Taylor posted the commentary on the FDA Voice site yesterday. The commentary deals in part with the aftermath of a two-day meeting called by the Institute of Medicine at FDA’s behest to examine the question of the addition of caffeine to new categories of food.
“All in all I think it was a very balanced an appropriate statement,” Marc Ullman, a Garden City, NY-based attorney with the firm Ullman, Shapiro & Ullman told FoodNavigator-USA.
Caffeine turning up in new places
Taylor said again what the agency has said in on a number of occasions, that caffeine has been in the human diet for a long time in the form of coffee, tea and chocolate and poses no special health risk in reasonable doses. But the introduction of the stimulant to new food groups, such as energy drinks, waffles and syrup, is a cause for reflection, he said.
“The availability of caffeine in these products has been accompanied by a sense of boundaries and some health-related advice: Coffee has traditionally been thought of as a drink for adults; pregnant women have been advised to limit caffeine intake; and parents have monitored young children’s consumption of caffeinated soda,” Taylor wrote.
“In addition, most of these traditional products have not typically been marketed for their stimulant properties,” he added.
“By breaking far outside the traditional boundaries surrounding caffeine as a component of the food supply, these products pose challenging public health and regulatory questions. They stem from the fact that these products are being marketed explicitly for their stimulant properties, are prone to being consumed under a range of new and different conditions, and are providing caffeine in forms that are attractive and accessible to children and adolescents,” Taylor wrote.
Nutritive value claims
That’s an interesting distinction, Ullman said. It raises the question of the regulatory underpinning of functional food, in other words, what constituents ought to be included in a food product (as opposed to a supplement) and what a marketer can say about those constituents.
“You are getting back to the concept that the only claims you should be making for foods is for nutritive value. And clearly energy from caffeine is not for nutritive value. But after FDA stretched the definition of nutritive value for plant sterols (allowing a heart disease risk reduction claim for these ingredients), how much of that limitation is left? FDA had a kind of tortured analysis (to allow the sterol claims). There may be an attempt to pull back, but it’s kind of hard to pick and choose like that,” Ullman said.
Taylor said there are many facets of the issue yet to be worked out, such as whether rapid caffeine consumption, which the energy drink delivery system makes easier, is a true health concern. And whether caffeine showing up in a wider range of products means that consumers, especially young ones, will consume more of it.
Safety is still No. 1
But in the meantime, Taylor reminded companies that regardless of the current regulatory ferment regarding caffeine, the responsibility of companies making consumer products remains clear.
“Companies adding caffeine to foods and beverages have an obligation to ensure there is a sound scientific basis for concluding that their uses are safe. FDA’s job is to be sure they have met that obligation. To ensure safety, FDA has the authority to place limits on the amount of caffeine that is added to food, if the science warrants such a step,” he wrote.
Taylor said FDA is committed to evaluating the data delivered at the recent IOM workshop as it decides what new regulatory guidelines—if any—need to be issued regarding caffeine content in foods and beverages. In the meantime, he said the agency was glad to see that companies were “exercising restraint” in regards to caffeine.
Restrained approach
Ullman said the blog post was welcome because it signaled that FDA will be moving with restraint and considering all points of view as it responds to alarm bells both within the medical community and those sounded by Senators Dick Durbin, D-IL and Richard Blumenthal, D-CT.
“It’s an opportunity to have a reasonable discussion. And it’s a stern reminder that if you claim your ingredients are GRAS, they’d better be GRAS,” Ullman said.
To read Taylor’s full post, click here.