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FDA Issues Guidance on Hops and Wine Grapes

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.

  1. 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.

  2. 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.

© 2020 McDermott Will & Emery

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About this Author

Christopher Lahiff, Attorney, McDermott Law Firm
Partner

Christopher M. Lahiff is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C. office.  He focuses his practice on matters regarding the regulation of pesticides by the U.S. Environmental Protection Agency as well as of food by the Food and Drug Administration and the U.S. Department of Agriculture.

202-756-8219
Marc E. Sorini Alcohol Distribution Attorney McDermott Will law firm
Partner

Marc E. Sorini is a partner in the law firm of McDermott Will & Emery LLP and is based in the Washington, D.C. office.  He heads the Firm’s Alcohol Regulatory & Distribution Group, where he focuses on regulatory and litigation issues facing the alcohol beverage industry and non-beverage alcohol users.

Marc's alcohol beverage practice covers licensing, labeling, advertising, trade practices, distribution, import-export, formulation and excise taxation.  He has represented alcohol beverage suppliers before federal and state courts, the Alcohol & Tobacco Tax & Trade Bureau (TTB), (formerly the Bureau of Alcohol, Tobacco & Firearms or ATF), the Federal Trade Commission (FTC) and state alcohol beverage control agencies, and he advises clients on compliance with the regulations and policies of TTB, FTC, the Food & Drug Administration and U.S. Customs and Border Protection (CBP).  Chambers USA ranks McDermott’s Alcohol Practice in its first tier and Marc is the only lawyer listed as a “Star Individual” in this field.  

His work also spans a number of traditional areas of legal practice that affect beverage companies, including the following:

  • Corporate, such as drafting and negotiating distribution and co-pack agreements and handling the alcohol regulatory and due diligence aspects of industry transactions
  • Food and beverage, such as counseling on product formulation matters and representing companies in potential product recall situations
  • Government affairs, such as testifying at legislative hearings, preparing legislative and regulatory proposals, and participating in rulemaking proceedings
  • Litigation, such as handling investigations by government alcohol regulatory authorities and representing companies in disputes with distributors
  • Intellectual property, such as reviewing and clearing advertising and labeling under alcohol beverage laws, voluntary industry codes, and false advertising principles
  • Tax, specifically federal and state excise tax matters

Marc has represented alcohol beverage suppliers before federal and state courts, the US Alcohol and Tobacco Tax and Trade Bureau (TTB, formerly the Bureau of Alcohol, Tobacco and Firearms, or ATF) and Federal Trade Commission (FTC) and state alcohol beverage control agencies. He advises clients on compliance with the regulations and policies of the TTB, FTC, Food and Drug Administration (FDA) and Customs and Border Protection (CBP). Marc also advises companies in the chemical, flavor and extract, energy, health care supply, soft drink and other industries on federal and state regulation of non-beverage alcohol. Marc often brings his in-depth knowledge to bear in legal projects involving many other practitioners, working with transactional deal teams from McDermott and other firms, litigation teams in commercial disputes or government investigations, subject matter specialists in food, agriculture, international trade and other areas, and a network of local lawyers and professionals skilled at handling the state and local zoning and licensing issues that arise in this industry.

202-756-8284