Possible areas of focus for FDA Foods Program under Biden Administration

New Era of Food Safety

• If Frank Yiannas stays at the FDA, he will likely continue with this agenda. Note, however, that it is largely based on voluntary programs, while Democratic administrations tend to favor mandatory or regulatory ones.
• If the Democrats win the Senate, the “New Era” document could become a blueprint for new legislation, with traceability at the top of the list.

Compliance and Enforcement

• FSMA enforcement: Once COVID-19 restrictions lift, expect a return to Food Safety Modernization Act (FSMA) enforcement, which has been somewhat limited the last several years. It could take the FDA several years to ramp up, but we might expect a consistent uptick in inspections, Form 483s, Warning Letters, and Injunctions over that time. Along these lines we might expect a progression starting with Modernized Good Manufacturing Practices, then Preventive Controls, then Supplier Verification, with Foreign Supplier Verification Programs and Importers mixed in, as FDA is able on a parallel path.
• Added enforcement: The FDA may also pick certain areas, like food allergens, to focus on, as allergen recalls have long been a concern of the FDA staff and are viewed as avoidable, with sustained effort. Recent Warning Letters may be a forerunner of this. Emphasis on swab-a-thons and micro-contamination will surely continue.
• Imported foods: Part of the FDA’s longer term plan was a constant increase in foreign inspections and better targeting at the border, so we might expect increased emphasis there. Also expect the FDA to push for additional companies to participate in the Voluntary Qualified Importer Program (VQIP).
• Remaining FSMA rules: The FDA will likely seek to finalize the recent proposed rule on traceability and complete any loose ends on FSMA rulemaking, including laboratory accreditation.
• Remote inspections: As FDA officials have recently stated, the FDA wants to conduct remote inspections, and plans to phase these in voluntarily. If Democrats win the Senate, the FDA might seek new legislation to clearly provide legal authority for remote inspections (with additional provisions to be determined).

Nutrition and labeling

• Sodium reductions: Expect the FDA to resurface its sodium reduction proposals, possibly revised.
• Traffic light-type labeling might be revisited, or some way to better flag which foods are “better for you” – could include new “Healthy” regulation but with possibly more restrictive criteria (e.g., criterion for “added sugars”). We could also see revisiting (by FDA, Federal Trade Commission, or others) of children’s advertising initiatives.
• Ingredient labeling reform could be on the table, as (other than allergens) there has been none for decades, and this is a continuing issue internationally. In particular, the FDA could consider expanding Quantitative Ingredient Declaration (QUID) requirements, either administratively or in coordination with Congress.
• The FDA will likely revisit its priorities from the Nutrition Innovation Strategy, possibly with a renewed interest in imposing greater restrictions or issuing guidance on certain labeling claims, such as claims about whole grain content or other ingredient claims, or additional disclosures related to “added sugars” content.
• Congress and the FDA could work together to expand the list of major food allergens, following the passage by the House and Senate of the FASTER Act requiring sesame allergen labeling and to include sesame and the FDA’s recent draft guidance on voluntary labeling.

Premarket review

• Expect consumer advocacy groups to again push for Generally Recognized As Safe (GRAS) reform, with emphasis on eliminating the self-GRAS allowance.  
• Staffing shortages in GRAS and possibly food contact substances could finally open the door to user fees, as backlogs are starting to grow and these types of programs are seen as highly successful in the drug and device areas.

Authored by Martin Hahn, Joseph Levitt, Maile Gradison Hermida, Brian Eyink, and Veronica Colas.