The FDA issued long anticipated guidance this week for dietary supplements and beverages, including controversial energy drinks that have raised concerns about how the manufacturers of the highly caffeinated beverages have been able to largely avoid federal regulation by categorizing their products as supplements.
The guidelines are aimed at clarifying the role of certain dietary supplements, which are substances added to foods and beverages, focusing on the of energy drinks.
Manufacturers of energy drinks have been able to avoid disclose details about the contents and levels of caffeine contained in their products because they are usually classified as dietary supplements. However, the new guidance hopes to evaluate each liquid product on an individual basis before determining whether it falls under dietary supplement guidelines or should be categorized as a food product, which include a beverage subcategory.
The guidelines indicate the FDA will focus on how the product is marketed, including graphics on the product, product labels, websites and social media. This is meant to evaluate how the product is represented and how the product is intended to be used.
Late last year, Monster Beverage Corp. proposed industry marketing guidelines to the American Beverage Association, but refused to release details of the plans to the public. The secret guidelines were drafted to address the concerns about the aggressive marketing of energy drinks that are often directed at children. However, the company indicated that it will only adopt the guidelines if all energy drink makers, including makers of Red Bull, Rock Star, 5-Hour Energy and others, agree to adopt the voluntary industry guidelines as well.
Other factors that will also be considered in the new FDA guidance are whether the product claims to “refresh” or “hydrate” the consumer. The FDA indicates products that advertise such claims are being represented as a beverage, not a dietary supplement, as many energy drink makers claim.
Monster announced in February 2013 that it would drop the dietary supplement facts panel and begin to classify their products as beverages, voluntarily placing them under FDA regulations. The move means Monster relinquishes its right not to withhold information about the amounts of caffeine and other stimulants in its products. However, the decision came only after the manufacturer faced strong criticism about their marketing and concerns about the potental risk of life-threatening health problems linked to Monster energy drinks.
While the step was voluntary in the case of Monster, many other energy drinks might soon be required to follow suit under the new FDA guidelines. The FDA said it was up to manufacturers to make sure the substances added to foods and used in dietary supplements comply with the regulatory requirements set forth by the agency.
The guidance also highlights if a product is not generally recognized as safe (GRAS) by food experts, showing scientific evidence of reasonable safety, it will be considered a food additive and will require premarket approval by the FDA.
The FDA warns many substances which have not been previously used in conventional foods may be unapproved as food additives.
Other substances have been present in the food supply, but are now being added to foods and beverages in amounts in excess of traditional use levels. In many instances, high levels of caffeine and other substances used in energy drinks.
“This trend raises questions as to whether these higher levels and other new conditions of use are safe,” agency officials stated recently.