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Food Safety and FDA

FDA Issues Guidance on Hops and Wine Grapes

by Christopher M. Lahiff | Apr 5, 2019 | Food Safety and FDA

The FDA recently issued Guidance announcing its decision to exercise enforcement discretion with regard to the Produce Safety Rule for entities growing, harvesting, packing or holding hops and wine grapes, as well as almonds and pulse crops (dry, edible seeds in the legume family harvested solely in dried form).

More specifically, while the FDA considers rulemaking to address the unique circumstances of these four crops, the FDA does not expect entities growing, harvesting, packing or holding these commodities to meet any of the Produce Safety Regulation requirements with respect to these commodities.

Hops: The FDA’s rationale for exercising enforcement discretion for hops is that hops used in the making of beer receive adequate pathogen reduction through means other than a cook step (e.g., pH, alcohol content and fermentation) and hops are not used outside of the brewing process.
Wine Grapes: For wine grapes exclusively grown for use in winemaking, the FDA believes similarly, i.e., that wine grapes receive adequate pathogen reduction through means other than a cook step citing again pH, alcohol content and fermentation. In addition, the FDA believes that wine grapes grown, harvested and used solely for wine are a sufficiently distinct commodity from table grapes so they can be regulated differently (table grapes remain subject to the Produce Safety Rule). Furthermore, in the law that ended the government shutdown earlier this year, Congress said that no funds may be used to enforce the Produce Safety Rule with respect to grape varietals that are used solely for wine and receive commercial processing that adequately reduces the presence of microorganisms of public health significance. Undoubtedly, this helped move the FDA towards its decision to not enforce the Produce Safety Rule with regard to wine grapes.

The FDA’s guidance is effective immediately.

Bioengineered Food Disclosures

by McDermott Will & Emery | Nov 27, 2018 | Food Safety and FDA, Legislation

Earlier this year, the U.S. Department of Agriculture (USDA) proposed a new regulation that would require food manufacturers to disclose information about bioengineered (BE) food and BE food ingredients. The proposed rule is the result of a 2016 law that required the USDA to establish a National Bioengineered Food Disclosure Standard for all food. For purposes of the BE disclosure law, “food” includes alcohol beverages intended for human consumption as well as non-alcohol beverages.

Read the full article.

Originally published in The New Brewer, November/December 2018.

DEA Schedules a FDA-Approved CBD Drug

by McDermott Will & Emery | Oct 5, 2018 | Cannabis, Food Safety and FDA

As beverage manufacturers mull the creation and distribution of cannabidiol (CBD)-infused products, the US Drug Enforcement Administration’s (DEA) recent actions regarding an approved CBD drug merit exploration. CBD is one of many chemicals in the cannabis plant, and the US Food and Drug Administration (FDA) has stated that CBD does not produce the same euphoric effect as tetrahydrocannabinol (THC), marijuana’s psychoactive component.

In June, FDA approved the first drug comprised of an active ingredient (CBD) derived from marijuana, Epidiolex. FDA approved the CBD oral solution for patients two years of age and older who have seizures associated with two forms of severe epilepsy. According to DEA and FDA, the CBD in Epidiolex is extracted from the cannabis plant and is a purified drug substance. Though it is derived from the cannabis plant, the FDA-approved drug has no more than 0.1 percent residual THC.

Last week, DEA announced an order scheduling Epidiolex under the least restrictive schedule of the Controlled Substances Act (CSA), schedule V. Notably, DEA still considers marijuana (which includes industrial hemp) and marijuana compounds other than Epidiolex to be schedule I controlled substances under the CSA. As a result, beverage manufacturers should carefully consider all legal implications prior to developing products that contain CBD. (more…)

California Court of Appeal Holds That “Safe Harbor” Defense Precludes Suit Based on Presence of Inorganic Arsenic in Wines

by McDermott Will & Emery | Jun 1, 2018 | Advertising and Marketing, Food Safety and FDA

Last month, the Court of Appeal of California, Second Appellate District, Division Four, issued an opinion in Charles v. Sutter Home Winery, Inc. (2018 Cal. App. LEXIS 418*; 2018 WL 2126987). The court considered the Plaintiffs’ appeal of their dismissed putative class action complaint brought under the Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as Proposition 65. The appeal challenged the adequacy of the warning label that the Defendants, a group of wine suppliers, provided on wines that contained allegedly unsafe levels of inorganic arsenic, a chemical listed by the State of California as a carcinogen and a reproductive toxicant (a “listed chemical”). In a win for the wine industry, the Court of Appeal upheld the dismissal of the case.

Proposition 65 requires that any person who knowingly and intentionally exposes another person to a “listed chemical” in the course of doing business must provide a “clear and reasonable” warning before the exposure. California’s Office of Environmental Health Hazard Assessment (OEHHA), the lead agency responsible for implementing Proposition 65, has adopted several “safe harbor” warning provisions deemed to satisfy Proposition 65’s requirements, including a safe harbor warning for general consumer products and one for alcohol beverages, specifically. (more…)

USDA Publishes Proposed GMO Labeling Regulations

by McDermott Will & Emery | May 14, 2018 | Advertising and Marketing, Food Safety and FDA, Legislation

The Agricultural Marketing Service of the US Department of Agriculture (USDA) recently published a proposed rule containing regulations to implement the National Bioengineered Food Disclosure Standard mandated by Congress in 2016. See 83 Fed. Reg. 19860 (May 4, 2018). The proposed regulations would govern the labeling of raw agricultural products and packaged foods whose labeling is governed the federal Food, Drug & Cosmetics Act, including wines below 7 percent alcohol by volume and non-malt beer (e.g., “hard seltzers”). The proposed regulations would not directly apply to alcohol beverages whose labeling is governed by the Federal Alcohol Administration Act, including all distilled spirits, wines containing 7 percent alcohol by volume or greater, and beer containing malted barley and hops. Nevertheless, the Alcohol and Tobacco Tax and Trade Bureau may look to the bioengineered food disclosure regulations as persuasive guidance in developing its own policies towards the disclosure of bioengineered ingredients (often called “genetically modified organisms” or “GMOs”). (more…)

FDA Extends Compliance Date for Updated Nutrition Facts Label

by Christopher M. Lahiff | May 4, 2018 | Advertising and Marketing, Food Safety and FDA, Trade Practices

The Food and Drug Administration (FDA) is extending the compliance dates for updating the familiar Nutrition Facts labels, from July 26, 2018 to January 1, 2020, for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales will receive an extra year to comply – until January 1, 2021.

FDA explained that after considering a range of stakeholder comments, there was a need for manufacturers to have additional time to make required label changes. The approximately 18-month extension accomplishes this goal and will provide sufficient time to transition to the new version of the Nutrition Facts label. Finally, FDA said it is committed to ensuring that all manufacturers have guidance to help implement the required label changes by the upcoming compliance dates and the additional time will help FDA achieve that objective.

FDA Releases Draft Guidance on Public Warnings and Notifications of Recalls

by Christopher M. Lahiff and McDermott Will & Emery | Jan 23, 2018 | Distribution, Food Safety and FDA

The Food and Drug Administration (FDA) recently issued a draft guidance on the agency’s voluntary recall process and announced the agency’s intention to notify the public faster when a product is recalled. The guidance aims to assist and provide recommendations to industry and FDA staff regarding the use, content and circumstances for issuance of public warnings and public notifications for firm‑initiated or FDA‑requested recalls. In addition, the guidance discusses what information to include in a public warning, as well as the parties responsible for issuing it. Notably, the draft guidance does not specifically address recalls of alcohol beverage products regulated by the Federal Alcohol Administration (FAA) Act or the primary role of the Alcohol and Tobacco Tax and Trade Bureau (TTB) in seeking and monitoring recalls of such beverages. Comments on the draft guidance are due by March 20, 2018. (more…)

The Intersection of Spirits and Marijuana

by McDermott Will & Emery and McDermott Will & Emery | Dec 15, 2017 | Advertising and Marketing, Cannabis, Food Safety and FDA, Legislation, TTB COLAs and Formulas

In the past three years, TTB has approved an increasing number of certificate of label approvals (“COLA”) for hemp-flavored vodka, from Mill Six’s hemp, white tea and ginger flavored vodka to Olde Imperial Mystic’s hemp infused vodka. Distillers have designed labels with green smoke-like images and psychedelic sixties-style lettering to hint at their cultural connection to marijuana. As more states have legalized recreational cannabis, distillers have been thinking more ambitiously about combining their distilling business with one or more aspects of the emerging marijuana business.

Read the full article.

Originally published in Artisan Spirit: Winter 2017.

Government Affairs Extra | Craft Beer and Marijuana

by McDermott Will & Emery and McDermott Will & Emery | Nov 21, 2017 | Advertising and Marketing, Cannabis, Food Safety and FDA, Legislation, TTB COLAs and Formulas

It’s hard to deny that marijuana has a cultural connection with craft beer, or at least with substantial segments of the craft brewing community. Many craft brewers have signaled to their fans that they know a thing or two about the rituals and lingo of marijuana consumption. But with the legalization of recreational cannabis by several states since 2012, many brewers have been thinking more ambitiously about combining their brewing business with one or more aspects of the emerging marijuana business.

Read “Government Affairs Extra | Craft Beer and Marijuana.”

This article originally appeared in The New Brewer November/December 2017.

FDA Publishes Supplemental Guidance on Menu Labeling for Chain Restaurants

by Arthur J. DeCelle | Nov 20, 2017 | Advertising and Marketing, Food Safety and FDA, Import/Export, Legislation, Trade Practices, TTB COLAs and Formulas

On November 7, the US Food and Drug Administration (FDA) published the latest in a series of industry draft guidance documents to help implement menu labeling and nutrient disclosure regulations applicable to chain restaurants (Draft Guidance). FDA guidance documents are advisory in nature and represent the views of the FDA at a given point in time. Accordingly, guidance is subject to change, but is useful for developing a compliance plan for retail establishments covered by the menu labeling regulations. Changes are usually incremental and based on agency experience and input from regulated industry members.

The FDA established a 60-day period for comments on the draft menu labeling and nutrient disclosure guidance. The comment period ends on January 6, 2018.

The current compliance date for menu labeling and nutrient disclosure regulations is May 7, 2018.

Implementation of federal menu labeling and nutrient disclosures by chain restaurants is a study in modern American political and administrative processes. For those who already tried to comply with the formal FDA regulations and prior guidance, an explanatory note about delays in the administrative process appears at the end of this post.

Two sections of the Draft Guidance explicitly address alcohol beverages.

Guidance is offered for beer lists on menus and the discussion has broader application to wine and spirits products and cocktails that are standard menu items on chain restaurant menus.
Sources of nutrient information for beer, wine and spirits are also discussed to provide an alternative to expensive laboratory testing for each brand that a manufacturer offers.

The Draft Guidance also:

Includes several plain-language explanations of key terms in FDA regulations with useful distinctions between regular menu items and season or special items;
Displays a number of graphics designed to assist retailers with standardized formats to communicate calorie content of various foods to consumers and to distinguish menus from marketing materials;
Directs manufacturers and retailers to reliable sources and methods to prepare and display compliant nutrient disclosures; and
Provides information on presentation of mandatory standard menu notices alerting consumers to the federal government’s recommended 2,000 calorie diet and availability of nutritional information for standard menu items upon request to a server or manager at a retail establishment.

The FDA guidance and the formal regulations use subjective terms about legibility (e.g., contrasting, clear and conspicuous). Those terms aim to ensure that information is consumer-friendly, but they could lead to nuisance complaints from regulators. FDA regional personnel and local inspectors under contract with the FDA will monitor compliance with menu labeling regulations. Since chains will, by nature, have locations in multiple jurisdictions, consistency in enforcement poses a challenge to industry and government.

To mitigate regulatory risks, a conservative approach is advisable to mandatory disclosures. All aspects of calorie and nutrient disclosure should be reviewed by counsel or a knowledgeable compliance professional. The review should start with the manner used to ascertain calories and nutrients and continue through preparation and publication of new and easy-to-read menus and nutrient disclosures. [...]

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