FDA’s tobacco regulation draft proposal weakened by the White House

Author: Toni Clarke and Sharon BegleySource: huffingtonpost.com  WASHINGTON, June 25 (Reuters) - White House changes to proposed rules for tobacco products significantly weakened language detailing health risks from cigars and deleted restrictions that might have prevented online sales of e-cigarettes, published documents show. The White House's Office of Management and Budget (OMB), which analyzes the potential economic consequences of proposed regulations, deleted language in the U.S. Food and Drug Administration's recently proposed regulations describing how the rules would keep thousands of people from taking up cigar smoking and have enormous public health benefits. The OMB also weakened language detailing the FDA's concerns about the safety of e-cigarettes, according to documents published Tuesday in the Federal Register. Emily Cain, a spokeswoman for OMB, said that as with any rule, OMB's office of information and regulatory affairs conducted an interagency review process "to ensure that the regulations through which agencies implement policies are efficient, well-designed to achieve their objectives, and based upon the best available evidence." "It is routine for agencies to make changes to their draft rules during the course of OMB review," she added. "The goal is to maximize the effectiveness and benefit of the rules we complete." An FDA spokeswoman, Jennifer Haliski, said the FDA does not comment on changes to a proposal during the review process but said the period for the public to comment on the proposal is still open until Aug. 8. "All comments will be carefully considered as the final rule is being developed," she said in [...]

2014-06-25T12:26:37-07:00June, 2014|Oral Cancer News|

FDA proposes rules to disclose e-cigarette ingredient information and ban sales to children

Source: usatoday.comAuthor: Wendy Koch  As electronic cigarettes soar in popularity, the U.S. government Thursday is proposing historic rules to ban their sale to minors and require warning labels as well as federal approval. Three years after saying it would regulate e-cigarettes, the Food and Drug Administration is moving to control not only these battery-powered devices but also cigars, pipe tobacco, hookahs (water pipes) and dissolvable tobacco products. Currently, the FDA regulates cigarettes, roll-your-own tobacco and smokeless products such as snuff. The proposed rules won't ban advertising unless the products make health-related claims nor will they ban the use of flavors such as chocolate or bubble gum, which public health officials say might attract children. "This is an important moment for consumer protection," said FDA Commissioner Margaret Hamburg, noting tobacco remains "the leading cause of death and disease in this country." The rules will require manufacturers to report their ingredients to the FDA and obtain its approval. They also ban free tobacco samples and most vending-machine sales. "Some of these regulations will be very restrictive," said Ray Story, founder of industry group TVECA (Tobacco Vapor Electronic Cigarette Association), who added he obtained his own pre-release copy of the rules. He said they could be costly for smaller businesses and slow the growth of a product that advocates say has helped many smokers kick the habit. Still, Story said, consumers might benefit, because "it provides them a product that will be consistent." E-cigarettes contain varying ingredients and levels of nicotine that are [...]

2014-04-24T15:19:30-07:00April, 2014|Oral Cancer News|

Current tobacco reports show 50 years of progress

Source: the-scientist.comAuthor: Jef Akst  In 1964, the U.S. Surgeon General released the first report on the effect that cigarettes and other forms of tobacco have on human health, presenting strong evidence of the link between smoking and lung cancer, among other adverse consequences. During the last 50 years, significant progress has been made in terms of understanding how smoking causes various diseases and how to treat them, and educational campaigns have contributed to a drop in smoking rates from 42 percent to 18 percent of US adults. Nevertheless, more than 480,000 Americans still die from tobacco-related diseases each year, and additional health consequences continue to be linked to smoking. “Between now and mid-century, nearly 18 million Americans will die preventable avoidable deaths if we don’t do something to alter that trajectory,” Mitchell Zeller, the director of the Center for Tobacco Products of the Food and Drug Administration (FDA), said during a press conference held today here at the American Association for Cancer Research (AACR) meeting in San Diego, California. To this end, the AACR released a compilation of peer-reviewed research and review articles, published across seven of its journals, covering basic scientific research on the molecular mechanisms of tobacco carcinogenesis, tools for the diagnosis of lung cancer and other tobacco-related diseases, and the impact of the original Surgeon General’s report on tobacco control. Ellen Gritz from the University of Texas MD Anderson Cancer Center helped put the new report together. “Together, these reports add to the broad reach of important tobacco-related [...]

2014-04-17T11:21:58-07:00April, 2014|Oral Cancer News|

The FDA’s power over cigars

Source: www.latimes.com/health Author: editorial The 2009 federal law that required the U.S. Food and Drug Administrationto begin regulating cigarettes also gave it the option of regulating cigars. Now two bills, one in each chamber of Congress, would remove the agency's authority over "traditional" cigars — the regular size that you're used to, not the ones the size of cigarettes. It's true that cigarettes are the far bigger health scourge in the United States, accounting for nearly one in five deaths each year, according to the U.S. Centers for Disease Control and Prevention. Traditionally, cigars have not been popular among young people, which is significant because preventing smoking among youth is one of the key reasons for regulating tobacco. But there's nothing good to be said about the health effects of cigar smoking levitra de 20 mg xifaxan médicament. Even though cigar lovers don't typically inhale the smoke, their lung cancer rates are higher than those of nonsmoking Americans — though lower than those of cigarette smokers. According to the National Cancer Institute, cigars have higher levels of tar, toxins and carcinogens than cigarettes and cause cancers of the mouth, lips, throat and esophagus. They also produce more secondhand smoke. The rate of cigar smoking have been increasing for the last two decades, and cigars can now be found in fruit and candy flavors, including chocolate — the same kind of flavor tweaking that got many teenagers hooked on cigarettes. That was why the Family Smoking Prevention and Tobacco [...]

The Gardasil Problem: How The U.S. Lost Faith In A Promising Vaccine

Source: Forbes Magazine, written by Matthew Herper Neal Fowler, 50, the chief executive officer of a tiny biotech called ­Liquidia, was assuming a position common to road-warrior entrepreneurs: leaning his elbows on the seat-back tray in an airplane so he could gaze at the screen of his laptop. That’s when he felt the lump in his neck. Fowler, a pharmacist, figured his lymph node was swollen by a recent cold, but the oncologist seated next to him—his chairman of the board—thought they’d better keep an eye on it. The chairman was right. Over the next week the lymph node got bigger and harder. It was not sore to the touch, as happens during a cold. Fowler went to the doctor, then a specialist who knew exactly what he was seeing: a new form of throat cancer that ear, nose and throat specialists across the U.S. now say dominates their practices. Some 8,000 of these tonsil tumors turn up each year nationwide, courtesy of strain 16 of the human papilloma virus—the same sexually transmitted virus that causes cervical cancer. Usually transmitted when men perform oral sex on women, it can also spread through other forms of contact, perhaps even just kissing. His prognosis was good—80% of those with this new tumor survive. His status as a drug industry veteran and chief executive of a biotechnology company didn’t hurt, either. He went from diagnosis to having the primary tumor removed from his tonsil in just a day. His first team of doctors [...]

2012-04-05T21:25:34-07:00April, 2012|Oral Cancer News|

Court: Tobacco Health Labels Constitutional

Source: Reuters.com Combination picture of new graphic cigarette packages, released by the U.S. Food and Drug Administration June 21, 2011, shows a varied collection of a man on a ventilator, diseased lungs and dead bodies were among the graphic images for revamped U.S. tobacco labels, unveiled by health officials who hope the warnings will help smokers quit. Credit: Reuters/U.S. Food and Drug Administration/Handout By Terry Baynes (Reuters) - A U.S. law requiring large graphic health warnings on cigarette packaging and advertising does not violate the free speech rights of tobacco companies, a federal appeals court ruled on Monday. Cigarette makers had sued to stop the U.S. Food and Drug Administration's new labeling and advertising requirements on grounds the rules violated their First Amendment right to communicate with adult tobacco consumers. But the Cincinnati-based U.S. Court of Appeals for the 6th Circuit upheld the bulk of the FDA's new regulatory framework, including the requirement that tobacco companies include large warning images on cigarette packs. The decision comes on the heels of a Washington, D.C., judge's ruling in a different, but related, case that rejected the FDA requirements and seems to set up a clash over the constitutionality of the FDA rules. Floyd Abrams, a lawyer for Lorillard, noted the difference in tone in the two rulings and said the 6th Circuit case, the Washington case, or both, would likely end up in the U.S. Supreme Court. The difference in the two cases is that the FDA had not introduced the specific [...]

2012-03-21T10:43:06-07:00March, 2012|Oral Cancer News|

Judge Rules Graphic Cigarette Warning Labels Unconstitutional

 Source: Time Magazine- Healtland The government’s effort to put graphic warning labels about the dangers of smoking on cigarette packs hit another legal snag on Wednesday. A Washington judge declared unconstitutional a Food and Drug Administration (FDA) mandate that would force cigarette makers to use the labels, which include images of a corpse of a smoker, smoking-damaged teeth and gums and diseased lungs, saying that it violated cigarette makers’ freedom of speech under the First Amendment. U.S. District Judge Richard Leon wrote in his ruling that the images “were neither designed to protect the consumer from confusion or deception, nor to increase consumer awareness of smoking risks; rather, they were crafted to evoke a strong emotional response calculated to provoke the viewer to quit or never start smoking.” SPECIAL: FDA Unveils Final Cigarette Warning Labels That’s been the argument of cigarette makers, who say that the images go beyond merely informing the public to forcing the manufacturers to advertise the government’s anti-smoking agenda, with the purpose of convincing smokers to give up the habit. Leon’s ruling fell in line with his previous decision in the case in November, when he issued a temporary injunction blocking the new labeling effort. That decision has already been appealed by the government. The Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA regulatory authority over tobacco products for the first time. Under that law, the FDA required cigarette makers to cover the top half of the front and back of cigarette [...]

2012-03-01T14:10:43-07:00March, 2012|Oral Cancer News|

HPV Vaccine Not Linked To Autoimmune Disorders, Study

Source: MedicalNewsToday.com A two-year study of nearly 190,000 girls and women, finds that Gardasil, the human papillomavirus (HPV) vaccine made by Merck & Co, does not trigger autoimmune disorders such as lupus, rheumatoid arthritis, type 1 diabetes and multiple sclerosis. The results are published in the Journal of Internal Medicine. Study lead author Dr Chun Chao, a research scientist at the Kaiser Permanente Department of Research & Evaluation in Pasadena, California, said in a statement released on Friday, that: "This kind of safety information may help parents with vaccination decisions." ""These findings offer some assurance that among a large and generalizable female population, no safety signal for autoimmune conditions was found following HPV4 vaccination in routine clinical use," said Chao. Gardasil is a "quadrivalent" vaccine because it helps protect against 4 types of HPV. In girls and young women age 9 to 26, it targets 2 types that cause about 75% of cervical cancers, and 2 other types that cause 90% of cases of genital warts. The vaccine, which is given as three injections over six months, also helps protect boys and men age 9 to 26 against 90% of cases of genital warts. Genital warts is the most common sexually transmitted infection in the US, where it infects about 6.2 million people every year. It can also lead to cervical cancer in women. Gardasil received US Food and Drug Administration (FDA) approval in 2006. But a longstanding concern about links with autoimmune disorders has surrounded the vaccine, and many [...]

2012-02-03T10:40:12-07:00February, 2012|Oral Cancer News|

Third Head and Neck Indication for Erbitux

Source: The ASCO Post, January 1, 2012, Volume 3, Issue 1, Matthew Stenger   In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.Cetuximab (Erbitux) was recently approved by the FDA for use in combination with platinum-based therapy plus fluorouracil (5-FU) for the first-line treatment of patients with recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck.1-3 Cetuximab has prior indications in combination with radiation therapy in locally or regionally advanced squamous cell head and neck cancer and in recurrent or metastatic head and neck cancer that has progressed after platinum-based therapy. It also has indications in colorectal cancer. The most recent approval is based primarily on results of a study conducted outside the United States in 442 patients with metastatic or locally recurrent squamous cell carcinoma of the head and neck who were not suitable for curative treatment with surgery or radiation. The study used a European Union (EU)-approved cetuximab rather than the U.S.-approved cetuximab (Erbitux). Erbitux provides approximately 22% higher exposure than the EU-approved cetuximab; these pharmacokinetic data, together with the results of the study conducted in Europe and other data using Erbitux establish the safety and efficacy of Erbitux at the recommended dose.In this trial, the addition of cetuximab (n = 222) to platinum-based therapy plus 5-FU (n = 220) significantly increased median overall survival from 7.4 to 10.1 months, representing a 20% reduction in risk of death [...]

UI professors: HPV editorial misses the mark

Source: The Daily Iowan The Nov. 29 editorial "Recommend Pap smears, not vaccines, to prevent cervical cancer" completely missed the mark with regard to HPV vaccines. We are researchers and clinicians at the University of Iowa who study and treat HPV and other infectious diseases. It is disturbing to think that the article might dissuade individuals from getting a safe and effective vaccine that can prevent cancer. First of all, it has been conclusively demonstrated that the vaccines are effective at preventing HPV infection. Cervical cancer is caused by HPV. Additionally, cancers of the head and neck are linked to HPV, including cancers in males. It has been clearly shown that the vaccines prevent the development of precursors to cervical cancer. In the editorial, Dr. Diane Harper was quoted as saying, "If doctors tell patients that this vaccination will prevent cancer, they're telling them a lie." This statement from Dr. Harper is simply misleading. In the vaccine studies, non-treatment of precursor lesions in the placebo group in the context of a clinical trial was considered unethical, and therefore, any precursor lesions were treated. Subsequent development of cancer in the placebo group was prevented by the required ethical treatment. Thus, the trials could not evaluate prevention of advanced cancer, per se. Because it takes cervical cancer a long time to develop, it will take about 15 more years to have data on incidence rates of cervical cancer from a large vaccinated general population. Because the vaccines prevent HPV infection and HPV-associated [...]

2011-12-08T10:31:17-07:00December, 2011|Oral Cancer News|
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