US Supreme Court Asked to Clarify the Interaction Between the 21st Amendment and the Commerce Clause

The Texas Package Stores Association has asked the US Supreme Court (via a “Petition of Certiorari”) to hear a case that could clarify the interaction between the 21st Amendment and the non-discrimination between states principle of the “dormant” Commerce Clause.

The case arose in Texas, where the Court of Appeals for the Fifth Circuit ultimately held that the Supreme Court’s Granholm v. Heald (2005) decision did not limit the reach of the Commerce Clause in alcohol cases to situations where a state discriminates against producers or products. Decisions by two other federal Court of Appeal’s Circuits (the Second and the Eight) have expressly limited Granholm’s reach to discrimination against producers and products. Thus, the Texas Package Stores Association would like the Supreme Court to reverse the Fifth Circuit and explicitly limit the non-discrimination principle of Granholm to cases involving alcohol products and producers.

The Supreme Court hears only a small fraction of the cases brought before it on a Petition of Certiorari, so the chances that the Supreme Court ultimately reviews the Fifth Circuit’s decision remain low. Nevertheless, the existence of a “split” of opinion between different federal Courts of Appeal increase the chances of Supreme Court review.

Summary Judgment Granted in Tito’s “Handmade” Vodka Case

On September 27, 2016, the Northern District of Florida issued a decision in Pye v. Fifth Generation, Inc., N.D. Fla. No. 4:14cv493-RH/CAS, one of many false advertising class actions brought against the makers of Tito’s “Handmade” Vodka.

Although Tito’s has lost a number of decisions on motions to dismiss and summary judgment motions in other jurisdictions, Pye delivers a win. Having already dismissed claims related to the generic “handmade” claim, the recent Pye decision grants summary judgment on the final challenged claim – that Tito’s is made in “an old fashioned pot still.” According to the court, any pot still can be described as “old fashioned” when compared to a column still, and no reasonable consumer could read the claim to represent that all Tito’s comes from the same still.

Two New TTB Rulings Issued on General Use Formulas

On September 29, the Alcohol & Tobacco Tax & Trade Bureau (TTB) issued two new Rulings announcing the creation “general use formulas” for certain distilled spirits and agricultural wines. These general use formulas permit the production or importation of these products without the need to first obtain an approved formula (for domestic products) or a pre-import approval (PIA – for imported products) from TTB.

TTB Ruling 2016-2 exempts from the regulations’ formula and PIA requirements most “agricultural wines,” a category that generally encompasses wines fermented from materials other than fruit. Most notably, honey wine (mead) is now exempt from the requirement to file for a formula or a PIA prior to applying for label approval and/or introducing the product into commerce.

TTB Ruling 2016-3 exempts certain categories of distilled spirits from formula and PIA requirements. For certain categories of spirits made with less than 2.5 percent “harmless coloring, flavoring, or blending materials,” certain specific materials are now authorized without the need to obtain formula or PIA approval. The categories and materials are:

  1. Vodka made with sugar (up to 2g per liter) and/or citric acid (up to 1 g per liter);
  2. Rum made with sugar, brown sugar, molasses and/or caramel;
  3. Certain types of whiskies made with sugar, caramel and/or wine; and
  4. Certain types of brandy made with sugar, caramel, fruit from the same fruit used to make the brandy and/or wine fermented from the same fruit.

These changes represent a modest but helpful attempt to reduce the number of formula and PIA submissions filed by the industry.

FDA to Redefine “Healthy” Claim for Food Labeling

The Food and Drug Administration (FDA) recently took two actions involving the use of the claim “healthy” on food labels. First, FDA opened a docket to solicit comments on whether, and if so how, to revise the criteria that must be meet in order for a food to bear the claim “healthy.” This reflects changes in public health recommendations for various nutrients since FDA first published the criteria for making “healthy” food labeling claims in 1993. For example, FDA’s view of healthy dietary patterns now focuses on food groups and the type of fat rather than the total amount of fat in a food. Food manufacturers can continue to use the term “healthy” on foods that meet the current regulations while FDA further considers any comments submitted.

Second, FDA issued Guidance announcing that it does not intend to enforce certain regulatory requirements for products that use the term “healthy.” Specifically, FDA says it will not take enforcement action against a food that bears the claim “healthy” but which does not meet the regulatory definition of low fat provided that: (1) The amounts of mono- and polyunsaturated fats in the food are declared on the label; and (2) the sums of mono- and polyunsaturated fats are greater than the total saturated fat content of the food. Similarly, FDA will not take enforcement action with respect to the current regulatory requirement that any food bearing a “healthy” claim contain at least 10 percent of the Daily Value (DV) of vitamin A, vitamin C, calcium, iron, protein, or fiber if, instead, the food contains at least 10 percent of the DV of potassium or vitamin D. These two changes reflect the most-recent dietary guidance.  For fat, the recommendations have shifted from limiting total fat intake to encouraging consumption of mono- and polyunsaturated fats. For mineral and vitamin content, potassium and vitamin D are now nutrients of public health concern, while vitamins A and C are no longer nutrients of public health concern.

A copy of FDA’s “Healthy” Guidance is attached here.

The BA’s Growing Influence on Capitol Hill

How is it that the Brewers Association—an organization that has no political action committee, has employed a staff lobbyist for only 18 months, and has only had a strong presence in Washington since 2009—has gained significant traction among policymakers in the nation’s capital?

The BA is now a serious player in Washington. That is not by accident; it’s a carefully conceived strategy implemented by the BA board and senior staff—including president and CEO Bob Pease—over the last seven years that seeks to leverage the inherent strengths of America’s small craft brewers.

Read the full article, originally published in the September/October 2016 issue of The New Brewer.

Another Taxpayer Victory in Illinois False Claims Act Litigation, Affirming a Taxpayer’s Right to Rely On Qualified Third Parties For Tax Return Preparation

On August 30, 2016, following a one day bench trial, Cook County Circuit Judge Thomas Mulroy ruled in favor of Treasury Wine Estates (TWE) in Illinois False Claims Act (Act) litigation filed by the law firm of Stephen B. Diamond, PC (“Relator”). Relator alleged that TWE had violated the FCA by knowingly failing to collect and remit Illinois use tax on the shipping and handling charges associated with its internet sales of wine shipped to Illinois customers. State of Ill. ex rel. Stephen B. Diamond, P.C. v. Treasury Wine Estates Americas Company, d/b/a Treasury Wine Estates, No. 14 L 7563 (Cir. Ct. of Cook County, Ill. Aug. 30, 2016) (Order). The Court held that Relator failed to prove that TWE knowingly violated the FCA or that it acted in reckless disregard of any Illinois tax collection obligation.

Read the full article here.


New TTB Final Rule Released on Denatured Alcohol

The new TTB Final Rule that was released in the Federal Register on August 20, 2016 will partially streamline the use of non-beverage alcohol products in the US. While statutory requirements do not permit TTB to completely de-regulate the distribution and sale of denatured alcohol, the attached rule, among other things:

  1. Reclassifies a number of “specially denatured alcohol” (“SDA”) formulas as “completely denatured alcohol” (“CDA”). As the regulatory requirements for distributing CDA are much less stringent than those that apply to SDA, these reclassifications amount to a lessening of regulatory burdens for companies dealing in such products.
  2. Establishes additional “general use formulas,” which permit the production of SDA products without the need for a specific TTB formula approval.
  3. Exempts distilled spirits plant (“DSP”) operators from the requirements to obtain an additional permit to produce and handle SDA products within the bonded premises of a DSP.
  4. Makes a variety of technical changes and deletions to the regulations in order to meet what TTB views as current industry practice.

While the TTB reforms do not deregulate SDA use to the extent that most producers and users would like, the Final Rule represents a welcome step in the direction of deregulation and simplification. A substantially more radical deregulation of such products would require statutory changes and therefore are beyond the realm of what TTB can accomplish on its own.

Texas Court Strikes Down Prohibition on Payments for Brand Rights

Late last week, a district judge in Texas declared unconstitutional under the Texas Constitution a provision of the state’s Beer Industry Fair Dealing Law (i.e., the beer “franchise” law) that expressly prohibits a brewer from accepting a payment in exchange for a grant of territorial distribution rights.  Section 102.75(a)(7) of the Texas Alcoholic Beverage Code, enacted in 2013, applies generally to “manufacturers,” including both in-state brewers and out-of-state brewers holding nonresident manufacturer’s licenses in Texas.  In 2014, three small Texas brewers – Live Oak Brewing Company, Revolver Brewing and Peticolas Brewing Company – sued the Texas Alcoholic Beverage Commission (TABC) and its executive director, Sherry Cook, arguing that Section 102.75(a)(7) violates the Texas Constitution.

In a short summary order, the district court judge agreed.  The court found that Section 102.75(a)(7) violates the Texas Constitution’s “Due Course of Law” provision, Texas’ analog to the US Constitution’s Due Process Clause, which states that a Texas citizen may not “be deprived of life, liberty, property, privileges or immunities, or in any manner disfranchised, except by the due course of the law of the land.”  Tex. Const. Art. I, § 19.

The court granted the plaintiff breweries’ motion for summary judgment on their Due Course of Law argument and enjoined the TABC and Ms. Cook (and their respective employees, agents and successors) from enforcing Section 102.75(a)(7) against the plaintiffs and any other brewers.  The court dismissed the plaintiffs’ claim that Section 102.75(a)(7) amounted to a taking of private property in violation of the Texas Constitution, though, and also dismissed the plaintiffs’ request for attorney’s fees.

Although the judge’s order did not contain any detail regarding her reasoning, the case restores an important opportunity for brewers distributing – or interested in distributing – beer in Texas.  Further, although the TABC may appeal, the decision should remind state legislatures that state restrictions on the conduct of private parties in the alcohol industry in the name of protecting the three-tier system must still pass muster under federal and state constitutional principles.

FDA Issues Final Rule on Food Ingredients that May Be Generally Recognized as Safe (GRAS)

The US Food and Drug Administration (FDA) has issued this final rule detailing the criteria for concluding that the use of a substance in human or animal food is “generally recognized as safe” (GRAS).  By way of background, if an ingredient is GRAS, food additive petition is not required and FDA does not have to approve the ingredient before it can be used in foods.  FDA has been studying the existing process that currently results in a company conducting the GRAS assessment via a panel of experts and then either proceeding to immediately use the ingredient in foods, or submitting a GRAS affirmation petition to FDA before the ingredient is used in a food.

FDA’s new regulation provides the information FDA believes a company should have to make a GRAS determination or conclusion.  Manufacturers remain free to conduct their own GRAS evaluations and then proceed to incorporate the substance into food.  FDA’s final rule changes what had been a voluntary GRAS affirmation process into a voluntary “notification” process. Under this new process, if a company decides to use the notification process, the company conducts the requisite safety assessment and then prepares a notification submission to the FDA.  The contents of the notification submission are detailed in the regulation.  Once the voluntary notification had been submitted to FDA, the agency is supposed to respond within 180 days, though that can be extended for an additional 90 days (for a total of 270 days) before the substance can be included in a food, assuming FDA does not question the basis for the notifier’s GRAS conclusion.

DEA Declines to Change Stance on Marijuana but Opens Door to Federally Sanctioned Marijuana Research

On August 11, 2016, the Drug Enforcement Administration (DEA) formally declined to change its position on the medical or recreational use of marijuana, denying two petitions urging the federal government to change marijuana’s drug classification under the Controlled Substances Act. The petitions, filed in 2009 and 2011, urged the DEA to change marijuana’s status as a Schedule I drug—a drug without any accepted medical uses—to a Schedule II drug—a drug with potential medical value but high potential for abuse—or to a drug “in any schedule other than [S]chedule I.” Despite a trend towards decriminalization and legalization on the state level, the DEA’s denial of these petitions indicates the Obama administration has not changed its stance on marijuana.

Twenty-five states currently allow some form of marijuana to be used for medical purposes.  Four state—Alaska, Washington, Oregon, and Colorado—and the District of Columbia allow the recreational use of marijuana for adults. Nevertheless, the DEA, citing an evaluation and scheduling recommendation from the Department of Health and Human Services (HHS), concluded that marijuana “has no accepted medical use in the United States, and lacks an acceptable level of safety for use even under medical supervision.” The Agency ultimately declined to remove marijuana from Schedule I because of its “high potential for abuse,” lack of “currently accepted medical use in treatment in the United States,” and lack of “accepted safety for use under medical supervision.”

The DEA’s Thursday announcements were not uniformly anti-marijuana. Most notably, the Agency also published a policy statement designed to increase the number of entities registered to grow marijuana to supply researchers in the United States. Currently the only registered facility is at the University of Mississippi, which has been the single grower registered to supply medical marijuana research for nearly 50 years. In its policy statement, the DEA gave its full support to expanding research into the “potential medical utility of marijuana.” Based on its discussions with the National Institute of Drug Abuse (NIDA) and the Food and Drug Administration (FDA), the DEA concluded that “the best way to satisfy the current researcher demand” of marijuana “is to increase the number of federally authorized marijuana growers.”  This new policy will allow more people to register with the DEA as marijuana growers.

The DEA on Thursday also signed onto a Statement of Principles on Industrial Hemp published by the Department of Agriculture and the FDA. The Agricultural Act of 2014 legalized the growing and cultivating of industrial hemp for research purposes in states where such activities are legal under state law. Growing and cultivation is limited to institutions of higher education or state departments of agriculture for purposes of agricultural or other academic research. The three federal agencies published the Statement of Principles “to inform the public regarding how Federal law applies to activities involving industrial hemp” so that those hoping to participate in industrial hemp agricultural pilot programs can do so in accordance with federal law.