In the 4,155-page omnibus bill, legislators earmarked an additional $226m in budget authority funding for FDA – a 6.5% increase – for fiscal 2023 with the expectation that the money would support both existing programs and activities established in the prior budget and an additional $41m for food safety activities, including $20m for the New Era of Smarter Food Safety, $8m for emerging chemical and toxicology issues, $1m for machine learning, $1m for sodium reduction targets, $1m for standards of identity and $10m for maternal and infant health and nutrition.
In making the allotment for food safety, legislators noted concerns about the “fragility” of the infant formula and other food supply chains and “recent missteps and delayed actions” related to food safety and applied nutrition revealed last month in a scathing audit conducted by the Reagan-Udall Foundation at the behest of FDA Commissioner Dr Robert Califf.
Noting the “serious consequences of FDA continuing to operate with a fragmented organizational structure and lack of accountability” that was revealed in the Reagan-Udall report, the legislation “encourages the FDA to strongly consider the report’s recommendations and develop a restructuring plan, that includes stakeholder engagement and input, that establishes and unifies all capacities of the food program.”
The Consumer Brands Association lauded the financial support for restructuring FDA’s oversight of food, which currently is scattered under different agency divisions.
“A well-structured and efficiently governed FDA is vital to ensuring our industry can actively pursue innovations that move products at the speed of consumer demand,” CBA’s vice president of regulatory and technical affairs Roberta Wagner said in a statement.
“A fully empowered, accountable and expert deputy commissioner is needed to lead and unify the FDA’s foods program, and we’re grateful for congressional support to make this a reality,” she added.
“We’re confident that this structural shift, combined with modernization of outdated policies and procedures in key areas will allow FDA to more effectively deliver on its mission and restore public confidence in the agency by seeing that consumers have access to a variety of safe foods.”
Congress calls for ‘farm to bottle’ assessment of infant formula supply chain
Over the years, CBA and other stakeholders have called for FDA to elevate food safety and nutrition, but the most recent call reached a crescendo when an infant formula recall triggered massive national shortages.
To better understand the “risks and resilience of domestic supply chains of infant formula, including specialty formula, and identifying potential solutions to address vulnerabilities,” legislators in the budget directed FDA to “continue to monitor supply,” and requested an investigation by the Health and Human Services Inspector General as well as the GAO.
“The assessment should cover the full ‘farm to bottle’ supply chain, including ingredient production, processing and manufacturing and distribution, including the inputs and regulatory approval needed at each of these steps,” legislators wrote in the budget justification.
Could more domestic inspections be on the horizon?
Legislators also acknowledged FDA’s efforts to streamline foreign infant formula companies’ path to the domestic market and to bypass certain requirements that domestic companies must meet.
In the bill, they direct FDA to report to Congress within 90 days how the agency determined “that the oversight of foreign facilities participating in enforcement discretion and foreign pathways was easier, safer and potential impacts towards expanding and growing domestic infant formula production.”
Legislators’ concern about the safety of infant formula extends to other areas of food production as well – prompting a directive within the budget to increase the frequency of domestic human food inspections and outline in a report operational changes and resource implications for inspecting high-risk domestic facilities every 18 months and non-high-risk domestic facilities every three years.
Among the specific inspection targets called-out by legislators in the bill include adopting a risk-based approach to sampling imported food that have higher pesticide violation rates than domestically produced food.
Standards of identity raised as priority concern
The legislation also calls for increased enforcement of standards of identity for some foods, including “dairy products that do not contain dairy,” yogurt, for which a new standard of identity was recently finalized, and different grades of olive oil.
While not a standard of identity concern per se, legislators also noted consumer confusion about nutritional labelling for ‘added sugar’ for products such as honey and maple syrup. As such, the budget directs FDA to “continue working with impacted industries to ensure clear and appropriate labelling.”