New U.S. UV Filters and the Cosmetic Outlook in Canada for Sunscreens

Mar 27th, 2015

Daniel Noble and Robert Ross-Fichtner, Focal Point Research Inc.

In the last four decades, the occurrence of skin cancer has increased tremendously. This is the most common type of cancer, affecting the lives of 2.2 million Americans annually.¹ With the level of innovation in today’s cosmetic and drug industries, however, some of these cases should be avoidable. Ironically, skin cancer is a preventable disease, and only recently has industry pressure and political leadership compelled changes in the North American regulatory paradigm for sunscreen products.

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These are extraordinary times; in the United States, the Sunscreen Innovation Act looks to revolutionize the current process for approving new sunscreens while in Canada, sunscreens could change to a “cosmetic” status. These changes could pave the way for more innovative and highly efficient sunscreens to combat the recent pandemic of skin cancer, bringing North America closer to Europe and other forward-thinking jurisdictions.

Wavelengths and Filter Type

Sunscreens are formulations that act to stop ultraviolet (UV) radiation from reaching the skin. UV radiation is composed of three wavelength groups: UVA, UVB and UVC.² These wavelengths differ in their biological activity and ability to penetrate to different depths in the skin.³ UVC is the shortest wavelength, making it the most dangerous. Fortunately, the Earth’s atmosphere filters out this wavelength, leaving only UVA (320-400 nm) and UVB (290-320 nm).⁴

UVB, the next shortest wavelength, imposes a direct physiological effect in skin, as it is responsible for tanning and burning. In addition, it promotes skin aging and the development of skin cancer.⁵ UVA comprises most of the UV radiation that reaches the Earth’s surface and is responsible for immediate tanning and wrinkles, as well as skin aging and cancer.⁵ While early sunscreens filtered out only UVB, as measured by the “SPF factor,” contemporary understanding of skin health clearly shows that both UVA and UVB must be stopped.

To combat UV radiation, sunscreens are applied to the skin to reduce exposure to UV wavelengths. For these products to fulfill their function, UV filters must be present in the formula. These filters are divided into two groups: organic absorbers and inorganic “blockers.” Some are also “broad-spectrum,” meaning they protect against both UVA and UVB radiation.² Not all UV filters are considered broad-spectrum, though, and many are not photostable.

New Drug and OTC Monograph

In North America, sunscreens are regulated as drugs, and for new innovative drug formulations to be produced, companies must first seek approval from the U.S. Food and Drug Administration (FDA) or Health Canada.

New Drug Application: Under current regulatory processes, it is brutally difficult to bring “new drugs” to the market in the United States or Canada.

In the United States, new sunscreen filters must follow the New Drug Approval (NDA) process, which requires extensive documentation of the drug and a lengthy pre-market approval process. Included in this process are evaluations of formulations, results from human and animal clinical tests, studies of the drug’s behavior in the body, and details regarding its manufacture and labelling.⁶ Unique to the NDA, approved labelling is distinct to the drug, and the approved NDA is the sponsor’s “license” to market.⁶ Unlike products complying with the OTC drug monograph, NDA-approved products retain their potential for marketing exclusivity.⁷ With this knowledge, the FDA reviewer will make an informed decision based on whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.

Parallel to the NDA, in Canada, a New Drug process exists, and drugs can be sold only after successfully completing the process. A New Drug Submission is filed and reviewed by scientists in Health Canada’s Therapeutic Products Directorate (TPD). After the drug review is completed, a Notice of Compliancy (NOC) and Drug Identification Number (DIN) are issued, indicating official acceptance and permitting the sale of the product in Canada.⁸

OTC drug monograph: In contrast to the NDA, the OTC drug monograph process uses already-validated technologies to gain approval. Drugs conforming to this monograph can skip the premarket approval process required by an NDA. Each OTC drug monograph covers acceptable ingredients, doses, formulations, labeling and sometimes testing parameters.⁹ This OTC monograph is established through a three-step, public rule-making process. After each phase, a Federal Register document is published to allow time for comments or data submission responses.⁷ Historically, Canada’s Sunscreen Monograph has been heavily influenced by the FDA.

Hope: The Sunscreen Innovation Act

Unfortunately, no new UV filters have been approved in North America since 2002,¹⁰ although many new and superior actives^a are available and routinely used in the European Union (EU) and elsewhere. These new actives are more photostable and provide more effective broad-spectrum protection than historic filters. So how is it that products exposed to 500 million people in the EU cannot be rubber-stamped in North America? Fortunately, the New Sunscreen Innovation Act has the potential to change this. In North America, the regulatory system for UV filters has been stuck behind FDA barriers. The new Sunscreen Innovation Act (SIA), however, aims to expedite the FDA’s process for approving new sunscreen actives as well as blends for use in non-prescription sunscreen products under the Food, Drug and Cosmetic Act (FDCA). The SIA also will address the backlog of applications awaiting responses from the FDA.

Any sponsor can request and provide information on an OTC sunscreen ingredient or ingredient blend in relation to its safety and efficacy.¹¹ The secretary will then determine if the information provided is sufficient enough to perform a review. The Secretary of Health and Human Services must also review ingredients in commercial use that were not included in the FDA Monograph.¹²

One of the most important changes brought about by the SIA is the time frame by which ingredient reviews must be completed. For a newly filed active ingredient request, the review must be completed within 300 days and it must be published in the Federal Register.¹² For ingredient review requests pending before the SIA was enacted, the FDA must complete its review and issue a proposed sunscreen order within 90 days of the SIA’s enactment. If a letter was previously issued, it will be deemed a proposed sunscreen order and the “generally recognized as safe and effective” (GRASE) determination will be published within 45 days after the enactment of the SIA.¹² If a determination is not made within the given time frames, the sponsor can request that the Commissioner of Food and Drugs make the determination.¹²

Finally, the SIA requires the secretary to issue a Final Sunscreen Order within 90 days, 210 days or 270 days based on specific circumstances.¹² Again, if the FDA does not issue a Final Sunscreen Order within the specified time, the Office of the Commissioner can be notified to make the order within 60 calendar days.⁷ Another important change is the ability of sponsors to receive updates on the progress of the review procedure.¹² The FDA will be required to report on decisions made regarding the safety and efficacy of active ingredients, the time between submission and decision, the cost of the determination process, and any improvements recommended to the review process.¹²

Sunscreens as Cosmetics in Canada

In contrast to the United States, Canada is rethinking all Consumer Health Products, of which sunscreens are a part. Industry is pressing regulators to consider all sunscreens as “cosmetics”—similar to the decision made on antiperspirants some years ago. A major industry consultation is under way to solicit broad input on the future of all OTCs. The developments on sunscreens in the United States will undoubtedly create added complexity for regulators in Canada.

Conclusion

Although these extraordinary developments in government oversight aim to create more efficient regulatory processes, they are not without uncertainty. The previous U.S. process, in which no new sunscreen actives received decisions from the FDA, created dismay within the U.S. industry. Pending applications were stuck in limbo—some for more than a decade.¹³ How effective the SIA will be can only be established over time. And with the growing incidence of skin cancer, is Health Canada ready to treat sunscreens like mascara?

While it is easy to follow EU product classifications, it is important to note that European regulations on cosmetics are far more extensive than in Canada, let alone the United States. What we all can agree on is that sunscreens are among the most vitally important products used topically by consumers, and there is no excuse to delay the approval of proven, superior products via faster, more efficient regulatory processes.