Archives: Food Safety and FDA

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Legal, Political and Practical Challenges in Regulating Recreational Marijuana

On March 30, eight bills were introduced by senior members of Congress from both parties to legalize, regulate and tax marijuana. The bills were referred to at least five House Committees, as they address federal criminal law, taxation, banking, transportation, immigration, veterans’ affairs, access to federal benefits and other issues. The legislative activity follows establishment … Continue Reading

Implications of EU Ingredient Labeling Proposal for US Suppliers

On March 13, the European Commission approved a report that calls on members of the alcohol beverage industry to develop a comprehensive self-regulatory system of ingredient and nutritional labeling for beer, wine, and distilled spirits. The Commission is composed of representatives of each member nation of the European Union (EU) with a range of administrative … Continue Reading

President Trump Issues Executive Order Aimed at Reducing Regulation and Controlling Regulatory Costs

On January 30, 2017, President Trump issued Executive Order No. 13771, entitled “Reducing Regulation and Controlling Regulatory Costs.” A link to Executive Oder 13771 appears here.  The Order provides: For Fiscal Year 2017 (which ends September 30, 2017): For each new “regulation” published for notice and comment “or otherwise promulgated,” the agency in question must “identify” … Continue Reading

FDA Issues Final Rule on Food Ingredients that May Be Generally Recognized as Safe (GRAS)

The US Food and Drug Administration (FDA) has issued this final rule detailing the criteria for concluding that the use of a substance in human or animal food is “generally recognized as safe” (GRAS).  By way of background, if an ingredient is GRAS, food additive petition is not required and FDA does not have to … Continue Reading

DEA Declines to Change Stance on Marijuana but Opens Door to Federally Sanctioned Marijuana Research

On August 11, 2016, the Drug Enforcement Administration (DEA) formally declined to change its position on the medical or recreational use of marijuana, denying two petitions urging the federal government to change marijuana’s drug classification under the Controlled Substances Act. The petitions, filed in 2009 and 2011, urged the DEA to change marijuana’s status as … Continue Reading

FDA Brewery Inspections

Most breweries have numerous deal­ings with the Alcohol and Tobacco Tax and Trade Bureau (TTB) and un­derstand the need to comply with TTB regulations; this includes preparation for TTB audits and inspections. But the TTB is not the only federal agency with the authority to con­duct a brewery inspection. The Food and Drug Administration (FDA) … Continue Reading

FDA to Hold Public Workshops Addressing Menu Labeling Final Rule

The US Food and Drug Administration (FDA) has announced a series of public workshops about menu labeling to help the industry comply with requirements to provide calorie and other nutrition information to consumers. The workshops will address the menu labeling final rule, which require certain chain restaurants and similar retail food establishments to give consumers … Continue Reading

FDA Releases Final Guidance Regarding the Food Labeling Term “Evaporated Cane Juice”

The US Food and Drug Administration (FDA) has released final guidance stating its view that sweeteners derived from sugar cane should not be declared in the statement of ingredients as “evaporated cane juice.”  FDA’s view is that the term “evaporated cane juice” is false or misleading because it suggests that the sweetener is fruit or … Continue Reading

FDA Publishes Final Rule for Protection Against Intentional Adulteration as Part of Food Safety Modernization Act

FDA has published as part of the Food Safety Modernization Act (FSMA) a final rule concerning mitigation strategies to protect food against intentional adulteration.  The rule will require domestic and foreign food facilities that are required to register as food facilities under the Federal Food, Drug, and Cosmetic Act (FFDCA) to address hazards that may be introduced … Continue Reading

FDA to Issue Revised Guidance on Nutrition and Supplement Facts and Serving Size Regulations

This Friday, May 27, 2016, the US Food and Drug Administration (FDA) will publish its revised Nutrition and Supplement Facts and Serving Size regulations. The Serving Size regulation in public inspection view is close to 180 pages and the Nutrition Facts regulation is close to 1,000 pages. Significantly, for beverages: Serving size will be 12 ounces. The new … Continue Reading

FDA Announces Availability of Final Guidance on Menu Labeling

On May 5, 2016, the US Food and Drug Administration (FDA) announced the availability of its final menu labeling guidance, “A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II (Menu Labeling Requirements in Accordance with 21 CFR 101.11).” The guidance is designed to help businesses comply with the menu labeling … Continue Reading

FDA Delays Enforcement of Restaurant Menu Labeling Rule

This week, the Food and Drug Administration’s (FDA) Director of the Center for Food Safety and Applied Nutrition (CFSAN) formally announced that the agency will delay enforcement of its final rule entitled “Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments.” The statement marked the second time the agency … Continue Reading

Product Recalls

Potential product recall situations rank among the most stressful that a producer can face. Things move fast and decisions must be made with less-than-perfect information. While no preparation will render such situations easy or routine, a producer can reduce the stress level and help navigate this “worst-case” scenario by understanding the process and taking certain … Continue Reading

Update: FDA Extends Comment Period for Input on Uses of “Natural” in Food and Beverage Labeling

On December 28, 2015, the U.S. Food and Drug Administration (FDA) extended by 90 days the public comment period on the use of the term “natural” in food and beverage labeling.  As discussed in an earlier post, the FDA is interested in receiving comments on the use of the term “natural” for foods that have … Continue Reading

Raw Materials Compliance

Imagine that you’re waiting for an international hop order to clear customs and you receive a panicked call from your broker. She tells you that the U.S. Food and Drug Administration (FDA) tested the hops for pesticide residues and found some that are not approved for use on hops in the United States. The government will not allow … Continue Reading

FDA Releases Guidance on Voluntary Labeling for Foods Derived from Genetically Engineered Plants

On November 23, 2015, the U.S. Food and Drug Administration (FDA) issued a guidance to assist food and feed manufacturers that would like to label their plant-derived food products or ingredients as produced with or without the use of genetic engineering.  On a voluntary basis, a manufacturer may choose to label its food as produced … Continue Reading

FDA Seeks Input on Uses of “Natural” in Food and Beverage Labeling

Earlier this month, the U.S. Food and Drug Administration (FDA) invited public comments on uses of the term “natural” in food and beverage labeling and whether “natural” should apply only to “unprocessed” foods.  The FDA’s definition of “food” includes alcohol beverages.  The FDA’s current policy is not to restrict use of “natural” unless a food … Continue Reading

Labeling and Advertising Gluten-Free Beer

In the past decade, millions of Americans have converted to gluten-free diets. Originally a practice dictated solely by the medical needs of those who suffer from celiac disease, gluten-free has entered the mainstream. This article will explore the evolving and somewhat uncertain status of labeling and advertising beer as “gluten-free.” Read the full article, originally … Continue Reading

Supreme Court to Decide Important Administrative Law Issue

On December 1, 2014, the United States Supreme Court will hear oral argument in a case that will have significant implications for federal regulatory agencies like the U.S. Food and Drug Administration (FDA) and the Alcohol and Tobacco Tax and Trade Bureau (TTB). The case is Mortgage Bankers Ass’n v. Harris, 720 F.3d 966 (D.C. … Continue Reading

Join Marc Sorini and Art DeCelle at the Wine, Beer & Spirits Law Conference – September 18-19, 2014

Wine, Beer & Spirits Law 19th Annual National Conference The Mayflower Renaissance Hotel Washington, D.C. September 18-19, 2014 Click here to register. View the conference brochure. McDermott Speakers Marc E. Sorini, Partner, Program Co-chair Arthur J. DeCelle, Counsel Please join McDermott partner and program co-chair, Marc Sorini, at the Wine, Beer & Spirits Law 19th … Continue Reading

Hard Cider for Brewers

Hard cider has shown phenomenal growth in the past several years.  With rising consumer demand, more and more craft brewers are entering this rapidly expanding market. Although hard cider is typically distributed and mar­keted like a beer product, the federal gov­ernment and most states actually tax and regulate cider as a type of wine.  Brewers … Continue Reading

TTB Issues Ruling on Formulas for Beer

On June 5, 2014 the Alcohol and Tobacco Tax and Trade Bureau (TTB) issued TTB Ruling 2014-4, exempting from TTB’s formula  and pre-import approval (PIA) submission requirements beer made with dozens ingredients as well as beer subjected to wood aging processes.  TTB now finds these ingredients and processes to be traditionally used in the production … Continue Reading
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