August 7, 2014
Editor’s note: This article is the first of a three-part series on energy drink regulation, which will cover the regulatory framework and outlook for this sector in the United States and Europe, as well as the potential legal vulnerabilities that exist for the sector. Part one will focus on the United States’ regulatory framework and the outlook for enforcement.
Few sectors of the food market have grown as quickly as the energy drink sector over the past decade. As the sector has grown, so has public outcry for regulators to address concerns about the increased consumption of these foods. More recently, the tempo of consumer liability claims has increased as well. Particular concerns regarding energy drinks have been raised regarding the popularity of the sector among young adults and teenagers, as well as the vulnerabilities of those populations to both primary and secondary effects from high consumption levels of stimulants. The concerns in the United States are bolstered by the relatively weaker regulatory framework as compared to Europe.
Energy drinks make up a sector that has straddled the regulatory divide between conventional foods and dietary supplements in the United States. In the past, most products in the sector have categorized themselves as dietary supplements to take advantage of the lower requirements for establishing the safety of ingredients. Recently, more products have been reclassified as conventional foods by manufacturers for a variety of reasons, which include avoiding stricter requirements regarding adverse event reporting (AER) and current good manufacturing practice (cGMP) requirements for dietary supplements. It is this regulatory bifurcation that figures prominently in FDA’s past and current regulatory enforcement approaches.
To understand the current situation and the regulatory outlook for energy drinks, we need to understand the relationship between FDA’s regulation of food ingredients and dietary ingredients in supplements. In the United States, the use of ingredients in conventional food must either be sanctioned by FDA or USDA prior to January 1, 1959 (so-called prior sanctioned), authorized by FDA in a regulation or generally recognized as safe (GRAS). GRAS ingredients do not require review or authorization by FDA, but their use must conform to FDA’s established regulations on GRAS determinations. GRAS determinations must be based on the same quality and quantity of data as a food additive safety determination by FDA. In addition to meeting the same safety standard as a food additive, the safety of a GRAS ingredient must be generally recognized. General recognition means that information underlying safety must be publically available (i.e., generally available) and there should be no significant scientific disagreement among scientific experts regarding the available data on safety (generally accepted).
The majority of food ingredients are GRAS, so they do not require premarket approval by FDA. However, recent criticism of FDA’s implementation of the GRAS provisions of the law has caused FDA’s enforcement posture toward independent GRAS determinations to shift in the past few years. Since the late 1980s, FDA has generally taken the position that the agency needed to in order to assert that an ingredient caused harm, or at least had a reasonable potential to cause harm, under its intended conditions of use before FDA would pursue aggressive enforcement. However, in 2009, public opinion and other interest in so-called alcoholic energy drinks (AEDs) resulted in FDA reconsidering its longstanding enforcement posture. FDA’s warning letters on AEDs issued in November of 2010 focused on the uncertainties regarding safety, but did not go so far as to claim actual harm. In these cases, FDA challenged the general recognition of safety rather than safety itself. Similarly, FDA’s tentative determination that partially hydrogenated vegetable oils (PHOs) are no longer GRAS (published November 2013) is also based on uncertainties among experts about safety rather than safety itself. This shift by FDA is intended to reduce the burden of proof of potential harm for FDA, while also placing a burden for addressing questions about general recognition of safety squarely on the industry.
Although dietary supplements are food, their ingredients have a very different regulatory framework than conventional food ingredients. Dietary ingredients in supplements do not require FDA review as new dietary ingredients (NDIs) if they were marketed in dietary supplements October 15, 1994 (21 U.S.C. 350b(c)). In a way, this provision mirrors the GRAS provision for food ingredients, but the more modern date can sweep in many ingredients used between 1958 and 1994. If a dietary ingredient does not qualify for either exemption, then it must be successfully notified to FDA as an NDI prior to its use in dietary supplements. This requirement can be problematic, given the historically low success rate for NDI notifications (roughly 80 percent of NDI notifications are rejected by FDA, according to a presentation by Daniel Fabricant, April 2014). This is true, despite the fact that the safety standard for dietary ingredients is lower than that for conventional food ingredients. Another important restriction for dietary supplements is that they may not be marketed in the form of a conventional food. Under 21 U.S.C. 321(ff)(2)(B), the term “dietary supplement" means a product that, among other requirements, “is not represented for use as a conventional food or as a sole item of a meal or the diet."
With the publication of two guidance documents in January 2014, FDA has taken another step toward defining a stronger enforcement position with respect to the energy drink sector. These two guidance documents deal with the distinction between beverages as conventional foods and liquid dietary supplements, as well as the differing regulatory requirements for dietary ingredients and conventional food ingredients. The first guidance document describes the factors that FDA will consider and which industry should consider to determine if a liquid dietary supplement is, in fact, a beverage. These factors include: labeling and advertising, product name, product packaging, serving size and recommended daily intake, recommendations or directions for use, composition marketing, and other representations about the product. Manufacturer’s should expect FDA to use these factors to target those energy drinks marketed as beverages, but claim to be dietary supplements and contain non-traditional food ingredients.
By reclassifying such products to conventional food products, FDA may apply the stricter safety standard for food ingredients. For those ingredients in energy drinks that are not specifically authorized for use in food, FDA may then apply the GRAS standard regarding general recognition of safety. Following the example of recent actions referenced above, FDA can be expected to take action against ingredients based on significant questions and uncertainties regarding the currently available safety data relating to the use of the ingredient. FDA could raise uncertainties relating to the broader population or to specific vulnerable subpopulations. FDA may not necessarily believe it needs to establish harm to take enforcement action regarding a conventional food ingredient. Thus, FDA’s reclassification of the dietary supplement to a conventional food form (i.e., a beverage) gives FDA much more flexibility in taking enforcement action, putting energy drinks, especially those with non-conventional ingredients, at risk.
For help with understanding laws regulating the dietary supplement and functional foods industry, visit INSIDER’s Regulatory Content Library.
Craig Simpson is a senior European legal advisor (Brussels office), Mark Fitzsimmons is a partner (Washington office) and Mitch Cheeseman is managing director, regulatory and industry affairs department (Washington office) at Steptoe & Johnson LLP. The authors acknowledge the valuable assistance and ideas of Blandine Gayral, paralegal in the Brussels office of Steptoe & Johnson, in preparing this article.
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