New Biennial Registration Requirement with the Food & Drug Administration

By Cary Greene
A member winery recently asked about changes in Food & Drug Administration (“FDA”) registration requirements. It’s an important question, and it seemed like a good opportunity to remind all wineries about the new requirements.
Since the Bioterrorism Act of 2002 was passed, the FDA has required wineries to complete a one-time registration as a “food facility.” To FDA’s credit, the guidance for registration is fairly user-friendly, though it inevitably presents its challenges, http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/RegistrationofFoodFacilities/OnlineRegistration/default.htm.
With the official passage of the Food Safety Modernization Act (the “FSMA”) back in January, the one-time registration has been modified to a biennial registration. The statute explains that “food facilities” will need to register: “[d]uring the period beginning on October 1 and ending on December 31 of each even-numbered year.” See 21 U.S.C. § 350d(a)(3) (emphasis added).
In all likelihood, starting in October 2012 (and every alternating year following), wineries will have a three-month window to re-register as “food facilities” and satisfy FDA’s new requirement. This may be subject to change as FDA has yet to issue final rules on biennial registration.
As we reported on numerous occasions last year (e.g., http://wineamerica.org/newsroom/newsletters/September_2010_Newsletter.pdf), the original versions of the FSMA contained a variety of onerous requirements (including an annual $500 fee that wineries would have needed to pay to FDA) that WineAmerica played a major role in avoiding. While wineries have ultimately been included in the FSMA’s biennial registration requirement, this is a relatively modest burden compared to the possibility of what could have been. There was a real chance we could have faced conflicting FDA and Alcohol & Tobacco Tax & Trade Bureau (“TTB”) safety standards. This would have been a source of significant business disruption.
Because of WineAmerica’s efforts, in coordination with our industry partners, wineries aren’t stuck in a regulatory morass, TTB remains our primary regulator, and FSMA’s requirements for wineries are straightforward. This was a big victory for the American wine industry, and something that should make you feel good about the investment you’re making as a WineAmerica member.
We’ll keep you updated if FDA publishes new information on the biennial registration requirement.

The 2011 Wine Bloggers Conference

By Michael Kaiser

This past weekend, the fourth annual Wine Bloggers Conference was held at the Omni Hotel in Charlottesville, Virginia. It was a great opportunity for wine bloggers and others in the industry to really be introduced to the wonderful world of Virginia wine. Virginia wineries really delivered and they illustrated why the state has become so respected in the wine world.

WineAmerica had the honor of being asked to speak at the conference. Cary Green and I discussed the Legalities of Wine. Not the most exciting of subjects, but an important one. Cary discussed the CARE Act and the current state of wine distribution laws in the states. I handled the TTB regulatory discussion. It was a varied topic and we had some lively discussion with those in attendance.

The two keynote speakers at the conference were Jancis Robinson, the wine correspondent for the Financial Times, and Eric Asimov from The New York Times. They provided a good bridge from traditional wine writing and the relatively new medium of wine blogging.

Friday nights event at Monticello featured more than 30 Virginia wineries showcasing one red wine and one white wine. It was a great chance for me to meet some people face to face that I have been talking to for five years now. Despite the oppressive heat, the event was a huge success.

Saturday featured winery visits and a dinner that featured food pairing with some excellent Virginia wines.

The world of wine blogging is a relatively new world. As someone who reads wine blogs on a daily basis, I find them to be a unique way of learning about the wine industry from a different perspective. The medium will only continue to grow.

WineAmerica Signs Joint Industry Comment on FDA Menu Labeling


July 5, 2011

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Re: Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments (Docket No. FDA-2011-F-0172, and RIN 0910-AG57) (76 Fed. Reg. 19192 (April 6, 2011))
Dear Sir or Madam:

On behalf of the undersigned trade associations representing virtually all alcohol beverage producers, including brewers, distillers, vintners, and importers, we greatly appreciate the opportunity to share our views regarding the Food and Drug Administration’s (FDA) proposal to implement the menu labeling provisions of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act).

We support FDA’s proposal to exclude alcohol beverages from the Agency’s menu labeling rules. The rationale underpinning FDA’s decision will best serve the intent of Congress to provide consumers with nationally uniform and readily available information about the caloric content of food served at chain restaurants and similar retail food establishments covered by the menu labeling requirements.
FDA’s position is well taken because:
(1)       the Alcohol and Tobacco Tax and Trade Bureau of the Department of Treasury (TTB) is the primary regulatory authority on the labeling of alcohol beverages pursuant to the provisions of the Federal Alcohol Administration Act (FAA Act) (27 U.S.C. 201 et seq.)[1];
 
(2)       TTB has a “Serving Facts” rulemaking underway that is intended to establish a clear and consistent manner for determining and expressing nutrient values for alcohol beverages; and 


(3) establishment of an FDA menu labeling requirement for alcohol beverages while a TTB rulemaking on alcohol beverage container labeling is underway could result in inconsistent information between alcohol beverage container labels and menu caloric information, creating uncertainty and confusion.
The course of action set forth in FDA’s proposal, particularly FDA’s recognition of TTB’s expertise in alcohol beverage labeling, preserves the historical bifurcation of jurisdiction between two fellow federal agencies, and helps support the goals of the Act to provide consistent and accurate information for consumers.
I. TTB/FDA Alcohol Beverages Regulatory Framework

As FDA recognized in its proposed rule, the primary federal regulatory Agency overseeing alcohol beverage labeling is TTB. In exercising its broad and longstanding regulatory authority, TTB is very familiar with the entire range of alcohol beverage products, as well as the day-to-day practices of producers and importers across the beer, wine and spirits categories. The Bureau regulates virtually every aspect of alcohol beverage products and the industry members who produce and/or import these products. Within the broader food industry, alcohol beverage importers and domestic manufacturers are the only entities required to undergo an investigation prior to commencement of operations. TTB requires completion of employment and financial questionnaires by key personnel and investors, as well as detailed information on the location and operation of each business.

TTB’s regulatory authority over labeling and formulation of alcohol beverages includes statutory pre-approval processes and testing designed for consumer protection and tax classification purposes. Each year, over 100,000 alcohol beverage label and container designs are pre-approved by TTB to ensure that “packaging, marking, branding, and labeling and size and fill of container” will not deceive consumers and that statements and other information on each product are not likely to mislead consumers.[2] Label approval must be received by a U.S. importer before a product is imported into the United States or introduced into interstate commerce by a domestic producer.[3]
TTB and the FDA operate under a longstanding Memorandum of Understanding (MOU) that has been updated various times since the 1940s. The most recent version reiterates TTB’s statutory authority and the scope of existing TTB regulations and states that the Bureau of Alcohol, Tobacco and Firearms (TTB’s predecessor agency), “will be responsible for the promulgation and enforcement of regulations with respect to the labeling of distilled spirits, wine, and malt beverages pursuant to the Federal Alcohol Administration Act.”[4] The bifurcation of jurisdiction between TTB and FDA has well served the consuming public and the respective goals of each Agency.
Congress has expressly encouraged TTB and FDA to work together in implementation of two recently enacted statutes governing areas where FDA and TTB jurisdiction overlap, the Food Allergen Labeling and Consumer Protection Act of 2004[5] and the Food Safety Modernization Act of 2010.[6] Cooperation in rulemaking between TTB and FDA is beneficial because it helps minimize uncertainty and confusion in the marketplace for consumers, industry and the federal agencies. Coordination between TTB and FDA in rulemaking is also not unusual. Two recent examples of TTB coordination of rulemaking with FDA include:
a) Major Food Allergen Labeling for Wines, Distilled Spirits and Malt Beverages, mandatory labeling standards for major food allergens used in the production of alcohol beverages subject to the labeling requirements of the Federal Alcohol Administration Act and the Federal Food, Drug and Cosmetic Act contained in the Food Allergen Labeling and Consumer Protection Act of 2004.[7]
b) Disclosure of Cochineal Extract and Carmine in the Labeling of Wines, Distilled Spirits, and Malt Beverages, revisions to TTB regulations to require the disclosure of the presence of cochineal extract and carmine on the labels of any alcohol beverage product (addressed separately in a final rule issued by the Food and Drug Administration).[8]
As recognized by FDA, given detailed prior Acts of Congress and the history of alcohol beverage policy in the United States, TTB has a clear, multifaceted and ongoing administrative and regulatory mission with respect to labeling and public disclosure of information about alcohol beverages. The discharge of this mission has served well the retail customers of our industry and our consumers who choose to drink alcohol beverage products.
We respectfully submit that the goals of the Affordable Care Act will best be effectuated by the continuation of the long history of cooperation and coordination between TTB and FDA.
II. Interim Steps for Menu Labeling of Alcohol Beverages
TTB has invested several years of careful effort, analysis and Agency resources in the “Serving Facts” rulemaking, and it has done so within the broader context of other labeling challenges, some of which are unique to alcohol beverages and to TTB’s statutory authority. Likewise, industry members participated in the administrative activity including, but not limited to the following:
a) Caloric and Carbohydrate Representations in the Labeling and Advertising of Wine, Distilled Spirits and Malt Beverages, Agency guidance on making truthful and specific statements about calorie and carbohydrate content in the labeling and advertising of wine, distilled spirits, and malt beverages, addressing false or
misleading claims or representations about calorie or carbohydrate content in the labeling and advertising, and prohibiting statements that imply that the consumption of low carbohydrate alcohol beverages is a part of a specific weight reduction plan.[9]
b) Labeling and Advertising of Wines, Distilled Spirits and Malt Beverages, a notice of proposed rulemaking regarding “Serving Facts,” which would amend current alcohol content disclosure requirements and, for the first time, require nutrient information (calories, fat, carbohydrates, and protein) on all alcohol beverage labels.[10]
c) Labeling and Advertising of Wines, Distilled Spirits and Malt Beverages, an advance notice of proposed rulemaking to solicit public comment on general approaches to disclosure of nutrient information and alcohol content.[11]
Just as FDA experienced considerable challenges grappling with the Nutrition Labeling and Education Act (NLEA) labeling mandates, TTB has studied various methodologies and approaches to calculating caloric and nutrient content in a manner that is workable for thousands of alcohol beverage brands sold in the United States. No final rule has been published at this time; therefore, no certainty exists about the manner in which nutrition values for alcohol beverage labeling and advertising will be determined and communicated to millions of consumers. For long-term consistency and to avoid potential conflict, the TTB “Serving Facts” rulemaking should be completed before the FDA takes further action.
FDA correctly pointed out in the NPRM that a menu labeling requirement for alcohol beverages at this point creates uncertainty for both regulators and industry. The absence of Congressional hearings prior to enactment of the menu labeling law prevented both agencies and industry representatives from advocating a straightforward means to address potential conflicts between specific alcohol beverage labeling requirements and labeling requirements that are generally enforced by the FDA for other food and beverage products, such as NLEA.
Simply put, the current alcohol beverage regulatory framework does not establish a clear and consistent manner for determining or expressing nutrition values for alcohol beverages. That situation should change in the foreseeable future as TTB completes the pending “Serving Facts” rulemaking.
Conclusion
Again, the undersigned organizations appreciate FDA’s recognition of the dilemma posed for alcohol beverage products and for proposing a common-sense approach that will ultimately serve the public interest, as well as efficiency and economy in government by avoiding inconsistent calorie and nutrition information on TTB-approved product labels and FDA-sanctioned menu labeling. In excluding alcohol beverages from the menu labeling rule at this
early stage in the process, FDA implicitly recognizes the schedule for administrative action in the Affordable Care Act cannot be perfectly coordinated with ongoing administrative actions, such as TTB’s pending “Serving Facts” rulemaking.
In sum, it is incumbent on TTB and FDA to continue working collaboratively in the future. Our associations and the industry members we represent stand ready to cooperate in those important efforts.
Sincerely,
Mr. Joseph S. McClain Mr. Charlie Papazian Ms. Lynne J. Omlie
Beer Institute Brewers Association Distilled Spirits Council
Mr. William T. Earle Ms. Victoria I. McDowell Mr. Cary M. Greene
National Association of Presidents’ Forum WineAmerica
Beverage Importers
Mr. Wendell C.M. Lee
Wine Institute



[1] We acknowledge that FDA exclusively regulates the labeling of alcohol beverages that are not under TTB's jurisdiction, including beers 
that do not meet the definition of a “malt beverage” under the Federal Alcohol Administration Act (FAA Act) (27 U.S.C. 201 et seq.) 
and wine beverages containing less than 7 percent alcohol by volume. See, e.g., FDA, “Guidance for Industry: Labeling of Certain Beers 
Subject to the Labeling Jurisdiction of the Food and Drug Administration; Draft Guidance.”  August 2009.
[2] 27 U.S.C. 205(e).
[3] 27 CFR Parts 4, 5 & 7.
[4] Memorandum of Understanding Between the Food and Drug Administration and the Bureau of Alcohol, Tobacco and Firearms, § III(A), November 20,1987.
[5] P.L. 108-282, August 2, 2004.
[6] P.L. 111-353, January 4, 2011.
[7] 71 F.R. 42329, July 26, 2006.
[8] 75 F.R. 67669, November 3, 2010.
[9] TTB Ruling 2004–1, April 7, 2004.
[10] 72 F.R. 41860, July 31, 2007.
[11] 70 F.R. 22275, April 29, 2005.

WineAmerica Disappointed in the Times Failure to Check Their Facts

By Cary M. Greene
This past weekend, the New York Times published an article Congress’s Man of the Vines, Including His Own on one our industries biggest advocates, Congressman Mike Thompson (D-CA). The portrait of Congressman Thompson painted by the Times was wholly unfair. As a representative of wineries in nearly every state, WineAmerica knows as well as anyone that Congressman Thompson’s efforts on behalf of American wine and grape growers are simply an acknowledgement of the potential of a dynamic and growing rural industry.
The reality is that wineries are at the core of a rural economic renaissance that has continued unabated for more than three decades. The numbers speak for themselves. In 1975, there were fewer than 600 wineries. Today, there are more than 7,500 and number continues to rise even in face of a challenging economy.
American winemaking is a farm-based business that is dynamic, profitable and productive. It has allowed thousands of family farms throughout the United States to hire new employees, create billions of dollars in direct and indirect economic benefit to their local communities, and introduce millions of Americans to the beautiful landscapes and agricultural potential of their own backyards. These thousands of mom and pop businesses are a vital source of rural jobs and economic activity and are at the heart of agritourism and the “buy local” movement.
It only makes sense to try to enable policies that continue to allow a young and dynamic industry to reach its potential. Congressman Thompson’s support should be applauded, not questioned.