Web-Based Resources Web-Based Resources

for Completing for Completing

TTB Form 5154.1TTB Form 5154.1

Edward LimowskiEdward Limowski

(240) 264-1593(240) 264-1593

Past Formula SubmissionsPast Formula Submissions

20052005 Processed 6419 Processed 6419

SubmissionsSubmissions

Jan – Oct 2006Jan – Oct 2006 Received 5440 Received 5440

SubmissionsSubmissions Processed 4950 Processed 4950

Submissions (91%)Submissions (91%)

72%

5%

23%

Approved

Disapproved

Returned

76%

5%

19%

Approved

Disapproved

Returned

Turnaround TimeTurnaround Time

Very Difficult to Meet 10 Day Very Difficult to Meet 10 Day TurnaroundTurnaround

High Volume of Formula SubmissionsHigh Volume of Formula Submissions Errors in Naming Product, Items 9 & 10Errors in Naming Product, Items 9 & 10 Information Missing from SubmissionsInformation Missing from Submissions Ambiguous Information on SubmissionsAmbiguous Information on Submissions Is a Sample Required?Is a Sample Required?

TTB Laboratory WebsiteTTB Laboratory Websitehttp://www.ttb.gov/ssd/http://www.ttb.gov/ssd/

TTB Drawback Tutorial TTB Drawback Tutorial WebsiteWebsite

http://www.ttb.gov/ssd/drawbacktutorial.shtmlhttp://www.ttb.gov/ssd/drawbacktutorial.shtml

• Link through the Laboratory’s Webpage

• Google: “Drawback Tutorial”

• Add to Your Favorites

FDA Naming GuidelinesFDA Naming Guidelines

Natural Flavor: Flavor comes only from the Natural Flavor: Flavor comes only from the named material named material (Nat. Cherry Flavor)(Nat. Cherry Flavor)

Natural Flavor Natural Flavor WONFWONF: A Natural Flavor, With : A Natural Flavor, With Other Natural Flavors Not from Named Other Natural Flavors Not from Named Material Material (Nat. Cherry WONF)(Nat. Cherry WONF)

Natural Natural TypeType Flavors: All Natural Flavor, but Flavors: All Natural Flavor, but No Source of the Named Material No Source of the Named Material (Nat. Cherry Type)(Nat. Cherry Type)

Naming Natural FlavorsNaming Natural Flavors

Natural Cherry

AlcoholWaterCitric AcidCherry Juice

Natural Cherry WONF

AlcoholWaterCitric AcidCherry JuiceNatural BenzaldehydeNatural Ethyl Acetate

Natural Cherry Type

AlcoholWaterCitric Acid

Natural BenzaldehydeNatural Ethyl Acetate

Note: Citric Acid is a fixed acid and not considered a flavor chemical.

FDA Naming GuidelinesFDA Naming Guidelines

Natural & Artificial Flavor: Natural Source of Natural & Artificial Flavor: Natural Source of the Named Material, and Artificial Flavors the Named Material, and Artificial Flavors (N&A Cherry Flavor)(N&A Cherry Flavor)

Natural & Artificial Natural & Artificial TypeType Flavors: No Source of Flavors: No Source of Named Material, but Natural & Artificial Flavor Named Material, but Natural & Artificial Flavor (N&A Cherry Type)(N&A Cherry Type)

Artificial Flavors: Predominant Flavor is Artificial Flavors: Predominant Flavor is Artificial Artificial (Art. Cherry Flavor)(Art. Cherry Flavor)

Naming Artificial FlavorsNaming Artificial Flavors

N & A Cherry

AlcoholWaterCitric AcidCherry JuiceArt. Ethyl AcetateNat. Benzaldehyde

N & A Cherry Type

AlcoholWaterCitric Acid

Art. Ethyl AcetateNat. Benzaldehyde

Artificial Cherry

AlcoholWaterCitric Acid

Art. Ethyl AcetateArt. Benzaldehyde

Vanillin: Natural vs. ArtificialVanillin: Natural vs. Artificial Vanillin when Derived from Vanilla Beans is Vanillin when Derived from Vanilla Beans is

Considered NaturalConsidered Natural

Vanillin is Considered Artificial when Derived Vanillin is Considered Artificial when Derived from:from:

– – TurmericTurmeric – Eugenol– Eugenol

– – CloveClove – Lignin – Lignin

Natural Vanillin from Rhodia, Inc.Natural Vanillin from Rhodia, Inc. Natural Process Natural Process Natural Product   Natural Product  

TTB GuidelinesTTB Guidelines

N&A Flavors with Less than 0.1% Artificial TopnoteN&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 BeverageConsidered Natural when Used in Alcoholic Beverage

Calculation Does Not Include Art. Vanillin, Art. Maltol, Calculation Does Not Include Art. Vanillin, Art. Maltol, Ethyl Vanillin, or Ethyl MaltolEthyl Vanillin, or Ethyl Maltol

If Greater than 0.1% Artificial If Greater than 0.1% Artificial Considered Considered Artificial for Alcoholic Beverage Labeling PurposesArtificial for Alcoholic Beverage Labeling Purposes

Missing InformationMissing Information

Disclose & Quantify All Sources of EthanolDisclose & Quantify All Sources of Ethanol Essences, Distillates, IntermediatesEssences, Distillates, Intermediates List Each Item Separately List Each Item Separately Provide Percent Alcohol by Volume and Total Volume UsedProvide Percent Alcohol by Volume and Total Volume Used

Disclose & Quantify All Limited IngredientsDisclose & 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 ChemicalsGrouping of Chemicals List and Quantify Predominant IngredientsList and Quantify Predominant Ingredients Separate Natural Flavor Chemical from Artificial Flavor Separate Natural Flavor Chemical from Artificial Flavor

ChemicalsChemicals Group by Chemical Class (Aldehydes, Esters, Ketones)Group by Chemical Class (Aldehydes, Esters, Ketones)

Essences, Distillates, & Essences, Distillates, & AromasAromas

List Each Product Containing Ethanol as a List Each Product Containing Ethanol as a Separate Line ItemSeparate Line Item

State the Percent Ethanol by Volume and State the Percent Ethanol by Volume and the Volume Usedthe Volume Used

If the Product is Water-Based, Please State:If the Product is Water-Based, Please State:““No Alcohol. No Limited Ingredients”No Alcohol. No Limited Ingredients”

Possible Presence of Methanol in EssencesPossible Presence of Methanol in Essences Please Be AwarePlease Be Aware Please Screen, Quantify, and DisclosePlease Screen, Quantify, and Disclose

Limited IngredientsLimited Ingredients

Limited Ingredients can be found in:Limited Ingredients can be found in: TTB Website TTB Website – 21 CFR Part 184– 21 CFR Part 184

Common Limited Ingredients:Common Limited Ingredients:Acetic Acid, Propylene Glycol, CaffeineAcetic Acid, Propylene Glycol, Caffeine

Malic Acid, Tannic Acid, Sulfur Dioxide (caramel color)Malic Acid, Tannic Acid, Sulfur Dioxide (caramel color)

TTB Limited Ingredients:TTB Limited Ingredients:Artificial Vanillin Artificial Vanillin Ethyl VanillinEthyl Vanillin

Artificial MaltolArtificial Maltol Ethyl MaltolEthyl Maltol

Prohibited IngredientsProhibited Ingredients Prohibited Ingredients can be found in:Prohibited Ingredients can be found in:

TTB Website TTB Website – 21 CFR Part 189– 21 CFR Part 189

Prohibited Colors: Prohibited Colors: FD&C Red #1, FD&C Red #2, FD&C Green #1, FD&C FD&C Red #1, FD&C Red #2, FD&C Green #1, FD&C

Green #2Green #2FD&C Red #3 Calcium Lake, FD&C Red #3 Aluminum FD&C Red #3 Calcium Lake, FD&C Red #3 Aluminum

LakeLake

Prohibited Botanicals Prohibited Botanicals (Partial Listing)(Partial Listing)::Calamus, Comfrey, Echinacea, Calamus, Comfrey, Echinacea,

Kava Kava, Ginkgo Biloba, YohimbeKava Kava, Ginkgo Biloba, Yohimbe Ginseng Restrictions:Ginseng Restrictions:

Panax Ginseng Panax Ginseng (Panax quinquefolium) (Panax quinquefolium) ≤ ≤ 30% Ethanol30% Ethanol Siberian Ginseng Siberian Ginseng (Eleutherococcus senticosis) (Eleutherococcus senticosis) ≤≤ 24% Ethanol 24% Ethanol

Avoiding AmbiguityAvoiding Ambiguity Specify the Proof & Type of Spirit UsedSpecify the Proof & Type of Spirit Used

Specify Units for All IngredientsSpecify Units for All Ingredients

Avoid Abbreviations or Obscure NamesAvoid Abbreviations or Obscure Names

Provide Chemical Name and FEMA NumberProvide Chemical Name and FEMA Number

Use TTB Numbers (Not Product Numbers)Use TTB Numbers (Not Product Numbers)

Specify Alcohol Content by VolumeSpecify Alcohol Content by Volume

Identify the Solvent in Extracts & Essences Identify the Solvent in Extracts & Essences

– – Quantify if Propylene GlycolQuantify if Propylene Glycol

– – If Ethanol, Provide the Volume of the Extract & Ethanol by If Ethanol, Provide the Volume of the Extract & Ethanol by

VolumeVolume

State “No Alcohol, No Limited Ingredients, No Colors”State “No Alcohol, No Limited Ingredients, No Colors”

Other Helpful ItemsOther Helpful Items

Provide Both a Weight Yield and a Volume YieldProvide Both a Weight Yield and a Volume Yield

Provide a Density or Specific Gravity for Your ProductProvide a Density or Specific Gravity for Your Product

Provide Your Phone Number & Email AddressProvide 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 IngredientsMust Quantify Ethanol (v/v), Limited Ingredients Must list Colors and DensityMust list Colors and Density

Do Not Send Copies of:Do Not Send Copies of: Specification Sheets for Intermediates with TTB #sSpecification Sheets for Intermediates with TTB #s

Instead list the TTB# and Company Name on the formInstead list the TTB# and Company Name on the form Flavor Ingredient Data (FID) Sheets for the Formula You’re Flavor Ingredient Data (FID) Sheets for the Formula You’re

SubmittingSubmitting

Don’t Send a Sample Don’t Send a Sample When…When…

No Alcohol in ProductNo 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 FormulaNo Masking Agents are Present in the Formula

Formula is a Simple Mixture and Lists At Least 1% Formula is a Simple Mixture and Lists At Least 1% of a Chemical on the 1% List and No Masking of a Chemical on the 1% List and No Masking Agents are Present in the FormulaAgents are Present in the Formula

See Handout for Unfit Guidelines Concerning:See Handout for Unfit Guidelines Concerning:Citric Acid, Salt, Vanillin, Ethyl Vanillin, Citric Acid, Salt, Vanillin, Ethyl Vanillin,

Maltol, Ethyl Acetate, and Essential Maltol, Ethyl Acetate, and Essential OilsOils

Examples of Combining Examples of Combining Approved FormulationsApproved Formulations

Using 1% Solutions in Your Products Using 1% Solutions in Your Products May Not Necessarily Make the May Not Necessarily Make the Product UnfitProduct Unfit

Combining Multiple Approved Combining Multiple Approved Formulas May Not Necessarily Result Formulas May Not Necessarily Result in an Approved Formulain an Approved Formula

When Does “Unfit + Unfit = Fit” ?When Does “Unfit + Unfit = Fit” ?

Using 1% SolutionsUsing 1% Solutions Mix Ten 1% SolutionsMix Ten 1% Solutions

1000 Pounds Total1000 Pounds Total 990 Pounds Ethanol990 Pounds Ethanol 1 Pound of Each Chemical 1 Pound of Each Chemical

(0.1 %)(0.1 %)

Approximately 94% Approximately 94% Ethanol by VolumeEthanol by Volume

Formula Formula Might NotMight Not Be Be Approved (Even If a “No Approved (Even If a “No Action” Formula)Action” Formula)

1% Solution1% Solution 100 Pounds Total:100 Pounds Total:

99 Pounds Ethanol99 Pounds Ethanol 1 Pound of Chemical 1 Pound of Chemical

from 1% Listfrom 1% List

Approximately 94% Approximately 94% Ethanol by VolumeEthanol by Volume

Each Formula Each Formula Would Be Approved Would Be Approved for Drawbackfor Drawback

Combining Approved Combining Approved FormulasFormulas

Meets the Meets the Requirements for a Requirements for a Sauce/SyrupSauce/Syrup Less Than 12% Ethanol Less Than 12% Ethanol

(v/v) AND (v/v) AND More Than More Than 60 60 g Residual Solids/100 mLg Residual Solids/100 mL

Ingredients:Ingredients:190 Proof EtOH190 Proof EtOH 7.0 lbs 7.0 lbs 1.03 gallons1.03 gallons

Sugar Sugar 49.0 lbs 49.0 lbs

Strawberry JuiceStrawberry Juice 15.0 lbs 15.0 lbs

WaterWater 29.0 lbs 29.0 lbs

Final YieldFinal Yield 100.0 lbs100.0 lbs 9.50 gallons9.50 gallons

Meets the Meets the Requirements for Requirements for Citric AcidCitric Acid Need (0.1 x Percent Need (0.1 x Percent

Ethanol (Upper Limit)) Ethanol (Upper Limit)) g/100 mL g/100 mL

Ingredients:Ingredients:190 Proof EtOH190 Proof EtOH 38.3 lbs 38.3 lbs 5.64 gallons5.64 gallons

Citric AcidCitric Acid 5.4 lbs 5.4 lbs

Cranberry JuiceCranberry Juice 27.3 lbs 27.3 lbs

WaterWater 32.0 lbs 32.0 lbs

Final YieldFinal Yield 100.0 lbs 100.0 lbs 13.26 gallons13.26 gallons

• 40.4 ± 2.0% Need 4.24 g/100 mL• Contains 4.9 grams per 100 mL

Combining Approved Combining Approved FormulasFormulas

Simple Mixture:Simple Mixture:Approved Sauce FormulationApproved Sauce Formulation 10.3% Alcohol10.3% Alcohol 65.0 lbs 65.0 lbs 6.18 gallons 6.18 gallonsApproved Citric Acid FormulationApproved Citric Acid Formulation 40.4% Alcohol40.4% Alcohol 35.0 lbs 35.0 lbs 4.64 gallons 4.64 gallons Final YieldFinal Yield 100.0 lbs100.0 lbs 10.82 gallons10.82 gallons

Contains:Contains: 23.2 23.2 ± 1.5% Ethanol (v/v)± 1.5% Ethanol (v/v) 2.09 grams Citric Acid/100 mL2.09 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 GuidelinesDoes Not Meet Guidelines

Too Much Alcohol for SauceToo Much Alcohol for Sauce Contains Sugar (32 pounds) Which May Be a Mitigating Contains Sugar (32 pounds) Which May Be a Mitigating

Factor Factor Must Conduct Organoleptic AnalysisMust Conduct Organoleptic Analysis Send Sample to Laboratory with Form 5154.1Send Sample to Laboratory with Form 5154.1

Send a Sample When…Send a Sample When… Product is Produced Outside of the United StatesProduct is Produced Outside of the United States

Formula Does Not List Significant Amounts of Flavor ChemicalsFormula Does Not List Significant Amounts of Flavor Chemicals Only Essences, Concentrates, Extracts are ListedOnly Essences, Concentrates, Extracts are Listed

Low Levels of Essential Oils in a Washed ExtractLow Levels of Essential Oils in a Washed Extract

Formula Contains Masking AgentsFormula Contains Masking Agents Sugar, High Fructose Corn Syrup, Glycerin, JuicesSugar, High Fructose Corn Syrup, Glycerin, Juices

Ingredient Making Formula Unfit is Not Listed on FormulaIngredient Making Formula Unfit is Not Listed on Formula(Send Sample Even If You Include Internal Taste Panel Results)(Send Sample Even If You Include Internal Taste Panel Results)

Product is a Sauce/SyrupProduct is a Sauce/Syrup Ethanol is Not More than 12% (v/v) and Residual Solids Ethanol is Not More than 12% (v/v) and Residual Solids ≥≥ 60g/100 cc 60g/100 cc

Vanilla ExtractsVanilla Extracts Less than 1 FoldLess than 1 Fold 1X or 2X with Ethanol Greater than 45% (v/v) in Item 101X or 2X with Ethanol Greater than 45% (v/v) in Item 10

What Does This Mean?What Does This Mean?

““Please contact the manufacturer for Please contact the manufacturer for status of their product”status of their product”

TTB# Listed is InvalidTTB# Listed is Invalid TTB# Listed was DisapprovedTTB# Listed was Disapproved Product # is Listed, Not TTB#Product # is Listed, Not TTB# TTB# and Product Description Don’t TTB# and Product Description Don’t

MatchMatch Formula has been Returned to CustomerFormula has been Returned to Customer

Do I Need a New TTB Do I Need a New TTB Number?Number?

You MAY Keep Your Current TTB Number If:You MAY Keep Your Current TTB Number If: Yield Changes Due to Processing ChangesYield Changes Due to Processing Changes Correcting an Error or Omission in an Ingredient Correcting an Error or Omission in an Ingredient

that is NOT Limited by FDA or TTBthat 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 Changing the Quantity of a TTB or FDA Limited

IngredientIngredient Adding or Deleting a ColorAdding or Deleting a Color Changing a Component that Would Affect Changing a Component that Would Affect

Labeling Status of the ProductLabeling Status of the Product Changing a Component that Would Affect the Changing a Component that Would Affect the

Beverage Character of the ProductBeverage Character of the Product