Healthcare Legislation!
Dietary Supplement Reform

Healthcare legislation is all slanted in favor of prescription drugs and the traditional medical establishment.  The media, congress and any organization that benefits from big pharma spreading its cash around have little incentive to try for change.

One example of how entrenched the pharmaceutical industry is in congress is seen in the "Direct to Consumer (DTC)" ads on TV.  

In response to complaints from their constituents about TV drug commercials, various congressmen over the years have been trying to get healthcare legislation in place that would allow the FDA to ban DTC ads.   

All efforts have failed since a series of court decisions beginning in 2007 ruled that product advertisements were a form of commercial speech and banning or restricting them would violate the First Amendment protections of freedom of speech. 

Why does the pharmaceutical industry keep shelling out billions of dollars every year (est. $4.16 billion in 2011) for DTC ads?  Simple, they work.  Since the advent of such advertising, it is estimated by physicians that office appointments to discuss a particular drug for a particular condition rose by 27%.

The U.S. and New Zealand are the only two countries in the world that allow such advertising.  Why?  Could it be that the intention is to brainwash U.S. citizens that pharmaceuticals are the only answer to sickness?  So it would seem given the intense battle the pharmaceutical industry has waged against giving dietary supplements and natural cures the same rights.

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The FDA Power Grab

Regarding the FDA, current regulations give them the power to totally tie the hands of anyone or any company engaged in manufacturing or marketing dietary supplements. 

It is absolutely forbidden to make any claims to the effect that a supplement might actually cure, heal, prevent or mitigate a disease condition. 

The catch is that, under current healthcare law, only an FDA authorized drug can make those claims, so if anyone makes such a claim for a dietary supplement that has not been through the FDA New Drug Approval process then its off to jail or pay a heavy fine for selling an unapproved drug.

Similarly, personal testimonies as to how a supplement healed or cured a disease is a no-no; no freedom of speech when it comes to your health and nutritional supplement usage.  It's not only speech either...written material about dietary supplements cannot hint about cures or healing nor be used to convey personal testimonies.

The tax code allows medical deductions for prescription drugs for your sickness but no such deduction exists for dietary supplements that will keep us healthy and possibly prevent us from ever needing those prescriptions.  Wonder where the money came from to get that in the tax code?  Could healthcare legislation be for sale?

Nevertheless, the dietary supplement industry does have a few friends in congress and help may be on the way.  On the flip side it has a formidable array of enemies in congress who are hell-bent on requiring supplements to be controlled by the FDA and be subjected to the same clinical trials that prescription meds go through.

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Healthcare Legislation is an Ongoing Fight

A few items of current interest about natural food and dietary supplements are discussed below to illustrate just how hard it is to make any progress against the entrenched and very well funded big-food and big-ag and big-drug establishment.  The first deals with our right to choose what food we consume.

H.R. 1830...The Right to Choose

While not related to supplements, House of Representatives Bill H.R. 1830 gets to the heart of the FDA's usurped power to tell us what we can and cannot eat.

The bill was introduced by Rep. Ron Paul on May 11, 2011 and referred to the House Committee on Energy and Commerce the same day where it died in committee.  That means the committee chose not to consider it. 

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It was intended to authorize the interstate traffic of unpasteurized milk and milk products that are packaged for human consumption.  Anyone following these developments will know that the FDA and many states have criminalized the sale and consumption of raw milk and gone so far as to conduct armed raids on small family farms that produce this natural, healthy product. 

The problem is that the FDA isn't smart enough to distinguish between the dead, white liquid produced by large factory-farm dairies and live, healthy milk from free range, grass fed cows. Organic milk would be a good term since it would be free of growth hormones and antibiotics and not have all its beneficial bacteria killed by the heat of pasteurization. 

The issue is that once again the FDA is protecting the large industrial farming and dairy interests and the stakes involve our very freedom to choose the type of food we eat or specifically in this case, what type of milk we want to drink.

Dr. Ron Paul is discussed below if for no other reason than to illustrate the type of congressman he was and why more like him are needed.

What's In the Bottle?

The Dietary Supplement Labeling Act of 2011 was introduced in the senate by Sen. Richard Durbin (D-IL)on June 30, 2011 as S.1310. It died in committee but was reintroduced as S. 1425 on August 1, 2013.

Sen. Dick Durbin is an ardent foe of dietary supplements and works tirelessly to restrict their use by imposing more and more regulations on the industry.

On the surface S.1425 sounds OK in that it calls for dietary supplement producers to register their supplements with the FDA and amend labeling requirements with respect to their supplements.  It requires the FDA to work with the Institute of Medicine (IOM), both of which are heavily biased against dietary supplements.   

What is worrisome is that the bill could be an end run for giving the FDA more power over supplement makers and weakening DSHEA which already addresses labeling of dietary supplements.

Go to Alliance for Natural Health for a very complete writeup of the ramifications of this suspicious piece of healthcare legislation.

The article talks about S.1310 but S.1425 is the same piece of legislation.

The prognosis for S.1425 is that it has no chance of making it out of committee.  Thank God for every Dick Durbin, there is an Orrin Hatch (R-UT) and Erik Paulsen (R-MN).  Read on.

Dietary Supplements Could Become
Eligible Medical Expenses

H.R.2194 (Rep. Erik Paulsen, R-MN) and S.1031 (Orin Hatch, R-UT), both titled The Family and Retirement Health and Investment Act of 2013 contain a provision that would expand the IRS code to include dietary and nutritional supplements as eligible medical expenses.

If, by some miracle, this bill actually becomes law, it would allow Health Savings Account (HSA) funds to be used for dietary supplements without having to get a doctor's prescription.  It would also apply to Flexible Spending Accounts (FSAs). 

The new law would expand "medical care" to include dietary supplements and allow up to $1000/year.  A 2012 study by The Rand Corporation found that if half of the consumers who had employer-sponsored coverage had HSAs or FSAs, healthcare costs in the U.S. would fall by $57 billion.

The original bills were filed in the Senate and House on May 26, 2011 as H.R. 2010 and S.1098 and referred to the House Committee on Energy and Commerce and the Senate Committee on Finance. 

Both bills died in committee but were reintroduced as H.R. 2194 and S.1031 on May 23, 2013 and both are still in committee.  The House bill has 48 co-sponsors and the Senate bill has 3 and both could use a lot more.  Unfortunately the odds-makers give both bills a 0% chance of becoming law.

This legislation is long overdue but has powerful enemies in big pharma who will pull all the stops to make sure that both bills die in committee again.  Does anyone believe the pharmaceutical industry will let $57 billion slip through their fingers without a fight?

What needs to happen now is for all of us to contact our senators and representatives and strongly urge them to co-sponsor these bills immediately.  Directions on how to contact your elected officials are given at the end of this webpage below.


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"Died in Committee" Healthcare Legislation:
Six That Didn't Make It

There were six healthcare legislation bills that have been introduced in the House of Representatives that would have had a huge impact on personal freedoms concerning supplements, choices in health care and tax treatment if they made it into law.

Unfortunately none of them made it into law but healthcare legislation is always a hot topic and there are more recent bills to which we must turn our attention.

Representative Dan Burton (R-Indiana) introduced three vitally important bills concerning healthcare legislation.

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Who is Dan Burton?

Dan Burton retired from public office and concluded his fourteenth term on January 3, 2013 as a United States Representative from Indiana's Fifth Congressional District. His first term in Congress began in January of 1983. 

When Congressman Burton assumed the Chairmanship of the House Committee on Oversight & Government Reform in the 105th Congress, he became the first Hoosier Republican to Chair a full House Committee in more than sixty years. 

Congressman Burton served as Ranking Member of the House Foreign Affairs Subcommittee on the Middle East and South Asia. Also, he is a Senior Member on the Oversight and Government Reform Committee and was deeply devoted to bringing healthcare legislation reform to benefit the dietary supplement industry.  His work on behalf of our freedom of choice in dietary supplements will be greatly missed.

Representative Burton was born on June 21, 1938, in Indianapolis, Indiana. He attended Indiana University and the
Cincinnati Bible Seminary.

He served in the U.S. Army and the U.S. Army Reserves (1957-1962). Before his election to Congress, Mr. Burton held office in the Indiana State Senate (1969-70 and 1981-82), as well as in the Indiana House of Representatives (1967-68 and 1977-80). 

Rep. Burton was up for reelection in 2012 when he decided to retire due to "personal problems with family health".  It may be significant that of the 7 bills he has sponsored to date, none have become law and of the 226 bills he has co-sponsored, only one made it into law.

The three bills concerning healthcare legislation from Congressman Burton follow.

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Allow Tax Deductions for
Dietary Supplements

Update:  This bill died in the House Ways and Means Committee and never became law.  The rationale and main points of the bill are itemized below to illustrate what this piece of healthcare legislation would have done for consumers of dietary supplements. 

Mr. BURTON of Indiana introduced the following bill; which was referred to the Committee on Ways and Means:                                                      

                                                     A BILL

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.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act shall be known as the `Dietary Supplement Tax Fairness Act of 2009'.

SEC. 2. FINDINGS.

The Congress finds that--

(1) the inclusion of foods for special dietary use, dietary supplements, and medical foods in the deduction for medical expenses does not subject such items to regulation as drugs,

(2) the Internal Revenue Code of 1986 treats such items as allowable for the medical expense deduction, but only if such items are prescribed drugs,

(3) such items have been shown through research and historical use to be a valuable benefit to human health, in particular disease prevention and overall good health, and

(4) children with inborn errors of metabolism, metabolic disorders, and autism, and all individuals with diabetes, autoimmune disorders, and chronic inflammatory conditions, frequently require daily dietary interventions as well as medical interventions to manage their conditions and such dietary interventions often become a significant economic burden on such individuals.

Section 3 of the proposed healthcare legislation would "allow amounts paid for foods for special dietary use, dietary supplements, or medical foods treated as medical expenses."

Furthermore, it stipulates that amounts paid for insurance covering foods and supplements shall be treated as medical insurance costs if such foods and supplements comply with applicable good manufacturing practices prescribed by the Food and Drug Administration or with other comparable standards.

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H.R. 3262
Full Funding for DSHEA

Update:  This bill died in committee and never became law.  It was referred to the House Committee on Energy and Commerce and then to the Subcommittee on Health.  The rationale and main points of the bill are itemized below to illustrate what this legislation would have done to fund and empower DSHEA. 

The second piece of healthcare legislation from Congressman Burton is H.R. 3262 which calls for funding that would enable the government to fully enforce the Dietary Supplements Health and Education Act.

The full text of H.R. 3262 can be seen on govtrack.us.
111th CONGRESS
1st Session
H. R. 3262
IN THE HOUSE OF REPRESENTATIVES
July 20, 2009
Mr. BURTON of Indiana introduced the following bill; which was referred to the Committee on Energy and Commerce.
A BILL
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.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘DSHEA Full Implementation and Enforcement Act of 2009’.

SEC. 2. FINDINGS.

A few of the pertinent congressional findings are:

(1) Over 158,000,000 Americans regularly consume dietary supplements to maintain and improve their health.

(2) Consumer expenditures on dietary supplements reached a reported $17,100,000,000 in 2000, double the amount spent in 1994.

(3) According to a recent report issued by the Food and Drug Administration (in this Act referred to as the ‘FDA’) the use of dietary supplements is likely to grow due to factors such as the aging of the baby boom generation, increased interest in self-sufficiency, and advances in science that are uncovering new relationships between diet and disease.

(10) DSHEA created the Office of Dietary Supplements within the National Institutes of Health to expand research and consumer information about the health effects of dietary supplements.

(11) The FDA has not adequately used its authority to enforce DSHEA.

(12) The FDA needs adequate resources to appropriately implement and enforce DSHEA. Congress has appropriated additional funds over the last several years beyond those requested in the President’s budget to implement and enforce DSHEA, reaching $9,700,000 in fiscal year 2003.

(13) However, according to the FDA, full implementation of DSHEA would require substantial additional resources. The FDA asserts that between $24,000,000 and $65,000,000 per year will be needed to fully implement DSHEA.

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H.R. 3261
Freedom of Choice in Health Treatment

Update:  This bill died in committee and never became law.  It was referred to the House Committee on Energy and Commerce and then to the Subcommittee on Health.  The rationale and main points of the bill are itemized below to illustrate what this legislation would have done to protect our freedom of choice in selecting our methods of personal medical treatment.

The third piece of healthcare legislation from Congressman Burton is H.R. 3261 which would permit individuals to be treated by the health care method of their choosing.

The full text of H.R. 3261 can be seen on govtrack.us.
111th CONGRESS
1st Session
H. R. 3261
IN THE HOUSE OF REPRESENTATIVES
July 20, 2009

Mr. BURTON of Indiana introduced the following bill; which was referred to the Committee on Energy and Commerce

                                                   A BILL

To permit an individual to be treated by a health care practitioner with any method of medical treatment such individual requests, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘Access to Medical Treatment Act’.

The key part to this proposed healthcare legislation is Section 3 below which, in part, states:

SEC. 3. ACCESS TO MEDICAL TREATMENT.

(a) In General- Notwithstanding any other provision of law, and except as provided in subsection (b), an individual shall have the right to be treated by a health care practitioner with any medical treatment (including a medical treatment that is not approved, certified, or licensed by the Secretary) that such individual desires, or that the legal representative of such individual authorizes, if--

(1) such practitioner has personally examined such individual and agrees to provide treatment to such individual;

(2) the administration of such treatment does not violate applicable licensing laws;

Who is Ron Paul?

Three pieces of healthcare legislation pertinent to freedom in natural health were introduced by Dr. Ron Paul. 

Congressman Ron Paul of Texas enjoyed a national reputation as the ultimate Libertarian. Dr. Paul was the leading spokesman in Washington for limited constitutional government, low taxes, free markets, and a return to sound monetary policies based on commodity-backed currency.  Dr. Paul ended his political career on January 3, 2013 when he retired from Congress.

He was known among both his colleagues in Congress and his constituents for his consistent voting record in the House of Representatives: "Dr. Paul never votes for legislation unless the proposed measure is expressly authorized by the Constitution". In the words of former Treasury Secretary William Simon, Dr. Paul is the "one exception to the Gang of "535" on Capitol Hill.

Ron Paul was born and raised in Pittsburgh, Pennsylvania. He graduated from Gettysburg College and the Duke University School of Medicine, before serving as a flight surgeon in the U.S. Air Force during the 1960s.

He and his wife Carol moved to Texas in 1968, where he began his medical practice in Brazoria County. As a specialist in obstetrics/gynecology, Dr. Paul has delivered more than 4,000 babies! As a member of the medical establishment, Dr. Paul has a deep interest and understanding of needed healthcare legislation.

His tireless work on behalf of our access to dietary supplements will be missed.

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H.R. 3396
Restrains Power of Regulatory Agencies

Update:  This bill died in committee and never became law.  It was referred to the House Committee on the Judiciary and then to the Subcommittee on Commercial and Administrative Law.  The rationale and main points of the bill are itemized below to illustrate what this piece of healthcare legislation would have done to reign in power of agencies to make and enforce laws without going through Congress and specified in the U.S. Constitution.

The first important piece of healthcare legislation introduced by Rep. Paul is H.R.3396.

H.R. 3396, The Congressional Responsibility and Accountability Act prohibits regulations promulgated from regulatory agencies from going into effect unless passed into law by Congress in the way in which the Constitution designates.

The full text of H.R. 3396 can be seen on govtrack.us.
111th CONGRESS
1st Session
H. R. 3396
IN THE HOUSE OF REPRESENTATIVES
July 29, 2009

Mr. PAUL introduced the following bill; which was referred to the Committee on the Judiciary

                                                A BILL

To amend title 5, United States Code, to prohibit agencies from enforcing rules that result in a specified economic impact until the requirements of those rules are enacted into law by an Act of Congress, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘Congressional Responsibility and Accountability Act’.

This proposed bill is related to healthcare legislation by tying any new regulation to its economic impact.  Economic impact limits are detailed in Section 2 as follows:

(i) Costs to any individual of $5,000 or more in a year.

(ii) Costs to any partnership, corporation, association, or public or private organization, but not including the

Federal Government or a State government, of $10,000 or more in a year.

(iii) Costs to all persons in the aggregate, but not including the Federal Government or a State government, of $25,000 or more in a year.

(iv) The loss by 1 or more United States citizens of existing employment in a year.’.

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H.R. 3395
Restraints on FDA
Regarding Dietary Supplement
Health and Cure Claims

Update:  This bill died in committee and never became law.  It was referred to the House Committee on Energy and Commerce and then to the Subcommittee on Health.  The rationale and main points of the bill are itemized below to illustrate what this piece of healthcare legislation would have done to protect our freedom of speech in the area of dietary supplement health claims relative to specific disease conditions. 

The second piece of healthcare legislation introduced by Rep. Paul is H.R. 3395.

H.R. 3395, The health Freedom Act, removes the FDA's power of prior restraint over all nutrient-disease relationship claims.

The full text of H.R. 3395 can be seen on govtrack.us.
111th CONGRESS
1st Session
H. R. 3395
IN THE HOUSE OF REPRESENTATIVES
July 29, 2009

Mr. PAUL (for himself and Mr. BURTON of Indiana) introduced the following bill; which was referred to the Committee on Energy and Commerce

                                                   A BILL

To amend the Federal Food, Drug, and Cosmetic Act concerning claims about the effects of foods and dietary supplements on health-related conditions and disease, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘Health Freedom Act’.

Section 2 of this proposed healthcare legislation says that,

"The Federal Government may not take any action to prevent use of a claim describing any nutrient in a food or dietary supplement (as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)) as mitigating, treating, or preventing any disease, disease symptom, or health-related condition, unless in a final order of a Federal court following a trial on the merits finds clear and convincing evidence based on qualified expert opinion and published peer-reviewed scientific research that--

(1) the claim is false and misleading in any material respect; and

(2) there is no less speech restrictive alternative to claim suppression, such as use of disclaimers or qualifications, that can render the claim non-misleading."

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H.R. 3394
Restraints on FTC
Regarding Dietary Supplement Advertising

Update:  This bill died in committee and never became law.  It was referred to the House Committee on Energy and Commerce and then to the Subcommittee on Health.  The rationale and main points of the bill are itemized below to illustrate what this piece of healthcare legislation would have done to protect our freedom of speech from overreaching powers of the FTC in dietary health claims.

The third piece of healthcare legislation introduced by Rep. Paul is H.R. 3394.

H.R. 3394 The Health Information Protection Act prevents the FTC from taking action against any advertiser that communicates a health benefit for a product unless the FTC first establishes based on clear and convincing evidence that the statement made is false and that its communication causes harm to the public.

The full text of H.R. 3394 can be seen on govtrack.us.
111th CONGRESS
1st Session
H. R. 3394
IN THE HOUSE OF REPRESENTATIVES
July 29, 2009

Mr. PAUL (for himself and Mr. BURTON of Indiana) introduced the following bill; which was referred to the Committee on Energy and Commerce

                                                  A BILL

To amend the Federal Trade Commission Act concerning the burden of proof in false advertising cases involving dietary supplements and dietary ingredients.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘Freedom of Health Speech Act’.

SEC. 2. HEALTH INFORMATION.

This piece of healthcare legislation is vitally important to sellers of dietary supplements in the area of "burden of proof".  Section 2 states:

The Commission shall not commence any investigation of an advertiser of a dietary supplement or a dietary ingredient to determine whether the advertiser has disseminated a false advertisement unless it possesses before the commencement of such investigation clear and convincing evidence that the advertisement is false and misleading.

(5) BURDEN OF PROOF FOR FALSE ADVERTISEMENT CASES- In every proceeding before a court or the Commission in which an
advertiser of a dietary supplement or a dietary ingredient is charged with false advertising, the burden of proof shall be on the Commission to establish by clear and convincing evidence that the advertisement is false, that the advertisement actually caused consumers to be misled into believing to be true that which is false, and that but for the false advertising content the consumer would not have made the purchase at the price paid.

If a claimed health benefit of a dietary supplement or dietary ingredient is alleged to be false advertising, the Commission must additionally establish based on expert scientific opinion and published peer-reviewed scientific evidence that the claim is false. No order adverse to the advertiser shall be entered except upon the Commission satisfying this burden of proof.

Now it is our turn to act!

Congressmen Dan Burton and Ron Paul have done their part by introducing the aforementioned healthcare legislation.  Although these particular bills all faced formidable opposition and died in committee, these two Congressmen will be remembered for their support of our freedom to consume and market dietary supplements without fear of prosecution and to be afforded the same tax treatment that the pharmaceutical industry enjoys. 

Our task now is to keep abreast of House and Senate bills affecting our access and freedom to choose our own path to health and make our voices heard. 

When important bills such as those discussed above leave the House of Representatives and go to the Senate, contact your Senators and request their support of those bills when they come up for sponsorship.  Having passed the Senate, then contact the President and demand that he sign them into law. 

<p>Rest assured, big pharma will be pulling out all the stops to make sure no healthcare legislation regarding our freedoms concerning dietary supplements ever become law.

Directions for finding and contacting Your district representative. Directions for finding and contacting Your State Senators. Directions for contacting The President of the United States

In contacting any government official, be polite, be respectful and make your request clearly and intelligently. 

Remember that all contacts with these offices are likely to reside in some government database forever.



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