As part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by the President in 2009, the U.S. Food and Drug Administration this week proposed a new rule that would extend the agency’s tobacco authority to cover additional tobacco products.
Products that would be “deemed” to be subject to FDA regulation are those that meet the statutory definition of a tobacco product, including currently unregulated marketed products, such as electronic cigarettes (e-cigarettes), cigars, pipe tobacco, nicotine gels, waterpipe (or hookah) tobacco, and dissolvables not already under the FDA’s authority. The FDA currently regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.
"This proposed rule is the latest step in our efforts to make the next generation tobacco-free," said HHS Secretary Kathleen Sebelius.
Consistent with currently regulated tobacco products, under the proposed rule, makers of newly deemed tobacco products would, among other requirements:
-Register with the FDA and report product and ingredient listings;
-Only market new tobacco products after FDA review;
-Only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole; and
-Not distribute free samples.
In addition, under the proposed rule, the following provisions would apply to newly “deemed” tobacco products:
-Minimum age and identification restrictions to prevent sales to underage youth;
-Requirements to include health warnings; and
-Prohibition of vending machine sales, unless in a facility that never admits youth.
“Tobacco remains the leading cause of death and disease in this country. This is an important moment for consumer protection and a significant proposal that if finalized as written would bring FDA oversight to many new tobacco products,” said FDA Commissioner Margaret A. Hamburg, M.D. “Science-based product regulation is a powerful form of consumer protection that can help reduce the public health burden of tobacco use on the American public, including youth.”
“Tobacco-related disease and death is one of the most critical public health challenges before the FDA,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “The proposed rule would give the FDA additional tools to protect the public health in today’s rapidly evolving tobacco marketplace, including the review of new tobacco products and their health-related claims.”
The FDA proposes different compliance dates for various provisions so that all regulated entities, including small businesses, will have adequate time to comply with the requirements of the proposed rule.
Products that are marketed for therapeutic purposes will continue to be regulated as medical products under the FDA’s existing drug and device authorities in the Food, Drug &Cosmetic Act.
The proposed rule will be available for public comment for 75 days. While all comments, data, research, and other information submitted to the docket will be considered, the FDA is requesting comments in certain areas, including:
-The FDA recognizes that different tobacco products may have the potential for varying effects on public health and is proposing two options for the categories of cigars that would be covered by this rule. The FDA specifically seeks comment on whether all cigars should be subject to deeming, and which other provisions of the proposed rule may be appropriate or not appropriate for different kinds of cigars.
-The FDA seeks answers to the many public health questions posed by products, such as e-cigarettes, that do not involve the burning of tobacco and inhalation of its smoke, as the agency develops an appropriate level of regulatory oversight for these products. The FDA seeks comment in this proposed rule as to how such products should be regulated.
For more information:
-Consumer Update: Recognize Tobacco in Its Many Forms
-FDA Voice Blog: Proposed Rule Would Expand FDA’s Tobacco Control Authority
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
The CDC estimates that vaccinations will prevent more than 21 million hospitalizations and 732,000 deaths among children born in the last 20 years. Despite the U.S. immunization program’s success, according to CDC officials, 129 people in the U.S. have been reported to have measles this year in 13 outbreaks, as of April 18.
In 1994, the Vaccines for Children program (VFC) was launched in direct response to a measles resurgence in the United States that caused tens of thousands of cases and over a hundred deaths, despite the availability of a measles vaccine since 1963. The VFC program provides vaccines to children whose parents or caregivers might otherwise be unable to afford them.
This year’s 20th anniversary of the VFC program’s implementation is occurring during an increase in measles cases in the U.S. In 2013, 189 Americans had measles. In 2011, 220 people in the U.S. were reported as having measles--the highest number of annual cases since 1996.
"Thanks to the VFC program, children in our country are no longer at significant risk from diseases that once killed thousands each year,” said CDC Director Tom Frieden, M.D., M.P.H. “Current outbreaks of measles in the U.S. serve as a reminder that these diseases are only a plane ride away. Borders can’t stop measles, but vaccination can.”
The CDC reports 34 people, among the 129 cases this year, brought measles into the U.S. after being infected in other countries. Though not direct imports, most of the remaining cases are known to be linked to importations. Most people who reported having measles in 2014 were not vaccinated or did not know their vaccination status.
Because measles is a highly contagious disease, it can spread quickly among unvaccinated people. The CDC recommends people of all ages keep up to date with their vaccinations. CDC recommends two doses of MMR (measles, mumps, and rubella) vaccine for everyone starting at age 12 months. Infants 6 through 11 months old should receive 1 dose of MMR vaccine before international travel.
For children born during the VFC era, the U.S. immunization program continues to pay enormous benefits. According to analysis by the CDC, hospitalizations avoided and lives saved through vaccination will save nearly $295 billion in direct costs and $1.38 trillion in total societal costs. Parents can learn more about the VFC program at http://www.cdc.gov/features/vfcprogram/.
April 26th is the start of National Infant Immunization Week, which will bring together communities across the country in raising awareness about the importance immunization. For more information, go to www.cdc.gov/vaccines.
However, not all diseases that threaten U.S. borders can be prevented today by vaccines and require different strategies to protect Americans. “The health security of the United States is only as strong as the health security of all nations around the world. We are all connected by the food we eat, the water we drink, and air we breathe,” said Dr. Frieden. “Stopping outbreaks where they start is the most effective and least costly way to prevent disease and save lives at home and abroad – and it’s the right thing to do.”
The Affordable Care Act (ACA), also known as the health care law, was created to expand access to coverage, control health care costs, and improve health care quality and coordination. Under ACA, more Americans than ever will qualify to get health care coverage that fits their needs and budget, including important preventive services such as vaccine coverage available at no cost for eligible children through the Vaccines for Children Program. Visit Healthcare.gov or call 1-800-318-2596 (TTY/TDD 1-855-889-4325) to learn more.
Healthy Smiles, Healthy Children: The Foundation of the American Academy of Pediatric Dentistry (HSHC) is now accepting applications for its 2015 Access to Care Grants. HSHC is committed to supporting community based initiatives providing Dental Homes to children whose families cannot afford dental care. HSHC supports this goal through its Access to Care Grants targeting children up to age 18.
HSHC Access to Care Grants are one year matching grants of up to $20,000, supporting community-based initiatives in the U.S. that provide dental care and ultimately serve as a Dental Home to underserved/limited access children. Special consideration will be given to programs supporting the Age-One dental visit and providing care to special needs patients.
HSHC funds may be applied to cover costs of dental care, clinic supplies and instruments, patient/parent/caregiver education materials, take-home supplies (toothbrushes, toothpaste, etc.), salary, education and/or outreach to recruit dentist participation in program activities or other activity with clear, direct impact on child oral care and a direct link to the Dental Home.
Access to Care Grants must be expended within 12 months of the award.
Guidelines and application instructions are available at www.healthysmileshealthychildren.org. Applications are due Monday, August 18, 2014. For further information, contact Tracey Schilligo, Grant and Corporate Relations Manager at 312-337-2169 or via e-mail at firstname.lastname@example.org
DAYTON, Ohio— Midmark Corporation recently announced the 2014 Dental Sterilizer Promotion and partnership with Crosstex®. The promotion, themed Great Alone, Better Together, creates a “win-win” situation for dental professionals as two recognized industry leaders come together to deliver a complete sterilization and monitoring solution.
The promotion, which runs until June 30, 2014, offers dentists a holistic instrument processing solution with top-quality products and rebates ranging from $300 - $700, while also providing education, via the Crosstex Compliance Essentials Kit and CE course, on proper sterilization and patient safety – the upmost priority for both companies. For each eligible Midmark sterilizer purchased during the promotion, along with a sterilizer donation to Direct Reliefl®, the customer will receive an additional $200 rebate.
“Having the right equipment and tools are two critical components for proper instrument processing; however, there is a gap between sterilization guidelines and how instruments are being processed in the dental office,” stated Cathy Klein, product manager for Midmark. “We want to provide the equipment, tools and education to ensure proper instrument processing for every dental facility.”
“Crosstex is dedicated to ensuring practices have correct products to meet CDC guidelines and ensure practice and patient safety,” stated Andrew G. Whitehead, Crosstex senior vice president of marketing and business development. “This dental sterilizer promotion helps ensure that clinicians are following appropriate infection control procedures from the very first day their equipment is installed.”
Important program dates:
Order period: April 1 – June 30, 2014
Dentist’s shipment and invoice date must be between: April 1 – July 15, 2014
Must claim incentives by: August 1, 2014
Donations to Direct Relief must be received by: August 31, 2014
For complete program details, visit midmark.com/springsterilizer2014. For product inquiries, call the Midmark Dental Customer Experience Department at 1-800-MIDMARK and for questions regarding the promotion, call 1-800-MIDMARK, ext. 7575.
Chicago, IL — In light of the recent prevalence data that finds almost half of American adults age 30 and older are suffering from periodontal disease, the American Academy of Periodontology (AAP) is launching a national consumer awareness campaign devoted to educating the public on the importance of prevention and early diagnosis of periodontal disease.
The campaign, “Love The Gums You’re With,” is aimed at teaching Americans to take better care of their gums by implementing simple steps into their routine, such as brushing twice a day, flossing daily, and receiving an annual comprehensive periodontal evaluation from their general dental professional or periodontist.
To gain national awareness and to help consumers better understand periodontal disease, the AAP is teaming up with Chris Harrison, host of ABC’s “The Bachelor,” to launch these efforts. In Harrison’s role as Bachelor host, he has become a love guru of sorts, having garnered the experience to know what goes into making a successful long-term relationship. Harrison will help patients understand how to ensure a life-long relationship with healthy gums.
“On behalf of the AAP, we’re extremely excited to have the opportunity to educate the public about the high prevalence of periodontal disease,” shares Stuart J. Froum, DDS, president of the American Academy of Periodontology, clinical professor, and director of clinical research at New York University’s Department of Periodontics and Implant Dentistry. “We’re hopeful that increased awareness about this common disease and its link to other chronic diseases, such as diabetes, cardiovascular disease, rheumatoid arthritis, Alzheimer’s disease and even cancer, will drive more patients to visit their dental practitioner and focus on preventive care and early treatment, if necessary.”
Over the course of the campaign, patients may visit their dentist or a periodontal specialist for additional information about periodontal disease prevention and treatment. You may contact your referral periodontist or visit perio.org for more information.
(HealthDay News) -- An antibiotic-resistant "superbug," long a problem in health-care settings, is now taking up residence in people's homes, a new U.S. study finds.
Cick here to learn more.
ST. LOUIS, MO – Rebecca Hobbs DMD, MAGD of Augusta GA received the Orkos Award for providing the most comfortable and effective periodontal treatment for her patient with Parkinson’s disease. The Orkos Award honors dental professionals for excellence in case study. In this case, Dr. Hobbs is recognized as a compassionate provider who offered excellent individualized treatment and took seriously the important role of a caregiver in periodontal disease management.
Patients with Parkinson’s disease face many oral health challenges. The Parkinson’s Disease Foundation (pdf.org) explains that bradykinesia, a general reduction of spontaneous movement and defining feature of Parkinson’s, causes difficulty with repetitive movements like tooth brushing. Moreover, dental office visits may need to be limited due to tremors, rigidity of muscles, a decreased range of muscle motion, or common tightness of the neck and shoulders. Because treatment for gum disease routinely requires multiple, lengthy visits to the dentist with regular three-month recall appointments, the frequency and duration of periodontal treatment is especially difficult for patients with Parkinson’s.
Homecare was a clear challenge for Dr. Hobbs’s patient. Even if a caregiver is largely responsible for everyday personal hygiene needs, as was the case for this patient, tooth brushing can be difficult to perform well, resulting in plaque accumulation and gingival inflammation. This patient exhibited generalized red, tender gums, with periodontal pockets ─the spaces that develop between teeth and gums─measuring 4-6mm. In healthy mouths, periodontal pockets are 1-3mm deep.
When considering treatment options, “Utmost in my mind,” explained Dr. Hobbs, “was providing comfortable care for my patient. I try to treat each patient the way I would want my family members treated. This patient has special considerations. I wanted to keep his appointments as brief and comfortable as possible and I also wanted to help make his homecare easier for better and longer lasting results.”
Dr. Hobbs recommended starting with Perio Tray® delivery of medication to help reduce bacterial infections, plaque, and inflammation before scaling. Because scaling can be so uncomfortable that it requires a local anesthetic, Dr. Hobbs hoped that Perio Tray® delivery would combat the infections in the most comfortable way possible and reduce the amount of scaling needed as well as the time to perform it.
Dr. Hobbs asked her patient to wear the prescriptions trays four times a day for fifteen minutes with a small amount of 1.7% hydrogen peroxide gel (Perio Gel®, QNT Anderson, Bismarck, ND) and three drops of an antibiotic (Vibramycin®, Pfizer, New York, NY) in each tray. This schedule was prescribed for two weeks. With help from the caregiver, the patient was able to complete the treatments. At the end of two weeks, the patient returned when the second image was taken. Inflammation had subsided dramatically and tissue health was significantly improved. The most minimally invasive treatment could then be completed.
The Orkos Award was founded by Perio Protect, LLC to encourage and recognize the contributions of dental professionals using minimally invasive methods to treat gum disease. “This case caught our attention,” explained Tanya Dunlap, Program Development Director at Perio Protect, “because of the concern Dr. Hobbs showed for her patient’s comfort and convenience. We respect and value individualized patient care and congratulate Dr. Hobbs on her excellent approach.”
Dr. Hobbs completed her Doctorate of Dental Medicine from the Medical College of Georgia, School of Dentistry in 2001. In additional to the obvious concern for her patients shown in this case, she maintains a high commitment to her dental education through the Academy of General Dentistry’s Mastership program in Georgia, and she is one of the youngest recipients of the Academy’s rigorous Fellowship and Mastership accreditations. To learn more about Dr. Hobbs and her dental practice, visit hobbsdentistry.com or call 706-955-9516. To learn more about the prescription Perio Tray® or the Perio Protect approach to patient care, visit PerioTray.com or PerioProtect.com. Additional case studies and other Orkos Award winners are available at TheOrkosAward.com. Schedule a live consultation by calling 877-434-GUMS (4867).
An international research team led by Cesar A. Arias, M.D., Ph.D., at The University of Texas Health Science Center at Houston (UTHealth) has identified a new superbug that caused a bloodstream infection in a Brazilian patient. The report appeared in the April 17 issue of The New England Journal of Medicine.
The new superbug is part of a class of highly resistant bacteria known as methicillin-resistant Staphylococcus aureus or MRSA, which is a major cause of hospital and community-associated infections. The superbug has also acquired high levels of resistance to vancomycin, the most common and least expensive antibiotic used to treat severe MRSA infections worldwide.
Most worrisome is that genomic analyses indicated that this novel vancomycin-resistant MRSA superbug belongs to a genetic lineage that is commonly found outside hospitals (designated community-associated MRSA), said Arias, the report's senior author and an associate professor of medicine, microbiology and molecular genetics at the UTHealth Medical School.
Previous research has suggested that community-associated MRSA can disseminate rapidly among people and is responsible for the majority of skin and soft tissue infections (sores) in patients of all ages. Some of these infections can become serious and even fatal.
Since community-associated MRSA is thought to be transmitted mainly by skin contact, the new superbug may affect not only sick people or those with a weakened immune system but also healthy individuals, according to Arias. Apart from causing localized skin infections, the MRSA superbug has the ability to invade the bloodstream and may become a serious threat.
"This is the first-ever reported bloodstream infection caused by a highly vancomycin-resistant MRSA bacteria," Arias said. "If we lose vancomycin, it would make it very difficult and expensive to treat these infections," he said.
Arias and his colleagues conducted microbiological and genetic analyses of an MRSA superbug recovered from the blood of a 35-year-old Brazilian man and identified a novel transferable genetic element (plasmid) that carries the genes necessary for vancomycin resistance (vanA gene cluster).
"The presence and dissemination of community-associated MRSA containing vanA could become a serious public health concern," report the authors in the paper.
However, since this is the only documented case of this type of infection, Arias said, it is too early to tell if this specific superbug will lead to a bigger threat.
Barbara E. Murray, M.D., report co-author and director of the Division of Infectious Diseases at the UTHealth Medical School, said, "The worst resistance possible has now appeared in the community-associated MRSA clone."
What is the next step?
"There will have to be increased surveillance in South America and worldwide in the future," said Murray, who is the holder of the J. Ralph Meadows Professorship in Internal Medicine at the UTHealth Medical School and president of the Infectious Diseases Society of America.
Evidence-based interventions at the local and national levels provide promising strategies for reducing racial and ethnic health disparities related to HIV infection rates, immunization coverage, motor vehicle injuries and deaths, and smoking, according to a new report by the CDC’s Office of Minority Health and Health Equity.
The report,published today as an MMWR Supplement, describes CDC-led programs addressing some of the health disparities previously highlighted in the CDC Health Disparities and Inequalities Reports, CHDIR, 2011 and 2013. The CHDIR reports highlight differences in mortality and disease risk for multiple conditions related to behaviors, access to health care, and social determinants of health – the conditions in which people are born, grow, live, age, and work.
“Reducing and eliminating health disparities is central to achieving the highest level of health for all people,” said CDC Director Tom Frieden, M.D., M.P.H. “We can close the gap when it comes to health disparities if we monitor the problem effectively and ensure that there is equal access to all proven interventions.”
Examples of the programs and health disparities addressed:
The Vaccines for Children (VFC) Program, managed by CDC, provides vaccines at no cost to eligible children who might otherwise not be vaccinated because of inability to pay. After the introduction of the VFC Program, racial/ethnic disparities in childhood immunization coverage do not exist for measles-mumps-rubella and poliovirus vaccines.
Many Men, Many Voices (3MV) is an evidence-based HIV/STD prevention intervention developed by and for black men who have sex with men (MSM) that can lead to decreased rates of HIV infection and increased access to preventive services and treatment among MSM of color. It uses small group education and interaction to increase knowledge and change attitudes and behaviors related to HIV/STD risk among black MSM. In a randomized clinical trial, 3MV reduced participants’ high-risk sexual activity and increased rates of HIV testing. The program has been implemented in 37 states, the District of Columbia, and Puerto Rico and has been adapted to serve other MSM of color.
Four American Indian/Alaska Native tribal communities implemented tribal motor vehicle injury prevention programs, using evidence-based road safety interventions to reduce motor vehicle-related injuries and deaths. Each tribal community showed increased use of seat belts and child safety seats, increased enforcement of alcohol-impaired driving laws, or decreased motor vehicle crashes involving injuries or deaths. The effective use of communication tools –billboards, radio and television media campaigns, and school and community education programs– contributed to the success of this public health program.
“These interventions demonstrate progress toward health equity. They show the elimination of health disparities as an achievable goal and encourage further implementation of evidence-based initiatives and interventions addressing health disparities and inequities,” said Leandris C. Liburd, Ph.D., M.P.H., M.A., CDC’s associate director for Minority Health and Health Equity.
The release of this supplement coincides with 2014 National Minority Health Month, which raises awareness about the health disparities that continue to affect racial and ethnic minorities across the United States.
For more information about health disparities visit the CDC’s Office of Minority Health and Health Equity site.
Washington, DC—A diagnosis of obstructive sleep apnea may raise the risk of osteoporosis, particularly among women or older individuals, according to a new study published in the Endocrine Society's Journal of Clinical Endocrinology & Metabolism (JCEM).
Sleep apnea is a condition that causes brief interruptions in breathing during sleep. Obstructive sleep apnea, the most common form, occurs when a person's airway becomes blocked during sleep. If sleep apnea goes untreated, it can raise the risk for stroke, cardiovascular disease and heart attacks.
"Ongoing sleep disruptions caused by obstructive sleep apnea can harm many of the body's systems, including the skeletal system," said one of the study's authors, Kai-Jen Tien, MD, of Chi Mei Medical Center in Tainan, Taiwan. "When sleep apnea periodically deprives the body of oxygen, it can weaken bones and raise the risk of osteoporosis. The progressive condition can lead to bone fractures, increased medical costs, reduced quality of life and even death."
The retrospective cohort study used records from Taiwan's single-payer National Health Insurance program to track treatment of 1,377 people who were diagnosed with obstructive sleep apnea between 2000 and 2008. During the course of the next six years, researchers compared the rate of osteoporosis diagnosis in this group of obstructive sleep apnea patients to 20,655 people comparable in age and gender who did not have the sleep disorder.
Researchers found the incidence of osteoporosis was 2.7 times higher among patients with sleep apnea than their counterparts, after adjusting for age, gender, other medical problems, geographic location and monthly income. Women and older individuals faced increased risk of developing the bone condition.
"As more and more people are diagnosed with obstructive sleep apnea worldwide, both patients and health care providers need to be aware of the heightened risk of developing other conditions," Tien said. "We need to pay more attention to the relationship between sleep apnea and bone health so we can identify strategies to prevent osteoporosis."