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Web-Based Resources for Completing TTB Form 5154.1 Edward Limowski (240) 264-1593. Past Formula Submissions. 2005 Processed 6419 Submissions Jan – Oct 2006 Received 5440 Submissions Processed 4950 Submissions (91%). Turnaround Time. Very Difficult to Meet 10 Day Turnaround
Web-Based Resources for Completing TTB Form 5154.1 Edward Limowski (240) 264-1593
Past Formula Submissions • 2005 • Processed 6419 Submissions • Jan – Oct 2006 • Received 5440 Submissions • Processed 4950 Submissions (91%)
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?
TTB Laboratory Website http://www.ttb.gov/ssd/
TTB Drawback Tutorial Website http://www.ttb.gov/ssd/drawbacktutorial.shtml • Link through the • Laboratory’s Webpage • Google: • “Drawback Tutorial” • Add to Your Favorites
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)
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 Naming Natural Flavors Note: Citric Acid is a fixed acid and not considered a flavor chemical.
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)
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 Naming Artificial Flavors
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
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
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)
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
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
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
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”
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
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
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” ?
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 Using 1% Solutions
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 Combining Approved Formulas • 40.4 ± 2.0% Need 4.24 g/100 mL • Contains 4.9 grams per 100 mL
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
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
What Does This Mean? “Please contact the manufacturer for status of their product” • TTB# Listed is Invalid • TTB# Listed was Disapproved • Product # is Listed, Not TTB# • TTB# and Product Description Don’t Match • Formula has been Returned to Customer
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