03.11.19
Food and Drug Administration (FDA) Commissioner Scott Gottlieb said he will resign next month, creating some uncertainty about how the agency will move forward with regulatory initiatives in the dietary supplement industry.
In February, Gottlieb announced FDA will embark on a plan to implement “one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years,” with a public meeting to be scheduled in May on possible amendments to the Dietary Supplement Health and Education Act (DSHEA). At the same time the agency sent about a dozen warning letters to companies selling illegal, unapproved new drugs marketed as dietary supplements.
FDA also recently announced it will hold a public meeting in April about a legal regulatory path for cannabidiol (CBD), which the agency has to date considered illegal in dietary supplements and food because it was the subject of substantial clinical investigations before it was marketed as a food or supplement.
Loren Israelsen, president of the United Natural Products Alliance, said in a memo to members that the news of Gottlieb’s resignation came out of the blue. However, he added it appeared that Gottlieb made his decision to resign several months ago, before the two major announcements regarding possible amendments to DSHEA and a regulatory path for CBD. “Can we conclude that these two announcements are institutional views at the agency, and therefore they will proceed?”
Gottlieb’s resignation was reportedly a surprise to the Trump Administration as well, and a successor has not been announced.
Natural Products Association President and CEO Daniel Fabricant, PhD, commented, “We 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 cannabidiol (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.
“We commend Commissioner Gottlieb for his service and look forward to working with the FDA during this transition,” Fabricant continued. “The U.S. 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.”
In February, Gottlieb announced FDA will embark on a plan to implement “one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years,” with a public meeting to be scheduled in May on possible amendments to the Dietary Supplement Health and Education Act (DSHEA). At the same time the agency sent about a dozen warning letters to companies selling illegal, unapproved new drugs marketed as dietary supplements.
FDA also recently announced it will hold a public meeting in April about a legal regulatory path for cannabidiol (CBD), which the agency has to date considered illegal in dietary supplements and food because it was the subject of substantial clinical investigations before it was marketed as a food or supplement.
Loren Israelsen, president of the United Natural Products Alliance, said in a memo to members that the news of Gottlieb’s resignation came out of the blue. However, he added it appeared that Gottlieb made his decision to resign several months ago, before the two major announcements regarding possible amendments to DSHEA and a regulatory path for CBD. “Can we conclude that these two announcements are institutional views at the agency, and therefore they will proceed?”
Gottlieb’s resignation was reportedly a surprise to the Trump Administration as well, and a successor has not been announced.
Natural Products Association President and CEO Daniel Fabricant, PhD, commented, “We 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 cannabidiol (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.
“We commend Commissioner Gottlieb for his service and look forward to working with the FDA during this transition,” Fabricant continued. “The U.S. 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.”
