FDA Announces Priorities Plan for 2013-2014

Drug and medical device lawyers at Pintas & Mullins Law Firm report on the FDA’s recent release of its regulatory agenda via the Center for Food Safety and Applied Nutrition (CFSAN). It is the Center’s responsibility to ensure U.S. food and cosmetics are safe and adequately labeled.

FDA and CFSAN duties are extremely broad and complex, which is why they release regulatory agendas every year. For 2013-2014, the agency outlined a plan focused on providing useful nutritional information on food and cosmetic labels. This plan identifies and explains new tools, authorities, and responsibilities established by the federal government, including the Food Safety Modernization Act (FSMA).

The program’s six goals are outlined in the plan, including how the agency plans to achieve them, accounting for any shifting national priorities and funding limitations. These six goals are:

1. To reduce foodborne illness and cosmetic injury rates;
2. To achieve optimal use of staff and resources;
3. To increase compliance within the farm-to-table continuum;
4. Developing and deploying methods for identifying, containing, and eliminating food and cosmetic hazards.
5. Improving public health indicators through better nutrition and dietary choices 6. Establishing policies, standards, guidances, and inspection and compliance strategies based on best science, public health risk, and prevention practices.

The FDA goes on to list a full list of specific objectives within each of these goals, which totals about 80 points, and can be found here. Among these 80 specific objectives include the highly-publicized effort to publish final rules defining what foods can be labeled “gluten-free,” and final rules for infant formula manufacturing. It will also draft rules for recordkeeping for high-risk foods (such as imported produce) to simplify tracing.

For dietary supplements, the agency plans to modernize postmarket surveillance as well as published guidances on dietary ingredients to increase premarket oversight, and publish guidances to help supplement manufacturers determine how certain products (like energy drinks) should be labeled.

Among its provisions, the Affordable Healthcare Act requires chain restaurants (20 or more locations) to list caloric information on standard menu items. For example, at McDonald’s restaurants, underneath every menu item it will list how many calories and other information like fat, cholesterol, sodium, carbs, sugars, and fiber. Many restaurants, such as Panera Bread and Native Foods Café, already do this. The FDA has a number of drafted guidelines in place to help make this new standard roll out smoothly.

For cosmetics, this year the FDA will finalize guidelines for nanomaterial safety in products, including the presence of lead in lipstick among other violative products. In its efforts to protect U.S. food from contamination, the agency plans to develop and publish new rules for an array of circumstances, including transporting food, processing facilities, and the risk of BSE. The FDA will continuously post scientific updates for preventative control standards, including examinations of salmonella, arsenic and listeria contamination.

By the end of this year the FDA should have developed policy and regulatory options for energy drinks, which have been subject to increasing lawsuits over caffeine content. Because they were deemed “dietary supplements” by the FDA they were not required to disclose the exact amounts of caffeine on its labels, leading to several deaths and dozens of cardiac events.

Perhaps most importantly for food safety, the FDA will refocus its efforts on ensuring that safety standards are the same for imported food and cosmetics as they are for domestic products. When foodborne illness outbreaks occur, such as multi-state salmonella illnesses, it is more often than not borne from imported foods. We have reported on several of the most recent outbreaks here.

Contaminated food lawyers at Pintas & Mullins Law Firm will continue to report the FDA’s developments, policies and new guidances as they are announced. If you or a loved one was seriously injured, sickened or killed as a result of a defective, contaminated, or recalled food or drug, you have important legal rights. Contact a skilled attorney today to be informed of your legal rights and available options.