bad name” along with PABA and numerous other chemicals – not the natural market. And the CIR “IS NOT” an alternative resource of information – the groupmakes decisions based on the information that industry provides – not independent scientists. Additionally, FDA’s job is not claim substantiation. It is stopping claims that involve misbranded drugs, cosmetics, devices … etc., from entering into the market misleading people and/or causing harming. So, expecting FDA to control puffery claims like “clean and natural” is somewhat unrealistic.

The association that natural means non-toxic is and always was absurd … in fact, synthetic was started so that the toxins in natural products could be removed … 5-methoxypsoralen (active in bergapten) had to be removed from natural citrus type essential oils because of phototoxic outbreaks. However, the synthetic process has also lead to more reactions from time to time as well … eugenol is less reactive than its synthetic counterpart isoeugenol with respect to allergic contact dermatitis. The rules of toxicology have not changed since the 1500’s … it is the dose not the poison that is the problem.

Additionally, the recent JAMA publication observed clearly what many of us have been trying to tell FDA for years … that organic petrochemical based sunscreens absorb through the skin at significant levels and that the molecular weight of these chemicals are below 500 Daltons, allowing them to pass through the skin and placenta barriers. The FDA statement “we do not yet have data to link this systemic absorption with toxic or adverse effects, and that sunscreens remain critical in our defense against keratinocytic skin cancers” is misleading. The FDA requested data … the following link - https://www.regulations.gov/docketBrowser?rpp=25&so=DESC&sb=commentDueDate&po=0&s=Joe%2BDiNardo&dct=PS&D=FDA-1978-N-0018 - was submitted and summarizes few hundred papers demonstrating a variety of toxicities produced in many species ranging from coral death to human reproductive effects. This is why FDA is requesting that industry provide more toxicity information. The data already exists; all anyone has ever had to do is read it … a task that is no harder than finding time to sit and review the data for one’s self. Additionally, the World Health Organization has published global data that clearly states that sunscreens are not effective at reducing basal cell carcinoma or melanoma and the American Cancer Society has published data showing that the melanoma rate has increase 3 to 4 fold in the US since 1975. Believing in what a $10 billion a year industry has to say about the safety of their own products falls somewhat short of being prudent.CONFLICT OF INTEREST: None ReportedREAD MORE
October 1, 2019
Natural vs Synthetic Response
Bruce Brod, M.D. | University of Pennsylvania Department of Dermatology
We would like to thank Mr. DiNardo for his interest in our article and thoughtful comments. We appreciate his historical perspective and examples of how industry has gone to great lengths to remove potentially hazardous substances from personal care products. While we agree that misinformation about the safety of skincare ingredients is problematic, we do not believe that there is sufficient scientific evidence at this time to substantiate claims that sunscreen ingredients cause environmental harm or human reproductive effects.

While there is a large body of literature that comments on the potential toxicities of sunscreenagents, it is important to critically evaluate these studies before drawing conclusions. In the studies on potential coral reef bleaching, experimental coral was exposed to sunscreen agents in concentrations much higher than ever measured in wild coral reefs. Because the concentration of sunscreen agents used in these coral studies does not mimic the way that sunscreen agents are dispersed to wild coral, the generalizability of this data is questionable (Danovaro et al, 2008, and Downs et al 2016). More recent studies examining the levels of UV filters in water around Hawaii found substantially lower amounts than what was required to induce bleaching of coral in a laboratory setting. Multiple studies show that the most important cause of coral reef bleaching is warming of the ocean water, which has nothing to do with levels of UV filters (Schneider et al 2018). Professor Terry Hughes, who is the Director of the ARC Centre of Excellence for Coral Reef Studies has said, “there is actually no direct evidence to demonstrate that bleaching due to global heating is exacerbated by sunscreen pollutants. Similarly, there is no evidence that recovery from thermal bleaching is impaired by sunscreens, or that sunscreens cause coral bleaching in the wild.”

The studies about the toxic reproductive effects of parabens have been similarly problematic. While studies have shown that some parabens have weakly estrogenic activity in rats and yeast cells, they were found to be thousands to millions of times weaker than estradiol, which is an endogenous sex hormone. Additionally, very high concentrations of parabens were used in these studies (higher than would ever be found in a personal care product), and they were injected under the skin of the organism (rather than applying to the skin’s surface as you would a personal care product), which severely limits the generalizability of these studies (Routledge et al 1998). The study that claimed to find parabens in human breast tumors lacked a control group as they did not analyze any normal human tissue. Even more concerning, they found parabens in blank samples containing no human tissue at all, raising the question of whether the parabens came from the containers in which the breast tissue was stored (Darbre et al 2004). The Cosmetic Ingredient Review has done an extensive review of the scientific literature on paraben safety, and has concluded that parabens are safe in personal care products.

(Continued)

Courtney Rubin MD, MBE and Bruce Brod MDCONFLICT OF INTEREST: None ReportedREAD MORE
October 1, 2019
Natural vs Synthetic Response (Continued)
Bruce Brod, M.D. | University of Pennsylvania Department of Dermatology
While the recent pilot study by Matta et al published in JAMA showed systemic absorption of sunscreen ingredients based on maximum use conditions, it does not prove that sunscreen ingredients are unsafe at these levels. Chemical-based sunscreens have been in use since the 1970s and there is no data to indicate any associated adverse health effects. While there may be some inconsistencies in the data regarding the benefit of sunscreens, there is robust evidence to implicate ultraviolet light from the sun as the primary risk factor for melanoma and keratinocyte skin cancers. Thus, sunscreen should be one of severallines of defense against the hazards of UV light, amongst seeking shade and sun protective clothing. Data must be measured against the risk-benefit ratio to patients.

While it is true that the rate of melanoma has increased since 1975 we feel this is not due to the lack of efficacy of sunscreens. Most of the reported increase is attributable to increased detection of early stage melanoma that is very curable. Additionally, rates of melanoma may be rising due to the recent popularity of indoor tanning beds. The rate of advanced melanoma, on the other hand, has remained stable over this same time period.

We agree that the FDA does not currently have the authority to substantiate false claims. Ideally, there should be a robust self-policing mechanism in place from the personal care products industry. The Food, Drug, and Cosmetic Act of 1938 is antiquated and has not been updated in 80 years. Relatively recently, legislation was proposed that would have provided the FDA with more authority to require companies to register ingredients and report adverse events, as well as require a review of several ingredients every year.

Finally, we would like to mention that although propylene glycol was the designated “Allergen of the Year” by a committee of contact dermatitis experts, it was primarily chosen in 2018 to raise awareness of the nuances of patch testing to this agent, and not to raise concerns about the safety of propylene glycol as a personal care product ingredient. In fact, the article points out that the prevalence of reactions to propylene glycol is relatively low in juxtaposition to its widespread use and cautions about the potential for false positive reactions when it is patch tested at certain concentrations. (Jacob et al 2018)