SCIENTIFIC SUBSTANTIATION OF MECHANISMS FOR IMPLEMENTING A HEALTH INSURANCE SYSTEM
Abstract
ABSTRACT. The relationships between health insurance and access to health
care, and health insurance and care received, have been the subject of hundreds of
studies over the past several decades. More recently, the relationship between health
insurance and health outcomes has also been examined. This chapter describes the
Committee's analytic approach to its critical review of this research to inform the
understanding of the relationships between health insurance, health care, and health
outcomes for adults.
References
REFERENCES
[1] Section 5 of the FTC Act prohibits “unfair or deceptive acts or practices in or
affecting commerce,” and Section 12 prohibits the dissemination of false
advertisements for foods, drugs, devices, services, or cosmetics. 15 U.S.C. §§ 45,
52. Section 15 of the FTC Act defines “false advertisement” as “advertising that
is misleading in a material respect[.]” 15 U.S.C. § 55(a)(1).
[2] See FTC Policy Statement on Deception, appended to Cliffdale Assocs., Inc., 103
F.T.C. 110, 174 (1983), https://www.ftc.gov/public-statements/1983/10/ftc-
policy-statement-deception (“Deception Policy Statement”); FTC Policy
Statement Regarding Advertising Substantiation, appended to Thompson Med.
Co., 104 F.T.C. 648, 839 (1984), aff’d, 791 F.2d 189 (D.C. Cir. 1986),
https://www.ftc.gov/public-statements/1983/03/ftc-policy-statement-regarding-
advertising-substantiation (“Substantiation Policy Statement”).
[3] See discussion at Section III.B.
[4] See, e.g., Complaint at 7, FTC v. Sunrise Nutraceuticals, Inc., No. 9:15-cv-81567
(S.D. Fla. Nov. 16, 2015) (stipulated final judgment) (claims made in a press
release and on website); Complaint at 5-24, FTC v. NourishLife, LLC, No. 1:15-
cv-00093 (N.D. Ill. Jan. 7, 2015) (stipulated order) (claims made in social media,
sponsored links, brochures, product packaging, emails, and websites); Complaint
at 5-13, FTC v. Sensa Prods., LLC, No. 1:14-cv-00072 (N.D. Ill. Jan. 7, 2014)
(stipulated final judgment) (claims made in a book, infomercials, print and radio
ads, and email); Daniel Chapter One, 148 F.T.C. 832, 904-35 (2009) (initial
decision) (“Daniel Chapter One Initial Decision”) (claims made in radio
programs, newsletter, catalog, and website).
[5] For a discussion of the five factors that determine whether speech is commercial,
see POM Wonderful, LLC, 155 F.T.C. 1, 74-75 (2013) (citing R.J. Reynolds
Tobacco Co., 111 F.T.C. 539, 544-46 (1988)), aff’d in part, POM Wonderful LLC
v. FTC, 777 F.3d 478, 504-05 (D.C. Cir. 2015).
[6] See, e.g., FTC v. LeadClick Media, LLC, 838 F.3d 158, 167-73 (2d Cir. 2016)
(affiliate advertising network); POM Wonderful, LLC, 155 F.T.C. at 82-84
(individual officer); FTC v. Fitness Brands, Inc., No. 1:12-cv-23065-CMA (S.D.
Fla. Aug. 23, 2012) (stipulated final judgment) (infomercial host); Dreher, 150
F.T.C. 560 (2010) (consent order) (expert endorser); Campbell Mithun LLC,133
F.T.C. 702 (2002) (consent order) (ad agency); Tru-Vantage Int’l, LLC, 133
F.T.C. 299 (2002) (consent order) (infomercial producer).
[7] See Novartis Corp. v. FTC, 223 F.3d 783, 787-88 (D.C. Cir. 2000) (corrective
advertising is appropriate where challenged ads played a substantial role in
creating or reinforcing a false belief about a product and that misbelief is likely to
linger).
[8] See, e.g., Memorandum Opinion and Order at 10, FTC v. Kevin Trudeau, No. 1:03-
cv-03904 (N.D. Ill. Aug. 7, 2008) (imposing three-year ban on Trudeau from
participating in any infomercial for any product).
[9] Memorandum of Understanding Between the Fed. Trade Comm’n and the Food
and Drug Admin., 36 Fed. Reg. 18,539 (Sept. 16, 1971),
www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandi
ngMOUs/DomesticMOUs/ucm115791.htm.
[10] Some forms of marketing may constitute both labeling and advertising under the
two agencies’ laws. For example, a website where a dietary supplement can be
purchased would fall within the FDA’s definition of labeling in addition to being
advertising under FTC law.
[11] DSHEA amended the Federal Food, Drug, and Cosmetic Act (FDCA). Pursuant
to DSHEA, “structure/function” refers to an FDA regulatory term for a category of labeling claims that describe the normal structure or function of the human body
or general well-being. Under FDA law, such claims must be truthful, not
misleading and substantiated, but do not require prior FDA review or approval.
See Structure/Function Claims, Fed. Drug Admin. (last updated Dec. 14, 2017),
www.fda.gov/food/food-labeling-nutrition/structurefunction-claims. The term
has no legal significance under FTC law relating to claim substantiation.
[12] See Daniel Chapter One, 148 F.T.C. 832, 1086 (2009) (finding no authority that
the DSHEA amendment to the FDCA regarding “structure/function” claims is
binding on the Commission), aff’d, 405 Fed. App’x 505 (D.C. Cir. 2010).
[13] Id. at 1085-86 (rejecting Respondents’ argument that the FDCA distinctions
between foods, drugs, or dietary supplements are binding on the FTC’s
enforcement of Sections 5 and 12 of the FTC Act). See also FTC v. NPB Advert.,
Inc., 218 F. Supp. 3d 1352, 1365 n.4 (M.D. Fla. 2016) (passage of DSHEA
“imposes no duty on the FTC in this false advertising action”); Bristol-Myers Co.
v. FTC, 738 F.2d 554, 559 (2d Cir. 1984) (“FDA requirements and regulations . .
.simply do not govern this case”).
[14] See Enforcement Policy Statement on Food Advertising, 59 Fed. Reg. 28,388,
28,393-94 (June 1, 1994), www.ftc.gov/public-statements/1994/05/enforcement-
policy-statement-food-advertising (“Food Advertising Policy Statement”).
[15] Id.
[16] In 2008, the FDA issued a guidance document detailing how it evaluates
substantiation for structure/function claims in dietary supplement labeling, stating,
“The FTC has typically applied a substantiation standard of ‘competent and
reliable scientific evidence’ to claims about the benefits and safety of dietary
supplements and other health-related products. FDA intends to apply a standard
for the substantiation of dietary supplement claims that is consistent with the FTC
approach.” Guidance for Industry: Substantiation for Dietary Supplement Claims
Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act, Food
and Drug Admin. (Jan. 2009), https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/guidance-industry-substantiation-
dietary-supplement-claims-made-under-section-403r-6-federal-food.
[17] Novartis Corp., 223 F.3d at 787; Kraft, Inc., 114 F.T.C. 40, 121-22 (1991), aff’d,
970 F.2d 311 (7th Cir. 1992).
[18] Deception Policy Statement, 103 F.T.C. at 174-75, 179. See also FTC v. Roca
Labs, Inc., 345 F. Supp. 3d 1375, 1385 (M.D. Fla. 2018); FTC v. Direct Mktg.
Concepts, Inc., 569 F. Supp. 2d 285, 298 (D. Mass. 2008), aff’d, 624 F.3d 1 (1st
Cir. 2010); FTC v. Nat’l Urological Group, Inc., 645 F. Supp. 2d 1167, 1189 (N.D.
Ga. 2008); Removatron Int’l Corp. v. FTC, 884 F.2d 1489, 1497 (1st Cir. 1989).
