Photo of Sarah Roller

Email
(202) 342-8582
Bio

This week, the Food & Drug Administration (FDA) made a series of announcements in connection with its efforts to address the outbreak of COVID-19.  The Agency sought to reassure the American public that the U.S. food supply remains safe and that there is no evidence of food or food packaging being associated with the transmission

As the novel coronavirus (COVID-19) has reached pandemic levels, companies of all sizes and in all industries face myriad impacts to business operations and the health and well-being of employees.

To help clients navigate these new challenges, including the unpredictability of any outbreak-related business disruption, Kelley Drye has compiled a free resource center to help

Greater than the Sum of Its Parts: FDA Releases Supplemental Draft Completing its Draft Guidance Regarding Protecting Food Against Intentional AdulterationFDA’s recently released Supplemental Draft Guidance entitled “Mitigation Strategies to Protect Food Against Intentional Adulteration:  Guidance for Industry” serves as a substantial supplement to the lengthy Revised Draft Guidance that FDA issued in March 2019 which shares the same title.[1]  Once finalized, these guidance documents will together serve to help covered companies comply with

On March 5, 2019, FDA Commissioner Scott Gottlieb, M.D. and FDA/CFSAN Director, Susan Mayne, Ph.D., released new independent test results confirming asbestos contamination in certain cosmetic products sold by Claire’s and Justice retailers.  The agency also issued a safety alert warning consumers not to use the cosmetic products sold by Claire’s that had tested positive

The National Milk Producers Federation (NMPF) yesterday submitted a citizen petition to FDA related to the use of dairy terms such as “milk,” “yogurt,” “cheese,” “ice cream” and “butter” in the statements of identity for non-dairy plant-based substitutes. The petition argues that the use of these standardized dairy terms to name non-dairy foods falls short

On June 20, 2018, the FDA released draft guidance regarding the FDA’s Mitigation Strategies to Protect Food Against Intentional Adulteration Rule (IA Rule).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 the following:

  • Vulnerability assessment: an assessment that identifies vulnerabilities in a facility’s food manufacturing processes and provides actionable process steps, which are places in the process where a facility can implement mitigation strategies to minimize or prevent the vulnerability;
  • Mitigation strategies: strategies that significantly minimize or prevent significant vulnerabilities at actionable process steps;
  • Food defense monitoring procedures: procedures, including the frequency with which they are to be performed, for monitoring mitigation strategies to assess whether mitigation strategies are operating as intended;
  • Food defense corrective action procedures: actions taken if the mitigation strategies are improperly implemented based on the nature of the actionable process step and the mitigation strategy; and
  • Food defense verification procedures: verification activities to ensure that monitoring is being conducted and appropriate decisions about corrective actions are being made.

This guidance covers the vulnerability assessment, mitigation strategies, and food defense monitoring procedures. Remaining FDA guidance will cover food defense corrective actions, food defense verification, reanalysis, and recordkeeping.
Continue Reading FDA Releases Guidance Regarding Strategies to Protect Against Food Adulteration

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

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

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. Paul, Minnesota. The related complaint filed by the U.S. Department of Justice on behalf of the FDA in the U.S. District Court for the District of Minnesota alleges that the products are adulterated under the Federal Food, Drug, and Cosmetic Act in reliance on 21 U.S.C. §342(a)(4). The seized products are worth approximately $73,000 and include barley flour, spices, pasta, dried beans, tea and cookies.

Continue Reading FDA: Still in Action on Food Safety Violations

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.

Word gluten free written in white flour on a old wooden table from top view in vintage tone, surrounding by baking tools.

The proposed rule builds on the FDA’s 2013 final rule defining the term “gluten-free” for voluntary use in labeling of foods.