FDA’s Proposed Regulation of Brewers’ Spent Grains is All Wet

spent brewing grains

spent brewing grains

During his February 5, 2014 appearance at a House Energy and Commerce Committee hearing, Food and Drug Administration (FDA) Deputy Commissioner Michael Taylor stated that “the whole goal of [the Food Safety Modernization Act (FSMA)] is to achieve the food safety goal without imposing regulations, just for the sake of regulation.” Dr. Taylor must have been unaware of his agency’s proposal to require that brewers, distillers, and vintners develop extensive hazard analysis and control plans before selling or donating their spent grains or grape pomace to farmers for livestock feed. This proposal seems to be the epitome of regulating for the sake of regulating.

Farmers have been procuring and feeding their livestock spent brewing grains and grapes for centuries. These livestock “happy hour” arrangements advance environmental sustainability, engender bonds among local businesses, and financially benefit both parties. Farmers get low cost whole grain feed packed with fiber, protein, and, of particular importance to livestock in arid climates, moisture. Alcohol makers save millions by not having to landfill the by-products.

FSMA Section 116 exempts activities at facilities which “relateto the manufacturing, processing, packing, or holding of alcoholic beverages.” In a proposed animal food safety regulation, FDA essentially nullifies this statutory exemption. The agency “tentatively concludes” that when brewers or distillers go through the “mashing” process—soaking grains in hot water—and then offer the by-product to farmers, they suddenly become food producers. The same goes for winemakers and their grape pomace. FDA’s conclusion has sparked a deserved firestorm of opposition from the affected industries as well as members of Congress. Continue reading

WLF Briefing Discusses FDA’s “Plaintiffs’ Bar Over Patients” Generic Drug Labeling Proposal

FDA’s Generic Drug Labeling Proposal: Unauthorized and Counterproductive Disturbance of the Hatch-Waxman Balance

Our Panelists

  • Ralph G. Neas, The Generic Pharmaceutical Association
  • Alex Brill, American Enterprise Institute
  • Richard A. Samp, Washington Legal Foundation

Accompanying Materials

 

Update: FDA Drags Feet on Approval of Internationally-Accepted Vaccine While Drexel Student Dies of Meningitis B

Drexel University

Drexel University

The Centers for Disease Control and Prevention (CDC) have concluded that a Drexel University student who died in early March was infected with the same strain of meningitis, “serogroup B,” that some Princeton University students contracted in late 2013. The two schools are separated by about an hour in the greater Philadelphia area.

We discussed the outbreak at Princeton, as well as another one at the University of California Santa Barbara, and the need for those schools to “import” a meningitis B vaccine from overseas, in a December 19 post, The Meningitis B Outbreak: Heavy Doses of Government Can Be Costly. The vaccine had to be imported under an emergency exception because the Food and Drug Administration (FDA) has still not approved its use in the United States.

The situation at Drexel could parallel the developments at Princeton as opposed to those at UCSB. The Drexel student was reportedly in contact with Princeton students who had visited her at Drexel just a week before her death. In response, Princeton, which obtained and administered Novartis’s Bexsero vaccine after a lengthy federal government-required process, will be offering another round of vaccinations next week. News reports do not indicate whether the Princeton students in contact with the deceased Drexel student had received the inoculations that were made available on their campus, but only 80% of Princeton students have received both recommended doses of vaccine. One hopes that any students who bypassed the inoculations last time around have learned their lesson and will take full advantage of the next round of inoculations being offered.

Meanwhile, students at Drexel and their families will have to be satisfied with CDC’s conclusion that because there are no other meningitis B cases identified at the university, “members of the Drexel community are not considered to be at increased risk.”  Continue reading

FDA Action Should Take the Juice Out of Some Food Labeling Class Actions

Unevaporated Cane

Unevaporated Cane

We admit that before scrutinizing the related wave of food labeling class action litigation, we had never seen the term “evaporated cane juice” (ECJ).  It might be fair to wonder whether many of the plaintiffs in these suits had ever noticed it on food labels either. But claims alleging that using ECJ on a food label violate federal rules (and thus also California law) have become ubiquitous. As of January 22, there were over 50 suits pending in federal courts with an ECJ claim. Thanks to an action yesterday by the Food and Drug Administration (FDA), those claims may not survive beyond March.

FDA formally reopened the comment period for draft guidance first published on October 7, 2009. That draft guidance informed industry that “dried cane syrup,” not evaporated cane juice, is the common or usual name under federal rules for “the solid or dried form of sugar cane syrup.” FDA never finalized that guidance, but true to FDA form, the agency still invoked it in warning letters sent to companies using the term evaporated cane juice. Continue reading

Food Court Delivers Plaintiffs’-Lawyer Consortium Mixed Results in Four January Rulings

food-courtCross-posted at WLF’s Forbes.com contributor site

Last July in a Legal Pulse post entitled “Who’s Filling the Food Court with Lawsuits: Consumers or Lawyers?,” we noted the extensive involvement in food “mislabeling” class actions of a consortium of plaintiffs’ lawyers, some of whom had been active in tobacco litigation. Led by the law firm Pratt & Associates, the group filed 24 class actions in the Northern District of California in less than two months in 2012. We’ve now identified a total of 34 cases the consortium has brought to the Food Court.

In that post we offered a chart tracking the current status of the consortium’s cases.  Our updated chart is available here. Kindly let us know if we missed any.

Northern District of California judges have been busy this month on the group’s cases, issuing four substantive rulings.

Gustavson v. Wrigley Sales Co. Judge Koh’s order in this case is the only complete victory of the four for plaintiffs or defendants. After rejecting Wrigley’s motion to dismiss on preemption grounds last September, Judge Koh reversed herself on that issue in this January 7 decision. What changed? Wrigley cited FDA commentary on a 1993 nutrient content labeling rule which supported the company’s use of the term “sugar free” on its gum. The plaintiff’s suit would require placement of certain FDA-required qualifying language on the gum label in a manner different from what FDA rules allow, so Judge Koh held the claim expressly preempted. She dismissed Gustavson’s claims with prejudice. Continue reading

WLF Media Briefing Program Focuses on Government’s Regulation of Information on “Off-Label” Drug Uses

Coleen Klasmeier, a partner with Sidley Austin LLP, Geoffrey M. Levitt, Senior Vice President and Associate General Counsel of Pfizer, Inc., and Jonathan L. Diesenhaus, a partner with Hogan Lovells US LLP discussed the impact of the Second Circuit’s December, 2013 Caronia decision on federal health product regulation and identify the latest developments and trends to follow in 2014 for public and private law enforcement targeted at off-label speech.

Sixth Circuit Affirms Preemption Defense in Suit against Branded and Generic Drug Companies

Cruz-Alvarez_FFeatured Expert Column

by Frank Cruz-Alvarez, Partner, Shook, Hardy & Bacon, L.L.P., Miami office, and Travis Robert-Ritter, an associate in the firm’s Miami office.

On December 6, 2013, the U.S. Court of Appeals for the Sixth Circuit in Strayhorn v. Wyeth Pharm., Inc., No. 12-6195, — F.3d —-, 2013 WL 6224337 (6th Cir. Dec. 2, 2013) significantly limited drug manufacturers’ exposure to liability from harm caused by generic prescription drugs. Applying recent U.S. Supreme Court precedent, the Sixth Circuit held that the federal scheme governing generic prescription drugs preempts state-law failure-to-warn claims against generic drug manufacturers for injuries caused by their products. Id. at *6-17. The court also concluded that under state law, brand-name drug manufacturers may not be held liable for harm caused by other companies’ generic versions of their drugs. Id. at *20-26. In sum, the Sixth Circuit reasoned that federal and state law combined to eliminate failure-to-warn claims for injuries caused by generic prescription drugs.

The appeal arose out of the consolidation of seven cases filed against the manufacturers of the drug Reglan and its generic equivalent, metoclopramide. Id. at *1. The plaintiffs alleged that they ingested generic metoclopramide, causing them to develop a serious neurological disorder known as tardive dyskinesia. Id. The district court dismissed plaintiffs’ claims against both the generic and brand-name manufacturers. Id. An appeal ensued.

Turning first to plaintiffs’ claims against the generic drug manufacturers, the Sixth Circuit concluded it was bound to dismiss the claims based on the Supreme Court’s reasoning in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013). See Strayhorn, 2013 WL 6224337 at *5-17. In PLIVA, Inc. v. Mensing, the Supreme Court held that state-law failure-to-warn claims raised against certain generic drug manufacturers were preempted by federal law. 131 S. Ct. at 2577-2578. A group of plaintiffs had argued that the generic drug manufacturers should be held liable under state law because the warnings on their drugs were inadequate. Id. at 2572-2574. The Supreme Court soundly rejected the argument, explaining that the federal statutory scheme governing generic drugs limits manufacturers to using the same label and warnings approved for the generic drug’s brand-name equivalent. Id. at 2574-2578. Because this federal limitation made it impossible for the manufacturers to meet their obligations under both federal and state law, plaintiffs’ failure-to-warn claims were preempted. Id. Continue reading

The Meningitis B Outbreak: Heavy Doses of Government Can Be Costly

Princeton University campus

Princeton University campus

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

President Obama often makes reference to how trying times can provide “teachable moments.” The recent outbreak of bacterial meningitis on college campuses is such a moment, but don’t expect the President to notice. The fact that school officials had to seek federal government permission to import a vaccine not yet legally available in the U.S., reveals anew the human cost of overbearing government regulation.

Seven cases of infection with the “B” strain of bacterial meningitis have occurred at Princeton University, and four have been confirmed at the University of California at Santa Barbara (UCSB). Statistically, 10% of those infected with meningitis B die, and 20% of those who recover suffer from severe side effects such as deafness and limb loss. Vaccines for every strain of meningitis have been approved for use in the United States except meningitis B; however a vaccine called Bexsero has been approved for use in Europe, Australia, and Canada.

At Princeton. Last October, with terrified students and their parents demanding action, school and state health officials had to ask federal health officials if Bexsero could be imported and administered at Princeton. Cue the creaky wheels of bureaucracy. The Centers for Disease Control and Prevention (CDC) asked the Food and Drug Administration (FDA) to issue an investigational new drug application, which is required to import Bexsero. The vaccine finally arrived at Princeton in early December, and immunization began there last week. Continue reading

Two More Food Labeling Class Action Rulings: Harbingers of the New Year?

Not from lactating cows

Not from lactating cows

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

In our Legal Pulse commentaries on regulation-by-litigation of food labeling, one issue has predominated this year: What is a “reasonable consumer”? Two court decisions issued on consecutive days last week, one from the infamous Food Court (the Northern District of California) and the other from the Southern District of Florida, turned in large part on that issue and indicate that judges will continue addressing the question in 2014.

You Mean They’re Not from Cows? Ang v. Whiteway Foods, authored by Judge Conti of the ND of California, involved consumer fraud claims against the maker of soymilk/almond milk/coconut milk and related yogurt products. The plaintiffs challenged the use of the term “milk” in the products as well as ingredient references to “evaporated cane juice” (ECJ).

Judge Conti found that an earlier settlement in a similar Florida lawsuit barred Mr. Ang’s ECJ-based claims due to res judicata. He then turned to the soy/almond/coconut “milk” claims. He first found that federal labeling rules preempt Mr. Ang’s claims. Federal rules do not prescribe how the plant-based beverages must be labeled, and the rules relating to “milk” only “pertain to what milk is, rather than what it is not.” In such situations, federal rules require that products use “the common or usual name” for the food. Judge Conti found that the “Silk” drink makers did that, and thus Mr. Ang’s suit would improperly impose rules beyond what FDA requires. Continue reading

FDA’s Disrespect for the First Amendment (and Federal Courts) Dips to a New Low

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

The Food and Drug Administration (FDA) has long had “commitment issues” in its relationship with the First Amendment.  It possesses statutory authority to prevent the sale and distribution of drugs whose intended use and labeling are not FDA-approved, but in doing so it routinely treads on manufacturers’ speech.  Federal courts have held repeatedly that the First Amendment severely restricts FDA’s regulation of truthful speech about approved drugs.  The agency has responded with assurances that it will comply fully with those court decisions.  Recent actions make clear, however, that FDA shows little or no respect for those rulings and apparently believes it is not bound by the First Amendment.

The latest example of FDA’s defiance took the form of a Warning Letter issued by FDA’s Office of Prescription Drug Promotion (OPDP) on November 8, 2013 to Aegerion Pharmaceuticals.  OPDP’s letter objected to an appearance by Aegerion’s CEO on a CNBC talk show directed to the financial community.  During the course of his interview, the CEO suggested that Juxtapid, a drug manufactured by Aegerion, was safe and effective for several off-label uses that are closely related to its approved uses.  For example, the CEO could reasonably have been understood to say that the drug, when taken by itself, was effective in reducing a patient’s “bad” cholesterol levels, even though FDA has approved Juxtapid as a treatment for reducing “bad” cholesterol only as an “adjunct” to a “low-fat diet and other lipid lowering treatments.”  The Warning Letter did not contend that the CEO’s statement regarding efficacy was false, but it nonetheless charged that the statement was illegal because it rendered Juxtapid “misbranded.”  The letter demanded that Aegerion “immediately cease misbranding Juxtapid” and to issue “corrective messages” to rectify the situation.

So how did OPDP reach the remarkable conclusion that truthful statements made on a television talk show aimed at the financial community can render an otherwise lawful drug “misbranded?”  OPDP noted that a “misbranded” drug is defined to include a drug that lacks adequate directions for all intended uses.  It is safe to assume that a drug’s approved labeling does not include adequate directions for uses that have not been approved by FDA.  So if a manufacturer distributes a drug with the objectively verifiable intent that it be sold for an off-label use, the drug can be deemed “misbranded.”  So far so good.  Continue reading