Will FDA Recall Contaminated Sunscreen?
Valisure Asks The FDA To Recall Sunscreen Due To The Presence of Carcinogen
After conducting tests, the independent research company Valisure, LLC determined that 78 sunscreens and aftercare products contain benzene, a dangerous carcinogen. The Food and Drug Administration (FDA) classifies sunscreen as a drug subject to their regulations. The FDA also regulates aftercare products such as lotions under the category of cosmetics.
Some of the products tested contained high levels of benzene, which is an industrial chemical known to cause cancer. Valisure has sent a citizen petition to the FDA, asking the agency to recall the contaminated batches of sunscreen. Valisure would also like the FDA to revisit its guidelines regarding benzene in cosmetics and drugs.
What is Benzene?
Benzene is an industrial chemical solvent widely used in the US. According to the CDC, it is one of the top 20 chemicals for production volume.
Benzene is often used to create other chemicals, which are then used to make resin, plastics, nylon, and synthetic fibers. Benzene can also be used to make pesticides, lubricants, detergents, dyes, rubber, and drugs.
The National Institute of Occupational Safety and Health identifies several types of exposure to benzene that can be harmful: inhalation, digestion, skin absorption, eye contact, and skin contact.
Exposure to benzene can cause cancer, Leukemia, in particular. The chemical damages the bone marrow and decreases your body’s ability to make red blood cells. Anemia, cancer, and infections can result. Studies have also shown that exposure to benzene can affect a woman’s menstrual cycle and ovaries. Studies of animals indicate that inhaling benzene while pregnant affected the growth and bone marrow of animal fetuses.
Why is Benzene in Sunscreen?
Valisure has asked the FDA this very question. The rules about benzene state that it is a:
“Class 1 solvent” that “should not be employed in the manufacture of drug substances, excipients, and drug products because of their unacceptable toxicity … However, if their use is unavoidable in order to produce a drug product with a significant therapeutic advance, then their levels should be restricted,” and benzene is restricted under such guidance to 2 parts per million (“ppm”).”
This means that the FDA allows benzene in sunscreen if using benzene is unavoidable to produce the product. If it is unavoidable, benzene must be limited to 2ppm.
According to Valisure:
- many of the sunscreens it tested and aftercare sun products contained benzene levels significantly higher than 2ppm.
- many of the sunscreens it tested contained NO benzene, which suggests benzene is NOT necessary to the production of sunscreen. Using benzene is avoidable.
Valisure Asks the FDA to Recall Dangerous Sunscreens
In its petition, Valisure has asked the FDA to recall the batches of sunscreen and after-sun products containing high levels of benzene, a known human carcinogen. Valisure claims these products are “misbranded” and “adulterated.”
Valisure also wants the FDA to:
- Investigate the manufacturing and process and documentation regarding sunscreen and aftercare products and adjust their labels accordingly.
- Share information with the public about sunscreens not adulterated with benzene and the importance of using safe sunscreen to prevent skin cancer.
- Develop guidance to analyze the use of benzene in sunscreen and related products
- Revisit and revise and clarify its guidance regarding the use of benzene in drugs and cosmetics, including sunscreen, that does not require benzene for manufacturing.
- Work with the Environmental Protection Agency to develop an initiative to address benzene contamination.
Will the FDA Recall Contaminated Sunscreen?
Valisure presented its petition to the FDA on May 24, 2021, and set forth what seems to be a logical argument supporting its request for a recall.
The FDA recommends the daily application of sunscreen to protect people from harmful UV rays. The FDA also prohibits the use of benzene in drugs unless it is unavoidable. If unavoidable, benzene must not exceed 2ppm. There is no controversy regarding the danger of benzene, and according to Valisure, it is unnecessary to use benzene in sunscreen products.
The frequency of sunscreen application and its absorption into the skin makes the presence of benzene in any amount particularly worrisome. Valisure has requested the FDA act promptly “given the high potential risk to public safety.”
Our Lawyers at Alonso Krangle, LLP represent victims injured by dangerous drugs and consumer products. If you or a loved one was diagnosed with cancer after possible exposure to benzene, call our office to schedule a free case evaluation and learn about your legal rights.
You might be entitled to collect compensation. Call Alonso Krangle, LLP today at 800-403-6191.