Frequently Asked Questions on Benzene Contamination in Drugs
Q: What is benzene?
A: Benzene is a chemical used in the production of a wide range of industrial products, including chemicals, dyes, detergents, and some plastics. Benzene is released into the air in cigarette smoke, emissions from automobiles, and burning coal and oil.
Q: What should consumers know about drugs being recalled for benzene contamination?
A: Certain hand sanitizers and aerosol (spray) drugs, including antiperspirants and sunscreens, have been recalled due to benzene contamination.
Consumers should stop using products that have been recalled as well as those hand sanitizers FDA recommends consumers should not use, including hand sanitizers tested by FDA and found to contain unacceptable levels of benzene.
Q: What is the risk from using drugs contaminated with benzene?
A: The health consequences of benzene exposure depend on the amount, route, and length of time of exposure, as well as age and preexisting medical conditions. FDA recommends consumers do not use products that are being recalled or those hand sanitizers FDA recommends consumers should not use.
In small amounts over long periods of time, benzene can decrease the formation of blood cells. Long term exposure to benzene through inhalation, oral intake, and skin absorption may result in cancers such as leukemia and other blood disorders.
FDA continues to monitor the quality of drugs and, when appropriate, encourages retailers to remove products from store shelves and online marketplaces when issues arise.
Q: Should consumers continue using sunscreen?
A: Yes. Sun safety is important for everyone and all skin colors, and consumers can reduce risks from sun exposure with continued use of sun protection measures, including sunscreen. FDA recommends consumers use broad spectrum sunscreens with SPF values of at least 15, which have been shown to reduce the risk of skin cancer and early skin aging when used with other sun protection measures. These kinds of sunscreens are only one element of a skin-cancer prevention strategy that should also include other sun protective behaviors such as wearing protective clothing that adequately covers the arms, torso, and legs; wearing sunglasses and a hat that provides adequate shade to the whole head; and seeking shade whenever possible during periods of peak sunlight. Medical authorities such as the Center for Disease Control and Prevention, the American Academy of Dermatology, and major physicians’ associations endorse similar recommendations. More about sun protection and sunscreens can be found on the FDA website. Pregnant women and persons concerned about using sunscreens on infants or children are encouraged to consult their health care professional. In addition, FDA recommends consumers do not use recalled sunscreen products.
Q: What is FDA doing to protect consumers from drugs contaminated with benzene?
A: FDA is committed to ensuring drugs Americans use are safe and effective. FDA continues to monitor the issue of benzene in drugs and is proactively working with companies, when appropriate, to recall products and encourage retailers to remove products from store shelves and online marketplaces when quality issues arise. FDA is evaluating the root cause of benzene contamination and has alerted companies to the risk of benzene contamination in drug products and reminded them of their obligation to ensure their products meet appropriate quality specifications. We continually gain additional knowledge about drugs which allows us to identify and quickly address previously unknown risks to consumers. FDA will communicate new information as it becomes available.
Q: Is benzene in drugs a new problem? Why have there been so many recent reports of drugs containing benzene?
A: While benzene is not usually used in the manufacture of drugs, the contamination may be related to inactive ingredients in drugs such as carbomers (thickening agents), isobutane (a spray propellant), or other drug components made from hydrocarbons (chemicals made of hydrogen and carbon).
FDA has recommended the United States Pharmacopeia (USP) remove (or “omit”) certain carbomer monographs from their compendium that allow for unacceptable levels of benzene (a USP monograph is a written document that provides the quality expectations for a medicine or ingredient). FDA and USP are working on the official removal of those carbomers and are planning to provide manufacturers with a period of time to reformulate products using safer drug components to avoid causing supply disruptions from the immediate removal of the carbomer monographs.
The agency has also alerted drug manufacturers to the risk of benzene contamination in certain drugs. This alert has resulted in, among other things, several recent recalls of drugs containing unacceptable levels of benzene.
FDA has ongoing assessment, surveillance, compliance and pharmaceutical quality efforts across every product area, and we will continue to work with drug manufacturers to ensure the availability of safe and effective drugs for the American public.
Q: Why did FDA not immediately alert manufacturers to the potential of benzene in drugs if this was a concern brought to FDA in March 2021?
A: FDA has been working with companies to address benzene issues in drugs prior to March 2021, including through recalls. In 2020, FDA identified the potential for unacceptable levels of benzene in certain carbomers (which may be used as thickening agents in drugs) based on the allowable limits in USP monographs. FDA has been in communication with USP about removing (or omitting) those carbomer monographs from their compendium since late 2020.
In March 2021, FDA received a citizen petition raising concerns about the level of benzene in certain hand sanitizers and other products. Subsequently, two other petitions were filed raising concerns about the level of benzene in spray sunscreens, spray antiperspirants, and other drug and cosmetic products. FDA evaluates and assesses the information provided in citizen petitions of this type and, if appropriate, initiates an independent testing and verification process. This process includes securing product samples and performing independent evaluation of collected samples to assess the data presented in the citizen petition. If FDA’s testing raises any safety concerns, then FDA will work with manufacturers to address those concerns. We are going through that process with each of these citizen petitions. During this time, FDA has also been working with companies on multiple recalls related to the identification of unacceptable levels of benzene in drugs.
Q: What should manufacturers know about benzene in drugs?
A: FDA has alerted drug manufacturers to the risk of benzene contamination from drug components and other potential risk factors. Manufacturers should generally not use benzene in the manufacture of drugs. The International Conference on Harmonization (ICH) Q3C Impurities: Residual Solvents guidance describes limited cases where the presence of benzene may be tolerated.
Drug manufacturers are required to ensure the safety and quality of their drugs. As FDA works to better understand the potential sources of benzene in drugs, FDA reminds manufacturers of drugs marketed under approved applications and manufacturers of other drugs, including over-the-counter monograph drug products, of their obligation to ensure their products conform to appropriate quality specifications.
Drug manufacturers with a risk for benzene contamination should test their drugs accordingly and should not release any drug product batch that contains benzene above 2 ppm, consistent with the recommendations described in ICH Q3C. Drug manufacturers should contact FDA using the information provided in FDA’s alert if their testing reveals benzene in a product.