March 15, 2018
California’s Prop 65 (officially the Safe Drinking Water and Toxic Enforcement Act of 1986) requires businesses in the state to inform Californians about exposure to chemicals identified by the state as causing cancer or reproductive toxicity. Inconveniently, though the obligation is on the producer of the product to ensure that the consumer is warned, it is the retailer that must display a notice sign at the point of sale to comply with the law. The Act provides for reimbursement of attorney fees to claimants who bring suit based on missing notice signs, leading to watchdog lawsuits calling out different consumer goods producers. To address the responsibilities of alcoholic beverage suppliers, whose products often include a number of chemicals from the list, three key trade bodies, the Beer Institute, the Wine Institute, and the Distilled Spirits Council, set up the Prop 65 Sign Management Company in 2014. This group distributes signs to retail licensees free of charge, on behalf of all members of the alcohol industry. These signs generally indicate that the consumption of alcoholic beverages may expose drinkers to Prop 65 chemicals, but do not name specific chemicals. This means that when new chemicals are added to the list, such as the impending August 2018 addition of a common ingredient in caramel color, the signs do not need to change.
One of the main aspects of Prop 65 is that chemicals are added to the list if the State of California identifies them as potentially harmful. This means that the California list does not always correlate with guidance from other regulators. As an example, in 2015, the state added Bisphenol A (BPA) to the Prop 65 list of chemicals, for warning to be provided where it is “intentionally added” (which can include where it is present in materials that consumer goods are exposed to – BPA is a common ingredient in linings of lids and beverage cans, and is often used in equipment such as hoses at production facilities). Although the regular Prop 65 warning doesn’t have specific language, in the case of BPA, California created emergency regulations in 2016 with a special safe harbor warning notice. That regulation ran out in January, meaning that sign is no longer mandatory until the regular regulations take effect in August, but it is recommended by trade bodies to keep distributing it in the interim. Prop 65 Sign Management Company distributes a safe harbor warning, but only on behalf of identified suppliers (who are encouraged to add their affected products directly at the site).
The Food & Drug Administration (FDA) allows the use of BPA, and opposed California’s addition of BPA to the list in 2015, indicating the FDA’s research did not indicate it caused reproductive toxicity. A draft report released by the National Toxicology Program (NTP) this month also found only minimal effects on persons exposed to BPA. On the other hand, a new Regulation passed by the European Commission (EU 2018/213) in February introduces stricter measures for BPA use in food contact materials in Europe from September this year, and the European Food Safety Authority (EFSA) is re-evaluating its impact after it originally cleared its use in 2015, in the face of many health bodies calling for a complete ban on its use. Despite the differences of opinion among regulatory agencies, both in the US and abroad, BPA remains on the Prop 65 list and suppliers whose products or packaging are exposed to BPA are subject to the California signage requirements.
Any businesses selling alcoholic beverages in California should be aware of the impact of Prop 65 on their activity. If you have any questions, contact one of the attorneys at Strike & Techel.
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.
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 •
June 16, 2014
In an industry ruling issued June 5, the Alcohol and Tobacco Tax and Trade Bureau (TTB) announced that malt beverages made with certain ingredients, including honey and certain fruits and spices, would no longer be subject to formula approval requirements. Additionally, the ruling exempts beer aged in barrels previously used in the production of wine or distilled spirits from the need to get a formula approval. Under the TTB regulations, ingredients and processes used in the production of malt beverages must be deemed “traditional” in order to be exempt from formula and certain labeling requirements. Until the ruling was issued, TTB had a very limited view of what met the requirements for “traditional” malt beverage production.
The ruling stems from a years long battle with the Brewer’s Association, which petitioned back in 2006 and 2007 to exempt certain ingredients and processes from rigorous approval requirements in light of growing experimentation and trends in the beer industry. The petition identified the most popular ingredients and processes, and urged the TTB to broaden their definition of “traditional” brewing methods. Initially, the TTB gave a limited response and exempted beers with added brown sugar, candy sugar or lactose from approval and special labeling requirements. With the new ruling, the options for adding ingredients to standard beers and other malt beverages without needing to go through the formula approval process are greatly expanded. Additionally, there is an opportunity for brewers to request exemption from formula requirements even if their ingredients are not already on the approved list. A full list of the approved ingredients and processes can be viewed here.
Before the ruling, if flavors were added before, during, or after the fermentation process, that had to be included on the label. Now, the requirement for flavors is that the statement be truthful and in accordance with trade understanding. So for example, a brewer cannot say “ale brewed with cherries” if the cherries were added after the brewing process. To be clear, a statement must still appear on the label to show the addition of any non-standard beer ingredient; the ruling now simply allows for more relaxed processing and avoids the need for formula approval.
The TTB’s expanded ruling of “traditional” brewing ingredients and methods bodes well for brewers and importers looking to get a quick(er) approval for their products and will help speed up all formula approvals due to the reduced TTB workload. Currently approved formulas and labels will not be affected by the ruling.
For questions about brewing requirements, contact one of the attorneys at Strike & Techel.
Imbiblog is published for general informational purposes only and is not intended as legal advice. Copyright © 2014 · All Rights Reserved ·
June 03, 2014
Following our blog post on May 6 (http://strikeandtechel.com/imbiblog/nysla-expands-suppliers-ability-to-entertain-consumers/), regarding the new advisory from New York covering supplier events, here are some more advisories recently published by New York. The advisories summarized here cover limited availability items and closeout sales, new brand registration rules, growler information for beer and cider, and the use of third party agents for consumer tastings.
Limited Availability Items – #2014-5
New York is one of a number of states around the country which continues to require its wholesalers to post prices for wine and spirits around five weeks in advance of sale. The retail posted pricing (from in-state manufacturers and wholesalers to retailers) is available to any retailer who wants to buy the products at the posted price. In the case of products with limited availability, or in the case of closeout sales with limited inventory, the SLA published an advisory in 2013 and now replaces it with this one.
A limited availability item is one where the New York manufacturer or wholesaler believes that demand will exceed supply. As an exception to the general, and strongly enforced, rule against channel pricing, limited availability items can be allocated differently between on- and off-premises retail buyers. A closeout sale occurs when the manufacturer or wholesaler intends to sell its entire remaining inventory of an older or seasonal item at a price at least 10% lower than the last posted price.
In the case of limited availability items, the SLA is switching over the whole current price posting system to create a new category for these types of items. The new system will allow a manufacturer or wholesaler to indicate how it will allocate limited availability items. The system will also allow a manufacturer or wholesaler to move items to limited availability after prices have been posted if there is an exceptional event like a high score from a trade or consumer publication or a celebrity endorsement. In the advisory, the SLA gives a number of examples of allocation methods which are permitted.
Brand Label Registration – #2014-7
In addition to federal certificate of label approval (COLA) requirements from the Alcohol and Tobacco Tax and Trade Bureau (TTB), New York requires brand labels to be registered with the state for almost all alcoholic beverages. Wines over 7% alcohol which have a COLA do not generally need to be registered. Many of the changes in the new advisory parallel recent TTB changes allowing a number of label alterations without requiring a new COLA.
Brand labels must contain the brand or trade name, the class and type of alcoholic beverage, the net contents and other labeling information required for a COLA. If there is any change to the brand name, the flavor description, age or geographic appellation, or if qualifiers like “kosher” or “organic” are added to a label, a new registration must be obtained. If the alcoholic content of a brand registered product changes more than 1.5%, or 0.5% in the case of a cider or a “wine product,” a new registration must be obtained. Unlike wine, “wine products” can be sold in grocery stores if they meet the state-specific definition, which requires things like carbonation and added flavoring materials. Registrations are filed by the brand owner, if they are a New York licensee, or otherwise by the New York wholesaler appointed by the brand owner to post prices for and sell the product.
Brand label registrations are valid for a set calendar year depending on the type of alcoholic beverage. Current registrations will remain in effect until they expire and will then be transitioned to the new schedule. There will be additional use-up periods allowed for non-compliant products.
Private labels owned by retailers who sell them exclusively are exempt from price posting requirements. The labels do not have to contain the retailer’s name, but the brand name must belong to the retailer or the retailer must have the legal right to use the name. A retailer can license the brand name from another entity but cannot license a brand name belonging to a manufacturer or wholesaler. The use of terms like “exclusively bottled for” or “exclusive to” cannot be used to try and create a private brand label for a retailer.
Growlers – #2014-11
The advisory covers the sale of beer and cider in growlers by off premise retailers authorized to sell those beverages and confirms that liquor and wine cannot be sold in growlers in New York. In the case of beer and cider, either the consumer can provide the container or the retailer can. Due to local open container laws, retailers serving growlers should provide sealed containers where applicable.
Authorized Agents for Tastings and Bottle Sales – #2014-13
Certain New York licensees, and certain out-of-state suppliers with supplier marketing permits, are allowed to provide tastings in accordance with an advisory published in July 2013. This new advisory confirms that the licensee or supplier can use another manufacturer or wholesaler licensee as its agent for such a tasting. The only exception is that a beer wholesaler is not allowed to act as an agent for a brewer.
Imbiblog is published for general informational purposes only and is not intended as legal advice. Copyright © 2014 · All Rights Reserved ·
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 ·
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.
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 ·
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.
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 ·
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 ·
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 ·
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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