• On November 1, the FDA published a proposed rule which would amend the prior notice regulations to:
    • Require that prior notice for articles of food and feed arriving by international mail include the name of the mail service and a mail tracking number; and
    • Require prior notice and food facility information be submitted within a certain timeframe after certain notices of refusal or holds have been issued.
  • “Prior notice” refers to the information that must be provided to the FDA in advance of the arrival of food at the U.S. border. The FDA uses prior notice information to determine what products should be inspected upon arrival. As stated in their press release, to effectively carry out the Agency’s responsibilities to detect food articles offered for import that violated FDA requirements, the FDA must be able to identify and inspect food items imported via international mail. Knowing the name of the mail service and tracking number would enable the FDA to better coordinate with the U.S. Postal Service (USPS), U.S. Customs and Border Protection (CBP), and other agencies to track and inspect articles that have been identified as a possible bioterrorism risk.
  • Additionally, requiring a timeframe for post-refusal and post-hold submissions may reduce the amount of time food articles subject to refusal or holds are held at ports which would also reduce associated monetary charges. It may also help limit the need for the FDA to review multiple and duplicative submissions.
  • Stakeholders may submit comments on this proposed rule until January 30, 2024. Keller and Heckman will continue to monitor any revisions to the prior notice regulations.
  • On October 24, FDA released a revised draft guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.” This draft guidance supersedes the 2014 draft guidance “Distributing Scientific and Medical Publications on Unapproved New Uses—Recommended Practices.”
  • The draft guidance pertains to approved/cleared medical products, including certain medical devices, human drugs, and animal drugs.
  • The revised guidance provides information relating to firms, i.e., “persons legally responsible for the labeling of medical products,” communicating about scientific information on unapproved uses (SIUU) to healthcare providers. SIUU communications must be truthful and non-misleading, and FDA proposes not to use communications consistent with the guidance alone as evidence of a new intended use requiring premarket authorization.
  • The draft guidance answers questions about appropriate source publications, necessary information, presentation considerations, and other general recommendations for SIUU. Source publications should be scientifically sound and clinically relevant. In addition to being truthful and non-misleading, SIUU should “provide all information necessary for HCPs to interpret the strengths and weaknesses and validity and utility” of the information. The communications should be clear, objective, distinct from promotional language about approved use, and shared on appropriate media.
  • FDA is also seeking comments on two specific questions related to the guidance regarding considerations unique to communications of SIUU to researchers and any other factors firms should consider when sharing presentations to healthcare providers.
  • FDA is accepting comments until December 26, 2023. Keller and Heckman will continue to monitor developments in this area.
  • According to a recent Consumer Reports study, about one-third of chocolate contains high levels of lead and cadmium. The study tested 48 cacao-containing foods, including cocoa powder, chocolate chips, milk chocolate, and brownie, cake, and hot chocolate mixes, and follows a report of heavy metals in dark chocolate bars that we covered last December.
  • Consumer Reports assessed the lead and cadmium by comparing the amount in a serving of each product with the Maximum Allowable Dose Level (MADL) for each metal established under California’s Proposition 65. Sixteen of the 48 tested products contained levels of at least one metal that exceeded the MADL. Dark chocolate tended to have higher levels of both metals, while some of the other products had high levels of lead. The report suggests this is likely because lead and cadmium are concentrated in cocoa solids, and dark chocolate contains more cocoa solids than milk chocolate.
  • Lead and cadmium are of particular concern for pregnant women and young children, as the metals have been linked to developmental delays and learning and behavior problems. According to the report, eating just an ounce of chocolate with high levels of the metals could lead to harm.
  • The National Confectioners Association (NCA) responded to the report, saying that “chocolate and cocoa are safe to eat and can be enjoyed as treats as they have been for centuries.” According to the NCA, the report disregards lead and cadmium levels set in a Consent Judgment by the Superior Court of the State of California set in 2018 that are still in effect, and chocolate makers “remain dedicated to being transparent and socially responsible.”
  • Keller and Heckman will continue to follow and report on this issue.
  • About two years have passed since cases were first filed alleging that product marketing deceptively conveyed a lack of PFAS. At this point, many demands have been made, and over 25 cases have been filed. Cases have targeted a variety of products, including fast food packaging, microwave popcorn, juice, waterproof mascara, cosmetic powders and foundation, mouthwash, floss, tampons, waterproof apparel, period underwear, and anti-fog spray for glasses.
  • A handful of cases have targeted claims like “PFAS Free” and “No long-chain PFAS.” Largely, however, plaintiffs argue that claims, such as the following, convey an absence of PFAS: “Safe and comfortable,” “We hold ourselves to the highest quality standards,” “Full of what’s good for you, free of harsh chemicals,” “All the flavors you crave without the ingredients you don’t,” “Ingredients sourced from nature,” “100% Natural,” “Feel good about what’s in this bottle,” “Working toward a sustainable future,” and “Good for you and good for the planet.” Plaintiffs have also targeted claims that products are certified by entities like OEKO-TEX, Forest Stewardship Counsel, and Fair Trade – even where neither the advertising nor the certifiers, themselves, purported to guarantee an absence of PFAS.
  • Most plaintiffs allege that claims are deceptive where testing allegedly showed 100 ppm or more of organic fluorine – which, according to plaintiffs, indicates intentionally added or a “material” amount of PFAS. One case, however, alleged that the threshold was lower, at 20 ppm.
  • So far, over five cases have been dismissed with courts reasoning, for instance, that either the presence of PFAS was disclosed or a company had no duty to disclose PFAS, that migratory chemicals are not “ingredients,” that plaintiffs identified no representations as to PFAS, that plaintiffs failed to test the specific products they purchased, or that organic fluorine does not necessarily indicate the presence of PFAS. Unfortunately, even with such holdings, there is little comfort where courts have not coalesced (and may never coalesce) around how to handle these cases. At least five motions to dismiss remain pending, and at least one motion to dismiss was denied nearly in its entirety. Several cases have settled confidentially, and one settled publicly, with the company agreeing to (1) pay up to $6.5 million in refunds and attorneys’ fees, and (2) take measures to avoid intentionally added PFAS.
  • Keller and Heckman will continue to follow and be available to assist managing risk around PFAS.
  • On October 24, the FDA announced that it published its Pesticide Residue Monitoring Report for Fiscal Year 2021. The report summarizes findings from FDA’s testing of human and animal foods for approximately 750 different pesticides and selected industrial compounds from October 1, 2020 through September 30, 2021.
  • The Pesticide Residue Monitoring Program is intended to ensure that FDA-regulated foods comply with pesticide tolerances set by the EPA. FDA has prepared an annual pesticide report since 1987. Previous reports are available here.
  • The report delivers results from 1,367 human food samples (300 domestic samples and 1,067 imported samples). The levels of pesticide residues measured by FDA were generally in compliance with the pesticide tolerances set by the EPA. Specifically, FDA found that 96.7% of domestic samples and 89.3% of imported samples were compliant. No pesticide chemical residues were detected in 35% of domestic samples and 44.5% of imported samples.
  • FDA also tested 80 animal feed samples (16 domestic samples and 64 imported samples). 100% of the domestic samples and 98.4% of the imported samples were compliant with federal regulations. No pesticide chemical residues were detected in 37.5% domestic samples and 40.6% of imported samples.
  • FDA noted that, due to the COVID-19 pandemic, sample collection and analysis was significantly impacted. Approximately 68% fewer human food samples and 78% fewer animal food samples were collected in 2021 as compared to 2019. Therefore, only limited conclusions can be drawn from these results.
  • Parents of a deceased college student filed a lawsuit against Panera Bread Company, alleging that the company’s “Charged Lemonade” caused the death of their daughter who suffered from a heart disorder which makes the heart’s rhythm sensitive to stimulants.
  • The lemonade was described on the store menu board as “Plant-based and Clean with as much caffeine as our Dark Roast coffee.” The complaint alleges that the failure to specify the size of coffee providing a comparable amount of caffeine rendered the warning ineffective. Per the complaint, the caffeine content of the Charged Lemonade ranges from 260 mg (20 fl. oz. regular size) to 390 mg (30 fl. oz. large size), whereas the caffeine content of Panera’s coffees ranges from 161 mg (12 fl. oz. small coffee) to 268 mg (20 fl. oz. large coffee). Charged Lemonade also contains the stimulant guarana.
  • FDA’s webpage on caffeine indicates that 400 mg a day is “not generally associated with dangerous, negative effects,” but that the level of sensitivity can vary widely.
  • FDA has taken the position that caffeine added to alcoholic beverages is an unsafe food additive and that highly concentrated caffeine supplements are adulterated because they present a significant or unreasonable risk of illness or injury. However, neither concern expressed by FDA is implicated here; in the former case, FDA’s concern was related to the combination of alcohol and caffeine, while in the latter, the caffeine content was much higher (as much as 3,200 mg/teaspoon).
  • Keller and Heckman will continue to monitor and report on this case and other litigation affecting the food industry. 
  • James Jones, the newly appointed Deputy Commissioner for Human Foods, released a statement on October 19 outlining his commitment to Commissioner Robert Califf’s framework for the proposed Human Foods Program (HFP). Jones said that he is “committed to upholding and executing this framework guided by the principle of protecting and promoting the health and wellness of all U.S. consumers.” The framework contains three priority areas: preventing foodborne illness, decreasing diet-related chronic disease, and safeguarding the food supply.
  • Under the foodborne illness prevention prong of the framework, FDA is proposing to set up an Office of Critical Foods, which will regulate infant formula and medical foods. This office is intended to work with industry to avoid recalls and shutdowns, particularly in infant formula manufacturing. The HFP will also use FDA’s New Era of Smarter Food Safety blueprint to further progress to regulate the food supply under the Food Safety Modernization Act.
  • To aid in decreasing diet-related chronic diseases, the HFP will prioritize reducing sodium in food, creating more accessible food labels, promoting healthy habits, and supporting innovation. On November 16, the Agency is co-hosting a public meeting with the Reagan-Udall foundation to hear input on front-of-package labeling and from November 6-8 will hold virtual public meeting and listening sessions regarding strategies to reduce added sugar consumption.
  • The HFP will also work to safeguard the food supply by reducing exposure to contaminants and other harmful chemicals in foods. FDA is working on a proposed rule regarding Brominated Vegetable Oil in food, as well as continuing its work on the Closer to Zero initiative, which we have covered previously, to reduce exposure to heavy metals in foods for babies and young children.
  • Keller and Heckman will continue to follow and report on the HFP.
  • The Federal Trade Commission (FTC) has issued a new proposed rule targeting what it calls “junk fees,” following the agency’s October 2022 announcement that it would explore such a rule and its November 2022 Advance Notice of Proposed Rulemaking.
  • The proposed Rule would not restrict the sorts of fees that can be imposed, but it would require businesses to display the total price more prominently than any other pricing information. It would bar companies from misrepresenting the purpose of a fee and require companies to disclose up front whether fees are refundable. Voluntary gratuities, shipping, and government-imposed charges are excluded from the scope of the rule altogether. While the proposed Rule would apply to all industries, the Commission identifies hotels, short-term lodging, ticket sales, rental housing, financial services, auto sales, and internet service providers as particular areas of concern.
  • The proposed Rule is accompanied by a series of questions on which the Commission specifically invites comment on a broad range of issues. The comment period closes 60 days from the date of publication of the proposed Rule in the Federal Register, which has not yet occurred as of the time of this writing. Given the volume of comments submitted to the FTC in the earlier round, there is certain to be significant interest in the proposal.
  • The Biden Administration has criticized these sorts of fees repeatedly over the past year, and the Consumer Financial Protection Bureau also recently released an advisory opinion that asserts that consumers are entitled to basic banking information without having to pay “excessive” fees. A proposed rule from the CFPB that requires banks to allow consumers to securely send transaction data to other companies is expected later this month. California’s recently-passed SB478 also requires disclosure of all mandatory fees whenever prices are advertised, effective July 2024.
  • Click here to read Keller and Heckman’s Client Alert covering the same topic. We will continue to monitor this proposed rulemaking and will relay any developments.
  • On October 13, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) released a revised draft of the Guide for Submitting Permit Applications for Microorganisms Developed Using Genetic Engineering Under 7 CFR Part 340 and Response to Comments from the first draft that was published March 23, 2023.
  • The draft has been revised based on the public comments APHIS received from the first draft.  APHIS grouped the various comments and responses into the following categories: 1) permit application data requirements; 2) principle risk proportionality when determining data requirements; 3) permit requirements when conducting research in a contained facility; 4) coordination among regulatory agencies; and 5) clarification on modified microbes to support their commercialization.
  • The purpose of requiring permits for genetically engineered microorganisms under 7 CFR 340 is to protect and enhance US agricultural and natural resources using a science-based and risk-based regulatory framework to ensure the safe movement of these microorganisms.  Regulated microorganisms include plant pests and other microorganisms that could pose a plant pest risk.
  • Keller and Heckman will continue to follow and report on these important regulatory developments.
  • On October 17, the FDA published “Catching Up with Califf: Advancing Nutrition, Healthy Food Options and Front-of-Package Labeling.” The update, written by FDA Commissioner Robert Califf, discussed the agency’s nutrition efforts in response to last year’s White House Conference and National Strategy on Hunger, Nutrition, and Health.
  • Commissioner Califf stated that the development of front-of-package (FOP) labeling is “front and center” in terms of agency attention. FOP labeling could help consumers better understand nutrition information and has the potential to be one of the most momentous changes to food labeling since the Nutrition Facts label. The FDA is now conducting consumer research to understand responses to various elements of an FOP labeling system. The agency intends to use these results to inform next steps, including consideration of approaches to take as part of a planned proposed rule for public comment. Commissioner Califf also announced that on November 16 the Reagan-Udall Foundation will host a public meeting to discuss FOP labeling with stakeholders.
  • In addition to the update on FOP labeling, Commissioner Califf highlighted other nutrition initiatives already accomplished by the agency:
    • Published a proposed rule to update the definition of the nutrient content claim “healthy”
    • Updated the food code to include recommendations on food donations
    • Issued a draft guidance on Dietary Guidance Statements
    • Published a proposed rule to permit salt substitutes in standardized foods
    • Published a Request for Information on food labeling in online grocery platforms
    • Hosting an upcoming Virtual Public Meeting and Listening Sessions to reduce added sugar consumption in the US