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Caffeine in Food and Dietary Supplements: Examining Safety

Remarks by Dr. Margaret Hamburg, FDA Commissioner
To a meeting of the Institute of Medicine,
Food and Nutrition Board and Board on Health Sciences Policy
National Academy of Sciences, Washington, DC
August 5, 2013

Thank you, Dr. Goldman, for that generous introduction, and for taking on the responsibility of chairing this important committee.  I also want to thank the members of the committee for their service and for bringing their knowledge, expertise and insights to bear on the issues surrounding the potential health hazards associated with the consumption of caffeine in food and dietary supplements.

As a brief glance around the room this morning confirms, many of us begin our days with some caffeine, in the form of a cup of coffee, tea and, for some, diet cola.

That’s not surprising. Caffeine is probably the most frequently ingested pharmacologically active substance in the world. A central nervous system stimulant, it occurs naturally in more than 60 plants, including coffee beans, tea leaves, kola nuts used to flavor soft drinks and cocoa pods used in making chocolates. 

But if the barrage of coffee cups across the room is not surprising, neither should it be seen as alarming. Years of research and study have shown that moderate consumption by adults of products with naturally occurring sources of caffeine is not associated with adverse effects.   

Of course, the traditional cup of coffee or tea – even when it’s “supersized,” as is so often the case today – is not the concern or focus of your important work here today. For the Food and Drug Administration, caffeine is both a drug and a food additive. And your mission is to take a closer look at the many new and novel products that are inundating the marketplace today that have added sources of caffeine. 

Some of these products have already begun to be publicly examined and challenged – by consumer advocates, scientists and the medical profession.  For instance, we’ve seen a good deal in the news recently about some of the energy drinks that are loaded with caffeine. But the assortment of products being created with caffeine added to them is much more extensive.  It includes everything from waffles and syrup to chewing gum; breakfast oatmeal to jelly beans; marshmallows to sunflower seeds. It even includes caffeinated water.

This new marketplace raises many questions and concerns, both for us as the public health regulatory agency responsible for overseeing these products, and also for the food industry whose responsibility it is to ensure the safety of its products.  And we’re asking you to take a close look at these products.  Surely a key question – one already identified by numerous consumer advocates, medical professionals and scientists – concerns the safety, availability and marketing of many of these products primarily to target populations that we might not ordinarily associated with caffeinated products, primarily children and adolescents.

Studies have demonstrated that, compared to adults, children are at increased risk for possible health effects from ingestion of even naturally occurring dosages of caffeine.  And, with caffeine now appearing in so many different product types, it’s possible that a young child may be at risk of ingesting caffeine from many sources in a given day without even having any sense of the exposure they are having from what they are eating and drinking. The consequences of this cumulative exposure are deserving of greater analysis, attention and understanding.

All of which is why we have asked the Institute of Medicine to undertake this workshop. 

Specifically, we have requested that this workshop review the relevant literature, describe the vulnerable populations of concern and the health risks from dietary supplements and foods to which caffeine is being added, and, importantly, to identify data gaps.

Before you begin to drill down into these tough issues, let me briefly remind you of a little of the history in this field to help put this workshop into a broader regulatory and public health context. As I mentioned, caffeine in coffee and other similar products, used by adults, is generally considered to be safe. In addition, the use of caffeine in cola-type beverages up to 200 parts per million in accordance with good manufacturing practice has been listed as “generally recognized as safe” (GRAS) in FDA’s regulations since 1959.  But, even early on, there have been concerns about the effects of caffeine consumption beyond moderate levels and in vulnerable populations, such as children and pregnant women.  In a 1978 report, for instance, the Select Committee on GRAS Substances (SCOGS) raised questions about whether the chronic consumption of caffeine in cola-type beverages by children during a period of brain growth and development might affect behavior.  The evidence was not conclusive.

Most recently, in the last 10 years, the marketplace has been jolted, if you will, with an influx of energy drinks and caffeinated alcoholic beverages. This led to FDA’s sending four warning letters in 2010 to manufacturers of caffeinated alcoholic beverages, whose products – alcoholic malt beverages to which caffeine had been directly added as an ingredient – were subsequently removed from the market.  FDA had not approved the use of caffeine in alcoholic beverages at any level.  We were concerned about the safety of these beverages because published peer-reviewed studies suggest that the consumption of beverages with added caffeine and alcohol is associated with risky behaviors.  Caffeine appears to mask some of the sensory cues an individual might normally rely on to determine his or her level of intoxication.

While those products are no longer on the shelf, the energy drink marketplace has continued to expand, and is today a multibillion-dollar business. The products come in a range of sizes and are marketed as either conventional beverages or dietary supplements. Several contain other compounds that interact with the added caffeine – or add yet another effect to that caffeine. And many of these products, just as with the other products that add caffeine to their mix, appeal especially or even particularly to a young audience.

All of which brings us back to your starting point today – the ever-expanding list of products with caffeine added to them – and what role FDA should play in terms of the broader regulatory and public health context for this marketplace. There are three primary points I hope you will focus on in your discussions:

First, it’s your charge to examine the health risks associated with the use of caffeine beyond moderate levels and for specific populations. Some studies have suggested that heavier consumption or habitual use of caffeine increases this risk, particularly for vulnerable populations, such as pregnant women or children. For example, the literature suggests there may be reproductive effects, such as reduced fecundity and a decrease in birth weight, even at lower intake levels.  And there is also some limited evidence of anxiety in children at low doses. By examining and evaluating the epidemiological, toxicological, clinical and other literature, you will help us have a better and more complete understanding of these health risks for each of these various populations of concern.

Second, you should focus on the issues surrounding the marketplace for these products and the expanded availability of caffeine and the conditions under which these products are used.  The American Academy of Pediatrics, as well as a 2007 Institute of Medicine report, have expressed concern about making caffeine more readily accessible and attractive to children and adolescents. We need to know what the research suggests about caffeine exposure, particularly the additive effects and the conditions under which it is used, including in energy drinks and similar sources, and whether the FDA should be more closely monitoring and regulating these products, especially, as I’ve said, in more vulnerable populations.

Third, as this workshop indicates, it is our goal to be as transparent as possible in our investigation and study of this area and these kinds of products.  To this end, we have worked cooperatively with the food and beverage industries, and they have shared their expertise and experience.  We’ve reached out to public health and medical specialty groups, as well as consumers and consumer advocates. And we have conducted preliminary analyses of adverse event databases that are available to us. But this is a time we need to delve as deeply as possible.   

We also are encouraged by how some in the industry have responded to concerns about the risk that children could be over-exposed to caffeine, as demonstrated by Wrigley’s recent announcement not to market a chewing gum with caffeine.  Such voluntary restraint is helpful at this time when we are still searching for information and considering how to better define the regulatory boundaries around caffeine.  And we look forward to continuing to work with the different parts of the industry. 

But despite the laudable restraint that we’ve seen in some instances, we also know some companies have been adding caffeine to their products based on their opinion that such use is GRAS, without engaging the FDA or being transparent about what they’re doing. As a result, they are raising numerous questions about the scope and rigor of their safety analysis. This approach threatens to implicate the credibility of the industry as a whole, and potentially undermines FDA’s carefully balanced regulatory oversight, which is designed to allow innovation while ensuring safety.

The meetings today and tomorrow will allow us to take a close and thorough look at what is happening in the marketplace, how industry is proceeding with so-called innovation, what the science reveals about this area, and what actions, if any, might be necessary.  It occurs at a critical time and offers a critical opportunity to evaluate the data and to reach some informed conclusions.  Your deliberations will help guide us as we consider the right steps forward to protect public health.

Thank you.