FDA’s list of food priorities include finalizing rules for GRAS & gluten-free labeling for fermented foods

“There has been controversy over the GRAS self-determinations, which are permitted by law,” said Susan Mayne, who less than three months ago became director of FDA’s Center for Food Safety and Applied Nutrition, Foods & Veterinary Medicine. For example, currently “FDA cannot force companies to submit GRAS notifications for new or expanded uses of a substance,” she said at the Food Drug Law Institute’s Annual meeting in Washington, D.C., April 20. Nor does FDA “have the authority to issue mandatory data calls to support reconsideration of GRAS over time. That authority would require a change to the law,” she added. However, “enhancements are being discussed in the context of GRAS and that will feed into an overhaul of our food ingredients program with both pre-market and post-market enforcement under consideration,” she said. The agency has until August 2016 to finalize the GRAS process, which was proposed in 1997 but remains unfinished. The deadline is part of a settlement to resolve a lawsuit brought by the Center for Food Safety calling for the agency to vacate the GRAS proposal because FDA allegedly does not verify claims of safety for ingredient self-determined as GRAS. To ensure the “programmatic improvements … meet both agency and stakeholder expectations in the setting of GRAS” FDA will “definitely need additional resources,” Mayne said, echoing her predecessors. Industry needs to help improve GRAS Mayne also called on industry to help improve the GRAS process and ensure GRAS self-determinations done by industry are based on sound information and data publically available. “We encourage industry to voluntarily engage with the FDA by participating in GRAS pre-submission meetings, by submitting GRAS notices and proactively discussing broader food ingredient issues with us,” she said. “We also encourage industry to make GRAS determinations transparent – particularly if you are not engaging with the FDA,” she added. Finally, she said, industry can improve the credibility of the GRAS process by sharing decisions regarding food ingredient safety via publications and other means so it is in the public domain. Other updates underway The GRAS process is not the only thing Mayne says CFSAN is modernizing. It also is updating the Total Diet Study, which tests levels of nutrients and contaminants in commonly consumed processed foods and beverages. Specifically, the agency is reevaluating the sampling plan and looking at how to do the study, which started in 1961, so that it better aligns “in this point in time,” Mayne said. The agency also is taking a second look at a risk assessment process to evaluate the issue of arsenic in food, Mayne said. She noted the agency is aware of lingering concerns about arsenic in rice following FDA’s determination that the arsenic levels in rice are too low to pose an immediate adverse health effect. Nutrition priorities for 2015 Regarding nutrition – “the N in CFSAN” – Mayne said the division has several “major” initiatives for 2015, including:

FDA’s list of food priorities include finalizing rules for GRAS & gluten-free labeling for fermented foods

FDA is considering adding pre- and post-market enforcement “enhancements” to the final rule for the process of determining food substances are GRAS – or generally recognized as safe, according to a top agency official.

Related Topics

Particulars of GRAS process leave it open to criticism, expert says

Conflicts of interest are ‘ubiquitous’ in GRAS determinations, alleges study

AHA GRAS attack reaction: Why self-affirmed GRAS is not ‘GRAS lite’