With 30 years of clinical dermatology research under her belt, Draelos responds to recent benzene and BPO news in this Q&A.
Zoe Diana Draelos, MD, is a consulting professor of dermatology at Duke University School of Medicine in Durham, North Carolina, and Dermatology Times' Editor in Chief Emeritus. Draelos is a clinical and research dermatologist with 30 years of clinical dermatology research experience and has studied the safety and efficacy of numerous over-the-counter cosmetics and drugs. Additionally, Draelos has expertise in designing research protocols.
Following the news of Valisure LLC's Citizen's Petition to the US Food and Drug Administration (FDA) regarding its findings of high levels of benzene in benzoyl peroxide (BPO)- containing skin care products, Draelos reached out to Dermatology Times to provide her concerns with the findings and Valisure's testing methods.
Dermatology Times has previously spoken with Valisure's president and co-founder David Light, as well as Christopher Bunick, MD, PhD, to discuss methods and data. Read more here.
"This is a major issue for dermatology as BPO is one of our most effective acne drugs and has been used for years with great safety. It is well known that BPO is unstable and that it must be specially handled and packaged. I think it needs to be stated that prescription drugs or OTC drugs that contain BPO carry labeling noting how the product is to be properly stored for safety reasons," Draelos said. "Subjecting BPO to temperatures above those recommended on the packaging is not appropriate. The current news stores questioning the safety of BPO under heated conditions outside the recommended range resulting in benzene production is not good science and should be disregarded."
Q: What is your initial reaction to the findings from Valisure?
A: Valisure created artificial conditions under which benzoyl peroxide was placed. I am not sure why anyone would cook BPO preparations for 10 days and then look for benzene. All drugs must be stored according to packaging conditions.
Q: How do research labs approach testing consumer products for potential benzene/other contamination? With this, could you speak to the role of stability testing for such consumer products?
A: BPO is a well known unstable substance. It is a pro-oxidant. This is how it kills c. acnes on the skin surface. All large manufacturers have standard operating procedures in place to test for purity of ingredients prior to product manufacture.
Q: With recent concerns about benzene contamination in consumer products, what steps should research labs take regarding methodologies or protocols to stay ahead of emerging risks?
A: Consumer product testing labs should test products under the conditions that are specified for consumer storage. Most drugs will break down when exposed to high heat for extended periods of time.
Q: In light of the recent benzene news, how do you communicate risk assessments and findings to relevant stakeholders, such as regulatory agencies, industry partners, and consumers?
A: It is crucial to stress to consumers that drugs must be stored under specified conditions labelled on the tube. Drugs should not be left in a hot car in the summer.
Q: What role do you believe research labs play in addressing public health concerns related to chemical contaminants like benzene in everyday products, and how would you advocate for greater awareness and action in this area?
A: I think contaminants and break down products should only be assessed in drugs that are properly stored. This is critical. For example, if you store milk at 122 degrees F for 10 days it will break down, spoil, and become contaminated. The milk was not refrigerated as it states on the milk container. Drinking this milk that was not properly stored may make you sick and will have all types of breakdown ingredients and contamination.
Q: What should dermatologists and consumers be aware of regarding these findings? What actions, if necessary, should they take?
A: I do not think there is any need for action regarding the Valisure findings. The take home message here is do not leave BPO in a hot car for extended periods of time.
Q: Is there anything we didn’t ask that you would like to expand on?
A: I would like to know the motivation behind the Valisure testing. Who will benefit from this type of information? BPO is a prescription and OTC drug. It is a drug because it has to be used carefully and stored carefully. Most drugs will breakdown if cooked for extensive periods of time, which is why the labeling contains temperature instructions.
What are your thoughts on recent benzene news as more data and insights emerge? Email us at DTEditor@mmhgroup.com.
