This week’s attention to the effectiveness of a zinc oxide sunscreen made by The Honest Company has renewed scrutiny of how sunscreen products are tested for effectiveness and safety in the United States. The company was originally criticized by public relations experts for their initial response over the weekend to customer complaints and negative reviews, including online customer photos of adults and children with sunburns, after using Honest’s reformulated “mineral-based” sunscreen.
But within a day, co-founders Jessica Alba and Christopher Gavigan released a more personal message on The Honest Company’s blog, expressing their empathy with fellow parents and their pro-active desire to “make things right” with each customer who expressed dissatisfaction with the sunscreen product. According to the blogpost, Alba and Gavigan themselves fielded phone calls on their customer service line and their team “reached out to everyone who posted on social media.”
“We develop and use Honest Sunscreen to protect our own children – Honor, Haven, Luke, Evie, and Poppy – at the park, in the pool, outside, every day. As with everything we do, we take sun protection seriously here at Honest,” writes founders Jessica Alba and Christopher Gavigan at the company’s Honestly blog. Photo credit: The Honest Company
I was curious as to why the company didn’t simply issue a blanket recall of their product and was referred to PMK*BMC, the Los Angeles PR firm handling The Honest Company’s media relations. Their spokesperson told me that staying customer-focused was the company’s priority. “They want to engage on a personal level to satisfy each customer, ‘making things right’ on an individual basis.”
The spokesperson reiterated that this year’s reformulated product, Honest Sunscreen Lotion SPF 30, met regulatory testing standards as determined by a third party laboratory. My request for a copy of the technical report was declined, citing company policy.
In 2011, the FDA dropped the requirement for manufacturers to test sunscreens in human subjects for broad-spectrum protection against ultraviolet rays (PDF, pg. 35649). So it’s not known if The Honest Company had their new product tested for human skin protection or simply relied on the required laboratory tests for absorption, reflection, or scattering of the specific wavelengths of skin-damaging ultraviolet light from a “solar simulator.”
How could faulty sunscreen make it to market?
Current and former FDA officials authored two prescient perspectives last month in the New England Journal of Medicine that shed light on why the agency’s tailored process leading to 2014′s two-decade record of 41 prescription drug approvals has not been replicated with sunscreen products and other over-the-counter drugs. Unlike the situation in Europe where sunscreen ingredients are considered under cosmetics guidelines, the FDA is required to define sunscreens as drugs since they are advertised to prevent sunburn and, more recently, the risk of skin cancer.
In a NEJM interview accompanying his primary article, “A Spotlight on Sunscreen Regulation,” Joshua M. Sharfstein, MD, said, “It’s one agency with two entirely different approaches.” Sharfstein was the FDA deputy commissioner from 2009 to 2011 and is currently a professor and associate dean for public health training and practice at the Johns Hopkins Bloomberg School of Public Health.
In a telephone interview last night, Sharfstein expanded on the laborious, inflexible and sorely underfunded process of approving new over-the-counter product ingredients. “I’ve always seen the OTC process as more time-consuming,” said Sharfstein. “With prescription drugs, you have a new drug application and a decision on specific product data on safety and efficacy.”
Sharfstein pointed out in his NEJM article that for prescription drugs, “the agency tailors its approval decisions to the data at hand, receives extra resources (from user fees) for drug reviews, and if problems emerge after approval, has the ability to move quickly with a range of actions to protect the public.”
“For over-the counter drugs, the agency goes through a rulemaking procedure where the label is established through a public process,” said Sharfstein. Beginning in 1978, each of the 17 FDA-sanctioned sunscreen ingredients were established through one or more public hearings, publication of proposed and final rules, and comment periods to develop how the ingredient must be formulated in products and tested.
“Once approved or set, then anyone can make a product, but it’s very hard for the agency to act on any safety issues,” said Sharfstein. In the case of customer reports of inadequate sun protection with The Honest Company’s sunscreen lotion, Sharfstein said that the only way that the FDA could intervene is if the product was not prepared in a manner consistent with the published zinc oxide monograph.
Why are there no new sunscreen ingredients?
The OTC regulation of sunscreen products is a holdover from the monograph system developed in response to 1960s rules requiring that prescription drugs be tested for safety and efficacy prior to marketing. The National Academy of Sciences-National Research Council convened advisory committees for the FDA, called the Drug Efficacy Study, that reviewed then-existing data for prescription and OTC drugs sold between 1938 and 1962 and established standards for continued sale of drug ingredients – not specific finished products – that were deemed “generally recognized as safe and effective,” or GRAS/GRASE.
Sharfstein points out that the system that we maintain today for OTC products was never intended for innovative drug ingredients but rather older drugs with decades of use and well-understood safety profiles; innovation, albeit delayed, really only comes when prescription drugs are converted to OTC status.
Two years ago, a group of patients with melanoma, physicians, and makers of proposed new sunscreen ingredients came together under the umbrella of the PASS (Public Access to Sun-Screens) coalition and spurred Congress to pass the Sunscreen Innovation Act. Many thought that the Act would expedite the U.S. approval of new sunscreen ingredients that had been sold in Europe for more than five years. But as pointed out by both Sharfstein and the accompanying NEJM letter to the editor by new FDA Deputy Commissioner for Medical Products and Tobacco, Rob Califf, MD, and Acting Commissioner of the FDA, Stephen Ostroff, MD, the Act still requires the agency to use the cumbersome and iterative monograph system.
After FDA convened an independent advisory committee last September that assessed the research on sunscreen ingredients and safety, a particular concern arose over the systemic absorption of these new sunscreen ingredients and the potential risks especially to children who, as Califf and Ostroff pointed out, “have a high ratio of body-surface-area to weight.” The agency has therefore decided not to approve eight newly-proposed sunscreen ingredients without further safety testing.
This opened the agency to criticism of being overly cautious and even a Newsweek article on Monday suggested that the FDA was to blame for Jessica Alba’s challenges with her company’s sunscreen product. But Sharfstein defended the agency, saying that we mustn’t forget that a sunscreen is a product used on healthy adults and children, without disease, and that preventive drugs require a higher safety threshold than those used to treat a disease.
As for new sunscreen ingredients, Sharfstein feels they are only one part of the picture. He points out that melanoma rates are most likely continuing to rise because of tanning bed use, especially by young people, and the continued practice of intentional sun exposure by light-skinned people to obtain a tan.
In fact, a greater challenge may be that people need to use the sunscreens that we already have, rather than approve new ingredients. Sharfstein pointed me to a Journal of the American Academy of Dermatology paper published in July by investigators from the Centers for Disease Control and Prevention survey results that shows men are particularly infrequent users of sunscreen on either the face or body (18.1% and 19.9%, respectively). Women were far more wise with 42.6% and 34.4% using sunscreen on the face or other exposed areas of skin, respectively. But use in other demographic groups was particularly low and 40% of sunscreen users didn’t know if their products offered broad spectrum protection.
We must also address the misconception that African-Americans and those of darker-skinned ethnic descent – those with class III to VI skin on the Fitzpatrick Skin Type classification (PDF) – needn’t use sunscreen. The body pigment, melanin, does not absorb all damaging UV radiation. I would always remind my HBCU pharmaceutical sciences students that reggae musician Bob Marley died of metastatic malignant melanoma that he mistook for a recurrent toe injury from playing soccer. Marley ultimately died of metastases to the brain.
So what’s the solution?
Sharfstein thinks it would be too overwhelming to revamp the entire OTC drug approval system. “But we could certainly implement a system that’s somewhere in between the current OTC monograph approach and a new drug application.”
If the FDA were granted the flexibility to require post-marketing surveillance and the ability to act quickly on product safety issues, they would then have some necessary tools that might be precluding approval of new ingredients. We’d also then get into issues of whether these new ingredients are superior in terms of efficacy, application frequency, or resistance to water, sweat, and concomitant use of insect repellant.
For now, use your sunscreen – in slathering amounts – and reapply regularly. Protect your skin and eyes with clothing, hats and sunglasses. And stay out of the sun if you can during the peak hours of 11:00 am and 4:00 pm (during Daylight Savings Time).
For more health and pharmaceutical news and commentary, follow me on Twitter @DavidKroll, or here at Forbes.com.