You are on page 1of 3

J AM ACAD DERMATOL Research Letters 1015

VOLUME 82, NUMBER 4

College of Medicine, Taipei Medical University, We conducted an online search of the largest
Taiwan.c online retailer, Amazon, in June 2019 to identify
the most popular sunscreens and included all
Funding sources: None.
those with at least 150 reviews. We separated
Conflicts of interest: None disclosed. these by whether they did and did not make
a claim to be ‘‘reef safe’’. We analyzed and
IRB approval status: Not applicable.
recorded the price-per-ounce cost and ingredients
Reprints not available from the authors. of each product. Products with zinc oxide or
titanium dioxide were considered to contain
Correspondence to: Yu-Chen Huang, MD, Depart-
nanoparticles unless otherwise stated. Data were
ment of Dermatology, Wan Fang Hospital, Taipei
analyzed using SPSS 25.0 software (IBM Corp,
Medical University, No. 111, Sec 3, Xinglong Rd,
Armonk, NY).
Wenshan District, Taipei City 116, Taiwan
We evaluated 97 products, with 52 (54%) labeled
E-mail: dhist2002@yahoo.com.tw as ‘‘reef safe’’. The 52 products marketed as ‘‘reef
safe’’ were analyzed to determine whether the
REFERENCES labeling reflected NOAA and legislative criteria.
1. Thappa DM, Chiramel MJ. Evolving role of immunotherapy in Fig 1 outlines the percentage of sunscreens labeled
the treatment of refractory warts. Indian Dermatol Online J. as ‘‘reef safe’’ and the proportion of compliant
2016;7:364-370.
2. Liu PT, Stenger S, Li H, et al. Toll-like receptor triggering of a
products. Table I lists the cost of each sunscreen
vitamin D-mediated human antimicrobial response. Science. type.
2006;311:1770-1773. Representative products were obtained from a
3. Osborne JE, Hutchinson PE. Vitamin D and systemic cancer: is single distributor, and the number of reviews was
this relevant to malignant melanoma? Br J Dermatol. 2002;147: used as a proxy for popularity; both are limitations
197-213.
4. Abou-Taleb DAE, Abou-Taleb HA, El-Badawy O, Ahmed AO,
of this study. Many labels failed to specify the
Thabiet Hassan AE, Awad SM. Intralesional vitamin D3 versus size of zinc or titanium dioxide particles.
intralesional purified protein derivative in treatment of We considered these as nanoparticles. This
multiple warts: a comparative clinical and immunological could have caused underestimation of NOAA
study. Dermatol Ther. 2019;32(5):e13034. compliance.
A proportion of the ‘‘reef safe’’elabeled
https://doi.org/10.1016/j.jaad.2019.10.059
sunscreens do not meet legislative (4%) or NOAA
(48%) criteria. In theory, the label should
Evaluation of ‘‘reef safe’’ sunscreens: help consumers select safe products. However, the
Labeling and cost implications for current United States Food and Drug Administration
consumers sunscreen labeling regulation lacks a formal ‘‘reef
To the Editor: In 2013, an in vitro study at the safe’’ definition, allowing companies to meet
National Oceanic and Atmospheric Administration standards of ‘‘truthful and non-misleading’’ labeling
(NOAA) identified benzophenone-2, a common without providing evidence.5 Clearly, defining ‘‘reef
chemical in sunscreen, as toxic to corals.1 Since safe’’ could resolve this issue.
then, several in vitro studies identified additional Our study suggests ‘‘reef safe’’ sunscreen—
ultraviolet filters as toxic to coral. The NOAA whether defined by label, legislative standards, or
currently cites 8 toxic sunscreen chemicals.2 NOAA criteria—may be more expensive than regular
Although these ex situ studies have been scruti- sunscreen. This substantiates concerns that sun-
nized for inaccurately reflecting reef conditions and screen bans may create an increased economic
testing chemicals at unrealistically high concentra- burden that disproportionately affects individuals
tions,3,4 they have received widespread publicity of lower socioeconomic status.
leading to legislative and marketing changes. In Although efforts to preserve reefs and improve
2019, Key West, Florida, followed Hawaii in sunscreen safety should not be ignored, the existing
banning sunscreens containing oxybenzone and literature provides insufficient evidence to conclude
octinoxate. Sunscreen brands have responded by that these sunscreen ingredients threaten reef
implementing ‘‘reef safe’’ labeling. safety.4 Future research efforts should clarify the
This study aimed to determine what proportion of impact of these sunscreen ingredients under
sunscreens labeled as ‘‘reef safe’’ met the legislative authentic reef conditions and sunscreen concentra-
ban and NOAA criteria. A secondary aim was to tions. In the meantime, it is important for legislators
determine whether ‘‘reef safe’’ sunscreens cost more to consider the public health impact of sunscreen
than regular sunscreens. bans.
1016 Research Letters J AM ACAD DERMATOL
APRIL 2020

Fig 1. The ‘‘reef safe’’ label is an unregulated term commonly used in sunscreen marketing. The
term has no strict definition. aHawaii and the Florida Keys have issued legislative bans on the use
of oxybenzone and octinoxate-containing sunscreen. bThe National Oceanic and Atmospheric
Administration (NOAA) proposes more stringent criteria for ‘‘reef safe’’ sunscreen, citing 8
sunscreen chemicals as toxic to coral: oxybenzone and octinoxate, octocrylene, benzophenone-
1, benzophenone-8, octyl-dimethyle para-aminobenzoic acid (OD-PABA), 4-methylbenzylidene
camphor, 3-benzylidene camphor, nano-titanium dioxide, and nano-zinc oxide. Sunscreens were
considered to be nano-sized unless otherwise stated on package labeling.

Table I. Cost of sunscreen according to labeling and compliance with various ‘‘reef safe’’ standards
Product type No. Average cost (95% CI) in dollars/oz P value
Products labeled as ‘‘reef safe’’ 52 3.84 (3.07-4.61) .027
Products not labeled as ‘‘reef safe’’ 45 2.61 (1.83-3.38)
Products free of oxybenzone and octinoxate 66 3.94 (3.20-4.68) \.001
Products contain oxybenzone and/or octinoxate 31 1.83 (1.43-2.24)
Products meet NOAA criteria 28 4.55 (3.96-5.13) \.001
Products do not meet NOAA criteria 69 2.75 (2.04-3.46)

CI, Confidence interval; NOAA, The National Oceanic and Atmospheric Administration.

John Tsatalis, BA, Brandon Burroway, MBA, and IRB approval status: IRB approval was not required
Fleta Bray, MD for this study.
From the Dr. Phillip Frost Department of Derma- Reprints not available from the authors.
tology and Cutaneous Surgery, University of Miami
Correspondence to: Fleta Bray, MD, Dr. Phillip
Miller School of Medicine, Miami, Florida.
Frost Department of Dermatology and Cuta-
Authors Tsatalis and Burroway contributed neous Surgery, University of Miami Miller School
equally and are cofirst authors. of Medicine, 1600 NW 10th Ave, RMSB, Room
2023-A, Miami, FL 33136
Funding sources: None.
E-mail: fleta.bray@jhsmiami.org
Conflicts of interest: None disclosed.
J AM ACAD DERMATOL Research Letters 1017
VOLUME 82, NUMBER 4

REFERENCES the literature and media focus on biotin after the FDA
1. Downs CA, Kramarsky-Winter E, Fauth JE, et al. Toxicological warning.
effects of the sunscreen UV filter, benzophenone-2, on
planulae and in vitro cells of the coral, Stylophora pistillata.
Altmetric (Altmetric, London, United Kingdom),
Ecotoxicology. 2014;23(2):175-191. a tool that measures the degree of online
2. National Ocean Service, National Oceanic and Atmospheric attention surrounding scientific research, and
Administration (NOAA). Skincare Chemicals and Coral Reefs. therefore its public dissemination, was used to
Available at: https://oceanservice.noaa.gov/news/sunscreen- find biotin-related articles (search term ‘‘biotin’’)
corals.html. Accessed August 13, 2019.
3. International Coral Reef Initiative. Action plan of the Interna-
after the FDA warning (November 28, 2017-August
tional Coral Reef Initiative (ICRI) Secretariat (2016-2018). 25, 2019). Only articles in English were chosen
Available at: https://www.icriforum.org/icri-secretariat/ for inclusion, exclusion criteria were other
current. Accessed August 13, 2019. languages, book chapters, news stories, and
4. Lim JW. Update on photoprotection: what dermatologists need data sets. These articles were analyzed for mentions
to know. Dermatol World Am Acad Dermatol; 2019. Available at:
https://aadmeetingnews.org/2019-summer-meeting-dailies/up-
of risk and the FDA warning and media attention
date-on-photoprotection-what-dermatologists-need-to-know/. reach.
Accessed August 13, 2019. The Altmetric search resulted in 119 biotin articles
5. Center for Drug Evaluation and Research. Labeling and during the study period; of these, 25 of 119 (21%)
Effectiveness Testing: Sunscreen Drug Products for cited biotin associated risks, and only 6 (5%)
Over-The-Counter Human Use—Small Entity Compliance Guide.
Rockville, MD: U.S. Food & Drug Administration; 2012.
mentioned the FDA warning (Table I). For the top
Accessed August 13, 2019. 10 impact factor journals in this group, only 2
articles mentioned the FDA warning and 4 cited
https://doi.org/10.1016/j.jaad.2019.11.001 biotin risks. Of the top 10 articles with the highest
Altmetric Attention Score, 4 mentioned risk and 2
cited the FDA warning (Fig 1). For reference,
Altmetric analysis of biotin in the highest Altmetric score of 88 corresponds to
scholarly outputs after the biotin only 17 tweets, 11 news stories, 1 blog, and
Food and Drug Administration 1 Google1 post. Of the 25 articles citing biotin risk,
warning 9 (36%) had scores of #2; these articles accounted
To the Editor: Biotin is an essential cofactor for for only a few tweets.
metabolic pathways in humans. Supplementation is Our study demonstrates that although scholarly
rarely required because adequate levels are work regarding biotin is well represented in the
consumed in average Western diets.1 A United States literature after the November 2017 FDA warning,
Food and Drug Administration (FDA) notice in only a minority of articles mentioned biotin risks
November 2017 warned that biotin supplementation and even fewer mentioned the FDA warning.
can interfere with laboratory tests and lead to Furthermore, those that cited risks/warnings were
misdiagnosis, inappropriate patient management, generally not published in high-impact journals and
and death.2 did not receive a high Altmetric score.
There is limited evidence that biotin improves Despite limited evidence that biotin supplemen-
dermatologic conditions, but it is still commonly tation improves dermatologic conditions,1 a survey-
self-prescribed by patients or recommended by based study reported that 66% of dermatologists
physicians.1 A survey-based study revealed that recommended supplementation.4 Furthermore, of
supplementation was highly prevalent among the top 1% of most reviewed biotin products on
outpatient dermatology patients despite this Amazon (November 2018), none listed the FDA
warning.3 Therefore, our objectives were to analyze warning on the label, and most of the reviews stated

Table I. Number and percentage of articles citing biotin risk (laboratory interference, missed diagnoses) and
the Food and Drug Administration (FDA) warning from November 28, 2017, to August 24, 2019*
Biotin articles Articles citing biotin risk Articles citing FDA warning
Variable No. No. Percent No. Percent
All articles 119 25 21 6 5
Top 10 Altmetric Attention Score articles 10 4 40 2 20
Top 10 impact factor journals 13 4 31 2 15

No., Number.
*Data sourced from Altmetric.com.

You might also like