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

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

3. Turnaround Time Very Difficult to Meet 10 Day Turnaround High Volume of Formula Submissions High Volume of Formula Submissions Errors in Naming Product, Items 9 & 10 Errors in Naming Product, Items 9 & 10 Information Missing from Submissions Information Missing from Submissions Ambiguous Information on Submissions Ambiguous Information on Submissions Is a Sample Required? 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 Link through the Laboratory’s Webpage Google: “Drawback Tutorial” Add to Your Favorites

6. FDA Naming Guidelines Natural Flavor: Flavor comes only from the named material (Nat. Cherry Flavor) 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 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 Natural Type Flavors: All Natural Flavor, but No Source of the Named Material (Nat. Cherry Type)

7. Naming Natural Flavors Natural Cherry Alcohol Water Citric Acid Cherry Juice Natural Cherry WONF Alcohol Water Citric Acid Cherry Juice Natural Benzaldehyde Natural Ethyl Acetate Natural Cherry Type Alcohol Water Citric Acid Natural Benzaldehyde Natural Ethyl Acetate Note: Citric Acid is a fixed acid and not considered a flavor chemical.

8. FDA Naming Guidelines Natural & Artificial Flavor: Natural Source of the Named Material, and Artificial Flavors 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 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) Artificial Flavors: Predominant Flavor is Artificial (Art. Cherry Flavor)

9. Naming Artificial Flavors N & A Cherry Alcohol Water Citric Acid Cherry Juice Art. Ethyl Acetate Nat. Benzaldehyde N & A Cherry Type Alcohol Water Citric Acid Art. Ethyl Acetate Nat. Benzaldehyde Artificial Cherry Alcohol Water Citric Acid Art. Ethyl Acetate Art. Benzaldehyde

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

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

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

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

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

15. Prohibited Ingredients Prohibited Ingredients can be found in: Prohibited Ingredients can be found in: TTB Website – 21 CFR Part 189 TTB Website – 21 CFR Part 189 Prohibited Colors: 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) : Prohibited Botanicals (Partial Listing) : Calamus, Comfrey, Echinacea, Kava Kava, Ginkgo Biloba, Yohimbe Ginseng Restrictions: Ginseng Restrictions: Panax Ginseng (Panax quinquefolium) ≤ 30% Ethanol Panax Ginseng (Panax quinquefolium) ≤ 30% Ethanol Siberian Ginseng (Eleutherococcus senticosis) ≤ 24% Ethanol Siberian Ginseng (Eleutherococcus senticosis) ≤ 24% Ethanol

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

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

18. Don’t Send a Sample When… No Alcohol in Product No Alcohol in Product More PG by Volume than Ethanol (Upper Limit) and 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 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: 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 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 Combining Multiple Approved Formulas May Not Necessarily Result in an Approved Formula When Does “Unfit + Unfit = Fit” ? When Does “Unfit + Unfit = Fit” ?

20. Using 1% Solutions Mix Ten 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 1% Solution 100 Pounds Total: 100 Pounds Total: 99 Pounds Ethanol 99 Pounds Ethanol 1 Pound of Chemical from 1% List 1 Pound of Chemical from 1% List Approximately 94% Ethanol by Volume Approximately 94% Ethanol by Volume Each Formula Would Be Approved for Drawback Each Formula Would Be Approved for Drawback

21. Combining Approved Formulas Meets the Requirements for a Sauce/Syrup Meets the Requirements for a Sauce/Syrup Less Than 12% Ethanol (v/v) AND More Than 60 g Residual Solids/100 mL Less Than 12% Ethanol (v/v) AND More Than 60 g Residual Solids/100 mL Ingredients: Ingredients: 190 Proof EtOH 7.0 lbs1.03 gallons Sugar 49.0 lbs Strawberry Juice 15.0 lbs Water 29.0 lbs Final Yield100.0 lbs9.50 gallons Meets the Requirements for Citric Acid Meets the Requirements for Citric Acid Need (0.1 x Percent Ethanol (Upper Limit)) g/100 mL Ingredients: Ingredients: 190 Proof EtOH 38.3 lbs5.64 gallons Citric Acid 5.4 lbs Cranberry Juice 27.3 lbs Water 32.0 lbs Final Yield 100.0 lbs13.26 gallons 40.4 ± 2.0%  Need 4.24 g/100 mL Contains 4.9 grams per 100 mL

22. Combining Approved Formulas Simple Mixture: Simple Mixture: Approved Sauce Formulation10.3% Alcohol 65.0 lbs 6.18 gallons Approved Citric Acid Formulation40.4% Alcohol 35.0 lbs 4.64 gallons Final Yield100.0 lbs10.82 gallons Contains: Contains: 23.2 ± 1.5% Ethanol (v/v) 23.2 ± 1.5% Ethanol (v/v) 2.09 grams Citric Acid/100 mL 2.09 grams Citric Acid/100 mL Would Need at Least 2.82 g/100 mL Would Need at Least 2.82 g/100 mL Approve or Disapprove? Approve or Disapprove? Does Not Meet Guidelines Does Not Meet Guidelines Too Much Alcohol for Sauce Too Much Alcohol for Sauce Contains Sugar (32 pounds) Which May Be a Mitigating Factor Contains Sugar (32 pounds) Which May Be a Mitigating Factor Must Conduct Organoleptic Analysis Must Conduct Organoleptic Analysis Send Sample to Laboratory with Form 5154.1 Send Sample to Laboratory with Form 5154.1

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

24. What Does This Mean? “Please contact the manufacturer for status of their product” TTB# Listed is Invalid TTB# Listed is Invalid TTB# Listed was Disapproved TTB# Listed was Disapproved Product # is Listed, Not TTB# Product # is Listed, Not TTB# TTB# and Product Description Don’t Match TTB# and Product Description Don’t Match Formula has been Returned to Customer Formula has been Returned to Customer

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