Home.Advertising, Labeling and Formulation FAQ 24
Advertising, Labeling and Formulation FAQ 24
III. SPECIFIC INGREDIENTS
VI. IMPORTERS
VII. MALT BEVERAGES
VIII. WINE
Q1: Why has TTB come out with this new form?
A1: By using one form for all products, TTB is streamlining its operations to be more effective, resulting in faster processing times for your formulas. Also, by streamlining the formula submissions form, we are setting an important cornerstone for enabling industry to submit formulas electronically in the future.
We designed the new form to address some of the problems with the old forms so that we can get all of the information we need the first time. We believe that this new form will generate faster service and provide us with a clearer understanding of the product.
Q2: Can I still submit my formulas using the previous forms?
A2: Yes, you may still use the previous forms. Currently, use of this form is voluntary. It will not be mandatory until TTB updates the regulations. We will alert industry members when use of TTB F 5100.51 becomes mandatory.
Q3: Is there a fee to submit this form?
A3: No.
Q4: Can I use this form to submit a flavor formula?
A4: No. This form is only for beverage alcohol. For any flavors or other nonbeverage products, please use TTB Form 5154.1, "Formula and Process for Nonbeverage Product."
Q5: What size paper should I use to print this form?
A5: We suggest legal size paper (8" x 14"), but you also may print this form on multiple standard-size pages.
Q6: Do I need to resubmit to TTB all of my previously approved formulas?
A6: No. This form is only for new submissions.
Q7: What is required in the box "Formula #" in the upper right hand corner?
A7: In this box, write down the formula number that you have assigned to this product. Every formula needs to have a formula number assigned to it in ascending order.
For example, if this is the first formula that you are submitting to TTB, then you must use the number "1" in this box.
Q8: What is required in the box "Superseding Formula" in the upper right hand corner?
A8: If you are updating an already approved formula, then check this box. Also, make sure that you use the same formula number as the formula that you are replacing.
A superseding formula contains a change in ingredients, processes, or quantities from a previously approved formula. However, these changes do not impact the classification or labeling of the product or require the submission of a new certificate of label approval (COLA) for the product. If changes to an approved formula require the submission of a new COLA, then a superseding formula cannot be used.
Q9: If I supersede a formula, do I need to submit a new label for approval?
A9: No. If a formula is approved as superseding, you may still use the approved label. A superseding formula cannot contain changes that impact the classification or labeling of the product. If the new formula does contain changes that impact the classification or labeling, the formula will be rejected and will require a new formula submission with a new formula number.
Q10: Why is TTB asking for a contact person in Item 2 on the form?
A10: So that we can process your formula more quickly. If we have a question about the formula and no contact information is given, the formula will be rejected and returned to the applicant.
Q11: I do not have a Brewer's Number/Basic Permit/ Plant Registry yet. What do I need to do to get one?
A11: The "plant registry/basic permit/brewer's number" requested in Item 3 is issued by TTB's National Revenue Center when you qualify with TTB as a distilled spirits plant, winery, brewery, or importer. You must qualify with TTB before you begin the business of producing wine, distilling, brewing, or importing. If you need to qualify with TTB, please contact the National Revenue Center for more information at 1-877-TTB-FAQS (1-877-882-3277) or visit the NRC page of our Web site.
Q12: How do I determine what class and type to put in Item 4?
A12: Please check the specific FAQ section for Beer, Wine, or Distilled Spirits to learn where to find this information.
Q13: What does TTB mean by "Product Name" in Item 5?
A13: This is the brand name that you are planning to use for your product. If you have not yet chosen a brand name for the product, please leave this item blank.
Q14: In Item 6, do I need to provide a specific quantity of each ingredient or can I provide a range?
A14: A range may be used for the ingredients. Please note that any item that affects labeling (e.g., flavors, colors) cannot have a minimum of 0 in the range.
Q15: Can I express the quantities of ingredients in Item 6 as a percentage?
A15: Yes, you can use percentages to show how much of each ingredient you are using. Â Please make sure to indicate whether the percentages are by weight or by volume.
Q16: What information must I provide to describe the method of manufacture in
Item 7?
A16: This item should provide a step-by-step explanation of how the ingredients listed in Item 6 are used to make the final product. Please make sure that all ingredients listed in the method of manufacture in Item 7 are also listed in Item 6.
Q17: What does "Total Yield" mean in Item 8?
A17: The total yield identifies how much of the beverage is produced with the quantities given in Item 6 (e.g., 100 gallons, 1 liter.) If you used percentages in Item 6, then you do not need to provide a total yield.
Q18: What am I required to provide in Items 9a and 9b?
A18: These items only apply to Malt Beverages with added flavors. If you are not producing such a product, please disregard these two items.
If you have more questions about these two items, please refer to the Malt Beverage section
Q19: I want to add an herb or flower to my product. What information do I need to provide to TTB?
A19: Please note the scientific name (genus and species) of the flower or herb you are adding. Additionally, if you know the regulatory status of this item from the Food and Drug Administration or the Flavor and Extract Manufacturers Association of the United States (FEMA), please provide that too.
Q20: I am purchasing flavors from a flavor manufacturer. What information do I need to include about these flavors?
A20: Please provide the name of the flavor, the name of the flavor manufacturer, and the TTB/ATF number for the flavor. Every flavor that has been approved by our laboratory for use in an alcohol beverage will have a TTB/ATF number.
To speed up the process, please acquire a Flavor Ingredient Data (FID) Sheet from the manufacturer for that flavor. Please note that a FID sheet is different from a Product Specification Sheet. Please contact the flavor manufacturer's Government compliance officer to make sure that you have the correct information.
Q21: The flavor I am using has not yet been approved by TTB. What do I need to do?
A21: Please have the flavor manufacturer submit a four ounce fluid sample and a copy of TTB Form 5154.1 to the following address:
Alcohol and Tobacco Tax and Trade Bureau
National Laboratory Center
Nonbeverage Products Laboratory
6000 Ammendale Road
Beltsville, MD 20705
Please note that the flavor information is proprietary information and as such our laboratory can only discuss the status of a flavor with the flavor manufacturer.
In addition, please be aware that the process of acquiring flavor approval by TTB is under review, and it may have changed from the time of this publication. Please contact the laboratory at (240) 264-3700 or visit the Drawback Tutorial on our Web site for the latest procedures.
Q22:I am producing a flavor in-house and using it in my product. What do I need to do?
A22: If your product is not a compounded flavor consisting of flavor chemicals and/or limited ingredients, please provide TTB with a complete list of ingredients and a method of manufacture for the flavor. If there is not enough space on TTB Form 5100.51 to include this information, then please provide it on a separate page printed on your company's letterhead.
If you are using flavor chemicals or limited ingredients to produce the flavor, then you will have to submit the flavor for testing to the TTB laboratory. Please follow the procedure explained in above, in FAQ 21.
Q23: Do I need to provide allergen information on the formula form?
A23: TTB does not currently require you to list allergen information on this form. The use of an allergen as defined in the Food Allergen Labeling and Consumer Protection Act of 2004 in an alcohol beverage does not in and of itself currently require a formula submission.
Please see the Food Allergen Labeling page of our Web site for more information on voluntary allergen labeling.
Q24: Where do I submit my formula?
A24: Please mail your completed formula to:
Alcohol and Tobacco Tax and Trade Bureau
Advertising, Labeling, and Formulation Division
1310 G Street NW
Suite 400W
Washington, DC 20220
Q25: Can I submit my label with my formula?
A25: No. You must have formula approval before you apply for label approval. Please wait until you have received an approved formula before submitting your label application. When you submit for label approval, include a photocopy of the approved formula.
Q26: Can I submit my formulas electronically?
A26: No. Currently we are only accepting paper copies of the formulas. You can fill the form out on your computer, print it, sign it, and then mail it to us.
Q27: Who do I contact if I have questions not covered in these FAQs?
A27: Please contact our customer service team at (866) 927-ALFD (2533) x4 or at (202) 927-8140 x4 between 8:30 a.m. - 4:30 p.m. EST, Monday through Friday (except Federal holidays). You can also e-mail us at alfd@ttb.gov.
For any questions related to importing or producing a product in general, please refer to the specific section.
For any questions that are commodity specific (distilled spirits, malt beverages, or wine), please refer to the appropriate FAQ section.
Q28: What is the first thing I need to do before applying for formula approval?
A28: First, you need to check TTB Industry Circular 2007-4, Pre-COLA Product Evaluation. This circular will tell you if we require an approved formula before we can approve a label.
Q29: My product does not require a formula approval. What do I need to do next?
A29: You may now submit for label approval. Please use TTB Form 5100.31, Application for and Certification/Exemption of Label/Bottle Approval.
If you have already registered for COLAs Online, you may apply for label approval electronically. Please call our toll-free phone number (866) 927-ALFD (2533) x3 or at (202) 927-8140 x3. You can also email us at alfd@ttb.gov for more information about electronic submission of labels.
Q30: What happens to my formula once I submit it to TTB?
A30: A Formula Specialist will review the information to verify that it complies with all Federal regulations. The turnaround time is three weeks but may be longer if we need additional information. If there are additional questions, a Formula Specialist will contact you. Once you have received the approved formula, you may then apply for label approval.
Q31: Is there an expiration date for my formula?
A31: No, only formulas for imported products have an expiration date.
Q32: What is the first thing I need to do before applying for Pre-Import Approval?
A32: First, you need to read TTB Industry Circular 2007-4, Pre-Cola Product Evaluation. This circular will tell you what we require before a product can be imported into the United States.
Q33: My product requires a laboratory analysis. What do I need to do?
A33: Please submit a 750 ml sample of the product along with a completed TTB Form 5100.51 to our laboratory at:
Alcohol and Tobacco Tax and Trade Bureau
National Laboratory Center
Beverage Alcohol Laboratory
6000 Ammendale Road
Beltsville, MD 20705
If this is your first time submitting a laboratory sample, you must include a copy of your importer's permit.
Q34:My product does not come in 750 ml bottles. Can I submit two 375 ml bottles instead?
A34: Yes, you may submit your samples in any size bottle or can. Just make sure that you submit at least 750 ml of the product to test if required as per TTB Industry Circular 2007-4.
Q35:I forgot to include a copy of my importer's permit. Will my product still be tested?
A35: If you have submitted products to our laboratory before with a copy of your importer's permit, then we will have it on file and you do not need to submit another copy of your importer's permit with the sample.
If this is the first product that you have submitted to us, we will not test your product until the laboratory has received a copy of your importer's permit. The sample will be held for 90 days and then destroyed if a copy of your importer's permit is not received. You may contact the laboratory with questions at (240) 264-1665 or e-mail them at laboratory@ttb.gov.
Q36: What happens to the product once I have submitted it to the TTB lab?
A36: The National Laboratory Center will send you a letter confirming the receipt of the sample. We will then start testing the product. It normally takes our laboratory 30 days to complete its analysis of a product; however, if there are additional questions, the testing may take longer.
After the testing has been completed, the laboratory will forward its results to the Formulation Office of the Advertising, Labeling, and Formulation Division in Washington, D.C. A Formula Specialist will verify that all of the ingredients follow Federal regulations concerning the safety and the classification of the product. The Formulation Office has a turnaround time of three weeks in addition to the 30 days required by the lab; however, if there are additional questions, then this step may take longer. Once you have received the approved formula, you may then submit for label approval.
Q37: My product requires a Pre-Import Letter. What do I need to do?
A37: TTB Form 5100.51 replaces Pre-Import Letters. Please complete and submit this form to:
Alcohol and Tobacco Tax and Trade Bureau
Advertising, Labeling, and Formulation Division
1310 G Street NW
Suite 400
Washington, DC 20220
Q38: What happens after I have submitted this information via TTB Form 5100.51?
A38: The information will be reviewed by a Formula Specialist to verify that it complies with Federal regulations. The turnaround time is three weeks but may be longer if additional information is needed. If there are additional questions, the Formula Specialist will contact you. Once you have received the approved formula, you may then apply for label approval.
Q39: My product does not require laboratory analysis or a Pre-Import Letter per TTB Industry Circular 2007-4. What do I need to do?
A39: You may now apply for label approval. Please use TTB Form 5100.31 for Label Approval.
If you have already registered for COLAs Online, you may apply for label approval electronically. Please call our toll-free phone number (866) 927-ALFD (2533) x3 or at (202) 927-8140 x3. You can also e-mail us at alfd@ttb.gov for more information about the electronic submission of labels.
Q40: Who is supposed to fill out TTB F 5100.31? The importer or the producer?
A40: The producer must fill out the information in Item 6 (list of ingredients) and Item 7 (method of manufacture). However, the U.S. importer should sign and date the form (Items 11 and 12).
Q41: How long may I import a product once I receive formula approval?
A41: You may import the product up until the expiration date listed in Item 16. If you wish to continue importing a product after that date, you must resubmit TTB F 5100.31 in its entirety at that time.
For any questions regarding filling out TTB Form 5100.31, please refer to the FAQ section SUBMITTING THE FORM. For any questions that are commodity specific (distilled spirits, malt beverages, or wine), please refer to the appropriate section below.
Q42: Can I still submit for approval on my company letterhead?
A42: Yes, however, TTB Form 5100.51 will soon be mandatory for malt beverages pending the necessary changes in the Code of Federal Regulations. This form replaces Statements of Process on letterhead.
Q43: When do I need to submit a formula?
A43: Whenever you modify a malt beverage and it results in a change in color or taste, a formula is required. For example, barrel-aging, adding fruit or other fermentable material to the wort, adding concentrates or other flavors to a finished malt beverage, using artificial sweeteners, and using artificial colors to a finished malt beverage are all instances when a formula must be submitted.
Q44: I am having trouble determining what class and type designation to give my product in Item 4. Where can I find a definition of the different classes and types?
A44: Please refer to chapter 4 of the TTB P 5130.3 Beverage Alcohol Manual for Malt Beverages. You also can refer to the regulations at 27 CFR 7.24.
Q45: If I use "Malt Beverage Specialty" in Item 4, will I have to use the same phrase on the label?
A45: No. The statement of composition that the Formula Specialist will write for you in Item 13 will serve as your class and type designation on the label. Please make sure that the statement of composition on your label follows all of the same labeling guidelines as those for the class and type designation.
Q46: I plan to make a malt beverage with added flavors. What information do I need to put in Items 9a and 9b?
A46: You need to specify how much of the alcohol in the final product is coming from the malt beverage base and how much alcohol is coming from the added flavors. You can break this down by percentage. For example, amount of alcohol from flavors: 49 percent; amount of alcohol from base: 51 percent.
Q47: Are there any limits to how much alcohol can come from the flavor?
A47: Yes, if the final product has an alcohol by volume of 6 percent or less, than at least 51 percent of the alcohol must come from the malt base, and at most 49 percent may come from the flavors as per 27 CFR 7.11(a)(1).
Q48: What if I want to make a flavored malt beverage with added alcohol that is higher than 6 percent alcohol by volume?
A48: If the alcohol by volume is higher than 6 percent, only 1.5 percent of the total alcohol content can come from flavors. For example, if the product has a final alcohol by volume of 9 percent, a minimum of 7.5 percent must come from the base, and the remaining 1.5 percent can come from the flavors as per 27 CFR 7.11(a)(2).
Q49: I am adding a fermentable ingredient to the wort. Do I need to specify how much alcohol comes from this fermentable ingredient in Item 9a?
A49: No, you do not. Items 9a and 9b only apply to flavors that are added to a finished malt base.
Q50: I submitted my label and it was rejected. TTB stated that I needed a formula approval as the reason for rejection. But when I submitted a formula, my rejection notice said no formula approval is required. What do I need to do to get my beer approved?
A50: The reason for the rejection may be that on the label you made references to the flavors and aromas imparted by the malts or the yeast. If you are not adding any flavors or flavoring materials to the malt beverage, then you can indicate in Item 19 of the COLA form that no flavors or flavoring materials are being added to the product. If you are submitting electronically, you can indicate this in the item that starts with "Show Extra Wording," which is step 3 of 3 in the COLAs Online submission process. This will make it clear to the Labeling Specialist that a formula is not required; however, the Labeling Specialist may still contact you if there are any questions about the language on the label.
Q51: Where can I find the guidelines for labeling?
A51: You can find these guidelines in 27 CFR 7.20 to 7.29. Also, they can be found in a summarized form in the TTB P 5130.3 Beverage Alcohol Manual for Malt Beverages.
Q52: Can I provide a range for the alcohol content in Item 9?
A52: Yes, you may. However, the range cannot cross tax classes. The lists of acceptable ranges are as follows: for a table wine, 7 to 14 percent; for a dessert wine or a fortified wine, above 14 to 21 percent; the third tax class, above 21 to 24 percent.
Q53: I am having trouble determining what class and type designation to give my product in Item 4. Where can I find a definition of the different class and types?
A53: Please refer to chapter 5 of the TTB P 5120.3 Beverage Alcohol Manual for Wine. You also can refer to the regulations at 27 CFR 4.21.
Q54: If I use "Other than Standard Wine" in Item 4, will I have to put this phrase on the label?
A54: No. The statement of composition that the Formula Specialist will write for you in Item 13 will serve as your class and type designation on the label. Please make sure that the statement of composition follows all of the same labeling guidelines as those for the class and type designation.
Q55: I want to produce wine from a wine kit. What information do I need to provide?
A55: Please list all of the ingredients in the wine kit in Item 6 and go through the steps for making a wine from this kit in Item 7. Contact the producer of the wine kit to find out if the flavors and the other materials used for treatment of the wine have already been approved by TTB. If they have, please obtain Flavor Ingredient Data (FID) sheets for the flavors they are using. If the flavors have not been approved, please have the flavors approved as explained in the General Questions section, FAQ 22.
Q56: I want to produce a honey wine. What information do I need to provide?
A56: Please provide the density of the honey-water mixture before fermentation in degrees Brix.
Q57: I want to blend several different types of fruit wine together. Do I need to provide a formula?
A57: Yes, you do. Please provide the amount of each wine that you are using by its percentage in the final product. For example: 50 percent finished apple wine, 25 percent finished grape wine, 25 percent finished pear wine. In Item 7, explain how the products are blended and mention if there is any filtering afterwards.
Q58: I want to combine several different types of fruit juice together and then ferment them. Does this require a formula approval?
A58: No, it does not. You may now apply for label approval. Please use TTB Form 5100.31 for Label Approval.
If you have already registered for COLAs Online, you may apply for label approval electronically. Please call our toll-free phone number (866) 927-ALFD (2533) x3 or at (202) 927-8140 x3. You can also e-mail us at alfd@ttb.gov for more information about the electronic submission of labels.
Q59: When I submit my fruit wine formula to the Formulation Office, it is returned saying that no formula approval is required. However, when I submit my label, the Labeling Office is asking for formula approval. What do I need to do?
A59: Please note that "fruit wine" is not a recognized class and type designation on the label. You need to specify what type of fruit is used in the production of the fruit wine on the label (e.g., apple wine, grape-pear wine.)
Q60: I want to produce an ameliorated fruit wine. What are the requirements for this?
A60: To ameliorate a fruit wine, it must meet the requirements set out in 27 CFR 24.178.
If all of these requirements are met, then no formula is required for the fruit wine.
If you do not meet one of these requirements, then a formula is required and the product will be classified as an "Other than Standard Wine."
Q61: Can I use tartaric acid in a fruit wine?
A61: No. If you use tartaric acid, then the fruit wine is classified as an Other than Standard Wine. The only acids that you may use to stabilize a fruit wine are sorbic, fumaric, and citric.
Q62: I am taking a grape wine and adding fruit flavor to it. Does this count as a fruit wine?
A62: No, this product would be classified as an Other than Standard Wine, and, as such, it would require formula approval.
Q63: I am interested in making a cooking wine? What do I need to do?
A63: A cooking wine is classified as a nonbeverage wine in our regulations. A nonbeverage wine must be rendered unfit for beverage use. If a wine is rendered unfit by the addition of 1.5 grams of salt per 100 milliliters of wine, please prepare and submit TTB Form 5100.51.
If it is rendered unfit by other means, please submit a completed copy of TTB Form 5100.51 along with a sample to the TTB laboratory for organoleptic testing. Once you have received the results of this testing, please submit a completed copy of TTB Form 5100.51 along with a copy of your results to the Formulation Section.
Q64: Where can I find the guidelines for labeling?
A64: Regulations regarding the labeling of wine can be found in 27 CFR 4.30 to 4.39.
Q65: Can I provide a range for the alcohol content in Item 9?
A65: No, distilled spirits must provide the exact alcohol by volume of the product for proper tax classification.
Q66: I am having trouble determining what class and type designation to give this product in Item 4. Where can I find a definition of the different class and types?
A66: Please refer to chapter 4 of the TTB P 5110.7 Beverage Alcohol Manual for Distilled Spirits. You also can refer to the regulations at 27 CFR 5.22.
Q67: If I use "Distilled Spirits Specialty" in Item 4, will I have to use the same phrase on the label?
A67: No. The statement of composition that the Formula Specialist will write for you in Item 13 will serve as your class and type on the label. Please make sure that the statement of composition follows all of the same labeling guidelines as those for the class and type designation.
Q68: What information do I need to include about any distillation I am doing?
A68: Please provide the proof at distillation. This is the proof of the product as it comes off the still before any water has been added to it.
If you are distilling a product several times, please include the proof at distillation for each distillation.
Q69: Where can I find the guidelines for labeling?
A69: Regulations regarding the labeling of distilled spirits products can be found in 27 CFR 5.31 to 5.42. Also, you can find these regulations in a summarized form in the TTB P 5110.7 Beverage Alcohol Manual for Distilled Spirits.
| Page last reviewed/updated: 09/04/2012 |
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