Robert Califf Named New FDA Commissioner
Robert Califf Named New FDA Commissioner
The senate has voted, and Robert Califf, a cardiologist and academic researcher most recently at Duke University, will be the next Food and Drug Administration commissioner. The vote, which was held last month, was 89 to 4.
“Dr. Califf is the right person with the right experience to build on the FDA’s unsurpassed record of protecting public health while encouraging innovation and the introduction of new life-saving therapies to the market,” Health and Human Services Secretary Sylvia M. Burwell said in a statement.
Califf joined the FDA one year ago and has been met with some opposition for his views, especially regarding the prescription painkiller epidemic to genetically engineered salmon.
“I think my record shows that I’m for medical products that work and are effective. When they’re not, I’ve been outspoken,” Califf told The Washington Post shortly after his confirmation. “I think the best testament is that I went through an amazingly rigorous committee, hundreds of pages of written documentation, and then a full senate review, and came out pretty well.”
Califf succeeds Margaret A. Hamburg, and he has received support from the American Heart Association, the Leukemia & Lymphoma Society and Friends of Cancer Research, according to The Washington Post.
Broughton Laboratories and Nerudia have announced a new partnership that will see the companies working in tandem to support customers in complying with the requirements of the European Tobacco Products Directive (TPD), which comes into effect on May 20.
The partnership brings the strengths and expertise of the two companies together and will bring cost benefits to customers through economies of scale and knowledge, along with the convenience of having a single point of contact between the two businesses.
Peter Beckett, Nerudia Head of Compliance, said, “The analytical capabilities and expertise of Broughton Laboratories are a perfect fit with Nerudia’s regulatory knowledge and our own services. Our partnership will bring cost effective and accessible services to the entire market, from the smaller firms up to larger organizations, as we believe that the cost of TPD should not be prohibitive to anyone.”
Chris Allen, M.D., of Broughton Laboratories, said, “The partnership of Nerudia and Broughton Laboratories means that clients will receive a premium level of service for both regulatory support and emissions testing studies for EU TPD compliance. Combining our experience and expertise of working within global regulated industries enables us to offer clients a pragmatic and scientifically-sound approach to complying with the EU TPD regulations. Alongside Nerudia Compliance we will continue to work closely with the MHRA and other EU Member States to develop, establish and promote international quality standards for the electronic cigarette industry.”
To mark the partnership, there will be an offer of 10 percent discount on all analytical and regulatory services booked during March.
For more infomation, contact email@example.com.
ABOUT NERUDIA AND BROUGHTON LABORATORIES:
Nerudia offers the development, manufacture, testing and regulatory compliance of nicotine products for the e-cigarette and pharmaceutical markets, along with innovation for next generation products.
Broughton Laboratories is an independent MHRA and FDA inspected laboratory offering product development and analytical testing services, with over five years’ experience specializing in nicotine products for both the consumer and health care markets.
Subjects to be covered include:
- Diacetyl Threats and Litigation
- Product Standards and Innovation
- Challenges to Standardized E-Liquid Testing
- Non-Nicotine Nutraceutical E-Liquid Regulation
Las Vegas Convention Center
Hall 3, Room S229
Event Date and Time:
Monday, March 14
11 a.m.-3 p.m.
Kawala concentrates his practice in the defense of civil litigation and earned his B.A. at Northwestern University and his J.D. from the University of Illinois College of Law. Kawala’s experience has focused on a variety of personal injury litigation, including construction and transportation professional negligence litigation, general liability litigation, products liability and chemical exposure liability matters. Kawala is a member of Chicago, Illinois State and American Bar Associations and Defense Research Institute.
Kawala’s trial experience includes more than 30 trials in state and federal courts in Illinois and Indiana. He has also been admitted pro hac vice in the following states: Indiana, Wisconsin, Iowa, Ohio, Missouri, Pennsylvania, Maryland, New Mexico, Texas, California, Washington, Georgia, Florida and South Carolina.
Kawala has been at Swanson, Martin & Bell, LLP since 1992. Prior to joining the firm, he was at Wildman Harrold Allen & Dixon from 1987-1992 and Chadwell Kayser from 1985-1987.
“Product Standards & Innovation” presented by Gal Cohen
Gal Cohen, Ph.D. is head of Scientific and Regulatory Affairs for PAX Labs, Inc., a vaporization technology company based in San Francisco, Calif. He has 25 years of experience in medical devices and biomedical engineering. His industry experience includes product management and business development related to inhaled pharmaceuticals at Nektar Therapeutics and strategic planning for the diabetes division of Medtronic. Cohen has a Ph.D. in neuroscience/cellular and molecular physiology from Stanford University, where he was a Hughes Fellow. He graduated with honors and distinction from Stanford with an undergraduate degree in biology and a master’s degree in electrical engineering.
“Challenges to Standardized E-Liquid Testing” presented by Kim Hesse
Hesse is a business development manager at Global Laboratory Services with a history of customer service in the laboratory industry. Her career in the laboratory industry began January 2008 in Germany where she was trained on instrumentation used within the lab and its application in the analysis of crop protection agents. Since then, Hesse has expanded to working more in-depth in the tobacco laboratory industry and pharmaceutical industry.
As business management manager at Global Laboratory Services, Hesse speaks at numerous events nationally and internationally. She continues to help the vaping industry grow in the understanding of the what analyses are routinely being performed on e-liquids and e-cigarettes and listens to what the industry wants next in means of testing and data.
She earned her master’s and bachelor’s degrees from Kent State University and attended Arizona State University’s School of International Business Management.
“Non-Nicotine Nutraceutical E-Liquid Regulation” presented by Todd Harrison, Esq.
Todd Harrison focuses his practice on Federal Food and Drug Administration (FDA), United States Department of Agriculture’s Food Safety and Inspection Service (FSIS)/Animal and Plant Health Inspection Service (APHIS)/Agricultural Marketing Service (AMS), Federal Trade Commission (FTC), and the Drug Enforcement Administration (DEA), as well as other federal, state and international consumer protection agencies governing rules and regulations related to drugs, foods, dietary supplements, homeopathic remedies, medical devices, medical foods and cosmetics. Harrison works extensively in the areas of food and dietary supplement safety, labeling and advertising claims. He drafts opinion letters regarding the status of food ingredients in the United States and assisted in the preparation of food additive petitions, GRAS notifications, and new dietary ingredient notifications. He also assists companies in developing self-determined GRAS position for food ingredients.
Harrison advises clients on issues related to FDA and FSIS’s labeling requirements as well as on organic products and genetically modified organisms. Additionally, he advises clients on international food issues.
To start the call, Michelle Corrigan of Stinson Leonard Street in St. Louis, Mo., drew upon her nearly 20 years of experience in the areas of products liability, personal injury and business litigation. With that expertise, she spoke about the future of liability cases and how businesses should be preparing themselves.
Sarkis Kaladzhyan, president of Calco Commercial Insurance, discussed the importance of warning labels in protecting yourself from frivolous lawsuits. He also addressed the ins and outs of insurance and what gaps you will want to be sure to fill when purchasing a policy.
Chicago Mayor Rahm Emanuel says that his proposed tobacco ordinance—which would enact a new tax on other tobacco products, set minimum cigarette and tobacco prices, mandate minimum package sizes, prohibit the redemption of tobacco product coupons, and raise the legal age to buy tobacco to 21—is all about Big Tobacco. CSPNet.com says that this isn’t the case.
So far Emanuel’s proposal includes “raising the cigarette tax to a nationwide high of $7.17 per pack when state, county and city cigarette taxes are all added together, imposing a tax on e-cigarettes, prohibiting the use of e-cigarettes where smoking is currently restricted, and banning the sale of most flavored tobacco products within 500 feet of schools,” CSPNet.com reports.
Aldermen have said publicly that this would aid Chicago’s “black market” for vaping and cigarette purchases. It also would force paying customers to travel out of the city for products, costing many shops and employees their business and jobs. While Emanuel says that this is about combating Big Tobacco and minors vaping and/or smoking, it may do more harm than good.
The next council meeting will be held this month.
The Salt Lake Tribune recently published an op/ed by Shilo Platts, our friend and member of the Utah chapter of SFATA. In the editorial, Platts serves up some points about why the vaping industry shares the same goal of reducing both vaping and tobacco usage in minors. Here are some of his points:
- We want to put Big Tobacco out of business as an alternative to smoking.
- Vapor products are NOT tobacco products.
- We do not want to see minors vaping. Vapor products and e-cigs are only for adults, sold by adults and targeted toward adult smokers and vapers. Research shows that nearly all vapers are former smokers, and the average age of a vaper is 39 years old.
- While the Utah Legislature’s Social Services Appropriations Subcommittee heard a report on e-cigarettes use among Utah youth showing growth in experimentation, it provided no evidence that minors who experiment with vapor products actually continue to use them.
- Combustible tobacco smoking rates have reached a historical low nationally, but the CDC shows no decline in overall tobacco use between 2011 and 2014, which means minors are still trying many different products. In any event, parents and guardians should speak with their children about not using any age-restricted product.
- Science shows that vaping is 95 percent less harmful than smoking.
- A black market for vapor products and e-liquids would be dangerous for public health.
- Our industry always has supported science-based regulations such a national standards on labeling and packaging. A patchwork of local laws only creates confusion and unneeded complexity for businesses and their customers.
For the full story, visit http://www.sltrib.com/opinion/3544742-155/op-ed-vaping-industry-shares-utahns-goals.