Dr Gottlieb, who took the helm at the FDA in May 2017, will remain with the Agency for another month before stepping down. The reason cited is that he wishes to spend more time with his family.
During his two years with the FDA, Dr Gottlieb started many discussions affecting dietary supplements, with a wide ranging statement about revamping the regulations drawing support from stakeholders. These revamps included the inception of a public discussion of possible changes to DSHEA (the Dietary Supplement Health & Education Act of 1994), the launch of a Botanical Safety Consortium, and ways to reinvigorate the NDI (new dietary ingredient) process.
Dr Gottlieb also announced that the Agency would explore the initiation of a rule making procedure on cannabidiol (CBD), with the goal of creating “an appropriately efficient and predictable regulatory framework for regulating CBD products.” According to FDA’s reading of federal law, CBD is not a legal dietary ingredient because it has previously been researched as a drug before promoters started bring CBD-containing supplements to the market. (Epidiolex, a CBD-based antispasmodic drug, was approved by FDA in 2018.)
However, Gottlieb also said the agency has the power to make special exceptions for certain ingredients. “As such, for CBD to be legally marketed as an ingredient in a food or dietary supplement, the law requires that the FDA first would need to issue a regulation to permit such marketing,” he said.
“A lot of ideas were put in motion”
Judging by initial reactions from across the dietary supplements and food industries, Dr Gottlieb was a respected partner for business.
Dan Fabricant, PhD, president and CEO of the Natural Products Association (NPA), told us that the announcement was not a surprise, and he imagines one of the deputies will be appointed to run the Agency, perhaps until the 2020 election.
Despite this, Dr Fabricant added that the NPA will urge President Trump to consider a new leader for the FDA that will use the Agency’s enforcement powers to get tough on bad actors and lead on new areas like CBD and other promising natural products.
“A lot of ideas were put in motion on trade, NDI intellectual property protection, and NDI enforcement, and we need a partner in government who can help bring those home for consumers and small businesses,” said Dr Fabricant.
“We commend Commissioner Gottlieb for his service and look forward to working with the FDA during this transition. The US has the safest nutritional supplements in the world because of collaborative efforts between our industry and federal regulators, and we are confident that collaboration will continue under new leadership.”
Laying the groundwork on key issues
Steve Mister, president and CEO of the Council for Responsible Nutrition, said that his organization is disappointed to see Dr Gottlieb’s departure for a couple of reasons.
“Firstly, we really saw an effort to interact and collaborate with industry while also protecting consumer health,” said Mister. “Second, when you look at the statement from earlier this year, he really acknowledged the industry could contribute to public health. Supplementation is part of the American lifestyle, and we hadn’t heard that from a Commissioner before.”
Mister added that CRN hopes that FDA would be able to move forward on the various issues spearheaded by Dr Gottlieb, such as modernization of DSHEA and CBD.
“Commissioner Gottlieb has laid the groundwork to move forward on these initiatives, but we are concerned because FDA doesn’t tend take bold actions without a Commissioner.
“There’s a certain urgency for CBD,” added Mister, “because the responsible side of the industry is not going to dip their toes into CBD until they know there’s a legal pathway, but it allows less responsible to come into the space and build brands and consumer awareness.”
Loren Israelsen, President of the United Natural Products Alliance, added that the commissioner's decision to resign was apparently made several months ago, "meaning his two major announcements [CBD & DSHEA modernization] were apparently made after he had decided to resign. Can we conclude that these two announcements are institutional views at the agency, and therefore they will proceed?"
“A vocal advocate”
Scott Melville, President and CEO of the Consumer Healthcare Products Association (CHPA), issued the following statement: “Commissioner Gottlieb has been a vocal advocate for ensuring consumer access to safe and reliable self-care options including over-the-counter (OTC) medicines and dietary supplements. His tenure at FDA has been marked by tremendous progress on modernizing the regulatory framework for OTC medicines and beginning similar work for dietary supplements. CHPA will continue to advocate for these important public health initiatives moving forward […] CHPA thanks Commissioner Gottlieb for his active leadership of the Agency.”
GMA: Gottlieb was “a strong and effective champion of public health”
Geoff Freeman, president and CEO of the Grocery Manufacturers Association, issued the following statement: “Under the leadership of Commissioner Scott Gottlieb, the Food and Drug Administration was a strong and effective champion of public health. His candor, transparency and willingness to work together was a welcomed approach in the regulatory environment.
“The consumer packaged goods industry believes in smart, uniform regulation and a strong FDA is a critical partner in building trust in the products Americans use every day.”
Not everyone was a fan of Dr Gottlieb’s approach to dietary supplements, however. Dr Pieter Cohen from Harvard Medical School and an outspoken critic of the industry, criticized Dr Gottlieb for not taking a tougher stance on dietary supplements. Dr Cohen told the Washington Post: “It’s disheartening, if you look at the last two years of the agency’s work with supplements. It’s inaction. It’s lack of forward motion. It’s maybe treading water.”