The letters were sent Thursday by Sens. Dick Durbin, D-IL and Richard Blumenthal, R-CN and Rep. Edward Markey, D-MA to the makers of some major brands such as 5-Hour Energy, Monster Energy, PepsiCo, Coca Cola and Red Bull. Letters were also addressed to the maker of a gel product–Clif Shot Energy Gel–and some lesser-known energy drinks such as Arizona Energy and Archer Farms.
The letters have to be understood in the context of gathering regulatory and legislative pressure on the sector, said Jason Sapsin, a Denver-based attorney with Polsinelli Shughart who is a former associate chief counsel with FDA.
“We know that for some time the agency has been particularly concerned about dietary supplements being marketed in such a way that they can be construed as beverages,” Sapsin told FoodNavigator-USA.
While stopping short of saying receiving such a letter might present a threat to a company, Sapsin said the response should be very carefully considered, with the caveat that he his not trying to tell any of the companies involved what to do.
“When you see politicians and the agency both reacting in such a manner in which they think public health is at risk, it’s a concern,” he said.
The letters were sent from the three members of Congress and not issued under the aegis of a committee, an important distinction in terms of whether it is obligatory to reply. But Marc Ullman, an attorney with New York-based Ullman, Shapiro & Ullman, said most companies would choose to comply, even if they were not being compelled by a committee. Federal lawmakers and their staffs have ways of getting what they want, he said.
“These guys can be very persuasive,” Ullman told FoodNavigator-USAcom.
The letters include 13 sets of questions seeking details about whether the companies classify their products as foods or supplements and how they measure the amount of caffeine in their products. The questions also ask whether manufacturers account for the caffeine contribution of other ingredients, such as guarana, and whether the products contain other stimulant ingredients.
“There are some frivolous questions. Are you a supplement or a food? Look at the label.
“There are some serious questions, too, relating to caffeine content,” he said.
In addition to asking about caffeine, how it is measured and how it is labeled (if at all), the letters ask about two areas that Ullman though could pose difficulties for some companies.
“There are some potential vulnerabilities. Question 9, for example, which asks about marketing to children and teenagers.
“Or Question 12, which asks if the company has performed any studies on the safety of the product,” Ullman said.
“I would be shocked if the major companies on this list don’t have that data. The second and third-tier companies? Who knows what they have?
“I sometimes have clients who are reminded by FDA that if they are marketing a food everything in it has to be GRAS. So I tell the client, let’s clean this up, and let’s go to our suppliers to get this data. And we’ll get a letter back from a supplier saying, ‘I’ve been selling this for twenty years and never had an adverse event so it’s GRAS,’ ” he said.
Supplement vs. beverage
Sapsin said a manufacturer might choose to go the dietary supplement route if they want to include ingredients that do not have GRAS status. Or they might want to make health claims on their product, which is easier to do for a supplement than it is for a conventional food.
Durbin and Blumenthal have asked FDA on a number of occasions to make final its draft guidance on liquid dietary supplements, something that they feel would clear up some of the confusion about how a give product should be classified.
Some energy product manufacturers do themselves no favors in this argument. Some products say “drink” on the label yet have a supplement facts panel on the back. It’s this fuzzy area that the members of congress are driving at, Sapsin said.
“They understand that there are some unclear areas. They are trying to see if they can get the companies to take a stand,” Sapsin said.