Web-Based Resources for Completing TTB Form 5154.1 Edward Limowski 240 264-1593

1. Web-Based Resources for Completing TTB Form 5154.1 Edward Limowski (240) 264-1593

2. Past Formula Submissions 2005 Processed 6419 Submissions Jan � Oct 2006 Received 5440 Submissions Processed 4950 Submissions (91%)

3. Turnaround Time Very Difficult to Meet 10 Day Turnaround High Volume of Formula Submissions Errors in Naming Product, Items 9 & 10 Information Missing from Submissions Ambiguous Information on Submissions Is a Sample Required?

4. TTB Laboratory Website http://www.ttb.gov/ssd/

5. TTB Drawback Tutorial Website http://www.ttb.gov/ssd/drawbacktutorial.shtml

6. FDA Naming Guidelines Natural Flavor: Flavor comes only from the named material (Nat. Cherry Flavor) Natural Flavor WONF: A Natural Flavor, With Other Natural Flavors Not from Named Material (Nat. Cherry WONF) Natural Type Flavors: All Natural Flavor, but No Source of the Named Material (Nat. Cherry Type)

7. Naming Natural Flavors

8. FDA Naming Guidelines Natural & Artificial Flavor: Natural Source of the Named Material, and Artificial Flavors (N&A Cherry Flavor) Natural & Artificial Type Flavors: No Source of Named Material, but Natural & Artificial Flavor (N&A Cherry Type) Artificial Flavors: Predominant Flavor is Artificial (Art. Cherry Flavor)

9. Naming Artificial Flavors

10. Vanillin: Natural vs. Artificial Vanillin when Derived from Vanilla Beans is Considered Natural Vanillin is Considered Artificial when Derived from: � Turmeric � Eugenol � Clove � Lignin Natural Vanillin from Rhodia, Inc. Natural Process ? Natural Product �

11. TTB Guidelines N&A Flavors with Less than 0.1% Artificial Topnote Should Comply with FDA Naming Guidelines (N&A) Considered Natural when Used in Alcoholic Beverage Calculation Does Not Include Art. Vanillin, Art. Maltol, Ethyl Vanillin, or Ethyl Maltol If Greater than 0.1% Artificial ? Considered Artificial for Alcoholic Beverage Labeling Purposes

12. Missing Information Disclose & Quantify All Sources of Ethanol Essences, Distillates, Intermediates List Each Item Separately Provide Percent Alcohol by Volume and Total Volume Used Disclose & Quantify All Limited Ingredients Solid Extracts (Commonly Propylene Glycol, Caramel) Purchased Flavors (Commonly Propylene Glycol, Acetic Acid) Grouping of Chemicals List and Quantify Predominant Ingredients Separate Natural Flavor Chemical from Artificial Flavor Chemicals Group by Chemical Class (Aldehydes, Esters, Ketones)

13. Essences, Distillates, & Aromas List Each Product Containing Ethanol as a Separate Line Item State the Percent Ethanol by Volume and the Volume Used If the Product is Water-Based, Please State: �No Alcohol. No Limited Ingredients� Possible Presence of Methanol in Essences Please Be Aware Please Screen, Quantify, and Disclose

14. Limited Ingredients Limited Ingredients can be found in: TTB Website � 21 CFR Part 184 Common Limited Ingredients: Acetic Acid, Propylene Glycol, Caffeine Malic Acid, Tannic Acid, Sulfur Dioxide (caramel color) TTB Limited Ingredients: Artificial Vanillin Ethyl Vanillin Artificial Maltol Ethyl Maltol

15. Prohibited Ingredients Prohibited Ingredients can be found in: TTB Website � 21 CFR Part 189 Prohibited Colors: FD&C Red #1, FD&C Red #2, FD&C Green #1, FD&C Green #2 FD&C Red #3 Calcium Lake, FD&C Red #3 Aluminum Lake Prohibited Botanicals (Partial Listing): Calamus, Comfrey, Echinacea, Kava Kava, Ginkgo Biloba, Yohimbe Ginseng Restrictions: Panax Ginseng (Panax quinquefolium) = 30% Ethanol Siberian Ginseng (Eleutherococcus senticosis) = 24% Ethanol

16. Avoiding Ambiguity Specify the Proof & Type of Spirit Used Specify Units for All Ingredients Avoid Abbreviations or Obscure Names Provide Chemical Name and FEMA Number Use TTB Numbers (Not Product Numbers) Specify Alcohol Content by Volume Identify the Solvent in Extracts & Essences � Quantify if Propylene Glycol � If Ethanol, Provide the Volume of the Extract & Ethanol by Volume State �No Alcohol, No Limited Ingredients, No Colors�

17. Other Helpful Items Provide Both a Weight Yield and a Volume Yield Provide a Density or Specific Gravity for Your Product Provide Your Phone Number & Email Address Do Send Copies of : Product Specification Sheets if No TTB # Must Quantify Ethanol (v/v), Limited Ingredients Must list Colors and Density Do Not Send Copies of: Specification Sheets for Intermediates with TTB #s Instead list the TTB# and Company Name on the form Flavor Ingredient Data (FID) Sheets for the Formula You�re Submitting

18. Don�t Send a Sample When� No Alcohol in Product More PG by Volume than Ethanol (Upper Limit) and No Masking Agents are Present in the Formula Formula is a Simple Mixture and Lists At Least 1% of a Chemical on the 1% List and No Masking Agents are Present in the Formula See Handout for Unfit Guidelines Concerning: Citric Acid, Salt, Vanillin, Ethyl Vanillin, Maltol, Ethyl Acetate, and Essential Oils

19. Examples of Combining Approved Formulations Using 1% Solutions in Your Products May Not Necessarily Make the Product Unfit Combining Multiple Approved Formulas May Not Necessarily Result in an Approved Formula When Does �Unfit + Unfit = Fit� ?

20. Using 1% Solutions Mix Ten 1% Solutions 1000 Pounds Total 990 Pounds Ethanol 1 Pound of Each Chemical (0.1 %) Approximately 94% Ethanol by Volume Formula Might Not Be Approved (Even If a �No Action� Formula) 1% Solution 100 Pounds Total: 99 Pounds Ethanol 1 Pound of Chemical from 1% List Approximately 94% Ethanol by Volume Each Formula Would Be Approved for Drawback

21. Combining Approved Formulas Meets the Requirements for a Sauce/Syrup Less Than 12% Ethanol (v/v) AND More Than 60 g Residual Solids/100 mL Ingredients: 190 Proof EtOH 7.0 lbs 1.03 gallons Sugar 49.0 lbs Strawberry Juice 15.0 lbs Water 29.0 lbs Final Yield 100.0 lbs 9.50 gallons Meets the Requirements for Citric Acid Need (0.1 x Percent Ethanol (Upper Limit)) g/100 mL Ingredients: 190 Proof EtOH 38.3 lbs 5.64 gallons Citric Acid 5.4 lbs Cranberry Juice 27.3 lbs Water 32.0 lbs Final Yield 100.0 lbs 13.26 gallons

22. Combining Approved Formulas Simple Mixture: Approved Sauce Formulation 10.3% Alcohol 65.0 lbs 6.18 gallons Approved Citric Acid Formulation 40.4% Alcohol 35.0 lbs 4.64 gallons Final Yield 100.0 lbs 10.82 gallons Contains: 23.2 � 1.5% Ethanol (v/v) 2.09 grams Citric Acid/100 mL Would Need at Least 2.82 g/100 mL Approve or Disapprove? Does Not Meet Guidelines Too Much Alcohol for Sauce Contains Sugar (32 pounds) Which May Be a Mitigating Factor Must Conduct Organoleptic Analysis Send Sample to Laboratory with Form 5154.1

23. Send a Sample When� Product is Produced Outside of the United States Formula Does Not List Significant Amounts of Flavor Chemicals Only Essences, Concentrates, Extracts are Listed Low Levels of Essential Oils in a Washed Extract Formula Contains Masking Agents Sugar, High Fructose Corn Syrup, Glycerin, Juices Ingredient Making Formula Unfit is Not Listed on Formula (Send Sample Even If You Include Internal Taste Panel Results) Product is a Sauce/Syrup Ethanol is Not More than 12% (v/v) and Residual Solids = 60g/100 cc Vanilla Extracts Less than 1 Fold 1X or 2X with Ethanol Greater than 45% (v/v) in Item 10

25. Do I Need a New TTB Number? You MAY Keep Your Current TTB Number If: Yield Changes Due to Processing Changes Correcting an Error or Omission in an Ingredient that is NOT Limited by FDA or TTB You NEED a New TTB Number If: Changing the Quantity of a TTB or FDA Limited Ingredient Adding or Deleting a Color Changing a Component that Would Affect Labeling Status of the Product Changing a Component that Would Affect the Beverage Character of the Product