US FDA Priorities For Food Safety, Cannabinoid Clear Even With Next Commissioner Unknown

FDA commissioner should be announced by mid-November and will likely continue to prioritize food and supplement safety, propelled by contaminants found in baby food, say two attorneys with Alston & Bird. A regulatory pathway for cannabidiol also is expected to be a priority once a commissioner is named.

Food and dietary supplement safety likely will be a continuing priority for the US Food and Drug Administration no matter who is commissioner, say two and beverage regulation attorneys.

The food and dietary supplement industries should expect to see increased inspections, warning letters and criminal enforcement actions, said Angela Spivey, a partner in Alston & Bird LLP’s Atlanta office.

The focus on food safety is largely propelled by recent findings of lead in foods for babies and young children. Acting Commissioner Janet Woodcock committed to addressing the problem in March after House members released a report finding many baby food products are tainted with “dangerous” levels of inorganic arsenic, lead, cadmium and mercury. (Also see "Gottlieb: No ‘Plan B’ If Woodcock Isn’t Nominated As US FDA Commissioner" - HBW Insight, 24 Mar, 2021.)

Spivey and Sam Jockel, a senior associate in Alston & Bird’s Washington office, declined to offer predictions on whether Woodcock will be named to the post permanently. “We don’t have a looking glass here and it’s not at all clear she will be nominated,” said Jockel.

Acting heads of federal agencies usually can serve 210 days but incoming administrations have an additional 90-day period, according to the Congressional Research Service. That would give the Biden team until 16 November to nominate someone. 

FDA Asks For $22M For Baby Food Safety

She seemed to double down on that commitment in a 24 June statement noting the FDA’s food and nutrition programs are “well-positioned to make progress” in 2021 on maternal and infant health and nutrition, with investments across the centers and offices involved in the foods program to make improvements in key areas related to food safety and nutrition.

angela spivey: "I would expect whoever it is [at fda helm], to see an increase in federal government regulations for the food, beverage and dietary supplement industries." Source: Morrison & Forrester

Woodcock noted the FDA’s fiscal year 2022 budget request of $22m, an increase of $18m above the FY 2021 level, for the Center for Food Safety and Applied Nutrition’s work on toxic elements in baby food. The increase would “improve the currently limited staff review capacity for premarket review of infant formula submissions to evaluate the safety and nutritional adequacy of infant formula and nutrition work specific to infants, toddlers, and pregnant and lactating women,”

Under a bill the House Appropriations Committee’s subcommittee approved on 25 June, the FDA would receive $6.29bn in the FY2022 budget, up $257m from its current budget but more than $200m less than the agency requested. (Also see "House Appropriators Go Low On FDA's Budget" - HBW Insight, 25 Jun, 2021.)

The bill, which was approved by the Appropriations Committee on 30 June, sets FY2022 spending for the FDA’s Center for Food Safety and Applied Nutrition and the Office of Regulatory Affairs’ related field activities, which include oversight of the dietary supplement industry, at $1.16bn, up slightly from the FY2021 level of $1.1bn but more than $32m less than the agency’s request.

Food safety user fees also are not stated in the bill. The FDA’s FY2022 budget request asks for $11.5 in those fees, up $215,000 from the FY2021 level.

Biden Had FSMA Role

With a commissioner appointed, “we expect to see FDA announce new, broad initiative and set long-term policy priorities. I would expect whoever it is, to see an increase in federal government regulations for the food, beverage and dietary supplement industries,” Spivey said.

She said Biden was a “key player” when the Obama administration ushered in the Food Safety Modernization Act in 2011, which gave the FDA more authority in regulating how food is grown, harvested and processed.

Jockel said an “uptick” in warning letters for supplements during the pandemic as the agency focused on COVID-19 claims is unlikely to go away. He noted the agency is spreading its enforcement to a broader variety of supplements that make drug claims, notably fertility products.

sam jockel: " it’s not at all clear [woodcock] will be nominated.” Source: Morrison & Forrester

On 20 May, the FDA and the Federal Trade Commission jointly warned five marketers because they claimed their supplements could help “prevent infertility and other reproductive disorders.” (Also see "US Fertility Supplement Marketers Don’t Deliver" - HBW Insight, 26 May, 2021.)

Movement On Cannabinoids Pathway

Spivey says she expects no matter who is appointed commissioner, the FDA will renew its focus on developing a regulatory pathway for lawful use of cannabinoids, with cannabidiol (CBD) the most common type, in products other than drugs subject to its oversight.

“For years FDA signaled it was evaluating whether there was a path forward for CBD to be used in food and dietary supplements. The signaling has evolved over time, whether optimistic or pessimistic, between different FDA commissioners. I think once we get a full-time permanent commissioner, we will see FDA focusing again on CBD.”

A regulatory pathway has been in limbo as FDA regulations prohibit using ingredients in supplements and food that have been studied or approved for use in drugs. Since the 2018 farm bill de-scheduled hemp – defined as cannabis or any part of the cannabis plant containing no more than 0.3% concentration on a dry weight basis of tetrahydrocannabinol – the agency has allowed cannabinoids in supplements and food made and marketed in compliance with other relevant regulations. (Also see "US FDA Continues Cannabinoid Analysis Required In FY2021 Budget" - HBW Insight, 19 May, 2021.)

While waiting on the FDA, the House in February and the Senate in May introduced bills directing the FDA to make lawful the use of cannabinoids; the House bill refers to supplements while the Senate bill includes food products as well as supplements. (Also see "US Senate Appetite For Lawful Use Of Cannabinoids Includes Food On Top Of Supplements" - HBW Insight, 19 May, 2021.)

Both Jockel and Spivey expect current Center for Food Safety and Applied Nutrition Director Susan Mayne will continue in her role.

In March, former FDA Commissioner Scott Gottlieb said he expected Woodcock would be nominated commissioner and that he believes her consumer health sector goals as commissioner would be keeping heavy metals out of baby food and enforcing against COVID-19 treatment claims. (Also see "Gottlieb: No ‘Plan B’ If Woodcock Isn’t Nominated As US FDA Commissioner" - HBW Insight, 24 Mar, 2021.)

Biden has waited 162 days, through 30 June, since his inauguration without nominating a commissioner, nearly a third longer than the combined wait times for the last two commissioners nominated by incoming presidents: Margaret Hamburg (53 days) and Gottlieb (52 days). (Also see "Like Sands Through The Hourglass, So Are Janet Woodcock’s Days As Acting FDA Commissioner" - HBW Insight, 23 Jun, 2021.)