 |
|---|
|
 Advertising, Labeling and Formulation FAQsRevised: 10/16/07 A2: I live in Pennsylvania and wish to send alcohol to my father in Arizona for his birthday. May I send this package through the mail or does the distributor have to send the package? The U.S. Postal Service does not ship alcohol. Therefore, you will need to contact a private courier service such as FedEx or UPS to ship the alcohol. Also, contact the States to and from which you are shipping to find out if either has any laws or regulations prohibiting this practice. You pay no fee either to obtain a copy of the form (TTB F 5100.31, Application for and Certification/Exemption of Label/Bottle Approval) or to apply for label approval. If you are applying for label approval for the first time, you will need to send a copy of your approved basic permit or brewer’s notice (depending on your business). You must also submit your application in duplicate with the labels attached to the front of the form. If your labels are too large to fit on the front of the form, you must reduce them and place the originals on the back of the form. Item no. 17 of the label application should reflect the percentage of reduction. On August 10, 1993, the Bureau of Alcohol, Tobacco and Firearms published an advanced notice of proposed rulemaking in the Federal Register that solicited comments from the public and industry on whether the regulations should be amended to require nutritional information on labels of alcohol beverages. The comment period for the ANPRM closed on February 7, 1994. ATF received 55 comments in response to the advance notice. Only seven of these comments came from consumers. However, five of the seven consumers who commented opposed nutrition labeling. Overall, 80 percent of the comments received in response to the ANPRM opposed nutrition labeling for alcohol beverages. Thirty-five of the comments opposing nutrition labeling were submitted on behalf of industry, both domestic and foreign. After careful consideration of the petition and the comments received in response to the advance notice, ATF determined that an amendment of the regulations to provide nutrition information on labels of alcohol beverages is unnecessary and unwarranted. The Food and Drug Administration has primary jurisdiction over the labeling of a fermented cider that contains less than 7 percent alcohol by volume. However, TTB has jurisdiction over some labeling requirements, most importantly the Government Warning Statement for any alcohol beverage over 0.5 percent alcohol by volume. These requirements are specified in 27 CFR part 16. 27 CFR § 13.21(b) allows TTB up to 90 days to take action on a label application, with a possible one-time extension of an additional 90 days if unusual circumstances require additional time to consider the issues presented by the application. However, TTB completes the vast majority of label applications within 30 days of TTB receipt and most label applications are finished in less time. Actual processing time will vary due to seasonal demands of the industry (e.g. holidays approaching, harvest time, etc.) and the amount of label applications submitted at any given time. Yes, we must issue you a permit, brewer’s notice or approval to operate a bonded wine cellar (BWC) or tax paid wine bottling house (TPWBH) before you submit an application for a certificate of label approval. Our National Revenue Center in Cincinnati, Ohio, issues basic permits and brewer’s notices. For information on obtaining a basic permit or brewer’s notice, contact the National Revenue Center. The toll free number is 1-800-398-2282. A certificate of label approval authorizes the certificate holder to bottle and remove or import alcohol beverages that bear labels identical to those shown on the certificate of label approval. If your label is etched, embossed, or painted directly onto the container, or is clear acetate, you must submit a photograph of a filled representative bottle so that we may determine contrast and legibility of mandatory information. Photos should clearly show each side of the container that contains label information. See instruction number 7 of the general instructions for completing and submitting the TTB F 5100.31, Application for and Certification/Exemption of Label/Bottle Approval. The instructions are found at the end of the form. Submit the proposed label on TTB F 5100.31, Application for and Certification/Exemption of Label/Bottle Approval with a transmittal letter requesting informal or preliminary comment. If the proposed label meets all applicable requirements, you will receive a certificate of label approval (COLA). If your label requires correction, your application will be returned with a correction sheet that identifies all necessary corrections. No. Twenty-three conditions exist under which labels can be changed without applying for a new certificate of label approval. The addition of an Internet address is one of these allowable conditions. We list all 23 conditions on the reverse side of TTB F 5100.31, Application for and Certification/Exemption of Label/Bottle Approval. You can check the status of your label application(s) by checking TTB’s COLAs Online Web site or by contacting the Alcohol, Labeling, and Formulation Division Customer Service Team at 202-927-8140 or toll free at 1-866-927-2533. If you do need to followup with the Customer Service Team, we recommend that you wait at least 15 days from the date you mailed your application(s). The 15 days allows for our established nine calendar-days processing time plus mailing time. Please provide the following information when you contact the Customer Service Team.
Please visit COLAs Online for additional information. A Statement of Process is a formula for a domestically produced flavored malt beverage, flavored or unflavored rice wine, or saké. A statement of Process consists of 1) a detailed and specific quantitative list of each ingredient in the product and 2) a step-by-step description of the production process. As a minimum, a Statement of Process must include information on the volume and alcohol content of the malt beverage base, identification and source of any flavoring material used in the product, the maximum volume and alcohol content of each flavoring material used in the product, the percentage of alcohol contributed by the flavor(s) to the finished product, a specific description of when flavoring material is added in the production of the product, and the total volume and alcohol content of the finished product. Statements of Process must be on brewery letterhead. A16: I operate a winery and was asked to sell wine bearing a “customized/personalized” label that my customers will use for weddings, corporate events, etc. How do I do this without having to submit each label for approval? You will have to submit a label application for a “personalized” label in order to get an approval that will allow you to customize labels without needing to get each specific example approved in advance by TTB. TTB will issue “personalized” label approvals for wine, malt beverages or distilled spirits if requested. The label(s) you submit must be a “template” sample of the personalized label and therefore must contain all of the mandatory label information in addition to either a sample of the personalization as it will appear on the label or a blank space where the personalization will appear. A personalized label approval will also allow you to add an additional label containing the customized information. Your label application MUST note “Personalized label” in Box 19 of a paper application or in the “Show any wording” box in Step 3 of an electronic application. Approvals for personalized labels will be issued with a qualification specifying that the personalizing information must not discuss either the alcoholic beverage or any characteristics of the alcoholic beverage. For instance, “This wine bottled for…” would not be permitted unless it was on the label template that was submitted for approval, but “For the wedding of…” would be an acceptable addition. You are not permitted to change mandatory information, such as the brand name or varietal designation, without getting a new approval. A17: What are bioengineered foods? Bioengineered foods are food or drink made from plant varieties that are developed from using recombinant deoxyribonucleic acid (rDNA) technology (which is often referred to as “genetic engineering” or “biotechnology”). Specifically, bioengineered foods are produced from plants whose genetic material has been altered by inserting DNA molecules from another organism for the purpose of reproducing beneficial characteristics, such as added nutrition, better flavor, or greater ability to fight pests or diseases, of the original species in the receiving species. In 1994, the Food and Drug Administration (FDA) established a consultation process that helps ensure that foods developed using biotechnology methods meet the applicable safety standards. A18: Do bioengineered ingredients have any apparent health and safety risks when used in the production of alcohol beverages? There are no apparent health or safety risks associated with bioengineered foods used in the production of alcohol beverages. TTB has no basis for concluding that alcohol beverages produced from bioengineered ingredients differ from other alcohol beverages in any meaningful or uniform way, or that, as a class, alcohol beverages made from plant ingredients developed by the new techniques present any different or greater safety concern than alcohol beverages made from ingredients developed by traditional plant breeding. A19: What is TTB's position with regard to the labeling statements about alcohol beverage products that are not bioengineered or that do not contain ingredients produced from bioengineered foods? For example, "Contains No GMOs,” “GMO Free-Zone" or any similar references on alcohol beverages? TTB has received several Certificates of Label Approval (COLA) applications proposing to display bioengineered-related information on alcohol beverage labels. Terms that are frequently mentioned in discussions about labeling alcohol beverages with respect to bioengineering include “GMO free” and “GM free.” “GMO” is an acronym for “genetically modified organism” and “GM” means “genetically modified.” The terms “genetically modified organism” and “genetically modified” are not synonymous with the term “bioengineered foods.” Plants can be genetically modified using any number of techniques, new or traditional. According to the Food and Drug Administration’s Draft Guidance: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering (January 2001): Terms like "not genetically modified" and "GMO free," that include the word "modified" are not technically accurate unless they are clearly in a context that refers to bioengineering technology. "Genetic modification" means the alteration of the genotype of a plant using any technique, new or traditional. "Modification" has a broad context that means the alteration in the composition of food that results from adding, deleting, or changing hereditary traits, irrespective of the method. Modifications may be minor, such as a single mutation that affects one gene, or major alterations of genetic material that affect many genes. Most, if not all, cultivated food crops have been genetically modified. Data indicate that consumers do not have a good understanding that essentially all food crops have been genetically modified and that bioengineering technology is only one of a number of technologies used to genetically modify crops. Thus, while it is accurate to say that a bioengineered food was "genetically modified," it likely would be inaccurate to state that a food that had not been produced using biotechnology was "not genetically modified" without clearly providing a context so that the consumer can understand that the statement applies to bioengineering. TTB believes it is not necessary to mandate any bioengineered food labeling requirements at this time. We also find that it is misleading to voluntarily refer to those bioengineered food labeling terms or any similar references on alcohol beverage labels. This is consistent with the Food and Drug Administration’s position. TTB will continue to monitor the domestic and international impact of the use of bioengineered foods on the labeling of alcohol beverages, as well as any international trade barriers that occur as a result of the mixed reactions surrounding the use and potential use of bioengineered foods. A20: What is required when applying for a certificate of exemption from label approval for my wine label instead of a Certificate of Label Approval on Form 5100.31? You may apply for a certificate of exemption from label approval for your wine only if it is produced or bottled in the United States and only if it will be sold, offered for sale, shipped, or delivered for shipment within the state in which it was bottled or packed (in other words, it will not be introduced into interstate commerce). This can be accomplished by selecting and completing item 18b on your label application, TTB Form 5100.31. Imported bottled wines are not eligible for a certificate of exemption from label approval and therefore must be covered by a Certificate of Label Approval. Wines labeled under a certificate of exemption from label approval must show the statement, “For sale in _________(name of State) only.” This statement may be added to a label covered by a certificate of exemption, or may be on an additional label that is affixed to the container. The statement does not have to appear on the label that is submitted to TTB, but must be on the container before it is removed from bond for consumption or sale. Although the labeling requirements in 27 CFR Part 4, Labeling and Advertising of Wine, do not apply when a certificate of exemption is used, all of the rules in the wine regulations under the Internal Revenue Code of 1986 (IRC), 27 CFR Part 24, continue to apply to all wine bottled and packed in the United States. For example, 27 CFR 24.257(a) outlines what information must appear on your label, as well as the minimum type size requirements, for each bottle or other container of beverage wine prior to removal for consumption or sale. In brief, each label must contain:
Please see the complete text of 27 CFR 24.257 for additional information and guidance. (Note that Part 24 does not apply in Puerto Rico. See 27 CFR 24.2.) The recordkeeping requirements in the IRC wine regulations continue to apply when a certificate of exemption is used. The wine regulations state in 27 CFR 24.257(b): “The information shown on any label applied to bottled or packed wine is subject to the recordkeeping requirements of [27 CFR 24.314, Label information record]," which states: A proprietor who removes bottled or packed wine with information stated on the label (e.g., varietal, vintage, appellation of origin, analytical data, date of harvest) shall have complete records so that the information appearing on the label may be verified by an [sic] TTB audit. A wine is not entitled to have information stated on the label unless the information can be readily verified by a complete and accurate record trail from the beginning source material to removal of the wine for consumption or sale. All records necessary to verify wine label information are subject to the record retention requirements of § 24.300(d). In addition, Congress recently amended section 5388(c) of the IRC (26 U.S.C. 5388(c)) to restrict the use of certain wine names of European origin for wines sold in the United States. These wine names are: Burgundy, Claret, Chablis, Champagne, Chianti, Malaga, Marsala, Madeira, Moselle, Port, Rhine wine, Hock, Sauterne, Haut Sauterne, Sherry, Tokay and Retsina. These names may be used on labels for wine from the European Community (and made in accordance with the requirements of the Community) and on certain previously approved non-Community wine labels if their uses are grandfathered as of March 10, 2006. Because the IRC applies to wine regardless of whether it is in intrastate or interstate commerce, the restriction on the use of these names applies in both contexts. Accordingly, TTB will not issue a certificate of exemption for wine using one of these wine names in a manner not authorized by the statute. The change in the law was effective on December 20, 2006. The Alcoholic Beverage Labeling Act of 1988, 27 U.S.C. 213 et seq., and implementing regulations in 27 CFR Part 16, which require a specified health warning statement on alcoholic beverages bottled or imported for sale or distribution in the United States, also apply equally to wine sold or shipped in intrastate or interstate commerce. Under Part 16, the required warning statement is a prerequisite for approval of a certificate of exemption from label approval, just as it is for a Certificate of Label Approval. Finally, other laws may apply to fraudulent conduct used to sell mislabeled wine or to mislead consumers, including certain federal criminal statutes relating to fraud carried out through the use of: the mail; private or commercial interstate carriers; or wire, radio, or television communication in interstate or foreign commerce. A21: Questions and Answers regarding Major Food Allergen Labeling for Wines, Distilled Spirits and Malt Beverages. 03/28/07
Third Party RepresentationA22: Third Party Representation in Labeling and Formulation Matters TTB has recently noticed an increase in questions from industry members as to whether or not it is mandatory to use third-party representatives in order to receive label or formula approval, and if the Advertising, Labeling and Formulation Division (ALFD) provides special assistance when such representatives are employed. TTB has created some FAQs in order to address these concerns. ALFD Third-party Representation FAQs CS 1. What is a third-party representative? A third-party representative is a person or firm retained by an industry member in order to provide specific services for the member in dealing with TTB. In the label/formula approval area these services range from simple submission and return of an application via the Public Room in order to bypass any mail-room delays, to negotiations over areas of the label/formula that ALFD feels are in need of correction. CS 2. Do I need a third-party representative? No. TTB provides the same level of service to third-party representatives as is provided to those who choose to work with TTB directly, but you may use a third-party representative if you so choose. ALFD Customer Service representatives will work directly with all industry members and representatives to answer label/formula questions and solve problems in a timely and accurate manner. The Public Room is open from 10am-12 and 1-3pm EST, M-F, and Labeling/Formulation Customer Service representatives are available by phone from 8:30am-4:30pm EST, M-F. CS 3. Do I need to obtain a third-party representative in order to request Expedited or Temporary Approval? No; TTB will work directly with the industry member or a representative. However; all requests to expedite a label application or temporary label approvals are reviewed on a case-by-case basis and require supporting documentation. All inquiries should be made directly to Customer Service at 866-927-2533. CS 4. Does TTB charge a fee for each label and formula application submitted? No. All labeling, formulation and advertising services provided to you by TTB are free of charge. CS 5. Can I use a third-party representative? Yes, TTB will work with a third-party representative if you choose to retain one. However, obtaining a third-party representative is completely voluntary. CS 6. How do I contact ALFD? For questions on alcohol advertising, labeling and formulation you may contact ALFD directly by e-mail or by phone at: Email: alfd@ttb.gov
|
|---|
