HHS Announces Regulatory Agenda for the Rest of 2021

On Wednesday, the Department of Health and Human services posted the Semi-annual Regulatory Agenda showing all major planned regulatory initiatives being pursued in the coming months. For the full list, click here. Regulatory initiatives include tobacco regulation, the use of hydrogenated oils, and the definition of the term “healthy.”

HHS is proposing to increase requirements for the manufacture, pre-production design validation, packing, and storage of a tobacco product with the goal of reducing adulteration of the tobacco products, whether as unintentional contamination or intentional creation of non-confirming products such as introduction of flavoring additives. The new regulation is expected to have several options for confirming with the regulation for the flexibility of the manufacturers while still permitting a definitive standard for enforcement by the FDA.

The agency also said that it plans to regulate characterizing flavors of tobacco products, such as grape, orange, and cocoa, which appeal disproportionately to younger consumers including youth that are too young to purchase the products. The regulation aligns the current regulations regarding cigarettes and proposes a ban on the same additives in cigars and cigar related products.

In alignment with the two proposed regulations above, HHS proposes to expand the detention authority of the FDA regarding tobacco products in commerce to permit inspection for failure to comply with the new anti-adulteration regulations as well as with the ban on flavoring additives.

Alongside the tobacco changes, the agency also announced a number of nutrition-related initiatives. To prevent consumer confusion and aid in the promotion of healthy dietary practices, HHS proposes to update the definition of the term “Healthy” and to tighten the circumstances within which this term can be used in a non-deceptive labeling practice.

In 2018, HHS posted regulations denying new applications for the use of partially hydrogenated oils in consumer foods. HHS, the announcement said, will now move to remove partially hydrogenated oils from the “Generally Recognized as Safe” (GRAS) list and to revoke all prior approved uses of partially hydrogenated oils in consumer foods.

Finally, in light of the increasing variety of analytical and clinical pharmacology, bioavailability (BA) and bioequivalence (BE) studies that have been made seeking permission for human studies, HHS proposes new minimum standards to ensure those studies are conducted appropriately and to verify the reliability of study data from those studies as well as harmonize the standards with international best practices.