Valisure Discovers Benzene in Sunscreens

The online pharmacy and independent testing company Valisure discovered the presence of the human carcinogen N-nitrosodimethylamine (NDMA) in Valsartan and Zantac and recently alerted the FDA to the presence of the human carcinogen benzene in many popular sunscreens.

Valisure’s Citizen Petition

 On May 24, 2021, Valisure filed a Citizen Petition with the U.S. Food and Drug Administration about its findings. As a result of the alarming levels of benzene discovered in a wide variety of sunscreens, including sprays and lotions, Valisure requested that the FDA “issue regulations, request recalls, revise industry guidance, and take other requested actions.”

Valisure tested and detected high levels of benzene in specific batches of sunscreen products containing active pharmaceutical ingredients, including: 

  • Avobenzone
  • Oxybenzone
  • Octisalate
  • Octinoxate
  • Homosalate
  • Octocylene
  • Zinc oxide

The Centers for Disease Control and Prevention (CDC) stated that the Department of Health and Human Services (HHS) determined that benzene can cause cancer in humans. The National Institute for Occupational Safety and Health recommends that workers wear protective equipment if they are going to be exposed to benzene at a concentration of 0.1 ppm because exposure can occur through “inhalation, skin absorption, ingestion, skin and/or eye contact.”

 The World Health Organization (WHO) and the International Agency for Research on Cancer (IARC) classified benzene as a Group 1 compound, which means that it is carcinogenic to humans based on sufficient evidence that benzene can cause acute myeloid leukemia (AML). IARC also noted that benzene exposure has been linked to acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), multiple myeloma, and non-Hodgkin lymphoma. Since benzene is associated with blood cancers such as leukemia, the fact that sunscreen’s ingredients are absorbed through the skin and into the bloodstream is especially concerning. The Citizen Petition stated: “The presence of this known human carcinogen in sunscreen products widely recommended for the prevention of skin cancer and regularly used by adults and children in large volumes makes this finding especially troubling.” 

The FDA also classifies benzene as a Class 1 solvent, stating that it “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.” The current benzene restriction is two parts per million (ppm). Although the current benzene restriction is 2 ppm, Valisure’s test results revealed that many sunscreens contained amounts of benzene well in excess of this limit.

Valisure provided the results of its testing in its Citizen Petition and included a list of sunscreens which did not contain detectable levels of benzene, demonstrating that sunscreen can be and is produced without unsafe levels of benzene.

Sunscreens with Benzene

Valisure’s testing detected benzene in the following sunscreens from various retailers: 

Neutrogena ***Benzene detected at 2 ppm or higher 

  • Ultra Sheer Weightless Sunscreen Spray, SPF 100+
  • Ultra Sheer Weightless Sunscreen Spray, SPF 70
  • Beach Defense Oil-Free Body Sunscreen Spray, SPF 100
  • Invisible Daily Defense Body Sunscreen Broad Spectrum, SPF 60+
  • Beach Defense Spray Body Sunscreen, SPF 50
  • CoolDry Sport Water-Resistant Sunscreen Spray, SPF 70
  • CoolDry Sport Water-Resistant Sunscreen Spray, SPF 50
  • Ultra Sheer Body Mist Sunscreen Broad Spectrum, SPF 30 Spray
  • Ultra Sheer Body Mist Sunscreen Broad Spectrum, SPF 45
  • Ultra Sheer Dry-Touch Water Resistant Sunscreen, SPF 70
  • Sheer Zinc Dry-Touch Face Sunscreen, SPF 50 

CVS Health ***Benzene detected at 2 ppm or higher

  • After-Sun Aloe Vera Soothing Spray 
  • Body Mineral Spray Sunscreen, SPF 50
  • Ultra Sheer Broad Spectrum Sunscreen Lotion, SPF 100 
  • Ultra Sheer Lotion Broad Spectrum Sunscreen, SPF 45
  • 70 Beach Guard Sun Sunscreen, SPF 70
  • Sport Clear Spray Sunscreen, SPF 100+
  • Sheer Mist Spray Broad Spectrum Uva/Uvb Cont. Spray Sunscreen, SPF 70

Sun Bum ***Benzene detected at 2 ppm or higher

  • Cool Down Gel 
  • Oxy Free Zinc Oxide Sunscreen Lotion, SPF 50 
  • After Sun Cool Down Aloe Vera Spray 

Fruit of the Earth ***Benzene detected at 2 ppm or higher 

  • Aloe Vera Gel 

Walgreens

  • Sport Lotion Sunscreen, SPF 50
  • Broad Spectrum Sport, SPF 50 Sunscreen 
  • Sunscreen Sport, SPF 50
  • After Sun Gel 

SunBurnt

  • Advanced After-Sun Gel 

Goodsense

  • Sunscreen Lotion, SPF 30

Banana Boat 

  • Kids Max Protect & Play Sunscreen C-Spray, SPF 100 
  • UltraMist Deep Tanning Dry Oil Continuous Clear Spray, SPF 4
  • Ultra Sport Clear Sunscreen Spray, SPF 100
  • Protective Dry Oil Clear Sunscreen Spray with Coconut Oil, SPF 15 
  • Ultra Defense Ultra Mist Clear Sunscreen Spray, SPF 100 
  • Kids Sport Sunscreen Lotion Spray, SPF 50 
  • Simply Protect Kids Sunscreen Spray, SPF 50+ 

Max Block

  • Sunscreen Lotion 4 Fl Oz Broad Spectrum Water Resistant, SPF 30
  • Sport Sunscreen Lotion Water Resistant Blue, SPF 30 

Raw Elements

  • Eco Formula Sunscreen Lotion, SPF 30

TopCare Everyday

  • Ultimate Sheer Sunscreen Lotion, SPF 70
  • Ultimate Sheer Sun Lotion Sunscreen, SPF 55
  • Sport Sunscreen Lotion, SPF 70

EltaMD

  • UV Aero Broad-Spectrum Full-Body Sunscreen Spray, SPF 45

Solimo

  • Sheer Face Sunscreen Lotion, SPF 55

Aveeno

  • Baby Continuous Protection Sensitive Skin Sunscreen Lotion Broad Spectrum, SPF 50

Coppertone

  • Whipped Sunscreen Lotion Spray, SPF 50

Ethical Zinc

  • Natural Clear Zinc Sunscreen SPF 50+

Babyganics

  • Kids Sunscreen Continuous Spray, SPF 50

La Roche Posay 

  • Anthelios Sunscreen Lotion Spray, SPF 60

Equate

  • Kids Broad Spectrum Sunscreen Lotion, SPF 50

Up & Up 

  • Clear Aloe Vera Gel 

Action Requested from the FDA

In their Citizen Petition, Valisure requested multiple actions from the FDA to amend the problem. Valisure requested that the FDA request recalls for the identified batches of sunscreens containing the benzene to protect public safety. In addition to the recalls, Valisure also wants the FDA to–at minimum–substantially lower the limit of 2 ppm of benzene because benzene should not be used at any point in manufacturing sunscreen. However, Valisure thinks that the FDA should go even further and revise the  rule to say that benzene “should not be employed in the manufacture of drug substances.” This would make it clear there is no acceptable level of benzene in consumer products such as sunscreen and after-sun care products. 

Currently, the FDA does not have any guidance on a permissible daily exposure for benzene in any drug product (including sunscreen) or cosmetic product (after-sun care products). Valisure urgently requests the FDA mandates a constant permissible daily intake or exposure limit due to the variability in product sizes and exposures per day that are common with an individual’s application of sunscreen and after-sun care products. This would guide users on the amount of sunscreen to use per application and how many daily applications are safe. 

Valisure requested that the FDA create rules or issue administrative orders requiring “independent batch-level testing and verification of sunscreen products” that are regulated as drugs by the FDA and/or revise the FDA’s proposed sunscreen rule in the Federal Register. In the meantime, Valisure urged the FDA to issue formal guidance recommending testing and verification to “serve public health and help protect Americans from adulterated drug products, an issue of growing concern.”

How GoldenbergLaw Can Help You

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Judge Denies Defendants’ Preemption Motions In Valsartan MDL

On December 17, 2020, U.S. District Judge Robert B. Kugler ruled that the plaintiffs’ claims are not preempted in the Valsartan contamination multidistrict litigation (MDL). This ruling makes sure that claims against manufacturers, wholesalers, and pharmacies will continue in the MDL over their alleged failure to keep contamination out of Valsartan. 

Specifically, Judge Kugler noted that the defendants failed to take into account the U.S. Supreme Court precedent that the states’ policing powers can supersede federal law if that was the clear intent of Congress.

What is the Preemption Argument from Valsartan Manufacturers?

Valsartan manufacturers have asserted that they were prohibited by federal regulations determined by the U.S. Food and Drug Administration (FDA) from warning consumers about the contamination within the drug. They claimed that they could not alter their manufacturing process without FDA approval in addition to the Food, Drug and Cosmetic Act and the Drug Supply Chain Security Act (DSCSA)’s requirements which they claim can only be enforced by the government. 

Valsartan manufacturers, wholesalers, and pharmacies such as Teva Pharmaceuticals USA Inc., Mylan Pharmaceuticals Inc., AmerisourceBergen, Cardinal Health Inc., CVS and Walgreens all made the preemption argument.

Background on Preemption Arguments

Preemption arguments stem from the Supremacy Clause of the U.S. Constitution. It states that when state and federal law conflict, the federal law preempts (overpowers) state law. In the case of prescription drugs, Congress has allowed the U.S. Food and Drug Administration (FDA) to set the minimum national standards; therefore, their powers are viewed as federal law. The FDA has the primary responsibility to review the safety, efficacy, and labeling of medical products. 

Regarding drug manufacturers, states usually cannot penalize drug manufacturers for not including a warning that the FDA has already deemed to be unnecessary as long as the manufacturer follows all of the FDA’s other guidelines. Therefore, manufacturers cannot be held accountable to differing laws and regulations that may be enacted in 50 different states. 

The federal drug labeling preemption argument is based on the requirement that the brand-name drug has been tested and vetted by the FDA prior to entering the market. Since generic drugs are required by federal law to be a bioidentical drug, the argument is that different warnings are unnecessary and that generic manufacturers therefore cannot be held responsible for failing to provide additional or different warnings regarding their medication.

Injuries from Contaminated Valsartan

Valsartan’s contamination with the probable human carcinogen N-nitrosodimethylamine (NDMA) can create an increased risk for the following cancers: 

  • Bladder Cancer
  • Blood Cancer 
  • Breast Cancer
  • Colorectal / Intestinal Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Kidney Cancer
  • Liver Cancer
  • Lung Cancer 
  • Pancreatic Cancer
  • Pharyngeal Cancer
  • Prostate Cancer
  • Uterine Cancers 

What Was Judge Kugler’s Reasoning Behind The Ruling?

Judge Kugler explained that Congress’ intent in passing the DSCSA was to protect consumers from exposure to drugs that may be “counterfeit, stolen, contaminated or otherwise harmful” by creating a national system for product tracing. He determined that the DSCSA does not preempt state requirements pertaining to aspects of distributing drugs: “Although the preemption clause seeks to eliminate inconsistent state regulations related to tracing of pharmaceuticals, Congress did not enact the DSCSA in an effort to displace all state law regarding defective pharmaceutical drugs. Under the defendants’ view of the Act, Congress would have barred most, if not all, relief for persons injured by defective pharmaceuticals.”  

Judge Kugler added that there is no danger of inconsistent rulings since the FDA has already researched the cause of the contamination sufficiently to develop an understanding about the chemical processes involved in creating it.

How Does It Impact the Valsartan MDL?

Valsartan MDL Judge Kugler’s rejection of the defendants’ dismissal motion based on the preemption argument is a boost for the plaintiffs in the Valsartan MDL. The personal injury, economic loss, and medical monitoring lawsuits that are at stake in the MDL may continue to move forward due to this ruling. 

GoldenbergLaw Can Help

If you or a loved one has been diagnosed with cancer after taking the blood pressure medication Valsartan, contact the Dangerous Drug Attorneys at GoldenbergLaw for a free consultation. With thirty-four years of experience, we have the knowledge, experience, and compassion to give you the Gold standard of advocacy that you deserve. Contact us today to discuss a free Valsartan lawsuit consultation and leave the sleepless nights to us!

NDMA: What Is it and Why Should I Be Concerned?

Many lots of the drug Valsartan were recalled last year due to the contamination of n-nitrosodimethylamine (NDMA), a known animal carcinogen and a probable human carcinogen. More recently, a number of manufacturers recalled their Zantac and ranitidine products due to the belief that the drugs can naturally produce high levels of NDMA as a byproduct of the digestion process.  In May 2020, the Food and Drug Administration (FDA) announced it had found high levels NDMA in certain batches of the type-2 diabetes drug Metformin. Many individuals don’t know what NDMA is or how it can impact their health and lifestyle. Here we’ll explore what it is and why the recall was necessary.

Do I Have a Zantac Case?

Do I Have a Valsartan Case?

Do I Have a Metformin Case?

What Is NDMA?

NDMA is a semi-volatile organic chemical that can form naturally or unintentionally through industrial processes. Unintentional NDMA can form as a byproduct of the chlorination of wastewater and drinking water. This process led NDMA to be found in Valsartan tablets produced by four different facilities:  Zhejiang Huahai Pharmaceuticals in China, Hetero Labs Limited in India, Aurobindo Pharma in India, and Mylan Laboratories, Ltd. in India.

NDMA can also be formed through natural processes. Ranitidine, the active ingredient in Zantac, has a molecular structure that makes it susceptible to naturally creating NDMA once it is ingested. Specifically, the ranitidine compound contains the two elements that are required to form NDMA: nitrite (“N”) and dimethylamine (“DMA”). The presence of both nitrite and dimethylamine in ranitidine’s chemical structure renders it highly capable of producing NDMA under the right conditions.

A recent independent study conducted by Valisure Online Pharmacy sought to understand how capable ranitidine was of naturally producing NDMA. During the testing, Valisure simulated the conditions that ranitidine is exposed to in the human stomach to see how the ranitidine would react; namely, they mixed ranitidine with the gastric fluid and sodium nitrites that stimulate the digestion process. They found that when the ranitidine interacts with the gastric fluid and sodium nitrites found in the stomach, high amounts of NDMA are produced. In fact, when exposed to the simulated stomach conditions, the ranitidine produced approximately 304,500 nanograms (ng) of NDMA per tablet. This is an alarming amount of NDMA, considering the FDA-approved acceptable amount of NDMA intake is 96 ng per day.

Concerns about the molecular generation of NDMA associated with ranitidine have led to several recalls of ranitidine products.

In September 2019, there were voluntary recalls by Sandoz, Inc. and Apotex Corp. The Sandoz ranitidine recall involves 14 lots of prescription capsules, while the Apotex ranitidine recall involves all of its 75mg and 150mg over-the-counter capsules. Many of the Apotex capsules were labeled and sold by popular pharmacies Walgreens, Wal-Mart, and Rite-Aid.

In October 2019, numerous additional voluntary recalls have been announced. On October 23rd, it was announced the Dr. Reddy’s Laboratories Ltd and Sanofi would be recalling ranitidine products. The Dr. Reddy’s recall involves all prescription and over-the-counter capsules manufactured by the company, while Sanofi issued a recall of its over-the-counter ranitidine. On October 28th, it was announced that Perrigo Company, Novitium Pharma LLC, and Lannett Company, Inc. would be recalling ranitidine products as well due to the presence of NDMA. Perrigo Company is recalling all over-the- counter ranitidine tablets; Novitium Pharma is recalling all ranitidine hydrochloride capsules; and, the Lannett Company recall involves all lots of prescription ranitidine syrup.

While several recalls have already occurred, several other countries, including Canada, have taken further action by ordering complete recalls of all Zantac and ranitidine products.

In December 2019, the regulators for multiple global health organizations began testing samples of the type 2 diabetes drug metformin for NDMA contamination. As of December 5, 2019, there has been no metformin recall in the United States. The FDA said in a statement that it has not confirmed any NDMA contamination of metformin sold in the United States, but that any contamination detected beyond the acceptable daily intake limit will lead to recommended recalls. Singapore’s Health Sciences Authority announced on December 4 that is was recalling three metformin medications due NDMA contamination.

In March 2020, Valisure filed a citizen petition with the FDA after it found high levels of NDMA in certain batches of metformin. The citizen petition described Valisure’s testing protocols that improved the accuracy of its tesdting and requested the agency recall the contaminated metformin. On May 27, 2020, the FDA announced it had found high levels of NDMA in some versions of metformin. The agency said it would be in contact with the manufacturers of the contaminated batches to determine the appropriate next steps.

Metformin is manufactured as a generic by multiple global pharmaceutical companies. Popular brand name drugs sold in the United States that contain metformin include Fortamet, Glucophage, Glucophage XR, Glumetza, and Riomet.

What Are the Effects?

NDMA can contaminate drinking water and humans often get NDMA exposure from consuming food or drink that was contaminated with NDMA. Exposure to NDMA in Valsartan can cause prostate cancer, lower esophageal cancer, non-hodgkins lymphoma, leukemia, multiple myeloma, colon, stomach, intestinal, or pancreatic cancer. Even small amounts of exposure can lead to liver damage. Exposure to NDMA in ranitidine has been linked to a number of cancers including stomach cancer, cancer in the small and large intestines, colorectal cancer, esophageal cancer, kidney cancer, bladder cancer, liver cancer, prostate cancer, pancreatic cancer, leukemia, non-hodgkin’s lymphoma, and multiple myeloma.

Classified as a Carcinogen

The EPA classifies NDMA as a B2 carcinogen, meaning it is a probable human carcinogen. B2 carcinogens do not have enough human data but have a sufficient amount of animal data to conclude that it’s a potential carcinogen. Many animal studies were done to test NDMA, and they found that various species, including rats and mice, developed tumors in the liver, respiratory tract, and blood vessels after exposure to NDMA. The U.S. Department of Health and Human Services believes that NDMA is “reasonably anticipated to be a human carcinogen.”

Contact GoldenbergLaw

If you or a loved one contracted cancer after taking Valsartan, ranitidine, or metformin, contact the dangerous drug attorneys at GoldenbergLaw. We are committed to promoting safety through accountability.