Nutraceutical update from washington: DSHEA and claims

The Foundation for Innovation in Medicine's Fifth Nutraceutical Conference

November 15, 1995
The Hyatt Regency Washington On Capitol Hill, Washington, DC

FACT: The U.S. Congress passed the Nutrition Labeling &Education Act (NLEA) and Dietary Supplement Health & EducationAct (DSHEA) to insure that the public has truthful informationregarding the benefits of nutraceuticals. A nutraceutical is afood or parts of food that offer medical-health benefits, includingprevention and/or treatment of disease. Stephen L. DeFelice, M.D.coined and defined the term “nutraceutical” in orderto create a single category which would cover a broad list ofterms such as dietary supplements, functional foods, designerfoods, hypernutritious foods, pharmafoods, certain categoriesof phytochemicals, etc. It can be a pill, drink, cereal or otherformulation. Ideally, the formulation should be the most appropriatedelivery system for the active ingredient(s) in the product.

FACT: In the fields of medicine and health, truthful informationis generated by data and information obtained through basic andclinical research.

FACT: There is comparatively little nutraceutical-orientedbasic-clinical research. There is, therefore, relatively littletruthful information available for educational purposes.

FACT: The proven way to generate basic-clinical nutraceuticalresearch is via a vigorous industryacademic research-orientedcomplex such as in the traditional pharmaceutical and biotechnologyindustries.

FACT: Clear regulatory ground-rules for disease-health claimsare necessary to attract corporate investment in nutraceuticalresearch.

QUESTION: Are the DSHEA ground-rules for claiming unclear andcontradictory, powerfully discouraging investment in nutraceuticalresearch?

QUESTION: Should Congress modify the DSHEA claiming ground-rulesto stimulate industrial support of basic-clinical nutraceuticalresearch?

The Foundation for Innovation in Medicine will hold a one-dayconference in Washington, DC, to review the claiming ground-rulesof DSHEA and discuss ways of improving them. Leaders from theCongress, industry, academic medicine, and other interested groupswill participate in what promises to be a stimulating and enlighteningday that includes opportunities for meeting people from all quartersof the nutraceutical world.

The session, “Physicians vs. the Lawyers” will highlightthe divergent views of medical and legal practitioners as to whatconstitutes a truthful claim. After reviewing the clinical dataon four products, the doctors will present what they considertruthful claims about these products. The lawyers will then evaluatewhether such claiming language, i.e., the truth, would be permittedunder the DSHEA. The answer? Come hear the debate!

Senator Tom Harkin (D-IA), the founder of the National Institutesof Health Office of Alternative Medicine, and Representative FrankPallone (D-NJ-6), who has submitted the Food and Dietary SupplementConsumer Information Act (HR.1951), will join representativesof various segments of the nutraceutical health community to commenton the claiming dilemma. A panel will then review and analyzethese comments, and discuss ways of improving the breadth andnature of the claiming groundrules in a way that will stimulatesubstantial increases in investment in nutraceutical research.

Three afternoon presentations will review how the food, traditionaldietary supplement, and herbal remedy industries have interpretedDSHEA, and examine the claims that companies are actually making.These will be followed by a presentation on the nutraceuticalindustry as an investment opportunity.

The day concludes with a reception where conference participantsand attendees and Congressional staff can meet and mingle andspeak with Senator Bill Frist, M.D. (R-TN), the Senate’s onlyphysician.


Nancy M. Childs, Ph.D.Professor of Food Marketing,St. Joseph's University

Lyn CioccaDirector, Trident Group

John B. CordaroPresident, Council for ResponsibleNutrition

Stephen L. DeFelice, M.D.Chairman, The Foundationfor Innovation in Medicine

Juanita D. DugganExecutive Vice President for GovernmentAffairs & Communications,National Food Processors Association

Senator Bill Frist, M.D. (R-TN)Senate Labor and HumanResources Committee; Chairman-Senate Subcommittee on DisabilityPolicy; Senate Budget Committee; Senate Small Business Committee

Peter Goldman, M.D.Professor of Health Science, Departmentof Nutrition, Harvard School of Public Health

Senator Tom Harkin (D-IA)Senate Labor and Human ResourcesCommittee; Ranking Member-Senate Subcommittee on Disability Policy;Senate Agriculture, Nutrition and Forestry Committee; RankingMember-Subcommittee on Research, Nutrition and General Legislation;Senate Appropriations Committee; Ranking Member-Labor, HHS, EducationSubcommittee; Senate Small Business Committee

Patricia Hausman,President, NutriProse

Loren D. Israelsen, Esq.Attorney at Law

Louis Lasagna, M.D.Dean, Sackler School of GraduateBiomedical Sciences, Tufts University

Robert J. Levine, M.D. Professor of Medicine, YaleUniversity School of Medicine

Tony Martinez, J.D.Director of Government Affairs,Nutritional Health Alliance

Stephen H. McNamara, Esq.Hyman, Phelps & McNamara, P.C.(former Associate Chief Counsel for Food, FDA)

Rep. Frank Pallone, Jr. (D-NJ-6)Author HR.1951 Foodand Dietary Supplement Consumer Information Act; Member-HouseCommerce Committee; Subcommittee on Health and Environment

Stuart M. Pape, Esq.Patton Boggs, L.L.P. (former ExecutiveAssistant to the Commissioner, FDA)

Fredric D. PricePresident and Chief Executive Officer,Applied Microbiology, Inc.

Fred R. Shank, Ph.D.Director, Center for Food Safety& Applied Nutrition, FDA

Bruce A. SilvergladeDirector of Legal Affairs, Centerfor Science in the Public Interest

Jay S. Skyler, M.D.Professor of Medicine, Pediatrics& Psychology, University of Miami School of Medicine

Robert E. Smith, Ph.D.Senior Vice President, Research,Nabisco Foods Group

Jur Strobos, M.D.of Counsel, Greenberg, Traurig, P.C.(former Director, Policy Research, Office of the Commissioner,FDA)