# Presentation: 255375

## 

Web-Based Resources 
for Completing 
TTB Form 5154.1

Edward Limowski
(240) 264-1593

- 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)*

## 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)*

## 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” ?

## 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

## 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**

-   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