The FDA on June 20 issued the first four chapters of a nine-chapter draft guidance titled “Mitigation Strategies to Protect Food Against Intentional Adulteration” (IA Draft Guidance). The IA Draft Guidance is intended to assist industry in developing and implementing a “food defense plan” (FDP) in accordance with the “Mitigation Strategies to Protect Food Against Intentional Adulteration” Final Rule (IA Rule). The IA Rule requires domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to address hazards that may be introduced with the intention to cause wide-scale public health harm by developing said FDP.
The US Department of Agriculture’s Food Safety Inspection Service (FSIS) recently released a new guideline in an effort to clarify whether or not a firm is exempt from the inspection requirements under the Federal Meat Inspection Act (FMIA). A copy of the guideline can be found here.
The guideline is effective immediately; however, FSIS provided the public 60 days to comment on the proposed rule, which closes on Monday, July 24, 2018. Anyone can submit their comments online here.
The new FSIS guideline specifies criteria and notes for familiar exemptions under traditional business models, such as livestock slaughtered for personal use, custom slaughtered or prepared livestock, retail stores, restaurants, central kitchen facilities, and caterers. As discussed in further detail below, the document essentially codifies established agency practice.
Three years after FDA’s final rule on menu labeling was published, the compliance date for the rule finally went into effect on May 7. The federal menu labeling rule requires that calorie information—which is already included on most packaged foods—must be posted on menus and menu boards in chain restaurants.
The menu labeling requirements apply to retail food establishments that are part of chains with 20 or more locations. “Covered establishments” must post the following on menus and menu boards:
- The number of calories contained in standard menu items
- The statement: “2,000 calories a day is used for general nutrition advice, but calorie needs vary.”
- The statement: “Additional nutrition information available upon request.”
The Food and Drug Administration (FDA) on Thursday announced the details of its planned delay to require manufactures to update Nutrition Facts and Supplement Facts labels on food packaging. The finalized rule extends the compliance dates for manufactures with $10 million or more in annual food sales from July 26, 2018, to January 1, 2020, while compliance dates for manufactures with less than $10 million in annual food sales will move from July 26, 2019, to January 1, 2021. As we previously discussed, FDA had announced last year that it was extending the compliance date to an undetermined time around the same time FSIS’s Nutrition Facts Panel proposed rule was placed on the list of “inactive” regulations by the White House Office of Management and Budget.
FDA explains in the final rule that the additional time will “help ensure that all manufacturers covered by the final rules have guidance from FDA to address, for example, certain technical questions [FDA] received after publication of the final rules, and that [manufacturers] have sufficient time to complete and print updated Nutrition Facts labels for their products before they are expended to be in compliance with the final rules.” Notably, FDA’s announcement came on the same day the US Department of Agriculture (USDA) published its much-awaited proposed rule establishing a National Bioengineered Food Disclosure Standard. UDSA’s labeling disclosure requirements will potentially require additional modifications to some types of labels. Therefore, FDA’s extension of the Nutrition Facts labels may more closely align the two compliance dates and possibly eliminate the need to change the labels twice.
Since our last post, more than 41 comments have been submitted in response to the US Cattlemen’s Association’s petition (USCA Petition) requesting that the USDA FSIS exclude from the statutory definitions of “meat” and “beef” those products that are not “derived from animals born, raised, and harvested in the traditional manner.” Such excluded products would presumably include plant-based products that resemble the appearance and taste of beef products and cell-cultured meat (CCM). While an exhaustive analysis of the submitted comments is beyond the scope of this article, we would like to highlight two comments we found interesting. We also would also like to highlight a separate but related approach taken by Rep. Rosa DeLauro (D-Connecticut), to understand how best to regulate these innovative food products.
In a petition (USCA Petition) submitted to the Food Safety and Inspection Service (FSIS) on February 9, the US Cattlemen’s Association requests that FSIS exclude from the statutory definitions of “meat” and “beef” those products that are not “derived from animals born, raised, and harvested in the traditional manner.” Such excluded products would presumably include plant-based products that resemble the appearance and taste of beef products and cell-cultured meat (CCM)—meat grown in a cell culture instead of culled from an animal (jointly, Alternative Products). The USCA Petition presents the following assertions to support such exclusions:
- Alternative Products, it maintains, do not meet the common dictionary or statutory/regulatory definitions of “meat,” “beef,” and related terms because the definitions contemplate products derived naturally from animals.
- The marketing of Alternative Products is potentially misleading because consumers would reasonably expect products labeled as “meat” and “beef” to be derived from animals slaughtered in the traditional manner.
In almost any area where an emerging technology intersects with a highly regulated industry, there is a dynamic of entrepreneurial spirit facing the realities of existing regulatory frameworks. One novel product facing this dilemma is “cell-cultured meat” (CCM)—meat grown in a cell culture instead of culled from an animal.
CCM is part of a new and emerging area of biotechnology known as “cellular agriculture” through which agricultural products are produced from the cellular level rather than taken from the whole plant or animal. Proponents of cellular agriculture highlight the process as creating a more sustainable, efficient, and predictable food supply, and the National Academy of Sciences estimates products of cellular agriculture will be in the marketplace within the next five years.
On February 6, the Agriculture Marketing Service (AMS) posted a notice in the Federal Register announcing it will delay further rulemaking on a Federal Milk Marketing Order (FMMO) in California while it awaits the US Supreme Court’s decision in Lucia v. Securities & Exchange Commission. On January 12, 2018, the Supreme Court granted certiorari to resolve a circuit split between the US Court of Appeals for the Tenth Circuit and for the DC Circuit.
Lucia calls into question whether administrative law judges (ALJs) working for the SEC are “inferior officers” under the Constitution and therefore fall under its Appointments Clause, which arguably mandates that ALJs be appointed by the president, a court, or a department head. While the immediate impact on the US Department of Agriculture’s (USDA’s) announcement will frustrate California dairy farmers, the broader impact is that a wide range of administrative proceedings within the USDA have been placed in abeyance pending Supreme Court action.
ALJs at USDA, like many other agencies, are not appointed but are chosen through a somewhat independent merit-based hiring system. If the Supreme Court in Lucia determines that such ALJs still function as government employees, the current selection process would be constitutional. But if it determines that ALJs have the power and responsibilities of “inferior officers,” they must be appointed by the president or an agency head to be constitutional.
An appellate court recently upheld the convictions of former employees of the now defunct Peanut Corporation of America (PCA), affirming what is the longest criminal sentence in a food safety case. Specifically, on January 23 the US Court of Appeals for the Eleventh Circuit unanimously denied the appeals of former PCA president Stewart Parnell, who was sentenced to serve 28 years in prison; his brother and peanut broker Michael Parnell, who was sentenced to serve 20 years; and PCA’s quality assurance director Mary Wilkerson, who was sentenced to serve 5 years.
In 2009, the peanut processing company was identified as the source of a massive salmonella outbreak in the United States, which led to an extensive recall. More than 700 individuals were reported to have salmonella poisoning that was linked to the outbreak, and there were at least nine deaths. On February 13, 2009, PCA ceased all manufacturing and business operations, and filed for Chapter 7 bankruptcy liquidation.
On November 15, the US Food and Drug Administration (FDA) published a draft guidance on best practices to help parties interested in convening a panel of experts to evaluate whether a substance is “generally recognized as safe” (GRAS) under the conditions of its intended use.
As previously discussed, the FDA last year published a Final Rule on the GRAS notification program, a voluntary premarket notification program for products used in food substances (GRAS notification procedure). This Final Rule was promulgated 19 years after the FDA established the “interim” GRAS notification program in a Proposed Rule.