If the Food and Drug Administration someday begins regulating electronic cigarettes and increases regulations on tobacco, Durham-based SciMetrika may be a leader in that effort after winning a contract to explore possible guidelines for the FDA.
The privately held consulting firm on Monday announced it had won a $40 million contract from the U.S. Food and Drug Administration to research the feasibility of various policy options” regarding control of tobacco products.
The contract covers five years. SciMetrika, which is a 12-year-old company, began initial research earlier this month.
“We are excited for the opportunity to provide research and present evidence to the FDA Center for Tobacco Products on this project,” said SciMetrika Chief Executive Officer Jean Orelien. “SciMetrika’s staff understands the special attention required for an initiative as important as the regulation of tobacco products. We look forward to serving the FDA using our deep knowledge of population health.”
The firm says it will put together a teamof “public health professionals” to “collect and synthesize evidence concerning tobacco products and inform the development of regulatory policy options to the FDA’s Center for Tobacco Products.”
SciMetrika focuses on life science and public health issues.
The FDA is charged with setting controls for tobacco under the 2009 Family Smoking Prevention and Tobacco Control Act. Specific areas include:
- Setting performance standards
- Reviewing premarket applications for new and modified-risk tobacco products
- Proposing and implementing new cigarette pack warning labels
- Eliminating flavor additives (except menthol) in cigarettes
- Investigating and ruling on the possible elimination of menthol flavoring in cigarettes
- Proposing a plan to regulate other tobacco products, such as cigars and smokeless tobacco
- Establishing and enforcing advertising and promotion restrictions