The U.S. Food and Drug Administration (FDA) recently finalized its  “Guidance for Industry: Determining the Number of Employees for Purposes of the ‘Small Business’ Definition in Parts 117 and 507 (CGMP and Preventive Controls Regulations for Human and Animal Food).” The Guidance is intended to help facilities determine whether they qualify as a “small business” for the purposes of Preventive Controls for Human Food (PCHF) and Preventive Controls for Animal Food (PCAF) regulations. Qualifying as a small business is significant because it may result in 1) exemptions from certain requirements for “farm mixed-type facilities” and 2) later compliance dates (which have already passed, with a few minor exceptions).

Notably, the Guidance explains that different entities within the same corporate structure may have different statuses under the rules (i.e., one entity could qualify as a small business while another does not). This memorandum provides a high-level summary of the Guidance, and we encourage any company claiming status as a small business to read the Guidance closely to confirm it is performing the analysis consistent with FDA’s expectations.

Click here to read more.

Yesterday, FSIS issued its long-awaited guidance on the labeling and packaging of “kit” products. Although FSIS has long informally applied its “kit policy,” this FSIS Compliance Guideline marks the first public guidance that FSIS has provided on the topic. The Compliance Guideline generally reflects the Agency’s informal policy without significant change.

Under its kit policy, FSIS allows certain multi-component products containing a separately packaged meat or poultry component to be assembled and labeled without FSIS inspection, provided the product and label meet certain requirements. Importantly, the kit policy exempts these products from FSIS inspection and label approval, but FSIS still has jurisdiction over the products. The Agency is currently requesting comments on the Guideline. However, FSIS is encouraging industry to begin using the guidance immediately.

Click here to read more. 

FDA recently released a Draft Guidance for Industry entitled, “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting” (“Draft Guidance”). The Draft Guidance addresses the growing, harvesting, conditioning, and holding of seed for sprouting.

The Draft Guidance notes that the FDA has reported 50 outbreaks of foodborne illness associated with sprouts in the last 22 years, resulting in approximately 2,600 illnesses. The agency suggests “contaminated seed is the likely source of most sprout-related outbreaks.” Although seeds for sprouting are not covered by the Produce Safety Rule, FDA clarifies that seeds are nonetheless considered “food” under the Federal Food, Drug, and Cosmetic Act (FFDCA), which makes growers, holders, conditioners, and distributors responsible for taking steps reasonably necessary to prevent adulteration.

Click here to read more. 

The Office of Management and Budget (OMB) recently released the Spring 2019 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.

Click here to read more. 

On June 18, the Food and Drug Administration (FDA) issued its final guidance document on added sugars labeling for (1) honey, maple syrup, and other single-ingredient sugars and syrups; and (2) certain cranberry products. In this blog post, we summarize the FDA’s guidance on the added sugars declaration for each type of product. Notably, for both types of products, FDA is exercising enforcement discretion until July 1, 2021, for implementation of the updated Nutrition Facts labeling rules. This is effectively an 18-month extension from the January 1, 2020 compliance date for larger manufacturers.

Click here to read more.  

The U.S. Food and Drug Administration (FDA) reached a settlement with the two consumer groups that sued FDA in October 2018 to compel the agency to implement the traceability provisions in the FDA Food Safety Modernization Act (FSMA). The consent order, which was approved by the district court judge on June 11, 2019, establishes a timeline for FDA to publish a list of high-risk foods and engage in rulemaking setting forth additional traceability recordkeeping 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). This memorandum provides background on the FSMA traceability provisions and then summarizes the consent order. As explained in more detail below, FDA is committing to designate the list of high-risk foods and issue a proposed rule that would establish recordkeeping requirements for these foods by September 8, 2020, and then issue the final rule by November 7, 2022.

Click here to read more.

On May 23, the Food and Drug Administration (FDA) issued a letter to the food industry “strongly support[ing]” the use of “Best If Used By” labeling to describe the date when a food will be at its best flavor and quality. FDA believes that standardizing the use of date labels for quality reasons will be one helpful step in reducing food waste. Importantly, date labeling is generally not required at the federal level other than for infant formula. It is, however, required by some states. The FDA guidance indicates that when date labeling is used for quality reasons, the recommended introductory phrase is “Best If Used By” – the same phrase recommended by a voluntary industry labeling initiative spearheaded by the Grocery Manufacturers Association (GMA) and the Food Marketing Institute (FMI).

The letter starts by noting that approximately 30 percent of food is lost or wasted at the retail and consumer level, amounting to approximately 133 billion pounds of food worth $161 billion each year. FDA has found that food waste by consumers can result from fears about food safety caused by misunderstanding around what the introductory phrases on product date labels mean (e.g., “Best If Used by,” “Use By,” and “Sell By”), along with uncertainty about the storage of perishable foods. The agency cites a source estimating that confusion over date labeling accounts for approximately 20 percent of consumer food waste.

Click here to read more.

Today the Food and Drug Administration (FDA) issued draft guidance announcing that the agency intends to exercise enforcement discretion to allow the use of “potassium chloride salt” as an alternative common or usual name for “potassium chloride.” Potassium chloride is often used as a partial substitute for sodium chloride (i.e., salt) to facilitate sodium reduction in foods. FDA therefore views today’s draft guidance as consistent with its multi-year Nutrition Innovation Strategy, which aims to reduce the burden of chronic disease through improved nutrition, as well as the agency’s efforts to encourage manufacturers to reduce sodium in foods in the interest of public health. FDA will accept comments on the draft guidance until July 19.

Click here to read more. 

The Office of Management and Budget (OMB) recently issued an updated memorandum to the heads of executive departments and agencies entitled, “Guidance on Compliance with the Congressional Review Act” (2019 Memo). The 2019 Memo, effective on May 11th, “reinforces the obligations of Federal agencies” under the Congressional Review Act (CRA) to submit rules to Congress, and also clarifies when a rule is to be considered “major” by OMB’s Office of Information and Regulatory Affairs (OIRA). The criteria and process the 2019 Memo sets for triggering OIRA “major” designation are the more significant aspect of the document, as they have the potential to noticeably impact FDA issuance of guidance documents.

Click here to read more.

We are writing this memo to bring to your attention that the Food and Drug Administration (FDA) recently published a new final guidance titled: “Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk” (FCN Guidance). The guidance contains recommendations regarding how the scientific information in food contact notifications (FCNs) for infant food use should demonstrate that the food contact substance (FCS) is safe for the specific intended use in contact with infant food. FDA has previously provided guidance for the safety assessment of FCSs. However, the earlier guidance document did not specifically address dietary exposure and safety assessment considerations related to the migration of chemical substances from packaging and other food contact articles as it pertains to infants. FDA meant to fill the gap with this new guidance and the FCSs that would be affected by this guidance document include infant formula packaging for liquid and powdered formula, baby bottles, bottle inserts, nipples, and any other materials that are in contact with infant food.

In this post, we highlight the FDA’s chemistry and toxicology recommendations. Click here to read more.