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FDA Takes Broad Aim at Caffeine

In the midst of supposed cinching of financial waist belts and hard budget choices, the FDA announced this past week that it would begin investigating the “trend” in foods that are being manufactured to include caffeine.  The announcement was thereafter memorialized on the FDA’s website.  This news arrives in the advent of Mars, Inc. announcing that its subsidiary, Wrigley’s, was introducing gum that contained caffeine.

FDA characterized the addition of caffeine to foods as “unfortunate.”  It cites the new gum, jelly beans, marshmallows, sunflower seeds, energy drinks, instant oatmeal, waffles, and syrup as examples of products to which caffeine has recently been added.

According to a 2007 memorandum, the FDA reports that 80% of U.S. adults consume caffeine every day with an average daily intake of 200 mg per person, which it equates to approximately two 5 oz. cups of coffee or four sodas.  It also notes that among children in 7th – 9th grade, students consumed an average of 53 mg per day, but that nearly 20 percent of students had more than 100 mg per day.  “Experts agree that four to seven cups of coffee or more each day is too much,” the FDA states.  It finds studies to have shown moderate amounts of caffeine not to be harmful.  The FDA rightfully admits that everyone processes caffeine differently depending on a number of factors (size, sex, individual physiological characteristics).

In December 2012, the FDA published findings that were completed by Consulting Food Scientist Laszlo P. Somogyi, Ph.D. concerning caffeine intake and amounts of caffeine in certain products.  The agency hired Dr. Somogyi to determine daily caffeine intake for the subpopulations of children 2-13, male and female teenagers 14-21, and women of childbearing age 16-45.  The report concluded that 97% of the caffeine intake of teenagers and adults and about 95% intake of the children 2-13 “come from beverage sources.”  Dr. Somogyi arrived at a
different amount of caffeine consumed daily by adults: 300 mg.  The analysis estimated that adults likely to drink energy drinks would have a daily caffeine intake of anywhere from 233 – 465 mg.  Of particular significance, Dr. Somogyi concluded that, “[a]ny significant change in the caffeine intake of the U.S. population would depend on modification of coffee drinking practices, given that all other caffeine sources make only a minor contribution to overall caffeine consumption.” (emphasis added).

Dr. Somogyi’s report compiled lists of products and their respective caffeine content.  Excedrin Extra Strength has 130 mg of caffeine per serving, which is two tablets.  Aspirin Bayer Select Maximum Strength has 65 mg. of caffeine per tablet.  One 8 fl. oz. cup of average coffee made from grounds has 95 mg; a large (16 fl. oz.) coffee from McDonalds: 145 mg; a Grande (16 fl. oz.) Starbucks regular coffee: 330 mg.  Coca Cola Classic has 35 mg per 12 fl. oz. can; Pepsi Cola: 38 mg per 12 fl. oz. can.  A 16 fl. oz. can of Monster Energy reportedly has 160 mg; its competitor Rockstar has 160 mg per 16 fl. oz.  An 8 oz. cup of Ben and Jerry’s Fair Trade Coffee Ice Cream has 70 mg.  Jelly Belly Extreme Sport Beans have 50 mg per 1 oz. bag; Mad-Croc energy gum has 40 mg per piece; and Penguin Mints have 7 mg per mint.

Coffee and soda are abundantly sold and available to any age group. The same can be said for chocolate.  Drugs that contain caffeine are rampantly sold to and consumed by the public.  Dr. Somogyi concluded that without lowering coffee consumption, there would be no meaningful reduction in caffeine intake.  Caffeine is currently included in a relative micro-fraction of food products and it’s not a stretch to say that vastly more cups of coffee are sold every morning than people who consume caffeinated breakfast foods, yet the FDA maintains that it is now concerned because of the “proliferation” of caffeinated foods, which will likely never cause a dent in total caffeine intake due to how much coffee the public drinks.

Considering the information and conclusions in Dr. Somogyi’s report, the FDA’s new aggressive posture toward caffeinated products does not appear justified.   Although promotion of caffeinated soda as mixers for alcoholic beverages rightly is of concern given the potentiation effect of those beverages on alcohol consumption, the presence of relatively small amounts of caffeine in food products appears not to justify restrictive actions.  One appropriate question that the FDA should consider would likely be whether increased availability of caffeinated products (however small) necessarily means a significant increase in total caffeine consumption outside accepted levels; but the FDA hasn’t remotely so narrowed the scope of its proposed inquiry.  So, could there be another reason behind the agency’s recent action?

One answer could be that the constant harping from Senator Richard Durbin for action on this front is finally bearing political fruit.  The FDA Commissioner could simply believe that to reduce the pressure from the Hill she must demonstrate that she is “doing something” to address the general topic of caffeine.  Among the majority of articles discussing caffeine in which the FDA is asked to comment, the FDA is forced to offer a similar standard response, which is essentially that it is monitoring the market and will act if it discovers a potentially harmful product.  Reports of caffeine being associated with reported injuries and deaths offer no basis for the FDA to imply that caffeinated products in any way caused those results.

A good example of a recent agency response is seen in a letter to Senator Durbin in August 2012. In the letter the FDA offers many of its standard responses, but it also seems to hint at a possible roadmap for how its newly initiated caffeine investigation may run.  First, the FDA says it intends to prepare in final its 2009 “Drinks Draft Guidance” that will discuss the factors that companies should consider when determining whether a product should be characterized as a dietary supplement vs. a conventional food.  Second, the agency notes that the agency may challenge a corporation’s determination that the levels of caffeine in certain of the corporation’s products are generally recognized as safe (GRAS) for those products’ intended use.  Third, it explained that “to restrict the use of a dietary ingredient in a dietary supplement, FDA must demonstrate that the ingredient adulterates the product under the dietary supplement adulteration provisions of the FD&C Act; e.g. because the ingredient presents an unreasonable risk of illness or injury under the conditions of use recommended in the labeling of the supplement.”  This may be exactly the type of evidence and information that the FDA is now searching for in its caffeine related investigations.

In its website announcement, Michael R. Taylor, deputy commissioner for foods and veterinary medicine at the FDA, acknowledges that regulations such as setting age restrictions for caffeine consumption would be impractical; however, capping levels of caffeine in certain products may be something that is considered.  How successful the FDA becomes in pursuing that option and those discussed in the FDA’s 2012 letter to Sen. Durbin may rest on how effectively the agency can continue to sell the argument that the increased availability of new caffeinated food products alone (even in relatively miniscule amounts) somehow equates with significantly increased overall caffeine consumption and a tangible danger to the public.  The evidence and science seem not to support that hypothesis.

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