By Etan J. Yeshua –
Three months after announcing a strategic research plan to support its regulatory agenda, FDA's Center for Food Safety and Applied Nutrition ("CFSAN") this week announced its regulatory priorities for 2013 and 2014, giving those in the food, dietary supplement, and cosmetic industries an indication of what to expect from FDA in the near future. The priorities include publishing and finalizing rules to enforce the Food Safety Modernization Act’s ("FSMA’s") food safety requirements and the Affordable Care Act’s menu labeling provisions, revising food labeling regulations, finalizing the Agency’s controversial New Dietary Ingredient ("NDI") guidance, developing a strategy to regulate energy drinks, and issuing various guidance documents regarding cosmetics.
The six “program goals,” most of which correspond to a dozen or so specific objectives are to:
- Reduce foodborne illness rates and cosmetic injury rates each year;
- Establish regulations, policies, guidances, and inspection and compliance strategies based on best science, prevention, and public health risk;
- Increase compliance with newly created preventive control standards across the farm-to-table continuum;
- Improve public health indicators through better nutrition and dietary choices;
- Develop and swiftly deploy the fastest most effective methods for identifying, containing, and eliminating food and cosmetic hazards; and
- Achieve optimal use of staff and resources.
The full list of over 80 specific objectives is available on FDA’s website divided by program goal, but we’ve identified a few that we think may be of particular interest to our readers and organized them by subject area. Check the FDA Law Blog for regular updates as FDA moves forward with the rules, guidance documents, and policies that the Agency forecasted this week.
Continuing its effort to implement FSMA, CFSAN plans to issue new regulations regarding food safety, and will develop approaches to several topics about which the Agency has yet to finalize its position. By the end of 2014, FDA plans to publish proposed rules for preventive controls in food transportation and for recordkeeping requirements for high-risk foods. By 2015, FDA plans to finalize rules regarding intentional food contamination, third party auditor accreditation, and preventive controls for food processing facilities and produce safety. Although we do not know whether to expect a proposed rule, draft guidance, or something else, FDA also plans to “address [an] approach to determine” the most significant foodborne contaminants (for FSMA § 104(a)) and an approach to determine high risk foods (for FSMA § 204(d)(2)).
To promote better dietary choices, FDA plans to roll out a number of new food labeling regulations. In the coming year, CFSAN plans to propose rules to update the nutrition facts label and serving size information and, before 2015, intends to propose rules about dietary guidance statements in food labeling (“to improve consumer understanding of the usefulness of a food or a category of foods in maintaining healthy dietary practices”); CFSAN also plans to issue final guidance about labeling foods made without bioengineered ingredients (e.g., “GMO-free”). In 2014, FDA intends to finalize rules that are required by the Affordable Care Act (and were delayed earlier this year) to require nutrition information on menus and on vending machines. To supplement these efforts, CFSAN also plans to complete a review of “nutrition and related activities to identify, with respect to nutrition in America, what problems we have now, in the near future, and in the next 10–15 years, and how CFSAN might best address them.” Together with this review, and for implementation in 2015, FDA will “complete a plan . . . to promote broad, gradual reduction of added sodium in the food supply.”
Other goals of note include determining whether to issue guidance or otherwise weigh in on arsenic levels in foods other than apple juice and rice, and publishing draft guidance on conflicts of interest for experts participating in GRAS panels—an issue spurred in part by the PEW Charitable Trust’s Food Additives Project.
In the supplement area, FDA may be making big waves in the coming years. The Agency intends to finalize its draft guidance on new dietary ingredients (NDIs) in 2014. The draft guidance has been a source of much recent debate between FDA and the supplement industry.
FDA also plans to “modernize [the] postmarket surveillance system for regulating dietary supplements.” Earlier this year, the National Institute of Health launched a database of supplement labels—a resource that the Agency may very well use in this effort.
Weighing in on a topic that may attract as much attention from Congress and the media as it will from industry, FDA intends to develop a regulatory approach in 2013 for energy drinks. This effort will include publication of a “final guidance to help dietary supplement and beverage manufacturers and distributors determine whether a liquid food product (such as energy drinks) may be labeled and marketed as a dietary supplement.”
Finally, this year, FDA plans to finalize its 2012 guidance regarding the safety of nanomaterials in cosmetic products and, in 2014, intends to develop draft guidance on lead in lipstick.