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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.

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 ·

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 ·

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 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.