FDA

Subscribe to FDA

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently issued a statement affirming that Produce Safety Rule inspections will begin this spring. Last year FDA chose to delay routine inspections to allow more time for farmers and state regulators to receive training on the rule. Routine inspections for large farms (i.e., farms with more than an average $500,000 in produce sales during the previous 3-year period) were delayed until spring 2019, and routine inspections for small farms, other than sprouts operations, were delayed until spring 2020. In his statement, Commissioner Gottlieb confirmed that routine inspections for large domestic and foreign farms will commence this spring, as planned.

FDA also has established a Produce Inspections webpage to serve as a central location for farms and state partners to find resources related to inspections. The webpage includes a new Fact Sheet with information on what farms should expect of their first inspection. It also includes new documents to be used during Produce Safety inspections, including the recently developed inspectional observation form and a procedure for dispute mitigation and resolution.

This blog briefly summarizes the fact sheet and new inspection documents, including FDA Form 4056 and Produce Safety Dispute Mitigation and Resolution Procedures. Click here to read more.

The U.S. Food and Drug Administration (FDA) has issued final Guidance regarding Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C. The document makes limited changes to the Draft Guidance that was issued in January 2018. The Guidance outlines circumstances when a company should issue a public warning about a voluntary recall, describes the general timeframe for companies to issue such a warning, discusses what information should be included in a public warning, and describes situations where the FDA may take action to issue its own public warning should a company’s warning be deemed insufficient. The document’s recommendations apply to all voluntary recalls, including both firm-initiated and FDA-requested recalls, and covers foods and dietary supplements (as well as all other FDA-regulated products).

This blog provides background for FDA’s development of the Guidance, as well as a high-level summary of the Guidance’s recommendations. Click here to read more.

What are the 3 letters that should strike fear into the heart of every food executive?  No, the 3 letters are not F-D-A.  Although the Food and Drug Administration is quite powerful, the agency can only wield that power against a particular food company ­­­­when it has the evidence to do so.

The 3 letters we are referring to are W-G-S – which stands for Whole Genome Sequencing – because this new scientific tool can give FDA that evidence – indeed, compelling evidence that a food needs to be recalled and, potentially, that a food facility needs to be shut down.  In this way, WGS is truly revolutionizing food safety.

Here is what we mean.  Even though there are hundreds of types of Salmonella – the most prevalent pathogen – each individual Salmonella strain found has its own unique gene sequence.  Think of it like a super fingerprint.

Click here to read more.

Please join us at 2 p.m. on Tuesday, February 26 for a webinar on the regulatory landscape for hemp-derived products, including cannabidiol, or CBD.

Martin J. Hahn and Samantha Dietle will provide an overview of the impact that changes to the Farm Bill will have on the FDA regulation of hemp and hemp-derived ingredients, as well as the Food and Drug Administration’s authority to regulate the use of hemp-derived ingredients in FDA-regulated foods, dietary supplements, and cosmetics.

Delia A. Deschaine will explore the Drug Enforcement Agency’s historical regulation of cannabis-derivatives under the Controlled Substances Act and the unique issues presented by the development of cannabis-derivatives as approved new drugs under the DEA’s and FDA’s authority.

Please click here to register for this complimentary webinar. 

As previously reported, the Food and Drug Administration (FDA) and the U.S Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) are operating under significantly reduced functions since funding for the agency lapsed on December 22, 2018. Recently, there have been a number of media reports with updated information from FDA Commissioner Gottlieb regarding the scope of FDA food facility inspections during the government shutdown, which is summarized in this memorandum. We will continue to monitor major developments related to the scope of FDA’s food safety activities during the government shutdown; food companies may also wish to follow Commissioner Gottlieb’s Twitter account for the most recent developments on this issue. In a related update, we understand that FSIS is now in the process of reviewing label submissions in a limited capacity.

Click here to read more. 

On December 22, 2018, funding expired for certain agencies within the federal government, including the Food and Drug Administration (FDA), the U.S. Department of Agriculture’s (USDA’s) Food Safety Inspection Service (FSIS), and the Consumer Product Safety Commission (CPSC). These agencies will be operating under significantly reduced functions until the shutdown ends, i.e., until Congress passes a new appropriations bill providing funding for these agencies. This post provides a summary of the scope of each of these agencies’ operations during the shutdown, as well as the implications for the food and other consumer product industries.

Click here to read more. 

The Food and Drug Administration (FDA) recently issued technical amendments to the final rule revising the nutrition labeling requirements. These technical amendments restore provisions that were inadvertently omitted when the new regulations were published, correct errors in FDA’s sample Nutrition Facts Panel (NFP) and Supplement Facts Panel (SFP) formats, and update cross references that were not updated when the new rules were issued. This post highlights the key changes affected by the technical amendments.

Click here to read more.

The California legislature has passed a law amending the state’s slack-fill statute for food containers subject to the Federal Food, Drug and Cosmetic Act (FFDCA). Assembly Bill 2632 (AB 2632), which Governor Jerry Brown signed into effect on September 19, 2018, revises the slack-fill statute by creating four new so-called “safe harbor” provisions, under which empty space in a container is not considered nonfunctional slack-fill. These new safe harbor provisions provide additional clarity on the types of food packages that will not be considered to contain nonfunctional slack-fill and may provide some relief to the food industry from the recent surge in purported class law suits seeking damages for allegedly slack-filled packaging. This memorandum summarizes the changes to the state slack-fill statute.

Click here for more information.

The U.S. Food and Drug Administration (FDA) last month announced it would exercise enforcement discretion over two qualified health claims characterizing the relationship between the reduced risk of coronary heart disease (CHD) and the consumption of oleic acid in edible oils (containing at least 70 percent of oleic acid per serving) when consumed in place of saturated fats (SFA). Oleic acid is the most common monounsaturated fatty acid (MUFA) and can be found naturally in numerous food sources, including edible oils, meat, cheese, nuts, seeds, eggs, pasta, milk, olives, and avocados. Oleic acid has been used as food or as components of food, such as olive oil, by man for many years, and has been approved as a direct additive to foods.

Click here to read more.

This week, the Food Safety Preventative Controls Alliance (FSPCA) released the online course “Conducting Vulnerability Assessments Using Key Activity Types” (KAT Course). This course satisfies the training requirement in the Mitigation Strategies to Protect Food Against Intentional Adulteration final rule (IA rule) to conduct a vulnerability assessment if using the Key Activity Types method. Below, we review the requirements for “qualified individuals” in the IA rule and provide additional details on the training courses available now and forthcoming from FSPCA.

Click here to read more.