Category Archives: Foods and Beverages

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FDA Announces Delay in Compliance Dates for Revised Nutrition Fact Requirements

The FDA announced today that it was delaying implementation of the final rule promulgated in May 2016 that revised regulations governing Nutrition Facts labels on food and dietary supplements.  The rule initially set a general compliance date of July 26, 2018, although manufacturers with annual food sales of less than $10 million were given an … Continue Reading

Senate Hearing on FDA Commissioner Nominee Scott Gottlieb Provides Insights on the Future of Food Safety and Labeling

Last Wednesday, April 5, the Senate Committee on Health, Education, Labor, & Pensions held a hearing on the nomination of Scott Gottlieb, MD, as Commissioner of the Food and Drug Administration.  As part of the hearing, Gottlieb was questioned on an array of topics from his prior service at FDA to his alleged financial interests … Continue Reading

Oregon Attorney General Announces $545,000 Settlement with Retailer

750px-Flag_of_Oregon_svgThe Oregon AG recently announced a $545,000 settlement with the Vitamin Shoppe over allegations that the store violated Oregon state law by selling dietary supplements containing ingredients that FDA has deemed unsafe or unlawful. The new settlement agreement places significant burdens on the Vitamin Shoppe to monitor developments on ingredient status. The burdens are the same regardless of whether the … Continue Reading

CFSAN Director Anticipates “Tweaks,” Not Rollbacks Despite Administration’s De-Regulation Emphasis

Dr. Susan Mayne, Director of FDA’s Center for Food Safety and Applied Nutrition, spoke on Thursday to the DC section of the Institute of Food Technologists.  Responding to questions from the audience, Dr. Mayne was asked to comment on how the Trump administration’s emphasis on deregulation is likely to impact CFSAN’s work.  Speaking generally, Dr. … Continue Reading

Placing Food on the EU Market? Prepare for Potential Regulatory Rollercoaster

In the world of food, 2017 promises to be a busy year across the European Union for regulators and regulated alike.  To the great disappointment of gourmands, farmers and producers, French foie gras exports remain blocked due to spread of avian influenza to wild ducks in France and detection of the H5N8 virus at a … Continue Reading

FDA to Redefine “Healthy;” Requests Public Comment and Issues New Guidance

FDA hinted in May that it was planning to reconsider its longstanding and controversial criteria for using the term “healthy.”  Today, it announced the beginning of the formal process to make changes to the definition of the term.  The agency opened a new docket and is publishing a Request for Information and Comments relating to … Continue Reading

Philadelphia Targets Sweetened Beverages for New Revenue; Imposes First Big-City Soda Tax

On Thursday Philadelphia became the first major U.S. city to approve a tax on sodas and other sweetened beverages.  In enacting Bill Number 16017601, the Council added a new Chapter 19-4100 to the city code, which imposes a $0.015 per fluid ounce tax on beverages and beverage concentrates sweetened with sugar-based sweeteners or artificial sugar … Continue Reading

FDA Releases Final Rules Revising Nutrition Facts Label and Certain Serving Sizes; Industry Given Two to Three Years to Comply

FDA announced today that it was finalizing two previously proposed rules that will require industry to overhaul Nutrition Facts panels on all food products sold in the United States and recalculate serving sizes for some foods.  The new rules mark the first time that FDA has engaged in rulemaking to update the framework for nutrition … Continue Reading

FDA Releases Draft Guidance on Determining What Constitutes a “Qualified Facility” under FSMA Preventive Controls Rules

On Friday, the FDA announced the availability of a draft guidance describing its current thinking on how to determine whether a business is a “qualified facility” that is subject to modified requirements under its previously released rules governing current good manufacturing practice, hazard analysis and risk-based preventive controls for human food and animal food (“the … Continue Reading

FDA Finalizes Additional Guidance on Medical Foods; Continues to Take Narrow View of Category

fda-logo-1_10770329FDA has finalized its guidance document relating to medical foods, a special class of products defined under the Orphan Drug Act. Although most of the content of the final guidance mirrors the draft guidance released in August 2013, the final guidance clarifies the following points: Medical foods are exempt from the labeling requirements for nutrient … Continue Reading

FDA to Chew Over Meaning of “Healthy”

Although “healthy” might sound like a subjective term, FDA has long-defined “healthy” under nutrient content claim regulations. For example, to be “healthy” an item must be low in fat and saturated fat.  Many stakeholders and health advocates have argued that this conception of “healthy” may be outdated, and the agency hinted this week that it … Continue Reading

FDA Final Rule for Foods and Cosmetics Aims to Reduce Risk of Mad Cow Exposure

Today the FDA issued its final rule prohibiting the use of certain cattle material in human foods, dietary supplements, and cosmetics.  The rule is focused on reducing the risk of human exposure to bovine spongiform encephalopathy (BSE), a fatal neurological disorder sometimes known as “mad cow disease.”  The rule will take effect on April 18, … Continue Reading

Coalition Challenges National Marine Fisheries Service Rules for Regulating Offshore Aquaculture in the Gulf of Mexico

On February 12th, a coalition led by the Center for Food Safety filed suit in the U.S. District Court for the Eastern District of Louisiana challenging the National Marine Fisheries Service’s (“NMFS”) final rule implementing the Fishery Management Plan for Regulating Offshore Aquaculture in the Gulf of Mexico (“FMP”). The rule is the first FMP … Continue Reading

San Francisco Backpedals on Ad Ban for Sugary Drinks, but Maintains Warnings Requirements

In June 2015, the San Francisco Board of Supervisors passed two sweeping ordinances concerning sugar-sweetened beverages designed to “inform the public of the presence of added sugars” and restrict certain advertising for these products.  The first ordinance requires warnings on certain advertisements for sugar-sweetened beverages to advise consumers about the “harmful health effects of consuming … Continue Reading

FDA Approves Genetically Engineered Atlantic Salmon as Safe and Effective for Human Food and Releases Related Draft Guidance on Voluntary Labeling

On Thursday, November 19th, the Food & Drug Administration (FDA) announced that it had approved an application for AquAdvantage Salmon, a type of Atlantic Salmon that has been genetically engineered to grow to market size more quickly than other salmon.  The agency regulates genetically engineered (GE) animals such as AquAdvantage Salmon under the new animal … Continue Reading

FDA Proposes Gluten-Free Labeling Standards for Fermented and Hydrolyzed Foods

Word gluten free written in white flour on a old wooden table from top view in vintage tone, surrounding by baking tools.On November 18, 2015, the FDA issued a proposed rule to set standards for making a “gluten-free” claim for foods that are fermented, hydrolyzed, or distilled, or that otherwise contain fermented or hydrolyzed ingredients. The proposed rule builds on the FDA’s 2013 final rule defining the term “gluten-free” for voluntary use in labeling of foods. … Continue Reading

FDA Issues Final Food Biotechnology Labeling Guidelines for Plant Foods; Discourages “GMO Free” Claims

On November 19, 2015, FDA issued its final guidance for industry concerning the requirements for voluntarily indicating whether food products have or have not been derived from genetically engineered plants.  The final guidance updates the FDA draft guidance originally issued on January 18, 2001.  Under the guidance, food manufacturers may voluntarily label their foods with … Continue Reading

New FDA Guidance Doubles-Down on 1980 Fortification Policy and Potential Misbranding Risks of “Inappropriate Fortification”

FDA recently released its Guidance for Industry: Questions and Answers on FDA’s Fortification Policy (Guidance) to “clarify the existing policy” in response to questions FDA has received from the food industry, other federal agencies, and academia, and also to “remind manufacturers of this policy.”  FDA’s “fortification policy” was first published in a 1980 Federal Register … Continue Reading

FDA Requests Public Comment on How “Natural” Claims Should be Regulated; Opening 90-Day Comment Period

FDA is requesting public comment on how “natural” claims should be regulated. The 90-day public comment period will open on November 12, 2015, when the FDA notice is published in the Federal Register.  In particular, FDA seeks information and public comment relating to a number of specific issues, including the following: Should FDA define the … Continue Reading

“The White Sauce” Decision (International Custom Products, Inc. v. United States) Highlights Importance of Administrative Procedures for Food Importers

The Court of Appeals for the Federal Circuit decision, International Custom Products, Inc. v. United States, 2015 U.S. App. LEXIS 11170 (Fed. Cir. June 30, 2015), was ten years in the making and provides a stern lesson for importers of food products to follow U.S. Customs and Border Protection’s administrative procedures carefully.  If not, importers … Continue Reading

FDA Extends Menu Labeling Deadline

Responding to input from stakeholders, the FDA has decided to extend the deadline for complying with its Menu Labeling Final Rule from December 1, 2015 to December 1, 2016.  In general, the Rule requires chain restaurants and other food service establishments to provide calorie information on menus and menu boards.  We discussed the specific requirements … Continue Reading

FDA Releases Draft Guidance on Voluntary Qualified Importer Program

The FDA announced last week the release of a draft guidance that outlines FDA’s plan to implement the Voluntary Qualified Importer Program (VQIP) mandated under the Food Safety Modernization Act (FSMA).  The draft guidance describes how FDA intends to determine eligibility to participate in the program, along with the benefits of participating, instructions for completing … Continue Reading
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