Science and Law
22nd February 2013

Regulatory Status of Caffeine

The FDA is responsible for protecting and promoting public health through the regulation and supervision of a range of products including (among others), drugs, foods, and dietary supplements. With respect to regulating caffeine, it really depends on its application and intended use – as part of a dietary supplement, a drug or food additive, for example.

Regulatory Status of Caffeine

Do you want to learn when and why caffeine is regulated as a food or a drug? In this post I will share our insights on this topic.

FDA REGULATES CAFFEINE in FOODS and OTC PRODUCTS

The FDA is responsible for protecting and promoting public health through the regulation and supervision of a range of products including (among others), drugs, foods, and dietary supplements. With respect to regulating caffeine, it really depends on its application and intended use – as part of a dietary supplement, a drug or food additive, for example. The distinction is important because the application will impact labelling, premarket approval, documentation requirements, and manufacturing standards.

On one hand, FDA regulates caffeine as a drug (which is a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease) through product approvals, labelling (both OTC and prescription), and manufacturing standards. OTC products – which do not require a doctor’s prescription – are regulated through OTC drug monographs. In a nutshell, products conforming to a monograph may be marketed without further FDA oversight, while those that do not, must undergo separate review and approval through the “New Drug Approval System” (FDA, 2011). However, the inclusion of caffeine in these monographs does not substitute for demonstrable safety and efficacy evidence of the drug – i.e. the manufacturer must demonstrate that the drug is fit for consumption prior to FDA approval.  The FDA has published a list of over approved 800 ingredients known as the OTC Active Ingredients List, which includes seven monograph entries/categories for caffeine: cough/cold, internal analgesic, menstrual/diuretic, night-time sleep aid, over-indulgence in food/alcohol, stimulant, and weight control (FDA, 2010).

On the other hand, caffeine is regulated as a food additive by the FDA’s Center for Food Safety and Applied Nutrition which aims to “assure that the food supply is safe, sanitary, wholesome, and honestly labelled” (FDA, 2011). Food is defined as “a raw, cooked, or processed edible substance, ice, beverage or ingredient used or intended for use or for sale in whole or in part for human consumption, or chewing gum” (FDA, 2009), whereas a food additive is “any substance that is reasonably expected to become a component of food” (FDA, 2012). When it comes to caffeine, it is included on the Food Additives Status List, Everything Added to Food in the United States (EAFUS), and Generally Regarded as Safe (GRAS) list. Interestingly, the GRAS designation makes caffeine “not subject to premarket review and approval by FDA because it is generally recognized, by qualified experts, to be safe under the intended conditions of use” (FDA, 2011), although this can be challenged by the FDA at its discretion. The GRAS status of caffeine is generally used in consideration of soft drink/beverage levels of 200 ppm [mg/L] or less (FDA, 2009). Currently there is no requirement to label the quantity of caffeine present in a food, beverage, or supplement, and the disclosure of this information by manufacturers is voluntary. Also, disclosure of caffeine as an ingredient is mandatory when the inclusion of caffeine in a product is considered an ‘additive’ and not naturally occurring within the ingredients (think chocolate).

CAFFEINE IN DIETARY SUPPLEMENTS

When it comes to dietary supplements (which includes many energy drinks), the Dietary Supplement Health and Education Act (DSHEA) of 1994 mandated the FDA to regulate these supplements as food and not drugs (NIH, 1994). This distinction means that dietary supplements are not subject to the same stringent safety and efficacy testing regulations that drugs must adhere to. In fact, the inclusion of caffeine as an ingredient depends on whether it has been added as an additive or in its natural form (USDA). If the chemical caffeine has been added, then it must be explicitly included in the ingredients list. If caffeine has been added in the form of a botanical, then only the botanical is required to be listed in the Supplement Facts panel. For energy drink products marketed as liquid dietary supplements, they are not restricted to the same caffeine requirements for “beverages” regulated as conventional foods (which are limited to prior-sanctioned use level of 200 ppm or mg/L). In addition, some energy drinks contain caffeine from “naturally occurring” sources (which by the way can be found in over 60 botanicals (e.g. kola nut, guarana, yerba mate). Such botanicals provide additional caffeine and can be added to dietary supplements since many of these botanicals are not likely be considered “new dietary ingredients” since they have most likely been in use as dietary ingredients prior to 1994 (granting them grandfathered status) and also precludes having to list caffeine as an ingredient.

RECENT DEVELOPMENTS

Further, according to a recent development, Monster Beverage Corp. indicated that it is changing the labels on their products to list “Nutrition Facts” rather than “Supplement Facts” as well as disclosing caffeine levels. Monster also indicated: “”As we have always said, dietary supplements are subject to as much if not more FDA oversight than are conventional foods, and in any case, Monster Energy drinks could equally satisfy the regulatory requirements applicable to both regulatory categories” (Food Product Design).

Clearly, this space is experiencing many fast developments, and ISS continues to monitor the science (see our previous blog postings: The Science of Caffeine ToxicityENERGY DRINKS: CAFFEINE LITIGATION ON THE HORIZON?DEFENDING CAFFEINE, ALCOHOL, AND ENERGY DRINKSFDA Crashing 5-hour Energy Dietary Supplement?) related to these important issues including the new report in BMC Medicine suggesting that drinking caffeinated drinks during pregnancy raises the risk of having a low birth weight baby. In the study, researchers evaluated data from approximately 59,000 pregnancies over a period of 10-years. Overall, investigators found no link between caffeine consumption (from food/drinks or coffee) and the risk of spontaneous preterm birth. But there was an association with low birth weight. However, as quoted in the NYTimes, “one study author, Dr. Verena Sengpiel of the Sahlgrenska University Hospital in Sweden, said the findings were not definitive because the study was observational, and correlation does not equal causation. But they do suggest that women might put their caffeine consumption “on pause” while pregnant, she said, or at least stay below two cups of coffee per day.”

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