Washington Post Parrots Activists’ Skewed Spin of FDA’s “GRAS” Process

The ScreamJust below the fold in the print and digital versions of this morning’s Washington Post blares the headline “Food additives on the rise as FDA scrutiny wanes.” The story dutifully advances the perspective of professional activists that the Food and Drug Administration’s (FDA) “generally recognized as safe” (GRAS) process for food additives is perilously broken. Food nanny organizations such as Center for Science in the Public Interest and the Natural Resources Defense Council have ramped up their attacks on GRAS over the past several years, assisted by a 2010 Government Accountability Office (GAO) report calling for changes to the process.

As explained in a Washington Legal Foundation Legal Backgrounder by Hyman, Phelps & McNamara attorneys Roberto Carvajal and Nisha Shah, the GRAS process dates back to 1958, when Congress determined that certain uses of substances in foods that were generally recognized as safe need not go through formal FDA approval. For nearly four decades, FDA applied that exception very narrowly, but the Clinton-era agency leadership altered that interpretation in 1997. They concluded that narrow application of the GRAS exception deeply strained agency resources and chilled food industry innovation. The agency’s new approach permitted food processors to self-report new uses of certain substances and provide FDA with the science supporting the GRAS conclusion. In response to the critical 2010 GAO report, the agency acknowledged that while the GRAS process could be improved, “FDA believes that the GRAS concept has continuing utility as a practical tool for distinguishing between substances and new uses of substances that merit a full pre-market safety evaluation by FDA and those that do not.”

FDA’s resolve on the GRAS process seems to be weakening, however. The Post article features a troubling front-page quote from FDA’s Deputy Commissioner Michael Taylor: “We simply do not have the information to vouch for the safety of many of these chemicals.” He goes on to proclaim later in the article, “We aren’t saying we have a public health crisis.” But of course Deputy Commissioner Taylor understands that when FDA uses the term “public health crisis,” even when denying the existence of one, it sounds alarm bells. FDA’s latest statements could be setting the stage for regulatory action against such common, widely-used ingredients as caffeine and sodium, which the agency has long considered GRAS.

For those who might be interested in learning more about the GRAS process from a far different perspective than the Washington Post provided today, watch WLF’s free July 10 Web Seminar, The Future of FDA’s “GRAS” Designation in an Era of Increased Scrutiny. The Powerpoint presentation utilized by our speakers, Keller and Heckman LLP’s Melvin Drozen and Evangelia Pelonis, is available here.

FDA Advisory Committee Not Rife with Conflicts of Interest? — “Please!” Quips Federal Judge

FDAIn order to achieve results that it believes are vital to public health, the Food and Drug Administration (FDA) has demonstrated time and again that it’s not afraid to trample laws and constitutional rights along the way. Occasionally, judges reintroduce FDA to the Rule of Law. We applaud one such recent rebuke by Judge Richard Leon, whose July 21 Lorillard v. FDA decision reminded FDA that it cannot stack a science advisory panel with members who will tell the agency what it wants to hear.

FDA tobacco control. After the U.S. Supreme Court rejected the agency’s attempt to seize regulatory oversight of tobacco products in 2000 (FDA v. Brown & Williamson), Congress granted FDA the authority it coveted in 2010. Banning or severely restricting the use of menthol in cigarettes has long been a goal of FDA’s friends in the anti-tobacco movement. FDA created a science advisory panel, the Tobacco Products Scientific Advisory Committee (TPSAC) to study menthol. The TPSAC concluded in 2011 that menthol had a negative effect on public health. Two companies filed suit in Febuary 2011, charging that FDA violated federal law by appointing members to the TPSAC who had clear conflicts of interest. The plaintiffs asked the court to strike the TPSAC’s report from the regulatory record.

Judge Leon’s opinion. The TPSAC members in question had ongoing contracts to testify as expert witnesses for plaintiffs in suits against tobacco companies. They also served as consultants to manufacturers of tobacco cessation products. FDA didn’t feel such relationships conflicted with their duties on the TPSAC. Judge Leon was quite flabbergasted by FDA’s decision. “Please!” he exclaimed, adding, “This conclusion defies common sense.” With regard to the members’ work with plaintiffs’ lawyers, Judge Leon explained that they had a financial incentive not to make any recommendations that would compromise the lawsuits in which they would testify. On the product consulting work, the judge noted that any FDA regulation of menthol would likely inspire more smokers to quit, potentially with the assistance of cessation products. Thus the TPSAC members also had a financial incentive to offer advice that would encourage a ban or restrictions on menthol. Judge Leon concluded that such blatant disregard for obvious conflicts violated federal law, and he enjoined FDA from utilizing the report in its assessment of menthol. Continue reading

There’s Nothing “New” about “Lone Pine” Orders for Active Case Management

faulkFeatured Expert Column − Complex Serial and Mass Tort Litigation

by Richard O. Faulk, Hollingsworth LLP*

To listen to the plaintiffs’ bar, you’d think that “Lone Pine” orders were a novelty recently conjured out of “thin air” by creative defense lawyers—or a device unsupported by any significant precedents. But although those orders may seem new to the uninitiated, they have deep roots in the history of active case management.

Many lawyers know—or have learned the hard way—why these case management tools are called “Lone Pine” orders, and what they are intended to accomplish. In Lore v. Lone Pine Corporation, No. L-03306-85, 1986 WL 637507 (N.J. Sup.Ct. Nov. 18, 1986), the plaintiffs claimed injuries resulting from contamination allegedly coming from a landfill. When the defendants presented a government investigation that found no offsite contamination, the court required the plaintiffs to make a preliminary showing of exposure, injury, and causation before allowing full discovery to proceed. This ruling led to other cases which recognized the propriety of “Lone Pine” orders when doubt existed “over what medical condition or disease, if any, can be causally related to the toxic agent exposure alleged by each plaintiff.”2 Lawrence G. Cetrulo, Toxic Torts Litigation Guide § 13:49 (2013). Since then, “Lone Pine” order have proliferated, not only in toxic tort litigation, but also in other types of cases.See generally, David B. Weinstein and Christopher Torres, Managing the Complex: A Brief Survey of Lone Pine Orders, 34 Westlaw Envt’l J. 1 (Aug. 21, 2013) (providing extensive list of categorized cases). Continue reading

Federal Workplace Police Have a Tough Week in Court

6th CircuitIf anyone doubts our democracy’s need for an independent judiciary to check the executive and legislative branches, consider two federal court opinions issued last week. Federal workplace police at the Equal Employment Opportunity Commission (EEOC) and the Department of Labor (DOL) each received a thorough (and richly deserved) judicial slapdown for arrogantly flouting the rule of law.

EEOC v. Kaplan Higher Education Corp. The unanimous U.S. Court of Appeals for the Sixth Circuit panel set the tone of this seven-page opinion by declaring, “In this case the EEOC sued the defendant for using the same type of background check that the EEOC itself uses.”

Kaplan implemented vigorous screening of job applicants, including the use of credit checks, in response to several instances of employee theft. Such increased self-policing earned the company an EEOC legal action. The Commission argued that Kaplan’s credit checks had a disparate impact on minorities.

To support its case, EEOC hired a psychologist to perform statistical studies using Kaplan’s applicant data. The “expert” filed numerous reports with the trial judge, most of which were either late or contrary to the judge’s demand that he cease providing reports. The judge found that the psychologists’ reports were unreliable under Federal Rule of Evidence 702 and dismissed EEOC’s case.

The Commission fared just as poorly on appeal. The Sixth Circuit agreed with the lower court’s conclusion that EEOC’s “expert” and his methodology failed every factor that courts utilize to assess expert testimony under the Supreme Court’s Daubert v. Merrell Dow opinion. The judges agreed that a court could neither test the psychologist’s technique, nor could it evaluate the test’s error rate. EEOC argued that its “expert’s” theory did not have to be subject to peer review. The Sixth Circuit found the argument “meritless.” As for the other Daubert factors, EEOC essentially argued that the burden fell on Kaplan to prove they had been met. The court pointedly retorted, “The law says to the contrary.”

The opinion ended as sharply as it began:

We need not belabor the issue further.  The EEOC brought this case on the basis of homemade methodology, crafted by a witness with no particular expertise to craft it, administered by persons with no particular expertise to administer it, tested by no one, and accepted only by the witness himself.

Gate Guard Services v. Perez. Here, the Department of Labor lost more than just a case.  Because of its antics, American taxpayers had to shell out $565,527.61 in attorneys’ fees to the enforcement target.

DOL accused Gate Guard Services (GGS) of misclassifying gate sentries as independent contractors. GGS counter-sued and sought a declaratory judgment. In February 2013, U.S. District Court for the Southern District of Texas Senior Judge John Rainey granted GGS summary judgment and dismissed DOL’s claims against the company. GGS then sought attorneys’ fees under the Equal Access to Justice Act (EAJA).

Under that statute, the government must prove that its position in a lawsuit had a reasonable basis in both fact and law (“substantially justified”) at every stage of the action. Judge Rainey agreed with GGS that DOL’s lead investigator departed from DOL enforcement procedures when he destroyed interview notes and assessed a $6 million fine after he had interviewed only three gate sentries.

“Had the DOL interviewed more than just a handful of GGS’s roughly 400 gate attendants,” Judge Rainey wrote, “it would have known [they] were not employees.” He listed ten different factors that DOL failed to reasonably consider, including “the federal government itself, via the ACE [Army Corps of Engineers] uses the services of gate attendants at federal parks and classifies these individuals as independent contractors.”

The court concluded that DOL’s actions both before and during the suit were not substantially justified and awarded fees to GGS.

Checked and Balanced. But for an independent judiciary, the executive branch would be free to engage in the type of hypocrisy and disrespect for rules that were on display in these two cases. It might routinely label employers’ credit checks discriminatory while utilizing the very same screening method, or it could categorize a company’s gate sentries “employees” while other federal agencies consider similarly situation workers “independent contractors.” Agencies would prosecute businesses for destroying internal documents while permitting federal investigators to freely do the same.

We should all be grateful that our federal courts did not tolerate such behavior from EEOC and DOL, and instead reminded them of principles most of us learned in kindergarten: play by the rules and live by the same rules you expect others to abide by.

Also posted at WLF’s Forbes.com contributor page

Demonization by Litigation: Food Ingredient Makers Face Frivolous Charges

fructoseCross-posted at WLF’s Forbes.com contributor site

When some future legal scholar writes the history of how the public health activist-plaintiffs’ bar-government regulator axis of paternalism tried to use litigation to alter America’s food choices, S.F. v. Archer Daniels Midland et al. may not even merit a mention. But for now, it stands as the most notorious illustration of how a baseless lawsuit can effectively demonize one disfavored food ingredient.

The Complaint. S.F. is the mother of S.E.F., a fourteen-year old who suffers from Type 2 diabetes. Archer Daniels Midland (ADM) and the other three defendants (Cargill, Ingredion Inc., and Tate & Lyle Ingredients Americas) make up the entire corn refiners industry. They refine corn into, among other things, high fructose corn syrup (HFCS), a food ingredient public health activists have long vilified. In her complaint, S.F. rattled off inflammatory allegation after another, including such unsubstantiated charges as “HFCS is a toxin.” She eventually got around to asserting that HFCS is “unreasonably dangerous” and caused her daughter’s diabetes. She demanded $5 million in damages.

The suit achieved its immediate, and perhaps only, goal of garnering sympathetic media attention. Most reports parroted the plaintiff’s outlandish statements and quoted professional food activists who are attacking HFCS in others venues, such as before the Food and Drug Administration (FDA). Of course only scant reporting has been done on the suit since, with just a few stories in the trade press about the defendants’ motions to dismiss, documents which have effectively exposed the suit as legally and factually baseless.

Undeniable Legal Flaws. The legal flaws in the plaintiff’s case, detailed in the defendants’ initial motion to dismiss and their November 1 reply memo, are abundant and clear, so we’ll only briefly summarize them here: Continue reading

The Federal Government is Coming For Your Magnets

Magnetic regulation?

Magnetic regulation?

Cross-posted at WLF’s Forbes.com contributor page

The U.S. Consumer Product Safety Commission held a public hearing Tuesday on its proposed safety standard for magnet sets.  Although the proposed standard originally issued last year, the agency failed to do the required oral hearing at that time and is now making up for that oversight.  In the interim, however, the agency filed a lawsuit against a manufacturer of magnet sets and its CEO, a lawsuit that is still pending in front of an Administrative Law Judge.  The Commissioners will sit in judgment as an appellate body if any party appeals the ALJ’s ruling in that case.  If any Commissioner thinks it inappropriate to nonetheless proceed with a ban on the product in question, it went unremarked at the hearing.  Does anyone believe that the Commission could impartially oversee such an appeal having already banned the product about which the ALJ is ruling?

The ostensible purpose of a public hearing is to ensure that all views are heard, yet not a single opponent of the regulations appeared to testify.  Not one.  Given that the written comments submitted to the agency last year included many comments opposing the agency’s action, it seems unlikely that no one wanted to testify in person against the agency’s proposal.  The agency apparently did a much better job of inviting supporters of the regulation from the medical and advocacy communities than from, say, the companies whose employees will lose their jobs when this product ban goes into effect.  One founder of a company directly affected by the agency’s action complained that he did not receive any notice of the event prior to the cutoff for submitting testimony.  One need not go very far out on a limb to speculate that the doctors who testified in front of the CPSC did not learn about the hearing from reading the Federal Register notice themselves.  Shame on the biased CPSC for not doing more to seek out the views from the affected industry at this hearing.  The agency did at least leave the hearing record open until Oct. 29, in case any latecomers want to file additional written comments. Continue reading

Anti-Hydraulic Fracturing Activists Focus Firepower on California

Monterey ShaleCross-posted at WLF’s Forbes.com contributor page

With a budget profoundly in the red and an unemployment rate hovering around 10%, one would think that elected officials and citizens’ groups in California would be figuring out how to move forward development of the massive shale “play” shown here to the right — The Monterey Shale. But instead, the same crowd that bestowed such regulatory gems as Proposition 65 on California’s business environment is busily plotting how to kill this golden goose.

Three proposals are currently advancing in the state Assembly to prohibit hydraulic fracturing in California until various studies can be done to definitively establish that the six decade-old gas extraction technique is 100% safe. The proposals eschew the traditional risk-based U.S. regulatory approach and embrace the European style of precaution, which demands ex post proof of safety even where no current evidence reveals environmental or health harms. Not surprisingly, a who’s who of activist groups support the bills, led by the Center for Biological Diversity, which has an ongoing suit against the state regarding hydraulic fracturing regulations. Even California’s state law schools are pitching in, with UC-Berkeley’s Center for Law, Energy and the Environment releasing a well-timed “report” calling for more controls.

“Let’s study the issue” is a non-threatening euphemism activists and government use in place of the scarier actual outcome sought: let’s forestall the activity being studied for as long as possible. New York’s moratorium on natural gas extraction has been dragging on for five years, with no timetable for release of the state health commission’s study of fracking (“I will continue to work on this until I am comfortable” says the Commissioner). While celebrity activists (or fracktivists as California-based think tank The Breakthrough Institute calls them) like Mark Ruffalo applaud the ponderous New York delays, jobs and revenue flow to neighboring states like Pennsylvania. Have any of the California legislators supporting the Assembly bills seen what natural gas development has done to nearby North Dakota’s economy?

The emergence of natural gas as an abundant, more efficient source of domestic energy than coal threatens the environmental activist movement’s utopian vision of alternative fuels. So hydraulic fracturing must be stopped. One supporter of a California moratorium from 350.org was clear on this: “We need a dramatic shift off carbon-based fuel: coal, oil and also gas,” calling natural gas “at best a kind of fad diet.” The three organizations listed as “co-sponsors” of one California fracking bill, AB 1301 – Center for Biological Diversity, Clean Water Action, and Food & Water Watch – each support outright bans on hydraulic fracturing.

The debate is ongoing in California, and as we learned from last year’s battle over mandatory biotech food labeling, when the public is fully educated about the negative ramifications of feel-good proposals, the best outcome for Californians can be reached. Here’s hoping that the facts can battle their way through the hype and emotion, so reasoned decisions can be made.

Here We Go Again? Mandatory Biotech Food Labeling Initiative Moves Forward in Washington (State)

Genetically-enhanced wheat

Genetically-enhanced wheat

Cross-posted at WLF’s Forbes.com contributor page

Not even a year after fighting a bruising and costly battle over the California Right to Know Genetically Engineered Food Act” (Proposition 37), proponents and opponents of mandatory biotech food labeling are poised for a rematch in the state of Washington. In February, the Secretary of State’s office certified ballot initiative I-522, The People’s Right to Know Genetically Engineered Food Act, and forwarded it to the legislature.

Under Washington law, the legislature can either enact it into law, reject it or refuse to act on it, or approve an amended initiative. If lawmakers don’t act on, it goes to a public vote in November. If the legislature alters it, then both the altered version and the original version go on the November ballot. The likeliest scenario is no legislative action, which puts I-522 in the voters’ hands.

The similarities between the defeated California initiative and the impending Washington proposal go beyond their titles. The Washington proposal, authored by an advertising executive, embraces the spirit, if not the letter, of many of Prop 37’s provisions. One provision it did not borrow from Prop 37 was that initiative’s prohibition of “Natural” and “All-Natural” on food labels.

Some initial thoughts on I-522: Continue reading

Study Exposes “Sin Taxes” as Counterproductive Social Engineering Tool

focus_introimg_sintaxesGuest Commentary

by John Andren*

Once directed at controlling the “social ills” of smoking, alcohol, and gambling abuses, sin taxes have become a favored tool of policy makers in their quest to make consumer’s food and drink choices for them as well. With little scientific evidence to support the effectiveness of such taxes and overwhelming economic evidence against them, you would think legislators wouldn’t waste their time with sin taxes.

But with state and national budgets suffering from large short falls, legislators are scrambling to find new ways to raise revenue. It just so happens soda and fast food appear to be on the top of their lists. The popularity of soft drinks and fast food in America has led to a vociferous debate between those who want to defend their freedom to eat and drink what they want and those who wish to engineer the diets of all American’s according to their own personal ideals.

A new working paper from George Mason University’s Mercatus Center, Sin Taxes: Size, Growth, and Creation of the Sindustry, provides a thorough overview of the supposed economic logic supporting the “need” for sin taxes, and further economic and public choice arguments against them. Continue reading

California Supreme Court Case Sets New Standards for Expert Testimony

mc sungailaGuest Commentary

by Mary-Christine Sungaila, Snell & Wilmer L.L.P.*

Experts testify in almost every civil case that goes to trial.  Indeed, in many types of cases, such as medical malpractice and product liability actions, a plaintiff cannot recover without expert testimony.  Despite the importance of this type of testimony, the California Supreme Court had remained silent about the proper standards for admitting it.  Until now.

In Sargon Enterprises, Inc. v. University of Southern California, the Court considered whether the trial court erred by excluding expert testimony to substantiate the lost profit damages allegedly stemming from USC’s refusal to clinically test a new implant designed by the plaintiff dental implant company; but for USC’s breach, the implant company claimed, the company would have become a worldwide leader in the implant industry and made millions of dollars in profit each year.  The Supreme Court affirmed the expert’s exclusion, concluding that “trial courts have a substantial ‘gatekeeping’ responsibility,” including the duty “to exclude speculative expert testimony.”

The Supreme Court explained that

under Evidence Code section 801, subdivision (b), and 802, the trial court acts as a gatekeeper to exclude expert testimony that is (1) based on matter of a type on which an expert may not reasonably rely, (2) based on reasons unsupported by the material on which the expert relies, or (3) speculative.”

The court further observed that other provisions of law, including case law, “may also provide reasons for excluding expert testimony.”  Citing to the U.S. Supreme Court’s decision in Daubert v. Merrill Dow Pharmaceuticals, the Court warned, however, that the focus of the trial court’s analysis must be on the principles and methodology espoused by the expert, and not on choosing between two competing expert opinions. Continue reading