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August 19, 2016


Greetings! We hope you had a comfortable and pain-free week! This week's top stories include an honor bestowed on our Assistant Administrator for Field Operations, an announcement about new FDA regulations about food ingredients that may be “generally recognized as safe” (GRAS), and a list of the past week's top distilled spirits pages at TTB.gov/.


Tom CroneThe U.S. Department of the Treasury recognized Tom Crone, TTB’s Assistant Administrator for Field Operations, as one of Treasury’s best leader-mentors as part of its 2016 Leadership Legacy Honors. This means Tom has been recognized as the best kind of leader – one who creates a Leadership Legacy by guiding others to the next level.

Throughout his 53-year federal career, Tom has always felt passionate about guiding and mentoring employees who demonstrate supervisory or managerial potential. As a testament to Tom's mentoring abilities, many of those individuals successfully pursued managerial positions.  In fact, several of the individuals he has mentored during his career have been appointed to the Senior Executive Service.

During Tom’s career with the Department of Treasury, he has distinguished himself as an inclusive, innovative, and persuasive leader who is respected TTB-wide for his personal engagement in issues and demonstrated record of developing employees and teams to achieve their highest potential.

Tom received this award earlier this year as part of Treasury’s observance of Public Service Recognition Week.


Each producer and importer of alcohol beverages is responsible for ensuring that the ingredients in its products comply with the laws and regulations that FDA administers, including rules regarding criteria for concluding that a substance is “generally recognized as safe” (GRAS). Industry members are reminded that TTB's approval of a COLA or formula does not imply or otherwise constitute a determination that the product complies with the Federal Food, Drug, and Cosmetic Act.

Source: FDA Constituent Update dated August 12, 2016

In a step to strengthen its oversight of food ingredients, the U.S. Food and Drug Administration today issued a final rule detailing the criteria for concluding that the use of a substance in human or animal food is "generally recognized as safe" (GRAS). Unlike food additives, GRAS substances are not subject to FDA pre-market approval; however, they must meet the same safety standards as approved food additives.

The rule addresses the types of scientific evidence that can be used to demonstrate safety as well as the role of publications in evaluating whether the scientific evidence of safety is “generally available and accepted.” The GRAS criteria require that the safe use of ingredients in human and animal food be widely recognized by the appropriate qualified experts. The final rule also formalizes the voluntary GRAS notification procedure, which was originally established under an interim policy and pilot program for human food in 1997 and animal food in 2010.

The FDA strongly encourages companies to inform the agency of GRAS conclusions through the notification procedure finalized with today’s rule. While the FDA can question the basis for an independent GRAS conclusion, whether notified or not, and take action as appropriate, the notification procedure yields important information that aids the agency’s food safety monitoring efforts.

The GRAS final rule is the most recent step we are taking to strengthen the FDA’s oversight of substances added to human and animal food. Next steps include issuing additional guidances related to the GRAS regulations. As part of the Foods and Veterinary Medicine Program’s Strategic Plan, the FDA will develop and implement innovative regulatory and compliance strategies to improve premarket oversight and safety evaluation of human and animal food additives and GRAS substances.

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