Many United States sunscreen makers have been trying to get approval from the Food and Drug Administration to use certain ingredients in their products since 2002, but the agency has yet to approve a single application for sunscreen ingredients — despite passing a law in 2014 aimed at streamlining and expediting the process — and wants to force companies into performing animal tests on their products first.
According to a U.S. Government Accountability Office report released last month, all applications for sunscreen active ingredients, many of which have been widely used outside of the United States for decades, are still pending because the FDA has requested additional information to determine that the ingredients are generally recognized as safe and effective (GRASE). Only then can the ingredients be added to the sunscreen monograph and sold in the U.S. without the FDA’s premarket approval. In order to get their applications approved, however, the agency is asking companies to perform slow, ineffective and expensive animal tests and is refusing to accept safety data from the companies’ more effective, non-animal testing methods.
Sponsors and stakeholders of some of the sunscreen applications have pointed out several concerns with the FDA’s standards, citing the following reasons for their uncertainty on conducting the tests and/or their decision not to do so:
- Return on investment. The testing FDA requested is extensive, would cost millions of dollars, or take several years to conduct, according to sponsor representatives. Some stakeholders and sponsor representatives said that sponsors are currently working to develop newer sunscreen ingredients and are therefore reluctant to invest in the testing FDA requested for the older ingredients covered by the pending applications.
- Alternatives not accepted. Some sponsor representatives and stakeholders said that when they proposed alternative testing methods for absorption, for example, the agency rejected the alternatives.
- Animal testing. One stakeholder and some sponsor representatives reported concerns about the effect that the animal testing requested by FDA may have on companies’ marketing of sunscreen products worldwide. Additionally, one stakeholder and representatives from one sponsor expressed concern that sunscreen manufacturers may face backlash from animal rights groups and shareholders if animal testing is conducted.
In addition to the high cost of the animal tests the FDA is attempting to force these companies to conduct, they would also likely involve smearing the substance on animals’ skin, force-feeding it to them every day for two years and exposing pregnant animals to see its effects on fetuses and offspring — practices a record number of Americans appear to oppose. However, a taxpayer watchdog group made up of small-government, fiscal conservatives and animal rights activists is working with Congress to change these requirements.
White Coat Waste Project (WCWP) has been in communication with several members of Congress in regard to bipartisan legislation called the Federal Accountability in Chemical Testing (FACT) Act, which if enacted into law would “improve reporting by EPA, FDA, NIH, USDA and other government agencies about their efforts to replace inefficient, multi-million-dollar animal tests with faster, less costly and more effective alternative methods for assessing the safety of chemicals, drugs, foods, cosmetics and other substances.” The bill currently has 65 co-sponsors in the House and is expected to be introduced in the Senate early next year, according to the group.
“Big government is the biggest problem when it comes to animal testing,” Anthony Bellotti, founder and president of WCWP, said in a statement to Rare. “Uncle Sam wastes billions of tax dollars each year on cruel, ineffective and bizarre animal experiments that most Americans oppose, and imposes stifling, irrational and burdensome regulations that force companies to pay for multi-million-dollar animal tests when they’d prefer to use alternatives that are cheaper, faster and more effective.”