FDA Extends Authority to All Tobacco Products, Including E-Cigarettes, Cigars and Hookah

Recently, the Food and Drug Administration issued a final rule effective August 8, 2016 Deeming Tobacco Products to Be Subject to the Federal Food, Drug and Cosmetic Act. This rule extends FDA’s authority to include the regulation of electronic nicotine delivery systems, all cigars, hookah tobacco, pipe tobacco and nicotine gels that went on sale after February 15, 2007.  According to a press release issued by the FDA this new rule would also ban the sale of e-cigarettes, hookah or cigars to anyone under the age of 18. The new rule also includes the following:
 
  • Registering manufacturing establishments and provide product listings to the FDA
  • Reporting ingredients and harmful and potentially harmful constituents
  • Requiring premarket review and authorization of new tobacco products by the FDA
  • Placing health warnings on product packages and advertisements
  • Not selling modified risk products unless authorized by the FDA
  • Not allowing the selling to tobacco products in vending machines
  • Not allowing the distribution of free samples. 
The new rule does not ban flavored tobacco products including e-cigarettes, nor does it ban advertising of products. 
 
What is next? According to an article in the Hill, a leading manufacturer of e-liquids has filed a lawsuit in the federal district court in Washington, D.C. challenging the deeming rule. Also, some members of Congress are leading efforts to attach policy riders to the Agriculture appropriations bills limiting FDA’s authority to implement this rule. AADR joined the broader public health community by sending a letter to the House Appropriations Committee and a separate letter to the Senate Appropriations Committee voicing our opposition to these policy riders. We will continue to monitor these efforts and advocate for FDA to have the authority to oversee all tobacco products, including e-cigarettes. 
 
Additional Information: For additional information the FDA Center for Tobacco Products (CTP) hosts a series of webinars on federal tobacco regulations. These webinars are designed to provide FDA tobacco compliance education and information to retailers and to small business manufacturers. Sign up to receive email updates about this webinar series.

House Subcommittee Approves Funding for NSF

This week, the House Commerce, Justice and Science (CJS) Appropriations Subcommittee approved its fiscal year 2017 appropriation bill. The CJS bill proposes funding allocations for the Department of Commerce, the Department of Justice, the National Aeronautics and Space Administration (NASA), the National Science Foundation (NSF) and other agencies. For NSF specifically, the House allocated approximately $7.4 billion, $57 million below the fiscal year 2016 enacted level and $158 million below the President’s budget request. According to a fact sheet released by the Subcommittee Research and Related Activities were increased by $46 million and reductions were made to equipment and construction costs.

AADR will continue to closely monitor these developments and work in partnership with the Coalition for National Science Funding as this bill moves forward.

 

AADR Joins 77 Organizations Opposing an Increase in SBIR Set Aside

Last week, AADR joined 77 scientific and professional societies, higher education associations, universities and research institutions in a letter expressing opposition to a provision included in the Commercializing on Small Business Innovation Act of 2016 (H.R. 4783) which would increase the SBIR set aside from 3.46 percent to 4.5 percent in FY2022. The organizations argued that there is no evidence that this increase is necessary or beneficial to the nation, and the larger set-aside will reduce the opportunity for other crucial sectors of the research enterprise to contribute to progress in science and technology.

This letter also urges the House Science Committee to, “…exercise its jurisdiction by holding hearings to review the outcomes of the last SBIR/STTR reauthorization and what would be accomplished through a renewal of the programs.” The organizations state that the SBIR/STTR set-aside should not be increased without a thorough evaluation of existing data on these programs and the merits of and justification for increasing the set aside.

What is next? Organizations are closely monitoring developments on the National Defense Authorization Act and any other attempts to attach this bill to legislation that is moving to the floor. AADR will keep you informed as this process moves forward.

Department of Labor Issues New Overtime Rule Impacting Postdocs

This week the Department of Labor finalized a rule to the Fair Labor Standards Act (FLSA) to update overtime protections. The final rule will take effect on December 1, 2016 and doubles the salary threshold from $23, 660 to $47,476 per year under which most salaried works are guaranteed overtime. A fact sheet issued by the White House indicates this new level will be automatically updated every three years. According to a Huffington Post op-ed authored by NIH Director Francis Collins and the US Secretary of Labor, Thomas Perez,  this rule will effect 37,000 to 40,000 junior scientists.

The authors state, “Under the new FLSA overtime threshold, universities, teaching hospitals, and other institutions that employ postdocs have a choice: they can carefully track their fellows’ hours and pay overtime, or they can raise their salaries to levels above the threshold and thereby qualify them for exemption. Biomedical science, by its very nature, is not work that neatly falls into hourly units or shifts. So, from our vantage point, it seems that the only option consistent with the professional nature of scientific work is to increase salaries above the threshold. In response to the proposed FLSA revisions, NIH will increase the awards for postdoctoral National Research Service Awards recipients to levels above the threshold. At the same time, we recognize that research institutions that employ postdocs will need to readjust the salaries they pay to postdocs that are supported through other means, including other types of NIH research grants. While supporting the increased salaries will no doubt present financial challenges to NIH and the rest of the U.S. biomedical research enterprise, we plan to work closely with leaders in the postdoc and research communities to find creative solutions to ensure a smooth transition.”

White House Launches National Microbiome Initiative and AADR Member is Recognized for its Commitment

Dr. John Holdren, Assistant to the President for Science and Technology, Director of the White House Office of Science and Technology Policy

Last week, AADR attended an event at the White House announcing the launch of the National Microbiome Initiative (NMI).  According to the fact sheet released by the White House, this initiative aims to advance understanding of microbiome behavior and enable protection and restoration of healthy microbiome function. The goals of the NMI are as follows:

  • Support interdisciplinary research to answer fundamental questions about microbiomes in diverse ecosystems.
  • Develop platform technologies that will generate insights and help share knowledge of microbiomes in diverse ecosystems and enhance access to microbiome data.
  • Expand the microbiome workforce through citizen science, public engagement and educational opportunities.

The NMI launched a combined Federal agency investment of $121 million in fiscal year 2016 and 2017 for cross ecosystem microbiome studies. This funding includes an extra $20 million at the National Institutes of Health and $16 million at the National Science Foundation.  The NMI also includes $400 million in financial and in-kind contributions that support the overarching goals of the NMI.

Dr. Wenyun Shi, Professor and Chair of Oral Biology UCLA School of Dentistry and Carolyn Mullen, AADR Director of Government Affairs

This past year AADR worked on behalf of its members with the White House Office of Science and Technology Policy to highlight the importance and value of the oral microbiome. As a result of our efforts, AADR Institutional Section Member The Forsyth Institute was recognized for its new commitment for oral microbiome research as part of the National Microbiome Initiative. Specifically, Forsyth will dedicate up to $100,000 per year for three years for pilot grant funding for novel microbiome projects. This multi-year commitment to invest in groundbreaking projects in its newly formed Host-Microbiome Center will provide funding to support exploratory or proof-of-principle studies for which no other funding sources are available. Such studies must have the potential to develop into full-fledged research projects that test new paradigms, and can lead to intellectual property, and NIH or other extramural funding.

In addition to the Forsyth Institute C3 Jian was recognized for its commitment of $75 million over the next 3 to 4 years to develop antimicrobials that correct microbial imbalances in many human diseases. The investment also includes C3J’s commitment to advance their lead microbiome program towards FDA approval for the prevention of dental caries in children, adolescents and adults. The NMI also included commitments from a number of educational institutions, including the University of Michigan, University of Pittsburgh, the University of California and many others.

AADR was extremely pleased to participate in this event and we look forward to working with the community to support provisions in the NMI.

For additional information:

Click here for information about the National Microbiome Initiative

Click here to read our press release

Click here to read C3 Jian’s press release