Recorded: Oct. 29, 2019
Duration: 2h 45m
- Members - $199
- Non-Members - $399
Dietary supplements must bear labeling in accordance with applicable provisions of federal law, including nutrition labeling requirements. Federal nutrition labeling requirements for dietary supplements were promulgated by the Food and Drug Administration (FDA) in 1999. Almost two decades later, on May 27, 2016, FDA published a final rule revising the nutrition labeling requirements for foods and dietary supplements. The revisions are intended to reflect the changes in science and dietary habits that have occurred over time.
This webinar provides an overview of the applicable federal labeling requirements and to create a better understanding of how to comply with the revised regulations. Steven Shapiro, of counsel at Rivkin Radler, LLP, will discuss the context of the regulations and how they have changed. Will Woodlee, partner at Kleinfeld, Kaplan & Becker, LLP, and AHPA general counsel, and T. Daniel Logan, associate at Kleinfeld, Kaplan & Becker, LLP, will discuss the content of AHPA’s recently revised Guidance: Federal Labeling Requirements for Herbal Dietary Supplements. Dr. Robert Wildman, chief science officer, Post Active Nutrition Brands, will provide insight on how the revised labeling regulations affect protein content calculation for sports nutrition products.
For dietary supplements, the revisions mostly affect products that provide significant levels of dietary ingredients with Reference Daily Intake (RDI) values or Daily Reference Values (DRV), including vitamins and macronutrients such as fat, sugars, and cholesterol. Since herbal supplements often do not provide significant amounts of these, many products’ labels will not require significant modifications to comply with the revised regulations. However, herbal supplement manufacturers should be aware of coming changes and ensure their products’ Supplement Facts boxes are compliant because FDA has indicated that products labeled on or after the relevant compliance date must comply with the revised regulations.
Major changes include revisions to what must be declared on the label. For example, vitamin D, potassium, and added sugars are now “mandatory nutrients” required to be declared when present at significant amounts, while vitamin A and vitamin C are no longer “mandatory nutrients.” Manufacturers must keep track of what sugars in the product are “added sugars” (including, for example, from acidulants and flavors) versus naturally occurring sugars. Likewise, folic acid must now be distinguished from naturally-occurring folate. Additionally, reference values used to calculate the percent Daily Value (DV) for declaration on the Supplement Facts box were updated for most dietary ingredients with established DVs. Further, units of measure were changed for a few dietary ingredients, such as vitamin A, folate, vitamin D, and vitamin E.
Answers to your questions
A 20-30-minute Q&A session follows the speaker presentations to answer attendees' specific questions.
- Steven Shapiro, Esq., Of Counsel, Rivkin Radler, LLP
- Robert Wildman, Ph.D., Chief Science Officer, Post Active Nutrition Brands
- Will Woodlee, Esq., Partner, Kleinfeld, Kaplan & Becker LLP & AHPA General Counsel