The FY2021 (full-year) Consolidated Appropriations Act, 2021, has been passed by Congress and signed by the President. Although some presidential rescission requests are expected (which can be rejected by the House Appropriations Committee), the Act currently provides for a net increase to FDA of $42.250 million. What are the funds designated for and what will it mean to the industry?
As summarized by StrenthenFDA.org, the funds are designated for FDA COVID-combat efforts, food safety, medical products programs, and cross-cutting initiatives to include:
COVID-19. $55 million
- For continued work on FDA efforts to facilitate the pre- and post-market development and review of COVID-19 medical countermeasures, devices, therapies, and vaccines.
- To support medical product supply chain monitoring and other public health research and response investments.
TAG’s interpretation for industry. As the food industry moves up the chain in vaccine priority, it comes ever closer to a return to business as (somewhat) usual. With this significant increase in funding for FDA’s fight against the virus, we can expect accelerated efforts as well as increased lessons learned for preventive – rather than reactive – measures against the next potential pandemic.
Food Safety. $10.250 million
- $1 million for strengthening response capabilities for foodborne outbreaks by expanding CFSAN's ability to ensure that contaminated food is detected and removed from the marketplace as quickly as possible.
- $6 million for a shrimp import inspection pilot program.
- $1.25 million for allergen labeling.
- $1 million for the National Antimicrobial Resistance Monitoring System (NARMS).
TAG’s interpretation for industry. With the additional funding, you can expect FDA to increase its activity in all these areas, particularly the outbreak response as this is a Core Element of the agency’s New Era of Smarter Food Safety initiative on which it is continuing to focus. With $6 million specifically designate for shrimp import inspection, it also would be wise for anyone importing this product to take a close look at its supply chain and ensure all food safety, quality, and regulatory measures are being met.
Food Safety/Cannabis. $5 million
- For FDA’s continued regulation of cannabis-derived substance usage, such as cannabidiol (CBD), in FDA-regulated products such as dietary supplements and when used as unapproved food and feed additives.
TAG’s interpretation for industry. Although cannabis legalization is continuing to make strides by federally and state-wide, FDA has continued to hold a tight rein on food/food-additive and dietary supplement approvals. Whether the $5 million granted for this regulation will increase the agency’s stringency or enable it to begin to allow for edible uses on the federal level is yet to be seen.
Medical Products. $22 million
- $5 million to help make the U.S. influenza vaccine supply more robust, secure, and nimble to combat both seasonal epidemics and potential pandemics.
- $9 million for building an integrated knowledge management system and portal for medical devices; $2 million for continued oversight of human drug compounding; $3.5 million for a foreign inspection pilot; and $2.5 million for rare cancer therapeutics.
TAG’s interpretation for industry. Although the medical products funding has less direct relevance to the food industry, the allocation for the influenza vaccine supply (presumably to include those for COVID-19) can have a direct impact on the workforce, thereby impacting one’s business.
Cross-Cutting Measures. $7 million (across food safety and medical products)
- For artificial intelligence and other emerging technologies for both food safety and medical products; and $1 million for the Office of Chief Counsel.
TAG’s interpretation for industry. With another key component of the New Era blueprint is that of “leveraging technology and other tools to create a safer and more digital, traceable food system,” and the pilot program the agency began in 2020 leveraging artificial intelligence (AI) and machine learning for the review of imported foods at ports of entry, it should come as no surprise that FDA requested $10.2 million for technology. Even if nearly half of the funding goes toward public health initiatives (as requested), the technological applications and lessons learned can likely be transferred as well toward food.
With the appropriations all but final (pending any rescissions), we can certainly expect it to have definite impact on the food industry in 2021. But there are a number of other factors we foresee as impacting the year; and other predictions the TAG team is making. Watch this space next week for the annual Upcoming Year Predictions from TAG.