Current Health Legislation That Needs Your Attention

Current Health Legislation That Needs Your Attenti...

Current Health Legislation That Needs Your Attention


URGENT! No Cloned Meat for Dinner!
So far, almost 40,000 consumers activists like you have written in to
the FDA. Now, responding to serious concern about its views on cloned
milk and meat, FDA has given the public an extra 30 days to voice their
opinions on whether milk and meat from cloned animals should be allowed
into our food, and if they should be labeled. FDA does not think labels should be required. Tell them what you think!

Your efforts have made a difference!
Thanks to your help, a strong bill was just introduced last Monday in
the US House of Representatives that would fix our broken drug safety
system and give the FDA more authority over drug companies. Let’s keep up the momentum and make sure this important bill becomes law! Right
now, drug company lobbyists are working hard to defeat this bill. Show
lawmakers in Congress that your voice is stronger than any special
interest. Tell your House member to stand up for patient safety and support this bill!

HR 4282, The Health Freedom Protection Act
To amend the Federal Food, Drug, and Cosmetic Act concerning foods and dietary supplements, to amend the Federal Trade Commission Act concerning the burden of proof in false advertising cases, and for other purposes. Introduced by Rep. Paul [TX-14] 11/9/2005. Currently has 12 cosponsors. Referred to the Subcommittee on Health. We had Rep. Ron Paul on the Deborah Ray show Nov. 1st discussing this bill and we've had discussions with a Senator about introducing it in the Senate. AAHF is also part of the Stop FDA Censorship coalition that is working on passing this bill.

HR 2792, Access To Medical Treatment
To amend the Food Drug and Cosmetic Act to allow persons and legally authorized health care practitioners access to any method of medical treatment approved or non-approved by the FDA that is proven to be safe and effective. Introduced by Rep. Burton [IN-5] 6/8/2005. Currently has 10 cosponsors. Referred to the Subcommittee on Health. We've been in discussion with about a dozen other members who will sign on shortly. Additionally, a cosponsor will be sending a "Dear Colleague" letter to other members. After meeting with Sen. Harkin, he has agreed to introduce AMTA in the Senate. His office has drafted the bill (the same as the one in the House) and we are working with a few other senators about being a cosponsor and it will be introduced in the Senate in the beginning of 2006. In the past two months, over 20,000 letters have been sent to Congress in support of this important bill and that's just the beginning. We are also contacting other organizations to gain their support of AMTA.

H.R. 4011, Mercury in Dental Fillings Disclosure and Prohibition Act
To prohibit after 2008 the introduction into interstate commerce of mercury intended for use in a dental filling, and for other purposes. Introduced by Rep Watson [CA-33] 10/6/2005. Currently has 14 cosponsors. Referred to the Subcommittee on Health. AAHF is working with the International Academy of Oral Medicine & Toxicology ( to raise awareness and support of this crucial bill.

HR 2352, Consumer Access to Health Information
Clarifies that truthful health labeling claims on a food or a dietary supplement shall not cause a food or supplement to be regulated as a drug by the FDA. Introduced by Rep Paul [TX-14] 5/12/2005. Currently there are no cosponsors. Referred to the Subcommittee on Health.

HR 2485, DSHEA Full Implementation
To ensure that the goals of the Dietary Supplement Health and Education Act of 1994 are met by authorizing appropriations to fully enforce and implement such Act and the amendments made by such Act, and for other purposes. Introduced by Rep Burton [IN-5] 5/19/2005. Currently has 1 cosponsor. Referred to the Subcommittee on Health.

HR 1545, Deductibility of Supplements as Medical Expenses
Similar to HR 2486, would treat expenses for certain meal replacement and dietary supplement products as being tax deductible as a medical care cost. Introduced by Rep Cannon [UT-3] 4/12/2005. Currently has 19 cosponsors. Referred to the House Committee on Ways and Means.

HR 2486, Dietary Supplement Tax Fairness Act of 2005
Similar to HR 1545, to amend the Internal Revenue Code of 1986 to provide that amounts paid for foods for special dietary use, dietary supplements, or medical foods shall be treated as medical expenses. Introduced by Rep Burton [IN-5] 5/19/2005. Currently has 5 cosponsors. Referred to the House Committee on Ways and Means.

S 334, Prescription Drug Reimportation
Would allow U.S. residents through pharmacists and prescription drug wholesalers to reimport prescription drugs from Canada, Australia, Japan, New Zealand, Switzerland, and certain European Union nations. Introduced by Sen. Dorgan [ND] 2/9/2005. Currently has 30 cosponsors. Referred to the Committee on Health, Education, Labor, and Pensions. Hearings held. Hearings printed: S.Hrg. 109-143. Introduced by Rep Emerson [MO-8] 2/9/2005. Currently has 22 cosponsors. Referred to the Subcommittee on Health.


HR 2510, Dietary Supplement Regulatory Implementation
Unlike the positive HR 2485, this bill is trying a back door approach to modifying DSHEA and would establish mandatory adverse event reporting for supplements. Introduced by Rep Pallone [NJ-6] 5/19/2005. Has 1 cosponsor. Referred to the Subcommittee on Health.

HR 3156, Dietary Supplement Access and Awareness Act
To amend the Federal Food Drug and Cosmetic Act with respect to dietary supplements. Would subject dietary supplements to even stricter oversight than these products experienced prior to the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994. This was the infamous HR 3377 bill in the 108th Congress but with a new section. Introduced by Rep Davis [CA-53] 6/30/2005. Currently has 2 cosponsors (had 10 cosponsors in 108th Congress). Referred to the Subcommittee on Health.

S 1137 & H.R.3937 DHEA Removal
Classifies DHEA supplements as an anabolic steroid, adding it to the list of DEA controlled substances, and removing it from the market. Introduced by Sen. Grassley [IA] 5/26/2005. Currently has 4 cosponsors. Referred to the Committee on the Judiciary. Introduced by Rep Sweeney [NY-20] 9/28/2005. Currently has 1 cosponsor. Referred to the Subcommittee on Health.

S 729 & HR 1507, Food Safety Administration
Creates a new food agency and transfers the FDA food functions, except dietary supplements, to the new agency. The "Food Czar" legislation would essentially repeal the Dietary Supplement Act (DSHEA). Introduced by Sen. Durbin [IL] 4/6/2005. Currently has 1 cosponsor (Sen. Clinton). Read twice and referred to the Committee on Agriculture, Nutrition, and Forestry. Rep DeLauro [CT-3] 4/6/2005. Currently has 8 cosponsors. Referred to the Subcommittee on Health.


There are about 10 other bills that we are considering adding to our Action Center for monitoring and encouraging grassroots activity. Below are two possible upcoming bills.

S.722 (108th Congress) Dietary Supplement Safety Act (Not yet introduced)
A bill to amend the Federal Food, Drug, and Cosmetic Act to require that manufacturers of dietary supplements submit to the Food and Drug Administration reports on adverse experiences with dietary supplements, and for other purposes. Introduced by Sen. Durbin. Had 4 cosponsors. Durbin's office recently told us that they will be reintroducing this bill in early 2006 and that they are adding new language. They also sent us the list of organizations that support it and are working on gaining more support. Sen. Durbin may not reintroduce this bill if he finds that Sen. Harkin & Hatch's "compromise" AER bill (see below) meets his requirements.

Adverse Event Reporting (AER) for Dietary Supplements Bill (Not yet introduced)
A June 21 2004 debate on the Senate floor between Sens. Richard Durbin (D-Ill.), Tom Harkin (D-Iowa) and Orrin Hatch (R-Utah) resulted in an agreement to collaborate on legislation during this session of Congress creating mandatory adverse event reporting (AER) for dietary supplements. Spurred by Durbin's introduction of a Department of Defense (DOD) authorization bill amendment which would require companies selling certain dietary supplements on military bases to report serious AERs to the government. Harkin and Hatch immediately introduced an alternative amendment that would have required the Department of Health and Human Services to develop a national AER reporting system and report back to Congress within six months. The debate went from Dietary Supplement Health and Education Act (DSHEA), enforcement by the Food and Drug Administration (FDA), to Ephedra and androstenedione and then to other dietary supplement topics. The debate concluded with an agreement to withdraw the amendments and work together to add a mandatory AER system to pending legislation classifying steroid precursors as controlled substances. The promised "AER Compromise" bill never happened in the 108th session so Sen. Durbin kept introducing his amendment to DOD authorizing bills as leverage to get the AER compromise bill going.

Well that time is about now. Sen. Harkin & Hatch are drafting with the assistance of HELP (Health, Education, Labor And Pensions) Chairman, Enzi an Adverse Event Reporting bill. Why are long-time supporters of dietary supplements Hatch & Harkin working with one of our most vocal opponents? Sen. Durbin has gained a lot of power in Congress by becoming Minority Whip (Democrat's second in command). Durbin needs Hatch & Harkin because he's not on the HELP committee (and they are) and he needs their support to get ANY type of AER bill through the committee. Any HELP Committee mark-up on the Harkin, Hatch, Durbin, Enzi FDA AER for Supplements bill is off the agenda until next year. No further negotiations have been held. As soon as we have more information on this bill, we will let our members know.


Don't be surprised if the long-awaited Good Manufacturing Practices (GMPs) for the dietary supplement industry is released during the holidays (they were submitted to the OMB two months ago). These long delayed GMPs are expected to be agreeable to the dietary supplement industry but there are concerns that the rule will not be put forth without the signature of a confirmed commissioner.

Which leads us the beleaguered FDA which has had high turnover during the past several years. After the speedy resignation of FDA Commissioner, Lester Crawford, President Bush named NCI Andrew von Eschenbach, M.D., an oncologist and current head of the National Cancer Institute (NCI) of the National Institutes of Health (NIH), as FDA's acting commissioner. Word around town is that Bush may not nominate a permanent replacement for quite a while (maybe up to 18 months) due to the politicization of the position and the resulting difficulty of winning confirmation in the Senate.

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