STARTING FROM SCRATCH?: REINVENTING THE FOOD
`ADDITIVE APPROVAL PROCESS
`
`LARS NOAH* & RICHARD A. MERRILL*
`
`INTRODUCTION ........................................................................ 330
`I. H ISTORY ....................................................................... 331
`A. The Food, Drug, and Cosmetic Act of 1938 ........................ 332
`B. The Food Additives Amendment of 1958 ........................... 336
`II. DEFINITION OF FOOD ADDITIVE ........................................... 341
`A. Components of Food ................................................... 341
`1. Indirect Additives .................................................. 343
`2. Dietary Supplements .............................................. 346
`B. Generally Recognized as Safe ........................................ 349
`1. The GRAS Concept ............................................... 349
`2. The FDA's GRAS Lists .......................................... 355
`3. Private GRAS Determinations ................................... 359
`C. Prior Sanctions Exceptions ........................................... 364
`III. APPROVAL PROCEDURES .................................................... 367
`A. Food Additive Petitions ................................................ 369
`B. GRAS Affirmation Petitions ........................................... 377
`Interim Food Additives ................................................ 382
`C.
`IV. APPROVAL CRITERIA ........................................................ 386
`A. The General Safety Standard ......................................... 386
`B. Carcinogenicity and the Delaney Clause ........................... 395
`V. CASE STUDIES ................................................................ 401
`A. Artificial Sweeteners: Aspartame .................................... 401
`B. Biotechnology: Calgene's Tomato ................................... 405
`C. Novel Macroingredients: Olestra .................................... 413
`VI. THE COMPOSITE PICTURE .................................................. 421
`A. Track Records Compared ............................................. 422
`B. A Catalogue of Proposed Solutions ................................. 429
`1. Internal Management Initiatives ................................. 430
`2. Statutory Hammers ................................................ 432
`
`Associate Professor of Law, University of Florida.
`.. Daniel Caplin Professor of Law, University of Virginia; Chief Counsel to the U.S.
`Food and Drug Administration from 1975 to 1977.
`The authors would like to thank the following individuals for their comments on the
`manuscript: Marsha N. Cohen, Catherine L. Copp, Margaret Gilhooley, Richard L. Hall,
`Lisa M.W. Hillman, Peter Barton Hutt, George H. Pauli, and other participants at the
`Food Forum workshop (held at the National Academy of Sciences on May 6-7, 1997)
`where an earlier version of this paper was presented.
`329
`
`Human Power of N Company
`EX1051
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`3. Prioritizing Reviews ...............................................
`433
`4. Imposing User Fees ...............................................
`437
`5. Third Party Review of Petitions .................................
`439
`C ONCLUSION .......................................................................... 443
`
`INTRODUCTION
`The safety of novel foods and food ingredients has been of intense public
`concern and periodic political interest at least since World War II, which in-
`spired heroic efforts to expand, extend, and improve the products of nature.
`One need only recall controversies over diethylstilbestrol (DES) in beef cat-
`tle, the artificial sweeteners cyclamate and saccharin, nitrite-treated bacon,
`Alar on apples, and bovine growth hormone (rBST) to be impressed by the
`popular and journalistic salience of putative hazards created by modern food
`production methods. In more recent years, truly innovative technologies-
`such as Procter & Gamble's fat-substitute olestra and Calgene's bioengi-
`neered tomato-have attracted significant attention, and their regulation by
`the U.S. Food and Drug Administration (FDA) has become the focus of a
`complex debate. Some have criticized the FDA for its lengthy delays in re-
`viewing these and other innovative substances added to food.' Others have
`argued that the Agency does not adequately ensure the safety of such sub-
`stances. These latest controversies pose significant questions about how best
`to regulate substances added to food.
`This Article explores the FDA's regulation of substances purposely added
`to food as it has evolved over the last several decades, and it concludes with
`a discussion of several possible avenues for reform. Debates about proposals
`to modify existing approaches must start with a proper appreciation of the
`difficulties encountered in the past. Moreover, the history of the food ingre-
`dient approval process illuminates recurring challenges faced in the design of
`regulatory programs. Past studies of other federal agencies have revealed
`valuable lessons about regulatory performance that transcend the particular
`program under study. 2
`
`I See, e.g., Delays in the FDA's Food Additive Petition Process and GRAS Affirmation
`Process: Hearings Before the Subcomm. on Human Resources and Intergovernmental Re-
`lations of the House Comm. on Gov't Reform and Oversight, 104th Cong. (1995)
`[hereinafter 1995 Hearings] (examining the reasons for, and consequences of, delays in the
`FDA's review of food additive petitions and the GRAS affirmation process); Peter Barton
`Hutt, Approval of Food.Additives in the United States: A Bankrupt System, FOOD TECH.,
`Mar. 1996, at 118, 122 (arguing that the FDA's regulation of food additives has failed be-
`cause of the Agency's sluggish review process).
`2 See, e.g., THOMAS 0. MCGARITY & SIDNEY A. SHAPIRO, WORKERS AT RISK: THE
`FAILED PROMISE OF THE OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (1993)
`(suggesting improvements in the Occupational Safety and Health Administration's regula-
`tory process); JERRY L. MASHAW & DAVID L. HARFST, THE STRUGGLE FOR AUTO SAFETY
`(1990) (evaluating the National Highway Traffic Safety Administration's regulatory efforts
`to promote automobile safety); GLEN 0. ROBINSON, THE FOREST SERVICE: A STUDY IN
`
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`FOOD ADDITIVE APPROVAL PROCESS
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`Part I describes the FDA's system for regulating food-use substances as it
`existed before the enactment of specific food additive legislation in 1958.
`The next three Parts explore, in turn, the definitional, procedural, and sub-
`stantive provisions of this legislation as implemented over the last several
`decades. Part V offers three recent case studies that expose some of the spe-
`cial difficulties encountered in the regulation of food-use substances. Finally,
`Part VI identifies several problems experienced by the FDA in recent years
`and analyzes an accompanying range of possible reforms. The time is ripe
`for reinventing this country's food ingredient approval process.
`
`HISTORY
`I.
`The federal government asserted authority over the quality and safety of
`food products early this century. In 1906, reacting to widely publicized ex-
`amples of filth and deception, Congress prohibited the introduction of adul-
`terated or misbranded food and drugs into interstate commerce. 3 The 1906
`Act provided that any food containing an "added poisonous or other added
`deleterious ingredient which may render such article injurious to health"
`would be deemed adulterated. 4 If federal officials suspected a safety prob-
`lem, they could initiate enforcement action to remove the product from the
`market, but the government would shoulder the burden of proving that the
`food ingredient, as consumed, posed "a reasonable possibility of injury." 5
`Congress replaced the original statute in 1938 with the Federal Food, Drug,
`and Cosmetic (FD&C) Act, 6 but the newer legislation retained the same ba-
`sic system of after-the-fact policing for adulterants in food. It was not until
`
`PUBLIC LAND MANAGEMENT (1975) (analyzing the U.S. Forest Service's organizational
`and administrative process in the context of general public land management); JAMES Q.
`WILSON, THE POLITICS OF REGULATION (1980) (collecting essays describing how various
`regulatory agencies ordinarily operate).
`3 See Pure Food and Drugs Act, Pub. L. No. 59-384, ch. 3915, § 2, 34 Stat. 768
`(1906) (superseded by the FD&C Act in 1938).
`4 Id. § 7.
`5 United States v. Lexington Mill & Elevator Co., 232 U.S. 399, 411 (1914) ("If it
`cannot by any possibility, when the facts are reasonably considered, injure the health of
`any consumer, such [product], though having a small addition of poisonous or deleterious
`ingredients, may not be condemned under the act."); see also United States v. Coca Cola
`Co., 241 U.S. 265, 279-85 (1916) (holding that caffeine added to beverage syrup was an
`"added"
`ingredient and that the government's evidence that caffeine was poisonous or
`deleterious should have been submitted to the jury).
`6 Pub. L. No. 75-717, ch. 675, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C.
`§§ 321-393 (1994)). The statute refers throughout to the Secretary of Health and Human
`Services (previously the Secretary of Health, Education and Welfare (HEW) and before
`that the Secretary of Agriculture (USDA)), see 21 U.S.C. § 321(d), but the Secretary has
`delegated most powers under the FD&C Act to the Commissioner of Food and Drugs, see
`id. § 393(b); 21 C.F.R. §§ 5.10(a)(1), 5.11(a) (1997).
`
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`the Food Additives Amendment of 19587 that Congress established a pre-
`market approval system for food ingredients. The detailed requirements of
`these two enactments are discussed more fully below.
`In the two decades that elapsed between the passage of the FD&C Act and
`the Food Additives Amendment, a number of developments rendered the
`original statutory design outdated. Indeed, the 1938 legislation, based as it
`was on the 1906 Act, focused on the control of "adulterants" and did not
`fully anticipate the rapid progress in food processing technology and the
`growing utilization of intentional additives that would follow. 8 Technologi-
`cal advances spurred by World War II allowed processors to offer more nu-
`tritious, palatable, and convenient foods, and consumers increasingly de-
`manded such improved products. Meanwhile, progress in the biomedical
`sciences increased the understanding of human nutritional needs and the
`causes of chronic diseases. These advances have not slowed, and, almost
`four decades later, Congress is being urged to consider once again updat-
`ing-or overhauling-the statutory system governing food additives. 9
`
`A. The Food, Drug, and Cosmetic Act of 1938
`Under the original FD&C Act, the FDA possessed broad responsibility
`but comparatively weak regulatory authority over substances added to food.
`Section 402(a) provided that a food shall be deemed to be adulterated under
`the following circumstances:
`(1) If it bears or contains any poisonous or deleterious substance which
`may render it injurious to health; but in case the substance is not an
`added substance such food shall not be considered adulterated under this
`clause if the quantity of such substance in such food does not ordinarily
`render it injurious to health; or
`(2)
`if it bears or contains any added poisonous or added deleterious
`substance which is unsafe within the meaning of section 406 ....
`l0
`
`7 Pub. L. No. 85-929, 72 Stat. 1784 (1958) (codified as amended in scattered sections
`of 21 U.S.C.).
`8 See 104 CONG. REC. 17,417 (1958) (statement of Hon. John B. Williams) ("The 1938
`law gave no recognition to substances deliberately added to food for beneficial purposes,
`such as retarding natural spoilage or keeping food moist or tasty. There is a gap in our
`pure food law as a result of advancing technology.").
`9 See, e.g., GENERAL ACCOUNTING OFFICE, FOOD SAFETY AND QUALITY: INNOVATIVE
`STRATEGIES MAY BE NEEDED TO REGULATE NEW FOOD TECHNOLOGIES, No. RCED-93-142
`(1993), at 1-2, 5 [hereinafter GAO, NEW FOOD TECHNOLOGIES] (discussing new food
`technologies, various possible responses to these new technologies, and unresolved regu-
`latory issues).
`10 FD&C Act § 402(a) (codified as amended at 21 U.S.C. § 342(a)). Section 406 of the
`Act provided:
`Any poisonous or deleterious substance added to any food, except where such sub-
`stance is required in the production thereof or cannot be avoided by good manufac-
`
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`The authority to promulgate food standards of identity under Section
`401 provided the FDA with another regulatory mechanism, though
`cumbersome, for restricting the use of added substances; it permitted
`the Agency to specify what ingredients could be used in standardized
`food. I
`To enforce Section 402(a) of the FD&C Act, the FDA (through the
`Department of Justice) could initiate judicial proceedings to seize adulterated
`food or enjoin its continued marketing. 12 Unless the product exceeded one
`of the very few tolerances ever established under Section 406, however, the
`Agency had to shoulder the burden of proving that the substance (1) was poi-
`
`turing practice[,] shall be deemed to be unsafe for purposes of the application of [the
`above-quoted clause]; but when such substance is so required or cannot be so
`avoided, the Secretary shall promulgate regulations limiting the quantity therein or
`thereon to such extent as he finds necessary for the protection of public health ....
`Id. § 406(a) (codified as amended at 21 U.S.C. § 346); see also H.R. REP. No. 75-2139,
`at 6 (1938) (explaining that the tolerance setting provision would provide greater flexibility
`in dealing with pesticide residues); Richard A. Merrill, Regulating Carcinogens in Food:
`A Legislator's Guide to the Food Safety Provisions of the Federal Food, Drug, and Cos-
`metic Act, 77 MICH. L. REv. 171, 175 (1978) ("In substance, Congress authorized the
`FDA to license the use of some potentially toxic substances in food, apparently in recogni-
`tion of their utility or of the importance of foods from which they cannot practicably be
`eliminated.").
`11 FD&C Act § 401 (codified as amended at 21 U.S.C. § 341); see also Federal Sec.
`Admin. v. Quaker Oats Co., 318 U.S. 218, 227-31 (1943) (upholding "standards of iden-
`tity" which were adopted in order to avoid consumer confusion); Atlas Powder Co. v.
`Ewing, 201 F.2d 347, 350-55 (3d Cir. 1952) (upholding FDA decision, after almost one
`decade of hearings, not to permit the use of certain emulsifiers in bread because of unre-
`solved safety concerns and the risk of consumer deception); Richard A. Merrill & Earl M.
`Collier, Jr., "Like Mother Used to Make ": An Analysis of FDA Food Standards of Identity,
`74 COLUM. L. REV. 561, 600 (1974) (establishing a framework for analyzing the costs and
`benefits of food standards). The FDA did have limited premarket approval powers under
`the 1938 Act through the listing and batch certification provisions applicable to coal-tar
`colors used in food. See FD&C Act § 406(b), 52 Stat. 1040, 1049 (1938), repealed and
`replaced by Color Additive Amendments of 1960, Pub. L. No. 86-618, tit. I, 74 Stat. 397
`(codified as amended at 21 U.S.C. § 379e).
`12 See 21 U.S.C. § 331(a)-(c) (designating the adulteration of food, or its delivery or
`receipt, in interstate commerce as prohibited acts); id. § 332(a) (authorizing injunctions to
`restrain violations of the Act); id. § 334(a) (authorizing seizure of products in violation of
`the Act); see also id. § 333(a) (authorizing the imposition of criminal penalties for viola-
`tions of the Act); United States v. Park, 421 U.S. 658, 671-74 (1975) (affirming the impo-
`sition of strict criminal liability under the FD&C Act in a case involving food adultera-
`tion); Brenda A. Bachman & Lori Ludemann, Note, Federal Food and Drug Act
`Violations, 33 AM. CRIM. L. REV. 757 (1996) (examining the criminal provisions of the
`FD&C Act). In practice, the FDA typically sends a warning letter first, threatening to pur-
`sue formal enforcement action only if the company fails to bring itself into prompt compli-
`ance. See Warning Letters; Procedure Manual, Chapter 8-10; Availability, 56 Fed. Reg.
`27,026 (1991).
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`sonous or deleterious and (2) could, in the amounts present, render the food
`injurious to health.' 3 As the Supreme Court held in construing the essen-
`tially identical language in the 1906 version of the statute, 14 the government
`must show that the food containing a poisonous or deleterious substance cre-
`ates a reasonable possibility of harm to consumers.15 Because of the time
`and effort required to undertake animal feeding studies of a substance, the
`FDA frequently could not satisfy this burden even if it had some legitimate
`basis for concern about safety. 16
`
`13 See, e.g., United States v. 29 Cartons of *** An Article of Food, 987 F.2d 33, 35
`(1st Cir. 1993) ("[T]he FDA can prevent sale of bottled BCO or any other 'food' only if it
`proves by a preponderance of the evidence that the food is 'injurious to health."'); United
`States v. Boston Farm Ctr., Inc., 590 F.2d 149, 153 (5th Cir. 1979) ("[I]n this case the
`expert evidence is uncontradicted that 20 ppb of aflatoxin may render corn harmful.");
`United States v. 2,116 Boxes of Boned Beef * * *, 516 F. Supp. 321, 328-30 (D. Kan.
`1981) (holding that, under the identically-phrased adulteration provision in the Federal
`Meat Inspection Act, the government must prove a reasonable possibility of harmfulness),
`aff'd, 726 F.2d 1481, 1485 (10th Cir. 1984); United States v. Anderson Seafoods, Inc.,
`447 F. Supp. 1151, 1155-56 (N.D. Fla. 1978) (holding that the injuriousness requirement
`does not mean harmfulness under any conceivable conditions of use), aff'd, 622 F.2d 157,
`159 (5th Cir. 1980) ("The 'may render' standard has been interpreted to mean that there is
`a reasonable possibility of injury to the consumer."); see also United States v. Coca Cola
`Co., 241 U.S. 265, 284-85 (1916) (construing similar language in predecessor statute).
`14 Pure Food and Drugs Act, Pub. L. No. 59-384, ch. 3915, § 7, 34 Stat. 768 (1906)
`(superseded by the FD&C Act in 1938).
`15 See United States v. Lexington Mill & Elevator Co., 232 U.S. 399, 411 (1914) ("If it
`cannot by any possibility, when the facts are reasonably considered, injure the health of
`any consumer, such [bleached] flour, though having a small addition of poisonous or
`deleterious ingredients, may not be condemned under the [1906] act."); see also Flemming
`v. Florida Citrus Exch., 358 U.S. 153, 161 (1958) (applying the holding of Lexington Mill
`to the adulteration provisions of the FD&C Act). The FDA shouldered an even greater
`burden of proof in the case of non-added substances (i.e., "ordinarily render it injurious to
`health"). See Merrill, supra note 10, at 189 ("The sparse case law suggests that the agency
`would have to demonstrate a probability of harm to some significant number of consum-
`ers."). Thus, the FDA often has stretched the concept of "added" so that it could act
`against harmful substances even though they were not intentionally added to food. See,
`e.g., Continental Seafoods, Inc. v. Schweiker, 674 F.2d 38, 42-43 (D.C. Cir. 1982)
`(salmonella in shrimp); United States v. Anderson Seafoods, Inc., 622 F.2d 157, 160-61
`(5th Cir. 1980) (mercury contamination in fish); Richard A. Merrill & Michael Schewel,
`FDA Regulation of Environmental Contaminants of Food, 66 VA. L. REV. 1357, 1372-75
`(1980) (discussing the judicial acceptance of the FDA's expansive interpretation of the
`term "added"); James D. Poliquin, Comment, The Incremental Development of an Extra-
`Statutory System of Regulation: A Critique of Food and Drug Administration Regulation of
`Added Poisonous and Deleterious Substances, 33 ME. L. REV. 103, 108-15 (1981)
`(describing some of the purposes behind the FDA's expansive interpretation of the term
`"added").
`16 See H.R. REP. No. 85-2284, at 1 (1958) ("[T]o prove an untested substance poison-
`ous or deleterious may require approximately 2 years or more of laboratory experiments
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`At the same time, another provision of the 1938 Act appeared to make the
`FDA's task too easy. Under Section 402(a)(2), absent a tolerance established
`under Section 406, any added poisonous or deleterious substance would ren-
`der a food adulterated, 17 even if the amount present was not "injurious" and
`it served a useful purpose. 18 In theory, Section 402(a)(2) reduced the FDA's
`burden of proof in taking enforcement action against a food product by
`eliminating any need for it to demonstrate that an added poisonous or delete-
`rious substance might render the food injurious to health. 19 The Agency still
`would have to show that an added substance was poisonous or deleterious at
`some level of exposure. But if such a showing could be made, as for most
`ingredients it could, the FDA would have difficulty allowing use at lower
`levels that would be safe.
`Thus, the original statute created a safety standard for substances added to
`food that was both unnecessarily rigid and difficult to administer. Because it
`shouldered the burden of proof, the FDA experienced problems in regulating
`the introduction and marketing of foods containing substances whose safety
`
`with small animals and during this period the Government cannot prevent the use of such a
`substance in food."); Federal Food, Drug, and Cosmetic Act (Chemical Additives in
`Food): Hearings Before a Subcomm. of the House Comm. on Interstate and Foreign Com-
`merce, 84th Cong. 71 (1956) [hereinafter 1956 Hearings] (statement of Glenn G. Paxton,
`appearing as counsel for various food industry associations) ("Today FDA must do its own
`testing and experimentation on an additive-admittedly a difficult task-and must sustain
`the burden of proof that it is poisonous or deleterious-admittedly a difficult burden-
`before it can obtain a court order to restrain its use."); Merrill, supra note 10, at 194 ("To
`enforce section 402(a)(1), the FDA ordinarily must locate contaminated food, conduct
`chemical analyses, find witnesses prepared to testify that the amount of the contaminant is
`potentially harmful to some portion of consumers, and prove these facts in court.").
`17 See 21 U.S.C. §§ 342(a)(2), 346 (1994); Young v. Community Nutrition Inst., 476
`U.S. 974, 977, 981-84 (1986) (noting that any added poisonous or deleterious substance
`for which no tolerance existed would be unsafe, but holding that the statute did not compel
`the Agency to regard such a substance as adulterated); United States v. Ewig Bros. Co.,
`502 F.2d 715, 720 (7th Cir. 1974) (describing the "per se" adulteration approach estab-
`lished by Section 406 for any poisonous or deleterious substance for which no tolerance
`had been promulgated). The phrase "poisonous or deleterious" is not separately defined in
`the statute, and the FDA has declined to include a definition in its implementing regula-
`tions. See Poisonous or Deleterious Substances, 42 Fed. Reg. 52,814, 52,816 (1977).
`18 See H.R. REP. No. 85-2284, at 1-2 ("[P]resent law entirely prohibits the use of these
`additives even if their use at safe levels would advance our food technology and increase
`and improve our food supplies."); 1956 Hearings, supra note 16, at 194 (statement of
`George P. Larrick, Comm'r, FDA) ("Once it was shown that the proposed additive was a
`poison, it was excluded unless it was necessary in production or unavoidable in good
`manufacturing practice. Over the years, only the pesticide chemicals have met this test of
`necessity. ").
`19 See Merrill, supra note 10, at 195-98 & nn.89 & 92 (discussing the regulatory
`framework provided by Sections 402(a)(2) and 406); Poliquin, supra note 15, at 111-15
`(applying Sections 402(a)(2) and 406 to five fact patterns).
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`had not been established. Moreover, because the statute did not require ad-
`vance notification of the introduction of a new additive, the Agency might
`not even learn of its use unless safety problems subsequently came to light. 20
`Although the FDA lacked the authority under the 1938 Act to insist that
`new additives be tested, chemical manufacturers and food processors had in-
`centives to undertake at least limited safety assessments of new ingredients.
`First, they might have feared eventual enforcement sanctions under the
`FDA's food adulteration provisions. Second, and more importantly, they
`could not risk the adverse publicity that would accompany the subsequent
`discovery of a hazard in their products. Finally, though perhaps less of a
`concern at the time, they might have faced significant tort liability if con-
`sumers suffered injuries. 21 In fact, most companies did test new additives to
`some extent, but nothing in the law prevented an unscrupulous firm from
`using an untested substance in food. 22
`
`B. The Food Additives Amendment of 1958
`In 1950, Congress turned its attention to the growing use of chemicals in
`food production. 23 After two years of hearings on the subject,24 a House se-
`
`20 See 1956 Hearings, supra note 16, at 112 (statement of J.M. Gillet, Mfg. Chemists'
`Ass'n) ("Under the present law there is no requirement that the [FDA] be advised in ad-
`vance of the use of any new chemical, and it has been up to them to find out that such
`chemical is being used," though most manufacturers voluntarily provide notification.).
`21 See, e.g., Robert C. Brown, The Liability of Retail Dealers for Defective Food Prod-
`ucts, 23 MINN. L. REv. 585, 596-610 (1939); R.D. Hursh, Annotation, Liability of
`Manufacturer or Seller for Injury Caused by Food or Food Product Sold, 77 A.L.R.2d 7
`(1961). For a more recent survey of decisions in this area, see Jane M. Draper, Annota-
`tion, Liability for Injury or Death Allegedly Caused by Spoilage, Contamination, or Other
`Deleterious Condition of Food or Food Product, 2 A.L.R.5th 1, 41-82 (1992).
`22 See Food Additives: Hearings Before a Subcomm. of the House Comm. on Interstate
`and Foreign Commerce, 85th Cong. 421-22 (1957) [hereinafter 1957 Hearings (even
`though the final session of the hearings took place in 1958)] (statement of Elliot L. Rich-
`ardson, Asst. Secretary, Health, Education & Welfare (HEW)) ("The commendable ac-
`tions of the great majority [of companies], however, cannot provide protection against the
`minority. We have had some narrow escapes in the food field.").
`23 See 96 CONG. REC. 8933 (1950). Congress called for an investigation into
`the nature, extent, and effect of the use of chemicals, compounds, and synthetics in
`the production, processing, preparation, and packaging of food products to deter-
`mine the effect of such chemicals, compounds, and synthetics (A) upon the health
`and welfare of the Nation and (B) upon the stability and well-being of our agricul-
`tural economy.
`
`Id.
`24 See Chemicals in Foods and Cosmetics: Hearings Before the House Select Comm. to
`Investigate the Use of Chemicals in Foods and Cosmetics, 82d Cong. (1952); Chemicals in
`Food Products: Hearings Before the House Select Comm. to Investigate the Use of Chemi-
`cals in Food Products, 82d Cong. (1951); Chemicals in Food Products: Hearings Before
`the House Select Comm. to Investigate the Use of Chemicals in Food Products, 81st Cong.
`
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`lect committee chaired by Representative James Delaney issued a report of
`its investigation. At the outset, the Committee remarked on the rapidly
`growing use of chemicals in the food supply: "There is hardly a food sold in
`the market place today which has not had some chemicals used on or in it at
`some stage in its production, processing, packaging, transportation, or stor-
`age."25 The Committee recognized the substantial value of this growing use
`of additives, but it also expressed concerns about the accompanying potential
`health hazards. 26 According to the report, the FDA estimated that approxi-
`mately 700 chemicals were used in food at the time but that only 428 were
`known to be safe. 27 The Committee expressed particular concern over the
`lack of information about the possible chronic risks of existing food-use
`chemicals, and it urged Congress to amend the FD&C Act so that food addi-
`tives would be required to undergo the same premarket review for safety re-
`quired for drugs at that time. 28
`In the six years following the investigations by the Delaney Committee,
`Congress considered numerous bills and held further hearings on the sub-
`ject. 29 Unlike other legislative reforms of the FDA's enabling statutes,
`which were prompted by apparent public health crises, the effort to equip the
`
`(1950).
`2 H.R. REP. No. 82-2356, at 4 (1952); see also National Academy of Sciences, The
`Use of Chemical Additives in Food Processing, NAS PUB. No. 398 (1956); Report of the
`Joint FAO/WHO Expert Committee on Food Additives, General Principles Governing the
`Use of Food Additives (1956).
`26 See H.R. REP. No. 82-2356, at 3-4; see also 1957 Hearings, supra note 22, at 421
`(statement of Elliot L. Richardson, Asst. Secretary, HEW) ("The potential danger of food
`additives, indeed, is more insidious [than untested drugs] because it is a danger from the
`daily intake of small amounts of chemical substances . . .
`."); cf. id. at 167 (statement of
`Hon. Leonor K. Sullivan) ("Seldom do the chemicals add anything of nutritional value.
`Mostly, they are intended to cut costs, or to cut comers, or to cut spoilage or waste. They
`are put into the foods mostly for the manufacturer's benefit ...
`rather than the con-
`sumer's.").
`27 See H.R. REP. No. 82-2356, at 4. Subsequent estimates ran much higher. See, e.g.,
`Food Additives: Competitive, Regulatory, and Safety Problems: Hearings Before the Sen-
`ate Select Comm. on Small Bus., 95th Cong. 52 (1977) (statement of Sherwin Gardner,
`Acting Comm'r, FDA) ("There are over 400 nonflavor GRAS substances; approximately
`1,650 flavors and spices, some of which are GRAS and some regulated additives; about
`400 regulated direct food additives and on the order of 10,000 GRAS and regulated indi-
`rect additives.").
`28 See H.R. REP. No. 82-2356, at 27. Some scientists viewed the Committee's conclu-
`sions as largely unsupported and inappropriately alarmist. See, e.g., Maurice H. Seevers,
`Perspective Versus Caprice in Evaluating Toxicity of Chemicals in Man, 153 JAMA 1329,
`1331-32 (1953) ("[Representative Delaney's] lurid article, a masterpiece of innuendo and
`fantasy, based principally on conjecture, was designed for the one purpose of frightening
`the [consumer] into demanding further legislation.").
`29 See, e.g., 1957 Hearings, supra note 22, at 43-49 (reproducing a chart prepared by
`subcommittee staff comparing the various food additive bills introduced in 1957).
`
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`BOSTON UNIVERSITYLAW REVIEW
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`[Vol. 78:329
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`Agency to cope with the emerging concerns about new food additives dis-
`played little urgency. Congress proceeded incrementally to design a regula-
`tory mechanism. 30 Its first step was to amend the FD&C Act in 1954 to cre-
`ate a premarket approval system for pesticide residues in food. The Miller
`Pesticide Amendments required the establishment of a tolerance for any pes-
`ticide chemical intended for use on a raw agricultural commodity. 31
`Food processors and ingredient suppliers accepted the need for some
`method of premarket FDA review of novel ingredients in processed food,32
`but initially they preferred a system of advance notification of an intent to
`market a new additive rather than a system that required the issuance of a li-
`cense by the Agency. 33 Administration officials objected that such a notifi-
`cation system "would give no effect, except a delaying effect, to an adverse
`safety evaluation of the Secretary." 34 Such a delay would give the FDA time
`to institute judicial proceedings to prevent marketing, where it only would
`have to establish that existing studies failed to demonstrate safety. However,
`the Agency would have to prove more than a reasonable possibility of harm
`in the abstract, under any condition of use; it would shoulder the more diffi-
`
`30 See S. REP. No. 85-2422, at 3-4 (1958) (describing extensive hearings leading up to
`the consideration of the final bill); 1957 Hearings, supra note 22, at 50 (statement of Hon.
`John B. Williams, Subcomm. Chairman) ("[fit seems to me that a 10-year period is a suf-
`ficiently long incubation period even for difficult legislation."); Vincent A. Kleinfeld,
`"Chemicals in Foods "-A Legal Viewpoint, 9 FOOD DRUG CosM. L.J. 115 (1954)
`(discussing the initial efforts at drafting legislation to regulate food additives).
`31 See