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.

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.

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Peter Arhangelsky, a principal in the firm’s Arizona office, commented on the April 21, 2014 oral arguments presented by POM, Coke, and the United States as an amicus curiae.  He found the Justices’ approach consistent with well-established principles of advertising law.  Read the full article here:

Elaine Watson, “POM v. Coke at the Supreme Court:  Who came out on top?” www.nutraingredients-usa.com (Apr. 21, 2014)

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Elaine Watson, “Big Win for Coke at Supreme Court could really upset apple cart, says attorney,” www.foodnavigator-usa.com (Apr. 18, 2014).

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All subscribers of the Emord blog, clients, and members of our LinkedIn Group  are cordially invited to attend our Gala Celebration on the occasion of Emord & Associates’ 20th Anniversary.  Over 160 people have already registered for this two day extravaganza featuring leading national figures in law, politics, journalism, nutrition science, and industry along with spectacular entertainment and richly memorable excursions to sites in our nation’s Capitol.  Registration, dinner, and excursion fees are waived for all who reserve by March 31.  Please join us.  Make your reservations today (202-466-6937).  Last date to reserve: July 31, 2014.

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California represents a major consumer market, and one most business can ill-afford to ignore, yet California has also enacted some of the nation’s harshest laws for businesses.  Many of those laws include “bounty hunter” provisions rendering them enforceable directly by plaintiff’s counsel.  Under California’s broad unfair competition law (UCL), a California consumer can maintain a private action for nearly any violation of law.  Moreover, because California state law mirrors and incorporates the federal law, the California courts have held that actions typically reserved only for the Federal FDA can be maintained by private plaintiffs in state court.  The laws and court decisions leave all businesses vulnerable, particularly those in the health, medical, or nutrition markets.

Even the prospect of litigation in California can result in substantial expense.  The costs to settle a pre-litigation claim often includes a measure of plaintiff’s attorney fees and, therefore, simple allegations can expose businesses to unwarranted costs.  For years Emord & Associates has been counseling its clients in all matters of overlapping federal regulation, and it has consulted and litigated California state matters while operating in close partnerships with California counsel.  Given the substantial increase in government regulatory activity and private litigation, the firm is now pleased to announce that it will undertake direct representation of clients in California matters.

The firm’s California practice will be headed by firm Principal Peter A. Arhangelsky.  Mr. Arhangelsky has achieved success with Emord & Associates in state and federal litigation.  He has handled complex litigation matters concerning health and nutritional products, including significant experience with issues of California law.  Working closely with founding Principal Jonathan Emord, Mr. Arhangelsky will continue contributing to the firm’s success by expanding his practice into California state matters.  Please do not hesitate to contact Peter at parhangelsky@emord.com or 602-334-4416 with any questions, and check back with us for future Emord & Associates’ publications concerning legal news, highlights, and insights related to California laws and regulations.

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The IND Guidance:

FDA’s guidance tells clinical investigators, sponsors, sponsor-investigators, and IRBs “when research studies involving human subjects must be conducted under an investigational new drug application…”  See IND Guidance at 1.  FDA addressed when an IND would be required for foods, including dietary supplements and medical foods.  Whether an IND is required for a dietary supplement depends upon the study objectives.  In its guidance, FDA explained that an IND is not required for a dietary supplement “[i]f the clinical investigation is intended only to evaluate the dietary supplement’s effect on the structure or function of the body[.]”  On the other hand, an IND is required when “the clinical investigation is intended to evaluate the dietary supplement’s ability to diagnose, cure, mitigate, treat, or prevent disease[.]”   FDA illustrated these points as follows:

 [A] clinical investigation designed to study the relationship between a dietary supplement’s effect on normal structure or function in humans (e.g., guarana and maximal oxygen uptake) or to characterize the mechanism by which a dietary supplement acts to maintain such structure or function (e.g., fiber and bowel regularity) would not need to be conducted under an IND. However, a clinical investigation designed to evaluate a dietary supplement’s ability to prevent osteoporosis or to treat chronic diarrhea or constipation would need to be conducted under an IND.

 See Guidance, at 12.  Similarly for conventional foods, a clinical investigation requires an IND if the study intends to evaluate the effect of a food on disease.  FDA examines the “primary purpose” for which the consumer has ingested the food article.  If the primary purpose for consumption is the product’s character as food (i.e., the product is consumed primarily for its taste, aroma, or nutritive value), an IND is not required because the product does not qualify as a “drug” under the Federal Food, Drug, and Cosmetic Act (“FDCA”).  If, however, the edible product is primarily being consumed for a purpose other than taste, aroma, or nutritive value (e.g. blocking the absorption of fat), an IND is required because the product is being used a drug for a physiological effect, not as food.

Perhaps the most significant element in FDA’s new guidance is the inclusion of Medical Foods within the broader discussion of conventional foods.  According to the guidance, a “clinical investigation intended only to evaluate the nutritional effects of a food (including medical foods) would not require an IND, but an investigation intended to evaluate other effects of a food on the structure or function of the body would.”  FDA illustrated those points as follows:

 [A] study of the effect of iron on hemoglobin levels in which subjects were fed beef or lamb as a source of iron would not require an IND, but a study of the effect of soy isoflavones on bone metabolism would.  Similarly, a study of the ability of an infant formula to support growth of infants or of other nutritional properties of the formula would not require an IND.  However, a study of other effects of the formula on the structure or function of the body (e.g., an investigation of the effects of docosahexaenoic acid in infant formula on visual acuity of infants) would require an IND.

 A clinical investigation intended to evaluate the ingredient’s safety generally does not require an IND.   The same is true for an investigation intended to evaluate the tolerability of a food in a specific subset of the population, including diseased persons (e.g., giving a novel food protein ingredient to a potentially allergic population to assess allergic reactions).

Regarding medical foods in particular, however, the guidance explains that an IND is required if the clinical investigation is intended to evaluate the medical food’s effect on disease, but not “if the medical food is simply being fed to subjects for nutritional purposes during a study examining the effects of another intervention.”  Yet FDA rightly observed that the definition of a “medical food” is a food “which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”  See Guidance at 13 n.21; 21 U.S.C. § 360ee(b)(3) (emphasis added).  Does it seem odd that FDA would expressly apply the drug regulations in Part 312 whenever a “medical food” study explored the product’s impact on disease?  A medical food by definition is intended to manage disease conditions, and by statutory definition medical foods are not drugs.

Similarly, the FDA announced that clinical investigations intended to support a new health claim (i.e., a claim characterizing the relationship between a substance and a disease or health-related condition) for a conventional food or dietary supplement, require INDs.  Dietary supplements making health claims are certainly not “drugs” under the DSHEA.  Yet, as with medical foods, FDA now plans to regulate the scientific support for those products through its drug regulations.  That approach improperly regulates conventional foods, medical foods, and dietary supplements as “drugs.”

FDA Regulates Dietary Supplements and Medical Foods as “Drugs”:

That begs the question, if the IND application process is explicitly reserved for investigational “drugs,” and medical foods or dietary supplements with DSHEA health claims are not “drugs,” then why would FDA regulate those latter products as “drugs” under the IND regulations?  After all, if FDA was concerned with protecting study subjects, one would think FDA’s Good Clinical Practices regulations would be sufficient.  See, e.g., 21 CFR parts 56 and 50.  Industry should recognize this maneuver for what it its:  an administrative power grab intended to give FDA more control over dietary supplement and medical food research, and also place manufacturers of such products in a regulatory dilemma.  There are material consequences to filing an IND application, not the least of which is an admission that the product studied is a “drug.”

The regulations in 21 CFR Part 312 are clear on their face.  In an IND application, Section 312.23(a)(7)(iv)(a) requires a “description of the drug substance…”  (emphasis added).  The regulations pertain to “drug” products exclusively.  Those regulations are tailored to the drug approval process, and the mechanisms by which companies seek drug approval, including the rigid clinical trial model involving randomized double-blinded, placebo-controlled studies.  See 21 CFR 312.23(a)(7)-(8).  As we have observed in other contexts, particularly for dietary supplement health claims, the FDA’s Evidence-Based Review System built on the drug model is often impractical in the food and dietary supplement context.  Proving drug efficacy in an acute disease or disorder is a different matter than studying the preventative effect of certain nutrients ingested over a lifetime.  To prove dietary supplement health claims through the traditional Randomized Clinical Trial (RCT) model would, therefore, be prohibitively expensive because of the long study durations and substantial population sets.  FTC experts recently estimated that if forced to follow the rigid drug model a suitable RCT study for dietary supplement health claims could cost as much as $600 million, a price perhaps expected for drug products, but not dietary supplements.  See FTC Initial Decision, In re POM Wonderful LLC, et al., FTC Docket No. 9344 (May 17, 2012), at 96, ¶ 650 (FTC experts “testified that studies of disease prevention should involve 10,000 to 30,000 men and that such studies are ‘incredibly expensive’ and in the range of $600 million”).  Instead, dietary supplement and food studies must make use of different data sets, including animal models, meta-studies, and observational studies that can provide persuasive support at lower costs which also mirror the reduced safety concerns in foods or supplements.  The IND application process does not accommodate those approaches because an IND application is in contemplation of seeking drug approval—something dietary supplement and medical food companies have no intention of pursuing.

Perhaps the most notable burden is the cost.  IND applications are substantial filings that require research and development.  Imagine now having to complete an IND application for a vitamin to study the risk-reductive effects of that vitamin in the development of a certain site-specific cancer.  IND applications require:  detailed statements of the investigative plans; an investigator’s brochure; detailed information concerning clinical protocols and investigator information; information on the composition, manufacturer, stability, and controls used for manufacturing the “drug” substance; and pharmacology & toxicology information, including prior human experience with the “investigational drug.”  Moreover, once studies begin under an IND, the sponsor must maintain that IND.  FDA also enforces regulations governing when and how a sponsor can charge for an investigation drug subject to FDA’s IND regulations.  See 21 CFR 312.8(b)-(c).

IND applications can actually prevent dietary supplements from qualifying as a “dietary supplement” under the DSHEA definition.  See 21 U.S.C. § 321(ff)(3)(B)(ii); 21 U.S.C. § 331(ll) (prohibiting the marketing of any food to which has been added a drug or biologic for which substantial clinical investigations has been made public, unless the drug or biologic was marketed in food before any substantial clinical investigations involving he drug or biologic were instituted).  FDA was therefore compelled to explain in its IND Guidance that “[m]arketing the substance of interest as a dietary supplement or as a food or in food before seeking an IND or beginning any clinical investigations preserves the option to continue to market the substance in those forms after substantial clinical investigations have been instituted and their existence has been made public.”  See Guidance at 11.  That sounds logical, if not also entirely unnecessary if FDA had not suddenly required all foods and dietary supplements to file investigational new drug applications before researching potential associations with disease prevention.

Medical foods have it even worse.  As explained above, “medical foods” cannot qualify for the statutory definition in Section 360ee without first having scientific evidence to support the product’s use in dietary management of disease.  Under FDA’s new IND guidance, however, medical food manufacturers must file an IND application before investigating the disease relationship.  So before the medical food can even become a “medical food,” it must first become a “drug” under FDA regulations, even though Congress expressly permitted “medical foods” to be associated with diseases without actually becoming drug products.

FDA’s IND guidance does not account for that discrepancy, nor does FDA explain the significance an IND designation might have on medical food products in development.  FDA buried this sweeping change within a separate discussion of conventional foods.  A company that first files an IND on a medical food formula might later discover that it cannot pursue medical food status because of the apparent drug purpose memorialized in the IND application.  Moreover, that same company cannot now protect marketability by arguing that its product was first marketed as a food or dietary ingredient, because FDA could find that the product fails the “medical food” definition for a different reason.  Under another recent draft guidance, FDA determined that medical foods cannot be marketed for diseases or conditions which can be managed through changes to the normal diet alone.  See Our Prior Blog Post here (a medical food must now be “intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone”) (emphasis added).

So if a company claims that its “medical food” was previously marketed as a conventional food or dietary supplement, then FDA could theoretically conclude that changes to diet alone are available to the patient which would obviate the need for a “medical food.”  Yet if the sponsoring company first filed an IND application to study the required connection with disease management, FDA could theoretically prevent the product from being sold as a “medical food” because it was studied first as a drug ingredient.  We assume FDA would not wield its authority so capriciously, but the IND Guidance should have devoted more explanation to these conflicts.  Instead it raised many unanswered questions.

In the realm of FDA regulated products, the FDA survives on its categorical distinctions between products like cosmetics, drugs, biologics, dietary supplements, etc.  Everything FDA handles is built into that system of classification-first, regulation-second.  The exact same molecular formula can be a drug, dietary supplement, cosmetic, or food, all depending on the product’s intended use.  In the IND Guidance the FDA should have focused on the intended use of the test article.  If an article is investigated for a non-drug use, then FDA has no authority to regulate the article as a drug during the research stage or at any stage thereafter.  After all, completion of successful testing does not make the medical food a “drug” simply because that testing investigated the product alongside disease.  A dietary supplement with an approved health claim does not become a “drug” simply because scientific studies explored the product’s relationship with the risk-reductive effect of certain diseases.  Dietary supplements do not become drugs just because the manufacturer relies on clinical intervention studies that tested against disease conditions, particularly when those studies also support the product’s use in maintaining a structure or function of the body.  Product characterizations should be established based on intended use in commerce, not scientific research into potentially non-drug or disease endpoints.

For years, FDA has made public its disdain for dietary supplements and medical food products, mostly because, unlike drugs and devices (i.e., products with user fees), FDA cannot exercise strict premarket control over products like dietary supplements.  This is not the first time FDA attempted to increase oversight of foods and supplements through controversial guidance documents.  In July 2011, the FDA published a draft NDI (New Dietary Ingredient) guidance document interpreting Section 350b of the FDCA.  That guidance imposed new and burdensome compliance measures on dietary supplement companies, measures designed to substantially increase the amount of premarket “notifications” filed by dietary supplement companies.  FDA’s instant IND Guidance has the same effect by requiring dietary supplement and medical food companies to submit extensive information before beginning valuable scientific research.

Particularly as applied to medical foods and dietary supplements seeking health claims, the FDA’s September IND guidance is arbitrary and capricious, and in conflict with the FDA’s enabling act.  The Federal Food, Drug, and Cosmetic Act as amended by the DSHEA and the Orphan Drug Act carefully preserved the distinctions between dietary supplements, medical foods, and drugs.  FDA acts arbitrarily and capriciously when it directly regulates all of those products under the drug regulations solely because certain research might involve an exploration of disease conditions.  The FDA IND guidance therefore substantially changes the substantive legal obligations of those dietary supplement and medical food manufacturers that would otherwise seek to support their products through scientific research.  The guidance therefore sets new rules that should not have been implemented through guidance documents.  As applied to medical foods, and particularly on the heels of FDA’s September 2013 revisions to the Medical Food Guidance, FDA should have given more attention to its discussion of “medical foods” in this IND Guidance.

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The draft guidance has us revisiting a seldom-discussed dietary supplement labeling exception for “classical nutrient deficiency disease” claims.  Such diseases (e.g., scurvy, pellagra) “that result from essential nutrient deficiencies (e.g., deficiencies of vitamin C, niacin) are typically caused by inadequate intake (e.g., famine, significant calorie restriction, eating disorders, alcoholism, diet practices/fad diets).”  See FDA Medical Foods Guidance at Section II.24.  In the medical foods context, FDA now explains that “[b]ecause such diseases can typically be managed through dietary modification alone, FDA generally would not consider a product labeled and marketed for these diseases to meet the regulatory criteria for a medical food.”  Id.  FDA’s admission is significant because it now claims that certain “diseases” can be managed or treated through dietary changes alone, including the use of dietary supplements.

For borderline medical foods the answer might be found in the nutrient deficiency exception in 21 U.S.C. § 343(r)(6).  A disease or health condition caused by a nutrient deficiency should be remedied by correcting that deficiency.  If FDA will not allow medical foods to address those conditions because changes in diet can remedy the deficiency, then surely dietary supplements should be allowed to advertise the benefits of certain products in correcting deficiencies.  After all, FDA just told us that these “diseases” can be managed by changes to dietary intake.  Many medical food products can theoretically be reformulated or relabeled as dietary supplements without a significant interruption in sales.

So can dietary supplement products claim to manage or “treat” diseases that are directly caused by nutritional deficiencies when medical food counterparts cannot?  FDA’s regulations suggest that possibility.

FDA frequently acts against dietary supplement products making therapeutic claims on grounds that those products are actually “unapproved new drugs.”  Section 101.93 governs permissible structure/function claims for dietary supplements and prevents so-called “disease” claims.  But Section 101.93(g)(1) expressly excludes certain ailments from the definition of “disease.”  The regulation defines “disease” as “damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.” (emphasis added).  In other words, “essential nutrient deficiencies” are not considered “diseases” for purposes of the dietary supplement claims regulations.  And if those health conditions are not “diseases,” then FDA’s campaign against unapproved “disease” language stalls.

If that sounds too good to be true it’s probably because FDA would not expand the “classical nutrient deficiency disease” exception to include any more than the most established deficiency diseases.  The exemption may not be as broad as Section 101.93(g)(1) suggests.  FDA would say that not all essential nutrient deficiencies qualify.  The enabling statute (21 U.S.C. § 343(r)(6)) and 21 CFR 101.93(g)(2) both limit the exception to “classical nutrient deficiency diseases.” (emphasis added).  We see that same language in the FDA’s medical food guidance.  The meaning of “classical” in this context is unstated and ambiguous, giving FDA discretion to interpret the word narrowly.  The FDA could therefore determine that the identified deficiency was not a “classical” deficiency subject to the exemption.  Moreover, many ailments can be attributed to a deficiency or lack of nutrition, at least in part.   Just as FDA sought to prevent medical foods from expanding into drug territory, so too would FDA curtail dietary supplements claims.  Companies seeking to rely on the Section 343(r)(6) exemption would, at minimum, need to prove through credible science that the nutrient deficiency is the exclusive cause of a disease in order to assert the exemption.  Although FDA enforcement in this area is limited, we might expect the agency to apply the health claim standard and require at least significant scientific agreement (SSA) showing that a disease is caused solely by the nutrient deficiency.  That alone raises substantial questions, including whether a qualified claims regime could exist for nutrient deficiency “treatment” claims under Section 343(r)(6).  On that note, medical food companies left scrambling after FDA’s draft guidance should also consider whether dietary supplement health claims or qualified health claims could provide patients with critical information outside of the medical food context.

Those points notwithstanding, by narrowing the medical food category, the FDA has at least reinvigorated the Section 343(r)(6) discussion.  Congress’s plain intent was to provide consumers information concerning the relationship of dietary supplements and nutrient deficiency states.  Forcing companies to seek drug approval for vitamin C in the treatment of scurvy would be absurd when consumers could simply be told that eating oranges cures the condition.  As medicine and technology evolve and provide greater insight into disease pathologies, the Section 343(r)(6) exemption, and the purpose motivating that clause, will have greater significance.  Scientific research may not operate under the FDA’s rigid structures.  We need a system that bridges technologies to provide patients the best possible care.  That might include treatment protocols involving both FDA approved drugs and nutritional products.  For instance, CMS has approved hospital ordering privileges for nutritionists, thus reinforcing the role of nutrition as a spoke in the therapeutic wheel.

So why can drug products advertise treatment benefits but dietary supplements and foods cannot similarly advertise their complementary roles in treatment or recuperation?  For instance, a dietary supplement can make a structure/function claim concerning health maintenance or general well-being before sickness onsets, but FDA prohibits a dietary supplement from claiming to support traditional therapies by providing the body with essential nutrition during treatment.  Or perhaps a better question, will the FDA’s system of censorship based on rigid, mutually exclusive categories (e.g., “drug,” “dietary supplement,” “medical foods”) remain  practical as medicine evolves?

While I agree that FDA should police the market for egregious offenders—i.e., those who would profit from junk science—the FDA’s recent position on medical foods stems from an inflexible system designed to control and regulate medical innovation.  The medical food category provides patients nutritional products that could help manage disease alongside conventional therapies.  If FDA intends to foreclose that regulatory category for certain diseases, then the “classical nutrient deficiency disease” exemption in Section 343(r)(6) should be interpreted broadly to provide helpful information concerning disease management.  If not through medical foods, the FDA must provide a means to disseminate that information outside the costly and burdensome drug approval process.

The post Does FDA’s Interpretation of “Nutrient Deficiency Diseases” in the Draft Medical Foods Guidance Create Room for Dietary Supplement Disease Claims? appeared first on Emord Blog.

In sum, the proposed FVSP rule requires importers to review the compliance status of food and foreign suppliers before importing.  Importers must analyze hazards associated with each food they import, and verify that those hazards are adequately controlled.  FDA would also require documentation of corrective activities for consumer complaints, which may require an investigation of responsible foreign suppliers.  The rule also includes record-keeping obligations.

FDA included several exemptions or modified requirements that are described in the FDA’s proposed rule.  See 78 Fed. Reg. 45732-45738 (July 29, 2013).  Of particular significance, the FDA relaxed the FSVP obligations for dietary supplement companies that already comply with the dietary supplement cGMPs in 21 CFR Part 111.  Nonetheless, dietary supplement importers might still be required to comply with certain provisions, including, for instance:  § 1.506(a) (listing of foreign suppliers); § 1.509 (identification of the importer at entry); 1.510 (records); and § 1.511(c) (supplier verification).  The supplier verification procedures in Section 1.511(c) are intended to ensure compliance with the dietary supplement cGMPs.  Those requirements could add substantial compliance costs for importers of finished dietary supplements.  For example, “[f]or each dietary supplement imported, the importer must conduct one or more of the verification activities listed in proposed § 1.511(c)(5(i) through (c)(5)(iv) before using or distributing the dietary supplement and periodically thereafter.”  See 78 Fed. Reg. at 45764-65.  That might include periodic onsite auditing, periodic or lot-by-lot sampling and testing, periodic review of the supplier’s food safety records, and any other procedure appropriate.  In short, the FDA expects dietary supplement importers will verify that their foreign suppliers conform to the cGMPs in 21 CFR Part 111.

For importers of conventional foods, the FDA’s FSVP proposal would create broad obligations to ensure that foreign suppliers are manufacturing food products in conformance with domestic law.  Failure to comply with the regulations proposed in 21CFR §§ 1.500-1.513 would result in refusal of admission for an imported article, and non-compliance will be deemed a prohibited act under the FDCA.  See 21 CFR 1.514(b) (proposed); 21 U.S.C. § 331(zz) (proposed).

Comments on the proposed FSVP rule are due November 26, 2013 and can be filed through www.regulations.gov, Docket No. 2011-N-0143-0023.

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Please join us in congratulating Jonathan on this achievement.

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FDA has begrudgingly implemented only part of the federal courts’ constitutional mandates and refuses to honor the letter and spirit of those decisions.  The Federal Trade Commission defers to the FDA’s decisions on qualified health claims and, so, does not take enforcement action against them.   Without an approved claim, any statement in labeling or advertising that reveals an intent to sell a dietary supplement for use in the cure, treatment, prevention, or mitigation of disease turns a “dietary supplement” into an unlawful, “unapproved new drug” under the federal Food Drug and Cosmetic Act (FDCA).  A qualified health claim accomplishes more than just a labeling exemption at the point-of-sale.  The qualified claim can also restore value to the Third Party Labeling Exemption, a statutory provision undercut dramatically by FDA’s application of the intended use doctrine.

For years the FDA has substantially limited the flow of information that should be accessible to consumers through the “third party labeling” exemption in 21 U.S.C. § 343-2.  FDA also resisted Congressional attempts to expand the free-flow of scientific information to consumers based on authoritative government statements concerning nutrient-disease relationships.  In the FDA Modernization Act of 1997, Congress expressly permitted use in food labeling of nutrient content claims and health claims based on authoritative statements issues by other governmental bodies.  See generally Food Labeling: Health Claims; Antioxidant Vitamins C and E and the Risk in Adults of Atherosclerosis, Coronary Heart Disease, Certain Cancers, and Cataracts, 63 Fed. Reg. 34084 (June 22, 1998).  FDA has refused to obey that clear legislative command.  FDA determined through rulemaking that such “authoritative statements” could only support health claims if those claims also satisfied FDA’s rigorous “significant scientific agreement” (SSA) standard.  See id. at 34086.  FDA determines for itself whether the SSA standard is satisfied based on existing evidence.  Unsurprisingly, therefore, the agency’s interpretation dramatically undercut the “authoritative statements” exemption in 21 U.S.C. § 343(r)(2)(G), which was supposed to be a less restrictive alternative to, not a re-embodiment of, the SSA standard.

The Dietary Supplement Health and Education Act (DSHEA), enacted in 1994, contained two significant statutory sections intended to expand consumer access to information about dietary supplements.  See 21 U.S.C. §§ 343(r) and 343-2.  Section 343(r) authorized “health claims” for dietary supplements.  Section 343-2 authorized the dissemination of truthful and non-misleading scientific information under certain conditions.  Both sections are “labeling” exemptions, allowing certain statements and information to be displayed at the point of sale, or in conjunction with a sale.  Section 343-2 provides, in pertinent part:

A publication, including an article, a chapter in a book, or an official abstract of a peer-reviewed scientific publication that appears in an article and was prepared by the author or the editors of the publication, which is reprinted in its entirety, shall not be defined as labeling when used in connection with the sale of a dietary supplement to consumers when it:

1.  is not false or misleading;
2. does not promote a particular manufacturer or brand of a dietary supplement;
3. is displayed or presented, or is displayed or presented with other such items on the same subject matter, so as to present a balanced view of the available scientific information on a dietary supplement;
4. if displayed in an establishment, is physically separate from the dietary supplements; and
5. does not have appended to it any information by sticker or any other method.

That “labeling” exemption, although poorly worded, should permit the dissemination of truthful scientific information directly to consumers.  However, the FDA has substantially limited that option.

In the early 2000s, the internet continued its rapid growth during the dot-com bubble.  The web became a powerful, readily accessible method for smaller companies to disseminate information.  With the emergence of finely tuned web-browsing platforms and search engines, companies could provide volumes of scientific information through a mouse-click.  When Congress enacted the DSHEA, that form of mass-dissemination was impractical with nascent technology.

Today members of the regulated industry frequently clash with FDA over internet policies.  FDA’s authority over dietary supplements and foods had once focused on product labeling.  “Labeling,” in the eyes of the 103rd U.S. Congress, referred to print materials affixed to the product or disseminated along with the product.  The FDA expanded the “labeling” concept to keep pace with burgeoning technology.  For example, in a 2007 letter to industry, the FDA explained that web pages are sometimes “labeling”:

FDA also recognizes that information available through the Internet, including those websites that provide truthful and non-misleading information about conventional food products can serve a valuable and useful function. … In certain circumstances, information that is disseminated over the Internet by, or on behalf of, a regulated company meets the definition of labeling in section 201(m) of the Act and is subject to the requirements of the Act. For example, if a company were to promote a regulated product on its website and allow consumers to purchase the product directly from the website, the website is likely to be “labeling.” As another example, if the label for a product contained a statement that referred the consumer to a specific website for additional information about a claim for the product, the website is likely to be “labeling.” The websites, in these cases, are considered written, printed, or graphic matter that supplements or explains the product and is designed for use in the distribution and sale of the product.

 See Letter from B. Schneeman, Ph.D., Director of FDA’s Office of Nutritional Products, Labeling and Dietary Supplements, CFSAN (Jan. 2007).

If FDA decides that your webpage is “labeling,” the agency has an upper hand.  FDA strictly regulates “labeling” content, including product claims.  The third party literature labeling exemption in 21 U.S.C. § 343-2 should have limited FDA’s ability to condemn or censor certain scientific information.  In other words, assuming you satisfy the five elements in Section 343-2(a), FDA should permit a full, objective scientific discussion concerning dietary ingredients—whether or not that discussion touches on diseases or abnormal health conditions, as the published literature often does.  Therefore, in reliance on the Section 343-2 exemption, companies compiled scientific databases and online forums to spread vital information.  They thought that Section 343-2 permitted scientific discussion even when they also sold the product or ingredient at issue.

FDA closed that door.  FDA’s “intended use” doctrine swallowed the exemption.  Under the “intended use doctrine,” courts allow FDA to consider any source of information when determining the seller’s intended use for the product.  If the product is intended for use as a drug, FDA regulates the article accordingly.  In other words, if you promote a product for a drug purpose in any way, the FDA will consider that product to be a drug.  FDA examines web pages, blogs, Facebook pages, product reviews, and educational pages when classifying products.  In fact, as we recently reported here, in April FDA acted against a company that published health information on unrelated webpages.  According to FDA, the scientific discussion established a “drug” purpose.  By hyperlinking to that content, the company established an unapproved drug use for the dietary supplement.

Put simply, under the intended use doctrine, if the science discusses a drug use (e.g., treatment, mitigation, cure, or prevention of disease), the science library could render the product a “drug.”  Sellers can argue that the science also supports and acceptable claim (e.g., structure/function language), and that the promotional content clearly limits the science to that purpose.  But FDA wields broad authority to draw meaning from promotional and informational content.

So what of the third party literature exemption and its five elements?  Well, labeling exemption or not, if the scientific information associates a dietary supplement or its ingredients with a therapeutic use, the product is a drug.  Just like that, FDA nullifies the exemption in Section 343-2 because that statue only created a “labeling” exemption.  The statute does not limit FDA from considering the material under the intended use doctrine.  A company selling the dietary supplement is therefore limited in the information they can disseminate concerning that dietary supplement.  The solution may be qualified health claims.

How Can Qualified Health Claims Help?

A qualified health claim disables FDA of its most efficient charge:  the unapproved drug claim.  The qualified claim permits dissemination of science related to the disease risk-reductive effect which supported the qualified health claim petition.  In other words, a company operating under an FDA-approved qualified health claim can theoretically publish scientific discussion concerning the subject disease, without fear that FDA will label the product a “drug” based on that scientific discussion.  Instead, the FDA could argue that the scientific discussion misleads consumers by exaggerating the strength of science supporting the FDA-approved claim.  That challenge, however, is harder for FDA to sustain because it requires proof that the scientific evidence is actually misleading or false.  The qualified health claim thus restores access to the vibrant scientific discussion intended by the third party literature exemption in 21 U.S.C. § 343-2, provided, of course, that the discussion remains largely focused on disease prevention featured in the original health claim petition.

Some background on qualified health claims is helpful.  A qualified health claim characterizes the relationship between a nutrient and the reduction in the risk of developing certain diseases.  FDA will approve a pure health claim (unqualified claim) only when a scientific consensus shows that the claim is supported.  For unqualified health claims, FDA generally requires “significant scientific agreement” by well-qualified experts in the relevant field.  Qualified health claims, by contrast, are attainable when the level of scientific evidence is supportive but inconclusive.  If at least some methodologically sound scientific evidence supports a claim, the First Amendment requires FDA to allow the claim subject to suitable disclaimers.

A qualified health claim begins with a health claim petition.  That petition must include all relevant citations to the supportive science, along with a discussion of negative evidence.  FDA examines that petition through its Evidence-Based Review System (EBRS).  Under the EBRS, FDA categorizes scientific evidence based on, inter alia, methodological quality.  FDA generally looks to clinical data.  To the extent FDA (or a federal court) finds evidence to support the claim, the industry may use the claim in labeling or promotional material, along with a suitable disclaimer that characterizes the level of scientific support.

When approving a claim, the FDA ordinarily rejects most studies and finds that just one or two studies support the claim (often out of hundreds submitted).  FDA dismisses whole categories of scientific data, including animal studies, meta studies, mechanistic studies, treatises, etc.  According to FDA, that evidence only provides background information, and does not directly support the health claim.  But those studies are part of the public scientific record.

After FDA approves a health claim or allows a qualified health claim, the agency cannot logically contend that the health claim is false or misleading.  Moreover, the First Amendment should allow a company to disseminate information related to the petitioning process.  Such information could include, for example, a detailed list of the science submitted to FDA in support of the claim.  The result is a robust disclosure of scientific information, and candid discussion of that information.  The scientific evidence in support might also include discussions of treatment protocols or therapeutic uses, provided that the scientific evidence also supported the qualified health claim at issue.  The qualified health claim thus opens the door to an information stream apart from the approved claim language alone.

Those points notwithstanding, the costs of obtaining a qualified health claim remain significant.  A claim petition requires thorough research and a willingness to press forward if FDA denies the initial petition.  Health claims can be used by any company that satisfies the designated criteria.  Members of industry are therefore hesitant to altruistically expend resources on a general claim that might also benefit competitors.  Consumer and industry groups have joined forces to help foster the free-flow of scientific information from industry to consumers.  Associations like the Alliance for Natural Heath (ANH) have contributed generously to the development and pursuit of qualified health claims.  Interested companies should consider joining or contributing to similar organizations, or contacting legal counsel to determine whether their specific product could be eligible for a qualified health claim.

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As the First Amendment commercial speech standards shift and courts begin to favor more freedom in the marketplace, industry could gain a significant edge on FDA in health claims cases.  Health claims and third party literature schemes could stand to gain the most from recent Supreme Court and federal precedent.  Do not hesitate to contact us if you have any questions concerning health claims or dietary supplement marketing.

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