In the U. S., sunscreen products are regulated by the Food and Drug Administration (FDA). Specifically, sunscreens are considered OTC drug products, required to abide by the monograph regulating such products. The OTC Drug Monographs establish conditions for safe and effective self-treatments. These are regulatory standards for marketing of nonprescription drug products not covered by New Drug Applications (NDAs). Products marketed in accordance with the monograph do not require FDA approval. An abbreviated chronology of the Sunscreen Monograph is presented in Table 3.
That sunscreens are considered drugs in the U. S. sets it apart form other regions of the world. The FDA considers cosmetics as articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance.” In 1978, the FDA recognized that products intended to be used for prevention of sunburn or any other similar condition should be regarded as drugs. As such, in the Advanced Notice of Public Rule Making (ANPRM) it states that “[sunscreens] reduce by varying amounts the solar radiation absorbed by the skin and thereby affect the physiological response and extent of the erythemal reaction (redness) produced. ” and as such fit the definition of a drug: “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”
Since the publication of the ANPRM in 1978 up to the publication of the Final Rule in 1999 (19) and beyond for a total of 27-plus years, the Sunscreen Monograph has been discussed and commented on by interested parties including industry, academicians, practicing dermatologists and various trade associations (65). There has been extraordinary criticism of the agency ranging from being too slow to completely unresponsive. Perhaps the critics are right. However, it should be noted that there are diverse opinions on many key aspects of sunscreens including product testing and labeling, the knowledge that consumers don’t apply enough product to achieve the labeled SPF, the absence of any meaningful and relevant acute endpoint for UVA protection, the need for sunscreens with unlimited SPF, i. e., beyond 100-plus, and what exactly such products are protecting against. This is compounded by the fact that there are sharp disagreements regarding how best to measure and label sunscreen products (see Sept. 2000 submissions to the FDA Sunscreen Docket 78N-0038). As such, it may not be surprising that the monograph has not been completed.
Beyond the monograph, there are other regulatory processes that can be followed in order to market a sunscreen product in the U. S. Options for marketing an OTC drug product besides the monograph include NDAs and the Abbreviated NDA (ANDA). An NDA is the same process that prescription drugs follow including the comprehensive safety and clinical testing. Approval is generally for a specific product including the 10-20 or so ingredients used to formulate a topically applied product. As such this approach is time consuming and costly and does not allow for minor reformulations of the product for marketing or other reasons. There are few sunscreen products which follow this process given the high cost in time and resources and the inflexible nature of this process.
Currently, there are several suppliers attempting to have specific UV filters added to the list of approved ingredients (Table 2). The Time and Extent Application (TEA) is being used. The purpose of TEA is to request that applicable conditions be considered for
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Table 3 Abridged Chronology of FDA Sunscreen Monograph
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inclusion in the monograph. This is a two-step process: first is the submission followed by demonstration of general safety and effectiveness. The demonstration of general safety and effectiveness has, to date, been the limiting factor for TEAs.
Whereas the debate regarding sunscreens being cosmetics or drugs and the criticism of the Sunscreen Monograph and FDA will continue, it again is worthwhile pointing out that in the U. S. such a process works by necessity if nothing else.