Though acne is not a life-threatening condition, it is a highly emotionally charged one, particularly for teenagers. In the early 1960s, when the Pannett Company used medical and scientific claims to convince adolescents to purchase their product, Acnotabs, their amazing advertising claims attracted the attention of the US Food and Drug Administration. Typically the Agency seized a product it considered mislabelled in terms of its ingredients or its efficacy; and most companies, not willing to face a potentially expensive fight, did not object to the action. In effect, they allowed the courts to issue a condernnation order by default. The Pannett Company, however, resisted the FDA's seizure and decided to present their case for Acnotabs in court. The Company insisted that their tests had demonstrated the usefulness of Acnotabs in treating the skin condition. The FDA claimed that there was no evidence for the effectiveness of Acnotabs and, moreover, that scientific and medical theory denied that the ingredients in Acnotabs would cure acne. The records of this case provide a unique demonstration of how a layperson, a judge, evaluated competing definitions of science and scientific proof.
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References
1.
In today's world, teenagers traumatized by acne can turn to a wide variety of over-the-counter and prescription drugs, hygienic rituals, dietary recommendations and even their own support group, located in London. See [Madison, Wisconsin] Capital Times, Support group focuses on acne. 24 June 1992.
2.
Cohen & Aleshire, Inc., Radio continuity, dated 7 June 1961. FDA RG88 AF-8-611.
3.
207 F. Supp. 758 (1962) (US vs. Acnotabs and Pannett Products Inc.); quotations are found on pp.3-5.
4.
For example, Ann-Shih Cheng, National Better Business Bureau, to Samuel L. Williams, Federal Trade Commission, letter dated 18 July 1960. FDA RG88, AF-8-611.
5.
See FDA RG88. Acc. No. 66A 1030, Box 70, for examples of consumers' letters on the subject of Acnotabs.
6.
Gordon T. LaFlash to New York District Director, memo dated 19 February 1960. FDA RG88, AF-8-611.
7.
Young, J. H. , 1967, The Medical Messiahs: A Social History of Health Quackery in Twentieth-Century America (Princeton, NJ: Princeton University Press), pp. 206-208, 338-359.
8.
Marks, H. M., 1987, Regulating medicine: the 1938 Drug Act, in Ideas as reforms: therapeutic experiments and medical Pratice. 1900-1980. PhD thesis. Massachusetts Institute of Technology, Chap. 2, pp.51-91.
9.
Post-trial memorandum. dated 9 July 1962. FDA RG88, Acc. No. 66A 1030, Box 70, p.29.
10.
For more on the administrative power of the Food and Drug Administration, see Austern, H. T., 1963, Sanctions in silhouette: an inquiry in to the enforcement of the federal Food, Drug and Cosmetic Act. Food Drug Cosmetic Law Journal, November, 617-631.
11.
The description of the case is drawn from the post-trial memorandum, dated 9 July 1962. FDA RG88, Acc. No. 66A 1030, Box 70.
12.
Acnotabs was promoted as a combination of pancreatin, bile salts, pepsin, and vitamins A and C. It contained 10 000 IU of vitamin A. Even in the 1960s, when vitamin A was used in conjunction with other therapies in treating acne, it was prescribed in doses of 25 000-150 000 IU. Today, synthetic vitamin A is frequently prescribed in doses of 300 000 units.
13.
Post-trial memorandum, dated 9 July 1962. FDA RG88, Acc. No. 66A 1030, Box 70, pp.22-23.
14.
Post-trial memorandum, dated 9 July 1962. FDA RG88, Acc. No. 66A 1030, Box 70, pp.24-28.
15.
Post-trial memorandum, dated 9 July 1962. FDA RG88, Acc. No. 66A 1030, Box 70, pp.24, 28.
16.
Post-trial memorandum, dated 9 July 1962. FDA RG88, Acc. No. 66A 1030, Box 70, pp.28-29.
17.
Post-trial memorandum, dated 9 July 1962. FDA RG88, Acc. No. 66A 1030, Box 70, pp.29-34.
18.
Marks, H. M., 1990, Historical perspectives on clinical trials: working paper prepared for the National Research Council, unpublished paper. I am grateful to Prof. Marks for sharing this paper with me.
19.
Post-trial memorandum, dated 9 July 1962. FDA RG88, Acc. No. 66A 1030, Box 70, pp.7-17, quotation on p.10.
20.
Post-trial memorandum, dated 9 July 1962. FDA RG88, Acc. No. 66A 1030, Box 70, pp.-41-42.
21.
Post-trial memorandum, dated 9 July 1962. FDA RG88, Acc. No. 66A 1030, Box 70, p.41.
22.
Reply Brief prepared by the Food and Drug Administration, dated 20 July 1962. FDA RG88 Acc. No. 66A 1030, Box 70, p.10.
23.
207 F. Supp. 758 (1962), quotation on p.13.
24.
207 F. Supp. 758 (1962), quotation on p.16.
25.
207 F. Supp. 758 (1962), quotations on pp.17-18.
26.
Letter from Goldhammer to Viault, 17 August 1962, memo of interview, 4 September 1962. FDA RG88 Acc. No. 66A 1030, Box 70.
27.
Smith, R. G. , 1961, Evaluation of safety of new drugs by the Food and Drug Administration. Journal of New Drugs, 1(2), 59-64. Smith was Director of the New Drug Branch, Bureau of Medicine, Food and Drug Administration.
28.
Quick, P. J. , 1980, Food and Drug Administration. The Politics of Regulation, edited by James Q. Wilson (New York: Basic Books), pp. 197-198, citing FDA Commissioner George Larrick.
29.
Summary: Secretary Fleming's Meetings with Representatives of National Organizations, December 11, 17, and 18, 1958 (typescript); National Academy of Sciences—National Research Council: Report of Special Committee Advisory to the Secretary of Health, Education, and Welfare to Review the Policies, Procedures, and Decisions of the Division of Antibiotics and the New Drug Branch of the Food and Drug Administration (typescript); Department of Health, Education, and Welfare: Staff paper, prepared by the Food and Drug Administration, 1 September 1960 (typescript). All three documents are to be found in the FDA History Office files, Rockville, MD. I wish to thank Dr John Swann, FDA Historian, for his assistance in locating these reports.
30.
Quoted in Temin, P., 1980, Taking your Medicine: Drug Regulation in the United States (Cambridge, MA: Harvard University Press), pp. 122-123.
31.
Marks, H. M. , 1990, Historical perspectives on clinical trials: Working paper for the National Research Council. Unpublished paper.
32.
Kohlstedt, K. G. , 1960, Developing and testing of new drugs by the pharmaceutical industry. Journal of Clinical Pharmacology and Therapeutics, 1, 192-201.
33.
See also Young, J. H., 1967, The Medical Messiahs: A Social History of Health Quackery in Twentieth-Century America (Princeton, NJ: Princeton University Press), pp. 413-422.
34.
and 1962, Drug amendments of 1962—Federal Food, Drug, and Cosmetic Act. Journal of New Drugs, 2, 314-320.
35.
For an interesting comparative study of regulatory agencies' grappling with scientific claims, see Gillespie, B., Eva, D., and Johnston, R., 1982, Carcinogenic risk assessment in the USA and UK: the case of Aldrin/Dieldrin. Science in Context, edited by Barry Barnes and David Edge (Cambridge, MA: MIT Press), pp. 303-335.
36.
Richards, E. , 1991, Vitmin C and Cancer: Medicine or Politics? (New York: St Martin's Press).
37.
Young, J. H. , 1992, Nutritional eccentricities. American Health Quackery (Princeton, NJ: Princeton University Press), pp. 165-181.
38.
Williams, L. , 1992, F.D.A. steps up effort to control vitamin claims. New York Times, 9 August.
39.
Findlay, S. , 1992, The next FDA target: The rules on selling vitamins, U.S. News and World Report, 4 May. p. 70.
