The U.S. Food and Drug Administration (FDA) recently released its Plant and Animal Biotechnology Innovation Action Plan (“Action Plan”). The Action Plan provides an overview of the key priorities FDA expects to pursue through 2020 to support innovation in plant and animal biotechnology. As highlighted in FDA Commissioner Gottlieb’s statement, the agency is committed to fostering innovative advances in the field while ensuring the safety of plant and animal biotechnology products used by consumers. The Action Plan identifies three concepts as critical to FDA’s success in fulfilling its goal: 1) advancing public health by promoting innovation; 2) strengthening public outreach and communication; and 3) increasing engagement with domestic and international partners.
On Friday, November 16, 2018, the U.S. Department of Agriculture (USDA) Secretary Perdue and U.S. Food and Drug Administration (FDA) Commissioner Gottlieb announced a joint regulatory framework to oversee cell cultured products. Under the proposed framework, FDA plans to oversee cell collection, cell banks, cell growth, and cell differentiation. USDA will oversee cell harvest, production, and labeling of food products derived from the cells of livestock and poultry. While the technical details of the framework remain undefined, the agencies have expressed their view that no legislation on the topic is necessary because the agencies have statutory authority to regulate cell cultured food products derived from livestock and poultry.
This announcement comes three weeks after USDA and FDA hosted a joint public meeting on the topic, and before comments on the meeting are due. The agencies also announced they continue to seek public comment on the issue and will extend the deadline to submit comments until December 26, 2018.
The Food and Drug Administration (FDA) recently issued final Guidance regarding its mandatory recall authority, which was granted to FDA by the FDA Food Safety Modernization Act (FSMA). Together with the release of this Guidance, FDA Commissioner Scott Gottlieb, M.D., released a statement addressing FDA’s goal of expanding use of the mandatory recall authority in cases where FDA has to intervene quickly to help protect consumers from unsafe foods.
The Guidance outlines how the FDA will give the responsible party an opportunity to conduct a voluntary recall before ordering a mandatory recall, as the law requires. It also offers more detail about the evidence or circumstances the FDA may consider when deciding to move forward with a mandatory food recall and provides clarity around situations when the FDA would deem a food a serious health risk. Commissioner Gottlieb’s statement explains that providing this additional clarity can enable the FDA to make more robust use of the mandatory recall authority.
The U.S. Food and Drug Administration (FDA) recently issued two guidance documents – one final and one draft – related to the new nutrition labeling requirements. The final guidance is an update to the previous draft guidance addressing the compliance date, added sugars definition, and quantitative declarations of vitamins and minerals.1 The draft guidance is focused on the serving size, Reference Amounts Customarily Consumed (RACCs), and determining the appropriate Nutrition Facts Panel (NFP) format, including dual-column labeling.
This post summarizes the major highlights of the guidance documents, particularly where FDA has offered interpretations not found directly in the final rules. All food companies should consult FDA’s new guidance documents as they continue to implement the new nutrition labeling requirements before the January 1, 2020 compliance date.
The U.S. Food and Drug Administration (FDA) recently issued a request for information seeking data and other information on the prevalence and severity of sesame allergies in the U.S. and the prevalence of sesame-containing foods in the marketplace that are not currently required to disclose the presence of sesame. FDA is collecting this data to inform potential rulemaking that could require food labels to disclose the presence of sesame as an allergen in order to protect and promote public health. In addition, FDA will use this data to respond to a Citizen Petition submitted by the Center for Science in the Public Interest (CSPI) requesting that FDA issue a regulation to require sesame to be labeled as an allergen in the same manner as the eight major food allergens under the Food Allergen Labeling and Consumer Protection Act (FALCPA).
The Food and Drug Administration (FDA) has issued two draft guidance documents intended to assist industry in complying with certain FDA Food Safety Modernization Act (FSMA) regulations regarding fresh produce. The first document is for farms covered by the Produce Safety Rule (PSR). The second document is for facilities subject to FDA’s Preventive Controls for Human Food (PCHF) rule and that manufacture, process, pack, or hold fresh-cut produce. The deadline for comments on both guidance documents is April 22, 2019.
Two consumer groups have sued the Food and Drug Administration (FDA) seeking to compel the agency to implement the traceability provisions in the FDA Food Safety Modernization Act (FSMA). Specifically, the plaintiffs want FDA to meet its obligation under FSMA to establish and publish a list of high-risk foods and engage in rulemaking setting forth additional traceability record keeping requirements for facilities that manufacture, process, pack, or hold those foods. The lawsuit was brought in the U.S. District Court for the Northern District of California by the Center for Food Safety (CFS) and Center for Environmental Health (CEH).
As a reminder, the Food and Drug Administration (FDA) requires all registered food facilities to renew their registration biennially in each even-numbered year. The current renewal period began October 1, 2018, and runs through 11:59 p.m. on December 31, 2018. Even if you have already registered or updated a facility registration in the last year, you are still required to renew the facility’s registration during this renewal period. If a facility fails to renew its registration, the registration is considered expired and will be removed by FDA.
The Food and Drug Administration recently issued a request for information on the use of the names of dairy foods in the labeling of plant-based products. This action arose from the agency’s Nutrition Innovation Strategy, one tenet of which is a focus on modernizing food standards. During Commissioner Gottlieb’s remarks at the Nutrition Innovation Strategy public meeting, he stated that requests for the agency to take a closer look at the dairy standards of identity is one of many reasons why FDA is interested in modernizing the food standards, and that this would be the first area in which FDA is going to have an active public process for reviewing the standards and how consumers understand the use of terms like “milk” on both animal-derived and plant-based products.
This RFI aims to gather information on how consumers use plant-based products and how consumers understand the use of dairy terms, such as “milk,” or “yogurt” when they appear on the labels of plant-based products, as well as the nutritional attributes of these products and how these products can help consumers meet the recommendations in the Dietary Guidelines for Americans.
On September 26, 2018, the Food and Drug Administration issued a statement by FDA Commissioner Scott Gottlieb, M.D. on FDA’s commitment to disclose retailer information for certain food recalls to improve consumer safety. Additionally, on September 27, 2018, FDA published a Federal Register Notice announcing availability of a draft guidance on the Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls. Publication of the Draft Guidance is the second of a series of policy steps the agency is taking as part of a broader plan to improve oversight of food safety and the recall process.