Contact:  Dr. Linda Lagemann, Liaison to the Petitioners (415-640-7343)

Attorney Jonathan Emord and his co-counsel Kendrick Moxon have filed a Supplement to their Citizen Petition of August 2016, protesting the FDA’s Proposed Order to reclassify and make more readily available the Electroconvulsive Therapy (ECT) Device used to give “shock-treatment.”  The reclassification would make it easier for doctors to give the treatment.  Shock treatment is well-known as the punishment given actor Jack Nicholson in the movie One Flew Over the Cuckoo’s Nest.  More recently it was portrayed in the TV series Homeland when given to the star, destroying her memory and intelligence.  Memory loss and brain damage are the central issue in the attorneys’ filing.

For 40 years, the FDA has been responsible to ensure evaluation of the shock devices, which send up to 460 volts through a person’s brain. Although federal law and FDA orders in the 1970s required manufacturers of these devices to prove they were both safe and effective, the FDA never enforced the order. This, according to Mr. Moxon, has “allowed millions of persons over decades to be permanently damaged.”  He further states “Rather than enforce the law now, the FDA has proposed to simply change the law by reclassifying the devices, so no proof of safety or effectiveness need ever be provided.”

The original Citizen Petition was filed on behalf of 5 persons damaged by electroshock treatments. It requests that ECT be banned from the market or, at the least, that the Proposed Order be withdrawn as the manufacturers have never done pre-market clinical trials to prove it is a “safe and effective” device. No other treatment in medicine is so subject to objection and protest by patients – so much so that when the reclassification was proposed, thousands of patients, deeming themselves to be victims of the treatment, objected.

Mr. Emord, who has successfully litigated against the FDA more times than any other attorney in the US, stated “The FDA has utterly ignored clear-cut evidence of brain damage, memory loss and death resulting from ECT treatments. ECT is barbaric and should be removed from the market.” It is only fair to note that even the manufacturers have stated that a “risk” of the device is brain damage and severe memory loss.

The attorneys claim there are substantial conflicts of interest with ECT device manufacturers and the studies referenced by the FDA to support its proposed “declassification” of ECT devices.  Mr. Moxon says “The FDA used ‘junk science’ to propose reclassifying ECT machines out of the most dangerous category of all devices, in which it has been classified since 1978. Worse, the FDA ignored contrary studies by researchers who did not have conflicts of interest.”

This is shaping up to be a David and Goliath scenario with individuals damaged by ECT on one side and the FDA, under pressure from the industry that profits from ECT, on the other.

Mr. Emord stated that the proposed reclassification is a radical and irrational departure from FDA’s prior precedent demanding rigorous clinical proof of safety before Class III devices (deemed the highest risk) are reclassified to permit more common use.  He expects a challenge to the FDA’s proposed order would be upheld in federal court, if the FDA attempts to move forward with the proposed reclassification.

Review or download the Supplement to the Citizen Petition through the link below:

Supplement to Citizens Petition 29 July 17

The post PRESS RELEASE: Jonathan Emord Goes Round Two with the FDA on Electroshock Devices appeared first on Emord Blog.

The FDA’s bow to barbarism:  Downgrading the brain injury risks from shock therapy is unjustified (Oct. 12, 2016) (opens in new window)

The post Jonathan Emord, “The FDA’s bow to barbarism” (Washington Times, Oct. 12, 2016) appeared first on Emord Blog.

Click the above link to read Dr. Linda Lagemann’s August 26, 2016 article.

The post FDA, straighten up! Attorney Jonathan Emord takes on FDA over shock therapy (ECT) appeared first on Emord Blog.

Attorney Jonathan Emord Takes on the FDA Over Electroshock (ECT) Device

 In December 2015, the FDA issued a proposed order to down-classify the device used to deliver electroshock therapy. Today, Attorney Jonathan Emord filed a Citizens Petition with the FDA on behalf of 5 individuals who were damaged by electroshock.

“I hope this is the beginning of the path to do away with shock [ECT]. Hopefully it’ll go the way of lobotomies, another ‘miracle treatment’.” ECT survivor, shocked as a teenager

Most people surveyed thought electroshock therapy, also called electroconvulsive therapy or ECT, did go the way of lobotomies. In fact, a conservative estimate is that over 100,000 individuals receive electroshock therapy each year in the U.S. Actual numbers are not available because there is no tracking of this.

The ECT procedure involves shooting up to 450 volts of electricity through the brain, intentionally causing a massive seizure. According to the FDA, electroshock therapy can cause cognitive impairment, memory impairment, prolonged seizures, dental trauma, manic symptoms, pulmonary complications, worsening of psychiatric symptoms, and death.

The ECT devices have never gone through standard clinical trials to establish safety and efficacy. The FDA has requested studies a number of times and the manufacturers have ignored them an equal number of times. The FDA has neglected to follow through, failing to take action to protect the public. Instead, the FDA issued the proposed order to reclassify the ECT device to a safer category, in the absence of clinical trial data establishing safety.

According to Emord, the FDA has gone against its own precedents and policies in its handling of the ECT device.

The FDA has reasons to be concerned:

• Emord has defeated the FDA in court more times than any other attorney in American history. He is a preeminent expert on the FDA.
• The Citizens Petition he filed cites numerous violations of the Administrative Procedures Act by the FDA in issuing their proposed rule to reclassify the ECT device to a safer category. The Petition makes a strong case that, in issuing the proposed order, the FDA’s actions constitute an “abuse of discretion and arbitrary and capricious agency action”.
• The petitioners, on whose behalf this action was taken, have compelling and haunting stories of the damage ECT did to them — dramatic memory loss, clear cognitive damage, lowered IQ, physical damages, and immeasurable emotional damages and want to speak out finally.

“People talk about the memory loss, but what’s worse is shock [ECT] destroys your ability to form relationships. You can’t trust anybody because you’ve been betrayed so bad.” ECT survivor

Emord’s petition exposes step-by-step how the FDA failed to protect patients in its proposed rule.

The FDA admits ECT can cause death, cardiovascular complications, memory loss, and cognitive impairment. The manufacturers admit in written submissions to the FDA that ECT does not provide benefits after the treatment stops. The petition confronts the FDA with these facts and their conclusion that the benefits outweigh the risks. Emord points out the FDA provides no explanation for why a device that can cause death and brain damage has not been required and is not now being required to submit standard clinical trial data to prove safety and efficacy.

For more information contact Dr. Linda Lagemann, who represents the damaged persons.

Review or download the Petition and supporting documentation through the links below:

• ECT Citizen Petition (08.24.2016) (Opens in New Window)
• Petition Exhibits Part 1
• Petition Exhibits Part 2
• Petition Exhibits Part 3

The post PRESS RELEASE: Attorney Jonathan Emord Takes on the FDA Over Electroshock (ECT) Device appeared first on Emord Blog.

ECM asks the Commission to stay its October 19 Order overturning the Administrative Law Judge’s Initial Decision and holding ECM liable for violations of the FTC Act.  The Commissioners are the same individuals that oversaw the pre-litigation investigation into ECM’s business practices and approved the filing of the Complaint against ECM.  Contrary to the scientific evidence which identifies through gas evolution testing whether a product is intrinsically biodegradable, the Commission remarkably found—contrary to the scientific evidence—that the word “biodegradable” may only be used on a product that can be proven to completely decompose within 5 years after disposal.  According to the scientific testimony offered by both ECM and Complaint Counsel, no product can meet that standard due to environmental variability (not even a piece of paper, wood, a banana, or an apple core).  In its application for a stay, ECM requests that the Federal Trade Commission stay its Order pending review in the U.S. Court of Appeals.  Given that the Order is unprecedented in several constitutional and procedural aspects, ECM urges FTC to table its Order until a federal court passes on its legality.

In the Application, ECM explains that the Commission was wrong in overturning the Administrative Law Judge’s finding that the ECM Additive renders plastic products “biodegradable,” as proven through expert testimony, peer-reviewed literature, and product testing.  The Commission’s Order misinterpreted critical and uncontroverted testimony by leading authorities in landfill biodegradation and brings about a complete ban on use of the term “biodegradable” in consumer packaging and advertising.  The FTC Order imposes unscientific environmental policies on a national scale.  The Commission’s decision also circumvents the protections of the First Amendment by censoring truthful scientific speech.  ECM contends that its Additive renders plastic products biodegradable, as defined in the scientific literature.  ECM therefore asks the FTC to stay its order to preserve the status quo ante pending review by the federal courts.

The post ECM Files Application for Stay appeared first on Emord Blog.

On October 19, 2015, the Federal Trade Commission issued its Final Decision and Order (“Decision”) against ECM Biofilms, an Ohio-based company that produces additives used in plastics manufacturing.  See In re ECM Biofilms, FTC Docket No. 9358 (Oct. 19, 2015).  A copy of ECM’s press release concerning that decision is available here.  We earlier posted about that ruling here.  The FTC’s Decision, if upheld, would substantially expand FTC authority in the consumer deception sphere.  Consumers, industry regulatees, and legal scholars should take notice of the FTC’s outright rejection of scientific facts in favor of its “significant minority” doctrine.  Below I outline the FTC’s unprecedented decision and explain its significance in prospective administrative cases.

Those in the plastics industry may have followed this case closely.  Others might benefit from a short outline.  The procedural history is complex and tortured, but can be summarized as follows.  ECM is a small company based in Painesville, Ohio that developed an additive for use in plastics manufacturing.  Its additive technology renders conventional plastics “biodegradable” when infused throughout the plastic via heat melding.  When uniformly distributed within plastic, the additive technology substantially accelerates biodegradation, which provides a long-term environmental benefit.  Conventional plastics otherwise require thousands of years to biodegrade (perhaps more).  ECM’s laboratory tests showed that plastic products manufactured with the ECM additive substantially biodegraded when compared to untreated plastics.  ECM showed that the biodegradation observed in its tests (i.e., the methane production) was sourced from the plastic itself and not the additive alone, thus proving that the additive rendered the conventional plastic “biodegradable.”  ECM’s technology, which keeps plastics recyclable, became a cost-effective way to reduce the overall environmental burden of certain plastics without requiring manufacturers to dramatically change processes or equipment.

In 2014, the FTC charged ECM with false advertising, alleging that ECM could not prove that its technology worked.  The central question became whether ECM could say plastics made with its additive were “biodegradable” if they required longer than five years to fully biodegrade in a landfill.  According to FTC, the problem stemmed from consumer impression.  Consumers know little about “biodegradation,” the FTC argued.  And whenever certain consumers see the word “biodegradable” on packaging, they think the product should disappear within one year after disposal—at least, that was FTC’s position in 2014 (FTC later changed its position to “five years”).  It therefore alleged that the naked word “biodegradable” was actually an implied claim that ECM’s plastics would fully biodegrade within one year.  Because ECM’s packaging used the simple “biodegradable” claim, and ECM could not prove that its products biodegraded within one year in a landfill, the FTC charged ECM with a violation of the FTC Act.

ECM prevailed at the ALJ level.  In perhaps the most favorable ALJ ruling in modern Commission history, the FTC’s Chief Administrative Law Judge D. Michael Chappell confirmed that, based on “competent and reliable” scientific testing, ECM had “demonstrat[ed] that plastics manufactured with the ECM Additive are anaerobically biodegradable.”  See ALJ Dec. at 284.  ECM’s testing proved that its additive accelerates the biodegradation of plastics, including those deposited in landfills.  See ALJ Findings of Fact Nos. 917, 951 (finding that “Inclusion of the ECM Additive … contributes to an acceleration of biodegradation” and that “[p]eer-reviewed literatures supports [the finding] that the ECM additive contributes to an acceleration of biodegradation”).

Despite that evidence, the Commission nonetheless ruled against ECM, rejecting the ALJ’s well-reasoned 323 page decision and most of his 1,539 findings of fact, almost all of which contradicted the Commission’s allegations.  The Commission’s final decision overturned or rejected all but several pages of the ALJ’s decision.  The Commission held that scientific definitions and standards concerning “biodegradability” were irrelevant.  The only relevant analysis was how consumers interpreted the word “biodegradable.”  The Commission then entered an order that prohibits ECM from conveying truthful information about its beneficial technology.  Under that Order, ECM cannot inform consumers that plastics made with its additive are “biodegradable” without substantial qualifications—language that presents a misleading impression of the science.

The FTC’s Final Order

The FTC’s decision in the ECM case now governs how and when any company can label its products “biodegradable.”  The Order prevents the entire plastics additive industry from advertising unqualified biodegradable claims because the standards set by the Commission concerning “biodegradable” labeling are scientifically impossible to satisfy.  The Commission will permit a “biodegradable” claim only if an advertiser can prove that the product fully and completely breaks down into elements in nature within five years after customary disposal.  “Customary disposal” is generally regarded as “landfilling.”  If the product does not degrade fully into elements within that time frame, it may not be called “biodegradable” without substantial qualifications explaining precisely when that product will degrade, or the “rate” by which it degrades.

The Commission has essentially doubled-down on its flawed “Green Guides” published in 2012, only instead of a “one year” rule for unqualified biodegradable claims, it adopted a new “five year” standard.  The agency endorsed that position despite serious concerns with the scientific legitimacy of the Green Guide standards.

The Commission’s decision has many egregious procedural and scientific flaws—too many to address here.  On the scientific issues concerning biodegradation, the Commission’s opinion flatly ignored almost all of the ALJ’s well-reasoned decision.  The Commission concocted scientific analyses and opinions that were wholly unsupported by the underlying record, directly conflicted with the ALJ findings, and were against basic scientific principles.  The Commission provided no explanation for many of those departures, and cited no applicable evidence that would justify same.  It disregarded independent laboratory tests of ECM-containing plastics based on unfounded criticisms, all of which the ALJ soundly rejected or discredited.  It did so without citing supportive expert testimony.  The Commission also rejected uncontroverted expert opinion in favor of on its own scientific argument that was nowhere advanced by other experts in the case.  It rejected principles of accelerated biodegradation testing and extrapolation of data despite the ALJ’s recognition that those principles were generally accepted.  Perhaps most troubling, the Commission adopted the “five year” standard despite having overwhelming evidence that nothing biodegrades within five years under customary conditions of disposal (i.e., landfills).

Scientists with expertise in the field have already been quick to discredit the FTC’s position.  Now the FTC must defend its erroneous standard before the United States Court of Appeals, a challenging task given the basic scientific flaws in the FTC’s opinion and self-contradictory standards in the final Order.  To fully appreciate the gaps in FTC’s approach, consider the restrictions in the FTC’s Final Order reproduced below.  To claim that a product is “biodegradable,” companies must now show:

[That] the entire item will completely decompose into elements found in nature within five (5) years after customary disposal; or

The representation [that a product is biodegradable] is clearly and prominently and in close proximity qualified by:

Either (1) the time to complete decomposition into elements found in nature; or (2) the rate and extent of decomposition into elements found in nature, provided that such qualification must disclose that the stated rate and extent of decomposition does not mean that the product or package will continue to decompose; and

See Final Order, at Part I.

First, as the FTC knows, nothing biodegrades in a landfill within five years.  Not banana peels, paper, or other “rapidly degrading” materials like food waste or sewage.  At trial, a representative of the Environmental Protection Agency (EPA)—the FTC’s own witness—explained that nothing would biodegrade within five years.  All of the other experts agreed.  So, at the outset, the Commission’s standard actually bars unqualified “biodegradable” claims completely, regardless of whether a product is actually “biodegradable” from a scientific perspective.  In other words, if the product biodegrades in seven years—which would be an exceptional outcome given that even paper requires decades to decompose—a company cannot call that product “biodegradable” absent detailed qualifications.

Second, as the FTC also knows, no company can show with any precision the rate or extent of biodegradation in a landfill.  Landfill environments are highly variable and heterogeneous.  Conditions fluctuate substantially even within the same landfill from cell to cell.  Moisture and temperature (two conditions needed for biodegradation) vary substantially within landfills and over time.  No expert in the ECM case (on either side) could offer a generally accepted test or combination of tests that would measure the rate or extent of plastics biodegradation in landfills.  Yet the “rate” requirement still appears in the Final Order.

Finally, the FTC also limited the type of testing that can support the required “qualifications,” and those testing standards are also deficient from a scientific perspective.  The FTC explains that, “[f]or qualified degradability claims, any scientific technical protocol (or combination of protocols) substantiating such claims must both:”

Assure the entire product will (1) completely decompose into elements found in nature in any stated timeframe or; (2) decompose into elements found in nature at the rate and to the extent stated in the representation; and simulate the physical conditions found in the type of disposal facility or method stated in the representation …

See Final Order, Definitions.

Looking at those standards in conjunction with the above restrictions on claims, one can readily see that FTC erected an impossible barrier to “biodegradability” claims (qualified or unqualified).  Those standards give the agency plenary discretion to prosecute any company making such claims.

For instance, we saw above that the “qualified” claim must indicate the “time to complete decomposition” or the “rate and extent of decomposition.”  And now we see that any test to support the “rate and extent” must precisely “simulate the physical conditions” of a landfill.  But we also know that nothing biodegrades in an actual landfill within five years.  So if a test must precisely “simulate” those conditions, how could any test prove that a product fully biodegrades within five years?  Under those conditions, proof of “full” or “complete” biodegradation is likely impossible.

Even rapidly degrading, natural materials are only expected to biodegrade perhaps ten percent (~10%) in a true “simulated” landfill environment over the course of a shortened laboratory test.[1]  But the FTC now limits biodegradable disclosures strictly to the amount observed in the test.  Under those limitations, we would advertise a banana peel to be just “10 percent biodegradable,” even though no one reasonably disputes that the material is completely biodegradable.  Because the FTC rejected any form of “extrapolation” from test data, a product can only claim to be “fully biodegradable” if the actual test shows that it completely disappeared.

The Final Order Applied

Let’s look at how these restrictions actually play in the market.  Say you have a product that biodegrades in about 20 years within a landfill.  That would be an exceptional achievement, and one many scientists would consider an environmentally positive outcome.  But to inform consumers that your product is fully “biodegradable,” you would need to test it to completion—the full 20 years.  Never mind that such a test is impossible to perform in a laboratory over that lengthy period.  Indeed, reading through the Commission’s Opinion and Order, there are no exceptions or conditions that would dodge this absurd result.  So the FTC outright prohibits a “fully biodegradable” claim.

Instead, you would run your “simulated” landfill test for perhaps 1-2 years.  The simulation would be under reduced moisture and temperature conditions, so the test would probably show some biodegradation, but nothing close to complete degradation.  Perhaps your test shows 8% biodegradation over 300 days.  The FTC now prohibits any suggestion “that the product or package will continue to decompose” after the test period.  Therefore, the only viable advertising claim under the FTC standards would be:  “This product biodegraded 8% in 2 years of testing.”

Consequently, consumers only receive the misleading impression that the product is just 8% biodegradable, even if that product is likely to fully biodegrade over a relatively short time in the landfill, and even if the product is, in fact, fully “biodegradable” under scientific principles.  The FTC cannot trust consumers to understand the word “biodegradable,” but it apparently expects them to correctly interpret and apply that limited gas evolution test data in the market.

Because of the time limitations inherent to commercial testing, the experts in the ECM case agreed that “accelerated” testing and extrapolation of data was essential to determine whether a plastic is “intrinsically biodegradable.”  If the material is intrinsically biodegradable, then it will biodegrade whenever conditions favor biodegradation.  For instance, a piece of copy paper is biodegradable, and it will biodegrade when exposed to proper conditions.  It will not, however, rapidly biodegrade while resting on an office desk, or in a very dry, cool landfill.  But the material still remains “biodegradable” because biodegradability is an intrinsic characteristic of that material.

The FTC ALJ found that “accelerated” testing and “extrapolation” of data are two concepts widely used—even by the FTC’s own experts in the field of biodegradation.  Scientists need to improve conditions of biodegradation in the laboratory so they can assess the ultimate or “intrinsic biodegradability” of the plastics tested.  The ALJ therefore held that “intrinsic biodegradability” was the critical analysis.  Conditions will differ from landfill to landfill, and so will rates of biodegradation.  But to make a “biodegradable” claim, the most important analysis is simply whether the material is biodegradable.  The Commission rejected that analysis completely, and claimed that intrinsic biodegradability was irrelevant.  Instead, speed of biodegradation was the only important assessment for the Commission.

ECM has a technology that can transform an otherwise non-biodegradable (or very slowly degrading) plastic into one that degrades in a small fraction of the time.  But, as it so happens, ECM’s plastics will not biodegrade within five years—nor will apple cores, banana peels, or copy paper.  So ECM cannot make an unqualified “biodegradable” claim.  Nor can it make a “qualified” biodegradable claim that accurately reflects the nature of ECM’s biodegradable plastics.

Constitutional and APA Implications

Why did this happen at the FTC level?  Perhaps one explanation is politics.  Or the need to avoid a cascade of litigation if the Green Guides were exposed.  The Commissioners are politically appointed, non-elected government officials who enter office with agendas.  One of those agendas was the revision of the FTC’s Green Guides in 2012.  Those Green Guides first introduced the concept that no product could be designated “biodegradable” unless it disappeared within “one year” after disposal.  That standard was discredited at the ALJ level in the ECM case—so thoroughly that Commissioner Ohlhausen later explained that “our own Green Guides are based on anemic, flawed evidence.”  But to accept the ALJ’s decision would have required the Commission to dismantle those Green Guides.  The Commission was unwilling to admit mistake, even after conceding in its majority opinion that the “determination about ECM’s implied claim related to the biodegradability of plastics may raise certain broader issues about the Commission’s Green Guides.”  See FTC Op. at 33 n.45 (emphasis added).  In other words, the Green Guides were wrong.

On the issues of “biodegradable” claims and “biodegradability” generally, ECM won at the ALJ level.  The ALJ determined that ECM’s claim was supported by competent and reliable scientific evidence, and the word “biodegradable” did not convey an implied claim of biodegradability within five years.  That ruling put the Commission in unchartered territory.  In consumer deception cases spanning the last twenty years, no litigant had ever prevailed at the ALJ level to the degree that ECM succeeded.  But the Commission has an impeccable record and a history of success to uphold.

In more than twenty years since the Kraft decision expanded FTC authority and the agency increased its administrative adjudications, no respondent has ever prevailed in an FTC consumer deception case at the administrative level.  That point bears repeating:  The Commission has never lost a case.  Perhaps that point is unremarkable, considering that the Commission authorizes the investigation, approves the Complaint, and then reserves plenary authority to decide the facts de novo.  The Commission is the investigator, charging officer, prosecutor, judge, and jury.

The FTC’s seemingly impossible success rate recently garnered attention from Congress in the antitrust sphere (where FTC had also enjoyed a standard of perfection for nineteen years).  In November 2013, Chairman of the House Judiciary Antitrust Subcommittee Spencer Bachus (R-Ala.) commented on the FTC’s partisan process:

With this kind of record and an unbeaten streak that Perry Mason would envy, a company might wonder whether it is worth putting up a defense at all in a system in which the FTC brings a complaint, the case is tried before an administrative law judge at the FTC, and the FTC holds the authority to overturn a decision adverse to the agency.

Unsurprisingly, the Commission would not let ECM tarnish its record of perfection, even in the face of an unprecedented ALJ decision rebuking the Commission’s charges.

The ECM decision is not within a vacuum.  When the ALJ ruled for ECM in January 2015, the Commission had already entered multiple consent orders against other parties selling “biodegradable” products.  Those consent decrees spanned several decades, and included other companies selling additive technologies.  None of those cases proceeded through a trial.  And all such consent decrees were based on the flawed scientific theory memorialized in the FTC’s flawed Green Guides.  So, by the time ECM challenged the scientifically flawed standards, the Commission had accrued a substantial, inescapable investment in its policies.  Backtracking on those biodegradability standards would risk adverse action from prior litigants, potential difficulties enforcing earlier consent decrees, and possible challenges from industry concerning the Green Guides under APA standards.

But, those points notwithstanding, how could the Commission reach such an untenable scientific position in the ECM case despite the record evidence to the contrary?  It simply rejected science.

The Commission determined that a “minority” of consumers think “biodegradable” claims imply complete biodegradation within five years.  It did that through the use of Google Consumer Surveys, an untested platform that had never been used in any case, adjudication, or litigation—state, federal, administrative, or otherwise.  Commissioner Ohlhausen explained that the consumer evidence used by the Commission was “flawed in methodology and application.”  See Dissent at 3.  The ALJ rejected that evidence in its totality, finding no redeeming qualities.  Yet, still, the Commission relied on that data to find that somewhere between 11-20% of U.S. consumers think the term “biodegradable” promises a product that will disappear in a landfill within five years (the actual percentage was unstated in the Final Opinion).

The fact that those consumer impressions were scientifically impossible or unreasonable never mattered.  At oral argument, when pressed on the scientific concerns, the FTC’s Chairwoman Ramirez wondered rhetorically:

But aren’t we concerned about what consumers think, so why should the scientific definition be dispositive?

Oral Argument at 18-19.  Well, for one, because scientific truths matter under constitutional principles.  A person is constitutionally guaranteed the right to convey truthful scientific information in commercial speech.

Nonetheless, the FTC imposed its arbitrary “five year” standard not based on science, but instead on the opinions of the consumer minority.  At oral argument, the FTC prosecuting attorney also dismissed any concerns with scientific facts:

We certainly don’t hold consumers to a scientific definition.  What makes a claim reasonable is whether a significant minority of consumers collectively hold a belief about a particular term.

Oral Argument at 56.  Reread that statement to properly understand the FTC’s position in this case.  The FTC is holding industry responsible for the misguided beliefs of a “minority of consumers,” and enacting legally binding standards applicable only to that minority position, simply because those consumers “collectively hold a belief about” biodegradation in landfills.  In other words, if enough consumers share a belief, that belief becomes “reasonable” under FTC law regardless of scientific fact.

In data submitted to the Commission, many consumers in the “minority” said they expected a biodegradable product to fully biodegrade in mere “seconds” within a landfill.  The Commission counted those responses when aggregating the “minority” position referenced above.  According to the Commission, therefore, because 11-20 percent of consumers thought that a biodegradable product degrades fully within five years, ECM was held responsible for conveying that “implied claim” to consumers globally.  And because ECM cannot support that “implied” five year claim (nor can anyone in industry), ECM violated law.

If that sounds problematic, also consider that recent polling in 2014 by the reputable National Science Foundation found that twenty six percent (26%) of Americans think the sun revolves around the earth, as opposed to the earth orbiting the sun.  Are our classrooms nationwide now deceiving students?  Are astronomers violating the FTC Act if they sell maps of our heliocentric solar system?

The tail-wag-the-dog approach to “implied claims” in the ECM case best illustrates the flaws in the FTC’s “significant minority” doctrine.  The ECM case is a prime example of our need for constitutional limits on FTC practice.  Commissioner Ohlhausen, cautioning the other Commissioners, stated that “[t]he FTC has never used extrinsic evidence of a ‘significant minority’ as a stand-alone basis to determine that a claim interpretation is reasonable.”  See Dissent at 9 (emphasis added).  Commissioner Ohlhausen wisely cautioned:

The [FTC’s] Deception Statement and FTC precedent show that an interpretation is not reasonable simply because it is held by a small number of consumers.  Yet, the majority’s approach of finding reasonableness by assembling enough consumers to comprise a “significant minority” risks reducing the reasonableness test to a mere game of stacking percentages.

See Dissent at 10.  “[That] fragile foundation cannot support the conclusion that the ‘average listener,’ ‘typical buyer,’ or ‘general populace’ understood ECM’s unqualified use of the word ‘biodegradable’ to mean that ECM Plastic would biodegrade within five years.”  Id. at 11.

The Commission’s result-oriented approach in the ECM case is obviously foreboding for the biodegradable products industry.  But that decision, if upheld, also threatens to broadly expand FTC authority beyond any reasonable boundaries.  Imagine if FTC could hold a dietary supplement company responsible for “implied” disease claims solely because a small minority of consumers thought that the claim “good source of vitamin C” was really a cancer claim, or the word “healthy” related to heart disease absent any other context.  What if Rand McNally could be sued for selling globes because a “significant minority” of consumers thought that the world was flat?

In the consumer deception sphere, the Federal Trade Commission’s sole activity is speech regulation.  But the FTC does nothing that other competitors or private plaintiffs cannot do through private litigation (e.g., false advertising or Lanham Act claims).  These are lawyers, often with no advanced scientific background or expertise, promulgating scientific standards that are unsupported and arbitrary.  The Commission has no particularized scientific expertise.  Unlike the FDA or EPA, it employs no army of scientific specialists.  But the Commission still plays by different rules in litigation, which include substantial advantages bestowed simply because the FTC is a government agency.  And because so many complex scientific issues eventually reach the consumer market through advertising claims, the FTC extends its authority to set policy in nearly all areas, from drugs to environmental plastics.  The ECM case is just another example of unbridled administrative authority gone awry.  In the end, perhaps Congress needs to revisit whether the FTC should be determining policy in so many areas where it has no demonstrable expertise.

For ECM the fight continues, now at the appellate level where it can finally present its case to a neutral arbiter.  Because its technology works, ECM’s product should ultimately reach consumers.  But the content of ECM’s message may be substantially truncated, as will the market for this type of product.  To be sure, no constitutional basis permits the Commission to censor ECM’s truthful scientific information from consumers.  No constitutional basis permits the Commission to redefine basic and undisputed scientific terminology based solely on erroneous beliefs of an uninformed subset of consumers.  On those key issues (and others not here discussed), ECM hopes for a positive ruling from the Court of Appeals sometime within the next twenty-four months.

For more information about the ECM case, the next stage of litigation, or to offer support, please visit ECMDefense.com.

* Emord & Associates represented ECM Biofilms before the Federal Trade Commission and represents ECM in its appeal to the Circuit Court of Appeals.

The post FTC’s Ban of “Biodegradable” Claims in the ECM Case Threatens an Expansion of FTC Authority (Case Comment) appeared first on Emord Blog.

Leading industry and scientific experts who testified in the case are quick to note that products do not biodegrade into “elements” but into compounds and elements. Moreover, intrinsically biodegradable substances cannot be predicted to biodegrade within any set time period, and depends instead on ambient environmental conditions and the relative presence of biota. Under the new FTC rule, a product that completely biodegrades five years and one minute after disposal is not lawfully labeled “biodegradable” but one that completely biodegrades just one minute before is.

In the FTC Administrative Law Judge’s decision, Judge D. Michael Chappell ruled that ECM Biofilms, maker of an additive that accelerates the biodegradation of conventional plastics, had proven the effectiveness of its product based on generally accepted, competent and reliable scientific evidence, including over twenty gas evolution tests that prove intrinsic biodegradability. Excerpts from the ALJ decision follow below.

The FTC rejected the ALJ’s decision without a scientific explanation and without identifying any other form of testing generally accepted in the scientific community that could support a biodegradable claim. Judge Chappell provided a detailed explanation of why accelerated gas evolution testing was appropriate for determining intrinsic biodegradability, a method of testing even affirmed as valid by FTC’s own testifying expert Dr. Thabet Tolaymat, a representative of the U.S. Environmental Protection Agency (EPA).  Without a reasoned explanation for departure from the science, the FTC adopted instead an arbitrary five-year cut off as the standard for allowing biodegradable claims.

Under the FTC’s new standard, only if a company can show that its product biodegrades into elements in nature within five years of customary disposal can it claim the product to be biodegradable. Moreover, the FTC precludes companies from extrapolating test results beyond the cutoff date for gas evolution tests, meaning that no natural material (including paper or food waste) can ever meet the Commission’s narrow definition of a fully “biodegradable” product.

“This is an egregious instance of abuse of agency discretion,” said Jonathan Emord of Emord & Associates, the firm representing ECM Biofilms. “The ALJ correctly ruled on the record evidence (including two dozen independent tests, peer-reviewed publication, and scientific testimony) that the ECM product renders plastic intrinsically biodegradable and accelerates plastic biodegradation (in other words that it works).  By forbidding ECM from claiming that its product makes plastics biodegradable despite overwhelming evidence that it does, and by erecting an arbitrary and unscientific five year cut off for use of the term ‘biodegradable,’ the FTC has imposed a constitutionally forbidden prior restraint on truthful speech.”  Emord also said, “FTC has created a new standard that will harm consumers and the environment and has presumed to establish national environmental policy, invading the exclusive province of the EPA.  ECM intends to appeal and vigorously contest this unconstitutional, unscientific, and arbitrary decision.”

FACT FINDINGS FROM THE ALJ DECISION:

“The ECM Additive helps to set in motion the attraction/migration of microbes and biological agents to the plastic, and to the areas of the plastic where weaknesses or hydrophilic defects exist.”  ALJ Finding of Fact # 910.

“Inclusion of the ECM Additive, a biodegradable substance and attractant for microbial growth, contributes to an acceleration of biodegradation.”  ALJ Finding of Fact # 917.

“Peer-reviewed literature supports Dr. Sahu’s opinion that the ECM Additive contributes to an acceleration of biodegradation.”  ALJ Finding of Fact # 951.

“Based on his statistical analyses and the test data he reviewed concerning ECM Plastics, Dr. Barlaz testified that competent and reliable scientific evidence exists to show that plastics manufactured with the ECM Additive are anaerobically biodegradable.” ALJ Finding of Fact # 1041.

“Based on his statistical analyses and test the data he reviewed concerning ECM Plastics and based on his review of the procedures used by the labs conducting the ASTM D5511 tests, Dr. Barlaz credibly and persuasively testified that [ECM’s] testing constitutes competent and reliable scientific evidence demonstrating that plastics manufactured with the ECM Additive are anaerobically biodegradable.”  ALJ Opinion at Page 284.

“Dr. Barlaz persuasively and credibly testified that competent and reliable scientific evidence shows that plastics manufactured with the ECM Additive are anaerobically biodegradable.”  ALJ Opinion at Page 283.

For More Information:

Read the ALJ Initial Decision

Read the Commission’s Decision

Read the Dissenting Opinion of Commissioner Ohlhausen

Read the Final Order from the Commission

Visit ECMDefense.com (for more information or to support ECM in its appeal)

CONTACT: Jonathan Emord (202-466-6937 | jemord@emord.com)

* Emord & Associates, P.C. is representing ECM on appeal of the decision to the U.S. Court of Appeals.

The post FTC Bans “Biodegradable” on Products appeared first on Emord Blog.

Click below to listen to Hours 1 and 2:

Coast to Coast – Jul 07 2015 – Hour 1

Coast to Coast – Jul 07 2015 – Hour 2

The post Jonathan Emord Appears on Coast to Coast AM with George Noory to Discuss the Passage of the California Vaccination Bill appeared first on Emord Blog.

Jurist Oliver Wendell Holmes Jr. decided that compulsory vaccination was constitutional under the 14th Amendment.  Mr. Emord explained that his decision was a deviation from constitutional jurisprudence.  While acknowledging that some vaccines may be helpful and beneficial, Mr. Emord stated that individuals should not be compelled to vaccinate by the power of the state, particularly when well-known serious adverse reactions can occur.  Rather than pushing mandatory vaccination, the government and medical establishment should devote resources to eliminating safety risks associated with vaccines, explained Emord.

Click below to listen:

Coast to Coast – Mar 17 2015 – Hour 1

Coast to Coast – Mar 17 2015 – Hour 2

The post Jonathan Emord Discusses Vaccines, Personal Rights and Freedoms on Coast to Coast AM with George Noory appeared first on Emord Blog.

For Immediate Release

Contact:  Jonathan W. Emord or Peter A. Arhangelsky (202-466-6937)

Washington, D.C.–On January 28, 2015, Federal Trade Commission Chief Administrative Law Judge D. Michael Chappell issued a precedent setting decision in the case of FTC v. ECM BioFilms, FTC Docket No. 9358.

In his decision, Judge Chappell held ECM’s claim that its plastics additive, ECM MasterBatch Pellets^tm, causes plastics to biodegrade was supported by competent and reliable scientific evidence.  He rejected FTC’s challenge to that claim.  He also rejected FTC’s argument that the term “biodegradable” implies that a product will completely biodegrade into elements found in nature within one year after customary disposal—a position articulated in the FTC’s Green Guides industry guidance.  He upheld the FTC’s position challenging the specific rate within which ECM plastic degrades, given the unpredictable fate of plastics in the environment.  ECM BioFilms discontinued making the challenged rate claim years before the decision.  Judge Chappell refused to include any fencing-in provisions as a part of his order.

ECM BioFilms intends to abide by all terms of the order and has issued the following corporate statement:  “ECM BioFilms respects the decision of Administrative Law Judge Chappell.  We are particularly gratified that Judge Chappell determined, based on a thorough review of all scientific evidence, that ECM’s representation that its ECM MasterBatch Pellets^tm cause plastics to biodegrade is supported by competent and reliable scientific evidence.  We have long since discontinued making claims concerning estimated periods within which biodegradation may occur and have no intention of making such claims in the future.”

ECM BioFilms is represented by the constitutional and administrative law firm, Emord & Associates, P.C.

Click here for a PDF version of the Press Release.

Click here to read the decision.

The post Biodegradable Plastics Claim Upheld Against FTC Challenge in Precedent Setting ECM BioFilm’s Case appeared first on Emord Blog.

In 2010, the FTC filed an administrative complaint contending that POM made false, misleading, and unsubstantiated representations in violation of the FTCA regarding the effects of POM products on heart disease, prostate cancer, and erectile dysfunction.  After administrative proceedings, the Commission, the same governmental body that decided to bring charges against POM, ultimately held that POM violated the FTCA by making misleading and inadequately supported claims about the health benefits of POM products.  Importantly, the Commission barred POM from running future advertisements asserting that their products treat or prevent any disease unless armed with at least two RCTs demonstrating statistically significant results of such causal connection.  While the court upheld most of the Commission’s ruling, the court found “inadequate justification … for the Commission’s blanket requirement of at least two [RCTs] as a precondition to any disease-related claim.”

The Commission found, and the D.C. Circuit Court upheld, that POM made both efficacy and establishment claims.  Efficacy claims are those claims which suggest that a product works as advertised, i.e. that a product prevents against cancer.  In contrast, an establishment claims suggests that a product’s effectiveness or superiority has been scientifically established, i.e. that scientific testing proves that the product prevents cancer.  The court accepted the Commission’s standard that, in making both efficacy and establishment claims, a party must possess evidence which experts in the relevant field would deem to be sufficient to make such claims.  The Commission found that experts in the relevant fields require one or more RCTs in order to establish a causal relationship between a food and the treatment, prevention, or reduction of risk of heart disease, prostate cancer, or erectile dysfunction.  The D.C. Circuit agreed with the Commission’s holding that, because POM violated the FTCA, POM must possess at least one RCT before making a future claim that a causal relationship exists between a food and the treatment, prevention, or reduction of risk of a disease or health-related condition.  As the court explained, that “forward-looking remedy is perfectly commensurate with the Commission’s assessment of liability for petitioner’s past conduct: if past claims were deceptive in the absence of RCT substantiation, requiring RCTs for future claims is tightly tethered to the goal of preventing deception.”  Because POM possessed no RCTs, the court upheld the Commission’s finding that POM violated the FTCA by making claims that suggested a causal relationship between the POM products and the treatment, prevention, or reduction of risk of heart disease, prostate cancer, or erectile dysfunction.

POM additionally argued that the FTC violated the First Amendment by requiring two RCTs establishing a causal connection between the product and the treatment or prevention of any disease before making a health or disease-related claim.  As the two RCT requirement acts as restriction on commercial speech, the court analyzed POM’s challenge under the intermediate scrutiny test first articulated by the Supreme Court in Central Hudson.  See Central Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557 (1980).  The Central Hudson test requires the government, when attempting to restrict commercial speech, to prove that the interest it asserts in regulating the commercial speech is substantial, that the means the government uses to regulate the speech directly advance the governmental interest asserted, and that those means are no more extensive than necessary to serve that interest.

Here, the D.C. Circuit Court held that the FTC violated the First Amendment by imposing a “blanket” requirement that all disease and health-related claims be substantiated by two RCTS.  The court explained that “the Commission fail[ed to] adequately [] justify a categorical floor of two RCTs for any and all disease claims.”  The court further reasoned that the Commission’s two RCT requirement may result in the consumer being “denied useful, truthful information about products with a demonstrated capacity to treat or prevent serious disease.”

That holding furthers well established First Amendment precedent holding that parties have a First Amendment right to disseminate truthful commercial information.  See Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999); Edenfield v. Fane, 507 U.S. 761 (1993).  In essence, the court in POM held that the government cannot prevent a company from disclosing truthful information.  Here, the court found that one RCT could, in at least some circumstances, provide sufficient evidence of a causal link between a product and disease or health related effects.  In other words, one RCT can be sufficient to prove the truthfulness of a disease or health-related claim.  Therefore, FTC’s blanket requirement of two RCTs would, at least in some circumstances, prevent consumers from receiving truthful information as substantiated by one RCT.  Indeed, the court explained that, where one RCT and other research establish proof of a supplement’s benefits for disease prevention, “there would be a substantial interest in assuring that consumers gain awareness of the dietary supplement’s benefits and the supporting medical research.”  The court went so far as to say that in that situation, the government cannot even require any disclaimer that the evidence is “inconclusive.”

To the benefit of entrepreneurs, the effects of the POM holding will be far reaching.  The government will continue to be forbidden from preventing parties from disclosing truthful commercial speech in advertisements or on labels.  So long as a company has competent and reliable evidence—as defined by experts in the relevant field—a company can make truthful claims about the causal link between a product and a disease or health-related condition.

The post D.C. Circuit: FTC’s Two RCT Requirement Violates the First Amendment appeared first on Emord Blog.

By Eric Awerbuch

In April, 2014, five members of Congress introduced a bill, H.R. 4432 (hereinafter “the Bill”) seeking to regulate, among other things, the labeling of bio-engineered food products.[i]  The Bill, also known as the “Safe and Accurate Food Labeling Act of 2014,” is remarkable in that it:  1) prohibits the States from regulating the labeling of bio-engineered foods; 2) gives the FDA the sole authority to regulate the labeling of bio-engineered foods, but severely restricts how the FDA can regulate the labeling of bio-engineered foods; 3) allows companies to voluntary label their products as bio-engineered when they so desire, subject to very few restrictions; and 4) prohibits under any circumstances the FDA’s ability to decide in the future whether bio-engineered foods are less safe than foods not bio-engineered.  Each of these points is discussed in detail below.

First, if the Bill passes, States will not be able to enact any laws regulating the labeling of bio-engineered foods.  Section 104(c) of the Bill explicitly states that:

No State or political subdivision of a state may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce any requirements for the labeling of a food by virtue of its having been developed using bioengineering, including any requirements for claims that a food is or contains an ingredient that was developed using bioengineering.

The quoted language would have the effect of nullifying efforts in at least 20 states to require mandatory labeling for foods that contain genetically modified organisms.[ii]  For example, Vermont enacted a law, effective July 1, 2016, that will require foods produced from genetic engineering be labeled as such.[iii]

Instead of allowing states to regulate the marketing of bio-engineered foods, the Bill purports to give the FDA such authority.  However, the FDA’s authority to regulate labeling of bio-engineered foods is greatly restricted by the terms of the Bill.  Specifically, the FDA may only require bio-engineered food labeling when it determines that 1) there is a “material difference” between the bio-engineered food and its comparable marketed food, and 2) where that difference “is necessary to protect health safety” or to prevent false or misleading labeling.[iv]  Even if those two elements exist, the FDA can only require specific labeling that “would adequately inform consumers of such material difference.”[v]  Stated differently, not only can the States not require genetically modified foods to be labeled as genetically modified, the FDA cannot even require that labeling, unless the FDA can meet the two elements identified above.  Even where the FDA can meet those two elements, the mandatory labeling must be narrowly tailored to inform consumers of the specific “material” difference between the bio-engineered food and its similar, non-bio-engineered counterpart.

What exactly is a “material difference” requiring that companies inform consumers of the difference?  The bill provides three types of differences which are considered to be material.  The first type of “material difference” is a difference that “significantly alters the characteristics, including the functional or compositional characteristics, of a food, such that the common name no longer adequately describes the food.”[vi]   It is difficult to know when such a situation would arise because “significantly alters” is not defined.  Therefore, should the Bill pass, the FDA would be entitled to a great amount of discretion to determine whether or not a bio-engineered product is “significantly altered.”  See Chevron U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 843 (1984) (explaining that an agency’s construction of a statute it administers is owed deference when “the statute is silent or ambiguous” on the issue).  Given the FDA’s conclusions that there is no material difference between bio-engineered food and non-bio-engineered food, it is highly unlikely that the FDA would ever require mandatory labeling when left to their discretion.[vii]  Indeed, while the statute does not define differences that are not material, it does state that the “use of bio-engineering does not, by itself, constitute a material difference.”  Id. at § 424(e).

Furthermore, even if there was such a material difference, given that the labeling must only “adequately inform consumers of such material difference,” this requirement could be met, for example, if the company selling the bio-engineered product simply markets the product in a different name than the “similar” non-bio-engineered product.  It seems that sweet and firm, bio-engineered “tomatoes” would be able to be marketed as “specially formulated sweet and firm tomatoes.”  That label would inform consumers of the material difference—that the new tomatoes are sweet and firm—without even revealing the fact that they are bio-engineered.

The second type of “material difference” is a difference that “results in a significantly different nutritional property in the food produced from, containing or consisting of the bio-engineered organism.”[viii]    Once again, given that the labeling must only “adequately inform consumers of such material difference,” a company could label bio-engineered corn with higher protein content than non-bio-engineered corn as “high protein corn,” without ever revealing the fact that the corn is bio-engineered.

The third difference resulting in a “material difference” is where the bio-engineered food contains an allergen that consumers would not expect to be present based upon the name of the food.[ix]  A company could simply label the product with a warning such as, “warning: this product contains [allergen.]”  Again, the company would not have to disclose the fact that the product is bio-engineered.  Indeed, given that the labeling must only “adequately inform consumers of such material difference,” it is likely that the FDA will never be authorized to require that companies disclose the fact that a product is bio-engineered when narrower labels adequately inform consumers of the material differences.

While mandatory labeling is allowed only in narrow circumstances under the Bill, companies would have great opportunity to voluntarily label their bio-engineered products as they so choose.  The Bill prevents the FDA from prohibiting persons “from disclosing voluntarily on the labeling of food developed with the use of bio-engineering the manner in which the food has been modified to express traits or characteristics that differ from its comparable marketed food.”[x]  Thus, a company is free to market the differences between their bio-engineered product and similar, non-bio-engineered foods. For example, a company selling bio-engineered tomatoes may claim that “our bio-engineered tomatoes benefit the environment more than non-bio-engineered tomatoes because our tomatoes consume less water during the growing process than non-bio-engineered tomatoes.”  Companies will also be free to voluntary advertise, other than in labeling, that the food was developed with the use of bio-engineering.[xi]

The Bill also regulates the labeling of foods that are not bio-engineered.[xii]  It explicitly prohibits the labeling of non-bio-engineered foods from suggesting that “foods developed without the use of bio-engineering are safer than foods produced from, containing, or consisting of a bio-engineered organism.”[xiii]  In a day and age where courts routinely defer to agencies because agency’s have “expertise” in certain, factual issues, see Marsh v. Oregon Natural Resources Council, 490 U.S. 360, 377 (1989) (explaining that the Court defers to the agency’s analysis when the issue requires a high level of technical expertise), it is alarming that, through the Bill, Congress is making a scientific determination that non-bio-engineered foods are not safer than bio-engineered foods.  While the FDA does not currently consider non-bio-engineered to be safer than bio-engineered foods,[xiv] the Bill prevents FDA from ever reconsidering that opinion.

The Bill will have the ultimate effect of keeping Americans in the dark about information they may deem material to their purchasing decisions.  By legislating that the fact that a food is bio-engineered is not per se material, without any supporting evidence, the Bill seeks to foreclose any opportunity for a party to prove with empirical evidence that, in fact, the fact that a food is bio-engineered is indeed material to consumers’ purchasing decision.  It is plausible that, if the Bill passes, no federal agency or any other governmental entity would be allowed to require companies to disclose the fact that their product is bio-engineered in any circumstances.  The Bill will act to, at best, fail to inform consumers that they are consuming bio-engineered products, and, at worst, mislead consumers into believing that there are no bio-engineered products on the market.

The post Proposed Federal Bill Would Prevent States, FDA, And Anyone Else From Informing Consumers Whether Food Is Bioengineered appeared first on Emord Blog.

The federal government is once again using tragedy to procure more regulatory power over private business.  Beginning in 2012, laundry detergent businesses began selling detergent pods—small, single-use packets of concentrated detergent encased in a water soluble membrane.[1]  Instead of having to pour and measure (an occasionally messy endeavor), Americans can insert one detergent pod per one load of laundry in the washing machine, regardless of whether he or she is washing whites or darks in hot or cold water.  The pods, which purport to clean, remove stains, and brighten, come at a reasonable price of about 35 cents per load.[2]

Unfortunately, approximately 17,230 children under the age of 6 have been poisoned by the pods since 2012.[3]  Of those 17,230 cases, 769 children were hospitalized.[4]  Worst of all, one 7-month old boy died in a Florida hospital because of poisoning after eating a pod.[5]  The source of danger apparently stems from the appearance of the detergent pods, which may resemble candy to certain children.

The fact that children have consumed detergent pods is a serious issue that should be addressed.  In response, one politician, U.S. Senator Charles E. Schumer (D-N.Y.), recently called on “manufacturers and federal consumer protection experts to make the product less attractive to children, and for them to use child safe caps on the dispensers …”[6]  The Senator specifically called on the Consumer Product Safety Commission “to issue stronger regulations on packaging and labeling these products …”[7]  One such regulation is to mandate that detergent manufacturers use “child safe caps” such as those “commonly used on prescription drug bottles.”[8]  Senator Schumer’s recent remarks are not his first attempt to encourage the government to increase regulations on the pods; he previously called on “the Consumer product Safety Commission to increase safety requirements for dishwashing and laundry detergent pods” and  advised that the “Consumer Product Safety Commission must fully explore both mandatory and voluntary safety requirements for companies to follow in order to prevent children from being able to access and consume detergent products.”[9]

Senator Schumer’s statements seem logical enough, and appear to be the prevailing logic applied by the vast majority of American politicians—if a product is harming consumers, especially children, then it is inevitably the government’s duty to protect those consumers.  But persuasive as that rhetoric may be, the emotional strings of our daily news cycle cannot dictate the scope of government.  The federal government already has ample power to protect children from the poisonous effects of the detergent.  Laundry detergent is currently regulated by three separate federal statutes and a bevy of federal regulations under the Federal Hazardous Substance Act,[10] the Consumer Product Safety Act,[11] and the Poison Prevention Packaging Act.[12]

Instead of regulating detergent under the existing legal framework, Senator Schumer, as politicians often do, has asked for new regulations.  At what point can the government accept that it has enough existing authority?  How can three separate federal statutes and their regulations not provide enough power to allow the government to ensure that children are not poisoned by laundry detergent?  In each instance, we see that government has the means available to regulate or remove from market dangerous products.  For example, the Federal Hazardous Substance Act already requires that hazardous substances include certain cautionary remarks on their labels, such as the statement “Keep our of the Reach of Children.”[13]  In addition, the Consumer Product Safety Commission has already implemented extensive regulations governing the packaging of products which may harm children.[14]  Those regulations specifically require that packaging be tested to ensure that 80 or 85 percent of the time, depending on the testing done by the manufacturer, children cannot open the package.[15]  The government could work within the current regulations to ensure that children are sufficiently protected from the harms of laundry detergent pods.

The logic that more regulation brings more safety is flawed, and it comes with great cost.  Federal regulations cost time and money to implement, abide by, and enforce.  That fact, combined with politicians’ inclinations to regulate anything and everything has resulted in an excessive amount of financial waste.  Indeed, according to the government’s own figures, the estimated burden of federal regulations in 2012 exceeded $1.8 trillion,[16] or about the same amount as Canada’s or India’s entire Gross Domestic Product.[17]  That $1.8 trillion is alarming, and begs the question, when, if ever, will the government stop expanding?

The dilemma we face regarding laundry detergent pods is nothing new.  On the one hand, children are being poisoned because of the pods.  On the other hand, the pods are a product of American consumers’ desires to be able to more conveniently run their washing machines.  So, the product has a benefit we want to keep, and a cost we want to avoid.  If we allow ourselves to escape the pervading view that government regulation alone must keep us safe, we will see that there are more efficient ways to prevent children from being poisoned by the pods.  For example, if a child is poisoned by a product, then that child’s parents’ have the ability to pursue a products liability action against the manufacturer to recover any damages suffered by the child and/or the family.  If indeed the manufacturer is at fault, it will be punished and forced to pay.  The manufacturer will then face a decision: to continue to risk additional lawsuits, or to change the way it packages and labels the laundry detergent pods.  If there are sufficient successful lawsuits and damages, then it will be in the manufacturers’ best interests to make the product’s packaging more child resistant in order to prevent future lawsuits.  The manufacturing company will then research and discover the most cost-efficient method to child-proof and/or sufficiently label the pods.

Given that our economy is already being excessively burdened by federal regulations, we must stop following our gut instinct to have the federal government regulate each and every potential risk of life.  Scare tactics, such as pronouncing that laundry detergent is a risk to our children, is often the easiest way for governments to expand their powers.  However, that line of logic has resulted in an astronomical waste of economic resources.  Therefore, our society’s first reaction to problems involving consumer goods’ risk versus reward must stop being to turn to the government to enact new regulations, especially where, as here, existing regulations are sufficient to prevent the harm.

The post New regulations on laundry detergent pods would be cumulative, inefficient, and an example of why our federal regulations cost as much as Canada’s entire GDP appeared first on Emord Blog.

The post Sacred Fire of Liberty Gala appeared first on Emord Blog.

Additional videos will soon be dispatched, including the remarkable speeches delivered by Bay Buchanan, Kate Obenshain, and Tammy Bruce at the Gala.

The post Video Replay Available of George Washington’s Address at the Sacred Fire of Liberty Gala appeared first on Emord Blog.

CONTACT: Connie Wood (202-466-6937)

Cambridge, Maryland—On September 5 and 6, 2014, the constitutional and administrative law firm Emord & Associates, P.C. held a spectacular celebration and awards program at the Hyatt Regency Resort on the occasion of its 20^th anniversary and in honor of George Washington.  The event was entitled the “Sacred Fire of Liberty Gala” (see sacredfiregala.com) and included over 300 people, inclusive of guests, speakers, and world class entertainers.  Fox News Chief National Correspondent Jim Angle (keynote); former Treasurer of the United States and Fox News Contributor Bay Buchanan; former Chairman of the Virginia Republican Party and Chief of Staff to Senator George Allen, Kate Obenshain; and New York Times best-selling author and radio talk show host Tammy Bruce each addressed the audience on September 5, and actor Dean Malissa (Acquarius (2000); The Real George Washington (2008); and LaFayette: The Lost Hero (2010)) gave a stirring speech as George Washington condescended from Heaven.

From nominations received throughout 2013 and 2014, an awards committee of the Emord firm selected the following individuals to receive excellence awards in the following categories:

Excellence in Nutrition Science Award: Dr. Sidney Stohs; Dr. Mary Enig; Dr. Melvyn Grovit; Dr. Adrianne Bendich; Dr. Charles B. Simone; Dr. Jeffrey Bland; Dr. Robert I-San Lin; Dr. Harry G. Preuss; Dr. Jeffrey Blumberg; Elwood Richard; Dr. Jeanne Drisko; Dr. Neal D. Barnard; Dr. Stanley Dudrick; Michael Stroka; and Sally Fallon Morell

Excellence in Integrative Medicine Award: Dr. Martin P. Gallagher; Dr. Dennis J. Courtney; Dr. Jonathan V. Wright; Dr. Julian M. Whitaker; Dr. Warren Levin; Dr. Charles B. Simone; Dr. Aruna Bakhru; Dr. Edmund Chein; Dr. Stanley Dudrick; Dr. Melvyn Grovit; Dr. Robert Verkerk; Dr. Harry G. Preuss; Dr. Alan R. Gaby; Dr. Gina Cushman; Dr. David Perlmutter; Dr. Joya Schoen; Dr. Stephen T. Sinatra; Dr. Carolyn Dean; Dr. Sherri Tenpenny; Dr. Sidney Stohs; Dr. Neal D. Barnard; Dr. Jonathan Collin; Dr. John Abramson; Dr. Ronald D. Hoffman; Dr. Michael Schachter; Dr. Andrew Weil; Dr. W. Lee Cowden; Dr. Joseph Mercola; Dr. Mark Hyman; Dr. Peter R. Holyk; Dr. Garry Gordon; Dr. Russell Jaffe; Dr. Mayer Eisenstein; Dr. Hyla Cass; Dr. Allan Magaziner; Dr. Bruce Shelton; Dr. Sara Gottfried; and Dr. Robban Sica

Excellence in Medical Research Award: Dr. Stanislaw Burzynski; Dr. Charles B. Simone; Dr. Charles B. Simone II; Dr. Nicole Simone; Dr. Neal D. Barnard; Dr. Harry G. Preuss; Dr. Alan R. Gaby; Bastyr University; the Center for Integrative Medicine at the University of Arizona College of Medicine; Dr. Joel D. Wallach; Dr. Melvyn Grovit; Dr. Stanley Dudrick; Dr. Jonathan Wright

First Amendment Hall of Fame Award: Durk Pearson; Sandy Shaw; Dr. Julian M. Whitaker; Dr. Joel D. Wallach; Ray Hamel; Peter Hamel; Gretchen DuBeau; Dr. Alexander Schauss; and Dr. Richard Kleinberger

Free Speech Global Award: Dr. Robert Verkerk

Sacred Fire of Liberty Award: Donald E. Washkewicz; Paul F. Glenn; Hunter Lewis; NOW Foods; Berkley Bedell; William Faloon; Ben Suarez; Dr. Julian M. Whitaker; Julie Whitman Kline; Dr. Joseph Mercola; & Manoj Bhargaba

Freedom of Informed Choice Award: Alliance for Natural Health—USA; Alliance for Natural Health—International; Life Extension Foundation; Institute for Responsible Technology; Bert Schwitters; Citizens Council for Health Freedom; Campaign for Liberty; Dr. John Abramson; Sheila Matthews-Gallo; Dr. Joseph Mercola; Mary Jo Siegel; Richard DeSylva; Dr. Jane Orient; Donna Navarro; Barbara Loe Fisher; Doris Wood; and Twila Brase

Excellence in Health Product Innovation Award: Dr. Mark Whitacre; Brian W. Shilhavy; Dr. Nicholas Perricone; Jerry Smith; Dr. Charles B. Simone; Dr. Patricia Bragg; Dr. Reginald McDaniel; Dr. Joel D. Wallach; Will Block; Dan Caudill; Dr. Luke Bucci; Corey Anderson; Janet Cherry; Frank Key; Scott Henderson; James Komorowski; Stan Soper; Durk Pearson; Sandy Shaw; Roland Jerch; Elwood Richard; Val Anderson; Scott Henderson; and Christian Wilde

Excellence in Health Journalism Award: James Gormley; William Skinner; Shane Starling; Robert Scott Bell; Dennis J. Courtney; John Rappoport; Bob Swientok; Frankie Boyer; Paul Rothfuss; Elaine Watson; Ron Waldman; Peter Starr; Vaishali; Dr. Ronald D. Hoffman; Deborah A. Ray; Dr. Joseph Mercola; Dr. Stephen T. Sinatra; Dr. Jonathan Collin; Joe Cosgrove; Dennis McCuistian; William Faloon; Dr. Neal D. Barnard; Mike Adams; and Dr. Julian M. Whitaker

Voice of Liberty Award: Ted Anderson; Erskine; Mike Adams; Alex Jones; George Noory; Jeff Rense; John Stossel; Lars Larsen; Jerry Doyle; Robert Scott Bell; Deborah Ray; Sean Hannity; and Erskine

Fount of Freedom Award: Paul Walter; Wayne Barrett; Peter Schweizer; Kim R. Holmes; Jay Sekulow; Robert Oulds; Ramona Morrison; Rae Capitka; Cheryl K. Chumley; and Tim Delmastro

The two-day gala, on September 5 and 6, was emceed by Hollywood actor and producer Terrence McNally and included musical entertainment from gospel music great Alma Randolph; world renowned tenor Mark Harris; Fresh Air Music Entertainment’s Motown revue; and George Mason University’s fife and drum, string ensemble, and brass quintet.

Over the next several weeks video footage from the gala will appear on the sacredfiregala.com web site and on YouTube.

# # # #

The post PRESS RELEASE: EMORD & ASSOCIATES HONORS LEADERS IN NUTRITION, INTEGRATIVE MEDICINE, MEDICAL SCIENCE, AND JOURNALISM AT SPECTACULAR GALA appeared first on Emord Blog.

Freedom From Choice investigates the loss of our liberties.  It asks whether our daily choices, from what we eat to what we read, are in fact our choices or whether they are choices that are being made for us by regulations and red tape, lobbyists and businesses.

In the film, experts, including Emord & Associates’ principal Jonathan W. Emord, explain how and why our choices have become limited.

Delmastro’s interview and a short excerpt of the film featuring Emord is scheduled to air on July 17 at 9 PM ET on Fox Business, with a likely re-run on July 20 at 10 PM ET on Fox News.  We invite you to tune in.

The post Emord Interview in Freedom From Choice to Appear on the Stossel Show appeared first on Emord Blog.