It seems like every week there is a story in the news about sunscreen safety. We have read about the impact of sunscreen ingredients on coral reefs, about the FDA setting new standards for sunscreen ingredient safety, and just this week, we read about studies showing how quickly certain sunscreen chemicals can be absorbed into the bloodstream. A consistent theme throughout all of this news is the recommendation that consumers look to mineral sunscreens for safe sun protection. Badger makes a full line of mineral sunscreens using zinc oxide as the only active ingredient and we have been watching all of this news very closely. Read on to learn more from our Regulatory Specialist, Jamie White.
Badger Blog: The FDA put a big spotlight on mineral sunscreens recently, prompting major news and TV outlets to cover the story. Can you tell us why?
Jamie White: Of course! We can all appreciate a positive news story and this one is both positive and exciting. Basically, the FDA is in the process of updating the sunscreen rules that would push the sunscreen industry to change for the better. The proposed rules aim to improve sunscreen safety, increase the FDA’s access to data, and increase standards and transparency throughout the sunscreen product development process. One of the most surprising changes put forth in this document involves the sunscreen active ingredients. The FDA has proposed categorizing zinc oxide and titanium dioxide as the only sunscreen active ingredients that are generally recognized as safe and effective (GRASE). The FDA also proposed banning two active ingredients, para-aminobenzoic acid (PABA) and trolamine salicylate. All other sunscreen active ingredients would be required to submit additional safety data before they could be used in a sunscreen product.
Hopefully, this proposed rule will help to support the legislative bodies that are considering or actively moving towards banning certain synthetic sunscreen ingredients, like oxybenzone and octinoxate.
Badger Blog: What exactly are the main reasons for the proposed changes?
Jamie White: The main reason for the changes, and really the reason that the FDA is in existence, is to protect public health. In the proposed rule change, the FDA is looking at the industry as a whole and identifying the deficiencies. Badger has always and will continue to follow high-quality standards in the development, production, testing and monitoring of the sunscreen products that we release. Unfortunately, not all companies share that commitment. The FDA, in the interest of public safety, is trying to set base safety and quality standards for all sunscreen companies to follow.
Here are the highlights of the FDA’s proposed rule changes:
- The FDA will accept zinc oxide as one of only two ingredients considered Generally Recognized as Safe and Effective (GRASE), the other being titanium dioxide.
- Increased Principle Display Panel (front of package) accuracy and transparency.
- More comprehensive interpretation of required broad spectrum, UVA I testing standards.
- More thorough safety assessments of dosing forms like SPF sprays, powders, and new drug applications for dosing forms like wipes, towlettes, and shampoos.
- Increased accuracy of test-based label claims.
- Increased FDA oversight and access to company testing records and testing facility quality standards.
- Active ingredient safety review of sunscreen-insect repellant products to ensure the absorptive qualities of chemicals like oxybenzone don’t pull pesticides like DEET into the body.
Badger Blog: You mentioned the FDA isn’t the only group talking about the benefits of mineral sunscreen. Can you talk a little about the new legislation in Hawaii, Palau, and Key West, Florida regarding coral reefs?
JW: Hawaii started this trend a year ago in May 2018 by passing legislation to phase out sunscreens that contain the reef-harming ingredients, oxybenzone and octinoxate by 2021. Bonaire and Palau followed and Key West passed similar legislation in February.
Badger supported the Key West legislation to ban the environmentally harmful sunscreen ingredients oxybenzone and octinoxate. Not only were we part of the effort to educate city officials (by sharing the latest scientific data and sunscreens samples from several mineral brands, including Badger), but we also had on-the-ground representation at an important public hearing testifying alongside individuals, businesses, and Reef Relief, a local advocacy group. Miami is now considering a similar ban as Key West, and we’re looking forward to repeating our efforts.
Insider Tip: For the most up-to-date research and information on the effects of people on ocean habitats, check out Craig Downs and the Haereticus Environmental Laboratory (HEL). HEL has published many peer-reviewed scientific research articles that identify sunscreen ingredients that are harmful to reefs. You can learn more here.
Badger Blog: Has there been any push-back from sunscreens brands that use the chemicals oxybenzone and octinoxate?
JW: During each legislative debate, the chemical sunscreen industry puts forward arguments that are inconsistent with the facts. Synthetic chemical sunscreen companies are using industry groups in an attempt to shift the conversation away from health and safety concerns. We, and the legislators that represent us, are being presented a false choice, public health vs. environmental health when in reality we can have both. Beware of some of the arguments that are being framed by industry groups. Arguments like, “there aren’t enough reef-friendly sunscreens to satisfy post-ban demand”, “scientific studies that illustrate coral harm are inconclusive” and “sunscreens without these ingredients are not safe and effective”.
We can see in the new rules proposed by the FDA that the science is not behind the claims of the chemical sunscreen industry. Still, we are seeing industry have an effect on State Houses. In Florida, the State House of Representatives just passed legislation that would make bans on sunscreen ingredients illegal. Let’s do more than hope that it doesn’t get through the State Senate, we can make a difference by committing to take action.
Badger Blog: In addition to choosing mineral sunscreens over synthetic chemical sunscreens, what other steps can people take to support these changes?
JW: We would like to encourage people and advocacy groups to first read the 13-page summary or the press release issued by the FDA and submit a public comment. You don’t have to read all 264 pages to gain an understanding of the issues presented.
Activism takes many forms: It could be reading an article from a trusted source, calling public officials to let them know what they should support and why, it could be making a small donation to an organization that you believe in (like the Haereticus Laboratory). Organizations like this are fighting the good fight every day. Personally, I have committed to once a month activism and I keep myself accountable to that by setting a reoccurring reminder on my e-calender.
As an organization, Badger will continue to make our voice heard in the conversation, which includes authoring and submitting comments and data to the FDA.
We will keep you updated on our progress. Folks should feel free to make full use of the comments section below; questions and discussions are encouraged. We will be there to support the discussion with additional data, as needed.
Badger Blog: Would any of the new FDA quality standard proposals alter the way Badger currently develops and manufactures its sunscreens?
JW: No, it wouldn’t. Badger has rigorous procedures for each step of the product development and release process. Badger also has a dynamic Quality Department that connects quality policy to each part of the process that brings the product to market, including testing, manufacturing, and third-party testing facilities. We take our commitment to the public seriously. We, like our customers, expect the highest quality product and that means that we must protect each part of the process that brings our products to market.
It is time for the FDA to create rules and standards that apply to each part of the sunscreen development and manufacturing process to hold industry accountable for the choices they make. The proposed FDA rules are comprehensive, make common sense and will better protect the public health.
Badger Blog: Thanks, Jamie! We appreciate you providing some clarity on the FDA’s new set of proposals for sunscreen safety and the ban on coral reef damaging chemicals.
Let’s keep the conversation going on this important topic! Feel free to comment below with your questions or suggestions. We’ll also do our part to keep you posted on any new developments.
Be sure to check out past Badger sunscreen blogs to learn more about how you can stay safe in the sun this summer: