Stealing pharma's sunshine

Oct. 26, 2020
How sunscreen is driving a resource and capacity shortage

The passage of the Sunscreen Innovation Act (SIA) in 2014 has increased oversight of the safety of sunscreens. Last year, the U.S. FDA issued a proposed rule that, if put into effect, will tighten regulatory requirements for most sunscreen products in the U.S.

But what does sunscreen have to do with the pharmaceutical industry? Sunscreens in the U.S. are considered over-the-counter drugs, rather than cosmetic products, like they are in many other countries. Since they prevent sunburn and skin cancer, sunscreens sold in the U.S. are subject to regulation as drugs.

Products being shipped to the U.S. from Europe and Asia, where many sunscreens are manufactured, have to meet the same 21 CFR 211 criteria. But how are cosmetics manufacturers in Europe expected to understand how to deal with the U.S. FDA, a regulatory agency now increasingly found at their doorstep?

Meeting FDA criteria and GMP compliance for overseas sunscreen has the cosmetics industry looking to the pharma industry for guidance in an unprecedented way. But pharma’s resources, including CMOs, consultants and engineering companies, are already wearing thin, stretched to the breaking point by the COVID-19 pandemic.

A case in point

A leading cosmetics manufacturer in France was producing and marketing a line of cosmetics, including foundations that claimed UV protection with sunscreen. They had an FDA inspection in 2018. Due to a lack of understanding around OTC/GMP regulations, the cosmetics manufacturer’s initial 483 response was not well formulated and they received a warning letter.

The cosmetic manufacturer assumed that a simple dedication of fill lines was enough to become GMP compliant, but as pharma is aware, the solution is often much more complex, involving complete fill line segregation to prevent cross contamination, with cleaning and process validation and the equipment qualification steps set up, and then kept in a full-time qualified state. Record keeping levels and personnel, plus costs, go up significantly, with shifts, batch records and cleaning records all needing to be taught, trained and kept up as regular practice.

In most of Europe and Asia, sunscreens are not regulated, so the local manufacturers are not familiar with FDA’s OTC requirements. Faced with FDA actions and timelines, many overseas cosmetics manufacturers look to U.S. consultants and engineering companies to help navigate the FDA landscape.

The hunt for a CMO

The fastest route to become compliant for an overseas manufacturer shipping their beauty lines to the U.S. is to use a well-respected U.S. contract manufacturer.

Yet, the CMO industry in the U.S. is already at capacity. To obtain campaign time at one of the larger CMOs, a prospective client can wait over a year. Additionally, sunscreen products may have specific manufacturing process requirements that further limit options. The need to satisfy the FDA’s requests for GMP compliance among OTC products is stretching the CMO supply chain in a manner that is troubling.

With the widespread use of sunscreen today and the increased regulatory investigations happening, OTC sunscreens will only receive increased scrutiny, much like drugs receive, in the years to come.

CMOs, pharma engineering and consultancy firms all may become even more resource stretched in the next few years, with overseas cosmetics manufacturers reaching out for help. Sunscreens imported into the U.S. are still big business but they also cannot continue to label them as sun protective without meeting FDA standards.

Overseas cosmetic manufacturers will either work towards bringing sunscreen facilities to U.S. FDA standards or continue to look to outsource to CMOs that understand the requirements — which means pharma manufacturers may increasingly find themselves having to share their partners.

About the Author

John McShane | Managing Partner

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