My Comment to the FDA's Proposed Final Rule on OTC Sunscreen Drug Products

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To whom it may concern –

As a consumer of sunscreen products and an advocate for their use, I applaud the decision of the Food and Drug Administration to issue a proposed rule regarding the use of nonprescription OTC sunscreen drug products. I appreciate and am grateful for the proposed regulations regarding UVA protection, sunscreen dosage forms, maximum SPF numbers, and changes to sunscreen labeling.

My comment seeks to express my concerns regarding:

  1. The impact of only allowing Zinc Oxide and Titanium Dioxide as active ingredients in sunscreens
  2. The Administration’s refusal to approve sunscreen ingredients widely available in Asia, Europe, and Australia, or for which approval was sought through TEA applications

I. The impact of only allowing Zinc Oxide and Titanium Dioxide

I am concerned by the possibility that the only allowed UV filters in the United States could be Zinc Oxide and Titanium Dioxide, as I find these ingredients are challenging to tolerate in sunscreen formulae. I raise this concern due to the fact that they are the only ingredients included in Category I in the proposed rule. I believe their lack of tolerability is likely to decrease the frequency of sunscreen use by many Americans. Zinc Oxide and Titanium Dioxide are generally inelegant in sunscreen products. These microfine particulate dispersions are generally formulated into textures which are of an unappealing aesthetic to consumers. This inelegance is rendered more obtrusive through the opaque whiteness which these ingredients leave on the skin after application. This issue of inelegance is more significant in Americans with dark and deep skin tones, on whom the opaque white cast is more visible.

While this issue is merely one of aesthetic tolerance, it must be stated that if sunscreen products are not pleasurable, they will not be used. If the agency is to recommend the use of a broad spectrum sunscreen to prevent skin cancers and skin photoaging, it is essential that the sunscreens in question be tolerable by the American public. It is logical that these issues of cosmetic inelegance will result in Americans using less sunscreen more infrequently, which may bring rise to an even greater incidence of ultraviolet radiation-related skin disease.

To forge a metaphor, the Administration has issued clear nutritional guidelines in the hopes of countering the epidemic of obesity in the United States. While the American resident is aware that eating broccoli is a more healthful choice than eating ice cream, obesity rates have not fallen. Indeed, the more pleasurable aesthetics of the less-healthful choice play a role in the behavioral healthcare decisions made by Americans. This informs my concern that only allowing Zinc Oxide and Titanium Dioxide based sunscreens will result in more infrequent sunscreen use, and, therefore, a higher rate of preventable UV-related skin health outcomes.

II. The approval of Sunscreen ingredients available in other countries, or for which approval was sought through TEA applications

I am frustrated by the Administration’s failure to approve the sunscreen active ingredients which are widely available in virtually every country with the exception of the United States. I refute the Administration’s claim that these ingredients lack the necessary safety data to be considered GRASE. In contrast, I believe that the failure of the Administration to allow these ingredients is reflective of a lax attitude towards the skin health of Americans. I refer specifically to the following ingredients:

  • Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine (Bemotrizinol, or Tinosorb S)
  • Diethylamino Hydroxybenzoyl Hexyl Benzoate (Uvinul A Plus)
  • Diethylhexyl Butamido Triazone (Iscotrizinol, or Uvasorb HEB)
  • Disodium Phenyl Dibenzimidazole Tetrasulfonate (Bisdisulizole Disodium, or Neo Heliopan AP)
  • Drometrizole Trisiloxane (Mexoryl XL)
  • Ethylhexyl Triazone (Octyl Triazone, or Uvinul T 150)
  • Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (Bisoctrizole, or Tinosorb M)
  • Terephthalylidene Dicamphor Sulfonic Acid (Mexoryl SX, or Ecamsule)
  • Tris-Biphenyl Triazine (Tinosorb A2B)

I wish to raise several concerns on this point:

  1. There is great controversy regarding the environmental and human health consequences of many sunscreen active ingredients included the Final Monograph. The public controversy seems to be the most robust in regards to Benzophenone-3 (Oxybenzone) and Ethylhexyl Methoxycinnamate (Octinoxate). While this proposed final rule seeks to determine the human health outcomes of these ingredients, it must be stated that their use in sunscreen products in the rest of the world is more infrequent. Furthermore, they are often used in lower concentrations in foreign sunscreen formulae. This can be attributed to the fact that sunscreen manufacturers in the rest of the world have a broader list of approved ingredients from which to choose when formulating safe and effective sunscreen products. Thus, if the health consequences of Benzophenone-3 and Ethylhexyl Methoxycinnamate are suspect, allowing American manufacturers a broader list of sunscreen active ingredients will reduce the prevalence of Benzophenone-3 and Ethylhexyl Methoxycinnamate in the market.

  2. The sunscreen active ingredients in the United States are heavily biased towards UVB protection. Indeed, the only allowed filters which protect against UVA radiation in the United States are Zinc Oxide and Avobenzone. Zinc Oxide is poorly tolerated, particularly by Americans with dark skins. Avobenzone is photo unstable, and cannot be relied upon for lasting UVA protection. The Administration makes clear the need for high UVA protection in the proposed final rule. Yet, manufacturers will be challenged to formulate sunscreen products with strong, photostable UVA protection if they are limited to choosing Zinc Oxide or Avobenzone.

In Australia, sunscreens are regulated as Therapeutic Goods, and can contain the following ingredients which can protect against UVA radiation:

  • Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, (Bemotrizinol) at concentrations of up to 10%
  • Diethylamino Hydroxybenzoyl Hexyl Benzoate (Uvinul A Plus) at concentrations of up to 10%
  • Disodium Phenyl Dibenzimidazole Tetrasulfonate (Bisdisulizole Disodium) at concentrations of up to 10%
  • Drometrizole Trisiloxane (Mexoryl XL) at concentrations of up to 15%
  • Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (Bisoctrizole) at concentrations of up to 10%
  • Terephthalylidene Dicamphor Sulfonic Acid (Ecamsule) at concentrations of up to 10%
  • Tris-Biphenyl Triazine (Tinosorb A2B) at concentrations of up to 10%

These ingredients provide strong and long-lasting UVA protection. With the exception of Diethylamino Hydroxybenzoyl Hexyl Benzoate, these ingredients have molecular sizes greater than 500 Daltons, and are unlikely to penetrate the skin barrier. They have long histories of marketing in many other countries, with no negative human health outcomes reported. Unlike many ingredients on the Administration’s current monograph, they lack data which demonstrates any harm to marine life.

  1. While the requirements for MUsT outlined in the rule allow for complete confidence in the safety of a given UV filter, I believe that this testing places undue burden on industry, which will prevent the approval of the aforementioned filters in the United States. Indeed, the threshold absorption for a filter, 0.5ng/ml receptor fluid, seems unduly minuscule for any ingredient with years of marketing data and no data regarding problematic human health outcomes. Indeed, the known carcinogen formaldehyde is normally present in the body at a concentration of 30 ng / ml receptor fluid.

The financial burden of these testing requirements will make the approval of new sunscreen ingredients unlikely. The enforcement of such stringent regulations suggests that the Administration is unwilling to consider the approval of new sunscreen filters at all.

III. Conclusion

I do wish to emphasize that I appreciate the work that the Administration undertakes to improve the health of Americans. However, I must candidly state my belief that this proposed final rule, if unamended to include filters other than Zinc Oxide and Titanium Dioxide, will limit the choice of sunscreens available to American consumers, will result in inadequate sunscreen use, and will lead to a higher incidence of ultraviolet radiation-related health outcomes.

Put candidly: All I want are sunscreen products which are tolerable and offer reliable, strong, and photostable UV protection. Sunscreens in the United States are 20 years behind the rest of the world, and this fact makes it challenging for Americans to select sunscreens which (1) provide excellent photoprotection and (2) are pleasurable to use.

In regards to the “excellent photoprotection” claim, I refer the Administration to Osterwalder & Herzog’s "Chemistry and Properties of Organic and Inorganic UV Filters," chapter 2 of Lim & Draelos’ Clinical Guide to Sunscreens and Photoprotection, published by Informa in 2009. One need only look at the extinction curves of Zinc Oxide against Tinosorb S, Tinosorb M, and Mexoryl XL to realize that better, broader UV coverage is possible through the use of sunscreen ingredients which are available in the rest of the world.

In regards to the “pleasurable to use” claim, I feel as though no one employed by the Administration has ever worn a Zinc Oxide sunscreen one day, and a sunscreen from Europe or Japan the next, and realized how inordinately superior his/her skin looked and felt when wearing the European or Japanese sunscreen. I would be glad to personally provide samples for testing to the Administration, as I believe this type of testing would radically change the Administration’s view of sunscreen products.

Finally, I feel as though the Administration’s sunscreen regulations are simply unamerican from a rhetorical perspective. The Declaration of Independence sets forth that the governing principle of the United States of America is to protect man's unalienable rights to “Life, Liberty and the pursuit of Happiness.” If we apply this superlatively American framework to sunscreen, we see that sunscreens should be regulated to protect life – they should offer excellent protection – liberty – consumers should be free to choose which sunscreen they want – and the pursuit of happiness – the sunscreen should be pleasant. If Jefferson had written “Life with UV induced erythema, Liberty to wear a Zinc Oxide sunscreen and look like Casper the Ghost, and the Pursuit of Sunscreens from other countries,” maybe I would change my tune. Indeed, people living in Northern Europe – where there is no sun for half of the year – have more freedom to choose sunscreen formula which provide excellent photoprotection and are pleasurable to use. I am sick and tired of having to beg friends and acquaintances traveling to other countries to bring back sunscreens for me. I envy the citizens of other countries who can stroll into a local drugstore and pick up an affordable sunscreen that is superlatively protective and elegant to wear.

I implore the Administration to consider these factors before issuing a final rule.

Thank you.

. . .

Osterwalder, U., & Herzog, B. (2009). Chemistry and Properties of Organic and Inorganic UV Filters. In Editor H. W. Lim & Z. D. Draelos (Eds.), Clinical Guide to Sunscreens and Photoprotection (pp. 33). New York, NY: Informa Healthcare USA, Inc