U.S. Senators, Richard J. Durbin (D-IL) and Richard Blumenthal (D-CT) have sent a letter to FDA commissioner Robert M. Califf, MD to address their concerns about the proposed reorganization of FDA’s Human Foods Program and Office of Regulatory Affairs.
Photo © iStockphoto.com/uschools
U.S. Senators, Richard J. Durbin (D-IL) and Richard Blumenthal (D-CT) have sent a letter to U.S. Food and Drug Commissioner Robert M. Califf, MD to address their concerns about the proposed reorganization of FDA’s Human Foods Program and Office of Regulatory Affairs. Califf recently appointed Jim Jones as Deputy Commissioner for Human Foods, tasking him with setting and advancing priorities for a proposed Human Foods Program. The senators’ concerns reflect some of the concerns of industry, specifically the place of the Office of Dietary Supplement Programs within this reorganization. According to FDA, ODSP will be merged with the Office of Food Chemical Safety, Dietary Supplements, and Innovation. What does this mean for oversight of dietary supplements?
“We are concerned that these changes could divert resources, funding, and attention from the supplement market at a time when it is needed more than ever,” the letter states. The senators point out that the ODSP already has limited resources, operating on just over $13 million in funding to oversee a $50 billion industry.
The letter asks Califf to answer several questions that will offer clarity on how the new Office of Food Chemical Safety, Dietary Supplements, and Innovation will oversee the dietary supplement industry and enforce regulations. The senators have given Califf until September 8, 2024 to respond.
Kratom sees impressive sales growth despite its regulatory status and stigma
March 12th 2025Despite its controversy, kratom is a top-selling ingredient that consumers see value in. That said, brands need to work hard to demonstrate safety and quality of kratom products in the absence of legal regulatory status. Will kratom be able to overcome its stigma for even more growth and consumer acceptance?
DOJ asks Utah court to dismiss FTC lawsuit against Xlear Inc.
March 11th 2025On March 10, the DOJ and the defendant filed a stipulation to dismiss with prejudice the lawsuit in which each party agrees “to be responsible for its own costs and fees and agrees that no party shall be responsible to any other party for any fines, costs, fees, or penalties arising from this case.”
HHS announces efforts to eliminate independent conclusion of GRAS
Published: March 11th 2025 | Updated: March 11th 2025U.S. Department of Health and Human Services (HHS) Secretary, Robert F. Kennedy Jr., is directing the acting U.S. Food and Drug Administration’s (FDA) acting commissioner to explore rulemaking that would eliminate the independent conclusion of GRAS provision.