https://www.access.fda.gov/oaa/logonFlow.htm?execution=e2s1 

For businesses who created a new registration after October 1, 2012, that registration also complies with the requirement to have updated information in the FDA system during the last calendar quarter of each even numbered year. 

Due to the delays experienced by members accessing the site we will be asking FDA to extend the window for renewals into the first quarter of 2013.

In addition, current pre-import letters and/or SOP that have not yet expired can be extended upon written request by the original applicant for an additional ten (10) years from the date of resubmission.

Importers can use TTB’s Formulas Online or a paper submission to request an extension for an existing pre-import letter or SOP. Importers may chose to wait closer to the expiration date of an existing letter before resubmitting your request, thereby getting full advantage of the new ten (10) year validity period. If submitting online or a paper submission, a copy of the existing pre-import letter or SOP must be attached to your request.

Please note that if there have been changes to your formulations, you must file for a new pre-import letter or SOP

A second panel of Customs and Border Protection officials met with NABI members following the TTB presentation.  Leading the CBP group, Maira Louisa O'Connell Trade Advisor to the Commissioner of CBP, invited recommendations on better harmonizing the work of CBP with other regulatory agencies.  She was very open to industry suggestions about ways to improve the interaction between the government and trade organizations.  NABI will be organizing its Customs Committee to make recommendations to Ms. O'Connell on ways to improve the cargo clearance process.  NABI members are encouraged to send ideas that will facilitate imports through the CBP organization. 

Find them at this link - 1st Qtr Stats

Click the link above to access the full edited deck of meeting slides

Fred Cooper wore custom-made suits from the same tailoring house that outfitted real estate magnate Arthur Rubloff, former New York mayor John Lindsay and composer Stephen Sondheim. His ties were from London’s Turnbull & Asser. He ate out every night at Chicago’s finest restaurants.
But he wasn’t making the scene to be seen.
In a sense, it was his job.
Mr. Cooper was vice chair of the liquor distributor Wirtz Beverage Group of Illinois. He was the man in the middle of a complex network of business relationships between restaurants, retail stores, winemakers and distillers. He made sure it all worked, said his boss W. Rockwell “Rocky” Wirtz.
“He was going out there as a goodwill ambassador,” said Wirtz, a Chicago Sun-Times investor and chairman of the Chicago Blackhawks.
Mr. Cooper’s death was mentioned during the Sunday evening telecast of the Blackhawks playoff game. He died Saturday at age 74 at Northwestern Memorial Hospital of complications from amyloidosis, abnormal protein build-ups in the body.
He was tireless and tenacious at his job. He watched the wine lists at area eateries to see if Wirtz Beverage Group was their distributor. If it wasn’t, he’d ask restaurateurs what his company needed to do to get their business. And if a client ran out of liquor, Mr. Cooper would handle it personally. He built unshakeable customer loyalty on his attention to detail.
Mr. Cooper would often drop by Lino’s, a now-shuttered Phil Stefani dining establishment. If Lino’s was out of the wine supplied by the Wirtz group, “He would call his salesman,” Stefani said. “The next day we would have it back.”
Often, Mr. Cooper would put the cases in his car and make the deliveries personally.
He visited vineyards and distillers, introducing himself to the artisans who crafted the wines and spirits. He convinced them to provide their products to his company, and then saw to it that Wirtz was also the choice of area restaurants and retailers for keeping their wine cellars and store shelves filled.
“Fred was very persistent. He didn’t understand the terminology ‘no,’ ” Stefani said.
He often spirited copies of wine lists out of restaurants so he could study them and figure out who was doing business with whom. “If there was a change to any wine list at any restaurant that did not favor his company, he was the first to know about it, and the first to do something about it,” said Michael Binstein, owner of Binny’s Beverage Depot.
He was born into the business. “His parents started selling wine or whiskey the day Prohibition was repealed,” said Bart O’Toole, his life partner of 28 years. The Coopers started Continental Distributing Company, which was acquired in 1996 by the Wirtz family distributorship.
Mr. Cooper grew up in Rogers Park. He was educated at Culver Military Academy and Carleton College in Minnesota before he joined the family business in 1959.
“There wasn’t a leader of a liquor or wine company that he didn’t know, or hadn’t done business with,” said Michael Binstein. “Sometimes he knew two and tree generations of people on the retail end of this business, or the retail suppliers’ side.”
He was instrumental in the success of Chicago Gourmet, Millennium Park’s upscale food fest, said John Colletti, managing partner of Gibsons Restaurant Group. The Illinois Restaurant Association wanted to create a celebration of Chicago food and wine, and “Freddie was the go-to guy,” Colletti said. “When I was inquiring about wineries and where to go, he set me up with a list in Napa — he set up a list of who to go to, and say hello to.”
Mr. Cooper “liked Italian wines, Amarones, Malbecs, Shiraz, Pinots, “whatever they were selling,” said Bart O’Toole, “because when you’re selling wine, you’ve got to be politic to your producers.”
Ironically, health problems meant he had to watch what he ate when he visited some of Chicago’s most exquisite restaurants. He usually dined on grilled chicken breast, a slice of raw white onion, a plain vegetable and a salad with lemons.
Mr. Cooper liked to buy his clothing in New York. He and O’Toole took memorable cruises on Cunard, “back when the Sea Goddess was the Sea Goddess,” his partner said. The ship was outfitted like a posh private yacht. On one trip to Vietnam, they dodged pirates and 18- foot swells.
He started shaving his head about a decade ago when he began to lose his hair, O’Toole said. “He was comfortable with himself,” including his sexual orientation, O’Toole said. “I was at all the suppliers’ daughters’ and sons’ weddings.”
He also wasn’t afraid to tell someone if he felt they weren’t doing their job. “He was blunt,” O’Toole said, “but he wasn’t rude, and he didn’t have a mean bone in his body.”Mr. Cooper was also a director of the Wine & Spirit Wholesalers of America; the National Association of Beverage Importers, and the Chicago chapter of the World Association of the Alcohol Beverage Industries.

The Alcohol and Tobacco Tax and Trade Bureau (TTB) announced the receipt of certification from the government of Italy for the 2006 Vintage of Brunello di Montalcino (DOCG).  A TTB press release can be found at this link: http://www.ttb.gov/press/vintage-brunello-certification.pdf

The 2010 summary statistical data is now posted on the member side of the website.

New EU wine rules will impact Exports 

New York City January 25, 2011 -  wine industry experts joined with regulators to discuss Common Market Organization rules that are meant to give new flexibilities to EU wine producing counties and their wine makers.  The rules will address over production and support spending in a more comprehensive way.  While protecting regional food and wine products the regime will allow supplier nations to create a new category of varietal wines.  The intent of the new design is to apply broad terms such as PDO - Protected Designation of Origin and PGI - Protected Geographic Indication to production from the regions.  These terms will work in parallel with national regimes that are meant to distinguish the wine and food unique to certain regions.  Also created as part of this initiative is a category of wines without origin.  In addition to the categories of red, while and rose there is added a new varietal group.  Formerly referred to a "table wines" the following varietal names can be used:

• Cabernet

• Cabernet Franc

• Cabernet Sauvignon

• Merlot

• Syrah

• Chardonnay

• Sauvignon

The EU plan is to label these wines with a national appellation principally for export.   Unfortunately this will present difficulties for this type of wine headed to the US market.  Federal labeling regulations require that any varietal designation on a label must also have an appellation below the national level.  Wine talks between the US and EU planned for March 2011 in Brussels will no doubt have this on the agenda. 

Recently, the PLCB Board approved a 6-month moratorium on a pending increase to the Logistics, Transportation and Merchandising Fee (LTMF) and any proposed price increases by the makers of wine and spirit products sold in Pennsylvania Wine and Spirit Stores. In lieu of the LTMF increase, the Board extended supplier payment terms to a 60-day payment schedule.

During the week of December 13th, all liquor suppliers will be converted to 60-day payment terms. When the conversion is complete, all purchase orders will indicate the 60-day terms. In addition, invoices in process that have not yet met match criteria between Pos, invoices, and receipts will be converted to 60-day payment terms. If an invoice cannot be seen in the iSupplier Portal on December 13th, it is most likely that the invoice is in a 60-day status.

FDA’s Emergency Telephone Number Has Been Changed
December 8, 2010
Office of Emergency Operations has moved to FDA’s White Oak Campus

As of December 10, 2010, the former FDA 24-hour emergency number, 301-443-1240, will be disconnected. The new numbers for the Office of Emergency Operations will be 1-866-300-4374 or 301-796-8240.

These numbers can be used to report the following types of problems to FDA:
A serious, life-threatening event involving an FDA-regulated product, i.e., foods, dietary supplements, cosmetics, human drugs animal drugs, medical devices, biological products, and radiation-emitting electronic products Requests from medical professionals for approval for the use of an emergency investigational new drug, device or biologic. Notifications to FDA from government agents acting in an official capacity about an urgent matter. Reports of an emergency involving an FDA employee or an FDA employee's family member. Reports of a non-life threatening adverse reaction to an FDA-regulated product that requires immediate reporting.

New House Majority Whip, Eric Cantor, published the calendar for the 112th Congress this week.  We have included Representative Cantors letter to House members.  The calendar can be found by clicking the highlighted link.

December 8, 2010

Dear Colleague:

I am pleased to release the 2011 congressional calendar for the U.S. House of Representatives. The calendar can be accessed today at RepublicanWhip.house.gov and starting January 5, 2011, at MajorityLeader.gov.

This year’s calendar is the result of substantial input gained by the Republican Transition Team from members of both the House Republican Conference and the House Democratic Caucus, and from many outside reformers. In total, it contains 123 days and 32 weeks of session. While the number of days in session is consistent with first sessions in years past, the number of weeks in session represents an eleven percent drop, resulting in less travel for Members and potential savings to the Member’s Representational Allowance (MRA).

Most importantly, the 2011 calendar was drafted with the following goals in mind:

Create Certainty for Members, families, staff, and the public;Increase Efficiency and Productivity in the legislative process;Protect Committee Time and conduct meaningful oversight; andListen to Constituents and reflect the American people’s will.
Above all else, the House calendar will enable Members to focus on the country’s most pressing concerns: the economy and jobs, reducing spending and limiting the size of government, and making Congress more transparent and accountable.

Create Certainty

Over the past decade, the House’s schedule has fluctuated on a week-to-week basis. Rarely do Members know when last votes will be scheduled for the day or week. As a result, meetings are often missed, congressional families are disappointed, and constituent events are left in limbo.

It is my intention to start floor votes no sooner than 1:00 p.m. and to regularly end voting on the floor no later than 7:00 p.m. each evening. When necessary, the House may continue to debate and consider legislation after 7:00 p.m., but votes will not be held past that point. As a result, Members will be able to plan their days with more certainty.

In addition, I intend to begin votes at 6:30 p.m. on the first day of each week and end votes at 3:00 p.m. on the last day of each week. (Votes on the last day may be necessary prior to 1:00 p.m.) All Members will have the ability to return home to their district by Thursday or Friday evening each week, however, the last day of the week will no longer be treated in a perfunctory manner.

Including this year, the House has not adjourned until December for eight straight years. Therefore, the House’s target adjournment has been moved from the end of the fiscal year to Thursday, December 8, in order to better reflect the anticipated workload of the Congress. This will allow Members to plan their fall and early winter schedules now. If we are able to adjourn before December 8, it will be the first time in fourteen years that the House has finished prior to its target adjournment date.

Increase Efficiency and Productivity

From input gained during the transition process, Members unanimously agreed that a Tuesday-through-Thursday schedule can create an inefficient, unproductive, and frenetic legislative body. The risks of such a schedule are bills rushed to the floor; Members voting on legislation without the benefit of time for review; and committees and the deliberative process becoming after-thoughts.

During the 110th Congress, for example, the House considered 2,185 bills on the floor, 70% of which were debated on the suspension calendar. This past year, during the 111th Congress, more than half of all suspension bills named a post office or building, congratulated an individual or team, or supported the designation of a particular day, week, or month. We can do better to reflect the will of the taxpayers who have elected us.

The goal for this Congress is to stress quality over quantity in terms of the flow of legislation to the House floor. I intend to lengthen the time for consideration of bills in order to improve quality and deliver results. Gone are congratulatory resolutions. Post office namings will be handled on a less frequent basis. In addition, legislation will be made available both three days prior to a committee mark-up and three days prior to floor consideration. Taken together, these reforms will allow more time for quality consideration while increasing the House’s efficiency and guaranteeing the public’s right to know.

Lastly, with the exception of January, the House will utilize four- and five-day work weeks. Members and staff should quickly gain an ability to better focus their time with less conflicts.

Protect Committee Time

Since the late 1970s and early 1980s, committee oversight hearings have declined by roughly 500 percent. If we are to reflect the commitment we have made to the voters who elected us, we must reverse this trend.

During the 112th Congress, it is my intention to create protected committee time each morning we are in session. Committee meetings will commence at 9:00 a.m. or 10:00 a.m. On the first day of each week, committees will be able to meet – uninterrupted – prior to 6:30 p.m. or after 7:00 p.m. During the middle two days of each week, committees will be protected from floor votes until 1:00 p.m. and after 7:00 p.m. Every effort will be made on a last day of the week to limit the number of floor votes from interrupting committee action. And we will hold ourselves accountable in conducting meaningful and deliberative work by posting committee attendance and votes online.

Listen to Constituents

American voters sent us a resounding message in November – Washington is out of touch with their concerns and priorities. Through much deliberation during the transition process, Members indicated the need to return home to listen to their constituents on a regular basis.

Accordingly, the schedule will reflect a guaranteed five-day constituent work week at least once each month for Members to visit with employers, employees, seniors, veterans, and other constituent groups Monday through Friday in their district, rather than just on the weekends. This time will be used to listen to constituents, solicit their input, and gain their feedback.

The results of these reforms should be a U.S. House of Representatives that more accurately reflects the Founders’ intent during the 112th Congress – that is, “direct and constant control by the citizens” (Thomas Jefferson, 1816).

I am ready to roll up my sleeves and get down to work with each of you on behalf of the American people. Please do not hesitate to contact me or my office if you have any questions.

Happy Holidays!

Sincerely,

Eric Cantor
Majority Leader-elect

Following the FDA action to ban the combination of caffeine and beverage alcohol, TTB has made notice to COLA holders of the targeted beverages that previously approved labels are misleading.  The letters to the COLA holders for these beverages and other background from TTB can be found at the following link:

http://www.ttb.gov/main_pages/caffeine-added.shtml

The FDA  and FTC have warned 4 malt beverage producers that their products are unsafe when manufactured with added caffeine.  You can read the entire release from the FDA & FTC links:

http://www.fda.gov/Food/FoodIngredientsPackaging/ucm190366.htm

http://www.ftc.gov/opa/2010/11/alcohol.shtm

Health care reform legislation signed into law on March 23, 2010 Section 4205 of the Patient Protection and Affordable Care Act of 2010 requires restaurants and similar retail food establishments with 20 or more locations to list calorie content information for standard menu items on restaurant menus and menu boards, including drive-through menu boards. Other nutrient information – total calories, fat, saturated fat, cholesterol, sodium, total carbohydrates, sugars, fiber and total protein – would have to be made available in writing upon request. It also requires vending machine operators who own or operate 20 or more machines to disclose calories for articles in food. The nutrition disclosure requirements apply to foods including alcohol beverages that are standard menu items listed on a menu or menu board, food on display and visible to consumers, or food for self service. The Food and Drug Administration (FDA) was required to issue proposed regulations to carry out these provisions by March 23, 2011. FDA published notice in the “Federal Register” requesting comments on how to implement the menu labeling requirements. Initiative comments were due by September 7, 2010. FDA also publish notice announcing the availability of a draft guidance documents on questions and answers regarding implementation of the menu labeling provisions of Section 4205 and the effect of this provision on state and local menu and vending machine labeling laws.

In the meantime, NABI, DISCUS, Presidents’ Forum, WineAmerica and Wine Institute in a joint comment dated September 7, 2010 asked the FDA to consult with TTB on this matter and in light of TTB’s pending “Serving Facts” rulemaking. The final comment period ends on October 12, 2010.  NABI will be formulating comments to the FDA notice.  We have been coordinating with other supplier groups on this issue, including staff from the National Restaurant Association.  NRA members are the business primarily impacted by these rules. 

In 2007, the TTB published a notice of proposed rulemaking soliciting comments on a proposal to require a serving facts statement on alcohol beverage labels to include information about the serving size, the number of servings per container, and per-serving information on calories and grams of carbohydrates, fat, and protein. The proposed rule would also require information about alcohol content. TTB received and reviewed approximately 800 comments on this proposal. To date however the proposed rulemaking is still pending.

It is our understanding that industry members may voluntarily include truthful and specific statements about calorie and carbohydrate content in the labeling and advertising of wine, distilled spirits, and malt beverages as long as the label also contains a statement of average analysis. See TTB Ruling 2004-1 http://www.ttb.gov/rulings/2004-1.pdf. False or misleading claims or representations about calorie or carbohydrate content in the labeling and advertising of alcohol beverages, including those that imply that the consumption of low carbohydrate alcohol beverages is a healthy part of a weight reduction or weight maintenance plan, are prohibited.

You can also read more about the Health Care Reform bills requirements for menu labeling on the government website.  A September 2010 article from FDA officials discusses the menu labeling requirements. 

Statement on the Death of ABL Executive Director Harry G. Wiles

Bethesda, MD – August 19, 2010 – American Beverage Licensees announces with profound sadness and regret that Harry G. Wiles passed away unexpectedly on Wednesday, August 18, 2010. Harry was ABL’s Executive Director and a leading member of the beverage alcohol community. He will be remembered as a true advocate for the entire industry and a loyal friend to those whose lives he touched.

Harry served as ABL’s Executive Director since 2002. He was chosen to lead the association and its nearly 20,000 members following its creation after the merger of the National Association of Beverage Retailers and the National Licensed Beverage Association. Under his leadership, ABL grew in scope and strength as he oversaw the partnering of on-premise and off-premise beverage licensees into a single, unified voice for the beverage retail community.

“Not only has our industry lost a leading advocate, we all have lost a dear friend,” said ABL President David Jabour. “Harry was the consummate industry ambassador and steward, and will be remembered for years to come. He was truly part of our industry family.”

An attorney and member of the Bar in the State of Kansas, the District of Columbia, and the United States Supreme Court, Harry followed his political instincts from Kansas to Washington, D.C. in 1976, where he worked on Capitol Hill before becoming a fixture in the beverage alcohol community.

Harry’s more than two decades of service to the industry began in 1987 when he became Senior Vice President of Federal Government Relations & Senior Counsel for the Wine & Spirits Wholesalers of America, a position he held for thirteen years.

In 2010, Harry was inducted into the Sky Ranch Hall of Fame, and served on the Executive Committee of the Sky Ranch Foundation. He also served as a board member of the Responsible Hospitality Institute (RHI), the Responsible Retailing Forum (RRF) and the Night Club & Bar Advisory Board.

An avid supporter of the western lifestyle and horseback riding, Harry was a member of western riding organizations Rancheros Visitadores, based in Santa Barbara, CA, and El Viaje De Portola in San Juan Capistrano, CA. He was also a board member of the Heartland Alliance of America, the association for rural Americans.

Harry is survived by his wife Cindy; his daughter Heather and husband, Troy Valerius; and four grandsons. Please keep them in your thoughts and prayers. Condolences may be sent to Harry’s wife Cindy Wiles at 10890 Woodleaf Lane, Great Falls, VA 22066. A remembrance gathering in honor of Harry will take place at a future date with details to follow.

 In lieu of flowers, the family requests that memorial contributions in Harry's memory be sent to “Cowboy Heritage Association of Fort Worth” P.O. Box 136639 , Forth Worth, TX 76136; or “Sky Ranch for Boys” 10100 Sky Ranch Place , Sky Ranch, SD 57724. A celebration of Harry's life will take place at a future date with details to follow.

Harry G. Wiles – Memorial Contributions UPDATE

As part of its facility, Sky Ranch for Boys maintains stables for horseback riding as part of the recreational component of its corrective thinking approach to treatment. Sky Ranch requires all boys to work on the Ranch, including taking care of the horses.

As many of you know, Harry was actively involved and a staunch supporter of both the western horseback riding lifestyle and Sky Ranch for Boys.

With that in mind, President Ralph Aguera and Secretary Barry Becton of the Sky Ranch Foundation have notified ABL that all memorial contributions to Sky Ranch for Boys in memory of Harry G. Wiles will be designated for improving the stables and acquiring new horses and saddles for the Ranch.

A true cowboy at heart, we know that Harry would be moved by this gesture.

Gifts should be payable to Sky Ranch Foundation and mailed to:

Harry Wiles Memorial c/o
Sky Ranch Foundation
P.O. Box 8420
Fredericksburg, VA 22408

Each gift will be acknowledged to the contributor and to the Wiles family.

Privitization is an issue for importers.  If you click on this "issue" highlight you will see an interesting analysis by the trade association for control state administrators, NABCA.  On August 5 the Washington Post published a current assessment of the political and budgetary factors that impact on Virginia.  Virginia controls spirits sales through over 300 retail stores.  Replacing the revenue stream generated by this system, roughly $250M per year, remains one of the fundamental constraints facing the Governor.

In a follow on story the Washington Post provides additional overview of the privatization issues on August 29.  The Post reports that the Virginia Governor's plan will be revealed on September 8, 2010.   We will add to this blog as this issue evolves. 

The Chicago Executive Committee meeting on July 29 included a presentation of current market conditions by Nick Lake from the Nielsen Company. I have included Nick's PowerPoint presentation here as an example of the resources we will be providing in the members only section of the website.

Download Presentation (PPTX)

The NABI Executive Committee will be holding its July meeting at the Crown Imports offices in Chicago, IL. Retiring NABI Board member and past officer, Mike Kelly, has been invited to Chicago to join the Executive Committee for their meeting.

Officials from TTB have acknowledged that they will present at this meeting. The new NABI website will be formally launched. Our hosts for this meeting, Jim Ryan and Crown Imports have arranged for a very special Major League Baseball evening at US Cellular Field following our meeting. The Chicago White Sox will be playing the Seattle Mariners. All Executive Committee members are encouraged to attend. Acknowledgements should be sent to Bernie Emamali.

Thanks to one of our associate members, Vinitaly, there is NOW an Italian translation of key parts of the TTB website for use by Italian language suppliers.

View Italian Translation

	Alcohol and Tobacco Tax and Trade Bureau: Access TTB Forms State Alcohol Beverage Boards
	U.S. Customs and Border Protection: www.cbp.gov
	Federal Trade Commission: www.ftc.gov
	Food and Drug Administration: www.fda.gov
	U.S. Trade Representative: www.ustr.gov
	U.S. International Trade Commission: Latest version of the Harmonized Tariff Schedule
	Federal & State Convening & Adjournment Dates: link coming

...

NABI President, Bill Earle, moderated a workshop at the Italian Embassy in Washington, DC focused on expanding understanding of Italian wine controls and oversight. This meeting brought together representatives of TTB, the US Trade Representative, US Department of Agriculture, Italian Trade Commission, Italian ministry of agriculture, Unione Italiana Vini, Instituto San Michele all’Adige and Italian press. The three hour workshop included presentations by Italian ministry officials and technical laboratory staff, as well as a question and answer session with all attendees. Ambassador Giulio Terzi di Sant'Agata opened the session by thanking NABI and other officials for their presentations and interest in improving the understanding of Italian oversight of wine particularly in the commerce of export to the United States. This meeting was part of the effort to educate US regulators in light of the controls then in place on Brunello.