AHPA Chief Information Analyst Merle Zimmermann, Ph.D. presented last week at the Mary Frances Picciano Dietary Supplement Research Practicum held by the Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) campus in Bethesda, MD.
Dr. Zimmermann provided an overview of AHPA’s work, including recent initiatives and resources, supporting the herbal supplement industry. He also participated in a Meet the Stakeholders panel of industry and consumer organizations involved in the dietary supplement marketplace.
This year's event provided an opportunity for industry stakeholders to address attendees' specific questions and concerns. Attendees were especially interested in how dietary supplements claims substantiation is conducted. Claims substantiation was also highlighted by Food and Drug Agency (FDA) and the Federal Trade Commission (FTC) staff as a key element of the U.S. regulatory system designed to keep American consumers well informed of the latest scientifically supported innovations. Of particular interest was FTC’s presentation on healthy aging supplements and ensuring that advertising and claims are well supported in this growing segment of the market.
AHPA has a webinar package discussing claims substantiation available online featuring an expert-selected panel of industry lawyers and an FTC official discussing legal standards, today’s regulatory environment and the lawsuit risks and liabilities marketers face if claims are not adequately supported.
At the ODS seminar, Joyce Merkel, M.S., R.D., scientific and health communications consultant in the National Institutes of Health (NIH) Office of Dietary Supplements (ODS), also presented on the purpose and value of several databases in conducting substantiation research to understand the scientific basis for potential claims.
With the FDA’s Open Public Meeting on CBD being conducted at the same time as the ODS Practicum, there was lively discussion of new dietary ingredients and the hemp provisions of the 2018 Farm Bill. Dr. Zimmermann reported on AHPA’s Industry Guidance on hemp and hemp-derived CBD, underscoring AHPA’s work to encourage industry to be mindful of existing federal regulations as FDA continues its review of the status of CBD.
Dr. Zimmermann used attendees' inquiries as an opportunity to demonstrate how the industry has been proactive in addressing safety issues and to highlight several AHPA initiatives and resources, including the Botanical Safety Handbook and the Botanical Identity References Compendium. Dr. Zimmermann and Dr. Sirois of the Consumer Healthcare Products Association (CHPA) discussed association requirements for members and recent self-regulatory efforts to illustrate how the industry goes beyond rigorous federal regulatory requirements to meet consumer demand for the quality and innovation which continues to drive our market forward.
"The incredible opportunity for connecting and building community between researchers and medical professionals, industry, and consumers which ODS provides at the Practicum can’t be overstated,” Dr. Zimmermann said. "The cross-pollination of ideas alone helps attendees and presenters share and build on current thought and innovation as we serve the American public."
Approximately 120 full-time health care providers as well as academic faculty, research practitioners, doctoral students, postdocs, and fellows involved in dietary supplement research and students in allied health schools participated in the two-and-a-half-day practicum.
Attendees were provided with a thorough overview and grounding on the issues, concepts, unknowns, and controversies about dietary supplements and supplement ingredients. Presenters emphasized the importance of scientific investigation to evaluate the efficacy, safety, and value of these products for health promotion and disease prevention as well as how to carry out this type of research.
Dr. Zimmermann's 2019 presentation is available online >>
Video of Dr. Zimmermann's 2017 presentation >>