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3-hr Virtual Seminar: FDA's Regulation of Energy Drinks

in IFSQN Events Calendar
Added by Simon, 22 Mar 2014

Taking place 22 Apr 2014 (Single Day Event)


Logo URL
Event Organizer ComplianceOnline
Contact Name Harshit Choudhary
Contact Number +1-888-717-2436
Contact Email editor@complianceonline.com
Event Category Live Webinar, Seminar
Event State/City Online Training
Event Country USA
Cost of Attendance $249.00
Event/Registration URL http://www.complianceonline.com/ecommerce/control/trainingFocus?product_id=703331&channel=am_IFSQN

Event Description

April 22, Tuesday 10:00 AM PDT | 01:00 PM EDT

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 Be Taken to Mitigate Potential FDA Enforcement Action

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.

Topic Background:

The US energy drink business is a yearly $5.4 billion industry. “Energy Drinks” are relatively new to the market, and manufacturers of these products have labeled some as dietary supplements and others as conventional foods. FDA regulates both dietary supplements and conventional foods under the Federal Food, Drug, and Cosmetic Act (the “FDCA”), but the requirements for each are different.

When it comes to product formulation, a food additive cannot be used in a conventional food unless it has been approved or deemed generally recognized as safe or “GRAS” by FDA for such intended use. Dietary ingredients however require no FDA pre-approval and FDA is required to prove that a product is unsafe under the conditions of use suggested in the labeling in order to take the product off the market. FDA does not exercise the same degree of regulatory authority over these products that it does over pharmaceutical and OTC drugs. There are no premarket review or approval requirements for Energy Drinks. Therefore, many drink claims have not been proven, the amount of added ingredients is neither standardized nor identified on the label, and FDA does not review the safety of these products before they go to market.

Despite the leniency of these requirements, energy drinks must still comply with FDA’s rules governing product labeling, beverage size, formulation, marketing and advertising claim substantiation; and adverse event reporting. The Federal Trade Commission also plays a role in the regulation of these products.

Common ingredients in energy drinks include caffeine, sugar, guarana, ginseng and taurine. Did you know that the FDA says that caffeine is both a drug and a food additive? Caffeine is used in both prescription and over-the-counter medicines to treat tiredness or drowsiness and to improve the effect of some pain relievers. However, it is also used as an ingredient in conventional foods like soda, coffee and energy drinks. In March 2013, a group of 18 doctors, researchers and public health experts jointly called upon the FDA to take action on Energy Drinks to protect children and young adults from the possible risks of consuming high amounts of caffeine. In a letter to FDA Commissioner Dr. Margaret A. Hamburg, the group wrote, “There is evidence in the published scientific literature that the caffeine levels in Energy Drinks pose serious potential health risks…” and called upon the Agency to restrict caffeine content in these drinks and to require manufacturers to include caffeine content on product labels.

There is also the issue of the use of caffeine in alcoholic beverages. In 2010 FDA issued a series of warning letters to the makers of such products stating that the use of added caffeine in alcoholic beverages does not satisfy the criteria for GRAS status. In each case, the subject beverage was deemed “adulterated” and was required to be taken off the market. Finally, there have also been an increasing number of filed lawsuits alleging that Energy Drinks pose a safety concern and health risk. These cases also raise issues of product liability and wrongful death. Considering the changing circumstances and all the confusion in the market, Energy Drink manufacturers are left wondering whether to go to market, and what precautions should be taken to mitigate the risks of both FDA enforcement action and plaintiff lawsuits.

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