In 1994 Congress passed legislation known as the Dietary Supplement Health and Education Act (DSHEA). The law restricted the Food and Drug Administration (FDA) in the regulations it could enforce limiting label claims on dietary supplements. Specifically, DSHEA allows dietary supplement labels to carry statements dealing with structure/function claims such as "supports the immune system." Section 6 of DSHEA states that structure/function statements are "statements of nutritional support . . . that describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans."
The intent of DSHEA was to provide consumers access to more health-related information about dietary supplements. However, sifting through the complicated language contained in the legislation is a formidable task. The fine line in semantics with respect to a supplement "supporting" a normal body function as opposed to "treating a disease" remains as controversial an area as the current debate over how the FDA actually defines "diseases." Members of the nutraceutical industry, including manufacturers, distributors, and sales associates, are becoming increasingly aware, however, of the importance of understanding and adhering to these oftentimes confusing guidelines in marketing nutraceuticals.
In an attempt to guide companies and their sales associates on the sales of nutraceutical products as allowed under DSHEA, the American Nutraceutical Association has prepared a DSHEA Home Study Course and Certification program. The program contains a video presentation on DSHEA by three leading attorneys in Washington, DC: Scott Bass, partner in the firm of Sidley & Austin; Jess Stribling, Former Partner- in-Charge of the Washington, DC office of King & Spalding; and Peter Barton Hutt, a partner in the Washington, DC law firm of Covington & Burling. Mr. Bass is recognized as a leading authority on FDA enforcement practices, including CGMP regulations. Mr. Stribling served in the FDA Chief Counsel's Office and also served as Executive Assistant to the FDA Commissioner. Mr. Hutt served as Chief Counsel for the Food and Drug Administration from 1971 to 1975. He currently teaches a course on food and drug law at Harvard Law School. Also on the video program is Eileen McMahon, a former partner with the Canadian law firm of Deeth Williams Wall. Ms. McMahon discusses the status of nutraceutical regulations in Canada.
The videotape is accompanied by a course syllabus, a copy of the DSHEA law, and articles on DSHEA prepared by ANA general counsel Fred Degnan. After viewing the educational video on DSHEA and studying the written materials, a pre-test is taken to help review the material. The final step is to take a test that is then returned to the ANA office for grading. For those scoring 80 or greater, a certification of proficiency is issued by the ANA.
Over 3,000 sales associates from nutraceutical companies and organizations have taken the Home Study Course.
The ANA DSHEA Home Study Course And Certification Program:
* Recommended for all Nutraceutical Sales and Marketing Associates
* Help protect you, your business and your company
* Learn the right way to present third party educational materials
* Become officially certified by The American Nutraceutical Association
* Gain increased credibility and professionalism with certification
The DSHEA Home Study Certification Course comes with a professional membership in ANA ($125), or can be purchased separately for $59.95 (plus $6.95 s/h).
Join ANA today and let the ANA be your resource guide to enhance your business, or purchase the DSHEA Course separately.
