Comments of the Indoor Tanning Association (ITA) and the

Comments of the Indoor Tanning Association (ITA) and the
American Suntanning Association (ASA)
March 21, 2016
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Re:
Docket No. FDA-1998-N-0880; Proposed Amendment to the Electronic Products
Performance Standard for Sunlamp Products and Ultraviolet (UV) Lamps
Intended for Use in These Products
Dear Sir/Madam:
The Indoor Tanning Association (ITA) and the American Suntanning Association
(ASA), trade associations of the indoor tanning industry, provide these comments to the Food
and Drug Administration (FDA) on the Agency’s proposed amendment to the electronic
products performance standard for sunlamp products and ultraviolet (UV) lamps intended for
use in these products. 80 Fed. Reg. 79505 (Dec. 22, 2015).
ITA and ASA members are committed to compliance with appropriate safety
standards, the provision of clear and accurate information to users and prospective users, and
the responsible use of indoor tanning products. In these comments, we focus on the following
issues: (1) the proposed recommended exposure schedule; (2) the absolute limit on UVC
irradiance; (3) the adoption of the IEC “equivalency code” system; and (4) the protective
eyewear transmittance requirements. In addition, ITA and ASA request that FDA clarify and
confirm that the requirements of any final rule will not be applied to any sunlamp products
currently in the marketplace and will not require modification or recertification of products
marketed prior to the effective date of any final rule.
ITA and ASA appreciate the opportunity to provide these comments. If you have
any questions, please contact: (1) John Overstreet, Executive Director, ITA, at 703-336-3632 , or
by email at [email protected]; and (2) Barton Bonn, President, ASA, by email at
[email protected].
Respectfully submitted,
_____________________
_____________________
John Overstreet
Executive Director
Indoor Tanning Association
Post Office Box OO
McLean, Virginia 22101
Barton Bonn
President
American Suntanning Association
P.O. Box 1907
Jackson, MI 49204
DOCKET NO. FDA-1998-N-0880
Comments of the
Indoor Tanning Association and American Suntanning Association
On FDA’s Proposed Amendment to the Electronic Products Performance Standard
for Sunlamp Products and Ultraviolet (UV) Lamps Intended for Use in These
Products
March 21, 2016
John Overstreet
Executive Director
Indoor Tanning Association
Barton Bonn
President
American Suntanning Association
Indoor Tanning Association
Post Office Box OO
McLean, Virginia 22101
American Suntanning Association
P.O. Box 1907
Jackson, MI 49204
EXECUTIVE SUMMARY
The Indoor Tanning Association (ITA) and the American Suntanning Association
(ASA) are trade associations of the indoor tanning industry, which currently employs
approximately 83,000 people in the United States. ITA and ASA are comprised of hundreds of
members, including manufacturers and distributors of sunlamp products, and indoor tanning
facility owners and operators. 1 Our members have extensive expertise and experience in the
design, manufacture, use, and operation of sunlamp products. Our members are committed to
compliance with safety standards and labeling, including the current performance standard set
forth in 21 C.F.R. § 1040.20.
ITA and ASA submit these comments on issues related to the Agency’s proposed
amendment to the electronic product performance standard for sunlamp products and
ultraviolet (UV) lamps intended for use in these products. This amendment includes revisions
to technical and labeling requirements.
ITA and ASA raise the following issues involving FDA’s proposed amendment of
the performance standard:
1. FDA’s proposal has shown a misunderstanding of the current sunlamp
products industry and the potential impact of the proposed amendments;
2. FDA should clarify that any final rule will not apply to products currently
in the marketplace, and will not require modification or recertification of
products in the market prior to the effective date of the rule;
3. ITA and ASA do not support FDA adoption of the IEC International
Standard exposure schedule;
4. The absolute limit on UVC irradiance, the IEC “equivalency code” system,
and the protective eyewear transmittance requirements present scientific
and practical concerns; and
5. FDA should delete proposed § 1040.20(h), which refers to medical device
classification under 21 C.F.R. § 878.4635, because it is not a proper
subject for inclusion in an electronic product performance standard
issued under 21 C.F.R. Part 1040.
1The
ITA and ASA members are listed in Exhibit A.
i
INTRODUCTION
Sunlamp products are regulated extensively under the Electronic Product
Radiation Control provisions of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §§
360hh-360ss, and implementing regulations, 21 C.F.R. Parts 1002-1010 and § 1040.20. These
regulations specify requirements for initial product reports, annual reports, test records,
distribution records, product performance standards, protective eyewear, timer systems, and
specified labeling statements. The performance standard at 21 C.F.R. § 1040.20 that applies to
sunlamp products and UV lamps intended for use in sunlamp products was originally published
in November 1979. 2 In September 1985, FDA amended § 1040.20 and made it applicable to all
sunlamp products and UV lamps intended for use in sunlamp products manufactured on or
after September 8, 1986. 3 FDA has not amended the performance standard since 1985.
On February 9, 1999, FDA published an Advance Notice of Proposed Rulemaking
(ANPR) concerning specific amendments to the sunlamp products performance standard. 4 FDA
presented its recommendations for amendments to the performance standard to the Technical
Electronic Product Radiation Safety Standards Committee (TEPRSSC) in June 2000. 5 In
response to the meeting, FDA held a two-day public meeting in February 2002 to solicit input
from affected parties on the possible performance standard amendments. 6 In October 2003,
FDA presented six amendments to TEPRSSC, which approved all six amendments with two
modifications. 7
FDA also regulates sunlamp products as class II medical devices (special
controls). Sunlamp products are subject to the FDCA’s general controls for medical devices,
which include requirements related to establishment registration, product listing, good
manufacturing practices, adverse event reporting, and labeling.
On December 22, 2015, FDA issued two proposed rules concerning the sunlamp
products industry. ITA and ASA submit these comments to FDA on issues related to the
proposed amendment to the electronic product performance standard, including technical and
labeling requirements. 8 ITA and ASA are submitting separate comments to address the
proposed rule concerning restrictions on the sale, distribution, and use of sunlamp products. 9
244
Fed. Reg. 65352 (Nov. 9, 1979).
350
Fed. Reg. 36548 (Sept. 6, 1985).
464
Fed. Reg. 6288 (Feb. 9, 1999).
580
Fed. Reg. 79505, 79508 (Dec. 22, 2015).
6Id.
7Id.
880
Fed. Reg. at 79505.
980
Fed. Reg. 79493 (Dec. 22, 2015). FDA regulates sunlamp products for tanning as Class II medical
devices subject to 510(k) notification and special controls under 21 C.F.R. § 878.4635.
ii
Table of Contents
EXECUTIVE SUMMARY................................................................................................................. i
INTRODUCTION............................................................................................................................ ii
I.
FDA Has a Fundamental Misunderstanding of the Current Sunlamp Products
Industry................................................................................................................................1
II.
FDA Should Clarify That the Final Rule Does Not Apply to Products in the
Marketplace Prior to the Effective Date of Any Final Rule. ............................................... 2
III.
ITA and ASA Comments on Specific Provisions of the Proposed Rule Regarding
Sunlamp Products............................................................................................................... 4
A.
Proposed § 1040.20(c)(1) - UVC Irradiance ........................................................... 4
B.
Proposed § 1040.20(c)(2)(ii) - Maximum Timer Interval ...................................... 5
C.
Proposed § 1040.20(d)(1)(iv) - Manufacturer’s Recommended Exposure
Schedule .................................................................................................................. 5
D.
Proposed § 1040.20(d)(1)(vi) and § 1040.20(d)(2)(ii) - Equivalency
Codes ....................................................................................................................... 7
E.
Proposed § 1040.20(e) - User Information Requirements .................................... 8
IV.
FDA Should Not Modify the Protective Eyewear Transmittance Requirements. .............. 8
V.
The Sunlamp Performance Standard Should Not Refer to the Classification of
Sunlamp Products as a Medical Device. ............................................................................. 9
VI.
Exhibit A
VII.
Exhibit B
VIII.
Exhibit C
iii
I.
FDA Has a Fundamental Misunderstanding of the Current Sunlamp
Products Industry.
The preambles to the two proposed rules and FDA’s required economic analyses10
reveal the Agency’s fundamental misunderstanding of the current sunlamp products industry.
FDA’s understanding is based on an August 2011 report published by the Eastern
Research Group (ERG) entitled, “Cost Analysis of Performance Standards” (ERG Report).
Reliance on the ERG Report has led FDA to mischaracterize the industry’s size and profitability.
The following chart depicts FDA’s inaccurate representation of the sunlamp products industry:
Category
Number of Indoor Tanning
Salons (3+ tanning units)
Number of “Other Facilities”
(1-2 tanning units)
Number of Tanning Units in
Operation
Number of Tanning Units
Produced Annually
Monetary Size of U.S.
Tanning Industry
FDA Estimate
18,000-19,000
ITA/ASA Estimate
9,50011
15,000-20,000
10,00012
257,000
110,00013
26,000
4,50014
$2.7 billion
$0.85 billion15
For several reasons, the sunlamp products industry has contracted rapidly over
the past six years. This contraction is not captured in the ERG Report or FDA’s narrative in the
preambles to the proposed rules. For example, in 2010, the Affordable Care Act (ACA) imposed
10Executive
Order 12866 requires that agencies promulgating “rules” or “regulations” to, among other
things, “tailor its regulations to impose the least burden on society, including individuals, businesses of
differing sizes, and other entities…, consistent with obtaining regulatory objectives, taking into
account…the costs of cumulative regulations.” See Exec. Order No. 12866, 58 Fed. Reg. 51735 (Oct. 4,
1993). The Regulatory Flexibility Act also requires agencies to analyze regulatory options that would
“minimize any significant impact of a rule on small entities.” See 80 Fed. Reg. at 79498.
11This
estimate is based on reviewing the two industry trade magazines (Smart Tan and Island Sun
Times) and surveying the largest distributors and producers of sunlamp products regarding customer and
prospective customer lists. These businesses have tracked the number of salons for well over 10 years
and have seen a substantial decline over the last six years.
12Id.
13We
calculated this estimate by adding 9,500 salon establishments averaging 10 units per location
(95,000) to 10,000 “other establishments” averaging 1.5 units per location (15,000).
14We
determined this estimate by directly contacting: (1) indoor tanning bed manufacturers that sell units
in the United States, and (2) the lamp manufacturers that sell the lamps for those beds to manufacturers.
FDA can actually confirm our estimate, since all manufacturers must disclose in their annual report
submitted to FDA exactly how many tanning units were produced.
15We
determined this estimate by analyzing the 10% tan tax. The Federal Government collected
$85,oo0,000 in 2015 from tanning establishments. Since that tax represents 10%, one can calculate that
there was $850,000,000 in UV tanning services sold in the United States.
1
a 10% excise tax on individuals receiving indoor tanning services. 16 Payable quarterly starting
on July 1, 2010, the levy was originally expected to raise $2.7 billion over 10 years but is now
projected to raise about one-third of that amount. 17 One of the main reasons for the decline in
projected “tan tax” revenues is that the tax and other factors have eliminated approximately
one-half of the indoor tanning salons. Since 2010, nearly 10,000 indoor tanning salons have
closed -- resulting in a loss of approximately 81,000 jobs and the loss of nearly two-thirds of the
industry’s $2.7 billion in annual revenues.
Another material factor contributing to the sunlamp product industry’s decline
over the past five years is FDA’s uncritical acceptance of and regulatory reliance on the highly
questionable 2006 International Agency for Research on Cancer (“IARC”) Report, which alleges
that UV exposure by individuals under age 35 is linked to higher rates of melanoma as compared
to a similar cohort of individuals who had not used sunlamp products. 18 As discussed in our
simultaneous submission to Docket No. FDA-2015-N-1765, the IARC Report has been
superseded and discredited by subsequent scientific studies.
Given the substantial changes that have re-shaped the sunlamp products industry
since the 2003 TEPRSSC meeting and the 2011 ERG Report, we request that FDA hold a public
meeting before finalizing any rule concerning an amendment to the sunlamp products
performance standard. This meeting should permit the submission and consideration of both
new scientific literature and new information concerning the size and profitability of the
industry. Further, before finalizing any rule, FDA should perform new economic analyses that
appropriately consider the sunlamp products industry’s current size and profitability.
II.
FDA Should Clarify That the Final Rule Does Not Apply to Products in the
Marketplace Prior to the Effective Date of Any Final Rule.
In the preamble of the proposed rule and the required economic analyses, FDA
does not address the rule’s impact on products now in the marketplace. This silence must be
interpreted to permit already-marketed products that meet the current performance standard to
remain in the market after the new performance standard becomes effective, and not to require
modifications of products in the market prior to the effective date of any amendments to the
standard. This would be consistent with FDA’s approach the last time it amended the
performance standard in 1985, when the Agency made the amendment applicable only to
“products manufactured on or after September 8, 1986.” 19
In proposed § 1040.20(a), FDA states: “The provisions of this section, as
amended, are applicable to all sunlamp products and ultraviolet lamps intended for use in
sunlamp products not later than [A DATE WILL BE ADDED 1 YEAR AFTER DATE OF
PUBLICATION OF A FUTURE RULE IN THE FEDERAL REGISTER].” We request that the
Agency revise this statement to mirror the language utilized in the 1985 amendment, and clarify
that any final rule will apply only to those products manufactured after the effective date of the
16Patient
Protection and Affordable Care Act, Pub. L. No. 111-148, § 10907, 124 Stat. 119, 1020-1021
(2010).
Ellis, Tanning Salons Burned by Health Care Bill, CNN Money (March 24, 2010), available at
http://money.cnn.com/2010/03/24/news/economy/tanning_tax/.
17Blake
1880
19
Fed. Reg. at 79496.
21 C.F.R. § 1040.20(a)(1).
2
regulation. We believe this clarification is especially important because the performance
standard is incorporated by reference into 21 C.F.R. § 878.4635(c), which regulates sunlamp
products under the medical device provisions of the FDCA.
This view is also consistent with the FDA economic impact analyses that were
required in connection with the two proposed rules, which do not discuss retroactive compliance
or take into account any costs associated with modification and/or recertification of alreadymarketed equipment. 20 Any different approach would necessitate a new or amended
rulemaking, because the Agency would be reversing course if it were to require all existing
sunlamp products to comply with an amended performance standard. 21 FDA would also have to
conduct a new economic impact analysis calculating the costs of requiring existing equipment to
be brought into compliance with the amended performance standard.
The costs required to bring existing equipment into compliance with the
amended performance standard would be substantial. For equipment currently being produced,
a manufacturer would be responsible for: (1) opening an Electrical Testing
Laboratory/Underwriters Laboratory (ETL/UL) report 22 ($1000-$2500); (2) performing
spectral analysis with ETL/UL witness testing ($10,000/session); (3) creating a new irradiance
report, which permits a manufacturer to create a new owner’s manual and new exposure
schedule label; (4) submitting a “supplemental report” to FDA for each model; (5) submitting all
documentation to ETL/UL to receive the Authorization to Mark (ATM); (6) purchasing new
owner’s manuals and exposure labels; and (7) updating certification/identification, if needed.
Customers of existing equipment may have to hire a manufacturer representative to travel to
location and update all labeling, manuals, and certification/identification labeling, if required.
If an indoor tanning operator has equipment from multiple manufacturers, then the operator
would have to pay each manufacturer in order to come into compliance.
For a discontinued model produced by a manufacturer still in business, the
manufacturer would have to decide if there are enough discontinued models in the marketplace
to justify recertifying the units. If the manufacturer determines that there are not enough
models to justify recertifying the units, then the customer would bear the entire cost of
recertification. We estimate that recertification costs would cost the customer, at a minimum,
approximately $14,000 per model.
Indeed, FDA states in the proposed rule’s economic analysis that “manufacturers would receive
adequate notice to exhaust existing [warning] label stock.” See FDA, “Preliminary Regulatory Impact
Analysis, Initial Regulatory Flexibility Analysis, Unfunded Mandates Reform Act Analysis” at 27, Docket
No. FDA-1998-N-0880 (Dec. 2015).
20
Allina Health Servs. v. Sebelius, 746 F.3d 1102 (D.C. Cir. 2014) (vacating final rule because it was not a
“logical outgrowth” of the proposed rule).
21
Before the paperwork concerning a sunlamp product is submitted to FDA for final approval, ETL/UL
visits the manufacturing site, inspects the product, and gives the product a “Listed Mark.” The ETL/UL
Listed Mark is proof of the product’s compliance (electrical and other safety standards) with North
American safety standards. This certification mark indicates that: (1) the product has been tested and has
met the minimum requirements of a widely-recognized U.S. product safety standard; (2) the
manufacturing site has been audited; and (3) the applicant has agreed to a program of periodic, follow-up
factory inspections to verify continued performance. The company that pays for the Listed Mark owns the
mark for that product(s). If anything on the sunlamp product (lamps, ballasts, timer, and label) is
changed or altered, the Listed Mark is void and a new ELT/UL Mark is required.
22
3
Additionally, required recertification would have serious implications for
customers with existing equipment where the manufacturer is no longer in business. We are
aware of approximately 52 manufacturers and importers in the United States that are no longer
in business (Exhibit B). A sunbed can have a lifespan of 20 or more years, and the vast
majority of the estimated 110,000 units in operation in the United States were either
manufactured by a company that is now out of business or are a model that is no longer
produced. Again, the customer would have to bear the entire cost of recertification. A customer
could instead choose to purchase new equipment; however, this would come at a cost of
$10,000-$40,000 per bed. In the preamble to the proposed rule, FDA even acknowledges that
purchasing a new sunlamp product is the “less expensive alternative” to recertifying an existing
product. 23 Indoor tanning operators may be faced with the proposition of purchasing all new
sunlamp products, which could effectively put these small businesses out of business.
For these reasons, FDA should amend proposed § 1040.20(a) to read as follows:
“The provisions of this section, as amended, are applicable to all sunlamp products and
ultraviolet lamps intended for use in sunlamp products manufactured on or after [A DATE
WILL BE ADDED 1 YEAR AFTER DATE OF PUBLICATION OF A FUTURE RULE IN THE
FEDERAL REGISTER].”
In addition, FDA should clarify and confirm in the preamble of any final rule
amending the performance standard that new 510(k) submissions for currently marketed
products are not required under the amended performance standard. When the Agency
incorporated by reference the performance standard into the device classification regulation for
sunlamp products, the Agency stated that if the performance standard were amended
“manufacturers would not need to submit a new 510(k) unless there are significant changes to
the device that trigger the need for a new 510(k) submission….” 24 FDA should confirm that the
proposed amendments to the performance standard do not constitute “significant changes” that
would trigger new 510(k) submissions.
III.
ITA and ASA Comments on Specific Provisions of the Proposed Rule
Regarding Sunlamp Products.
A fuller discussion of the current scientific literature to support our comments on
specific provisions of the proposed rule is included in Exhibit C to these comments.
A.
Proposed § 1040.20(c)(1) - UVC Irradiance
Proposed § 1040.20(c)(1) would set the irradiance limit for UVC radiation (200290 nm) at 0.03 Watts/meter2 (W/m2) measured at the shortest recommended exposure
distance from the sunlamp product.
80 Fed. Reg. at 79515. The proposed rule does not discuss the mandatory recertification/modification
of existing products. The proposed rule states that if a customer decides to modify an existing product,
then that customer becomes a manufacturer if the modification affects any aspect of the product’s
performance or intended function(s). See proposed § 1040.20(g). Under this particular situation, the
product would require recertifying. Id.
23
2479
Fed. Reg. 31205, 31208 (June. 2, 2014).
4
Because this limit is beyond the capability of being accurately measured in the
field, enforcement of the proposed UVC limit would be virtually impossible. In addition, if
manufacturers were held to this standard, it would require purchase of new, highly specialized
and expensive equipment adding additional costs to the manufacturing process. Europe
previously considered adopting this irradiance limit, but the proposal was ultimately rejected
because of the impracticality of measuring such extremely low light levels.
The existing allowable level of UVC in 21 C.F.R. § 1040.20(c)(1) offers a safe
exposure environment and poses no issues when the human body is exposed to that level.
B.
Proposed § 1040.20(c)(2)(ii) - Maximum Timer Interval
We support the proposed change of the UV dose measuring method from the CIE
LYTLE action spectrum currently used by FDA to the CIE Reference Action Spectrum for
Erythema used by the IEC. As stated in the preamble, the CIE Reference Action Spectrum is
universally accepted. 25
We also support the proposed change of the current maximum timer interval
dose of 624 J/m2 (CIE LYTLE action spectrum) to 500 J/m2 (CIE erythemal action spectrum),
for the reasons set forth by FDA in the preamble. 26
These proposals offer a uniform way to measure UV doses and are scientifically
sound. We therefore support adoption of these proposals by FDA.
C.
Proposed § 1040.20(d)(1)(iv) - Manufacturer’s Recommended
Exposure Schedule
Proposed § 1040.20(d)(1)(iv) provides that the manufacturer’s recommended
exposure schedule must be developed in accordance with Annex DD of IEC 60335-2-27, Ed. 5.0,
which Annex DD would be incorporated by reference into the amended performance standard.
The proposed rule also provides four specific exceptions to this Annex DD requirement, listed in
proposed paragraphs (A) through (D).
We believe FDA’s decision to adopt the IEC’s recommended exposure schedule is
based on an incorrect scientific analysis. FDA claims that the Annex DD parameters are “based
on current science, including recent human research conducted at FDA.” 27 Yet FDA has
acknowledged the limitations of current scientific studies: “Epidemiological studies of the
effects of UV radiation on incidence of cancer and other health problems are complicated by
latency between exposure and disease, difficulty controlling for environmental exposure to UV
radiation, and other factors.” 28
In 1986, FDA issued a policy letter to industry entitled, “Policy on Maximum
Timer Interval and Exposure Schedule for Sunlamp Products” (Aug. 21, 1986) (1986 Policy
Letter). This document explained the criteria FDA uses to evaluate the adequacy of the exposure
schedule and the recommended maximum exposure time for sunlamp products. The 1986
2580
Fed. Reg. at 79510.
26Id.
27Id.
at 79511.
28Id.
at 79506.
5
Policy Letter continues to reflect the current state of science and should remain the Agency’s
position on the recommended exposure schedule. The parameters in Annex DD to IEC 603352-27, Ed. 5.0, are different from those provided in the 1986 FDA Policy Letter. Therefore, FDA
should not adopt this proposal with respect to Annex DD.
Proposed § 1040.20(d)(1)(iv)(A) provides that the maximum single dose should
be 500 J/m2 , and not 624 J/m2 as stated in Annex DD. We support this proposal.
Proposed § 1040.20(d)(1)(iv)(B) addresses the maximum number of exposures
per year. FDA proposes that this should be based on a maximum yearly dose of 15 kJ/m2 ,
weighted according to the erythema action spectrum in figure 103 of IEC 60335-2-27, Ed. 5.0.
Although there is some scientific evidence that squamous cell carcinoma (SCC) is associated
with large amounts of cumulative lifetime sun exposure, the few studies on the subject indicate
that the threshold for any significant risk of SCC is 20,000 hours of lifetime sun exposure
(Kennedy 2003) 29. Indoor tanning might add some marginal amount to the risk of SCC, at least
theoretically, but with 30 annual sessions (the average in the industry) and each session being
equivalent to approximately 20 minutes of sun exposure, the total lifetime UV exposure from
indoor tanning of 150 hours (10 hours per year for 15 years of indoor tanning) is insignificant in
comparison with the 20,000 hours associated with the threshold for SCC risk. 30
It is our understanding that FDA’s proposed recommendation of an annual limit
is based on an assumption by the IEC many years ago that indoor tanning should not provide
more UV exposure per year than a Dutch indoor worker receives annually from the sun. This
arbitrary assumption of the IEC provides no scientific basis for the proposed rule. The study
cited by FDA as supporting FDA’s view that a tan can be maintained on a year-round basis with
an annual dose of 15 kJ/m2 examined only pigmentation and made no investigation of
epidermal thickening, an essential element of a tan, and thus also does not provide any scientific
basis for the proposed rule. In summary, there is no scientific basis for a recommended annual
limit of 15 kJ/m2 , or for a recommendation of a maximum number of annual exposures. For
this reason, we recommend that FDA not adopt proposed § 1040.20(d)(1)(iv)(B).
Proposed § 1040.20(d)(1)(iv)(C) would provide that the manufacturer’s
recommended exposure schedule must include the following statement: “Maximum sessions
per week =2.” Annex DD, however, does not recommend a maximum of two session per week.
FDA has failed to justify this proposed departure from existing recommendations, and there is
no scientific basis for FDA’s proposed recommendation. Indeed, existing scientific publications
29Kennedy
C, Bajdik CD, Willemze R, de Gruijl FR, Bavinck JNB. The Influence of Painful Sunburns and
Lifetime Sun Exposure on the Risk of Actinic Keratoses, Seborrheic Warts, Melanocytic nevi, Atypical
Nevi, and Skin Cancer. J Invest Dermatol 2003; 120:1087-1093.
30Tierney
et al. 2015 calculated, using a theoretical equation, that a median amount of indoor UV
exposure (176 SED/year) for 15 years would increase the risk of SCC for a person age 55 in the
Netherlands by 90%. Close examination of Tierney et al. 2015, however, reveals that the same equation
shows that incidence of SCC for a person age 55 in the Netherlands is 0.004 per 100,000 as compared to
25 per 100,000 for the Dutch population as a whole, so the increased risk of SCC at age 55 resulting from
15 years of indoor UV exposure is insignificant. See Tierney P, de Gruijl FR, Ibbotson S, Moseley H.
Predicted increased risk of squamous cell carcinoma induction associated with sunbed exposure habits. Br
J Dermatol 2015; 173:201-208.
6
would recommend the opposite of FDA’s proposal: for a given UV dose, a user should receive
that dose as quickly as possible without burning (De Gruijl 1983) 31.
Proposed § 1040.20(d)(1)(iv)(D) sets forth an “Example Schedule.” FDA
recommends 48 hours as the minimum time between exposures. We believe there is a scientific
basis for waiting 48 hours after the first indoor tanning session for a completely untanned
person before having the second session (Arbabi 1983) 32. The existing science would probably
also support 48 hours between the second and third sessions, and even between the third and
fourth sessions. After this, however, the science shows that, for a given dose of UV, the risk of
skin cancer would be reduced by receiving that dose as quickly as possible without burning (De
Gruijl 1983). FDA’s current recommended exposure schedule in the 1986 Policy Letter calls for
three sessions the first week, three sessions the second week, four sessions the third week, and
five sessions the fourth week. There is no scientific reason to change the current exposure
schedule set forth in the 1986 Policy Letter, because it remains consistent with the current
scientific evidence.
This “Example Schedule” also includes the statement: “Maximum tanning
courses per year = 6.” In conjunction with the exposure schedule, FDA proposes to add a
definition of “tanning course” to the performance standard. FDA states that, in the context of
the exposure schedule, “tanning course” means the “period of time over which a tan is
developed, starting with the first short exposure and building up to longer exposures over time,
usually requiring a period of 3 to 4 weeks.” It is not clear how FDA arrived at this definition,
including the 3 to 4 week time period. Any final rule should fully explain the current science
relied upon for the calculation of the 3 to 4 week time period.
D.
Proposed § 1040.20(d)(1)(vi) and § 1040.20(d)(2)(ii) - Equivalency
Codes
FDA proposes to adopt the IEC’s “equivalency code” system. In doing so, FDA is
proposing to incorporate by reference Annex CC of IEC 60335-2-27, Ed. 5.0.
Proposed § 1040.20(d)(1)(vi) would require the label of all sunlamp products to
indicate the equivalency code range of the UV lamp to be used in the sunlamp product.
Proposed § 1040.20(d)(2)(ii) would require the label of each UV lamp to indicate its UV lamp
equivalency code.
The industry objects to the use of the “Y” value in the “equivalency code” system,
as there is no clear photobiological or safety reasons for the “Y” value’s use. The “Y” value is the
ratio of the nonmelanoma skin cancer (NMSC) effective UV irradiance ≤ 320 nm and >320 nm.
31De
Gruijl FR, Van Der Meer, JB, Van Der Leun JC. Dose-Time Dependency of Tumor Formation by
Chronic UV Exposure. Photochem Photobiol 1983; 37:53-62.
32This
study showed that a single 0.75 MED irradiation of untanned Type II skin: (1) lowers the threshold
for erythema from a second irradiation for a period of approximately 48 hours after the first irradiation,
and (2) raises the threshold for erythema from a second irradiation approximately four days after the first
irradiation for UVB. The photoprotection from the single 0.75 MED irradiation four days later was
approximately 10% for UVB. However, the study did not determine the amount of the lowering or raising
of the threshold for erythema resulting from a second, third, fourth, fifth, sixth, etc. exposure on the same
patch of skin. See Arbabi L, Gange, RW, Parrish JA. Recovery of Skin from a Single Suberythemal Dose
of Ultraviolet Radiation. J Invest Dermatol 1983; 81:78-82.
7
In addition to having no photobiological significance, this value does not inform
the consumer of any information related to the safety or effectiveness of the sunlamp product or
the UV lamp.
The use of additional codes or values can only lead to confusion and
misunderstanding at the salon level. The use of an “X” code will satisfy all safety needs and
create minimal confusion. Therefore, we recommend that FDA not adopt these proposals.
E.
Proposed § 1040.20(e) - User Information Requirements
Under FDA’s current regulations in 21 C.F.R. § 1040.20(e)(1)(iv), a sunlamp
product users’ instructions must contain instructions for determining the exposure schedule for
persons according to skin type. “Skin type” refers to the historical Fitzpatrick skin typing system
developed in 1975 by dermatologist Thomas Fitzpatrick to predict skin categorization. Under
this system, Skin Type I is the fairest and most sensitive while Skin Type VI is the darkest and
least sensitive to UV radiation. The 1986 Policy Letter calls for exposure schedules to be
differentiated by skin type.
In the proposed rule, however, FDA claims that the same UV dose can be used to
develop and maintain a tan for Skin Types II, III and IV. 33 The Agency states that this was
confirmed in clinical studies performed at FDA. 34 FDA’s study, however, only examined
pigmentation, not epidermal thickening. Each skin type, including Skin Types II, III and IV,
should continue to have specific recommended exposure schedules in accordance with the
widely recognized Fitzpatrick system.
Accordingly, FDA should not adopt this proposal and instead should retain the
approach in the 1986 Policy Letter for exposure schedules to be differentiated by Skin Type.
IV.
FDA Should Not Modify the Protective Eyewear Transmittance
Requirements.
Proposed § 1040.20(c)(4)(ii) addresses protective eyewear and spectral
transmittance to the eye. FDA proposes to adopt the limit of 5 percent on the visible
transmittance in the range of 400-550 nm (and 10 percent in the range of 550-1,000,000 nm)
which must be measured in accordance with clause 32.102 of IEC 60335-2-27:2009, Ed. 5.
Blocking an increased range of visible light could potentially put the indoor
tanning user at risk. Users have the opportunity to read the warning label on all sunlamp
product equipment prior to initiating a tanning session. Protective eyewear should be able to
transmit sufficient visible light in order to read the warning label or interact with any technical
adjustments while the session is underway without risking direct UV exposure to the eyes.
Sunlamp products have a number of features that can be adjusted during the tanning session in
addition to terminating the session (intensity, cooling fan, music, and aroma). If the indoor
tanning user cannot see adequately, the customer may remove the protective eyewear to make
these adjustments.
3380
Fed. Reg. at 79511.
34Id.,
citing Miller, S., Coelho, S., Miller, S., et al., “Evidence for a New Paradigm for Ultraviolet Exposure:
A Universal Schedule that is Skin Phototype Independent.” Photodermatology, Photoimmunology &
Photomedicine, 28:187-195 (2012).
8
The current protective eyewear transmittance requirements in § 1040.20(c)(4)(ii)
maintain sufficient visibility in order to terminate the tanning session or to make adjustments to
intensity, cooling fan, music, and aroma. According to the Centers for Disease Control and
Prevention (CDC), there are no studies that show eye injuries occur when eyewear is used
properly. 35 More likely, injuries occur when the user selects not to wear eye protection. The
current performance standard adequately provides for user safety. Measurements and testing
procedures based on existing standards demonstrate that the amount of UV radiation permitted
through protective eyewear is not harmful.
Accordingly, FDA should not adopt this proposed change.
V.
The Sunlamp Performance Standard Should Not Refer to the Classification
of Sunlamp Products as a Medical Device.
Proposed § 1040.20(h) states: “Sunlamp products and ultraviolet lamps
intended for use in sunlamp products are subject to special controls and restrictions on sale,
distribution, and use as set forth in § 878.4635 of this chapter.”
This proposed section should be deleted prior to finalizing any amended
performance standard. It is not appropriate to refer to a medical device regulations in an
electronic product performance standard. A performance standard issued under FDCA §
534(a)(1) (21 U.S.C. 360kk(a)) is limited in scope to requirements “to control the emission of
electronic product radiation.” FDA is exceeding this limited scope in referencing or proposing
to incorporate in the amended performance standard all of the elements of the medical device
classification regulation. Accordingly, we request that FDA delete proposed § 1040.20(h).
35This
is based on email communications with Anita Blankenship of CDC.
9
Exhibit A
ITA and ASA Membership Lists
ITA and ASA Membership Lists
ITA Membership
A Cut Above
All Hours Distribution
Aloha Tan
Aloha Tan, Inc.
Audio Video Media
Bare Necessities Tanning Salon & Day Spa
Belle Fiole Tanning & Spa
Bloom Again European Tanning
Bloom Again Tanning & Vacation/Resort Wear
Bodicare Cosmetics
Body By Design
Body Heat Tanning
BodyBing Tanning
California Tan
Carolina Tan Factory
Club Tan
Coconut Tan
Dreamland Tanning
EJ's Tanning Salon
Electric Sun
Electric Sun Equipment And Supplies
Express Tan, Inc.
Eye Pro, Inc.
Flip Flop Cove Tanning, LLC
Full Throttle Salon
Glo Sun Spa
GoldenSun Tan
Great Tan - Castro
Great Tan - Union
Hawaiian TanFastic
Heartland Tanning Supply
House of Tans
Infusion Tanning
Instatan
Insurtec, Inc
Intelladon
Interlectric Corp
Island Sun Times, Inc.
Island Tanz
Island Tropics Tanning Salon
J. Wagner GmbH
Jill's Beach
Key West Tan
Kool Tan
Light Sources Inc
Lion in the Sun
Malibu Tan, Inc.
Max Tan
Mega Tan
MR International, LLC
Nails by Becky
New Sunshine, Australian Gold, ETS, Helios, Design
Nichesoft, LLC
No Sand Tan Ohio
Oasis Tans
On Track Tanning
Plumeria Spa LLC
Portofino Spas LLC
Power Group Company
Premier Tanning
Private Islands Tanning Salon LLC
ProSun International
R&R Insurance Services
Salon Owner / Taxpayer / Citizen
Shine On Tanning, LLC
Signatures Salon & Day Spa
SOLAR ESCAPE TANNING
Solar Tan
Solartech Inc.
Soleil Tan Spas
Sperti Sunlamp
Suds
Sun City Salon Inc.
Sun Connection
Sun Dial Tanning
Sun Factory Tanning Inc.
Sun Spot Atlantis
Sun Spot Tanning
Sun Spot Tanning Salon
Sun-Kissed Tanning Salon
SunRayz Tannery & Salon
Suns of Intanity, Inc.
Sunsational Tan (PA)
SunSations Tanning Salon, LLC
Suntan Seekers
Suntan Supply
Superior UV Technologies
Supra Brands Group
Supre Inc.
Tahiti Tan
Tan Incorporated
Tan 'N Tone
Tan Seekers
Tan This Inc
Tan Zone
Tanlines Salon LLC
Tanning Bed Inc.
Tanning Oasis
Tanning Salon
2
Tanning World Of Lewisburg
Tanorama Inc.
Tanpro
The Bronzing Station
The Daniel and Henry Company
The Sun Club
The Sunshine Factory
The Tanning Studio
Time Out
TNG Worldwide
T-N-T Tanning Salon
Tropical Sunsations
Twilight Teeth, Inc.
Ultraviolet Resources Int'l
Verve Tanning
WayTooTan, Inc.
Xclusive Tan
Year Round Brown
ASA Membership
Palm Beach Tan
Sun Tan City
Celsius Franchising
Larry Paul Tanning Spa
Club Tan
Portofino Sun Center
Tan ’N Tone
Body Perfect Tanning Salon
iTan Franchising
Tanning Oasis
Four Seasons Tanning Salon
Beaches Salon
Beach Bum Tanning
Tommy’s Tanning, Inc.
Bodies in Heat
Classic Tan
Laundry & Tan Connection
Zoom Tan LLC
Sol Spa Tan
Celebrity Tanning
Solar Dimensions
Sun Seekers By Rosie
Total Tan
South Beach Tans
Beach Body Tanning
3
Exhibit B
Manufacturers and Importers No Longer in Business in the United States
Manufacturers and Importers No Longer in Business in the United States
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
31.
32.
33.
34.
35.
36.
37.
38.
39.
40.
41.
42.
43.
44.
45.
46.
47.
48.
49.
50.
51.
52.
A.C.N
Alisun
American Quality
American Wolff
Bermuda Triangle
Dr. Kern
Dr. Muller
Electric Sun
European Tanning Systems (ETS)
Eurotan
Forever Tan
GardaSun
Hollywood Tan
ISM
Klafsun
Klaus
Magnum Sun
Mega Sun
Meritan
Montego Bay
Palm Spring
Peacock
Phoenix Sun
Power Sun
Pure Tan
Royal Sun
SCA
Shaw
Silver Solarium
Solaire
Solana
Solar Pacific
Soleil Systems
Sonnenbraune
Sontegra
Sportarredo
Summaria Sun
Sun Dash
Sunal
Sunbronze
Sunfit
Sunliner
Sunmaster
Sunsource
Tan America
Tan Body
Tan Seeker
Tans You
Ultra Bronze
USA Tan
Vita Sun
Zanders
Exhibit C
STATEMENT OF THE SCIENCE
SUNLAMP PRODUCTS AND SKIN CANCER
STATEMENT OF THE SCIENCE
SUNLAMP PRODUCTS AND SKIN CANCER
Re:
Docket No. FDA-1998-N-0880
Proposed Rule for Amendment to Electronic Performance Standard
Submitted by:
Indoor Tanning Association
Post Office Box OO
McLean, Virginia 22101
American Suntanning Association
PO Box 1907
Jackson, MI 49204
Date:
March 21, 2016
1. Introduction
There are known health benefits of sun exposure, but overexposure can increase the risk
of skin cancer. With respect to melanoma, the relationship with UV radiation is not
straightforward. Sunburns have been associated with a doubling of risk, while chronic sun
exposure has been associated with reduced risk [Ref. 1]. For example, research shows
melanoma cases are less frequent in outdoor workers than indoor workers [Ref. 2]. Squamous
cell carcinoma (SCC) risk is also doubled by sunburns [Ref. 3] but, unlike melanoma, chronic
sun exposure of very high lifetime amounts has been associated with increased risk of SCC [Ref.
4].
Lamps in indoor tanning equipment replicate sun-based UV radiation. FDA’s current
exposure guidelines as set forth in the 1986 policy letter entitled, “Policy on Maximum Timer
Interval and Exposure Schedule for Sunlamp Products,” are designed to prevent burning. We
are not aware of any evidence that a person who has followed FDA’s guidelines has been burned.
However, consumers who use sunlamp products at home in an unregulated setting may or may
not follow the exposure schedule or even limit themselves to the maximum timer interval.
Approximately 25% of indoor tanning occurs at home or in other unregulated settings [Ref. 5].
Studies that have segregated data from home use and tanning salon use have found little risk of
melanoma from tanning salons and high risk of melanoma from home use [Refs. 6-8]. Overall,
the most recent and most comprehensive meta-analysis [Ref. 9] found a combined risk of
melanoma from home use and tanning salon use of 16%, with most of the risk coming from
home use.
Cumulative, lifetime, nonburning UV exposure has been associated with SCC, but the
limited studies on the subject indicate that SCC is associated with 20,000 to 50,000 lifetime
hours of sun exposure [Ref. 4]. Indoor tanning adds some amount to the risk of SCC, at least
theoretically, but with 30 annual sessions and each session being equivalent to approximately
20 minutes of sun exposure, the total lifetime UV exposure from indoor tanning of 150 hours (10
hours per year for 15 years of indoor tanning) is insignificant in comparison with the 20,000
hours associated with the threshold for SCC risk.1
The purpose of indoor tanning is to receive a tan. A good tan provides significant
protection against subsequent sunburn. The protection is provided by increased pigmentation
and thickening of the epidermis [Refs. 16, 17, 22]. It is common knowledge that a tanned person
is much less likely to get burned outdoors than a non-tanned person. Scientific studies show
that a moderate dose of UV, such as that received from a tanning bed operated in accordance
with current FDA guidelines, produces a moderate tan with an SPF of 3 or 4 [Ref. 10]. This
Tierney et al. 2015 [Ref. 11] calculated, using a theoretical equation, that a median amount of indoor UV
exposure (176 SED/year) for 15 years would increase the risk of SCC for a person age 55 in the
Netherlands by 90%. Close examination of Tierney et al. 2015, however, reveals that the same equation
shows that incidence of SCC for a person age 55 in the Netherlands is 0.004 per 100,000 as compared to
25 per 100,000 for the Dutch population as a whole, so the increased risk of SCC at age 55 resulting from
15 years of indoor UV exposure is insignificant.
1
2
means it takes three to four times as much sun exposure to burn a person with a tan as it does a
person without a tan.
Burns are equally harmful at all ages, and there is currently an alarmingly-high
prevalence of outdoor sunburns in the United States. According to the Centers for Disease
Control and Prevention (CDC), the prevalence of sunburns in the United States increased from
32% of all adults in 1999 to 34% in 2004 [Ref. 12] and up to 50% in 2012 [Ref. 13]. Among
adolescents aged 12-18 in 1999, 83% reported at least one sunburn in the previous summer, and
36% reported three or more sunburns in the previous summer [Ref. 14].
By providing a tan, indoor tanning in a commercial tanning salon reduces the risk of
sunburn, and studies show that reducing sunburn reduces the risk of melanoma. Encouraging
persons to obtain their desired tan by using a sunlamp product in a tanning salon rather than at
home can also reduce risks from overexposure to UV radiation. The advent of tanning salons in
the early 1980’s may even be partially responsible for the slight flattening since 2005 in the
increase in melanoma incidence, which has been climbing since 1935. See Attachment A.
2. The Proposed Rule
FDA’s proposed rule introduces new recommendations/principles in the manufacturer’s
recommended exposure schedule:
•
A recommendation of 48 hours between all exposures;
•
A recommendation of not more than two exposures per week;
•
The manufacturer’s recommended exposure schedule must be based on a maximum
yearly dose of 15 kJ/m2; and
•
The manufacturer’s recommended exposure schedule need not depend on skin type.
3
3. Summary of Scientific Comments
FDA’s suggestions of limiting indoor tanning in a tanning salon to: (1) two times per
week, (2) once every 48 hours (except for the first half-dozen exposures in a tanning course),
and (3) 15 kJ/m2 per year, all appear to be based on a view that nonburning UV is somehow bad
for a person’s risk of skin cancer or is otherwise unhealthy and should be limited. Current
science does not support any of these limitations. To the contrary, there is significant science
indicating that insufficient UV exposure is one of the nation’s leading public health problems.
See Attachment B. The current state of the science shows that there is no harm in a person
staying tan year-round by using a commercial tanning salon, assuming there is no UV burning.
Whatever insignificant additional risk there may be for SCC is offset by reduced risk of
melanoma. The proposed twice-a-week spacing and 48-hour spacing (except for the first halfdozen exposures in a tanning course) is contraindicated by science that has been established for
30 years that, for a given dose of UV (in this case, the dose needed for the desired tan), skin
cancer risk is minimized by getting that dose as quickly as possible without burning [Ref. 15].
Melanoma risk is reduced by having chronic year-round UV exposure [Refs. 1,2], so an annual
limit is also contraindicated by science. The notion of limiting persons with Skin Type III and
Type IV to the UV doses appropriate for persons with Skin Type II also is a consequence of a
view that less UV exposure is always better than more. This view is contraindicated by the
science, as mentioned above.
4. Item-by-Item Comments
(a) Harmonization with International Electrotechnical Commission (IEC) (80 Fed. Reg.
79505, 79509-10 and proposed § 1040.20(c)(2)ii)). FDA proposes to alter its UV dose
measuring method from the CIE LYTLE action spectrum currently used by FDA to the CIE
Reference Action Spectrum for Erythema (1999) used by IEC. Accordingly, the current
4
maximum timer interval dose of 624 J/m2 (CIE LYTLE action spectrum) will be changed to 500
J/m2 (IEC action spectrum). These proposals offer a uniform way to measure UV doses and are
scientifically sound. We agree with these proposals.
(b) Costs and Benefits (80 Fed. Reg. at 79507). We disagree that one of the benefits of
the proposed rule is “reduced exposure to UV.” Science demonstrates that the U.S. public needs
more UV exposure, not less. See Attachment B. Recent science indicates that 12.8% of U.S.
deaths may be attributable to insufficient UV exposure [Ref. 18].
(c) Conformity to the IEC Standard (Annex DD) (80 Fed. Reg. at 79509, 79511). The
guidelines for the required manufacturer-recommended exposure schedule should not be
required to be in conformity to the IEC standard. The IEC standard is not based on current
science.
(i) Specifically, the required manufacturer-recommended exposure schedule
should not be required to contain the statement: “Waiting period between subsequent exposures
should be approximately 48 h due to cumulative behaviour of the erythemal reaction.” (Annex
DD attached hereto as Attachment C). The scientific basis for waiting 48 hours after the first
exposure before having the second exposure is Arbabi at al. 1983 [Ref. 19]. This study showed
that a single 0.75 MED irradiation of untanned Type II skin: (1) lowers the threshold for
erythema from a second irradiation for a period of approximately 48 hours after the first
irradiation, and (2) raises the threshold for erythema from a second irradiation approximately
four days after the first irradiation for UVB. The photoprotection from the single 0.75 MED
irradiation four days later was approximately 10% for UVB. However, Arbabi et al. 1983 did not
determine the amount of the lowering or raising of the threshold for erythema resulting from a
second, third, fourth, fifth, sixth, etc. exposure on the same patch of skin. It is known that the
threshold for erythema is raised 300% to 400% by the end of the four-week tanning course (the
5
SPF for tanned vs. untanned skin is three or four) [Ref. 10]. Interpolation between the 10%
resulting from the first exposure four days after the first exposure and to the 300% at
completion of the tanning course is required to determine the amount of photoprotection at
various times during the tanning course. A typical tanning course of four weeks under the
current exposure schedule would have three exposures the first week and three exposures the
second week. Thus, at the mid-point of the current four-week exposure schedule, a given patch
of skin would have been irradiated six times, each assumedly separated by 48 hours.
Arbabi et al. 1983 provides no figure for photoprotection from the first exposure two
weeks after the first exposure (calculations for photoprotection include only nine days), so we
must assume it to be the same 10% that existed four days after the first exposure. Similarly, the
photoprotection from the second exposure would also be 10% one and one-third week after the
second exposure, the photoprotecion from the third exposure would be 10% one week after the
third exposure, and the photoprotection from the fourth exposure would be 10% two-thirds of a
week after the fourth exposure, for a total of 40% photoprotection at the two-week mark midway
through the tanning course. The fifth and sixth exposures would not add much to this figure at
this point, but there would be no further reason after the mid-point to continue waiting 48 hours
between exposures. To the contrary, science would require a recommendation that the
remaining exposures in the second half of the exposure schedule be obtained a quickly as
possible without inducing erythema. De Gruijl et al. 1983 [Ref. 15] stands for the proposition
that, for a given dose of UV, cancer risk is minimized by obtaining the dose as quickly as possible
so long as erythema is avoided. This has been established science for 30 years.
In summary, the science supports a recommendation of 48 hours between exposures
during the first two weeks of a four-week tanning course but not thereafter. FDA should change
its proposed rule accordingly.
6
(ii) The required manufacturer-recommended exposure schedule should not be
required to contain the statement: “The recommended number of exposures per year for each
part of the body is to be based upon a maximum yearly dose of 15 kJ/m2, weighted according to
the erythema action spectrum shown in Figure 103 and taking into account the recommended
schedule of exposure” (Annex DD). There is no scientific basis for an annual limit. Although
there is some scientific evidence that SCC is associated with large amounts of cumulative
lifetime sun exposure, the few studies on the subject indicate that the threshold for any
significant risk of SCC is 20,000 hours of lifetime sun exposure [Ref. 4]. Indoor tanning adds
some marginal amount to the risk of SCC, at least theoretically, but with 30 annual sessions (the
average in the industry) and each session being equivalent to 20-30 minutes of sun exposure,
the total lifetime UV exposure from indoor tanning of 375 hours (25 hours per year for 15 years
of indoor tanning) is insignificant in comparison with the 20,000 hours associated with the
threshold for SCC risk. It is our understanding that the maximum yearly dose of 15 kJ/m2 in
Annex DD was adopted by IEC more than 10 years ago on the unscientific basis that indoor
workers in the Netherlands got 15kJ/m2 of annual sun exposure and that indoor tanning should
not be more than that amount.
In summary, the science does not support a recommendation of a maximum annual dose
of 15 kJ/m2 or any other amount. We recommend that FDA change the proposed rule
accordingly.
(d) Special label requirement that “The exposure schedule must also include the
statement: Maximum sessions per week = 2” (80 Fed. Reg. at 79521, proposed §
1040.20(d)(1)(iv)(C)). There is no such label requirement in IEC standard Annex DD, and there
is no scientific basis for such a statement. To the contrary, science would require a
recommendation that the desired dose be obtained as quickly as possible without inducing
erythema. De Gruijl et al. 1983 [Ref. 15] stands for the proposition that, for a given dose of UV,
7
cancer risk is minimized by obtaining the dose as quickly as possible so long as erythema is
avoided: “It is pointed out that, in similarity to chemo- and radio-tumorigenesis, the total dose
delivered to a mouse for the induction of tumors has to be higher if a high daily dose is used
than if a low daily does is used. It seems as though an animal becomes more resistant to the UVstimulus as the rate at which the stimulus is presented is increased: an adaptive phenomenon”
[Ref. 15]. This has been established science for 30 years.
(e) “[The proposed exposure schedule parameters] are based on current science,
including recent human research conducted at FDA. This requirement is aimed at reducing the
cumulative UV dose …” (emphasis added) (80 Fed. Reg. at 79511). As previously explained, the
proposed parameters of: (1) “Maximum sessions per week = 2,” (2) “Minimum time between
exposures = 48 hours,” and (3) “maximum yearly dose of 15 kJ/m2,” are contrary to current
science. Human research done by FDA was limited to a determination of how much UV
exposure was needed to produce certain levels of pigmentation of the skin of various human
subjects. No data were collected on epidermal thickening. As noted above, the purpose of
indoor tanning is to get a tan. This has cosmetic purposes, but studies show it can also have
protective benefits. A good tan provides significant protection against subsequent sunburn. The
protection is provided by increased pigmentation and by increased thickening of the epidermis
[Refs. 16, 17, 22]. The referenced human research conducted at FDA examined only
pigmentation and is thus inadequate for the purpose of determining how much UV exposure is
needed to produce a tan. The “aiming of a requirement” at reducing the cumulative UV dose is
potentially harmful to the public health for the reason that a tan provides some protection
against sunburn, as well as for the reasons described in Attachment B, and is therefore
inappropriate for FDA in the absence of a showing that cumulative UV exposure of this
magnitude is harmful. The cumulative doses involved in indoor tanning are insignificant in
comparison with the cumulative doses associated with SCC risk. See Section 3(d)(ii) above.
8
(f) “It has been shown (Ref. 14 – Pathak et al. 1983) that Skin Types III and IV can attain
a tan with UV doses that are similar to what is needed for Skin Type II. Thus, the same dose can
be used to develop and maintain a tan for all three Skin Types. This was confirmed in clinical
studies performed at FDA (FDA Refs. 14, 15 – Miller 2012)” (80 Fed. Reg. at 79511). The
referenced studies examined only pigmentation, not epidermal thickening. Pathak et al. 1983
[Ref. 20] and Miller et al. 2012 [Ref. 21] only examined the UV doses required to produce a
certain level of pigmentation, which the authors call a “tan.” As discussed in Section 3(e) above,
there is more to developing and maintaining a tan than just pigmentation. Epidermal
thickening is also involved [Refs. 16,17, 22]. Eliminating skin typing from the recommended
exposure schedule appears to be “aimed at reducing the cumulative dose.” Also, as discussed in
Section 3(e) above, the “aiming of a requirement” at reducing the cumulative UV dose is
potentially harmful to the public health for the reason that a tan provides some protection
against sunburn, as well as for the reasons described in Attachment B, and is therefore
inappropriate for the FDA in the absence of a showing that cumulative UV exposure of this
magnitude is harmful. The cumulative doses involved in indoor tanning are insignificant in
comparison with the cumulative doses associated with SCC risk. See Section 3(d)(ii) above.
In summary, the science does not support elimination of skin typing from the
recommended exposure schedule. We recommend that FDA change the proposed rule
accordingly.
(g) “The proposed rule would affect several aspects of the performance standards to
reduce risks associated with use” (80 Fed. Reg. at 79513). As explained above, the proposed
rule, insofar as it would involve recommendations of: (1) limiting use to twice per week, (2)
limiting use to once every 48 hours (except for the first two weeks of a tanning course), (3) use
of an annual limit of 15 kJ/m2 in developing the recommended exposure schedule, and (4)
eliminating use of skin typing in developing the recommended exposure schedule, would not
9
reduce risks associated with use; to the contrary, these recommendations would likely increase
risks associated with use.
10
REFERENCES
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11
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ATTACHMENTS
Attachment A
Graph of Melanoma Incidence, 1935 to 2012
Attachment B
Hoel DG. Risks and Benefits of Sun Exposure 2016
Curriculum Vitae of David G. Hoel, Ph.D.
Attachment C
Annex DD
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