The Free Speech About Science Act - H.R. 1364

HR 1364, HR 1830, S.216 and the Struggle for Health and Food Freedom Action Item: http://tinyurl.com/healthfreespeech

Yes, it's always nice when members of Congress respond to net-roots Push Back and introduce bills that would offer further protection for our Health and Food Freedom of Speech. And we are sure the latest such bill, H.R. 1364, entitled the Free Speech About Science Act, introduced in the House of Representatives April 2011 by Congressmen Jason Chaffetz (R-UT) and Jared Polis (D-CO) is such a bill. We've been calling for further legal protection for years. HR. 1364 ought to be amended to truly protect health free speech.

The Natural Solutions Foundation's Health and Food Freedom proposals, linked through the Health and Food Freedom of Speech Action Item, at http://tinyurl.com/healthfreespeech are detailed and include more than the current bill. Nonetheless, we certainly urge you to use the above Action Item to support that bill and urge its improvement.

Our gripe is aimed not at all those good folk who turn to Congress for protection, but at the Congress-critters who vote to protect us (or not) only to do nothing when the FDA thumbs its collective nose at Congress and the People by ignoring the protective laws Congress has adopted.

Frankly, we thought we had won the battle over being allowed to communicate truthfully about health and food in Congress and in the Supreme Court.

We thought that's what DSHEA was supposed to have done in 1994 with its Third Party Literature Provisions. Those provisions were further supported by the 1997 Labeling Commission which stated,

"Historically, FDA has considered literature used directly in connection with the sale of a product to be "labeling" for the product. Section 5 of DSHEA exempts certain publications used in connection with the sale of dietary supplements from being defined as "labeling." The exemption applies to "a publication, including an article, a chapter in a book, or an official abstract of a peer-reviewed scientific publication..."

And again we thought this matter had been determined by the Supreme Court in the 2002 landmark Thompson v Western States case, wherein the Court opined:

"If the First Amendment means anything, it means that regulating speech must be a last - not first - resort. *** We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making [even] bad decisions with the information...."

Finally even the FDA "enabling act" of 2007 specifically exempted DSHEA products from enhanced FDA oversight.

But repeatedly FDA has ignored these legal restrictions, prompting Dr Ron Paul to remark that, when the Congress gives more power to FDA, the agency always engages in an "abuse of power..." A couple years ago it ignored the 2007 restrictions to exceed its power and ban the interstate sale of certain vitamins. Just last year it sought to ban the entire Ear Candling industry and asked the Courts to recognize NO right of Americans to make their own dietary choices.

This is an agency run-amok. An agency that is so incompetent that about half of the dangerous drugs (including vaccines) it approves must be withdrawn from the market, or strictly curtailed, within 5 years of approval, thus proving that the Public has become the final stage in drug company research and development. All the while, supporting drug company exemptions from legal liability for the horrendous harm they cause the Public.

Meanwhile, what we call Sen. Leahy's Criminalization of Food and Speech bill, which claims to "increase criminal penalties for certain knowing and intentional violations relating to food..." but applies only to SPEECH, has reared its ugly head again, as S.216. While that dangerous bill slid through the Senate, we hope it will stall in the House. But the Senate may have more surprises in store for us, with Sen. Durbin planning on introducing a new Dietary Supplement labeling bill that would, for the first time, subject vitamins to registration with the federal government prior to sale.

While all this is happening, Dr. Ron Paul continues to urge "legalization of freedom" with his recent Raw Milk Freedom bill, HR. 1830. Read more about this Interstate Commerce Bill, see my interview with him, and use the Action Item to support it, here: http://tinyurl.com/rawmilkfreedom.

Yes, Congress, can pass new laws to protect us from its agents -- or subject us to even more harassment.

But better, DIVEST THE FDA OF FOOD AUTHORITY! Let it stick to messing up dangerous drugs and deadly vaccines... FREE US from this bureaucratic nightmare that leads to hundreds of thousands of unnecessary deaths every year!

And that's our gripe about a bill that's been introduced with the best intent, but with hardly enough clout to do the job of restoring our Health and Food Freedoms. To do that, please go to to www.HealthFreedomUSA.org for more information and more Action Items!

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Update: the Senate passed S.216 and sent it to the House.
The operative language of the bill is:

Any person who violates subsection (a), (b), (c), or (k) of section 301 with respect to any food--(A) knowingly and intentionally to defraud or mislead; and (B) with conscious or reckless disregard of a risk of death or serious bodily injury, shall be fined under title 18, United States Code, imprisoned for not more than 10 years, or both.'

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Update: This cogent comment by Attorney Diane M. Miller further suggests that HR.1364 needs to be amended to better protect health free speech:

NHFA opposes H. R. 1364 Science and Free Speech bill because it continually uses the term "legitimate scientific research” as the threshold for “permission to speak”. The better solution is to support 2010 HR 3394 which protects speech in the marketplace, as long as it is truthful and not misleading. “Legitimate scientific research” can be an extremely arguable term and will be abused and will be interpreted under conventional scientific rubrics. The bill will work to further entrench our freedom of speech prohibitions into the existing conventional science paradigm. It will once more insist that if you don't have "legitimate scientific research" (as interpreted by the FDA), then you will not be able to speak the truth about dietary supplements. Dietary supplements will continue to be construed to be legally considered “drugs” if a person says what they can do. This is a bill that could even more entrench the "evidenced based medicine model" that international forums are promoting.

Diane M. Miller J.D.
www.nationalhealthfreedom.org

Dr. Ron Paul Introduces Health Freedom Bills in Congress

This just in... Dr. Ron Paul, health freedom's friend in Congress, introduced two important bills yesterday that, if passed, would rein in the excessive interference in advanced health products by the FDA and FTC.

You can support these bills here:
http://salsa.democracyinaction.org/o/568/campaign.jsp?campaign_KEY=27732

Here is the Life Extension Foundation's description of the bills:

HR 3395: The Health Freedom Act. This bill removes FDA’s power of prior restraint over all nutrient-disease relationship claims. Under the bill, the FDA may not prohibit any statement concerning a nutrient affecting a disease (including treatment effects) from being made in the market and may only act against a statement once made if it possesses clear and convincing evidence that the statement is false. Presently the FDA blocks an enormous quantity of truthful information concerning the effects of nutrients and foods on disease from reaching consumers. That barrier is removed by the Health Freedom Act, but the Act preserves the power of the government to prosecute those who communicate falsehood. The essential purpose of the First Amendment is to disarm the federal government of the power to impose a prior restraint on speech. The FDA has imposed a prior restraint for decades to the health detriment of the public. Passage of the Health Freedom Act will restore constitutional governance by reasserting the supremacy of the First Amendment over the Food and Drug Administration.

HR 3394: The Health Information Protection Act. This bill prevents the Federal Trade Commission 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. Presently, the FTC reverses the Fifth Amendment burden of proof on the government when it charges advertisers with deceptive advertising and then demands that they prove their speech true based on contemporaneously held documentation or be deemed to have advertised deceptively. The Fifth Amendment requires that FTC bear the burden of proving advertising deceptive. It may not constitutionally shift the burden to the advertiser to prove its statements not deceptive. The First Amendment requires that FTC not act against speech unless the speech is probably false. It may not constitutionally accuse a party of false advertising yet lack proof that the advertising is false and condemn advertising based on an absence of documentation concerning the truth of the statement rather than the presence of evidence establishing the falsity of the statement.

These bills go to the heart of the issue of valid health claims for nutrient products: how do companies substantiate the claims they are making. Essentially the bills apply Constitutional principles to the making of claims, which are a type of speech, and are therefore protected from excessive bureaurcratic burden.

In this context it is useful to see what then Justice Sandra Day O'Connor wrote for the Supreme Court majority in the leading health claim free speech case, Thompson v. Western States Medical Center - 01-344, decided on April 29, 2002 - 535 U.S. 357 -

"If the First Amendment means anything, it means that regulating speech must be a last - not first - resort."

"We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information."

"Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring each ...to be labeled with a warning that the [product] had not undergone FDA testing and that its risks were unknown."

The basic rule, announced by the case, to determine constitutionally permitted government restrictions on Commercial Speech (speech that makes or is about an offer for a transaction) is a Two Prong Test: the first prong is to ask two questions: (1) is the speech in question about unlawful activity and (2) is the speech misleading. If "no" to both, the speech is entitled to protection unless the Government can carry its burden and prove (1) the governmental interest involved is "substantial", (2) the regulation must "directly advance" the governmental interest and (3) the regulation of Commercial Speech cannot be "more extensive than is necessary to serve that interest" (quoting Central Hudson v Public Service, 447 US 557, at 566).

Dr. Paul' s bills make it clear that the government has the burden of proof if it seeks to restrict what marketers say about their health related products. In this way, his bills preserve the Constitutional protections for Commercial Speech.

You can support these bills here:
http://salsa.democracyinaction.org/o/568/campaign.jsp?campaign_KEY=27732

And a final thought: “Liberty is to the collective body what health is to every individual body. Without health no pleasure can be tasted by man; without liberty, no happiness can be enjoyed by society.” –Thomas Jefferson

No Health Freedom without Freedom to Make Health Claims

Europe's Food Safety Authority (EFSA) continues to implement food supplement safety regulations so that meaningful information about health claims are very unlikely to be available in the EU market.

Originally rejecting over 90% of the claims dossiers offered, the agency has now rejected 7 of the first 8 dossiers that survived the first culling.

My June 2008 blog on the original rejections:
http://vitaminlawyerhealthfreedom.blogspot.com/2008/06/eu-denies-97-of-health-claims.html

Nutraingredients reports on the current denials: http://www.nutraingredients-usa.com/Publications/Food-Beverage-Nutrition/NutraIngredients/Research/Rising-to-the-health-claims-challenge/?c=gbrnO2ewSG1RZZaCgAJTsA%3D%3D

"Ten days ago, the European Food Safety Authority’s (EFSA) Panel on Dietetic Products, Nutrition and Allergies (NDA) rejected seven out of eight assessed claims for failing to demonstrate causality between consumption of specific nutrients or foods and intended health benefits.

According to Patrick Coppens, the secretary-general of the Brussels-based industry group, the European Responsible Nutrition Alliance (ERNA), the news came as a “shock to industry”."

At the heart of the issue is the standard for substantiation:

"But there are two sides to every argument, and pointing the finger at industry is not totally fair. Indeed, the European Commission was heavily criticized in April of this year when it issued guidance that it will reject scientific health claim dossiers that do not contain human clinical data.

This is tantamount to moving the goalposts, and at a relatively late stage.

The specifications for health claims are still relatively fuzzy, and so industry could claim that there has been a certain amount of groping around in the dark.

Moreover, some companies have been quick to note that the rejection is not a rejection of the ingredient or product, but just that the science submitted was incomplete."

This "clinical study only" approach rejects the clinical experience of practitioners, often a more effective 'real world' test of the benefits of a nutrient and also rejects Traditional Use wisdom that has been gained through millennia of human experience.

The reason that normal food substances are deemed to be safe is that they have been used for millennia by people across the world. Expensive double-blind, placebo controlled experiments are not needed to tell us what we already know...

...except as barriers against truthful commercial speech, for the ultimate benefit, not of the public, but of those who participate in the financial gains derived from the limited number of drugs that have been granted political approval.

There is no health freedom without freedom to make health claims about food substances!