• On June 15, 2023, FDA released its findings from a sampling assignment that collected and tested 747 refrigerated ready-to-eat (RTE) dips for the presence of Listeria monocytogenes and Salmonella spp. The Agency detected Listeria monocytogenes in three dip and cheese spread samples, and Salmonella spp. in one hummus sample.
  • This assignment is part of FDA’s risk-based approach to food safety outlined in the Food Safety and Modernization Act (FSMA) and was conducted in response to previous outbreaks in 2017 and 2019 that may have contributed to three deaths. The Agency noted the increased consumer consumption of RTE dips and spreads, their susceptibility to bacteria growth due to ideal pH and water activity levels, and consumption without a “kill step” (e.g., cooking, frying, pasteurization, etc.) contribute to the significant public health risk of such products.  
  • FDA specifically indicated all three Listeria monocytogenes contaminated products originated from the same manufacturer due to the absence of effective sanitation controls. The Agency recalled such products and underscored the benefits of adhering to good manufacturing practices (GMPs) and implementing preventative controls. FDA is reviewing the results of the assignment to identify common factors or patterns related to contamination of RTE dips and spreads, develop guidance, and update program priorities.
  • Keller and Heckman will continue to monitor developments in this space.
  • On June 8, 2023, GOOD Meat, the cultivated meat division of food technology company Eat Just Inc., became the first company to receive label approval from the U.S. Department of Agriculture (USDA) for its cultivated meat.
  • The label will use the term “cell-cultivated” although GOOD Meat and others in the industry prefer the term “cultivated” which we have previously discussed.
  • FDA and USDA share regulatory jurisdiction over cell-cultivated meats as detailed in a 2019 memorandum of understanding between the agencies. Following a voluntary pre-market consultation evaluating GOOD Meat’s production process, FDA issued GOOD Meat a “No Questions Letter.”
  • The next and final step in the regulatory review process before GOOD Meat’s cultivated chicken can go to market in the United States is for the company to receive grants of inspection from the USDA for the firm’s plant in Alameda, California, and its contract manufacturing partner, JOINN Biologics in Richmond, California.
  • GOOD Meat had previously obtained regulatory approvals for its cell-cultivated chicken in Singapore.
  • On June 14, 2023, Upside Foods became the second company to receive regulatory approval from the USDA for its label on cell-cultivated chicken. In November 2022, FDA completed the first pre-market consultation for human food made from cultured animal cells for Upside Foods, which was the first company to receive a “No Question Letter” from FDA.
  • Keller and Heckman will continue to monitor and report on regulatory developments of cell-cultivated meat.
  • On June 15, the FDA published a 30-day procedural notice on its plans to conduct a study about front of package (FOP) labeling, entitled “Quantitative Research on Front of Package Labeling on Packaged Foods.” The study is a follow up to focus groups that were conducted in 2022 that tested FOP concepts and draft FOP schemes.
  • The study will have two main parts: (1) a within-scheme comparison and identification of healthfulness profile and (2) a single-product (and scheme) evaluation. In Part 1, study participants will be given three levels of healthfulness (most, middle, and least healthful) on FOP draft schemes and will be asked to identify the most and least healthful profiles. In Part 2, participants will be randomly assigned to either a food product, scheme type, or level of healthfulness, and will be asked to use the label image to respond to various measures of the label’s effectiveness based on product perceptions (e.g., healthfulness and contribution to a healthy diet) and label perceptions (e.g., believability and trustworthiness).
  • The FDA is exploring the development of an FOP system to help consumers interpret nutrition information on food products. FOP labeling is intended to complement the Nutrition Facts Panel labeling by giving consumers additional context to identify healthier food selections. In the notice, the FDA states that “[t]he experiences of countries worldwide that have adopted front-of-package labeling suggest that such labeling may help nutrition comprehension and the ability to make healthier choices.”
  • Stakeholder comments are due by July 17, 2023. Please feel free to contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments.
  • On Tuesday, June 13, 2023, the House Judiciary Subcommittee held a hearing titled: “Where’s the Beef? Regulatory Barriers to Entry and Competition in Meat Processing” to examine how various aspects of government regulation may impede the development of a more competitive meat industry.  The subcommittee explored the potential impact on competition, should smaller entrants be subjected to less onerous food inspection requirements and be permitted to sell state-inspected meat across state lines.
  • As our readers recall, the spread of COVID-19 closed many meat and poultry processing facilities.  However, in 2022, the U.S. Department of Agriculture (USDA) made available $215 million in grants and other support to promote the competition, accessibility, and expansion of the meat and poultry industry, especially in rural America.  However, the three farmers who testified at Tuesday’s hearing alleged that certain regulations and USDA’s  inspection requirements tend to disadvantage smaller processing businesses.  The farmers urged the subcommittee to allow small operators to forego certain federal inspection regulations.
  • At this time, 21 U.S.C. § 623(a) only exempts custom slaughterhouses from inspections but only if the meat is for personal, household, guest, or employee use. 
  • On April 25, 2023, Thomas Massie, R-KY, and Chellie Pingree, D-ME reintroduced the Processing Revival and Intrastate Meat Act (PRIME). The PRIME Act exempts custom slaughter facilities from animal slaughter and carcass preparation inspections, regardless of use.  In the Senate, Angus King, I-ME, and Rand Paul, R-KY, introduced the companion legislation, PRIME, on March 22, 2023. Massie and Pingree urged members to adopt this legislation at the Tuesday meeting.
  • Keller and Heckman will continue to monitor and relay any changes in meat and poultry regulations.
  • FDA considers tattoo inks to be subject to regulation as cosmetics because they are “articles intended to be … introduced into, or otherwise applied to the human body . . . for cleansing, beautifying, promoting attractiveness, or altering the appearance.” See 21 USC 321(i) definition for cosmetics. However, unlike typical cosmetics, tattoo inks are directly injected into a consumer’s skin by piercing the protective dermal skin barrier. Any puncture of the barrier increases the risk of infection and can lead to rashes, lesions, and scarring, among other potential health consequences. 
  • Tattoo ink manufacturers are responsible for ensuring that the ink has not been manufactured under insanitary conditions which may render the ink injurious to health. See 21 USC 361 (“Adulterated Cosmetics”). With approximately 30% of people living in the United States having a tattoo, the FDA has acknowledged the importance of taking necessary steps to ensure tattoo inks are manufactured under sanitary conditions.
  • To that end, on June 13, 2023, FDA issued draft guidance recommending steps manufacturers and distributors of tattoo ink can take to avoid microbial contamination. Recommendations in the draft guidance include testing the ink and its components, conducting adequate cleaning and sanitation of manufacturing equipment, ensuring sterilization methods are validated, and establishing corrective measures to prevent the release of any tattoo ink that testing shows contains microorganisms of a type or at a level that may harm any consumer.   
  • Under the Modernization of Cosmetics Regulation Act of 2022 (see p. 1389 of 1653), the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label is required to report any “serious adverse event” associated with the use of the product to FDA. FDA is also required to establish good manufacturing practice (GMP) regulations for cosmetics under that law but has not yet done so. Further discussion of the implications of this law can be found here.
  • FDA is accepting comments on the draft guidance until September 11, 2023.

2nd Circ. Affirms Toss Of Heavy Metal Pet Food Case (Law360 Subscription Required)

  • In May 2017, following a poor rating of its premium-priced dog food by the Clean Label Project, Champion Petfoods released a white paper disclosing the levels of heavy metals in its products and reporting these were well within ranges for arsenic, cadmium, lead, and mercury deemed acceptable for dog foods by the National Research Council and FDA.  Then on October 16, 2018, a proposed class action lawsuit filed in New York federal court alleged that Champion Petfoods’ Acana and Orijen pet foods contain heavy metals known to pose health risks to humans and animals even though the foods are advertised as fit for humans.  The plaintiff did not allege that Champion’s pet foods were unsafe or harmed her pets but maintained that she would not have purchased Champion’s products at their retail prices if she had known that they contained heavy metals.  The district court granted summary judgment for Champion in dismissing all heavy metal fraud-by-omission claims on March 31, 2022.
  • On June 6, 2023, the Second Circuit upheld the trial court’s judgment in an order stating, “the factual record establishes that a reasonable consumer could have discovered that Champion’s pet foods had a material risk of containing some measurable amount of heavy metals” and the plaintiff failed to show that “the business alone possesses” this information, as required under the law.  Further, while acknowledging “the importance of consumer labeling, especially as it relates to food for both humans and pets alike,” the appeals court said that it is up to Congress or a federal agency such as FDA to determine what is disclosed on food labeling. 
  • The appeals court did state that if the plaintiff had claimed that Champion’s pet foods contained quantities of heavy metals in excess of safe thresholds, then that could be information that “the business alone” possessed.  This underscores a significant obstacle in other heavy metals litigation where plaintiffs have been unable to demonstrate that the unavoidable presence of heavy metals in low amounts renders the food inedible or unsafe to consume. 
  • On Monday, June 5, 2023, Saraya USA (Saraya) was denied its motion to dismiss a class action lawsuit that claimed it falsely advertises its granola as being “monk fruit sweetened” or “sweetened by monk fruit.”  U.S. District Judge Orrick found that it was possible for consumers to believe monk fruit was the sole or predominant sweetener, since “no other sweetener is mentioned on the front of label.”
  • In the complaint, the plaintiff Scott alleged that the granola product labels are deceptive because the granola is not entirely or predominantly sweetened with monk fruit and is instead predominantly sweetened with erythritol, which the complaint claims causes digestive problems and is linked to increased risk of heart attacks and stroke.  Monday’s order stated that, “Scott has plausibly alleged that these statements, read alongside the statements ‘sugar free,’ ‘no sugar added,’ or ‘zero sugar’ also appearing on the products’ front labels, would mislead a reasonable consumer to believe that they were solely or predominantly sweetened with monk fruit.”
  • Saraya, in its motion to dismiss, claimed that nowhere on the product label does it state the product is solely or predominantly sweetened by monk fruit, nor did it claim that the specific amount of monk fruit is in it.  Saraya also claimed the ingredient list specifically said the granola contained monk fruit sweetener, erythritol, and monk fruit extract.
  • Judge Orrick disagreed with Saraya’s argument, stating that, because no other sweetener was mentioned on the front of label, a consumer would reasonably be misled into thinking that monk fruit is the sole sweetener used.
  • Keller and Heckman will continue to monitor and report on this case and similar class action challenges.
  • On June 1, a group of bipartisan lawmakers led by Senator Mike Lee, R-UT, introduced the Formula 3.0 Act which would permanently remove tariffs and other trade restrictions on imported infant formula base powder. This bill follows the expiration of the Formula Act, an emergency measure signed into law by President Biden in July 2022 that temporarily removed tariffs on infant formula in response to the nationwide infant formula shortage. Proponents of the bill said the Formula 3.0 Act aims to address vulnerabilities in the domestic infant formula market highlighted by the shortage last year.
  • As our readers likely recall, FDA issued a recall of powdered infant formula originating from Abbott Nutrition’s facility in Sturgis, Michigan in February 2022. At the time, the Abbott facility supplied 40% of the nation’s infant formula. The recall and subsequent shutdown of the facility resulted in a monthslong infant formula supply shortage which drew attention to vulnerabilities in the domestic supply and to high tariffs and other obstacles imposed on imported infant formula.
  • According to a 2022 report from the Congressional Research Service, imports of infant formula have increased substantially over the last decade, accounting for approximately 4.3 million kilograms (valued at $28.8 million) of domestic consumption in 2021. The most-favored-nation (MFN) tariff rate for these products typically ranges from 14.9% to 17.5%. Though tariffs were temporarily waived by the emergency measures enacted in July 2022, these measures have since expired.
  • Keller and Heckman will continue to monitor developments on issues pertaining to infant formula.
  • On June 1, 2023, the FDA announced a final guidance for industry titled “Action Level for Inorganic Arsenic in Apple Juice.” The final guidance adopts an action level of 10 parts per billion (ppb) for inorganic arsenic in apple juice, which is the same action level as initially proposed in the agency’s July 2013 draft guidance. The final guidance reflects FDA’s continued efforts to reduce levels of heavy metal contaminants in food commonly consumed by babies and young children.
  • Inorganic arsenic is associated with adverse human health effects such as cancer, skin lesions, diabetes, detrimental birth effects, and cardiovascular and neurodevelopment toxicity. Although current FDA testing indicates an overall reduction of inorganic arsenic in apple juice, with many samples testing below 5 ppb, the agency considers a 10 ppb level to be protective of public health and widely achievable within the industry. The guidance is not legally binding and therefore if apple juice is found to contain inorganic arsenic above the action level, FDA will consider the level in addition to other factors, such as the agency’s “confidence in a measured analytical value,” to determine whether the food is adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1)).
  • Possible sources of inorganic arsenic in apple juice include “processing aids, prior use of arsenic based pesticides on land currently used for apple orchards, current use of arsenic-based pesticides in other countries, naturally high levels of arsenic in soil or water, atmospheric deposition from industrial activities” and “water used by manufacturers to dilute concentrate to prepare ready-to-drink juice.” FDA notes manufacturers may lower the level of inorganic arsenic in their apple juice by sourcing from apples or apple juice concentrates with lower inorganic arsenic levels, controlling the amount of inorganic arsenic in the water used to dilute concentrate, or changing filtering aids used to filter juices.
  • Keller and Heckman will continue to monitor the developments in FDA’s efforts to reduce heavy metal levels in food.
  • A high-level internal working group that FDA convened to explore potential regulatory pathways for cannabidiol (CBD) products announced by way of a January 26, 2023 statement that existing regulatory pathways are not appropriate for CBD.  As reported on this blog, the FDA working group examined studies related to the CBD-based drug Epidiolex, published scientific literature, information submitted to a public docket, as well as studies conducted and commissioned by FDA, and concluded it is “not apparent how CBD products could meet the safety standards for dietary supplements or food additives.”  FDA’s January statement also announced that the Agency is prepared to work with Congress on legislation to create a new CBD-specific regulatory pathway that is necessary to move forward. 
  • On May 25, 2023, in the last of three webinars intended to address lingering questions following its January statement, FDA reiterated that it is up to Congress to create a legal status for CBD and other hemp-derived cannabinoids.  FDA’s Stakeholder Webinar: “A New Way Forward for Cannabidiol (CBD) and Other Hemp Products” outline the factors that lead FDA to conclude statutory barriers prevent the regulation of these products as a food or dietary supplement.  Specifically, FDA cited CBD’s inherent risk profile (e.g., liver injury, interactions with certain medications, and possible harm to the male reproductive system) and the limited risk management options for the food ingredient and dietary supplement pathways (i.e., the inability for FDA to weigh any potential benefits against the safety risks).  FDA’s webinars advocate for the creation of a “harm reduction” approach for regulating CBD and other hemp-derived cannabinoids that would permit the Agency to set rules addressing known issues with current products, e.g., variable CBD content, incomplete ingredient labeling, contamination, and the risk of ingestion by children.  While recognizing the growing popularity of CBD and other hemp products, FDA insists it can take the harm reduction approach only if Congress enacts legislation for a specific new regulatory framework. 
  • Although there has been bipartisan interest in breaking the current stalemate, the timing for any new legal framework for CBD is unclear.  For the foreseeable future, FDA will continue to monitor the market and target enforcement efforts at products that pose the greatest risks.  Examples noted in FDA’s webinar slides are unapproved new drugs that purport to contain CBD, products that have been associated with serious adverse events, and products that are packaged and labeled to resemble cereal, candy and cookies that appeal to children.