Category archives for “FDA”

New FDA Menu Labeling Regulations Will Be Enforced Beginning May 2017

May 31, 2016

The Food and Drug Administration (“FDA”) recently released final industry guidance on the new menu labeling requirements in accordance with 21 C.F.R. § 101.11, implemented to comply with a provision of the 2010 Affordable Care Act. The new menu labeling rules require chain restaurants to provide calorie information on the menu and provide, upon customer request, additional nutritional information for menu items. The FDA’s final guidance can be found here, and will help industry members comply with these new menu labeling rules, which the FDA will begin to enforce in May 2017. This blog post provides a summary of the menu labeling rules and the FDA’s industry guidance.

What businesses must comply?

The new menu labeling rules apply to restaurants or similar retail food establishments, such as a bakery, a convenience store selling foods intended for immediate consumption, or a concession stand, that are a part of a chain with 20 or more locations that do business under the same trade name and that offer substantially the same menu items for sale. Additionally, a restaurant or retail food establishment may voluntarily register to be subject to the menu labeling requirements.

What is required of those businesses?

Under the new menu labeling rules, these businesses will be required to include calorie information on menus for all standard menu items. Additionally, these businesses will be required to have written information available upon customer request, regarding nutritional information for standard menu items, including the amount of total calories, calories from fat, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, dietary fiber, sugars, and protein. These requirements apply to standard menu items, and do not apply to daily specials, custom orders, alcoholic beverages on display that are not self-service, or temporary menu items that only appear on the menu for less than sixty days per calendar year.

Are alcoholic beverages included?

Yes, the new menu labeling rules apply to alcoholic beverages sold in a restaurant or similar retail food establishment that is required or has registered to comply with the menu labeling rules. The rules apply to all alcoholic beverages that are listed on the establishment’s menu, subject to the exceptions for daily specials, custom orders, alcoholic beverages on display that are not self-service, or temporary menu items that only appear on the menu for less than sixty days per calendar year. The exception for alcoholic beverages on display that are not self-service will be helpful for establishments preparing mixed drinks. If the liquor bottles are on display, and the drinks are not listed on the menu, the establishment will not be required to make available calorie or other nutritional information.

How can calorie and nutrient information for alcoholic beverage products be obtained?

An establishment must have a “reasonable basis” for determining the calorie and other nutritional information for standard menu items. Establishing a “reasonable basis” may include utilizing nutrient databases, published cookbooks that contain nutritional information for recipes in the cookbook, nutrition information determined by laboratory analyses, or any other means that is reasonable. The
U.S. Department of Agriculture (“USDA”) maintains a nutrient database, available here, which the FDA’s guidance refers to as reasonable basis for calorie and nutrient calculations.

How will alcoholic beverage producers be affected?

The new menu labeling regulations will impact all alcoholic beverage producers that sell products to chain establishments with 20 or more locations. Those establishments will likely request that the alcoholic beverage producer provide the calorie and nutritional information for its products sold at the establishment. As most alcoholic beverages are not subject to the FDA rules governing labeling and nutritional information, this law will mainly affect alcoholic beverage producers that do not currently maintain calorie or nutritional information regarding the beverages that they produce. Alcoholic beverage producers should check the USDA database referenced above to see whether their products match entries currently listed in the database, as the database includes entries for several common types of alcoholic beverages. Additionally, the Brewers Association has announced that it will be running laboratory analyses for approximately 100 beer styles over the next year, which the Brewers Association plans to submit for inclusion in the USDA database. Alternatively, producers could submit their products for laboratory analyses in order to obtain accurate nutritional information.

For more information about menu and product labeling requirements, contact one of the attorneys at Strike & Techel for a consultation.


TTB Further Expands List of Malt Beverage Ingredients Exempt from Formula Approval

December 28, 2015

The Alcohol and Tobacco Tax and Trade Bureau (TTB) has further expanded the list of ingredients used in the production of beer that are exempt from the formula requirements of 27 C.F.R. § 25.55. On December 17, 2015, the TTB issued Ruling 2015-1, Ingredients and Processes Used in the Production of Beer Not Subject to Formula Requirements (LINK), which modifies and supersedes Ruling 2014-4. Ruling 2014-4 exempted 35 ingredients from formula approval requirements, including ingredients such as honey, chocolate, cherries, oranges, allspice, and clove. Ruling 2015-1 now exempts more than 50 additional ingredients from the formula requirements, including ingredients such as tea, oyster shells, jasmine, rosemary, grapes, and figs. A complete list of ingredients used in the production of beer that are exempt from formula requirements is located in Attachment 1 to Ruling 2015-1 (LINK).

Ruling 2015-1 also clarifies the TTB’s position regarding extracts, essential oils, and syrups. These preparations may contain alcohol or other ingredients, and thus are not exempt from formula requirements. For example, although vanilla, spearmint, and strawberries are included on the list of exempt ingredients, the use of vanilla extract, essential oil of spearmint, or strawberry syrup would still trigger the formula requirements of 27 C.F.R. § 25.55.

Ruling 2015-1 was issued in response to an ongoing conversation between the TTB and the Brewers Association, which has been petitioning the TTB since 2006 to expand the list of exempt ingredients. The most recent Brewers Association petition was submitted on September 30, 2015, and Ruling 2015-1 exempts all of the ingredients requested by the Brewers Association in that petition, with the exception of licorice, juniper branches, pluot, spruce leaves, squid ink, and woodruff. The TTB declined to adopt licorice as an exempt ingredient due to Food and Drug Administration (FDA) regulations regarding that ingredient. The TTB declined to adopt the remaining ingredients at this time because it did not find that the available data established that these ingredients are “traditional” in the production of beer. Although the TTB did not exempt all the ingredients requested by the Brewers Association, the TTB is open to future petitions from brewers regarding additional ingredients that brewers believe should be exempted from formula requirements. A procedure for such a petition is located at 27 C.F.R. § 25.55(f).

Contact an attorney at Strike & Techel today with any questions about beer regulations or formula requirements.


Beer that isn’t Beer, Wine that isn’t Wine and Drinks that aren’t Beverages

April 27, 2015

Mostly in our practice at Strike & Techel we work with clients making fairly traditional alcoholic beverage products, albeit with new flavors, production methods and quality drivers. These classic alcoholic beverages are distilled spirits, wines and beers, subject to regulation by the Alcohol and Tobacco Tax and Trade Bureau (TTB). More and more, however, we are called upon to work with alcohol products that fall outside the TTB’s jurisdiction, either because they don’t meet traditional definitions, or because they simply aren’t classified as beverages.

Products that do not fit within TTB jurisdiction are subject to Food & Drug Administration (FDA) labeling requirements. Under TTB rules, wine must contain at least 7% alcohol, and beer must be malt-based. Because of these restricted definitions, common examples of drinks that are subject to FDA rules are wine coolers and ciders below 7% alcohol, and beers that aren’t made with malt. Any beers made with other grains, like sorghum, rice or wheat (usually to be sold as “gluten free” products), are under FDA rules. These beverages do not need to obtain label approval, as a standard alcoholic beverage would, but must comply with FDA rules on labeling, to avoid in-market audits for violations. In December 2014, the FDA finally published its guidance for industry on the labeling of non-malt-based beers, which had been in draft form since 2009 (LINK). It helpfully goes through all of the FDA labeling requirements that apply to such beers. These are the same requirements that apply to any FDA-regulated alcoholic beverage, including many ready to drink (RTD) beverages, as discussed in our recent blog post (LINK). Among the key distinctions from standard alcoholic beverage labeling are that the label must include an ingredient list and a nutritional statement.

As well as regulating alcoholic beverages, FDA also regulates certain non-beverage alcoholic products. These are products which are consumed – often as cocktail ingredients – but which are not classified as beverages by the TTB because they have been deemed “unfit” for beverage purposes under TTB regulations. Common examples of these products are bitters and other alcohol-based flavorings. Attaining non-beverage status is a goal rather than a failure for these products because products eligible for non-beverage status are exempt from payment of federal excise taxes and they can be sold by retailers without an alcoholic beverage license. Products with a lot of sugar or other flavorings or ingredients that serve to make them more palatable as beverages may not make the cut as non-beverages and would remain subject to excise taxes and TTB label jurisdiction.

TTB and FDA classifications of alcoholic products have significant implications on the way they are labeled, taxed and sold, so it is important to submit these products for TTB review before bringing them to market.

For more advice on alcoholic beverages and non-beverages, contact one of the attorneys at Strike & Techel.

Imbiblog is published for general informational purposes only and is not intended as legal advice. Copyright © 2015 • All Rights Reserved •


FDA Food Facility Registration Renewal: How to Renew and What to Watch out For

October 30, 2014

Under the Food Safety Modernization Act (“FSMA”), which was passed into law in 2011, all food facilities, including those where alcoholic beverages are produced or stored, are required to renew their FDA registrations by December 31, 2014. As we’ve previously blogged about here and here, the FSMA and related FDA laws include alcohol in the definition of “food,” and a “Food Facility” includes any “factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food,” not including restaurants and other retail food establishments. Accordingly, many in the alcohol industry must register with the FDA, including wineries, breweries, distilled spirits plants, alcohol beverage distributors, importers, warehouses, and wholesalers. Note that foreign facilities that produce food or alcoholic beverages sent to the U.S. are among those required to register.

The FSMA requires that all registered food facilities renew their registrations every two years between October 1 and December 31 of every even-numbered year. That means that even if your facility was first registered with the FDA in 2013, or even in early 2014, renewal is required before December 31, 2014. Renewal won’t be required again until October 1 through December 31, 2016.

FDA registration and renewal is a simple process that can be completed online and there is no fee for either the initial registration process or renewal. The FDA does not issue a formal certificate once the process is completed, and instead simply issues a registration number to registered facilities, along with a PIN that all registrants should keep available for the renewal process. Many registrants may have received emails or other correspondence from third parties that may claim to be affiliated with the FDA and that attempt to collect fees for FDA registrations. The FDA has recently warned registrants that it is not affiliated with any third parties, and that registration is always free, so be on the lookout for emails requesting a fee or other information related to FDA registration. More information on FDA registration and renewal can be found here.

Contact one of the attorneys at Strike & Techel if you have any questions about FDA registration or related issues.

Imbiblog is published for general informational purposes only and is not intended as legal advice. Copyright © 2014 · All Rights Reserved ·


Food Safety Modernization Act Facility Renewals Due Now

December 27, 2012

The Food Safety Modernization Act (“FSMA”) was passed into law in early 2011 and amends parts of the Federal Food, Drug, and Cosmetic Act. The act’s purpose, which we previously blogged about here, is to ensure that food produced in the U.S. or imported into the U.S. meets safety standards. The FSMA and related FDA laws include alcohol in the definition of “food,” and a “Food Facility” includes any “factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food,” not including restaurants and other retail food establishments. Accordingly, many in the alcohol industry stand to be affected by the FSMA, including wineries, breweries, distilled spirits plants, alcohol beverage distributors, importers, warehouses, and wholesalers.

Prior to the enactment of the FSMA, Food Facilities were required to register with the FDA one time only, and no renewal was required. Food Facilities are now required to renew their FDA registrations every two years, and the first renewal is required by December 31, 2012. However, the FDA’s registration renewal website was not available on October 1, 2012, when renewal was scheduled to open, leaving many scrambling to meet the deadline. The FDA has not formally extended the renewal deadline, but it recently confirmed that it would “exercise enforcement discretion” through January 31, 2013. Specifically, the FDA’s guidance provides that “because there was a delay in FDA’s implementation of biennial registration renewal for the 2012 cycle, and registration renewal did not become available until October 22, 2012, FDA intends to exercise enforcement discretion with respect to registration renewals submitted to FDA after December 31, 2012 for a period of 31 days, until January 31, 2013.”

FDA renewals can be completed online, but a registrant’s FDA number and login information is required before the process can be completed. Detailed guidance on the FSMA and the renewal process is available here. Contact one of the attorney’s at Strike & Techel if you have questions about the FSMA.

Imbiblog is published for general informational purposes only and is not intended as legal advice. Copyright © 2012 · All Rights Reserved ·


Maybe That’s Not Beer You’re Drinking

August 16, 2012

A professor once told me: “Always define your terms.” That statement rings true in much of the law and it turns out, also for beer. In today’s age of health consciousness and gluten intolerances, beers crafted from sorghum, rice, or wheat are starting to make inroads into the mainstream market. But from the perspective of the Alcohol and Tobacco Tax and Trade Bureau (“TTB”), those products don’t qualify as “malt beverages.” Only beverages made from both malted barley and hops meet the definition of “malt beverage” under the Federal Alcohol Administration Act (“FAA Act”). Thus, the labeling regulations that apply to these non-traditional beer products actually come from the Food and Drug Administration, as opposed to the TTB. Some TTB/FAA Act requirements do still apply – namely the government health warning and product classification required by the Internal Revenue Code to ensure proper tax classification and collection. Additionally, formula approval may be required through the TTB.

Wine beverages containing less than 7% alcohol by volume, such as many wine coolers and cider products are also subject to FDA labeling requirements because their low alcohol content causes them to fall outside of the TTB/FAA Act definition of “wine” and therefore outside of TTB’s labeling jurisdiction. Note that although sake is made from rice, it’s considered a wine product for labeling purposes and a malt beverage for tax purposes (confusing, right?), so it falls under the TTB/FAA Act labeling requirements, provided the product contains 7% or more alcohol by volume. How to identify these new products as “gluten-free” remains difficult as no final guidance has yet been issued by the FDA or TTB about the true definition of “gluten-free.” For more information about using “gluten-free” on alcoholic beverage labels, see our post from earlier this year. The landscape for labeling these non-traditional products is complicated. If you have questions, feel free to contact a Strike & Techel attorney.


Gluten Claims on Beer, Wine, and Distilled Spirits Labels

May 30, 2012

TTB issued an extensive ruling last week that provides guidance to industry members seeking to label their products with statements about gluten-content. TTB Ruling 2012-2, available here, serves as in interim policy on the gluten-related labeling claims, until such time as the FDA, which governs labeling for all food items, and TTB finalize rules on the subject. As consumer demand for all types of gluten-free foods and beverages has risen over the last several years, proper labeling of those products has been a difficult issue for both the FDA and TTB. At its core, the problem is that testing for gluten-content remains imprecise. As a result, laws and regulations that permit labeling products as “gluten-free” or claiming a certain amount of gluten content have been slow to develop, and TTB’s practice has been to reject label applications that include gluten-based claims. TTB’s interim policy provides a means for industry members to include some gluten-related labeling information on their labels, and will likely result in the approval of more labels that claim to be gluten-free or low in gluten.

The FDA, and by extension TTB, has struggled with a definition for “gluten-free” for nearly a decade. The FDA was first tasked with issuing a rule to define “gluten-free” with the passage of the Food Allergen Labeling and Consumer Protection Act of 2004. The FDA then issued a notice of proposed rulemaking in 2007, proposing to define the term “gluten-free.” The proposed definition included that the item have no more than 20 parts gluten per million. The FDA has still not issued a final rule, and in 2011 recognized that for some food types, including fermented foods, there are no validated methods to determine if the product contains less than 20 parts gluten per million. Throughout the FDA’s process, TTB has deferred making its own rules related to gluten. The interim policy is TTB’s first effort to address the issue.

TTB regulates alcohol labeling and advertising through the Federal Alcohol Administration Act “FAA Act” and its regulations at 27 CFR parts 4, 5, and 7. At issue are regulations that: a) prohibit the use of labeling or advertising statements that are false or untrue in any particular, b) prohibit, irrespective of falsity, statements that directly, or by ambiguity, omission or inference, or by the addition of irrelevant, scientific or technical matter, tend to create a misleading impression, c) prohibit the use of any health-related statements in the labeling or advertising of wine, distilled spirits, or malt beverages if such statements are untrue in any particular or tend to create a misleading impression.

In its interim policy, TTB agrees with the FDA that “there are no scientifically valid methods for accurately measuring the gluten content of fermented products.” Up until now, this fact and the requirement that TTB prohibit misleading labels and advertising has meant that labels that include gluten-related claims have been rejected. TTB’s new guidelines provide a means for industry members to get labels approved that previously would have been rejected.

The interim policy sets forth two primary rules. First, TTB will allow the term “gluten-free” on the labels of products that are produced without any ingredients that contain gluten. For example, wines produced from grapes or vodka produced from potatoes may include the statement “gluten-free” on their labels or advertising material. No products made from gluten-containing materials may be labeled as “gluten-free.” For those products made from gluten-containing materials, including spirits and malt beverages “produced using wheat, barley, rye, or a crossbred hybrid of these grains,” TTB will allow labels that contain all of the following information: a) a statement that the product is “Processed or Treated or Crafted to remove gluten;” b) a qualifying statement to inform consumers that (i) the product was made from a grain that contains gluten, (ii) there is currently no valid test to verify the gluten content of fermented products, and (iii) the finished product may contain gluten; and c) a detailed description of the method used to remove gluten from the product. Approved statements may not contain any reference to the level of gluten in the product. Additionally, in order to evaluate the method used to remove gluten from the product, TTB will require submission of results of the “R5 Mendez Competitive ELISA assay” for the finished product for the purpose of screening the validity and effectiveness of the method used to remove gluten. Such statements may only be made on labels where the gluten content is less than 20 parts per million.

Despite the strict standard set by the TTB for gluten-related labeling, the new guidance is likely to result in numerous submissions for label-approvals based on the new rules. For additional information on labeling issues, feel free to contact one of the attorneys at Strike & Techel.

Imbiblog is published for general informational purposes only and is not intended as legal advice. Copyright © 2012 · All Rights Reserved ·


Bioengineering and the TTB

September 09, 2011

People, especially in the San Francisco Bay Area, are often concerned about genetically modified organisms or bioengineering in their food. Given the fervor, does it make sense for suppliers to assume the concern extends to alcoholic beverages and label accordingly? While some manufacturers may want to highlight that their products are “GMO free” or “GM free,” the Alcohol and Tobacco Tax and Trade Bureau’s (TTB) current policy prohibits such labeling. Producers of non-alcoholic beverages have a little more latitude regarding GM labeling: The FDA’s position is that special labeling of bioengineered or genetically modified foods is not required, but manufacturers may voluntarily label their foods with such information. Additional information on the FDA’s position is available here. The TTB tends to be very cautious in allowing new types of information on alcohol labels and often prohibits any reference whatsoever until they have had the opportunity for careful review and can provide guidance in the proper manner of presenting such information. This has been true in the context of organic labeling and with respect to nutritional information (e.g., calories, fat, carbs, etc.). So we can expect that the TTB will weigh in with some direction on how GM-related statements can be offered in the future, but for now, they cannot be used on alcoholic beverage labels. Be sure to keep the TTB’s position in mind before submitting a certificate of label approval with any “GMO” related terms or references.


Food Safety Modernization Act Will Require Industry Members to Implement New Food Safety Standards

July 13, 2011

The Food Safety Modernization Act (“FSMA”) was passed into law early in 2011, and will affect several areas within the alcohol beverage industry. The FSMA is meant to implement a prevention-based model for food safety, and places new requirements on the FDA, food facilities, and importers. Most new guidelines and requirements under the FSMA will not go into effect until at least the middle of 2012, but given the comprehensive nature of the Act, those affected will likely want to begin preparing for the changes in the near future.

The FSMA and related FDA laws include alcohol in the definition of “food,” and the Act applies to “Food Facilities.” A Food Facility includes any “factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food,” not including restaurants and other retail food establishments. Accordingly, many in the alcohol industry stand to be affected by the FSMA, including wineries, breweries, distilled spirits plants, and alcohol beverage distributors, importers, warehouses, and wholesalers.

The first major requirement placed on Food Facilities is a requirement to implement written preventative control plans, including: (1) evaluating the hazards that could affect food safety, (2) specifying what preventive steps, or controls, will be put in place to significantly minimize or prevent the hazards, (3) specifying how the facility will monitor these controls to ensure they are working, (4) maintaining routine records of the monitoring, and (5) specifying what actions the facility will take to correct problems that arise. The final rule implementing this requirement is due 18 months after enactment of the FSMA, which falls in July 2012. Wineries should also be aware that the FDA must implement new mandatory produce standards by early 2013.

Food importers also have new responsibilities under the FSMA. Most notably, importers will have a responsibility to verify that their foreign suppliers have adequate food safety controls in place. The final regulation detailing this provision is due in January 2012. The Act also establishes a program by which third parties can become accredited to certify that foreign foods comply with U.S. food safety standards. This system will be established by early 2013. Other provisions that may affect importers include: a) establishment of a voluntary qualified importer program, which will enable expedited review and entry of foods by those importers; and b) increased FDA authority to deny entry of imported food.

Other key provisions of the FSMA include: increased frequency of inspections of high risk facilities; new standards imposed on FDA for food-testing laboratories; the FDA will have more authority to make mandatory recalls, detain products, and revoke registrations; a model for improved product tracing capabilities; additional record-keeping requirements for high risk foods; and, a plan to strengthen partnerships between FDA and state and foreign agencies.

Look for specific guidelines late this year or early in 2012.

Imbiblog is published for general informational purposes only and is not intended as legal advice. Copyright © 2010-2011 · All Rights Reserved ·


Am I Selling You Something Right Now?

April 21, 2011

The United States is home base for pop culture and advertising. According to a 2007 New York Times article, people living in cities see up to 5,000 advertising messages a day, over twice as many as those living in cities 30 years ago saw. And that figure is four years old. Ever since Andy Warhol’s famous Campbell’s Soup Cans, the lines between art, advertising, entertainment, and social commentary have been continuously blurring. But, as the TTB recently reminded people, nowhere are those lines more defined and regulated than in the alcoholic beverage industry. On March 26th and April 7th, the TTB released industry circulars on the application of alcoholic beverage advertising regulations to media personality sponsorships and television advertising. The Code of Federal Regulations requires, among other things, that a responsible advertiser statement containing the name and address of the responsible party, appear in all advertisements for wines, malt beverages, and distilled spirits (See 27 CFR §§ 4.62, 5.63, 7.52).

The TTB’s Industry Circular 2011-01 cautioned against the practice of media personalities who are compensated by alcoholic beverage companies, such as radio hosts, covering certain advertising talking points within a free form story told by the radio host (referred to as unscripted advertisements) without including the mandatory advertising language. The Circular also reminded the industry that such hosts should not make statements about alcoholic beverage products that are prohibited by the Federal Alcohol Administration Act (FAA Act) or TTB regulations. TTB Industry Circular 2011-02 addressed advertisements that are run by television stations more often than contractually required and in such instances often do not include the mandatory information required by the FAA Act and TTB regulations. On top of all that, there is the Federal Trade Commission, which prohibits deceptive and unfair advertising. Thus, if one is paying someone to say something nice about ones products that must be disclosed.

Which leads us to the question: What is an advertisement? The Code of Federal Regulations defines an advertisement as “any written or verbal statement, illustration, or depiction which is in, or is calculated to induce sales in, interstate or foreign commerce” (See 27 CFR §§ 4.61, 5.62, 7.51). The only exceptions from the definition are labels and things like press releases (“editorial or other reading material … in any periodical or publication or newspaper for the publication of which no money or valuable consideration is paid or promised, directly or indirectly, by any permittee, and which is not written by or at the direction of the permittee.”) That’s a pretty broad definition and it’s hard to see where the line exists in modern society. If Kim Kardashian (who reportedly earns $10,000 per tweet) mentions an alcoholic beverage company, does she need to fit the mandatory advertising language into 144 characters? Was Jay-Z’s “Show Me What You Got” music video an advertisement for Armand de Brignac? Whatever these projects are—Advertainment? Entertisement? (you heard the terms here first, unless you heard them somewhere else first)—marketers should remember they are still subject to the standard alcoholic beverages advertising regulations.

Imbiblog is published for general informational purposes only and is not intended as legal advice. Copyright © 2010-2011 · All Rights Reserved ·


Alcoholic Whipped Cream: More Than Just a Dessert Topping

December 14, 2010

This holiday season, thousands of households will be checking “whipped cream” off their shopping lists. The Alcohol and Tobacco Tax and Trade Bureau, or TTB, wants to make sure those households are putting the right product in their cart come shopping time. A handful of whipped cream products made with alcohol have popped up over the last year. The products are typically made with grain alcohol and look like traditional whipping cream. But they pack an alcoholic punch of around 16% alcohol per volume, or a little over 30 proof. Such items are not considered food products, but rather alcoholic beverages. As one manufacturer stated in the FAQ section of its website, they’ve never had the product tested for caloric content as it is “not a food product and is not subject to FDA [U.S. Food and Drug Administration] labeling requirements; it is an alcoholic beverage.”

The fact that the product is an alcoholic beverage as opposed to a food product means it is regulated by the TTB. For more information on the TTB’s relationship with the FDA, refer back to our post on caffeinated alcoholic beverages. As the TTB reminded producers last week, all alcoholic beverage products must abide by federal labeling requirements that prohibit consumer deception. Product labels for distilled spirits are required to have a statement of the class, type and alcoholic content, along with the government warning required by 27 U.S.C. 215, among other things. Additionally, such manufacturers must comply with Federal Alcohol Administration Act, or FAA, advertising laws and the various relevant state regulatory laws. If you are of the legal drinking age and decide to try one of these alcoholic whipped cream products this holiday season, just remember, as always, to imbibe in moderation.

Imbiblog is published for general informational purposes only and is not intended as legal advice. Copyright © 2010 · All Rights Reserved ·


Alcoholic Energy Drinks are Out, What’s Next?

December 06, 2010

At this point, we’ve all recovered from the landslide ban on alcoholic energy drinks that crossed the U.S. in November. We covered the opening act, here, when Michigan, quickly followed by Washington, banned the sale of alcoholic energy drinks. New York then reached an agreement with certain suppliers and distributors that halted caffeinated malt beverage sales in that state (review our coverage here). After that, the U.S. Food and Drug Administration (FDA) issued warning letters to four caffeinated alcoholic beverage companies. The letters warned those producers that caffeine added to their malt alcohol beverage products constitutes an “unsafe food additive.”

Substances added to food products, which includes beverages, are considered food additives and are subject to review and approval by the FDA, unless the substance is specifically excluded from the definition of “food additive,” has been sanctioned by the FDA, or is recognized by qualified experts as adequately safe when used as intended. This third category is referred to as Generally Recognized as Safe or GRAS.

As many know, the FDA isn’t the usual stop for federal regulation of alcoholic beverages, but rather the Alcohol and Tobacco Tax and Trade Bureau (TTB) which operates under the Federal Alcohol Administration Act (FAA Act). In this instance, the FDA’s statements meant that the beverages in question were considered adulterated under the Federal Food, Drug and Cosmetic Act (FFDCA). The TTB takes the position that adulterated beverages, even if their formulas and labels have been approved by the TTB, are mislabeled under the FAA Act. This means that shipping and selling such beverages violates the FAA Act, which can result in license revocations and misdemeanor penalties. As the TTB stated, “…each producer and importer of alcohol beverages is responsible for ensuring that the ingredients in its products comply with the laws and regulations that FDA administers. TTB’s approval of a label or formula does not imply or otherwise constitute a determination that the product complies with the FFDCA, including a determination as to whether the product is adulterated because it contains an unapproved food additive.”

Producers of alcoholic energy drinks likely thought their products fell under the GRAS status. The FDA’s announcement ended that assumption. The question is, what other assumptions might it have ended? Alcoholic beverage producers have been using caffeine in their products for years, the most popular being coffee. In the FDA’s Questions and Answers section about the warning letters, it states that the letters are not directed at “alcoholic beverages that only contain caffeine as a natural constituent of one or more of their ingredients, such as a coffee flavoring.” However, in that same section the FDA also stated that, “Other alcoholic beverages containing added caffeine may be subject to agency action in the future if the available scientific data and information indicate that the use of caffeine in those products is not GRAS. A manufacturer is responsible for ensuring that its products, including the ingredients of its products, are safe for their intended use and are otherwise in compliance with the law.” Further, the TTB stated that if requested by the FDA, it would share “formulas for beers containing added caffeine that are approved under 27 CFR Part 25 [TTB regulations].” In the upcoming months, and perhaps years, it will be interesting to see how the GRAS standard is applied to other alcoholic beverages containing some form of caffeine.

Imbiblog is published for general informational purposes only and is not intended as legal advice. Copyright © 2010 · All Rights Reserved ·


New York State Seals the Fate of Four Loko Alcoholic Energy Drinks

November 17, 2010

New York is the latest state to jump on the alcoholic energy drinks ban-wagon. On Sunday, November 14, 2010, New York Governor David Paterson and Chairman of the State Liquor Authority Dennis Rosen announced a voluntary agreement with Phusion Products, the makers of Four Loko, to stop shipment of caffeinated alcoholic beverages to New York by Friday, November 19, 2010. Additionally, the largest beer distributors in New York State agreed to stop selling malt beverages containing caffeine and other stimulants. Those distributors have until December 10, 2010 to sell off the remainder of their in-state inventory. The voluntary agreement effectively bans the products from New York State. In addition, Phusion Products agreed to fund educational alcohol awareness programs concerning binge drinking. The agreement comes after NYPD sting operations revealed sales of Four Loko products to minors by numerous stores in the Bronx area.

On Tuesday, November 16, 2010, New York Senator Charles Schumer went further, indicating that the Food and Drug Administration was expected to release findings that caffeine is an unsafe food additive for alcoholic drinks. Were such findings made, the Federal Trade Commission would send letters to manufacturers of such beverages warning that marketing such products could be illegal. The FDA spokeswoman Siobhan DeLancey did not confirm whether or not such findings were expected or when any findings on the matter would be released.

Precluding the need for any such findings, however, Phusion Products announced that same day, via their website, that it would remove caffeine, guarana and taurine from Four Loko. Phusion Products maintains that their products as originally formulated were safe; however, the company felt changes were necessary due to the current regulatory environment. Phusion Products isn’t the first company to remove ingredients from an alcoholic energy drink in response to regulatory pressure. In 2008, MillerCoors announced it would remove caffeine, guarana, ginseng, and taurine from its Sparks beverages after voluntary negotiations with various state attorney generals. Anheuser-Busch InBev underwent a similar reformulation process with its Tilt beverages in 2008.

Imbiblog is published for general informational purposes only and is not intended as legal advice.


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