Sarah Roller

Sarah Roller

Sarah Roller, J.D., R.D., M.P.H., is a partner in the Washington, D.C. office of Kelley Drye & Warren LLP and is Chair of the firm’s Food and Drug Law practice

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FDA Releases Guidance Regarding Strategies to Protect Against Food Adulteration

On June 20, 2018, the FDA released draft guidance regarding the FDA’s Mitigation Strategies to Protect Food Against Intentional Adulteration Rule (IA Rule).  This is the first of three installments of guidance the FDA plans to release related to the IA Rule. The new guidance covers the development of a food defense plan, which includes … Continue Reading

USDA and FDA Announce Proposed Bioengineered Disclosure Rules and Labeling Rule Compliance Date Changes

Both the USDA and the FDA recently released updates to food labeling regulations that will significantly affect food manufacturers. On Friday, May 4, the Agricultural Marketing Service (AMS) of the USDA proposed a rule regarding the National Bioengineered Food Disclosure Standard providing labeling requirements for disclosing whether a food product has been bioengineered. The proposed … Continue Reading

WTO and FAO Issue Publication on Trade and Food Standards

The World Trade Organization (WTO) and the UN Food and Agriculture Organization (FAO) recently issued a joint publication, Trade and Food Standards, which discusses the development of international standards and the need for additional regulations and involvement by all countries. Currently, the global food trade is valued at $1.7 trillion.  The FAO has 188 member … Continue Reading

FDA: Still in Action on Food Safety Violations

Vigorous food safety enforcement for basic violations continues under the leadership of new FDA Commissioner, Dr. Scott Gottlieb. On June 20, on the heels of an adverse FDA inspection, FDA announced that the U.S. Marshals Service had seized the food products held by Professional Warehouse and Distribution, Inc., at a food warehouse facility in St. … Continue Reading

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

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

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

Sysco Agrees to Pay $19.4M to Settle California Enforcement Challenging the Company’s Food Safety Practices and Related Public Statements

The world’s largest food distributor, Sysco Corp., has entered into a settlement with the California Department of Public Health to resolve allegations that the company had engaged in unlawful food transportation and storage practices and had misrepresented its practices on the company’s website.  The Department alleged that the company held “perishable food and other food … Continue Reading

FDA To Increase Civil Money Penalty Amounts

On February 3, 2014, FDA issued a Direct Final Rule to adjust for inflation the maximum civil money penalty (“CMP”) amounts it can seek for certain violations of the Food, Drug, and Cosmetics Act (“FDCA”).  The direct final rule revises the current list of statutory monetary penalties set forth 21 C.F.R. Part 17, including for … Continue Reading

FDA Targets Antibacterial Soaps in New Proposed Rule

On Monday, FDA announced a new proposed rule that would amend the 1994 TFM for OTC antiseptic drug products.  The change would require companies that sell antibacterial soaps and body washes that are labeled “antibacterial” or “antimicrobial” to prove through a “controlled clinical outcome study” that their products prevent the spread of illness better than … Continue Reading

Bulk Drug Importer Sues FDA For Refusing Entry of 20,000-Kilogram API Shipment

Recently, H&M USA, an importer of  periodic bulk shipments of active pharmaceutical ingredients (API) turned to the courts in an effort to gain relief when the company’s efforts to resolve an unexpected import detention through FDA’s administrative process proved unsuccessful.  The FDA issued a Notice of Refusal, alerting the company that it had failed to … Continue Reading

Court’s Decision Over “Spreadable Butter” Claims Upheld On Appeal

The 2nd District Court of Appeals agreed with the lower court’s decision that no reasonable consumer would be misled into thinking that a product labeled as spreadable butter with canola oil was not 100% butter.  Mary Simpson sued Kelley Drye clients Kroger Corp. and Challenge Dairy Products alleging that the labeling of Challenge’s “Spreadable Butter … Continue Reading

Honeygate II Highlights Supply Chain Risks For U.S. Buyers Of Imported Goods

Still buying imports of dubious foreign origin from unrelated U.S. importers? Consider the case of Groeb Farms, Inc., which recently accepted criminal responsibility for fraudulently entered Chinese honey that had avoided $79 million in duties – despite not being directly involved in the honey’s importation. The takeaway: Not being the importer of record for fraudulently … Continue Reading

FDA Proposes New User Fees to Finance Food & Cosmetic Safety

On April 10, 2013, the U.S. Food and Drug Administration (“FDA”) announced a proposal that could increase the cost of doing business for the food and cosmetic industry. In its budget request for fiscal year 2014, the FDA has proposed two new user fee programs for food companies to help pay for implementation of the … Continue Reading

Far-reaching PCA Criminal Indictments: A Harbinger for Things to Come Under the Food Safety Modernization Act?

Last week, the Department of Justice brought a sweeping indictment against several former Peanut Corporation of America executives alleging egregious, and intentional, violations of food safety laws that caused the salmonella peanut outbreak of 2008. The government charged four individuals who allegedly directed the scheme in an indictment that contains 76 counts of conspiracy, wire … Continue Reading

California Voters Reject Proposition 37 and the “Genetically Engineered” Food Labeling it Aimed to Compel

Californians voted against Proposition 37 yesterday, the California ballot initiative that would have compelled labeling for foods developed with the use of recombinant DNA and related technologies, as well as prohibited “natural” claims for certain processed foods. With 98.5 percent of precincts reporting, Californians had voted against Proposition 37 by a margin of 53 to … Continue Reading

DOJ Is Prosecuting Customs Fraud Through Sarbanes-Oxley’s Obstruction Of Justice Statute

Most products sold in this country – whether imported or made here – are subject to a matrix of federal laws and regulations intended to provide Americans with significant benefits, such as safe food, safe products and a cleaner environment. The compliance costs for producers here and abroad are substantial. Further, imports can be subject … Continue Reading

FDA Proposed Rule Would Place New Labeling and Reporting Requirements on Medical Device Manufacturers

On July 10, 2012, the Food and Drug Administration (“FDA”) published a proposed rule implementing Federal Food, Drug, and Cosmetic Act (“FD&C Act”) provisions establishing a unique device identification system for medical devices over the next seven years. The rule would require medical device manufacturers—including a specification developer, a single-use device reprocessor, a convenience kit … Continue Reading

USDA Proposal Would Establish Requirements for Program that Provides Fresh Fruits and Vegetables to Schools

Last month, the Food and Nutrition Service of the U.S. Department of Agriculture (“USDA”) issued a proposed rule that would establish regulatory requirements for the operation of the Fresh Fruit and Vegetable Program (“FFVP” or “Program”), as required by the Richard B. Russell National School Lunch Act (“NSLA”). 42 U.S.C. § 1758. Under the proposal, … Continue Reading

FDA Issues an Interim Final Rule and Guidance Regarding Expanded Recordkeeping Access Under the Food Safety and Modernization Act

On February 23, 2012, the Food and Drug Administration (“FDA”) issued an interim final rule and new guidance regarding provisions of the Food Safety Modernization Act (“FSMA”) that amended recordkeeping requirements of the Food, Drug, and Cosmetic Act (“FDCA”) for entities that manufacture, process, pack, transport, distribute, receive, hold, or import food. FSMA, which was … Continue Reading

GAO Report Recommends FDA Adopt Definition of Economic Adulteration and Take Steps to Combat Independently from Other Types of Adulteration

Responding to a request from Representatives Henry Waxman (D-CA), Frank Pallone (D-NJ), and John Dingell (D-MI), on October 24, 2011, the United States Government Accountability Office (GAO) issued a report which examines how the Food & Drug Administration (FDA) has addressed “economic adulteration” affecting the products it regulates and makes recommendations for strengthening regulatory and … Continue Reading

Future Uncertain for USDA Proposed Rule to Revise School Lunch Nutrition Quality Standards

On November 18, 2011, President Obama signed into law H.R. 2112, the Consolidated and Further Continuing Appropriations Act (Pub. L. 112-055), which, among other things, provides funding for the U.S. Department of Agriculture (“USDA”) for Fiscal Year 2012. The law includes policy “riders” blocking funding for key provisions of a rule proposed by USDA that … Continue Reading

California Voter Initiative: Labeling Genetically Engineered Foods

On November 9, 2011, the Committee for the Right to Know, a consumer advocacy group that focuses on consumer, public health, environmental, and food issues, submitted the California Right to Know Genetically Engineered Food Act to the California state attorney general for title and summary–a necessary step needed to place citizen-created initiatives on the California … Continue Reading

FDA Releases Guidance on Administrative Detentions on the Heels of its First Post- FSMA Seizure

Today, the Food and Drug Administration (“FDA”) released a guidance document for industry titled “What You Need to Know About Administrative Detention of Foods.” The guidance comes just a week after the FDA announced its first administrative detention under the expanded authority granted by Congress in the Food Safety Modernization Act. The FDA will issue … Continue Reading

IOM Issues Phase II Report Recommending Energy Star-Type Ratings for a Food Front-of-Package Nutrition Rating System

On October 20, 2011, the Institutes of Medicine (“IOM”) issued Phase II of a two-part report regarding front-of-package nutrition labeling systems and symbols. The report, created by an IOM Committee convened in response to a 2009 Congressional request, provides recommendations regarding implementation of a front-of-package nutrition rating system designed to “encourage healthier choices and purchase … Continue Reading
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