3-hr Virtual Seminar: FDA's Regulation of Energy Drinks: What Manufacturers Should Know To Safely Market and Sell These Products, and Steps That Can B

This three hour long virtual seminar will focus on the FDA regulation of energy drinks. It will cover regulatory requirements governing both conventional food products and dietary supplements, including rules governing product formulation, ingredient and product safety, and proper labeling. Attendees will also learn strategies for mitigating enforcement risk.

Why Should you Attend:

The US energy drink market has annual sales of more than $5 billion. Frequently, energy drinks may include a combination of caffeine, sugar, guarana, ginseng or taurine. For regulatory purposes, these products are regulated either as conventional foods or dietary supplements. Recently, the FDA has seen an increase in the number of reported adverse events and has taken steps to mitigate the potential risks to adolescents and the public generally.

This webinar will examine the FDA’s current regulation of energy drinks and the agency’s position on the marketing and sale of such products. It will analyze the conventional food vs. dietary supplement regulatory debate, and will discuss the requirements applicable to both. FDA’s rules governing product formulation, ingredient and product safety, and proper labeling will be covered. The use of caffeine in alcoholic beverages will also be analyzed. Finally, attendees will be provided with recommendations for complying with the FDA’s regulatory requirements and strategies for mitigating enforcement risk.

Learning Objectives:

Upon completion of this webinar, attendees will:

• Gain a basic understanding of the FDA’s regulation of energy drinks
• Learn the potential risks of marketing such products in the U.S.
• Be able to explain the regulatory rationale for energy drinks being marketed as both conventional food and dietary supplement
• Have a working knowledge of the FDA’s regulatory requirements governing both conventional food products and dietary supplements
• Become familiar with the FDA’s rules applicable to food ingredients and dietary ingredients
• Have a working knowledge of the FDA’s beverage regulations generally
• Understand the FDA’s position on the marketing and sale of alcoholic beverages containing caffeine and the agency’s 2010 actions against alcoholic energy drink manufacturers
• Leave the webinar with strategic recommendations for mitigating potential FDA enforcement risks

Areas covered in this webinar:

• FDA’s regulation of energy drinks
• The regulatory status of caffeine and the other ingredients commonly used in energy drinks
• FDA’s regulation of drinks and beverages generally including labeling, ingredient and finished product safety, manufacturing and adverse event reporting
• Safe ways to market and sell energy drinks in the U.S.
• Issues that have prompted enforcement action in the past.
• Suggestions for mitigation potential FDA enforcement risk

Who Will Benefit:

• Regulatory Affairs Professionals
• Managers
• Consultants
• Scientists
• Research Analysts
• State Policy Officials
• Insurers focusing on Representations & Warranties Insurance
• Investment Analysts
• Venture Capitalists
• Energy Drink Manufacturers, Labelers, Distributors and Retailers
• Foreign Energy Drink and Beverage Makers, Importers, Customs Brokers

Instructor Profile:

Karl Nobert, is a Food and Drug Regulatory Attorney in Washington, DC. He regularly provides FDA regulatory advice and counseling to domestic and international food and beverage manufacturers among others. He has served as a regulatory consultant to several large food and drink companies on issues including proper labeling, ingredient safety, marketing and advertising, manufacturing, cGMPs, packaging, distribution and FDA regulatory compliance generally. He has also prepped and readied both U.S. and foreign companies for FDA facility compliance inspections. He frequently presents and has published on such topics.