Promoting functional foods and nutraceuticals on the Internet

Food and Drug Law Journal

Volumn 54, Issue 3, 1999, Pages 423-451

  Taylor, Sarah E ^a   Feld, Harold J ^a,b  

^a Department of International Practice   (United States)

^b Media Access Project   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DIET SUPPLEMENTATION; FOOD COMPOSITION; FOOD INDUSTRY; FOOD PACKAGING; FOOD QUALITY; HEALTH SERVICE; HUMAN; INFORMATION SERVICE; INTERNET; REVIEW; SELF CARE;

ADVERTISING; COMMERCE; FORECASTING; HEALTH FOOD; HEALTH PROMOTION; HUMANS; INTERNET; NUTRITION PHYSIOLOGY; PRIVACY; PRODUCT LABELING; STATE GOVERNMENT; UNITED STATES; UNITED STATES FEDERAL TRADE COMMISSION; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0032755948     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (181)

1. H.J. Burnstein, S. Gelber, E. Guadagnoli & J. Weeks, Use of Alternative Medicine by Women With Early-Stage Breast Cancer, 340 NEW ENG. J. MED. 1733 (1999).
2. See E. Sloan, The Top Ten Up-and-Coming Nutraceutical Markets, NUTRACEUTICALS WORLD, Mar./Apr. 1999, at 58.
3. The terms "functional food" and "nutraceutical" commonly are used in marketing, but have no regulatory definition. Under the Federal Food, Drug, and Cosmetic Act (FDCA), Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301 et seq. (1994)), "functional foods" and "nutraceuticals" are regulated as "food" or "dietary supplements" depending on their characteristics. The adequacy of this existing legal framework is a matter of some controversy. For a recent critique of the framework, see Center for Science in the Public Interest, International, Functional Foods: Public Health Boon or 21st Century Quackery? (visited Aug. 1, 1999) 〈www.cspinet.org/reports/functional_foods/index.html〉. The FDCA defines "food" to mean "(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article." 21 U.S.C. § 321(f). The FDCA, as amended by the Dietary Supplement Health and Education Act of 1990 (DSHEA), Pub. L. No. 103-417, 108 Stat. 4325 (codified at 21 U.S.C. § 301 note (1994)), defines "dietary supplement" as follows: The term "dietary supplement" - (1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (A) a vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E); (2) means a product that - (A) - (i) is intended for ingestion in a form described in section 411(c)(1)(B)(i); or (ii) complies with section 411(c)(1)(B)(ii); (B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and (C) is labeled as a dietary supplement; and (3) does - (A) include an article that is approved as a new drug under section 505, certified as an antibiotic under section 507, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262) and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food unless the Secretary has issued a regulation, after notice and comment, finding that the article, when used as or in a dietary supplement under the conditions of use and dosages set forth in the labeling for such dietary supplement, is unlawful under section 402(f); and (B) not include (i) an article that is approved as a new drug under section 505, certified as an antibiotic under section 507, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262), or (ii) an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations have been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary's discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this Act. Except for purposes of section 201(g), a dietary supplement shall be deemed to be a food within the meaning of this Act. 21 U.S.C. § 321(ff).
4. The terms "functional food" and "nutraceutical" commonly are used in marketing, but have no regulatory definition. Under the Federal Food, Drug, and Cosmetic Act (FDCA), Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301 et seq. (1994)), "functional foods" and "nutraceuticals" are regulated as "food" or "dietary supplements" depending on their characteristics. The adequacy of this existing legal framework is a matter of some controversy. For a recent critique of the framework, see Center for Science in the Public Interest, International, Functional Foods: Public Health Boon or 21st Century Quackery? (visited Aug. 1, 1999) 〈www.cspinet.org/reports/functional_foods/index.html〉. The FDCA defines "food" to mean "(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article." 21 U.S.C. § 321(f). The FDCA, as amended by the Dietary Supplement Health and Education Act of 1990 (DSHEA), Pub. L. No. 103-417, 108 Stat. 4325 (codified at 21 U.S.C. § 301 note (1994)), defines "dietary supplement" as follows: The term "dietary supplement" - (1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (A) a vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E); (2) means a product that - (A) - (i) is intended for ingestion in a form described in section 411(c)(1)(B)(i); or (ii) complies with section 411(c)(1)(B)(ii); (B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and (C) is labeled as a dietary supplement; and (3) does - (A) include an article that is approved as a new drug under section 505, certified as an antibiotic under section 507, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262) and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food unless the Secretary has issued a regulation, after notice and comment, finding that the article, when used as or in a dietary supplement under the conditions of use and dosages set forth in the labeling for such dietary supplement, is unlawful under section 402(f); and (B) not include (i) an article that is approved as a new drug under section 505, certified as an antibiotic under section 507, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262), or (ii) an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations have been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary's discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this Act. Except for purposes of section 201(g), a dietary supplement shall be deemed to be a food within the meaning of this Act. 21 U.S.C. § 321(ff).
5. The terms "functional food" and "nutraceutical" commonly are used in marketing, but have no regulatory definition. Under the Federal Food, Drug, and Cosmetic Act (FDCA), Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301 et seq. (1994)), "functional foods" and "nutraceuticals" are regulated as "food" or "dietary supplements" depending on their characteristics. The adequacy of this existing legal framework is a matter of some controversy. For a recent critique of the framework, see Center for Science in the Public Interest, International, Functional Foods: Public Health Boon or 21st Century Quackery? (visited Aug. 1, 1999) 〈www.cspinet.org/reports/functional_foods/index.html〉. The FDCA defines "food" to mean "(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article." 21 U.S.C. § 321(f). The FDCA, as amended by the Dietary Supplement Health and Education Act of 1990 (DSHEA), Pub. L. No. 103-417, 108 Stat. 4325 (codified at 21 U.S.C. § 301 note (1994)), defines "dietary supplement" as follows: The term "dietary supplement" - (1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (A) a vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E); (2) means a product that -(A) -(i) is intended for ingestion in a form described in section 411(c)(1)(B)(i); or (ii) complies with section 411(c)(1)(B)(ii); (B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and (C) is labeled as a dietary supplement; and (3) does -(A) include an article that is approved as a new drug under section 505, certified as an antibiotic under section 507, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262) and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food unless the Secretary has issued a regulation, after notice and comment, finding that the article, when used as or in a dietary supplement under the conditions of use and dosages set forth in the labeling for such dietary supplement, is unlawful under section 402(f); and (B) not include (i) an article that is approved as a new drug under section 505, certified as an antibiotic under section 507, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262), or (ii) an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations have been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary's discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this Act. Except for purposes of section 201(g), a dietary supplement shall be deemed to be a food within the meaning of this Act. 21 U.S.C. § 321(ff).
6. While the Internet has proven a valuable tool to distribute scientific data and market health products, it also has proven to be a popular way to market products with unsubstantiated health claims. See CNET news.com, FTC Attacks Online Health Fraud (modified June 24, 1999) 〈www.news.com/News/ltem/0,4,0-38330,00.html?st.ne.140.head〉 (discussing FTC's "Operation Cure All").
7. CLIFFORD STOLL, SILICON SNAKE OIL: SECOND THOUGHTS ON THE INFORMATION HIGHWAY (1995).
8. The Internet Economy Indicators, Features (visited June 18, 1999) 〈www.internetindicators.com/ features.html〉.
9. Id.
10. Id.
11. Nua Internet Surveys, 92 Million Adults Online in United States (visited June 18, 1999) 〈www.nua.ie/ surveys/?f=VS&art_id=905354968&rel=true〉;
12. Nua Internet Surveys, How Many Online? (visited Aug. 25, 1999) 〈www.nua.ie/surveys/how_many_online/index.html〉.
13. U.S. Working Group on Electronic Commerce Policy, First Annual Report. Nov. 30, 1998 (visited Aug. 1, 1999) 〈www.doc.gov/ecommerce/E-comm.pdf〉.
14. Id.
15. Nua Internet Surveys, Small Businesses Sell $19 Billion Online (visited June 18, 1999) 〈www.nua.ie/ surveys/?f=VS&art_id=905354922&rel=true〉.
16. Nua Internet Surveys, 92 Million Adults Online in United States (visited June 18, 1999) 〈www.nua.ie/ surveys/?f=VS&art_id=905354968&rel=true〉; Nua Internet Surveys, Report Looks at Changing Face of the Net (visited June 18, 1999) 〈www.nua.ie/surveys/?f=VS&art_id=905354784&rel=true〉.
17. Nua Internet Surveys, 92 Million Adults Online in United States (visited June 18, 1999) 〈www.nua.ie/ surveys/?f=VS&art_id=905354968&rel=true〉; Nua Internet Surveys, Report Looks at Changing Face of the Net (visited June 18, 1999) 〈www.nua.ie/surveys/?f=VS&art_id=905354784&rel=true〉.
18. Nua Internet Surveys, Children Ready to Buy Online (visited June 18, 1999) 〈www.nua.ie/surveys/ ?f=VS&art_id=905354955&rel=true〉; Nua Internet Surveys, U.S. Kids to Spend $1.3 Billion Online (visited June 18, 1999) 〈www.nua.ie/surveys/?f-VS&art_id-905354944&rel=true〉.
19. Nua Internet Surveys, Children Ready to Buy Online (visited June 18, 1999) 〈www.nua.ie/surveys/ ?f=VS&art_id=905354955&rel=true〉; Nua Internet Surveys, U.S. Kids to Spend $1.3 Billion Online (visited June 18, 1999) 〈www.nua.ie/surveys/?f-VS&art_id-905354944&rel=true〉.
20. Nua Internet Surveys, Sixty Million Seek Health Info Online in the U.S. (visited June 18, 1999) 〈www.nua.ie/surveys/?f=VS&art_id=905354697&rel=true〉.
21. Nua Internet Surveys, Dramatic Increase in the Number of Medics Online (visited June 18, 1999) 〈www.nua.ie/surveys/?f=VS&art_id=905354889&rel=true〉.
22. Nua Internet Surveys, Online Health Advertising Has a Rosy Future (visited June 18, 1999) 〈www.nua.ie/surveys/?f=VS&art_id=905354560&rel=true〉.
23. The Internet Economy Indicators, supra note 6.
24. Nua Internet Surveys, Online Pharmacies Predicted to Thrive by 2003 (visited June 18, 1999) 〈www.nua.ie/surveys/?f=VS&art_id=905354928&rel=true〉.
25. Id.
26. See, e.g., Nua Internet Surveys, Majority of Users Will Be Non-English Speakers (visited June 18, 1999) 〈www.nua.ie/surveys/?f=VS&art_id=905354950&rel=true〉; Nua Internet Surveys, European Ecommerce to Top U.S. $8.6 Billion (visited June 18, 1999) 〈www.nua.ie/surveys/ ?f=VS&art_id=905354970&rel=true〉; Nua Internet Surveys, Over 1.2 Million Russian Users at Close of '98 (visited June 18, 1999) 〈www.nua.ie/surveys/?f=VS&art_id=905354958&rel=true〉.
27. See, e.g., Nua Internet Surveys, Majority of Users Will Be Non-English Speakers (visited June 18, 1999) 〈www.nua.ie/surveys/?f=VS&art_id=905354950&rel=true〉; Nua Internet Surveys, European Ecommerce to Top U.S. $8.6 Billion (visited June 18, 1999) 〈www.nua.ie/surveys/ ?f=VS&art_id=905354970&rel=true〉; Nua Internet Surveys, Over 1.2 Million Russian Users at Close of '98 (visited June 18, 1999) 〈www.nua.ie/surveys/?f=VS&art_id=905354958&rel=true〉.
28. See, e.g., Nua Internet Surveys, Majority of Users Will Be Non-English Speakers (visited June 18, 1999) 〈www.nua.ie/surveys/?f=VS&art_id=905354950&rel=true〉; Nua Internet Surveys, European Ecommerce to Top U.S. $8.6 Billion (visited June 18, 1999) 〈www.nua.ie/surveys/ ?f=VS&art_id=905354970&rel=true〉; Nua Internet Surveys, Over 1.2 Million Russian Users at Close of '98 (visited June 18, 1999) 〈www.nua.ie/surveys/?f=VS&art_id=905354958&rel=true〉.
29. Thus, while it appears to an end-user (i.e., website visitor) that he or she "visits" a website, in reality, the website "visits" the end-user. This difference is important. Because "visiting" a website involves downloading information into an end-user's own system, it becomes possible for the website to download information the visitor did not request into the end-user's system or to gather in formation from an end-user's system without the end-user's knowledge.
30. These programs are called "cookies." Their effect on consumer privacy is discussed infra, part III.D.
31. As discussed in part III infra, this ability raises both intellectual property concerns and consumer protection concerns.
32. The hypotheticals included throughout this article are entirely fictitious and are intended only to assist the reader in understanding Internet technology and related legal issues in the context of specific hypothetical fact patterns. Any resemblance of the fictitious parties named in the hypotheticals (e.g., "Global Garlic, Inc.," "Allicin Alliance," "Go Garlic Diet," "Garlic Lovers," etc.) to actual companies, organizations, groups, or to any marks used by any person, is unintentional. Descriptions of scientific evidence concerning garlic and garlic products, and other facts contained in the hypotheticals likewise are fictitious and are not intended to reflect actual scientific or other evidence relating to the benefits or risks of garlic products.
33. Some websites, however, (notably pornographic sites and sites that use a famous name in a deceptive fashion) construct their applets so that a new window launches whenever the end-user tries to move off the website or close the window. This makes it very difficult for the end-user to get away from undesired content without closing and restarting the browser.
34. See Robert D. Hof, Seanna Browder & Peter Elstrom, Internet Communities, BUS. WK., May 5, 1997, at 64.
35. See Nua Internet Surveys, Word of Mouth Drives Ecommerce (visited June 20, 1999) 〈www.nua.ie/ surveys/?f=VS&art_id=905354929&rel=true〉.
36. An example of this sort of promotion can be found at 〈www.deja.com〉, a webpage that allows users to create "personal communities."
37. See Yahoo!, GeoCities (visited Aug. 1, 1999) 〈geocities.yahoo.com/home/〉.
38. See iVillage.com: The Woman's Network (visited Aug. 1, 1999) 〈www.iVillage.com〉.
39. See, e.g., Nua Internet Surveys, E-Mail, a Powerful Marketing Tool (visited June 18, 1999) 〈www.nua.ie/ surveys/?f=VS&art_id=905354935&rel=true〉; FEDERAL TRADE COMMO'N, PRIVACY ONLINE; A REPORT TO CONGRESS (submitted June 6, 1998).
40. See, e.g., Nua Internet Surveys, E-Mail, a Powerful Marketing Tool (visited June 18, 1999) 〈www.nua.ie/ surveys/?f=VS&art_id=905354935&rel=true〉; FEDERAL TRADE COMMO'N, PRIVACY ONLINE; A REPORT TO CONGRESS (submitted June 6, 1998).
41. See, e.g., 〈www.prnewswire.com〉.
42. See, e.g., Interpretation of Rules and Guides for Electronic Media; Request for Comment, 63 Fed. Reg. 24,996, 24,998 (May 6, 1998) (noting that the Federal Trade Commission (FTC) has authority to apply its rules to the Internet, but soliciting comment on proper application of existing statutory and regulatory terms).
43. See, e.g., Interpretation of Rules and Guides for Electronic Media; Request for Comment, 63 Fed. Reg. 24,996, 24,998 (May 6, 1998) (noting that the Federal Trade Commission (FTC) has authority to apply its rules to the Internet, but soliciting comment on proper application of existing statutory and regulatory terms).
44. For an excellent check-list applicable to any business, see Ron N. Dreben & Johanna L. Werbach, Top 10 Things to Consider in Developing an Electronic Commerce Website, COMPUTER LAW., June 1999, at 17; Walter A. Effross, A Website Checklist, LEGAL TIMES, Mar. 1, 1999, at S34.
45. For an excellent check-list applicable to any business, see Ron N. Dreben & Johanna L. Werbach, Top 10 Things to Consider in Developing an Electronic Commerce Website, COMPUTER LAW., June 1999, at 17; Walter A. Effross, A Website Checklist, LEGAL TIMES, Mar. 1, 1999, at S34.
46. Specific concerns relating to the jurisdiction of the Food and Drug Administration (FDA) and FTC as regards to lheir special jurisdiction over labeling and advertising are addressed infra, pt. IV.A.
47. 521 U.S. 844 (1997).
48. Pub. L. No. 104-104, 110 Stat. 133 (1996).
49. See Federal Communications Comm'n v. Pacifica Found., 438 U.S. 726 (1978).
50. American Civil Liberties Union, 521 U.S. at 870.
51. See Id. at 853, 870; American Civil Liberties Union, 929 F. Supp. at 879-83 (opinion of Judge Dalzell).
52. See American Library Assoc. v. Pataki, 969 F. Supp. 160 (S.D.N.Y. 1997) (decided under Commerce Clause).
53. See Mainstream Loudoun v. Bd. of Trustees of the Loudoun County Library, 24 F. Supp.2d 552 (E.D. Va. 1998).
54. Pub. L. No. 105-277, 112 Stat. 2681-2728 (1998).
55. American Civil Liberties Union v. Reno, 31 F. Supp.2d 473 (E.D. Pa. 1999).
56. Bally Total Fitness Holding Corp. v. Faber, 29 F. Supp.2d 1161 (CD. Cal. 1998) (permitting use of Bally's trademarked name online in context of consumer commentary).
57. American Civil Liberties Union, 521 U.S. at 870. See generally Bernstein v. United States Dep't of Justice, 1999 WL 274111 (9th Cir. 1999) (noting that to the extent that government regulation impedes the flow of scientific information, it strikes "deep into the heartland of the First Amendment").
58. See Washington Legal found. v. Friedman, 13 F. Supp.2d 51 (D.D.C. 1998), amended, request denied, 36 F. Supp.2d 16 (D.D.C. 1999), amended, summ. judgment granted, injunction granted, 36 F. Supp.2d 418 (D.D.C. 1999) (striking down restrictions on the dissemination to doctors of medical information relevant to unapproved uses of approved drugs).
59. Pub. L. No. 104-104, 110 Stat. 56 (1996).
60. 1995 WL 323710 (N.Y. Sup. Ct. 1995).
61. 776 F. Supp. 135 (S.D.N.Y. 1991).
62. 47 U.S.C. § 230 (1994). This provision survived the Supreme Court decision striking down the indecency provisions of the CDA. See Elizabeth deGrazia Blumenfeld, Patrick J. Carome & Samir Jain, Federal Immunity for Online Sewices - 47 U.S.C. § 230, J. INTERNET L., Jan. 1999, at 20.
63. See id. at 20-21; 47 U.S.C. § 230(c) (granting immunity to "a provider or user of an interactive computer service").
64. 992 F. Supp. 44 (D.D.C. 1998).
65. Id. at 49.
66. Id.
67. Id.
68. Id. at 49-50.
69. See Zeran v. America Online, Inc., 129 F.3d 327 (4th Cir. 1997) (service provider not liable for statement posted on online "bulletin board"), cert. denied, 118 S. Ct. 2341 (1998); Doe v. America Online, Inc., 718 So.2d 385 (Fla. Dist. Ct. App. 1998) (service provider not liable for statements made in chat rooms).
70. See, e.g., Zeran, 129 F.3d at 332-34; Aquino v. Electriciti, Inc., 26 Media L. Rep. (BNA) 1032 (Cal. App. Dep't Super. Ct., Sept 23, 1997). See also Blumenfeld, Carome & Jain, supra note 53, at 24.
71. 47 U.S.C. § 230(e)(1).
72. Id. § 230(e)(2).
73. Pub. L. No. 105-304, 112 Stat. 2860 (1998).
74. Id. § 202 (to be codified at 17 U.S.C. § 512).
75. See. e.g., Smith v. Hobby Lobby Stores, Inc., 968 F. Supp. 1356, 1364 (W.D. Ark. 1997).
76. See GTE New Media Servs., Inc. v. Ameritech Corp., 21 F. Supp.2d 27 (D.D.C. 1998) (the jurisdictional issue is now before the D.C. Circuit Court of Appeals on interlocutory appeal), 44 F. Supp.2d 313, 1999 WL 193891 (D.D.C.) (Mar. 29, 1999)); Telco Communications v. An Apple a Day, 977 F. Supp. 404 (E.D. Va. 1997).
77. Panavision Int'l L.P. v. Toeppen. 141 F.3d 1316, 1321 (9th Cir. 1998).
78. Compare, e.g., Inset Sys., Inc. v. Instruction Set, Inc., 937 F. Supp. 161 (D. Conn 1996) (passive website containing toll free number to call for orders supports jurisdiction, even without evidence that anyone from the forum actually had contacted the company from the forum state) with Blackburn v. Walker Oriental Rug Galleries, Inc., 999 F. Supp. 636 (E.D. Pa. 1998) (website that permitted visitors to send e-mail to website operator but had no other interactive features insufficient to support jurisdiction) and Millennium Entertainment, Inc. v. Millennium Music, LP, 4 Elec. Com. L. Rep. 249 (D. Ore. 1999) (BNA) (interactive website and "sporadic" contacts with forum insufficient to support jurisdiction).
79. 952 F. Supp. 1119 (W.D. Pa. 1997).
80. Id. 1124.
81. Id.
82. Id.
83. Id. at 1123, 1125.
84. See, e.g., Cybersell, Inc. v. Cybersell, Inc., 130 F.3d 414 (9th Cir. 1997); Atlantech Distribution, Inc. v. Credit Gen'l Ins, 30 F. Supp.2d 534, 538 (D. Md. 1998) (citing other cases); American Homecare Fed'n, Inc. v. Paragon Scientific Corp., 27 F. Supp.2d 109, 113 (D. Conn. 1998); Edberg v. Neogen Corp., 17 F. Supp.2d 104, 114 (D. Conn. 1998) (harmonizing Zippo with Inset Systems); One World Botanicals Ltd v. Gulf Coast Nutritional, Inc., 987 F. Supp. 317, 325 (D.N.J. 1997) (finding reasoning of Zippo "persuasive"); Hobby Lobby, 968 F. Supp. at 1369. But see Telco Communications, 977 F. Supp. at 406 (rejecting Zippo and following Inset Systems).
85. See Effross, supra note 36, at S-34.
86. See, e.g., International Shoe v. State of Washington, 326 U.S. 310, 316 (1945); Hanson v. Denckla, 357 U.S. 235, 253 (1958); World-Wide Volkswagen Corp. v. Woodson, 444 U.S. 286, 297 (1980).
87. See, e.g., Millennium Entertainment, supra note 69 (insufficient contacts to sustain jurisdiction where plaintiff instigated defendant's contact with forum for sole purpose of obtaining jurisdiction); see also Wyman v. Newhouse, 93 F.2d 313 (2d Cir. 1937) (ruling personal jurisdiction procured by fraud void); May Dep't Stores Co. v. Wilansky, 900 F. Supp. 1154, 163-64 (E.D. Mo. 1996) (same).
88. This mechanism is sometimes referred to as a "clickwrap" clause or license because the user "clicking" on an icon signifies assent to the terms and conditions. The name derives from the practice of software manufacturers of including license terms for use of the software, terms to which the purchaser assents by tearing off the "shrinkwrap" that covers the product packaging. See ProCD, Inc. v. Zeidenberg, 86 F.3d 1447, 1449 (7th Cir. 1996) (defining "shrink wrap").
89. Decker v. Circus Circus Hotel, 4 Elec. Com. L. Rep. 506 (D.N.J. 1999) (BNA).
90. See generally Erika S. Koster. Zero Privacy: Personal Data on the Internet, COMPUTER LAW., June 1999, at 7; Walter A. Effross, Preparing, Preventing, and Parrying Public and Private Profiling, STAN. J. L. & TECH. (Spring 1999) 〈www.wel.american.edu/pub/faculty/efrross/homepage.html〉; A. Michael Froomkin, Flood Control on the Information Ocean: Living With Anonymity, Digital Cash, and Distributed Databases, 15 U. PITT. J.L. & COM. 395 (1996).
91. See generally Erika S. Koster. Zero Privacy: Personal Data on the Internet, COMPUTER LAW., June 1999, at 7; Walter A. Effross, Preparing, Preventing, and Parrying Public and Private Profiling, STAN. J. L. & TECH. (Spring 1999) 〈www.wel.american.edu/pub/faculty/efrross/homepage.html〉; A. Michael Froomkin, Flood Control on the Information Ocean: Living With Anonymity, Digital Cash, and Distributed Databases, 15 U. PITT. J.L. & COM. 395 (1996).
92. See generally Erika S. Koster. Zero Privacy: Personal Data on the Internet, COMPUTER LAW., June 1999, at 7; Walter A. Effross, Preparing, Preventing, and Parrying Public and Private Profiling, STAN. J. L. & TECH. (Spring 1999) 〈www.wel.american.edu/pub/faculty/efrross/homepage.html〉; A. Michael Froomkin, Flood Control on the Information Ocean: Living With Anonymity, Digital Cash, and Distributed Databases, 15 U. PITT. J.L. & COM. 395 (1996).
93. Issued by the Clinton Administration, July 1, 1997. The White House, Framework for Global Electronic Commerce (visited Aug. 1, 1999) 〈www.whitehouse.gov/WH/New/Commerce〉.
94. U.S. Government Working Group on Electronic Commerce, First Annual Report (visited Aug. 1, 1999) 〈www.doc.gov/ecommerce/E-comm.pdf〉.
95. Id.; see also Koster, supra note 81, at 13.
96. FTC REPORT, supra note 33, at iii, 23-24. Recent studies suggest, however, that the situation online has improved considerably since the FTC submitted its report. See Federal Trade Comm'n, FTC Chairman Robert Pitofsky's Statement in Response to Georgetown University's Internet Privacy Policy Survey (visited Aug. 1, 1999) 〈www.ftc.gov/opa/1999/9905/culnan.htm〉 (noting that over 65% of consumer websites, accounting for nearly 99% of all consumer traffic, posted privacy policies and that 12% followed FTCs recommended best practices).
97. FTC REPORT, supra note 33, at iii, 23-24. Recent studies suggest, however, that the situation online has improved considerably since the FTC submitted its report. See Federal Trade Comm'n, FTC Chairman Robert Pitofsky's Statement in Response to Georgetown University's Internet Privacy Policy Survey (visited Aug. 1, 1999) 〈www.ftc.gov/opa/1999/9905/culnan.htm〉 (noting that over 65% of consumer websites, accounting for nearly 99% of all consumer traffic, posted privacy policies and that 12% followed FTCs recommended best practices).
98. FTC REPORT, supra note 33, at 25.
99. Id. at iii-iv, 31.
100. Id. at 5-6, 33.
101. Pub. L. No. 105-277, 112 Stat. 2681 (1998).
102. 112 Stat. 2681-2728.
103. The act also includes several safe harbor provisions and a provision requiring the FTC to conduct a new form of negotiated rulemaking with industry representatives. The FTC recently has conducted a rulemaking to implement COPPA, See 64 Fed. Reg. 22,750 (Apr. 27, 1999).
104. FTC REPORT, supra note 33, at 7-8.
105. Id. at 8-9. There are types of choice/consent regime proposed: the opt-in regime requires a visitor to make some affirmative step to consent to the collection of personal data for the stated uses; the opt-out regime requires a visitor to affirmatively prohibit the collection and use of personal information.
106. Id. at 9.
107. 4 Elec. Com. L. Rep. 522 (1999) (BNA).
108. Directive 95/46, 1995 O.J. 281/31.The United States and the European Union are in continuing negotiations on the proper application of the Privacy Directive to U.S. corporations and citizens.
109. In assessing the risk of collecting personal information, it should be noted that the FTC has shown its willingness to file an enforcement action under the Federal Trade Commission Act, 15 U.S.C. § 45(a), in particularly egregious cases. See Koster, supra note 81, at 11. Private rights of action may also be available. Id. at 9-11.
110. Ch. 311, 38 Stat. 717 (1914) (codified as amended at 15 U.S.C. §§ 41-64 (1994)).
111. 15 U.S.C. § 45(a)(1) (FTC Act § 5(a)(1)).
112. Id. § 52(b) (FTC Act § 12(b)).
113. Id. § 52(a)(1) (FTC Act § 12(a)(1)) (emphasis added).
114. State v. Cusick, 248 Iowa 1168, 84 N.W.2d 554, 556 (1957); Commonwealth v. Allison, 227 Mass. 57, 116 N.E. 265 (1917); McDonough v. Board of Educ., 198 N.Y.S.2d 401 (1959).
115. People v. Montague, 274 N.W. 347 (Mich. 1937); People on Complaint of Moffitt v. Wendelken, 156 N.Y.S.2d 129, 131 (1956); Edwards v. Lubbock County, 33 S.W.2d 482, 484 (Tex. 1930).
116. See GEORGE: ERIC ROSDEN & PETER ERIC ROSDEN, THE LAW OF ADVERTISING § 17.02 (1999).
117. Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301 et seq. (1994)).
118. See 36 Fed. Reg. 18,539 (Sept. 16, 1971).
119. FEDERAL TRADE COMM'N, BUREAU OF CONSUMER PROTECTION, DIETARY SUPPLEMENTS: AN ADVERTISING GUIDE FOR INDUSTRY 3 (1998) [hereinafter DIETARY SUPPLEMENTS].
120. FEDERAL TRADE COMM'N, BUREAU OF CONSUMER PROTECTION, DIETARY SUPPLEMENTS: AN ADVERTISING GUIDE FOR INDUSTRY 3 (1998) [hereinafter DIETARY SUPPLEMENTS].
121. See 64 Fed. Reg. 14,156 (Mar. 24, 1999); 63 Fed. Reg. at 24,996; 61 Fed. Reg. 48,707 (Sept. 16, 1996).
122. See ROSDEN, supra note 104, §§ 13.06[1], 16.02.
123. 21 U.S.C. § 343-1(a)(5).
124. DIETARY SUPPLEMENTS, supra note 107, at 3; see also Deception Policy Statement, 103 F.T.C. 174 (1983); Substantiation Statement, 104 F.T.C. 839 (1984); Food Advertising Enforcement Policy Statement, 59 Fed. Reg. 28,388 (June 1, 1994).
125. DIETARY SUPPLEMENTS, supra note 107, at 3.
126. Id. at 24.
127. Id. at 9, 10.
128. See FEDERAL TRADE COMM'N, GENERIC COPY TEST OF FOOD HEALTH CLAIMS IN ADVERTISING: EXECUTIVE SUMMARY 5-6 (1998).
129. Id. at 10. Using the following rating scale (5=very sure, 4=somewhat sure, 3=neither sure nor unsure, 2=somewhat unsure, 1=very unsure), consumers participating in the study gave the following "highly qualified" claim an average score of 2.88, slightly under 3.0, a score defined to mean that scientists were "neither sure nor unsure" of the diet/disease relationship: "Scientists have known for some time about the special health benefits of fruits and vegetables that are rich in antioxidants like vitamins A, C and E. Eating plenty of these foods can reduce the risk of certain kinds of cancer. Some medical studies are now finding that supplements containing these same antioxidant vitamins may also reduce the risk of cancer. It's too early to tell for sure. Some recent studies have failed to show that these vitamins protect against cancer. Longer term research is needed . . . FEDERAL TRADE COMM'N, GENERIC COPY TEST OF FOOD HEALTH CLAIMS IN ADVERTISING 71, App. A at 24 (emphasis added). In contrast, consumers gave the following less-qualified health claim a score of 3.39, a score falling between "somewhat sure" and "neither sure nor unsure": Scientists have known for some time about the special health benefits of fruits and vegetables that are rich in antioxidants like vitamins A, C and E. Eating plenty of these foods can reduce the risk of certain kinds of cancer. Some medical studies are now finding that supplements containing these same antioxidant vitamins may also reduce the risk of cancer. It looks promising, but scientists won't be sure until longer term research is completed. In the meantime, always eat a balanced diet with 5 to 9 servings of fruits and vegetables a day. And to make sure you get the antioxidant vitamins you want, try new ACE Antioxidant Supplement. Id. at 71, App. A at 23 (emphasis added).
130. 21 U.S.C. § 343-2.
131. See DIETARY SUPPLEMENTS, supra note 107, at 24.
132. Id.
133. 21 U.S.C § 341-2(a) (DSHEA § 5).
134. Id.
135. WEBSTER'S II NEW RIVERSIDE UNIV. DICTIONARY 118 (A.H. Soukhanov & K. Ellis eds., 1994).
136. 21 U.S.C. § 321(m) (FDCA § 201 (m)) (emphasis added).
137. 335 U.S. 345 (1948).
138. 335 U.S. 355 (1948).
139. Kordel, 335 U.S. at 350.
140. Urbuteit, 335 U.S. at 357; see Kordel, 335 U.S. at 349-50.
141. Kordel, 335 U.S. at 349.
142. United States v. 110 V Vapazone, 194 F. Supp. 332 (N.D. Cal. 1961) (physical therapist acquired pamphlet from German vendor explaining use of device she bought while in Germany, then received delivery of device in United States).
143. United States v. Hohensee, 243 F.2d 367 (3d Cir. 1957) (lectures following closely on introduction of product locally); see also Nature Food Ctrs., Inc. v. United States, 310 F.2d 67, 70 (1st Cir. 1962) (lecture notes sold separately at lectures extolling virtue of products might "incur liability for false labeling").
144. United States v. Vital Health Prods, Ltd., 786 F. Supp. 761 (E.D. Wis. 1992), aff'd sub nom. United States v. Lebeau, 985 F.2d 563 (7th Cir. 1993) (considering newsletter published through separate corporation owned by manufacturer extolling virtues of "peroxide therapy" part of labeling of manufacturer's peroxide products); United Stales v. Sene X Eleemosynary Corp., Inc., 479 F. Supp. 970 (S.D. Fla. 1979) (holding separately organized "club" operated by person in close association with manufacturer and used to distribute information part of integrated scheme).
145. 218 F. Supp. 208, 209 (E.D. Mich. 1963), aff'd, 344 F.2d 288 (6th Cir. 1965).
146. 218 F. Supp. at 209-10.
147. Id. at 211-12.
148. 103 F. Supp. 626 (W.D.N.Y. 1951).
149. Id. at 628.
150. Id.
151. 338 F.2d 157, 159-60 (2d Cir. 1964).
152. Id.
153. Id. at 160.
154. Id. at 158-59.
155. 98 F. Supp. 23 (S.D. Cal. 1951), aff'd sub nom. Alberty Food Prods. v. United States, 194 F.2d 463 (9th Cir. 1952).
156. Id.
157. Id.
158. 21 U.S.C. § 321(g)(1)(B) (FDCA § 201(g)(1)(B)).
159. United States v. 46 Cartons . . . Fairfax Cigarettes, 113 F. Supp. 336 (D. N.J. 1953); 21 C.F.R. § 201.128. See also, United States v. B-Complex Cholinos Capsules, 362 F.2d 923, 926-27 (3d Cir. 1966); United States v. Vital Health Prods., Ltd., 786 F. Supp. 761, 772 (E.D. Wis. 1992), aff'd sub nom. Lebeau, 985 F.2d at 563; 250 Jars. 218 F. Supp. at 211.
160. 21 C.F.R. § 201,128.
161. See, e.g., V.E. Irons, Inc. v. United States, 244 F.2d 34, 40, n.6 (1st Cir. 1957).
162. 362 F.2d 923 (3d Cir. 1966).
163. Id. at 926.
164. Id.
165. 21 U.S.C. § 321 (g)(1)(B) (emphasis added).
166. Id. § 343(r)(3)(B). Under the NLEA, Pub. L. No. 101-535, 104 Stat. 2353 (codified at 21 U.S.C. §§ 301 note, 321, 337, 343, 343 notes, 343-1, 343-1 note, 345, 371 (1994)), FDA issues regulations approving health claims satisfying the rigorous "significant scientific agreement" standard. 21 U.S.C. § 343(r)(3)(B). Under established FDA policy, claims not satisfying this standard have been prohibited. The recent First Amendment decision in Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999), reh'g en banc denied, 1999 U.S. App. LEXIS 5954 (D.C. Cir. Apr. 2, 1999), applied the commercial speech doctrine to health claims. The decision requires FDA to reconsider four specific health claims banned under this policy to determine if they can be presented in a manner that renders the claims nondeceptive (and thus protected by the First Amendment) through the use of qualifying language or disclaimers. The Pearson decision also requires FDA to more fully explain the "significant scientific agreement standard" 164 F.3d at 654. For a discussion of First Amendment issues presented by the NLEA health claims policy, see Edward Dunkelberger & Sarah E. Taylor, The NLEA, Health Claims, and the First Amendment 48 FOOD & DRUG L.J. 631 (1993).
167. Pub. L. No. 105-115, 111 Stat. 2296 (1997).
168. 21 U.S.C. §§ 343(r)(3)(C), 343(r)(1)(B); see also 21 C.F.R. § 101.14(a)(1). FDA-approved health claims are codified at 21 C.F.R. pt. 101, subpt. E.
169. 21 U.S.C. § 343(r)(1)(B).
170. 63 Fed. Reg. 23,624, 23,632 (Apr. 19, 1998).
171. 21 C.F.R. § 101.72.
172. 21 U.S.C. § 321(g)(1)(C) (FDCA § 201(g)(1)(B)).
173. Id. §§ 321(n), 343(a).
174. Fed. Reg. at 23,624.
175. Id. at 23,632.
176. Id.
177. 21 U.S.C. §§ 343(q)(1),(r)(1)(A).
178. Id. § 321(f)(1).
179. 21 C.F.R. § 101.13. FDA-approved claims are codified at 21 C.F.R. pt. 101, subpt. D.
180. Id. § 101.13(i).
181. See FEDERALTRADE COMM'N, ENFORCEMENT POLICY STATEMENT ON FOOD ADVERTISING 6-17(May 1994).