In response to a recent report by the Department of Health and Human Services (HHS) Office of Inspector General (OIG), Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., announced that FDA will be issuing guidance on recall communications within the next six months. Commissioner Gottlieb’s announcement followed an OIG report that identified several shortcomings in FDA’s initiation and oversight of food recalls. OIG had issued an “early alert” in June 2016 notifying FDA of its preliminary finding that FDA lacks policies and procedures to ensure that firms or responsible parties initiate food recalls promptly. The complete report issued in December includes additional findings concerning issues such as the timeliness of FDA’s evaluation of health hazards and audit checks, as well as actions FDA has taken in response to the early alert. We summarize the report’s findings and the policy initiatives Commissioner Gottlieb has announced in response to it in the post below.
The Food and Drug Administration (FDA) recently issued Draft Guidance on its interpretation of what constitutes a refusal of inspection by a foreign food establishment or foreign government. Though the target audience is foreign food establishments and foreign governments, the Draft Guidance provides insight into FDA’s perspective on the legal obligations that apply to all food facility inspections. In particular, FDA describes refusal to permit photography during an inspection as a refusal of inspection. We provide an overview of the Draft Guidance, including the various actions FDA considers to constitute a refusal of inspection and the repercussions when foreign food establishments or foreign governments refuse inspection. FDA requests that comments on the Draft Guidance be submitted by February 26, 2018.
On November 16, 2017, the Food and Drug Administration (FDA or the agency) issued a federal register notice soliciting comments on its Draft Guidance for Industry, “Best Practices for Convening a GRAS Panel.”
The Draft Guidance is intended for persons responsible for a conclusion that a substance may be used in food on the basis of the generally recognized as safe (GRAS) provision of the Federal Food, Drug, and Cosmetic Act (FFDCA) when that person convenes a panel of experts (GRAS panel) to independently evaluate whether the available scientific data, information, and methods establish that the substance is safe under the conditions of its intended use in human or animal food.
FDA is continuing to release resources intended to assist industry with implementation of the FDA Food Safety Modernization Act (FSMA). This post discusses four such documents that were released recently. First, FDA released Draft Guidance explaining the meaning of the phrase “solely engaged,” which is used in the regulations to establish several exemptions from the Preventive Controls for Human Food (PCHF) and Preventive Controls for Animal Food (PCAF) rules. Second, FDA finalized its Guidance on current Good Manufacturing Practice (cGMP) requirements for animal food. Third, FDA developed a training program for carriers who are subject to the Sanitary Food Transportation rule. Finally, FDA released a new web page that lists compliance dates for rules that form the foundation of FSMA.
October 25 – 27
Hogan Lovells Office, Beijing, China
The new Preventive Controls for Human Food regulation issued by the U.S. Food and Drug Administration (FDA) under the FDA Food Safety Modernization Act (FSMA) is the most significant change to food regulation since the 1930s. FDA has started conducting inspections for compliance with the rule, both domestically and internationally.
The rule requires that key food safety management activities must be completed by a “preventive controls qualified individual” who has “successfully completed training in the development and application of risk-based preventive controls.” This requirement typically applies even if a company is located outside of the U.S., so long as it manufactures food for U.S. consumption.
Hogan Lovells attorneys Maile Hermida (Partner) and Xin Tao (Associate), both Food Safety Preventive Controls Alliance (FSPCA) lead instructors for this regulation, will present the training program developed by the FSPCA. This is the “standardized curriculum” recognized by FDA. Successfully completing this course is one way to meet the requirement to become “preventive controls qualified individual.”
October 31, 2017
Listeria monocytogenes bacteria sickens an estimated 1,600 people each year and of those about 260 die. The dangers of Listeria foodborne illness impacting U.S. consumers are very real and the implications of an outbreak can be enormously costly to the food processing industry.
FDA is currently reviewing public comments to the “Draft Guidance to the Industry on Control of Listeria Monocytogenes” which was published in January 2017. The industry can expect final Guidance from FDA soon. The new Guidance coupled with the Preventive Controls for Human Food (PCHF) enforcement is already resulting in a much more targeted approach by FDA with focus on both industry and FDA environmental swabbing. Positive swabs for L. mono. or indicator organisms could trigger aggressive FDA enforcement action.
Join presenters representing FDA, attorneys from Hogan Lovells and an EAS Independent Consultant and internationally known research microbiologist for a webinar focusing on the challenges and new FDA regulatory requirements for the detection and elimination of L. mono. This will provide attendees with leading edge and cross-cutting information on regulatory expectations as well as control mechanisms for L. mono. With this information, the food processing industry can improve existing L. mono. control programs, ultimately benefiting the consuming public. This webinar shares the perspectives of the new FDA enforcement strategy (preventive) from FDA’s view, a microbiologist sharing the latest information about L. mono as well as food industry counsel’s view. It is a “must attend” event for anyone with responsibility for complying with FDA’s new enforcement approach.
What do we know today about the “new” dangers of Listeria? What key monitoring and corrective action measures should the industry pay attention to, adopt and implement and how can we turn today’s risk assessment results into a safer and proactive approach to Listeria control?
The Department of Health and Human Services’ Office of Inspector General (OIG) issued a report last week detailing the results of its review the Food and Drug Administration’s (FDA’s) inspection of domestic food facilities, as well as its advisory and enforcement actions taken in response to significant inspection violations. The key takeaway from the report is that FDA should do more to ensure the food supply is safe by taking “swift and effective action” to ensure facilities promptly correct problems identified during inspections. We summarize the OIG’s key findings and recommendations and also discusses how the report may affect facility inspections and subsequent agency actions in the future. Read more.
The Food and Drug Administration (FDA) has issued a proposed rule to extend the compliance date for the final rules revising the requirements for the Nutrition and Supplement Facts Labels and the declared serving sizes and reference amounts customarily consumed (RACCs). Under the proposed rule, the compliance date would be extended by about 18 months – from July 26, 2018 until January 1, 2020 for large manufacturers and from July 26, 2019 until January 1, 2021 for manufacturers with $10 million or less in annual food sales. If FDA finalizes the proposed extension, it will result in a total compliance period of about 3.5 years from the date the final rules were initially published (May 27, 2016). In comparison, a number of food industry trade associations requested a 5-year compliance period – i.e., a May 2021 compliance date – that would have allowed for harmonization with the mandatory disclosure standards for bioengineered foods that are being developed by the U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS).
There have been several notable recent developments involving FSMA implementation. Most significantly, FDA proposed to extend the compliance dates for the agricultural water provisions of the Produce Safety rule and announced it will delay the start of Produce Safety rule inspections until spring 2019. Additionally, FDA has issued another chapter of its Preventive Controls for Human
Foods (PCHF) draft guidance, which addresses the use of heat treatment process preventive controls.
In addition to summarizing these developments, this post also provides a reminder that the next round of FSMA compliance dates for the Preventive Controls rules is September 18, 2017. Read more.
The U.S. Food and Drug Administration (FDA) has issued a broad request for comment to assist the agency in identifying regulations and related paperwork requirements that it could modify, repeal, or replace to reduce the regulatory burden on the public. The request is specific to products within the jurisdiction of the Center for Food Safety and Applied Nutrition (CFSAN) (i.e., human food, dietary supplements, and cosmetics) and presents a unique opportunity for industry to identify regulations and/or information collection (paperwork) requirements that are outdated, ineffective, or unnecessary; impose costs greater than their associated benefits; or limit job creation.
FDA issued the request as part of its implementation of Executive Orders (EOs) 13771 and 13777. EO 13771, entitled “Reducing Regulation and Controlling Regulatory Costs,” states that it is the policy of the executive branch to be prudent and financially responsible in the expenditure of funds from both public and private sources and to manage the costs associated with the government imposition of private expenditures required to comply with federal regulations. EO 13777, entitled “Enforcing the Regulatory Reform Agenda,” directs each agency to establish a Regulatory Reform Task Force to evaluate existing regulations and make recommendations regarding their repeal, replacement, or modification. The information the public submits in response to the request for comment will supplement FDA’s review of its regulations.
This post summarizes FDA’s requests and the specified formatting and instructions for providing comments. Read more.