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November 20, 2015


Greetings! We hope you had a resilient and robust week! This week's top stories include a reminder to file operational reports on time, Formulas Online 2.0 release, FDA proposed rule on “gluten free” claim, and a list of the past week's top advertising pages at TTB.gov/.


We did a recent analysis, which shows that many industry members who are required to file operational reports do not file them on time in compliance with federal regulations. Failure to file required operational reports by the due date is a violation of the conditions of your permit and can lead to adverse action.

We'd like to take this opportunity to remind members of the wine, beer, distilled spirits, and tobacco industries who are subject to operational report filing requirements of the due dates for these reports:

Filing due dates for operational reports

FILING TIP: We have noticed that industry members who file their operational reports via Pay.gov/ have a better record of filing on time!

Why not sign up to use Pay.gov/ today?


On Friday, November 20, 2015, we released Formulas Online version 2.0.  Our goals are to improve your user experience and help you perfect your application, so please take a look at some of the highlights of this new release:

All Users:

  • My Submissions Home Page Enhancements
    View ALL your submissions on your Formulas Online home page, no matter their status (In Process, Draft, Cancelled, Withdrawn, or Closed).  In addition, view the Approval/Reject Date for your formula submissions that have been approved or rejected by TTB.

Beverage Alcohol Formula Users:

  • Printable Version of TTB F 5100.51 Form (Pilot)
    Display and print a “printable version” of your approved formulas on TTB Form 5100.51 Formula and Process for Domestic and Imported Alcohol Beverages. 
  • Enhanced Instructions and Examples
    View detailed instructions on how to fully and accurately complete the ingredient list and method of manufacture portions of the application, which are routinely among the top causes of why we send applications back for correction.   We’ve also added examples for each commodity (malt beverage, distilled spirits, and wine) to help you perfect your application before you submit it.

For more information about additional Formulas Online enhancements see the release notes:

PDF Version or MP4 Video Version   

Contact Us:

  • Please contact the TTB Help Desk at TTB.Helpdesk@ttb.gov/ if you experience technical issues. 
  • Please contact the Advertising, Labeling and Formulation Division at Submit an Online Inquiry for general questions or concerns about beverage formula submissions.
  • Please contact the Nonbeverage Products Laboratory at Submit Inquiry> for general questions or concerns about nonbeverage formula submissions.


The FDA announced that it is soliciting comments on a proposed rule to establish requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and bear a “gluten-free” claim.  TTB’s current policy on “gluten-free” label claims on alcohol beverage labels can be found in TTB Ruling 2014-2.

Source: FDA Constituent Update

November 17, 2015

The U.S. Food and Drug Administration today released a proposed rule to establish requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and bear the “gluten-free” claim. The proposed rule, titled “Gluten-Free Labeling of Fermented or Hydrolyzed Foods,” pertains to foods such as yogurt, sauerkraut, pickles, cheese, green olives, vinegar, and FDA regulated beers.

In 2013, the FDA issued the gluten-free final rule, which addressed the uncertainty in interpreting the results of current gluten test methods for fermented and hydrolyzed foods in terms of intact gluten.  Due to this uncertainty, the FDA has issued this proposed rule to provide alternative means for the agency to verify compliance for fermented or hydrolyzed foods labeled “gluten-free” based on records that are made and kept by the manufacturer.

The proposed rule, when finalized, would require these manufacturers to make and keep records demonstrating assurance that:

  • the food meets the requirements of the gluten-free food labeling final rule prior to fermentation or hydrolysis, and
  • the manufacturer has adequately evaluated its process for any potential gluten cross-contact, and
  • where a potential for gluten cross-contact has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process.

Distilled foods such as distilled vinegars are also included in the proposed rule. Distillation is a purification process that separates volatile components from non-volatile components such as proteins.  Thus, when properly done, gluten should not be present in distilled foods. The proposed rule states that FDA would evaluate compliance of distilled foods by verifying the absence of protein (including gluten) using scientifically valid analytical methods that can detect the presence of protein or protein fragments in the distilled food.

The FDA is accepting public comments beginning Wednesday, November 18. To electronically submit comments to the docket, visit www.regulations.gov/ and type docket number “FDA-2014-N-1021” in the search box.

To submit comments to the docket by mail, use the following address. Be sure to include docket number “FDA-2014-N-1021” on each page of your written comments.

Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

For more information:

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