08.07.19

Leahy Joins Senator Blumenthal And Four Others In Demanding That FDA Direct Sunscreen Makers To Clearly And Accurately Inform Consumers About Their Products

(WEDNESDAY, Aug. 7, 2019) -- In a letter on Wednesday, Senator Patrick Leahy (D-Vt.) joined Senator Richard Blumenthal (D-Conn.) and four other senators in calling on the Food and Drug Administration (FDA) to swiftly implement new regulations requiring that non-prescription, commercially-available sunscreens are safe, effective, and labeled clearly and accurately. Although experts agree that sunscreen is vital to protect skin from the sun’s potentially harmful UV rays, the sunscreen industry has previously been largely unregulated – allowing manufacturers to confuse consumers with unsupported claims about their product’s efficacy, or sell sunscreens that include potentially dangerous and untested ingredients.

“In large part, the cumulative effects of most sunscreen ingredients on human health and the natural environment remain unknown, leaving consumers with a dizzying array of conflicting information. Given the increased vulnerability of children, pregnant women, and other populations to chemical exposure, rigorous testing on the systemic absorption of sunscreen ingredients is needed to ensure that these products are safe for routine long-term use,” wrote the senators.

Using new authority granted under the Sunscreen Innovation Act, the FDA has proposed regulations to establish stronger safety standards and oversight of nonprescription sunscreens. Once finalized, the sunscreen rule would:

  • Assess the safety and efficacy of twelve common active ingredients used in sunscreen for which data is lacking;
  • Propose safe and effective dosages of sunscreen;
  • Change the maximum proposed sun protection factor or “SPF” on product labels to 60+;
  • Require that SPF 15+ sunscreens provide broad-spectrum protection against UVA and UVB rays;
  • Require clear labeling of key active ingredients on packaging so that consumers can make informed choices;
  • Allow the FDA to assess industry compliance; and
  • Deem products that combine sunscreen and insect repellent as not recognized as safe.

In addition to Blumenthal and Leahy, the letter was signed by Senators Chuck Schumer (D-N.Y.), Edward Markey (D-Mass.), and Jeffrey Merkley (D-Ore.).

The full letter to FDA Acting Commissioner Sharpless is available here and below:

 
 

August 7, 2019

Dear Acting Commissioner Sharpless:

We write to urge swift implementation of the Food and Drug Administration’s (FDA) sunscreen rule. This proposed regulation will ensure that non-prescription, commercially-available sunscreens are safe, effective, and properly labeled. We support the FDA’s decision to investigate the efficacy and long-term health effects of over-the-counter sunscreens. The public deserves the truth about these largely unregulated products and their impacts on public health.

Over 90 percent of the 5 million skin cancer diagnoses each year have been linked to ultraviolet (UV) ray exposure.[1] Experts agree that sunscreen is a life-saving product that protects skin from the sun’s potentially harmful UV rays, which can increase the risk of skin cancer and sunburn.[2] When combined with other proactive methods like limiting time spent in direct sunlight and wearing protective clothing, most sunscreens decrease the prevalence of short- and long-term effects of sun exposure.

However, a curious paradox has emerged: sunscreen is more widely- and frequently-used than ever, but the rate of skin cancer cases in the United States is increasing.[3] Some experts are concerned that certain sunscreen ingredients may be absorbed into skin and bloodstreams, accumulating in the body over time and in certain cases potentially resulting in hormone disruption, skin irritation, or even skin cancer.[4],[5] In large part, the cumulative effects of most sunscreen ingredients on human health[6] and the natural environment[7] remain unknown, leaving consumers with a dizzying array of conflicting information. Given the increased vulnerability of children, pregnant women, and other populations to chemical exposure,[8] rigorous testing on the systemic absorption of sunscreen ingredients is needed to ensure that these products are safe for routine long-term use.

In November 2014, the Sunscreen Innovation Act was enacted, directing the FDA to establish a new process to review the safety and effectiveness of the active ingredients in nonprescription sunscreens.[9] As a result, the FDA released a proposed rule entitled “Sunscreen Drug Products for Over-the-Counter Human Use,” also known as the sunscreen rule, earlier this year.[10] This proposed rule will bring over-the-counter sunscreens up-to-date with the latest science, helping to keep the public well-informed and healthy.

Specifically, the sunscreen rule will: (1) assess the safety and efficacy of twelve common active ingredients used in sunscreen for which data is lacking, including: avobenzone, homosalate, octinoxate, octisalate, octocrylene, and oxybenzone; (2) propose safe and effective dosages of sunscreen; (3) change the maximum proposed sun protection factor or “SPF” on product labels to 60+; (4) require that SPF 15+ sunscreens provide broad-spectrum protection against UVA and UVB rays; (5) require clear labeling of key active ingredients on packaging so that consumers can make informed choices; (6) allow the FDA to assess industry compliance; and (7) deem products that combine sunscreen and insect repellent as not recognized as safe.

Consumers deserve transparent, truthful information regarding their sunscreen products. As such, we were pleased to see the FDA’s recent action to address the safety and efficacy of sunscreens to keep consumers safe and informed. We strongly urge you to finalize the FDA’s sunscreen rule in its current form and reject any attempts to weaken this critically important effort, specifically with regard to ingredient evaluations and clearer sunscreen labels.

Thank you for your attention to this important matter. We respectfully request a response by September 5, 2019.

Sincerely,

Press Contact

David Carle: 202-224-3693