Dr. Welch, director of the Office of Dietary Supplement Programs (ODSP) at FDA since March 2022, covered topics ranging from the reimagined human foods program, the regulations governing the industry, the definition of dietary supplements, how the landscape has changed in the last 30 years, the Agency’s regulatory responsibilities and challenges, and the value of data in establishing program priorities to make the best use of constrained resources.
‘A natural fit’
Under the current organization, ODSP is housed within the Center for Food Safety and Applied Nutrition in the FDA. A recently proposed reorganization would relocate it within a new Office of Food Chemical Safety Dietary Supplements & Innovation, which Dr. Welch called a “natural fit” because of the similarities of ingredients and chemicals in foods and supplements. Implementation could be expected from six months to a year as “reorganization of this magnitude takes time and then has to settle”.
She added that she spends a lot of time thinking about the definition of dietary supplements, and that they will be fully integrated into the program.
‘The right structure’
The presentation included a broad overview of the regulations governing dietary supplements including the Federal Food, Drug, and Cosmetics Act, the Dietary Supplement Health and Education Act (DSHEA), the Dietary Supplement and Nonprescription Drug Consumer Protection Act, the Food Allergen Labeling and Consumer Protection Act, and the FDA Food Safety Modernization Act.
Regarding DSHEA, Dr. Welch posed the question whether there are ways to make it better as it approaches its 30th anniversary.
“Maybe there aren’t, but that is the input that we would be happy to engage with, ensuring we have the right structure so that all stakeholders end up with a strong marketplace,” she said.
‘Market has definitely evolved’
Dr. Welch noted that the supplement marketplace has “definitely evolved” since DSHEA was created in 1994, just prior to the Internet boom. Since then, it has grown from $4 billion and 4,000 products to over $50 billion with more than 100,000 labels in the Dietary Supplement Label Database (DSLD).
She added that nearly 30 years on, the globalization of the supply chain, the ascendancy of the online marketplace and the advent of designer compounds as supplements has added to the complexity of FDA’s consumer protection responsibilities.
Other challenges stated included FDA’s reliance on post-market surveillance, lack of data about new products coming onto the market, and limited inspectional resources.
‘Big on data’
Dr. Welch also touched on program priorities, emphasizing that the Agency is big on generating new and better data to form a clearer picture of the marketplace and ensure the best use of resources in establishing program priorities. She said that FDA did not want pre-market approval but that there is no systematic way of knowing when a product comes onto the market or what it contains.
Current priorities include modernizing statutory authorities such as implementing mandatory product listings and ensuring FDA has the right tools to remove unlawful products; determining how to improve inspectional coverage; strategizing efficient and effective enforcement; strengthening new dietary ingredient (NDI) regulation; and informing decision-making through increased education, transparency and communication.
“The big picture goal is very much the same to ensure safe products to protect consumers,” she concluded before fielding a few questions from the close to 160 seminar attendees.
Upcoming ODS Seminar Series topics include Dietary Supplements and Neurological Resilience in Aging (Oct. 11), Botanical Use for Health in the Caribbean and Mexican Diasporas (Nov. 8) and Using Dietary Supplements Online Databases to Enable Precision Nutrition (Jan. 10).
