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
39 On all three fronts, the FTC frequently collaborates with the FDA on health issues. Although the FTC and the FDA both have jurisdiction over health-related products, the agencies coordinate closely pursuant to a longstanding agreement" Under this agreement, the FTC has primary responsibility to regulate the advertising of over-the-counter drugs, food, cosmetics, and devices, while the FDA regulates the labeling of these products. The FDA also has primary responsibility to regulate claims made in both the advertising and labeling of prescription drugs. In many cases, however, the agencies work together to leverage resources and have a greater effect on the marketplace. The agencies' project to address misleading claims for alternative hormone replacement therapy products sold on the Internet is a good example of these joint efforts. B. Targeting Deceptive Claims for Hormone Replacement Therapy Alternatives Hormone replacement therapy is medication containing female hormones that doctors prescribe to treat symptoms of menopause as well as other conditions. In 2002, the Women's Health Initiative (sponsored by the National Institutes of Health) terminated a clinical trial of hormone itheoapy because the overai nealth risks (e.g., erlacemen of heart disease and breast cancer) outweighed the benefits of the therapy." This stunning news fueled the growth of a market promoting "natural alternatives" to hormone replacement therapy. These products ° Working Agreement Between the FTC and FDA, 3 Trade Reg. Rep. (CCH) T 9,859.01 (1971). " National Institutes of Health News Release, July 9, 2002, www.nhlbi.nih.2ov/new/ press/02- 07-09.htm. Since that time, researchers further analyzed the trial data and one recent review suggests that the heart risks may have been overstated. Jacques E. Rossouw, MD, Postnenopausal Hormone Therapy and Risk of Cardiovascular Disease by Age and Years Since Menopause, 297 JAMA 1465-1477 (2007).
include "natural" progesterone creams and sprays." Some of the marketers claim that their 40 "natural" progesterone products are safe and effectively prevent, treat, or cure serious diseases, such as cancer, heart disease, and osteoporosis. However, the FTC is not aware of competent and reliable scientific evidence to substantiate these claims.' 3 Therefore, working in conjunction with the FDA, FTC staff surfed the Internet for websites claiming that their progesterone products were safe or could prevent, treat, or cure serious diseases. The staff used search engines to identify relevant websites and then examined the sites to determine whether they made potentially deceptive claims. The FDA staff conducted its own surf to identify websites. The FTC and FDA staff coordinated efforts and compared surf results so that each agency would send letters to different targets and therefore have a greater impact. The FTC found 34 websites making questionable safety and disease prevention claims and sent waming letters to each. The FDA staff sent letters to an additional 16 websites. The FTC staff's emails explained that the marketers must have competent and reliable scientific evidence to substantiate any health claim they make about their products. The emails urged the marketers to review their product claims to make sure they complied with the law. In addition, the FTC's emails provided information about FDA law, as well as links to resources the 12 In addition, some online pharmacies offer compounded hormones which they claim are customized to an individual's needs based on an analysis of a saliva sample. " FTC law requires that marketers possess competent and reliable scientific evidence to substantiate claims about the safety and efficacy of health-related products, including dietary supplements. FTC Policy Statement Regarding Advertising Substantiation, appended to Thompson Med. Co., 104 F.T.C. 648, 839 (1984), www.ftc.&ov/bco/auides/ ad3subst htm.
- 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 and 38: 34 Our staff identified 34 Web site
- Page 39 and 40: 1. Introduction 36 Chairman Kohl, R
- Page 41: diet and fitness products. 5 For ex
- 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
- Page 89 and 90: 86 The only thing the WHI proved wa
- Page 91 and 92: 88 Testimony Of T.S. Wiley before t
include "natural" progester<strong>on</strong>e creams and sprays." Some of the marketers claim that their<br />
40<br />
"natural" progester<strong>on</strong>e products are safe and effectively prevent, treat, or cure serious diseases,<br />
such as cancer, heart disease, and osteoporosis. However, the FTC is not aware of competent<br />
and reliable scientific evidence to substantiate these claims.' 3<br />
Therefore, working in c<strong>on</strong>juncti<strong>on</strong> with the FDA, FTC staff surfed the Internet for<br />
websites claiming that their progester<strong>on</strong>e products were safe or could prevent, treat, or cure<br />
serious diseases. The staff used search engines to identify relevant websites and then examined<br />
the sites to determine whether they made potentially deceptive claims. The FDA staff c<strong>on</strong>ducted<br />
its own surf to identify websites. The FTC and FDA staff coordinated efforts and compared surf<br />
results so that each agency would send letters to different targets and therefore have a greater<br />
impact. The FTC found 34 websites making questi<strong>on</strong>able safety and disease preventi<strong>on</strong> claims<br />
and sent waming letters to each. The FDA staff sent letters to an additi<strong>on</strong>al 16 websites.<br />
The FTC staff's emails explained that the marketers must have competent and reliable<br />
scientific evidence to substantiate any health claim they make about their products. The emails<br />
urged the marketers to review their product claims to make sure they complied with the law. In<br />
additi<strong>on</strong>, the FTC's emails provided informati<strong>on</strong> about FDA law, as well as links to resources the<br />
12 In additi<strong>on</strong>, some <strong>on</strong>line pharmacies offer compounded horm<strong>on</strong>es which they claim are<br />
customized to an individual's needs based <strong>on</strong> an analysis of a saliva sample.<br />
" FTC law requires that marketers possess competent and reliable scientific evidence to<br />
substantiate claims about the safety and efficacy of health-related products, including dietary<br />
supplements. FTC Policy Statement Regarding Advertising Substantiati<strong>on</strong>, appended to<br />
Thomps<strong>on</strong> Med. Co., 104 F.T.C. 648, 839 (1984), www.ftc.&ov/bco/auides/ ad3subst htm.
Change language