Energy drinks raise a monster of FDA and state legal concerns

Energy drinks, like dietary supplements promising energy boosts, weight loss, and other benefits, raise significant FDA legal challenges; how can manufacturers avoid the barrage of FDA and state enforcement actions? Michael was quoted in Tan Sheet 5-27-13:

“Attorney Michael Cohen said if the case goes to trial, Monster could argue that it would have to change labeling and marketing that already meets federal requirements. However, as much as ‘it may be an economic burden on the company,’ a court might not consider Herrera’s labeling demand an undue burden on interstate commerce,’ said Cohen, of Michael H. Cohen Law Group in Beverly Hills, Calif…

Arguing a constitutional amendment violation turns on a multiple variables, says Cohen. ‘Constitutional arguments need a lot of weight to gain traction. It’s all too easy to invoke the First Amendment, when there are competing interests, such as the municipality’s right to regulate locally,’ he said.”

The article was referring to the lawsuit filed by San Francisco City Attorney Dennis Herrera against Monster Beverage Corporation for violating California law with its marketing of highly-caffeinated energy drinks to children as young as six-years-old, despite scientific findings that such products may cause “significant morbidity in adolescents” from elevated blood pressure, brain seizures, and severe cardiac events.

Herrera’s lawsuit, which was filed in San Francisco Superior Court on May 6, 2013, came one week after Monster pre-emptively sued Herrera in an extraordinary legal attempt to halt his office’s months-long investigation into the marketing and sales practices of the nation’s largest energy drink manufacturer. Herrera’s office had been working with Monster in good faith to negotiate voluntary changes to its youth-targeted marketing practices when the Corona, Calif.-based energy drink manufacturer abruptly sued the City Attorney in federal court on April 29, 2013. Herrera characterized Monster’s litigation strategy as “forum shopping” and a bid to win the race to the courthouse, and has vowed to not back down.”

The case is ongoing.

FDA has issued Guidance for Industry: Distinguishing Liquid Dietary Supplements from Beverages. In this guidance, FDA describes factors that distinguish beverages from liquid dietary supplements. These factors include:

• labeling and advertising
• product name
• product packaging
• serving size and RDI
• recommendations and directions for use
• marketing practices
• composition

FDA prohibits false or misleading labeling. Moreover, health claims (which characterize the relationship between a substance (food or food component) and a disease or health-related condition, must be adequately supported, as must nutrient content claims and structure/function claims.

FDA investigates adverse events related to energy “drinks” and supplements, including illness, injury or death of people who took products marketed as “energy drinks” or “energy shots.” FDA notes:

Dietary ingredients (the “active ingredients” in dietary supplements) require no FDA preapproval to be used in a dietary supplement, and the FFDCA requires FDA 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.

Manufacturers, packers, and distributors of dietary supplements are required by law to report any serious adverse events to the FDA within 15 business days, and to provide (also within 15 business days) any additional medical information they obtain within a year of the adverse event report. However, the FFDCA does not require manufacturers, packers, or distributors of conventional foods to report serious adverse events to FDA. Therefore, all adverse event reports that FDA has received in connection with these products are voluntary….

FDA cautions consumers that products marketed as “energy shots” or “energy drinks” are not alternatives to rest or sleep. It is important for consumers to realize that, while stimulants such as caffeine may make one feel more alert and awake, judgment and reaction time can still be impaired by insufficient rest or sleep. If you are thinking about taking one of these products, please consult your health care provider to ensure that you don’t have an underlying or undiagnosed medical condition that could worsen as a result of using them.

If you’re marketing an “energy shot” or a liquid dietary supplement, ask FDA legal counsel to review your marketing and claims. Remember that FTC rules also prohibit deceptive or misleading advertising.

Our healthcare lawyers can craft ways to handle these imposing legal rules, but this requires creativity and savvy, and a strong working knowledge of all the various law and regulations, and how they work together.