EWGʼs Flawed Methodology
EWG RATED PRODUCTS for overall safety and efficacy in sun pro- tection considering two major factors, namely the health haz- ard and the sunscreen efficacy (sun hazard). The final score (0
through 8, with 0 being the safest and most effective) is calculated by
combining those two factors roughly equally.
The health hazard of the listed ingredients, according to EWG, is
based on a review of nearly 60 standard industry, academic, and government regulatory and toxicity databases. The sun efficacy is calculated based upon four factors: 28% for the UVA protection, 28% for the
UVB protection, 28% for the UVA/UVB balance and 16% for the stability (presumably the photostability).
EWG does not conduct any actual efficacy/photostability tests on
the sunscreen products. The information is taken from the product label
regarding SPF, individual sunscreen actives and their concentrations,
computing the transmission spectrum for the combination of actives,
and using this spectrum for further calculations and ratings.
This methodology leads to the following inconsistencies:
1. EWG’s analysis of sunscreen effectiveness that is based in part on
the absorbance spectrum of each active ingredient is ignoring the role
of the delivery system, SPF/PFA boosting and photostabilizing technologies, which can significantly increase the overall UVA/UVB efficacy
and photostability parameters of the formulations.
2. EWG is evaluating the products’ balance for UVA/UVB protec-
tion and assigning arbitrarily a score based on the ratio of UVA-PF to
the labeled SPF, which is similar to COLIPA 2009 parameter, but with-
out utilizing the specific pre-irradiation step/conditions recommended
by COLIPA 2009.4 EWG is also completely ignoring UVAI/UV Ratio after
pre-irradiation—a comprehensive efficacy parameter proposed by the
FDA in 2007.5
Products that contained one of the above four factors had a final
score of not less than 3 (borderline) whereas products that contained
two or more of the above four factors cannot score better than a 7
Thus the health hazard as defined by EWG dictated the overall rating of products regardless of their sunscreen efficacy. That is misleading the consumer and as NYU’s Dr. Darrel Rigel concluded recently
“Cancer-fear mongering would lead people to not using sunscreens.
That is what the real danger is."
More importantly, the FDA should issue the
Final Monograph and the TEA of the new
UVA ingredients to restore immediate confidence to the consumer. In May, a group of
about 100 scientists and practitioners in the
field petitioned the FDA to release the Final
Monograph and the TEA. 3 The FDA has
since separated the finalization of these two
issues and, presumably, will issue the report
on the TEA ingredients this month and the
Final Monograph in October. Amen!
Sunscreen manufacturers should pay
closer attention to the barrage of criticism
that is circulating in the press, on the internet, and among consumer advocacy
groups. This includes paying specific attention to the manufacturing of sunscreen
products that are truly broad-spectrum,
photostable and offer adequate UVA and
UVB protection. They should also abandon
the race for higher and higher SPF factors
and provide sound reasoning and justification for the need for SPF products of 50+.
Finally, they should investigate the safety of
nanoparticles, oxybenzone, retinyl plami-tate and any other ingredient that is currently under scrutiny.
While segments of the EWG report have
merit, the rating system needs a major overhaul. EWG’s sweeping conclusion that sunscreens are “modern-day snake oil” is
unwarranted sensationalism and a head-line-grabbing tactic. Recommending that
consumers use only hats, shade and protective clothing as the primary methods of protection is impractical and, perhaps, unwise.
Wild claims about such serious subjects can
only lead to chaos. •
4. Matts, P.J. et al. “The COLIPA invitro UVA
method: A standard and reproducible measure of sunscreen UVA protection. J. Cosm. Sci., 2010, 32, 35-46.
COLIPA (2009) recommends pre-irradiation dose D
equal to UVAPF0 x D0 J/cm2; D0 is unit UVA dose per
unit UVAPF0, to be applied with the UV source spectrum, experimentally determined to achieve a fair correlation between in vitro UVAPF and in vivo PPD
values; D0 value is 1.2 J/cm2 UVA.
5. Fed Reg 49070-49182, August 27, 2007. FDA recommends pre-irradiation dose equal to SPF of sunscreen product multiplied by 200 J/m2-eff (an
equivalent of 1 MED) multiplied by 2/3; according to
the FDA, SPF 30 sunscreen would require pre-irradiation dose of 20 MEDs.
I would like to thank Dr. Olga Dueva-Koganov
(Integrated Botanical Technologies, formerly at
Ciba), a leading expert in the testing of sunscreen
products, for assisting me in the evaluation of
EWG’s Sunscreen efficacy methodology.