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FDA to Make Major Decision About Flavored E-Cigarettes

Posted on September 9, 2021September 8, 2021

The Food and Drug Administration (FDA) is currently reviewing millions of applications from e-cigarette makers and must decide today if flavored e-cigarettes are “appropriate for the protection of public health.”

Use of Flavored E-Cigarettes

A study from the Centers for Disease Control and Prevention (CDC) revealed that roughly 15 percent of adult smokers successfully quit smoking using e-cigarettes. Additionally, a study in the New England Journal of Medicine found that, of those smokers who quit, 18 percent remained cigarette-free after a year.

Despite these positives, e-cigarettes have caused notable harm to public health. Lawmakers and public health advocacy groups focus on vaping’s appeal to teens and even children. A 2020 study from the CDC determined that nearly 20 percent of high school students and 5 percent of middle school students had vaped regularly. These users primarily partake in flavored e-cigarettes.

Because of this usage by America’s youth, several lawmakers and state attorneys general have urged the FDA to ban all flavors, including menthol. The agency has already banned the sale of reusable flavored e-cigarettes sold by companies like JUUL, but it currently allows the sale of disposable flavored products.

E-Cigarettes As A Cessation Device

Most public health experts agree that some kind of e-cigarettes should be available to help wean adults from cigarettes. However, anti-vaping advocates believe that flavors are unnecessary to sell e-cigarettes to individuals trying to quit smoking. After all, they are already familiar with tobacco-flavored products.

Plus, many of these businesses don’t play by the rules. “No one has attempted to file applications or legally market these products [before now]. No one has filed applications to make modified risk claims legally,” explains Desmond Jenson, a lawyer at the Public Health Law Center at the Mitchell Hamline School of Law. “The whole idea that e-cigs are a cessation device — why has no company filed a drug application to say it’s a cessation device?”

For more information about the investigation into flavored vaping products, contact us today.

Additional Reading:

FDA Removes 55,000 Flavored Vaping Products From Market

North Carolina Takes Legal Action Against JUUL

JUUL Labs Faces “Substantive Scientific Review” from the FDA

E-Cigarette, Vaping, and Juul Bans

FDA Removes 55,000 Flavored Vaping Products From Market

Posted on September 2, 2021September 2, 2021

Last week, the Food and Drug Administration (FDA) ordered three small e-cigarette makers to pull their products from the market, signifying the beginning of a larger agency crackdown on vaping products. JD Nova Group LLC, Great American Vapes, and VaporSalon must pull 55,000 existing or future flavored products from stores. These products include flavors like Apple Crumble, Dr. Cola, and Cinnamon Toast Cereal.

FDA Crackdown Against Flavored Vaping Products

According to regulators, the companies failed to provide “sufficient evidence” that their products offer a net public health benefit for adult smokers when compared to the “threat posed by the well-documented, alarming levels of youth use” of flavored vapes. These FDA orders mark the agency’s first marketing denials for e-cigarettes. “We know that flavored tobacco products are very appealing to young people, therefore assessing the impact of potential or actual youth use is a critical factor in our decision-making about which products may be marketed,” Janet Woodcock, acting commissioner of the FDA, said in a statement.

Of course, the agency’s orders come during a broader fight against the future of vaping. Public health advocates believe that e-cigarettes, especially flavored ones, have spurred an epidemic of nicotine-addicted youth rather than helping adults quit smoking. The FDA will determine the future of about two million vaping and other non-cigarette tobacco products by September 9th.

Vaping advocates, however, are alarmed at the FDA’s decision and shared a warning that the broader industry is in danger. As one tweet stated, “FDA bans 55,000 flavored e-cigarette products, crippling three vape companies. FDA clams applicants failed to demonstrate they are a net benefit to public health. No worries though, people can just switch back to smoking! #publichealth”

E-Cigarettes and America’s Youth

The focus here lies in potential danger to America’s young people. As the FDA prepares to rule on JUUL and other major companies, a regulator stressed that the agency would be carefully considering the potential risk to children. “Companies who want to continue to market their flavored [e-cigarette] products must have robust and reliable evidence showing that their products’ potential benefit for adult smokers outweighs the significant known risk to youth,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said.

For more information about the investigation into flavored vaping products, contact us today.

Additional Reading:

Judge Advances Bellwether Lawsuit Against JUUL for Deceiving Marketing Tactics

North Carolina Takes Legal Action Against JUUL

JUUL Labs Faces “Substantive Scientific Review” from the FDA

E-Cigarette, Vaping, and Juul Bans

Bladder Cancer Linked to Zantac Use in Recent Study

Posted on August 9, 2021August 9, 2021

Hundreds of plaintiffs have filed lawsuits arguing that, after years of using heartburn medication Zantac (ranitidine), they were diagnosed with bladder cancer. Now, a recent study supports their claims: The American Journal of Gastroenterology published research that indicates that users of Zantac products may face a higher chance of developing bladder cancer.

Link Between Ranitidine Use and Bladder Cancer

The new study looked at information from patients diagnosed with bladder cancer in Scotland between 1999 and 2011. Researchers matched the participants up with controls based on their age, gender, and general practice records. They ultimately gathered data on 3,260 cases of bladder cancer and 14,037 controls, showing that ranitidine users have a 22 percent higher risk of bladder cancer than non-users. The risk increased further if patients used the drug for over three years.

It’s important to note that these risks were not seen with proton pump inhibitors, another class of heartburn drugs. Examples include Nexium and Prilosec.

Although research linking Zantac and bladder cancer is in its early stages, there have been other studies that look at how ranitidine may increase levels of known carcinogen N-nitrosodimethylamine (NDMA) in the body. In a study from 2016, researchers collected urine samples from adult volunteers over a 24-hour period, both before and after taking 150mg of ranitidine. They then reviewed the samples for residual ranitidine, NDMA, and other nitrosamines. After ranitidine intake, urinary levels of NDMA increased 400-fold, while total N-nitrosamines increased 5-fold. Study authors noted that these rates “equaled or exceeded those observed in patients with schistosomiasis, a disease in which N-nitrosamines are implicated as the etiological agents for bladder cancer.”

FDA Recall of Ranitidine Products

In April 2020, the U.S. Food and Drug Administration (FDA) recalled all ranitidine products after studies revealed that storage time and high temperatures may increase the level of NDMA.

For more information about the Zantac recall and lawsuits, contact us today.

Additional Reading:

Zantac Relaunches With New Name and Ingredient After Recall Due to Increased Cancer Risk

Sanofi Accused of “Widespread” Email Deletion After Zantac Recall

Sanofi Accused of “Widespread” Email Deletion After Zantac Recall

Posted on July 15, 2021July 19, 2021

In a recent filing from lawyers representing over 70,000 former users of Zantac, Sanofi is accused of “widespread” email deletion related to its 2019 recall of the heartburn medication, which preceded the Food and Drug Administration’s (FDA) full ban in 2020. Lawyers claim that this tampering “resulted in the delay and/or postponement of many key Sanofi depositions.” They have asked for more time to prepare for these trials, which are set to begin next year.

A spokesperson for Sanofi revealed that the company “did not intentionally destroy any emails related to the Zantac litigation. Any suggestion to the contrary is false. Sanofi has provided hundreds of thousands of pages of relevant discovery to the plaintiffs, including internal emails, test results, safety assessments, and correspondence with regulatory authorities.”

Zantac Recall Timeline

In late 2019, Sanofi agreed to recall over-the-counter Zantac in the United States and Canada due to possible contamination with suspected carcinogen N-nitrosodimethylamine (NDMA). By April 2020, the FDA had removed the drug and all generic versions from shelves. In August 2020, Sanofi shared that it was the focus of a Department of Justice probe over potential violations of the False Claims Act in relation to the Zantac recalls.

Other drugmakers, including GlaxoSmithKline and Boehringer Ingelheim as well as multiple generic companies, are also accused in the Zantac lawsuits of failing to alert customers to the potential harm.

For more information about the Zantac recall and lawsuits, contact us today.

Additional Reading:

Zantac Relaunches With New Name and Ingredient After Recall Due to Increased Cancer Risk

Zantac Lawsuits & Updates

Zantac (Ranitidine) Commonly Asked Questions

Zantac Cancer Risk

Pfizer Halts Sales of Chantix Due To Possible Carcinogen Contamination

Posted on July 1, 2021July 2, 2021

Last month, Pfizer announced a pause in the distribution of smoking-cessation drug Chantix (varenicline) after identifying levels of nitrosamines, a potential carcinogen. The levels in drugs aren’t supposed to exceed an excess cancer risk of 1 in 100,000. The manufacturer is recalling multiple lots of the drug for the same reason.

In 2020, the Food and Drug Administration (FDA) discovered high amounts of NDMA (N-nitrosadimethylamine) in numerous drugs, including the diabetes drug metformin. In 2019, heartburn medication Zantac was also recalled due to NDMA contamination.

The History of Chantix

Chantix, which is used for 12 to 24 weeks, was initially approved by the FDA in May 2006 to help adults 18 and over quit smoking. Pfizer indicated that they were stopping distribution “out of an abundance of caution” and would continue investigations. They haven’t revealed which nitrosamines were discovered in the pills or how they got there.

Prior to the sales halt, the drug was already facing issues. Sales recently dropped 17 percent — from $1.1 billion in 2019 to $919 million in 2020 — due to the COVID-19 pandemic and the loss of patent protection in the United States in November.

As company spokesperson Steven Danehy told Reuters, Pfizer believe “the benefits of Chantix outweigh the very low potential risks, if any, posed by nitrosamine exposure from varenicline on top of other common sources over a lifetime.” It’s important to note that the potential carcinogen is also found in water and grilled meat.

For more information about the halted distribution of Chantix, contact us today.

The FDA’s Concerning Approval Of New Alzheimer’s Drug, Aduhelm

Posted on June 17, 2021July 8, 2021

Aduhelm, a new Biogen drug, received approval from the U.S. Food and Drug Administration (FDA) last week, with the hope that it will be a game-changer when it comes to caring for dementia patients. It is the first federally-approved drug that works to slow the biological process of Alzheimer’s instead of simply alleviate the symptoms.

Advocates believe that Aduhelm can slow disease progression, ultimately turning Alzheimer’s into a manageable chronic condition. Proponents, however, argue that the scientific evidence fails to support the claims of the drug. Considering this lack of evidence, they also balk at the $56,000 price tag on a year’s worth of treatment.

Scientists have expressed shock towards the FDA’s decision, especially because the agency ignored an outside advisory committee that voted almost unanimously against approval. Harvard Medical School Professor Aaron Kesselheim was one of three committee members who resigned in protest. He called the decision “probably the worst drug approval…in recent U.S. history.”

Widespread Reach of Aduhelm’s Approval

The cost of Aduhelm, coupled with the number of Americans who could end up using the drug, may have an even more widespread reach and play a role in the ongoing debate about reforming the FDA and enacting legislation to drive down the price of prescription drugs. Industry advocates worry that giving the government more power within the pharmaceutical industry will result in fewer medical breakthroughs. However, Aduhelm’s approval may show this line of thinking to be flawed. The FDA’s concerning approval of the drug may result in less productive future research, a longer wait for successful Alzheimer’s treatment, and more difficulties in funding programs that these patients and their families need.

For more information about the approval of Aduhelm, contact us today.

Additional Reading:

U.S. Food and Drug Administration Approval Process

FDA to Reconsider Approvals for Unproven Cancer Drugs

Posted on June 4, 2021July 8, 2021

Annually, the United States approves multiple new uses for cancer drugs based on early evidence that they can shrink or slow the spread of tumors. How often do these initial results equate to longer, more robust lives for patients though? At the end of April, the Food and Drug Administration (FDA) met for the first time in a decade to determine if they should revoke the approvals for drugs that have failed to show they extend or improve life after use for cancer treatment.

During the three-day meeting, the FDA examined unproven cancer drugs from Merck, Roche, and Bristol-Myers Squibb. The schedule included presentations from drugmakers as well as opportunities to seek advice from cancer experts. The hope is that, through this examination, the FDA can remove expensive, unproven cancer drugs from the market. As Dr. Ezekiel Emanual, a cancer specialist and bioethicist at the University of Pennsylvania explains, “Doctors are using these drugs and patients are receiving them with all their toxicities and without knowing whether they are actually doing anything. We should not be in a situation where we’re endlessly uncertain.”

There has been an “unprecedented level of drug development” in recent years, with spending on cancer drugs more than doubling since 2013 to over 60 billion dollars annually. The U.S. spends more per person on prescription drugs than any other nation, and new medications can cost as much as 300,000 dollars per year. Unfortunately, the prices have risen faster than patient survival rates.

For more information about the potential withdrawal of cancer drugs from the market, contact us today.

Novo Nordisk Recalls Samples of Insulin Medication for Diabetes

Posted on June 2, 2021June 2, 2021

The Food and Drug Administration (FDA) announced that global healthcare company Novo Nordisk has voluntarily recalled samples of its insulin medication taken for diabetes, a health condition that affects over 34 million people in the United States alone.

The company recently recalled nearly 1,500 samples of Levemir®, Tresiba®, Fiasp®, NovoLog®, and Xultophy® — all insulin products that are prescribed to lower a diabetes patient’s blood glucose levels. It was also revealed that all recalled items “are packaged in cartons with either a vial, pen-injector (FlexPen® or FlexTouch®) or a cartridge (PenFill®).” The company stresses that use of a recalled product sample may not deliver the correct dosage, possibly leading to “hyperglycemia or hypoglycemia resulting in adverse health consequences ranging from limited to life-threatening.”

The samples were not stored within the correct temperature ranges, which can cause diminished product efficacy. Fierce Pharma reports that the issues occurred during the winter storm power outages in Texas earlier this year as well as due to human error in physician offices. With about 1.5 million samples in-market, this recall affects 0.1 percent of samples from Novo Nordisk.

For more information about this recall, contact us today.

Class Action Lawsuit and FDA Probe Against Real Water

Posted on April 7, 2021May 16, 2021

A recent class-action lawsuit filed by Milberg Coleman Bryson Phillips Grossman PLLC (Milberg) argues that Nevada-based Real Water causes liver failure and other side effects due to unidentified toxins. Real Water, a product of Affinity Lifestyles.com, Inc., calls its drinking water the “healthiest” available thanks to its alkaline properties and infusion with negative ions. The company argues that its water can “help your body restore balance and reach its full potential.”

According to Milberg’s complaint, Real Water failed to disclose that its product is defective, causing health problems such as fever, fatigue, nausea, vomiting, jaundice, liver failure, and hospitalization. The lawsuit specifically states that Real Water has “caused liver damage to children due to non-viral hepatitis.” In November 2020, a two-year-old from Southern Nevada was taken to the hospital for liver malfunction. It was determined then that multiple children had had similar problems with the only common link being the consumption of Real Water.

The Food and Drug Administration began an investigation on March 16th, and only five days later, on March 21st, they issued a warning that consumers, restaurants, and retailers should not drink, cook with, or serve Real Water. In concordance with the FDA’s statement, a company press release revealed that Real Water has asked stores to immediately stop selling its products.

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Tag: FDA

FDA to Make Major Decision About Flavored E-Cigarettes

Use of Flavored E-Cigarettes

E-Cigarettes As A Cessation Device

Additional Reading:

FDA Removes 55,000 Flavored Vaping Products From Market

FDA Crackdown Against Flavored Vaping Products

E-Cigarettes and America’s Youth

Additional Reading:

Bladder Cancer Linked to Zantac Use in Recent Study

Link Between Ranitidine Use and Bladder Cancer

FDA Recall of Ranitidine Products

Additional Reading:

Sanofi Accused of “Widespread” Email Deletion After Zantac Recall

Zantac Recall Timeline

Additional Reading:

Pfizer Halts Sales of Chantix Due To Possible Carcinogen Contamination

The History of Chantix

The FDA’s Concerning Approval Of New Alzheimer’s Drug, Aduhelm

Widespread Reach of Aduhelm’s Approval

Additional Reading:

FDA to Reconsider Approvals for Unproven Cancer Drugs

Novo Nordisk Recalls Samples of Insulin Medication for Diabetes

Class Action Lawsuit and FDA Probe Against Real Water

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