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.

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The Office of Management and Budget (OMB) recently released the Fall 2018 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum summarizes the major actions that may be of particular interest to the food industry that are being planned by the U.S. Food and Drug Administration (FDA) and the United States Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS), Animal and Plant Health Inspection Service (APHIS), Food and Nutrition Service (FNS), and Agricultural Marketing Service (AMS). After highlighting the most significant priorities, we provide charts for each agency that provide additional details on their plans. More information can be found by clicking on the blue link next to each item, which will take you to a specific page about each agenda item on OMB’s website.

We want to caution that the dates included in the Unified Agenda are not commitments to act on or by the date shown and simply indicate the agencies’ aspirations. Rather than focusing on projected dates, the Unified Agenda is a valuable tool to identify the substantive issues the agencies consider to be priorities for rulemaking.

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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.

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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.

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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).

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On October 9, 2018, the U.S. Food and Drug Administration (FDA) issued a final rule revoking authorization for seven synthetic flavorings and adjuvants as food additives. Notably, FDA’s rigorous scientific analysis determined that these additives do not pose a risk to public health under the conditions of their intended use. The agency acknowledges that these flavorings and adjuvants are used in very small amounts and their use results in very low levels of exposures and low risk. Nonetheless, in light of the animal data showing carcinogenicity, the agency concluded it had to withdraw their authorization as food additives as a matter of law under the Delaney clause. FDA intends to enforce the Rule’s requirements only on products manufactured after October 9, 2020, containing one or more of the six synthetic flavoring substances.

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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.

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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).

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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.

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Last week, the California Office of Environmental Health Hazard Assessment (OEHHA), the lead agency that implements California’s Proposition 65, proposed an amendment to the existing regulation requiring: (1) the average concentration of a listed chemical as causing reproductive toxicity (e.g., lead) be based on products from the same manufacturing facility; and (2) the dietary exposure to a listed chemical as causing reproductive toxicity be calculated using the arithmetic mean. If adopted, the proposed changes would overrule the court decision in Environmental Law Foundation v Beechnut Nutrition Corp on how to determine the daily intake of listed chemicals as causing reproductive toxicity. The change could impose additional testing requirements on the industry and could create a more rigid standard for falling within a safe harbor. We encourage food companies to evaluate whether the proposed changes would adversely impact their current Proposition 65 compliance positions.

Comments to the proposed regulation are due by November 19, 2018. In addition, a public hearing on the proposed amendment would be scheduled on request. To request a hearing, OEHHA needs to be notified no later than November 5, 2018.

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