Food and Drug Administration

The Problem With Supplements

Source: Elemental Date: May 6, 2019 Author: Markham Heid Earlier this year, federal authorities announced plans to strengthen oversight of the supplement industry. “The growth in the number of adulterated and misbranded products — including those spiked with drug ingredients not declared on their labels, misleading claims, and other risks — creates new potential dangers,” said U.S. Food and Drug Administration (FDA) commissioner Dr. Scott Gottlieb in a February press release. Heightened oversight is needed, Gottlieb argued, because expansion and change within the supplement industry has made it difficult for his agency to keep pace. “What was once a $4 billion industry comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000 — and possibly as many as 80,000 or even more — different products available to consumers,” he said. From multivitamins and botanicals to probiotics and protein powders, roughly three out of four Americans now take some kind of supplement on a regular basis. Since the days of palliative tonics and snake-oil salesmen, Americans have been readily lured by the promise of health or longevity in the form of a drink, pill, or powder. While the terminology has evolved — “biohacking” and “nutraceuticals” are some of the buzzwords du jour — the implied benefits of most supplements still outpace or ignore the science. And despite recent studies that find supplements are frequently contaminated or that the best way to get nutrients is through food, Americans’ interest in supplements is only growing. And experts say many supplement users don’t recognize or appreciate the risks that accompany the [...]

Charlotte Parker2019-05-07T11:05:54-07:00May, 2019|Oral Cancer News|

Can your own immune system kill cancer?

Source: www.cnn.com Author: Jacqueline Howard There was another big win in the advancement of immunotherapy treatments for cancer this week. The Food and Drug Administration approved an immunotherapy drug called Keytruda, which stimulates the body's immune system, for the first-line treatment of patients with metastatic non-small-cell lung cancer. In other words, the drug could be the very first treatment a patient receives for the disease, instead of chemotherapy. Keytruda is the only immunotherapy drug approved for first-line treatment for these patients. So it seems, the future of cancer care may be in our own immune systems, but how exactly does it work, and what are its pros and cons? "It's certainly going to become an independent way of treating cancers," said Dr. Philip Greenberg, head of immunology at the Fred Hutchinson Cancer Research Center in Seattle, during a Q&A session at the International Cancer Immunotherapy Conference in New York in September. "We always talk about the three pillars of cancer therapy -- radiation therapy, chemotherapy and surgery -- and it's become quite clear now that there's going to be a fourth pillar, which is immunotherapy," he said. "There are times where it will be used alone, and there will be times that it will be used in conjunction with the other therapies, but there's very little to question that this is going to be a major part of the way cancers are treated from now on, going forward." Here's a look at the past, present and future of cancer immunotherapy. It [...]

Charlotte Parker2016-10-26T09:42:45-07:00October, 2016|Oral Cancer News|

Doctors Trying To Remind Americans That The HPV Vaccine Isn’t All About Sex

Source: thinkprogress.orgAuthor: Tara Culp-Ressler Dr. Ronald A. DePinho is on a mission. DePinho, who’s been a cancer researcher for decades and currently serves as the president of the University of Texas MD Anderson Cancer Center, wants to reframe the national conversation about the HPV vaccine to drive home a fundamental point. “It’s important to appreciate that this is a cancer vaccine. A cancer vaccine!” DePinho said in an interview with ThinkProgress. “It’s a dream come true that we’ve converted knowledge into something that can actually save lives and avoid getting cancer in the first place. It’s really what we have been hoping for, and now we have it.” Since the introduction of the HPV vaccine in 2006, the rate of human papillomavirus in teenage girls has plummeted. And the research in this field continues to advance. On Thursday, the Food and Drug Administration approved an updated version of the Gardasil vaccine that protects against nine strains of the cancer-causing virus — more than twice as many as the 2006 version, which covered just four strains. According to DePinho, that’s a really significant advance for cancer care. He doesn’t want it to get lost in the ongoing controversy about HPV vaccination, a round of shots that some parents still worry is unsafe or inappropriate for their kids. There’s a persistent myth, for instance, that giving teen girls the shots will spur them to become more “promiscuous” because they know they’ll be protected from a sexually transmitted infection. Large [...]

Charlotte Parker2014-12-12T10:46:44-07:00December, 2014|Oral Cancer News|

FDA Efforts to Reduce Youth Smoking

Source: USA TodayPublished: February 4, 2014 WASHINGTON — The Food and Drug Administration is launching the government's largest effort yet to curb tobacco use among at-risk teens. The $115 million media campaign stems from the FDA's new authority to regulate tobacco, granted by a 2009 law, says commissioner Margaret Hamburg. The ads will target the roughly 10 million American teens who are open to smoking or are already experimenting with cigarettes, she says. That investment "is one of the most important efforts in recent times in the effort to reduce youth smoking," says Matthew Myers, president of the Campaign for Tobacco-Free Kids. "The FDA has carefully researched which ads will have the greatest impact on at-risk youth. These were designed with the same scientific rigor that Madison Avenue uses to market its products." Many "at-risk" kids see smoking as a temporary coping mechanism to help them deal with the "chaos" caused by poverty, violence or family turmoil, said Mitch Zeller, director of the FDA's Center for Tobacco Products. This ad dramatizes one of the real costs of smoking, namely that smoking can cause wrinkles that age you prematurely.(Photo: FDA) "We are not talking about happy-go-lucky kids," Zeller said. "They don't see themselves as smokers. They think they will be able to quit." Although the first round of ads will aim for a broad audience, later campaigns will target specific groups, such as gay teens and Native Americans, Zeller said. Ads from the campaign, called "The Real Cost," will run on [...]

Charlotte Parker2014-02-05T15:27:10-07:00February, 2014|Oral Cancer News|

Cannabis chewing gum targets oral side effects

Source: Author: staff The company Medical Marijuana has acquired a 50% stake in CanChew, a cannabinoid (CBD)-based chewing gum developed as a pharmaceutical delivery mechanism to relieve pain, xerostomia, and other side effects of disease and disease treatment. The acquisition gives Medical Marijuana worldwide exclusive rights to develop, manufacture, market, and distribute both tetrahydrocannabinol (THC) and non-THC hemp-derived cannabinoid-infused chewing gum to medical marijuana consumers, according to the company. The U.S. Food and Drug Administration currently considers non-THC based hemp products to be "food-based" and therefore legal without a medical marijuana license. Cannabinoids have had positive effects in clinical trials on neuralgic pain, multiple sclerosis, and spinal cord injuries, nausea and vomiting from chemotherapy and radiation treatment, as well as palliative treatment of various cancers and HIV/AIDS, the company stated. According to Sanammad, the company that developed CanChew, the gum can: Alleviate acute and chronic pain Diminish nausea and vomiting, as well as cachexia, which is a syndrome common in cancer patients on chemotherapy that causes appetite loss and loss of weight and muscle-mass Enhance appetite Improve muscle relaxation, coordination, and mobility Diminish xerostomia Promote fresh breath and maintain oral hygiene "Functional chewing gum is well-established as an effective way to deliver pharmaceutical active ingredients," said Michael Llamas, president of Medical Marijuana. "A great example is Nicorette. Within 10 minutes of chewing Nicorette gum, the consumer's symptoms of nicotine withdrawal begin to ease. Our formulations also have an exceedingly safer side-effect profile compared to the currently available analgesics such as [...]

Oral Cancer Foundation News Team - A2012-06-08T08:02:29-07:00June, 2012|Oral Cancer News|

The 795 Thousand and Ending a Century of Tobacco

Source: Oxford Journals Tonight, a grandfather will read his grandson a soothing bedtime story. Yesterday, a mother saw her son perform a brilliant violin solo. Tomorrow, a grandfather will see his granddaughter complete the first unassisted triple play in their community's t-ball league history. What do these vignettes have in common? They represent just three of the 795 851 people––the 795 thousand––whose premature deaths from lung cancer were averted in the United States through aggressive tobacco control policies and interventions between 1975 and 2000, as determined by a series of consortium-based sophisticated modeling techniques and reported by Moolgavkar et al. (1) in this issue of the Journal. Sometimes, we become inured to the sheer number of deaths caused by tobacco—for example, a predicted 1 billion tobacco-caused deaths this century, 100 million people killed by tobacco in the 20th century, 6 million deaths per year globally, 443 000 deaths per year in the United States, etc. But, despite these enormous, and even numbing, numbers, we need to remember that every one of these 1 billion, 100 million, 6 million, or 443 000, was a father, mother, brother, sister, son, or daughter who, if tobacco had not intervened, would have enjoyed, and shared, a longer, healthier, and more fulfilling life. How did this happen? How did we allow tobacco, over the past 100 years, to kill and cause disease with such abandon? And, more important, how have we begun to turn the tide against the tobacco tsunami and how can we continue to learn from [...]

Charlotte Parker2012-04-04T08:27:45-07:00April, 2012|Oral Cancer News|

Strong Oral Carcinogen Identified in Smokeless Tobacco

Source: ScienceDaily.com Although smokeless tobacco products have long been linked with certain cancers, including oral cavity cancers and esophageal cancers, this is the first study to identify a specific chemical present in smokeless tobacco products that induces oral cancer in animals, according to Silvia Balbo, Ph.D., research associate at the Masonic Cancer Center of the University of Minnesota in Minneapolis, Minn. "(S)-NNN is the only chemical in smokeless tobacco known to cause oral cancer," Balbo said. "This finding provides mechanistic underpinning for the epidemiologic observations that smokeless tobacco products cause oral cancer." Balbo and colleagues administered two forms of NNN called (S)-NNN and (R)-NNN to four groups of 24 rats. The rats were given either (S)-NNN alone, (R)-NNN alone, a combination of both or tap water. The total dose was approximately equivalent to the amount of (S)-NNN to which a smokeless tobacco user would be exposed from chronic use of these products. All rats assigned to (S)-NNN alone or the combination began losing weight after one year of exposure and died by 17 months. Rats assigned to (R)-NNN or tap water were terminated at 20 months. All rats assigned to (S)-NNN had esophageal tumors and demonstrated 100 percent incidence of oral tumors including tumors of the tongue, buccal mucosa, soft palate and pharynx. In contrast, researchers found oral tumors in only five of 24 rats given (R)-NNN and esophageal tumors in three of 24 rats assigned to (R)-NNN. Twelve rats given the combination of (S)-NNN and (R)-NNN had 153 esophageal [...]

Charlotte Parker2012-04-02T16:22:05-07:00April, 2012|Oral Cancer News|

Tobacco Makers Must List Ingredients, Prove Safety Claims

Source: Businessweek.com Tobacco companies will have to begin reporting the amount of unsafe chemicals in their products and prove their so-called lower-risk alternatives to smoking such as snuff are actually safer, U.S. regulators said. The Food and Drug Administration moved today to implement pieces of a 2009 law giving the agency the authority to regulate tobacco products. The FDA released preliminary guidelines for the industry that it says can educate consumers on exactly what is in cigarettes, such as ammonia and formaldehyde, and police claims that certain tobacco products may be safer than others. The agency will share information on chemical amounts with the public within a year, Lawrence Deyton, director of the FDA’s Center for Tobacco Products, said in a telephone call with reporters. On the issue of less-risky tobacco items, the draft guidelines set up two categories: one with a higher evidence standard that lets companies claim less harm than cigarettes; and another with a lower standard that permits companies to market products as reducing exposure to unsafe ingredients. “We are forging new territory to ensure that tobacco companies provide accurate information and do not mislead American consumers,” FDA Commissioner Margaret Hamburg said in a statement. “We are committed to stopping such practices that may cause people to start or continue using tobacco products that could lead to preventable disease and death.” 93 Chemicals The FDA released a list of 93 chemicals that tobacco makers would have to report the quantity of in their products. The FDA is studying [...]

Charlotte Parker2012-04-02T09:56:47-07:00April, 2012|Oral Cancer News|

HPV vaccine myths put health, lives at risk, say health leaders: Airing the facts

Source: TheNationsHealth.org Vaccination rates for human papillomavirus are lagging for teens, and a complicated web of confusion and misinformation may be to blame, according to public health leaders. Several strains of HPV can cause cervical cancer, and two vaccines, Gardasil and Cervarix, have been shown conclusively to defend against those strains. The Food and Drug Administration recommended in 2006 that girls receive the vaccine before they become sexually active so that they are protected at the outset. In 2009, FDA approved the use of the vaccine for boys as well. According to the Centers for Disease Control and Prevention, about 6 million people in the U.S. become infected with HPV each year and each year about 12,000 women are diagnosed with cervical cancer, leading to about 4,000 deaths. Studies have shown the vaccine to be overwhelmingly safe, CDC said. As of June 2011, about 35 million doses of Gardasil had been distributed in the United States. CDC’s adverse event tracking mechanisms reported about 18,000 adverse events, 92 percent of which were nonserious events, such as fainting, swelling at the injection site and headache. Sixty-eight deaths were reported, but there is “no unusual pattern or clustering to the deaths that would suggest that they were caused by the vaccine, and some reports indicated a cause of death unrelated to vaccination,” CDC said. And yet, fed perhaps by misinformation or squeamishness about the idea of their children becoming sexually active, some parents are opting not to vaccinate, and the vaccination rates are [...]

Oral Cancer Foundation News Team - A2011-12-01T12:41:51-07:00December, 2011|Oral Cancer News|

Europe Bans X-Ray Body Scanners

Source: AVWeb.com The European Commission decided in November to ban airport body scanning X-ray backscatter machines after studies found a small number of cancer cases linked to use of the devices. The decision affects all airports in Europe, with an exception for U.K. airports that will be allowed to test them, but not deploy them permanently. According to the European Commission, "only security scanners which do not use X-ray technology are added to the list of authorized methods for passenger screening at EU airports." The commission does approve of full non-X-ray body scanners (radio wave scanners are among those used in the U.S.) when operated under specific guidelines and restrictions. In the U.S., the TSA uses more than 250 backscatter machines at the nation's 100 busiest airports and is unmoved by Europe's position. The degree of cancer risk varies somewhat depending on the source ... as does the degree of usefulness of the machines themselves. According to the U.S. Food and Drug Administration, backscatter machines bring a cancer risk of one in 400 million. Research reported by PBS Newshour/ProPublica states that the risk of developing cancer from the machines is "anywhere from six to 100" passengers per year. In a detailed paper submitted to the White House, University of California researchers said that because backscatter X-ray energy is absorbed mainly by the skin and underlying tissue, the skin dosage may be dangerously high in localized areas. The TSA says the amount of radiation emitted by a backscatter machine is similar [...]

Oral Cancer Foundation News Team - A2011-12-01T12:22:27-07:00December, 2011|Oral Cancer News|