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Though it requires an intentional effort, properly managing diabetes is key to staying healthy and avoiding complications that can be caused by the disease, such as nerve damage, Alzheimer’s or poor blood flow. 

Regulated by the Food and Drug Administration (FDA), glucose meters allow diabetes patients to measure the amount of glucose in their blood. The medical devices alert patients to dangerously high glucose and provide information on how certain foods and physical activities affect sugar levels.

Glucose meters and test strips can be life-saving, so making sure diabetes management equipment functions properly is essential.  Here are some FDA tips for managing diabetes with glucose meters and test strips.  

Checklist For Blood Sugar Testing

Did you buy a new glucose meter and unused test strips?

When purchasing glucose meters and test strips, it’s important to buy new, unused equipment. While some manufacturers attempt to markdown pre-owned glucose meters as an added incentive, the FDA urges patients to avoid secondhand strips altogether.

Though it isn’t illegal to sell pre-owned test strips, the devices may have been improperly stored, tampered with or expired. Used test strips may also cause infection if blood particles are present. Additionally, some test strips may be imported from other countries, meaning they haven’t been examined for U.S. quality standards.

“Pre-owned test strips can give incorrect results and may not be safe to use with your device,” according to the agency. “So the U.S. Food and Drug Administration recommends that you do not buy or sell previously owned glucose test strips.”

Did you read the instructions and quality check your device?

Each glucose meter comes with instructions, so it’s important to review the package insert to understand how the device functions. The instructions also include information on how to use a control solution to be sure your meter is providing accurate results.

Patients are encouraged to test their equipment regularly. Specifics on how often to conduct the tests are included in the instruction manual.

Do you understand how to test yourself and read the results?

Some test sites may give more accurate results than others. While patients can get a glucose reading from the forearm or palm, pricking the fingertip will provide the most accurate results. The fingertip gives the most immediate results, especially if glucose levels changed rapidly after eating or exercising.

Glucose meters may have different methods of displaying values. Some meters uses a “LO” and “HI” symbol to indicate the blood sugar level has exceeded beyond a number measurable by the device. Patients should familiarize themselves with the display of their individual meter to understand it’s unique messaging. 

Do you clean and disinfect your glucose meter?

For some, blood sugar testing is required throughout the day. It’s important to make sure glucose meters are clean and safe to use. Each meter will come with instructions on how to properly disinfect the equipment, and how often it should be cleaned. 

After reading the instructions, the FDA encourages patients to test themselves in front of their doctors to confirm the device has been used correctly. To make sure the device is working at its highest caliber, patients should go over the entire process of conducting a glucose level test, analyzing the results and then clean equipment with a physician.

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The Food and Drug Administration released a report in March informing doctors that certain scopes were sent to market without undergoing an evaluation. The model, recently identified as the cause of widespread bacterial infections, had been used for years without agency approval.

Devices Marketed Without FDA Review

Patients underwent scope procedures with devices that weren’t submitted to the FDA for approval.
Image: AMS vans

Although Olympus Corporation began selling duodenoscopes in 2010, each model was not individually approved by the FDA. The manufacturer claimed that the models weren’t submitted for careful examination because the design closely matched other products on the market.

But the Olympus TJF-Q180V actually differed from existing models. It was later discovered that the TJF-Q180V included a sealed channel that would be hard to fully disinfect when adhering to current cleaning standards.

In March 2014, the FDA delivered a letter compelling Olympus to apply for approval in order to sell the device. The agency subsequently issued a safety announcement to warn doctors and patients about the device’s potential to spread hidden bacteria.

Sending Out Safety Alerts

The FDA sent out an announcement that showed health professionals are unable to completely disinfect certain duodenoscope models.
Image: CNN

In March, the health department worked to track down 179 people that visited UCLA Medical Center and caught bacterial infections from dirty scopes between Oct. 2014 and Jan. 2015. The agency issued a safety alert to inform medical staff that cleaning “may not entirely eliminate” the risk of infection.

“Some parts of the scopes may be extremely difficult to access and effective cleaning of all areas of the duodenoscope may not be possible,” the FDA said. “Residual body fluids and organic debris may remain in these crevices after cleaning and disinfection.”

But UCLA isn’t the only hospital where contaminated scopes spread antibiotic-resistant infections. Eleven deaths at a hospital in Seattle, along with four infections at Cedars-Sinai Medical Center and 281 patients exposed to E.coli at Hartford Hospital proves that ineffective scope sanitation isn’t an isolated issue.

The FDA is working with the CDC and conducting “reviews of reprocessing validation data from each of the three manufacturers marketing duodenoscopes in the [U.S.] — FUJIFILM, Olympus and Pentax.”

The agency advised medical professionals to inform patients about the risk associated with scope procedures. However, individuals who had a medical procedure with a duodenoscopy and caught an infection might be eligible for legal assistance and compensation.

Take a short survey for a free, no-obligation case evaluation.

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The FDA began receiving injury reports related to IVC filters in 2005, which prompted the regulatory agency to evaluate the overall safety of the devices.

An inferior vena cava filter, also known as an IVC filter, is a medical device implanted into an essential vein that carries blood to the heart.  The devices are used to prevent life-threatening blood clots from traveling through the body and blocking the lungs from functioning properly.

The growing popularity of IVC filters has come with a variety of complications, including device migration, filter fracture, movement of the filter or its pieces to the heart or lungs, perforation of the vessel, and a challenging removal.

After receiving hundreds of reports of these complications, the FDA has issued a safety announcement about the device and continues to assess the adverse effects it may cause.

All About IVC Filters

The inferior vena cava is a large vein that brings blood from the lower portion of the body to the right chamber of the heart.
Image: My School Lights

The inferior vena cava is a vein that transports blood from the lower body to the heart. The small cage-like device is implanted into the major blood vessel to stop blood clots from traveling to the lungs.

The device is often recommended for patients with an increased risk of a blood clot moving toward the lungs, a condition known as pulmonary embolism (PE).

In many cases, these patients are unable to utilize pharmaceutical anticoagulant medications. While the some of the “retrievable” devices may be removed, some IVC filters are marketed as a permanent way to prevent blood clots from migrating to major organs.

The FDA Raises Concerns Once Again

In some cases, it may be very difficult to retrieve IVC filters from the body.
Image: Phase One Medical

In 2010, the FDA released an initial communication informing the public about the potential dangers of IVC filters. The regulatory body cited the growing popularity of these devices, which increased from 2,000 IVC filters used in 1979 to almost 167,000 filters in 2007.

The FDA refers to a number of difficulties that may arise from IVC filter implantation. The organization is working to analyze these occurrences in order to distinguish the frequency of the complications.

“Since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforations of the IVC, and 56 involved filter fracture,” according to the FDA’s report.

In 2014, the FDA released an updated communication on the subject of IVC filters. However, the organization will continue to collect additional data on both retrievable and permanent IVC filters.

What’s The Takeaway?

The FDA urges physicians to closely supervise treatment with IVC filters and measure the risk/benefit profile of each patient.
Image: Health Tap

While an IVC filter can be very beneficial, it can also be dangerous. Doctors must closely monitor all patients using the device by following up to check the status of each individual.

The FDA recommends that physicians weigh the benefits and the risks of IVC filters. If a patient’s risk of pulmonary embolism has diminished, doctors should consider removing the device in order to prevent problems in the future.

The FDA urges doctors and patients to be aware of issues with “device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device” and long-term risks such as “lower limb deep vein thrombosis and IVC occlusion.”

However, there are many patients who have already experienced complications from IVC filters. Complete a free, no-obligation case evaluation now to see if you qualify for compensation.

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Homeopathic remedies are controversial, and it’s important to evaluate characteristics that differentiate these natural medicines from traditional scientific treatments.

Homeopathic remedies are becoming increasingly popular in both conventional pharmacies and specialty drugstores.

While some praise natural medicines as the purest kind of cure, others claim that science-based treatments are the only proven form of medicine.

The Basic Differences

Homeopathic medicines aren’t evaluated by the FDA for safety and effectiveness.
Image: Allergies and Your Gut

One of the biggest differences between homeopathic remedies and prescription drugs is FDA approval. The FDA is charged with evaluating the safety and effectiveness of each drug that enters into the conventional medical market.

Homeopathy encompasses ancient practices that are based on the idea that like cures like. On example is Allium cepa (red onion), which is used to treat allergies. Red onion causes irritated eyes and a runny nose, which makes it a possible remedy for these symptoms in the homeopathic school of thought.

The active ingredient in homeopathic medicine is often diluted. The technique is to dilute the ingredient as much as possible to gain the most benefit.

Some critics argue that diluting an active ingredient would make the treatment less potent, which means it would be less likely to work. These kinds of natural remedies don’t conform to scientific norms, making them highly controversial.

A Look At The Ingredients

Active ingredients in homeopathic medicines are often diluted.
Image: The Telegraph

The active ingredient in homeopathic remedies often comes from natural sources such as plants and animals. The derivatives are then mixed with lactose or sugar pills, topical creams or inhalable liquids. These ingredients can often be bizarre, including additives like snake venom, arsenic or even heavy metals.

Sometimes these ingredients can be dangerous to consumers.

In March 2014, holistic healthcare manufacturer Terra-Medica recalled 1,768 products of six homeopathic medications made by the firm Pleo Sanum after the FDA found that some variations might have contained the antibiotic penicillin.

These recalls are not entirely uncommon. In 2010, the FDA cautioned against using Hyland’s Teething Tablets. The pills may have possessed derivatives of the deadly nightshade plant. Also known as belladonna, deadly nightshade causes rapid heartbeat, fever and difficulty urinating.

Studying the Effectiveness of Homeopathy

Many scientists argue that homeopathy is no better at treating illness than placebos.
Image: Platform 505

Because natural medicines contain diluted active ingredients, health professionals have argued that these treatments work no better than placebos. The National Health and Medical Research Council reviewed 176 studies of homeopathic medicine and concluded that this hypothesis was true.

It argued that “there are no health conditions for which there is reliable evidence that homeopathy is effective.”

“Some trials done 20 years ago seemed promising,” said Adriane Fugh-Berman, M.D., an expert in botanical medicine and an associate professor of pharmacology at the Georgetown University Medical Center in Washington, D.C. However, newer experiments have found that homeopathy isn’t as effective as originally thought.

Regulating Homeopathic Medicines

The labeling and advertising of homeopathic medicines are not subject to FDA scrutiny.
Image: Homeo Labels

Homeopathics are classified by the FDA as drugs, which means the labeling should disclose ingredients, provide detailed instructions and signify medical conditions that the product is meant to treat.  If the medication is made to treat a condition like cancer, it is necessary to get a prescription for the drug.

There is one big difference between prescriptions, over-the-counter drugs and homeopathic remedies. Homeopathics are not required to go through an FDA review that would evaluate the safety and effectiveness of each drug. These drugs are loosely regulated and lack a proven body of results.

Makers of homeopathic medications don’t have to provide evidence that homeopathic drugs work.  The only requirement is for the products to include ingredients listed in a database called the Homeopathic Pharmacopoeia of the United States, which is managed by the nongovernmental Homeopathic Pharmacopoeia Convention of the United States.

But as more people purchase these alternative remedies, the FDA is prompted to pay more attention. The regulatory body is leaning towards evaluating homeopathic products while the Federal Trade Commission would monitor false and misleading advertising.

Regardless of the many critics, natural medicine is more popular than ever. According to the Nutrition Business Journal, Americans spent $1.2 billion on homeopathic drugs in 2014. The figure has grown 33 percent since 2000.

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Addyi, a once-daily pink pill that treats hypoactive sexual desire disorder in women, will be released on Oct. 17.

Sexual dysfunction isn’t just a man’s problem. Lots of ladies deal with a low libido.

Medical professionals and gender equality advocates are making sure the female sex life is finally being addressed. Addyi, a pink pill created by Sprout Pharmaceuticals, focuses on reviving a woman’s sexual desire.

After multiple rejections and criticism from the medical industry, a powerful lobbying campaign prompted the FDA to finally stand behind Addyi.

The Story Behind ‘Female Viagra’

Addyi, also called flibanserin, is the first women’s libido pill of its kind.
Image: NY Times

Sprout Pharmaceuticals is a company “committed to breakthrough firsts in women’s sexual health.” About 7 percent of premenopausal women have hypoactive sexual desire disorder (HSDD), a condition that causes severe distress but is largely ignored by the medical community.

Addyi, also called flibanserin, is the first drug to treat a biological lack of sexual desire not attributed to factors like disease, side effects from medications or a flailing relationship. Taken once daily before bed, the 100 mg tablet works by regulating levels of dopamine and serotonin in the brain.

In 2010, Sprout bought Addyi from another manufacturer and began developing it. The pill was rejected by the FDA unanimously that same year and again in 2013.

The company partnered with women’s activists to launch a lobbying campaign that situated Addyi directly in front of the FDA. However, the opposition claimed that Sprout was using its buying power to influence a decision about a drug that shouldn’t be on the market.

Critics argue that the drug has few benefits and could be potentially dangerous.

“This is a product that is neither very effective nor particularly safe,” Dr. Susan Wood, a former FDA official now at George Washington University, told NBC News.

“It won’t benefit many women and at the same time the approval comes with a lot of restrictions, setting a precedent that a drug for women’s sexual health has to be treated in a very special way,” Wood said.

A Push To Even The Score

Nearly one-third of women aged 18 to 59 suffer from a lack of desire to have sex, according to WebMD.
Image: Patrick Chappatte

Gender equality activists have taken a few different avenues to push the drug through the approval process. The campaign generated a petition, called Even the Score.

Organizations such as the National Council of Women’s Organizations, the Black Women’s Health Imperative, Jewish Women International and some medical groups like the Association of Reproductive Health Professionals showed their support by reaching out to Congress about the drug.

“This is the biggest breakthrough for women’s sexual health since the pill,” said Sally Greenberg, executive director of the National Consumers League.

A major tenet of the campaign is the need for a level playing field. By approving a drug that was similar to Viagra and other men’s libido pills, the FDA would provide equal options for both sexes suffering from a lack of sexual desire. In addition to Viagra, men have six other options to treat sexual dysfunction.

“Today, we write a new chapter in the fight for equity in sexual health,” according to Susan Scanlan, chairwoman of the Even the Score campaign.

However, the FDA claims no gender bias exists. Viagra treats erectile dysfunction, not low sexual desire. The campaign collected more than 60,000 signatures to demonstrate the extent of the desire for the drug.

“The unmet need seems to be so strong that even for a drug with rather modest benefit, I think approving the product with strong limitations seems to be the right step at this point,” said Tobias Gerhard, a committee member and expert on drug safety at Rutgers University in New Jersey.

Female Sex Drive On The Move

Sprout has been purchased by Valeant Pharmaceuticals International with the intention of going global.
Image: NY Post

In June, Addyi was approved with an 18-6 vote by an advisory committee to the Food and Drug Administration. The FDA followed suit on Aug. 18, with specific attention to limiting risks and overuse.

Addyi has a boxed warning included on its label, which prohibits use with alcohol. If combined, Addyi and alcohol can increase the risk of low blood pressure and fainting. A few other drugs are also off limits, and people with liver impairment are excluded from prescription.

Doctors may be required to receive a certification to prescribe the drug that includes a presentation and comprehension test. The drug could cause potential side effects such as high blood pressure, fainting, nausea, dizziness, somnolence, fatigue, insomnia and dry mouth. Hypotension, syncope and central nervous system depression are also possible risks.

Recently, Valeant Pharmaceuticals International purchased Sprout for about $1 billion. It seems that Valeant is excited to be a part of the breakthrough by assisting in the development of medications that are tailored to women.

“We applaud the efforts of the Sprout team to address this important area of unmet need and look forward to working with them to bring the benefits of Addyi to additional markets around the world,” according to J. Michael Pearson, CEO at Valeant.

Cindy Whitehead, the chief executive of Sprout, hasn’t given a prediction about the sales of Addyi. The drug will be available starting Oct. 17.

Although it’s not clear if insurance companies will pick up Addyi, the price will be equivalent to the cost of male erectile dysfunction medication.

Read the full Certification Press Release and Distribution Strategy here.

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The FDA evoked the sale of four cigarette products manufactured by R.J. Reynolds.

The FDA, recently tightening its regulatory grip on cigarette manufactures, banned the sale of four kinds of cigarettes on Sept. 15.

Manufactured by R.J. Reynolds, the banned brands include Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13. The action was taken because the manufacturer failed to prove the cigarettes were not more harmful than comparable tobacco products.

The FDA Pulls Cigarettes Off The Shelves

The FDA ordered that four cigarette brands be removed from retails stores because they failed to achieve substantial equivalence status.
Image: Pipes Magazine

The Family Smoking Prevention and Tobacco Control Act of 2009 was passed to allow the FDA to deny cigarettes and other tobacco products that may pose a greater public health risk than comparable products on the market.

R.J. Reynolds released new products that were commercially marketed as of Feb. 15, 2007. In 2011, the company applied for substantial equivalence status.

To receive that status, R.J. Reynolds would have to provide evidence that the products didn’t raise new questions for public health. The company could also receive the status by proving the new products had the same characteristics as an existing product.

The FDA found that the four banned brands were not the same as their predecessors and questioned if the newer versions could be more harmful.

In the announcement, the FDA said that ingredients, engineering and chemistry of the products were analyzed. The agency also measured how these factors could influence cigarette toxicity, addictiveness and appeal to smokers.

For example, Camel Crush Bold cigarettes have a small menthol capsule in the filter, which might make the cigarette more appealing to consumers.

Matthew Myers, the president of Campaign for Tobacco-Free Kids, said the products “deliver menthol differently and at higher levels, have added sugars and other sweeteners, new filters, and tested differently for harmful and potentially harmful constituents.”

Retailers have been told to immediately stop the sale of banned brands and dispose of them within 30 days. The consequence of noncompliance is financial penalties or criminal prosecution.

“These decisions were based on a rigorous, science-based review designed to protect the public from the harms caused by tobacco use,” Mitch Zeller, the director of the Center for Tobacco Products at the agency, said in statement.

A Response From R.J. Reynolds

R.J. Reynolds claims that the FDA ban is unjust because the company successfully proved the substantial equivalence of their products.
Image: CBS News

The company gave a statement that asserted a strong disagreement with the decision.

“Our submissions to the agency on these brands were comprehensive, and we believe we effectively demonstrated substantial equivalence,” according to Jeffery S. Gentry, the company’s executive vice president for operations and chief scientific officer.

R.J. Reynolds is currently examining options for moving forward.

Financial services firm Cowen and Company said in a research note that the four banned products accounted for less than 1 percent of the company’s sales. It’s not likely that the action will have a serious impact on R.J. Reynolds.

The firm predicts that the company will file a legal injunction to suspend the action. The other option would be to pull the products before legally contesting the findings.

As the FDA increasingly wields its power, it’s interesting to reflect on the nation’s tobacco history. Gone are the days when cigarette companies could alter existing products and introduce new ones as they pleased.

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A new study confirms that youths who use electronic cigarettes are more likely to switch to traditional tobacco cigarettes.

Vaping is a relatively new fad, and researchers all over the world are trying to figure out how it will impact the population.

Because so many scientists are gathering data on vaping, the studies often conflict. Some support e-cigarettes as smoking cessation therapies, while others reject them as gateway products.

As the FDA grapples with how to regulate e-cigarettes, a new study sponsored by the National Cancer Institute shows that teens who vape are more likely to move on to traditional tobacco cigarettes.

The Study

Researchers surveyed approximately 700 e-cigarette users and non-users and tracked the amount who begun using traditional cigarettes one year later.
Image: West Texas News

The study will be published in the November edition of the journal JAMA Pediatrics. It’s one of many that attempts to discern the benefits from the negative effects of e-cigarettes.

Researchers at the University of Pittsburgh and Dartmouth-Hitchcock Norris Cotton Cancer Center conducted a study that tracked 694 people between the ages of 16 to 26. The majority of participants were considered to be “non-susceptible” and had no intention of smoking cigarettes. Only 16 people, or 2.3 percent of participants, were already using e-cigarettes at the start of the study in 2012.

One year later, 37.5 percent of e-cigarette users had transitioned to cigarettes, compared to only 10 percent of youths who were not already using e-cigarettes.

About 31 percent of e-cigarette users changed their mind about intending to smoke cigarettes, compared to 9.3 percent who were not using e-cigarettes at the beginning.

The authors took additional factors that could have influenced e-cigarette users into account. The study did not focus on the frequency of e-cigarette use, intention to experiment or if e-cigarettes and cigarettes were being used simultaneously.

Results And Regulation

The FDA is in the process of deciding how heavily e-cigarettes will be regulated.
Image: Electronic Cigarette Consumer Reviews

The study was limited by the small sample size of people already using e-cigarettes at the beginning of the trial. The small sample size made it difficult to prove the results would be easily replicated.

The results are based on the idea that e-cigarette users are becoming conditioned to enjoy sensation-seeking behavior, which could make them more likely to smoke traditional cigarettes. Some also argue that vaping is more attractive to younger generations.

“E-cigarettes are not subject to many laws that regulate traditional cigarettes, such as age limits on sales, taxation and labeling requirements,” said lead author Brian A. Primack, MD, PhD, director of CRMTH and assistant vice chancellor for health and society in Pitt’s Schools of the Health Sciences.

“They also come in youth-oriented flavorings that laws have limited in traditional cigarettes, such as apple bubble gum and chocolate candy cane.”

These individuals may have transitioned to smoking tobacco cigarettes regardless. But when the authors adjusted the study to include additional factors and sensation-seeking tendencies, there was still a link between e-cigarette use and a transition to traditional cigarettes.

The study authors cite three main reasons that e-cigarettes might be a gateway to traditional smoking:

• E-cigarettes deliver nicotine more slowly than traditional cigarettes, allowing a new user to advance to cigarette smoking as he or she becomes tolerant of nicotine side effects.

• Unlike other forms of nicotine, such as smokeless tobacco, e-cigarettes are designed to mimic the behavioral and sensory act of cigarette smoking, allowing the user to become accustomed to the act of smoking.

• E-cigarettes are not subject to the same regulations as traditional cigarettes, potentially renormalizing the act of smoking after decades of public health efforts to shift public norms around smoking.

The FDA is in the process of analyzing data from various studies to make decisions on how to regulate e-cigarettes. Some hope that e-cigarettes could be a healthier alternative to traditional cigarettes, whereas others believe the products could create a new generation of nicotine addicts.

“It will be important to continue surveillance among youth of both e-cigarette use and overlap with use of other tobacco products,” according to the study authors.

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The FDA has issued letters to three tobacco manufactures urging them to alter the advertising tactics used on natural and additive-free cigarettes. The FDA believes the wording will lead consumers to believe that some kinds of cigarettes are safer than others.

You’re a dedicated cigarette smoker, but this year you want to make an effort to be more health conscious. When shopping for cigarettes, you may see a product that has the words ‘natural’ or ‘additive-free’ written on the label. You compare the packaging and choose the brand that seems the healthiest.

In a recent crackdown, the FDA has demanded three tobacco companies stop advertising their cigarettes with wording that may be misleading to consumers.

This is the first time the FDA has taken action to enforce a law that was created six years ago. The historic move will change the way tobacco products are labeled.

Steps For Stricter Regulation

American spirit cigarette advertisements feature the standard surgeon general’s warning and an additional warning for cigarettes with no additives.
Via: Flickr

An FDA ruling in 2000 compelled cigarette companies that claimed their products use natural tobacco had to include “no additives in our tobacco does NOT mean a safer cigarette” on the labeling, along with the standard surgeon general’s warning.

But in 2009, legislators passed the Tobacco Control Act, which gave the FDA the authority to “regulate the manufacture, distribution, and marketing of tobacco products to help all Americans, especially young people, live longer, healthier lives.”

The law allowed the FDA to:

• Require new and more effective warning labels on tobacco products
• Establish and enforce restrictions on tobacco advertising and promotions
• Require tobacco companies to disclose what is in their products
• Review tobacco manufacturers’ claims of “modified risk” products to prevent misleading claims
• Educate consumers about the dangers of tobacco use, among other powers

The FDA first exercised the law by sending a warning to Santa Fe Natural Tobacco Co.,  ITG Brands and Sherman’s 1400 Broadway N.Y.C. about the advertising tactics used to sell their cigarettes. The brands sell American Spirits, Winston cigarettes and Nat Sherman cigarettes, respectively.

The warning letters discuss violations of section 911 of the Federal Food, Drug, and Cosmetic Act, urging the companies to alter their labeling to make sure that it doesn’t present “a lower risk of tobacco-related disease” that makes their product appear “less harmful than one or more other commercially marketed tobacco products.”

Setting An Example

The FDA is waiting for a response from three companies that have been asked to alter the advertising on their cigarette packages.
Via: Viral Sneak

The press release detailing the offense was issued on August 27. The three companies were contacted by the FDA and must respond to the letters in no more than 15 business days with an explanation of how they plan to remedy the issue.

The FDA believes these companies are not in compliance with the law. The companies have the option to give an explanation and  provide evidence if they believe they are not in violation of the law. If they fail to respond, the FDA may initiate civil financial penalties, criminal prosecution, seizure and/or injunctions.

ITG has responded in a statement that its product complies with the state and federal regulations. According to the representatives, “while we disagree with the FDA’s position on this issue, we intend to engage with the FDA and respond to their letter in the coming days.”

According to a statement from Mitch Zeller, director of the FDA’s Center for Tobacco Products, the agency is just doing its job.

“The FDA’s job is to ensure tobacco products are not marketed in a way that leads consumers to believe cigarettes with descriptors like ‘additive-free’ and ‘natural’ pose fewer health risks than other cigarettes, unless the claims have been scientifically supported,” he said.

“This action is a milestone, and a reminder of how we use the tools of science-based regulation to protect the U.S. public from the harmful effects of tobacco use.”

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The FDA has called on pharmaceutical manufacturers of testosterone drugs to conduct a single trial to gather data on how the medication is used to treat lifestyle issues.

Men having trouble in the bedroom use Low-T drugs to give their testosterone levels a boost. However, these drugs are only approved to treat certain medical conditions.

The frequency of the off-label use of testosterone drugs has prompted the FDA to call on pharmaceutical manufacturers to collaborate on a single trial that would analyze testosterone enhancers as a lifestyle drug.

A cooperative single trial would be faster, more convenient and less costly for all parties with a stake in Low-T medications. It would provide much-need information on a popular class of drugs that is being used for anti-aging and sexual enhancement.

The Argument For A Multi-Manufacturer Trial

The amount of male Americans using testosterone therapy increased from 1.3 million to 2.3 million from 2009 to 2013, according to the FDA.
Via: Ask Men

In March, the FDA required manufacturers of testosterone treatments to put warnings about possible heart attacks and stroke on the drug’s labeling. Additionally, the FDA did not want doctors to prescribe these drugs to aging men with sexual dysfunction. The ruling was supported by an advisory panel that voted 14-1 for the drugs only to be used for medical issues like brain damage, tumors or genetic disorders.

Despite these regulations, men are continuing to seek out testosterone therapy to improve testicular function or to treat other age-related conditions. In an issue of the New England Journal of Medicine published on August 20, the FDA cites an increase in the use of testosterone drugs to treat a lacking libido.

Testosterone side effects

The amount of male Americans using testosterone therapy increased from 1.3 million to 2.3 million from 2009 to 2013, according to the FDA.

Previous studies on Low-T as a lifestyle drug do exist, but data on the benefits of hormone therapy for older men are inconclusive or contradictory.

Dr. Christine Nguyen, an FDA deputy director of safety, wants the manufacturers to conduct tests that would give information about the drug’s dosage, advantages and side effects.

“The benefits and risks of testosterone therapy have not been established for the treatment of men who have low testosterone levels due to aging, even if there are symptoms that seem related to the low testosterone,” Nguyen said.

Will Low-T Manufacturers Agree?

AbbVie, the maker of Androgel, and Eli Lilly, the maker of Axiron, have signed on to conduct the collaborative single trial.
Via: Minn Post

Experts question if Low-T drugs will increase the likelihood of heart attack and stroke in older men. They wonder what it would mean if a pharmaceutical product could be prescribed to counteract the natural process of aging.

If pharmaceutical manufactures want to keep market sales steady, they will have to secure information that illustrates the safety and effectiveness of Low-T drugs.

AbbVie, the maker of Androgel, and Eli Lilly, the maker of Axiron, have stated that they are going to work toward researching testosterone drugs to assure that prescribing them for lifestyle improvement is in patient’s best interests.

“AbbVie and other sponsors of prescription testosterone treatments are working with the FDA to determine the best path forward for a clinical trial,” according to an AbbVie spokesperson.

Similarly, J. Scott MacGregor, Eli Lilly’s global communications director, said, “We’re continuing to work closely with the FDA in the best interests of men who use testosterone therapy.”

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