FDA Publishes Final Rule for Protection Against Intentional Adulteration as Part of Food Safety Modernization Act

FDA has published as part of the Food Safety Modernization Act (FSMA) a final rule concerning mitigation strategies to protect food against intentional adulteration.  The rule will require domestic and foreign food facilities that are required to register as food facilities under the Federal Food, Drug, and Cosmetic Act (FFDCA) to address hazards that may be introduced with the intention to cause wide scale public health harm.  More specifically, under this regulation, both domestic and foreign food facilities are required to complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate contamination where the intent is to cause wide-scale public health harm. Facilities will now have to identify and implement mitigation strategies to address these vulnerabilities, establish food defense monitoring procedures and corrective actions, verify that the system is working, ensure that personnel assigned to the vulnerable areas receive appropriate training and maintain certain records.

FDA to Issue Revised Guidance on Nutrition and Supplement Facts and Serving Size Regulations

This Friday, May 27, 2016, the US Food and Drug Administration (FDA) will publish its revised Nutrition and Supplement Facts and Serving Size regulations. The Serving Size regulation in public inspection view is close to 180 pages and the Nutrition Facts regulation is close to 1,000 pages.

Significantly, for beverages:

  • Serving size will be 12 ounces.
  • The new rules require dual column labeling if the container weighs at least 200 percent (e., 24 ounces) and up to and including 300 percent (i.e., 36 ounces) of the applicable referenced amount commonly consumed (here, 12 ounces).
  • Where dual column labeling is required, the label must show nutrition information listed (a) per serving and (b) per unit.

In addition, the new rules include “added sugar” labeling requirements that will likely prove quite controversial.

Assuming no congressional intervention or court challenges delay implementation (and the requirements for declaring “added sugar” may result in some), the compliance dates for the new rules are:

  • July 26, 2018 for manufacturers with $10 million or more in annual food sales; and
  • July 26, 2019, for manufacturers with less than $10 million in annual food sales.

FDA Announces Availability of Final Guidance on Menu Labeling

On May 5, 2016, the US Food and Drug Administration (FDA) announced the availability of its final menu labeling guidance, “A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II (Menu Labeling Requirements in Accordance with 21 CFR 101.11).” The guidance is designed to help businesses comply with the menu labeling final rule.

Under a law signed late last year, FDA’s enforcement of its menu labeling final rule cannot begin until one year after FDA published this notice of availability. As a result, enforcement of the final Menu Labeling regulations will start on May 5, 2017.

FDA’s guidance responds to many frequently asked questions that it has received. It differs from the draft guidance by providing additional examples and new or revised questions and answers on topics such as covered establishments (pages 6, 12–17), alcohol beverages (pages 50–55), catered events (page 14), mobile vendors (page 16), grab-and-go items (pages 40–41) and record keeping requirements (pages 42–47). Continue Reading

Guidance Provided on Interplay of “Dormant” Commerce Clause and the 21st Amendment

On April 21, the US Court of Appeals for the Fifth Circuit handed down its opinion in Cooper v. Texas Alcoholic Beverage Commission, No. 14-51343.  It provides further guidance, at least within the Fifth Circuit, on the interplay of the “dormant” Commerce Clause and the 21st Amendment following the Supreme Court of the United States’ oft-cited decision in Granholm v. Heald, 544 US 460 (2005).

The case arose when the Texas Package Store Association attempted to revisit the Fifth Circuit’s two-decade old decision in Cooper v. McBeath, 11 F.3d 547 (5th Cir. 1994).  Cooper v. McBeath permanently enjoined the Texas Alcoholic Beverage Commission (TABC) from enforcing certain residency requirements imposed on wholesalers and retailers by the Texas Alcoholic Beverage Code.  In that decision, the Fifth Circuit decided that the residency requirement was a protectionist measure and therefore unconstitutional under the so-called “dormant” Commerce Clause of the US Constitution.

In 2014, the Texas Package Store Association (TPSA) moved for relief from the Cooper v. McBeath injunction, arguing that Granholm and its progeny undermined the earlier decision’s reasoning.  The district court ruled that the TPSA lacked standing to seek relief, although it also suggested that TPSA’s motion for relief should be denied on the merits.

In last month’s Cooper v. Texas Alcoholic Beverage Commission decision, the Fifth Circuit concluded that TPSA had standing to seek relief from the Cooper v. McBeath injunction, but then held that TPSA’s motion should be denied on the merits.  Laying out the standard for relief as whether Granholm and its progeny represent a “significant change in decisional law,” the Fifth Circuit concluded that no significant change had occurred.

The Fifth Circuit begins its analysis by noting that Granholm expressly refused to overrule prior cases holding that the Commerce Clause qualified states’ rights under the 21st Amendment.  TPSA argued that the statement in Granholm labeling the three-tier system “unquestionably legitimate” essentially removed Commerce Clause protections from state laws dealing with the wholesale and retail tiers of the industry.  Characterizing that language in Granholm as “dictum,” the Fifth Circuit rejected TPSA’s argument as “unconvincing.”  Refusing to follow an Eighth Circuit decision that embraced logic similar to the argument advanced by TPSA, the Fifth Circuit instead relied on its own decision in Wine Country Gift Baskets.com v. Steen, 612 F.3d 809 (5th Cir. 2010).  Thus “state regulations of the retailer and wholesaler tiers are not immune from Commerce Clause scrutiny just because they do not discriminate against out-of-state liquor.”  Instead, although the 21st Amendment permits a state to impose a physical-residency requirement that may favor in-state businesses, it may not impose “a durational-residency requirement on the owners of alcoholic beverage retailers and wholesalers.”  (Quoting Cooper v. McBeath, emphasis in original).

The Fifth Circuit accordingly reasoned that nothing in Granholm and its subsequent application represent a significant change in the law.  It therefore reversed the decision of the district court and directed it to enter an order denying on the merits TPSA’s motion for relief.

Cooper v. Texas Alcoholic Beverage Commission represents yet another wrinkle in the federal courts’ ongoing struggle to reconcile the holding of Granholm (a state cannot discriminate between the shipping rights of out-of-state versus in-state wineries) with its dictum that the three-tier system is “unquestionably legitimate.”  By drawing a previously unrecognized distinction between “physical-residency” and “durational-residency” requirements and, perhaps, distinctions based on business location versus owner location, the Fifth Circuit also has introduced significantly more complexity and nuance into the Commerce Clause/21st Amendment analysis.

We expect that the Supreme Court will eventually address this subject again to reconcile what is now a clear “circuit split” between the Fifth and Eighth Circuits.  But the Court will likely allow the issue to further “percolate” in the lower courts, as the case law in this area remains quite new.  We also wonder whether litigants seeking to narrow Granholm, who have scored a number of significant “wins” in the Second, Fifth (Steen) and Eighth Circuits in the decade since Granholm, will put those decisions in jeopardy by seeking Supreme Court review of the Cooper v. Texas Alcoholic Beverage Commission decision.

Join McDermott Partner Marc Sorini at the Annual Craft Brewers’ Conference

The annual Craft Brewers’ Conference will be held on May 3-6, 2016 in Philadelphia, PA. McDermott partner, Marc Sorini will give two presentations:

  • Wednesday, May 4, 1:20-2:20 pm: Marc will kick off his annual government affairs presentation by summarizing the results of recent research to be published in The New Brewer proving that no legally-mandated three-tier system existed immediately following the repeal of Prohibition. He then will provide an update on the biggest legal issues facing the industry during the past year, including recent tied-house/trade practice activities, the false advertising class actions and a distribution update.
  • Friday, May 6, 1:55-2:55 pm: Marc will join two other lawyers and moderator Bill Covaleski of Victory Brewing to explore the issue of beer “franchise law” reform.

For more information or to register, please visit http://www.craftbrewersconference.com/.

Trademark Tips for Small Distillers

What’s in a name? (Or a slogan, logo, symbol or other source-identifying device?) Well, turns out a lot. While the craft spirits industry is a tight knit and collegial community, businesses must strive to create a unique and distinctive place in the market that makes their products stand out from the rest. For small distillers, who may have leaner advertising budgets than the spirits giants, one effective way to plant your flat in the ground and say “This is who we are, come and join us!” is through trademarks.

A trademark is any word, name, symbol, logo and/or device the identifies the goods and services of one party, and distinguishes such offerings from those of others.

Below we provide some tips and recommendations for small distillers to consider when selecting and protecting trademarks.

Read the full article (originally published in the Spring 2016 issue of Artisan Spirit).

Red Stripe Prevails in Alcohol Beverage Labeling Class Action

The latest merits decision in the ongoing false advertising/labeling class actions appears here.  This case involves allegations that the labeling and marketing of Red Stripe Beer misleads consumers into thinking they are purchasing beer made in Jamaica from Jamaican ingredients.  In fact, production of Red Stripe for the US market moved to the US in 2012.  The Southern District of California’s Dumas v. Diageo PLC decision to dismiss the plaintiffs’ case gives hope that companies with alcohol beverage brands originating overseas can produce those brands in the US without facing significant litigation risk.

The plaintiffs brought their case under several California statues and also alleged negligent and intentional misrepresentation.  Central to the plaintiffs’ allegations were statements on Red Stripe’s secondary packaging and labeling that the beer was a “Jamaican Style Lager” and contained “The Taste of Jamaica.”  The plaintiffs also pointed to the labeling and packaging’s continued display of the original Jamaican brewer’s logo as evidence of deception.  Finally, the plaintiffs pointed to the label’s statement that the beer “embodied the spirit, rhythm and pulse of Jamaica and its people.”  Of course, the labels and secondary packaging did disclose that the US market beer was brewed and bottled in Latrobe, Pennsylvania.

Looking only at the complaint and before any discovery, the court dismissed the case, concluding that “no reasonable consumer would be misled into thinking that Red Stripe is made in Jamaica with Jamaican ingredients based on the wording of the packaging and labeling.”  More specifically:

  • The mere fact that the words “Jamaica” and Jamaican” appear on the packaging does not support a conclusion that consumers would be confused about the origin and ingredients of the beer.
  • The statements on Red Stripe were similar to those made with respect to a “Swiss Army knife” – just as “Swiss” modified “Army,” in this case “Jamaican” modifies “Style” and does not connote the actual place of production.
  • Red Stripe’s display of “Jamaican Style” and similar claims are similar to Blue Moon making a “Belgian-Style Wheat Ale” and Harpoon making a “Belgian Style Pale Ale.”
  • “Taste of Jamaica” is too vague and meaningless to form the basis of a false advertising claim.
  • Red Stripe presents different facts from the facts that give rise to the false advertising case involving Beck’s Beer, where the labeling and packaging stated “Originating in Germany,” “brewed under the German Purity Law of 1516,” and “German quality.”
  • Even though consumers may have already held an expectation that Red Stripe is brewed in Jamaica based on past production on the island, no legal authority places a duty on marketers to counter such pre-conceived notions.

On the basis of this reasoning, the court dismissed the plaintiffs’ complaint as a matter of law.  It did, however, dismiss the case “without prejudice,” which will give the plaintiffs 15 days (until April 21, 2016) to assert new claims that might survive dismissal.

The Dumas opinion represents merely one battle won (at least temporarily) in what will no doubt prove a long war over alcohol beverage labeling in the United States.  Nevertheless, it provides helpful reasoning that may eventually influence other courts and provide guidance to marketers in the future.

Ruling Could Put Deceptive Labeling Cases on Hold

The U.S. Court of Appeals for the Ninth Circuit today placed on hold a consumer class action involving yogurt labels until the FDA issues final guidance on use of the terms at issue in the dispute—a decision that could ripple outward to the many other food and beverage cases alleging deceptive labeling.

The plaintiffs in Kane v. Chobani, LLC, No. 14-15670, alleged that Chobani deceptively labeled its yogurt as “natural” in violation of FDA regulations, and improperly used the term “evaporated cane juice” to describe the yogurt’s added sugar ingredient. But because the FDA is currently considering the scope and permissible usage of both terms, the court ordered a stay “until such time as the [FDA] completes its proceedings regarding the use of the terms . . . in food labeling.” The use of both terms “implicates technical and policy question that should be addressed in the first instance by the agency with regulatory authority over the relevant industry rather than by the judicial branch,” the court wrote, noting that it made no sense—and would be inefficient—to continue litigating the case while the FDA was mulling questions at the heart of the litigation.

Today’s ruling directly applies only to the Kane case, but other courts are likely to follow a similar path while awaiting guidance from regulators, rather than expending time and energy on continued litigation that could be rendered moot. The stay comes as other courts within the 9th Circuit and elsewhere are considering similar class actions involving alcoholic beverages, including from consumers claiming they were misled by labels calling popular products “handmade.” Although there are currently no pending FDA proceedings considering use of the term “handmade,” cases involving that word could also end up subject to a stay if that changes. As it is, some courts have dismissed such claims on the grounds that no reasonable consumer can believe spirits brands are “handmade” or because the use of such terms is non-actionable “puffery,” but others have been allowed to proceed.

A Practical Blueprint for Distribution

Whether you’re an experienced brewer getting ready to enter a new state, a startup packaging brewery looking to serve your home market, or a brewpub expanding to provide products to local retailers, you need a viable distribution plan. In recent years, individual brewers have deepened their understanding of industry dynamics in the heavily regulated beer distribution system. While many are effectively advocating reforms to accommodate new brewery business models, change occurs slowly in the political process. Those in business today who want to remain in business tomorrow need to deal with the existing realities of the marketplace. The following is a primer of common questions and answers related to distribution.

Read the full article, originally published in the March/April issue of The New Brewer.

Tied House Laws and Category Management: A Continuing Quandary

On March 16, the federal Alcohol and Tobacco Tax and Trade Bureau (TTB) published a list of frequently asked questions expanding further on a ruling issued in February on application of the federal “tied house law” to industry promotional activities, specifically category management practices employed by retailers.

TTB claims that a formal rulemaking to revise its tied house regulations is not necessary: “TTB Ruling 2016-1 merely provides guidance as to the plain meaning of the existing regulation under 27 CFR 6.99(b). It does not change TTB’s longstanding position, nor does it change the meaning of the plain language of this regulatory exception.” So let’s look at the plain language:

The act by an industry member [supplier or wholesaler] of providing a recommended shelf plan or shelf schematic for distilled spirits, wine, or malt beverages does not constitute a means to induce within the meaning of section 105(b)(3) of the [Federal Alcohol Administration (FAA)] Act.

That statement on its face is an open-ended authorization to provide shelf schematics. It says nothing about the products of other industry members or whether the plan is written on a napkin or in a sophisticated IT system that is used for inventory management at hundreds of stores.  Continue Reading

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