PETER BARTON HUTT
I. INTRODUCTION
This chapter provides a historical overview of seven important policies that the Food and Drug Administration (FDA) has addressed over the past fifty years. Each of these policies has had antecedents initially under the Federal Food and Drugs Act of 1906 (34 Stat. 768) and then under the Federal Food, Drug, and Cosmetic Act (FDCA) of 1938 (52 Stat. 1040) that replaced the 1906 act. Each of them has evolved over time and will continue to evolve in the future. FDA has always been a dynamic organization and must continually change to reflect new insights into both risk assessment regarding the products it regulates and risk management to provide a reasonable balance between fostering innovation and protecting the public health.
The origin of FDA extends back to 1839, when Congress first appropriated funds to the Patent Office for “the collection of agricultural statistics, and for other agricultural purposes.” An Agricultural Division was subsequently created in the Patent Office and a Chemical Laboratory was established within the Agriculture Division.1 When the United States Department of Agriculture (USDA) was created by Congress in 1862, the Agriculture Division of the Patent Office formed the nucleus of the new department, and its Chemical Laboratory became the organizational antecedent of what is now FDA. It was officially named the Chemical Division in 1862, the Division of Chemistry in 1890, the Bureau of Chemistry in 1901, the Food, Drug, and Insecticide Administration in 1927, and the Food and Drug Administration in 1930. It resided in the USDA until it was transferred to the Federal Security Administration in 1940, the Department of Health, Education, and Welfare in 1953, and finally the Department of Health and Human Services in 1979, where it resides today. Throughout this chapter, “FDA” will be used to refer to all of these antecedent organizations.
Today FDA regulates food, drugs, cosmetics, medical devices, and tobacco. Together, these consumer products comprise twenty-five cents out of every dollar spent by consumers in the United States. The scope and power of FDA is therefore enormously important for both economic and health reasons. There is a growing academic literature that explores the history and work of FDA, to which this volume makes an important contribution.
II. FDA MANAGEMENT
From its inception, even before it was given the regulatory authority conveyed by the 1906 act, FDA was administered by a single individual, who earlier was called the chemist or chief chemist but since 1940 has been called the commissioner. Throughout this time, the agency has been divided into two components: (1) the Headquarters staff located in Washington, D.C., and the vicinity, and (2) the Field Force, located throughout the entire United States. Although management of the Field Force remains largely unchanged throughout the history of FDA, the organization and management of FDA Headquarters has evolved over time. In the early days of FDA, the Headquarters was organized along functional responsibilities.2 The major functions were scientific research, regulation, and the field. During that time, the vast majority of work related to food, and thus there was no need for FDA to be organized by product categories. With enactment of the Drug Amendments of 1962 (76 Stat. 780) and the emergence of the modern medical device industry,3 the agency was completely reorganized along product lines in 1970. There are now centers within FDA for food, drugs, biological products, animal feed and drugs, medical devices, and tobacco.
Although there is no reliable historical statistical series reflecting the resources of FDA throughout its history, table 1.1 presents the best available data from 1900 to the present. The modest resources available to the agency through 1960 were reflected in a highly personal and close-knit management approach. The commissioner’s team was small and comprised individuals who had spent their entire careers at the agency. They knew most of the people in the Field Force and could reach out for information quickly and efficiently. Following enactment of the FDCA in 1938, there were only two congressional hearings before 1960 (Hutt 1983), and thus there was very little congressional distraction. FDA had not yet become the subject of the intense press interest that it is today. In short, the agency was a small, tightly run organization that attracted little public attention. By 1970, all that had changed. The thalidomide disaster (Mintz 1962), followed by the Drug Amendments of 1962, changed the agency forever.
TABLE 1.1
| Year |
Congressional Appropriation (Dollars) |
Employees |
| 1900 |
17,100 |
— |
| 1910 |
930,560 |
467 |
| 1920 |
1,391,571 |
374 |
| 1930 |
1,849,140 |
530 |
| 1940 |
2,741,000 |
719 |
| 1950 |
4,802,500 |
955 |
| 1960 |
13,800,000 |
1,678 |
| 1970 |
72,352,000 |
4,252 |
| 1980 |
312,796,000 |
7,517 |
| 1990 |
560,271,000 |
7,815 |
| 2000 |
1,048,000,000 |
7,728 |
| 2010 |
2,370,000,000 |
9,368 |
| 2014 |
2,557,963,000 |
9,940 |
Compiled from FDA reports. This table does not include user fees or employees paid with user fees.
From 1862 through 1965, there were fourteen FDA commissioners. Since the last career commissioner retired from FDA in 1965, there have also been fourteen FDA commissioners. Each has reflected his or her own personal management style. For some, their personal management philosophy has been clearly articulated and has had a major impact on the agency. For others, there has been relatively little impact and thus only minor change when a new commissioner has arrived. The following brief summary illustrates the differences that have occurred.
Charles C. Edwards, MD, was FDA commissioner from 1969 through 1973. Although he was trained as a surgeon, he spent the years before he came to FDA as a medical management consultant. He recruited business managers to the agency and initiated a project management system (PMS) to organize the increasing work at Headquarters. Every morning, Dr. Edwards and his immediate staff met with a director of one of the product bureaus (now called centers) and the bureau staff to review important programs and issues. Everyone knowledgeable with respect to an issue was included in the discussion, but the commissioner made the ultimate decision. No issue went unresolved for longer than a week or two.
As the issues proliferated and became more technical and complex and the resources of the agency increased dramatically, the close supervision and decisional authority of the commissioner eroded. By 1990, the weekly meetings of the commissioner with the center directors was abandoned. Since then, the commissioner has become involved in only the most important issues in the agency, as determined largely by Congress and the media. It is rare that a truly important scientific or medical issue will be reviewed by the commissioner, and even then it is usually not the commissioner who makes the final decision.
The personal interests of a commissioner nonetheless remain an important force within FDA. One of the more significant issues that is discussed within both FDA and the regulated industry is the extent to which relations between these two interested parties should be on a collaborative and cooperative level or at arm’s length. Some commissioners have unequivocally established their own policy on this issue (Hutt, Merrill, and Grossman 2007). Others have simply declined to enter the debate. Under the commissioners who have not established clear policy, the FDA employees who have daily contact with the regulated industry make their own personal determinations of what is an appropriate relationship.
Commissioners also leave their imprint on the agency by the type of personnel they recruit as part of the Headquarters team. As noted already, Commissioner Edwards recruited business managers to help him run the agency. In contrast, Commissioner McClellan recruited Ph.D. economists. The differences that occur from these approaches have had significant effects on the work of the agency.
As the number of FDA employees increases, FDA managers at every level within the agency know less and less about what is actually happening when applications of various types are reviewed and regulatory decisions are made. FDA has repeatedly expressed a commitment to preventing and resolving inconsistencies within the agency as a whole, the centers that review similar products, the offices within each center that have overlapping issues, and even down to the lowest agency employees who have direct regulatory responsibilities. But the potential for the lack of consistent policy and regulatory decisions only increases with the ever-larger size of the agency. Together with recent decisions that higher officials cannot overrule lower officials on regulatory decisions (Compare Food and Drug Administration 2009 with Ivy Sports Medicine, Inc. v. Sebelius 2013:938 and Sports Medicine, Inc. v. Burwell 2014:767), the increasing size of the agency has presented difficult and as yet unresolved management issues.
III. FDA RULEMAKING
FDA rulemaking began shortly after enactment of the 1906 act. In one year, the agency promulgated four regulations governing its regulatory authority that were virtually unamended for the next thirty years (Hutt 1981).
From 1906 to 1970, FDA used rulemaking for the technical decisions required by the FDCA for establishing food standards (21 CFR Parts 130–169) and food additive regulations (21 CFR Parts 170–186), but most new policy was developed through litigation and informal guidance. By the 1970s, however, it was clear to the agency that it needed to engage in substantial rulemaking for all of the products for which it was responsible in order to develop new policies and procedures.
The 1970s were the decade of FDA rulemaking. The agency reinterpreted the informal rulemaking provision in Section 701(a) of the FDCA as authorizing substantive rulemaking, not just general policy statements (e.g., National Nutritional Foods Ass’n v. Weinberger 1975:688). Major new programs were established, such as a transformation of all food labeling (Hutt 1989a), the requirement of nutrition labeling for half of the food supply (Hutt 1995), the development of the OTC Drug Review (21 CFR Part 330), the requirement for ingredient labeling on cosmetics (21 CFR § 701.3), and the initial regulations governing medical devices even before enactment of the Medical Device Amendments of 1976 (Hutt 1989b). From a procedural standpoint, FDA promulgated regulations governing implementation of the Freedom of Information Act (21 CFR Part 20) and the government in the Sunshine Act (21 CFR Part 14), as well as the broad procedural regulations that established requirements for all aspects of agency activities (21 CFR Parts 10, 12, 13, 15, 16). For the first time, moreover, it imposed the requirement of lengthy and detailed preambles to all regulations so that agency employees, the regulated industry, and the public would better understand agency requirements (Hutt 1972).
By establishing its policies as enforceable regulations, FDA sought to discourage unnecessary litigation. The agency invented the Regulatory Letter (later renamed the Warning Letter) in order to provide strong incentives for industry to comply with FDA regulations in an efficient and effective way (Hutt et al. 2007).
The era of FDA reliance on rulemaking lasted for roughly twenty years. In a series of statutes and executive orders, Congress and the president imposed requirements on rulemaking that crippled this form of agency policy making (Hutt 2008). The requirements for review of agency regulations both within the Department of HHS and in the Office of Management and Budget have dramatically slowed down even the smaller regulations that have been issued in the last twenty years. Thus, rulemaking is used by FDA today only where Congress explicitly requires it.
IV. FDA USE OF GUIDANCE
From its inception, FDA was a pioneer in the development of informal guidance (Lewis 2011; Martini 2009). FDA issued bulletins beginning in 1890 and circulars beginning in 1894 that presented its regulatory position on product issues. From 1902 to 1927, FDA issued 212 “Food Inspection Decisions,” and from 1938 to 1946 it issued 439 “Trade Correspondence” circulars for the same purpose. None of these had the force and effect of law. They were, however, invaluable in providing FDA views on regulatory matters for the regulated industry. Following enactment of the Administrative Procedure Act in 1946 (60 Stat. 237), FDA issued 131 policy statements on regulatory matters. In 1968, these were converted to Compliance Policy Guides, and they survive in this form to this day.
As part of its procedural regulations that were proposed in 1975 (40 Fed. Reg. 22950; 40 Fed. Reg. 40682) and promulgated in 1977 (42 Fed. Reg. 4680), FDA defined what it then called “Guidelines” and now calls “Guidance” (21 CFR § 10.90(b)). Following enactment of the statutory authority for the development of Guidance as part of the Food and Drug Administration Modernization Act of 1997 (Section 701(h) of the FDCA, 21 USC § 371(h)), FDA replaced its Guidelines regulation with its broader regulation governing all of Good Guidance Practices (21 CFR § 10.115). To date, the agency has issued more than 3,000 draft and final Guidances. Some, but not all, have been the subject of a brief notice published in the Federal Register. It is difficult, perhaps even impossible, to keep track of all these documents.
FDA has supplemented its informal Guidance in three ways. First, beginning in the early 1970s it has included extensive preambles explaining its proposed and final regulations (Hutt 1972). These are invaluable in understanding FDA policy. For example, the regulation defining the difference between a permitted structure/function claim for a food or dietary supplement and an illegal disease prevention claim is only half of one column, but the preamble takes up fifty pages in the Federal Register (65 Fed. Reg. 1000). Second, the FOI Act regulations promulgated by FDA in 1974 (21 CFR Part 20) are among the most liberal in the federal government. Extensive information on FDA policy issues is available from this source as well. Finally, it is widely acknowledged that FDA’s website is a model for the federal government. In order to avoid having thousands of FOI Act requests, FDA finds it easier simply to put significant documents on its website.
Nonetheless, one fundamental legal question that has received widespread discussion remains unresolved. In many instances, FDA has issued Guidance in one form or another that the regulated industry regards as an attempt illegally to engage in rulemaking without complying with the Administrative Procedure Act. It can be anticipated that as FDA pushes forward with additional Guidance, this issue will ultimately be addressed in the courts.
Nothing stirs more passion than the perennial debate whether FDA enforcement is increasing or decreasing. The raw enforcement data easily show that formal court enforcement actions have decreased (table 1.2). But that does not translate to a reduction in total FDA enforcement or in industry compliance. Formal court enforcement action has been replaced by three administrative compliance programs: (1) informal enforcement techniques, such as Warning Letters and Recall Requests; (2) the premarket approval programs for new drugs, OTC drugs, medical devices, and biological products, which involve FDA premarket scrutiny and approval of matters that once required enforcement surveillance; and (3) regulations, preambles, and guidance that most often provide a clear regulatory pathway for the regulated industry and thus reduce uncertainty and confusion that formerly resulted in court enforcement action.
TABLE 1.2
| Year |
Congressional Appropriations |
Employees |
Seizure Actions |
Injunction Actions |
Criminal Actions (Field Force) |
Warning Letters |
Recalls |
| 1940 |
2,288,000 |
719 |
1,697 |
0 |
337 |
— |
— |
| 1950 |
4,884,000 |
955 |
1,460 |
15 |
378 |
— |
17 |
| 1960 |
13,800,000 |
1,678 |
1,002 |
24 |
248 |
— |
39 |
| 1970 |
72,352,000 |
4,252 |
600 |
24 |
42 |
— |
1,427 |
| 1980 |
312,796,000 |
7,517 |
428 |
49 |
24 |
311 |
819 |
| 1990 |
600,979,000 |
7,629 |
144 |
9 |
19 |
498 |
2,352 |
| 2000 |
1,048,149,000 |
7,728 |
36 |
9 |
2 |
1,154 |
3,716 |
| 2010 |
2,370,000,000 |
9,368 |
10 |
17 |
0a |
673 |
3,799 |
aAll criminal actions have been transferred from the Field Force to the Office of Criminal Investigations.
Compiled from FDA reports. This table does not include user fees or employees paid with user fees.
On balance, these administrative programs unquestionably provide more efficient and effective compliance than formal court action. The only troubling informal enforcement technique is FDA’s unfettered use of publicity. Examples include the finding of aminotriazole in cranberries (1959), salmonella in Borden’s Starlac nonfat dry milk (1966), phenylpropanolamine (2000), and ephedra (2003). Each was an action taken by FDA by press release without any opportunity for public participation. For each one, publicity destroyed the ingredient, product, or industry involved, without an opportunity for the injured parties to participate. Publicity has become FDA’s most powerful weapon in today’s culture of instant communication and should be used sparingly and only when absolutely necessary.
VI. THE IMPACT OF USER FEES
User fees were imposed for certification of coal-tar colors (Section 706 of the 1938 FDCA, 52 Stat. 1049) beginning with enactment of the FDCA, for certification of insulin in 1941 (55 Stat. 851), and for all antibiotics in 1962 (76 Stat. 780). When user fees were proposed to finance the new drug approval system in the early 1970s, however, FDA vigorously opposed such an approach, primarily on two grounds (Kuhlik 1992). First, FDA regulation of new drugs benefits everyone, not just the industry. Second, FDA did not want to be financed by the industry because of the appearance of conflict of interest. Industry also opposed these fees. As a result, the issue was tabled for twenty years.
By the 1990s, however, it was clear that FDA could not conduct its new drug review and approval work by congressional appropriations alone. In contrast to the situation in the early 1970s, the FDA commissioner in the early 1990s strongly supported user fees. The turning point came when industry realized that it would actually save money by paying user fees that would get new drugs to the market faster. The cost of an approved new drug was so great that the amount of money paid as a user fee was less than the amount of money that would be paid just in carrying costs for three months. Thus, the Prescription Drug User Fee Act was passed by Congress in 1992 and renewed every five years thereafter (106 Stat. 449; 111 Stat. 2298; 116 Stat. 687; 121 Stat. 825; 126 Stat. 996). Since then, user fee statutes have been enacted for medical devices (116 Stat. 1588; 118 Stat. 572; 121 Stat. 842; 126 Stat. 1002), animal drugs (117 Stat. 1361; 122 Stat. 3509; 127 Stat. 451), animal generic drugs (122 Stat. 3515; 127 Stat. 464), human generic drugs (126 Stat. 1008), and biosimilar biological products (126 Stat. 1026). An attempt to impose user fees for the food industry, however, failed when the FDA Food Safety Modernization Act was enacted (124 Stat. 3885).
The impact of these user fees on the two industries that do not have them, i.e., food and cosmetics, is not widely appreciated. All user fee statutes require that Congress must increase appropriations proportionately as the industry user fees increase. Thus, unless congressional appropriations increase as user fees do, there will be less and less money for those programs that are not supported by user fees (Hutt 2008). In short, when there is a flat budget, the programs supported by user fees automatically take money away from the programs not supported by user fees, by operation of law.
For example, the new drug review and approval program is supported by user fees. The OTC Drug Review is not. As a result, the OTC Drug Review, which was started in 1972 (21 CFR Part 330), has completely stagnated. Forty years later, it is still only partly completed (79 Fed. Reg. 10,168). Faced with a lack of funds, the affirmation of generally recognized as safe (GRAS) status for food ingredients that was begun in 1973 (21 CFR § 170.35) was abandoned by FDA in 1997 and replaced by a simple notification process (62 Fed. Reg. 18,938). These are but two examples where user fees have devastated programs that do not have such funding.
When this was clearly pointed out in a 2007 report (Hutt 2008) prepared for the FDA Science Board, Congress held a hearing where both political parties pledged a substantial increase in FDA appropriations in order to repair the damage that had been done (U.S. Congress 2008). As a result of that report, FDA appropriations doubled between 2008 and 2013. In the current fiscal era, however, that type of extraordinary appropriation is not likely to be repeated. It remains to be seen whether more stable funding for FDA can be obtained without user fees.
VII. LEGACY PRODUCT PROGRAMS
Congress and FDA are very adept at creating new statutory and regulatory programs to review categories of ingredients or products. These are always well intentioned, but when the commissioner or the members of Congress who created the programs retire, there is no one to step into the void and make certain that the necessary funding is maintained. The six uncompleted programs of this nature shown in table 1.3 serve to illustrate the problem. Other programs have suffered as well. For example, FDA began the review of the food ingredient GRAS list at the direct request of President Nixon (“Consumer Protection” 1969), in 1969, forty-five years ago. When it became clear that FDA could not allocate sufficient funds to the project, FDA quietly just gave up and abandoned the program without completing it. For each one of these programs there is no line appropriation by Congress and no user fee, and each new commissioner has shown no interest in completing the work begun by a previous commissioner.
TABLE 1.3
| The Program |
Year Begun |
Years Since Program Began |
| Review and Approval of all Color Additives (74 Stat. 397) |
1960 |
54 years |
| Review of New Drugs with Effective NDAs During 1938–1962 (76 Stat. 780, 788) |
1962 |
52 years |
| OTC Drug Review of All Nonprescription Drugs Marketed Prior to 1972 (21 CFR part 330) |
1972 |
42 years |
| Review of Antibiotics Used in Animal Feed for Growth Promotion (21 CFR § 510.110) |
1972 |
42 years |
| Review of all Biological Products Licensed During 1902–1972 (21 CFR §§ 601.25, 26) |
1972 |
42 years |
| Review of all Pre-Amendments Class III Medical Devices (70 Stat. 539, 552–553) |
1976 |
37 years |
VIII. SCIENCE, POLICY, AND LAW
As long as FDA has existed, there have been heated disagreements about whether FDA decisions are scientific, policy, or legal in nature. Commissioner Wiley’s autobiography shows his continuous struggle with the USDA lawyer assigned as his chief counsel about implementation of the 1906 act (Wiley 1929). Commissioner Edwards held a famous debate with the chairman of a House subcommittee over whether FDA is a scientific or a regulatory agency (U.S. Congress 1970).
Both the 1906 and 1938 acts were written in an era when Congress gave broad authority to a government agency and left it to the discretion of the agency to determine how best to implement that authority. The basic provisions of the FDCA are sufficiently broad, ambiguous, and undefined that there is a wide degree of discretion and judgment in determining how implementation should be undertaken. This discretion is explicitly given by statute to the secretary of HHS. The secretary, in turn, has delegated it to the commissioner (Food and Drug Administration 2005). Some matters are delegated further to other officials within the agency.
It is difficult to find any significant issue faced by FDA that is not ultimately a matter of policy, informed by both scientific and legal considerations. But recently, FDA scientists have attempted to assert the primacy of their contributions to issues. Two examples will serve to illustrate this matter.
First, when Plan B was proposed to be switched from prescription to nonprescription status, the physicians and scientists who initially reviewed the matter concluded that it should be switched for any female sixteen years or older. The higher level managers who reviewed this recommendation, who were also scientists and physicians, concluded that the cutoff age should be eighteen, not sixteen. The lower level scientists claimed that their recommendation was “scientific” and therefore could not be changed by the higher level managers. At issue, from a matter of statutory law, was whether the additional two years is one of the statutory “collateral measures necessary to” use of the drug (Section 503(b)(1) of the FDCA, 21 USC § 353(b)(1)). By any analysis, this is not a scientific issue. It is a matter of public policy. Yet a court determined otherwise (Tummino v. Hamburg 2013:162).
A second example of public policy adopted in the guise of science is the convention of the confidence level of 0.05 for statistical significance with respect to a finding in a clinical trial. This is not set by statute or even by an FDA regulation. Whether to use a confidence level of 0.1, 0.01, or 0.05, or indeed any other level, is pure public policy. It just signifies the acceptable level of confidence in the result. It may be that some people would be quite willing to accept a drug with a smaller level of confidence than other people, and some people might even wish to have a higher level of confidence. That kind of issue represents policy, not science.
Thus, while these types of debates will not soon (if ever) be resolved, it appears that few, if any, FDA decisions involve solely a scientific determination. The statute and public policy always have a role in such decisions.
IX. CONCLUSION
The matters described and discussed here represent only a small sample of intractable FDA questions on which there is wide latitude for disagreement. The following chapters of this book provide a wealth of other issues that also inspire continuing debate. It is hoped that those who read these chapters will encounter and debate them with an open mind and thus pursue the spirit with which the coeditors have conceived this book.
NOTES
1. For the organizational history of FDA within the federal government, see Hutt 1990.
2. For the organizational history of FDA within the agency, see Brannon 1984.
3. The Medical Device Amendments were enacted in 90 Stat. 539 (1976).
Brannon, Michael. 1984. “Organizing and Reorganizing FDA.” Food and Drug Law 75:135–173.
“Consumer Protection.” 1969. Weekly Compilation of Presidential Documents 5 (November): 1516.
Food and Drug Administration. 2009. “Review of the ReGen Menaflex: Departures from Processes, Procedures, and Practices Leave the Basis for a Review Decision in Question.” Preliminary Report (September).
Hutt, Peter Barton. 1972. “Public Information and Public Participation in the Food and Drug Administration.” Quarterly Bulletin of the Association of Food and Drug Officials of the United States 36:216–217.
Hutt, Peter Barton. 1981. “About Fairness in Applying the Law.” FDA Consumer 15(5):23.
Hutt, Peter Barton. 1983. “Investigations and Reports Respecting FDA Regulation of New Drugs (Part 1).” Clinical Pharmacology and Therapeutics 33:537–539.
Hutt, Peter Barton. 1989a. “Regulating the Misbranding of Food.” Food Technology 43:288.
Hutt, Peter Barton. 1989b. “A History of Government Regulation of Adulteration and Misbranding of Medical Devices.” Food Drug Cosmetic L.J. 44 (99):110–112.
Hutt, Peter Barton. 1990. “A Historical Introduction.” Food Drug Cosmetic L.J. 45:17.
Hutt, Peter Barton. 1995. “A Brief History of FDA Regulation Relating to the Nutrient Content of Food.” In Nutrition Labeling Handbook, ed. Ralph Shapiro, 1–29 New York, NY: CRC Press.
Hutt, Peter Barton. 2008. “The State of Science at the Food and Drug Administration.” Administrative Law Review 60:431, Tables 2 and 3.
Hutt, Peter Barton, Richard A. Merrill, and Lewis A. Grossman. 2007. Food and Drug Law: Cases and Materials. St. Paul, MN: Foundation Press. 1529–1531.
Ivy Sports Medicine, Inc. v. Sebelius, 938 F. Supp. 2d 47 (D.D.C. 2013), rev’d Ivy Sports Medicine, Inc. v. Burwell, 767 F.3d 81 (D.C. Cir. 2014).
Kuhlik, Bruce N. 1992. “Industry Funding of Improvements in the FDA’s New Drug Approval Process: The Prescription Drug User Fee Act of 1992.” Food and Drug L.J. 47:483.
Lewis, Kevin M. 2011. “Informal Guidance and the FDA.” Food and Drug L.J. 66:507.
National Nutritional Foods Association v. Weinberger, 512 F.2d 688 (2d. Cir. 1975).
Tummino v. Hamburg, 936 F. Supp. 2d 162 (E.D.N.Y. 2013).
U.S. Congress, House of Representatives, Subcommittee of the Committee on Government Relations. 1970. Regulatory Policies of the Food and Drug Administration. 91st Cong., 2nd sess., 137–138.
U.S. Congress, Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce. 2008. Science and Mission at Risk: FDA’s Self-Assessment. 110th Cong., 2nd sess.
Wiley, Harvey W. 1929. The History of a Crime Against the Food Law. New York: Ayer Company Publishers. 156–160.
