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Citizen's Petition to FDA
Citizen's Petition to FDA
October 25, 1995
October 25, 1995
TO: Dockets Management Branch, Food and Drug Administration, Department of Health and Human Services, Room 1-23, 12,420 Parklawn Dr., Rockville, MD 20857.
The undersigned hereby submits this petition under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., under 21 C.F.R. § 10.25(a), and under the Administrative Procedure Act, 5 U.S.C. § 553(e), to request that the Commissioner of Food and Drugs assert jurisdiction over and regulate caffeinated beverages as drugs and/or devices.
A. ACTION REQUESTED
Petitioner Competitive Enterprise Institute ("CEI") requests the Commissioner to assert jurisdiction over and regulate caffeinated beverages as drugs and/or devices under 21 U.S.C. §§ 321(g)(1)(C) and 321(h)(3).
B. STATEMENT OF GROUNDS
Petitioner, the Competitive Enterprise Institute ("CEI"), is a non-profit public interest group committed to the principles of free markets and limited government. CEI has a longstanding interest in regulatory issues involving matters of health, safety and free speech. See, e.g., CEI and Consumer Alert v. National Highway Traffic Safety Administration, 956 F.2d 321 (D.C. Cir. 1992) (adverse safety effects of federal fuel economy standards); CEI v. U.S. Department of Transportation, 856 F.2d 1563 (D.C. Cir. 1988) (First Amendment challenge to regulation of airline computer reservation systems).
CEI hereby petitions the Food and Drug Administration (FDA) to assert jurisdiction over caffeine-containing beverages and to regulate them as drugs and/or drug delivery devices under the Federal Food, Drug, and Cosmetics Act (FDCA), 21 U.S.C. § 301 et seq. In CEI's view, such regulation of caffeine would not be socially beneficial; in fact, it would actually harm consumers by restricting the availability and advertising of products which should be freely available.
Nonetheless, CEI submits that caffeine beverage regulation follows directly from FDA's pending proposal on tobacco products. FDA has proposed to regulate nicotine in tobacco products based on its determination that these products meet the FDCA's definition of a drug under section 321(g)(1)(C), and its definition of a device under section 321(h)(3). As shown below, FDA's criteria for this determination are equally applicable to caffeine. CEI submits that, under FDA's newly expanded interpretation of the FDCA definitions of drugs and devices, the agency is now required to regulate caffeine-containing beverages as well.
REGULATION OF CAFFEINE-CONTAINING BEVERAGES UNDER THE FDCA
- The Common Sources of Caffeine
The most common sources of caffeine are coffee, tea, and caffeinated soft drinks. In coffee and tea, the caffeine occurs naturally. Methods exist for removing this caffeine from coffee and tea, and a small percentage of the coffee and tea sold is fully or partially decaffeinated. In caffeine-containing soft drinks, caffeine comes from both the caffeine in the kola nut used in some of these beverages, as well as from added caffeine. M.L. Bunker & M. McWilliams, "Caffeine Content of Common Beverages", J. Am. Dietetic Ass'n 28 (Jan. 1979); O.M. Graham, "Caffeine -- Its Identity, Dietary Sources, Intake, and Biological Effects", Nutrition Reviews, April 1978, at 97.
Soft drinks constitute the majority of caffeine consumed by children. J.E. James, Caffeine and Health 52 (Academic Press, 1991). In fact,
"[t]he largest percentage of caffeine consumers was among two- and three-year-olds, 91 and 93 per cent, respectively. Notwithstanding differences in the amount of caffeine reported in different studies, this and previous surveys confirm that habitual patterns of caffeine consumption begin early in life." Id.
Although there are no FDA efforts underway to regulate caffeinated beverages as drugs and devices, the agency has proposed to codify a prior sanction on the use of caffeine as a food additive in soft drinks. FDA, Proposed Rule: Caffeine in Nonalcoholic Carbonated Beverages, 52 FR 18,923 (1987). This proposed rule has yet to be finalized.
- Regulation of Drugs and Devices under the FDCA
Section 321(g)(1)(C) of 21 U.S.C. defines drugs as "articles (other than food) intended to affect the structure or any function of the body of man or other animals". Food, which is defined in section 321(f) to include both food and drink, is excluded from the definition of drug.
The statutory distinction between food and drugs is not clear, however, because there are many instances of food items intended to be used as drugs and and there are many instances of drugs that are derived from foods. "That a product is naturally occurring or derived from a natural food does not preclude its regulation as a drug." Nutrilab Inc. v. Scheiker, 547 F. Supp. 880, 882 (N.D. Ill. 1982), aff'd, 713 F. 2d 335 (7th Cir. 1983). The regulatory classification depends on intent. "If a product is intended by the user and the manufacturer or distributor to be used as a drug, it will be regulated as such." 547 F. at 881-82. Thus, the FDCA's exclusion of food from the definition of a drug does not preclude caffeinated beverages from being considered drugs.
Section 321(h)(3) defines device as an "instrument, apparatus, implement, machine, contrivance, part or accessory which is... intended to affect the structure or any function of the body of man or other animals ...."
- FDA's Proposed Application of the FDCA to Nicotine
FDA currently proposes that nicotine is a drug under section 321(g)(1)(C) and a device under section 321(h)(3), and has set out the criteria used to make this determination. FDA, Proposed Rule: Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco Products, 60 FR 41,314 (1995); FDA, Nicotine in Cigarettes and Smokeless Tobacco Products Is a Drug, 60 FR 41,454 (1995). FDA has summarized these criteria as follows:
"I. Cigarettes and smokeless tobacco "affect the structure or any function of the body" because they have pharmacological effects and lead to addiction.
"II. Tobacco manufacturers "intend" that their products have addictive and significant pharmacological effects.
- A. Objective intent is the appropriate standard.
- The addictive, psychoactive, and other pharmacological effects of nicotine are widely known and foreseeable by any reasonable person in the position of a tobacco manufacturer.
- Consumers use tobacco products to obtain the pharmacological effects of nicotine and to satisfy their addiction to nicotine.
- Tobacco manufacturers know that nicotine has pharmacological effects and that consumers use tobacco for those effects and have acted to facilitate that use.
"III. Nicotine-containing cigarettes and smokeless tobacco products are drug delivery systems that are appropriately regulated as devices."
Based on this declaration of jurisdiction, FDA is now proposing to regulate the sale, distribution, and advertising of tobacco products.
The same criteria, applied to caffeine and caffeinated beverages, suggest that they too are drugs and devices. With respect to Part I (effect), there is evidence that caffeine, like nicotine, has pharmacological effects. Caffeine acts as a central nervous system stimulant and also affects the cardiovascular system as well as other organ systems. James at 19-33. It also affects human behavior and sleep patterns. James, Caffeine and Health at 247-79, 301-08. FDA itself has stated that "[t]he major pharmacological effect of caffeine is on the central nervous system, but it can also stimulate the heart and increase cardiac output." FDA, Proposed Rule: Soda Water, 45 FR 69,815, 69,819/3 (1980).
There is also some evidence that caffeine may lead to addiction. A 1994 study, which builds on a substantial body of earlier work, states:
"these results, together with other experimental evidence, suggest that caffeine exhibits the features of a typical psychoactive substance of dependence." E.C. Strain et al., "Caffeine Dependence Syndrome", J. Am. Medical Ass'n 1043 (Oct. 5, 1994).
According to this study, a majority of those addicted to caffeine showed symptoms of "withdrawal (94%), use continued despite knowledge of a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by caffeine use (94%), persistent desire or unsuccessful efforts to cut down or control use (81%), and tolerance (75%)." Id. at 1043.
These are the same criteria that form the basis of FDA's proposal to regulate nicotine as an addictive drug. 60 FR 41,485-87.
With respect to Part II, Subpart A (objective intent), FDA's conclusion that tobacco manufacturers objectively intend that their products have addictive and pharmacological effects similarly applies to caffeinated-beverage manufacturers. As with nicotine, the effects of caffeine are widely known and are foreseeable to the producers of caffeine-containing beverages. This is evidenced by the above-mentioned medical literature, as well as by industry-sponsored research. See Caffeine: Perspectives From Recent Research 77-103 (P.B. Dews ed., 1984); J. Masterson, "Trends in Coffee Consumption", Tea and Coffee Trade J. (March 1983). Thus, Part II, subpart B1 (manufacturer knowledge and foreseeability) is met.
There is also evidence that consumers use caffeinated products to obtain its pharmacological effects and to satisfy their cravings. Again, this is found in the medical and industry literature discussed above. Most notably, the fact that a majority of caffeine users show a "persistent desire or unsuccessful efforts to cut down or control use" is evidence that caffeine-containing beverages are being consumed, at least in part, for their drug effects. Strain at 1043.
FDA Commissioner David Kessler has stated, in regard to smoking, that "many young people progress steadily from experimentation to regular use, with addiction taking hold within a few years." FDA, Nicotine in Cigarettes and Smokeless Tobacco Products Is a Drug, Appendices at A-291. Similar arguments have been made regarding caffeinated beverages, where doses known to be pharmacologically active are taken on a daily basis throughout the lives of many users. James at 52. The availability and relative unpopularity of similar-tasting no- or low-caffeine alternatives further attests to the fact that these beverages are taken for their pharmacological effects and to satisfy addictions. Thus, subpart B2 is met.
There is also evidence that the caffeinated beverages industry knows that caffeine has pharmacological effects, that it may be addictive, and that consumers use caffeine for these effects, and that the industry has facilitated this use. The above-cited medical and industry-sponsored research is evidence of this knowledge. Advertising of these products often indicates an attempt on the part of producers to use caffeine's psychoactive properties as a sales pitch. The name of one caffeinated soft drink, Jolt Cola, alludes to its stimulant effect, as does its slogan -- "all the sugar and twice the caffeine". Similarly, Final Exam Tea, a high caffeine iced tea, has a name which alludes to the benefits of its stimulant effects, particularly for students. Mountain Dew, which has one of the highest caffeine contents of any caffeinated soft drink, uses the slogan "You'll get a kick out of Dew," in its television advertisements. Several coffee brands, such as Folgers, emphasize caffeine's stimulant effects for those who are groggy in the morning. Their well known phrase is "the best part of waking up is Folgers in your cup." Thus, industry's own research and marketing efforts suggest the requisite knowledge.
In addition, there is evidence that, like nicotine, caffeine levels are "manipulated". The existence of low- or no-caffeine alternatives is evidence that manufacturers can and do adjust caffeine levels. This can also occur in the choice of coffee bean, as the robusta bean contains roughly twice the caffeine as the arabica bean. James at 56. One company is attempting the alter the amount of caffeine in coffee beans through genetic engineering techniques. H. Shand, "Gene-Altered Java", Utne Reader, Nov.-Dec. 1994, at 71-72. Thus, there is evidence of industry knowledge of consumer use (Subpart B3).
With respect to drug delivery systems (Part III), once caffeine is determined to be a drug, it follows that the various mechanisms for delivering caffeine to the human body are devices under section 321(h)(3). FDA analogizes cigarettes and other tobacco products to pre-filled syringes, transdermal patches, and metered dose inhalers, which are all regulated as devices. 60 FR 41,521. According to FDA, tobacco products are devices because they are used to deliver the drug nicotine into the body, after which the nicotine-depleted cigarette butt or smokeless tobacco material is discarded. 60 Fed. Reg. 41,521-22. Similarly, caffeinated beverages provide a means to deliver caffeine to the body, after which the coffee grounds, tea bags, or empty caffeinated beverage containers are discarded. By FDA's logic, these "caffeine delivery systems" are devices.
Because caffeinated beverages are both drugs and devices, they can be regulated as either or both. 56 FR 58,754, 58,754-55 (1991).
Although not part of the definition of a drug or device under sections 321(g)(1)(C) and 321(h)(3), FDA's primary reason for its proposed regulations is the use of tobacco products by children and young adults. FDA has expressed concerns that nicotine use among children is widespread, and that most adults addicted to nicotine began their use as minors. In fact, FDA states that there is a concerted effort by the tobacco industry to target minors in its advertising campaigns in order to generate future customers of addicted adults who began their habits as children, when they did not know better. 60 FR 41,314-15.
The same may be said of caffeine. There is evidence that caffeine use is widespread among minors, the primary source being caffeinated soft drinks. M.L. Arbeit et al., "Caffeine Intakes of Children From a Biracial Population: The Bogalusa Heart Study", 88 J. Am. Dietetic Ass'n. 466 (1988). Evidence also suggests that "life-long patterns of caffeine consumption are probably often established in childhood...." James at 265.
In addition, much of the advertising of caffeinated soft drinks seems to target young people, and some of the coffee and tea advertisements appeal to young adults. For example, the advertising agency designing the campaign for one brand of caffeinated soft drinks has chosen to specifically target young adults because, in terms of brand loyalty, "[i]f you capture them at that age, you capture them forever." A. Faiolo, "Pop Culture: RC Goes For the Youth Market", Wash. Post (Sep. 14, 1995) D-10, D-12. Thus, FDA's argument that addictions to nicotine are deliberately created at an early age may also apply to caffeine.
Once caffeinated beverages are defined as drugs and/or devices, FDA is required to initiate rulemaking proceedings to regulate them. FDA has proposed to assert jurisdiction over nicotine-containing products based on the determination that they are drugs and devices. CEI submits that the logic of this proposal requires that FDA similarly determine that caffeinated beverages are drugs and devices, and that the agency should promulgate similar regulatory restrictions on caffeine-containing beverages. CEI reiterates its view that such regulations would be socially harmful, injuring the ability of consumers to obtain products which they enjoy and which they should be free to purchase. Nonetheless, such regulations follow directly from FDA's tobacco proposal.
C. ENVIRONMENTAL IMPACT
Petitioners claim a categorical exclusion under 21 CFR §§ 25.24(c) and (e).
The undersigned certifies, that, to his best knowledge and belief, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition.
Sam Kazman General Counsel Competitive Enterprise Institute (202) 331-1010 October 25, 1995