Bioidentical Hormones - U.S. Senate Special Committee on Aging
Bioidentical Hormones - U.S. Senate Special Committee on Aging Bioidentical Hormones - U.S. Senate Special Committee on Aging
35 PREPARED STATEMENT OF THE FEDERAL TRADE COMMISSION on ALTERNATIVE HORMONE REPLACEMENT THERAPY PRODUCTS Before the SENATE SPECIAL COMMITTEE ON AGING Washington. DC Aprfl 19,2907
1. Introduction 36 Chairman Kohl, Ranking Member Smith, and Members of the
- Page 1 and 2: S. HRG. 110-129 Bioidentica
- Page 3 and 4: CONTENTS Page Opening Statement of
- Page 5 and 6: 2 The sale of bioidentical hormone
- Page 7 and 8: 4 ever, as Dr. Wartofsky points out
- Page 9 and 10: 6 with every stage of the disease:
- Page 11 and 12: 8 I am pleased to appear before thi
- Page 13 and 14: 10 When the trials began, many rese
- Page 15 and 16: Women who began treatment more than
- Page 17 and 18: 14 One small trial using oral estra
- Page 19 and 20: 16 FDA is aware that a growing numb
- Page 21 and 22: 18 DEPARTMENT OF HEALTH & HUMAN SER
- Page 23 and 24: 20 safety and efficacy. However, as
- Page 25 and 26: 22 adulteration and misbranding pro
- Page 27 and 28: 24 The 2002 CPG reflects FDA's curr
- Page 29 and 30: 26 Equally concerning are claims by
- Page 31 and 32: 28 concerned about the use and mark
- Page 33 and 34: 30 Part I: Materials and Partnershi
- Page 35 and 36: 32 drugs, when the compounding of t
- Page 37: 34 Our staff identified 34 Web site
- Page 41 and 42: diet and fitness products. 5 For ex
- Page 43 and 44: include "natural" progesterone crea
- Page 45 and 46: 42 unique to the computer age, such
- Page 47 and 48: computer users to spam(ftuce.0ov -
- Page 49 and 50: 46 accuracy of advertising for heal
- Page 51 and 52: 48 Now, you have identified in your
- Page 53 and 54: 50 claim." Therefore, since the ter
- Page 55 and 56: 52 Such quality control problems ha
- Page 57 and 58: 54 Statement Before the U.S. <stron
- Page 59 and 60: in the U.S., whereas WHI participan
- Page 61 and 62: 58 between science and hearsay and
- Page 63 and 64: 60 How can we determine whether bio
- Page 65 and 66: 62 doctors-are not getting the obje
- Page 67 and 68: 64 27. Writing Group for the PEPI T
- Page 69 and 70: 66 Dr. MANSON. Well, I think that m
- Page 71 and 72: 68 Statement of Leonard Wartofsky,
- Page 73 and 74: 70 in the WHI. In fact, no study as
- Page 75 and 76: In summary, the Endocrine Society i
- Page 77 and 78: 74 The FDA also regulates aspects o
- Page 79 and 80: Statement of Loyd V. Allen, Jr., Ph
- Page 81 and 82: Statement of Loyd V. Allen, Jr., Ph
- Page 83 and 84: Statement of Loyd V. Allen, Jr., Ph
- Page 85 and 86: 82 Senator SMITH. Dr. Allen, as I h
- Page 87 and 88: 84 Now, when you are talking about
1. Introducti<strong>on</strong><br />
36<br />
Chairman Kohl, Ranking Member Smith, and Members of the <str<strong>on</strong>g>Committee</str<strong>on</strong>g>, I am Eileen<br />
Harringt<strong>on</strong>, Deputy Director of the Bureau of C<strong>on</strong>sumer Protecti<strong>on</strong> of the Federal Trade<br />
Commissi<strong>on</strong> ("FTC" or "Commissi<strong>on</strong>").' I appreciate the opportunity to-discuss the<br />
Commissi<strong>on</strong>'s efforts to address the misleading <strong>on</strong>line advertising of "alternatives" to horm<strong>on</strong>e<br />
replacement therapy as well as its work to combat all types of Intemet fraud.<br />
Am<strong>on</strong>g its many benefits, the Internet provides c<strong>on</strong>sumers with access to a vast array of<br />
informati<strong>on</strong> and products, including health-related items. Unfortunately, the <strong>on</strong>line medium also<br />
provides an opportunity for irresp<strong>on</strong>sible marketers to prey <strong>on</strong> c<strong>on</strong>sumers with false or<br />
misleading claims that can cause ec<strong>on</strong>omic injury and have potentially serious c<strong>on</strong>sequences for<br />
c<strong>on</strong>sumers' health. Therefore, pursuant to its broad authority to prevent "unfair or deceptive acts<br />
or practices," 2 the FTC has a l<strong>on</strong>gstanding and active program to protect c<strong>on</strong>sumers in the <strong>on</strong>line<br />
envir<strong>on</strong>ment.<br />
This testim<strong>on</strong>y provides an overview of the FTC's efforts with respect to health-related<br />
fraud, including an explanati<strong>on</strong> of its jurisdicti<strong>on</strong> over health products and a discussi<strong>on</strong> of the<br />
FTC/FDA project to address the misleading marketing of horm<strong>on</strong>e replacement therapy<br />
alternatives. Pursuant to the <str<strong>on</strong>g>Committee</str<strong>on</strong>g>'s request, the testim<strong>on</strong>y then discusses the FTC's<br />
broader program to combat <strong>on</strong>line scams in general.<br />
'This written statement presents the views of the Commissi<strong>on</strong>. My oral testim<strong>on</strong>y and<br />
resp<strong>on</strong>ses to questi<strong>on</strong>s reflect my views and do not necessarily represent the views of the<br />
Commissi<strong>on</strong> or any individual Commissi<strong>on</strong>er.<br />
2 Secti<strong>on</strong> 5 of the Federal Trade Commissi<strong>on</strong> Act, 15 U.S.C. § 45(a). In additi<strong>on</strong>, Secti<strong>on</strong> 12 of<br />
the Federal Trade Commissi<strong>on</strong> Act prohibits the false advertisement of "food, drugs, devices,<br />
services, and cosmetics." 15 U.S.C. § 52.