Category: Food & Hospitality

Companies Gear Up For Mass Production of Cultured Meat

Could cultured meat be available in your U.S. grocery store in the new year? A previous article focused on the topic of “cultured meat” – meat made from the cells of animals and grown in a nutrient medium. While no cultured meat has yet been approved for sale in the U.S., companies are positioning themselves for mass production once needed approvals, licensing, inspections, etc., are obtained.

Earlier this month, Believer Meats broke ground on a $123 million plus facility in Wilson, North Carolina. The facility will be able to produce 10 metric tons of meat a year and will be the largest cultured meat facility in the world. The new facility will be Believer Meats’ second production facility. Last year it opened its first facility in Rehovot, Israel, with the capacity to make 500 kilograms of cultured meat a day. Believer Meats has developed processes to create cultured chicken, beef, pork, and lamb.

Investment in the cultured meat industry has been massive. For example, Believer Meats has $600 million in funding, and its investors include ADM Ventures, part of Archer-Daniels-Midland Co., and Tyson Foods.

Investment in the cultured meat industry has been massive.

So, with all of the investment and building of facilities, is the sale of cultured meat in the U.S. imminent? Cultured meat was first introduced in 2013. The eventual sale of cultured meat in the U.S. seems inevitable, but the timing is not yet clear. Before any cultured meat can be sold in the U.S., the FDA and USDA must approve the processes, license the facilities, inspect the facilities, inspect the meat, and approve labeling for the meat. Recognizing the rapid development of cultured meat products, the FDA established a premarket consultation process for companies to work with the FDA to start the process of regulatory approval for their cultured meat products. This premarket consultation process permits the companies to, voluntarily, work with the FDA, and to share information about their processes. The FDA premarket consultation does not, itself, “approve” the products, but evaluates the information shared by the companies – in order to determine if the meat is safe for human consumption. Specifically, as part of the premarket consultation, the FDA considers the cells used to make the cultured meat, the processes and materials used to create the cultured meat, and the manufacturing controls under which the cultured meat is created.

Recently, UPSIDE Food Inc. became the first cultured meat company to complete the FDA’s premarket consultation process. In November of this year, the FDA issued a No Questions letter to UPSIDE Food Inc. for its cultured chicken. The letter stated that information provided by UPSIDE Food Inc. to the FDA demonstrated that UPSIDE Food Inc.’s cultured chicken is safe and its production process prevents the introduction of contaminants that would adulterate the product. Last year, UPSIDE Food Inc opened a facility in Emeryville, California capable of producing 50,000 pounds of meat per year.

UPSIDE Food Inc.’s No Questions letter from the FDA is just the first step in the regulatory process. Pursuant to a 2019 agreement between the FDA and USDA, the FDA and the USDA will share oversight of the production of cultured meat. In addition to the premarket consultation, FDA will oversee the creation of the cultured meat up until the time of harvest, including licensing facilities, and inspecting the creation of the cultured meat. Inspections will ensure approved processes are being used and that the cultured cells are grown in a fashion that complies with Good Manufacturing Processes and food safety regulations.

When the cultured meat is harvested and processed into its final form, regulatory oversight will shift to the Food Safety Inspection Service (FSIS) of the USDA. As with traditional meat producers, cultured meat producers will have to apply for Grants of Inspection and be subject to similar inspections and food safety requirements. Labels for the cultured meat will also have to be preapproved by FSIS.

Before Believer Meats can sell any of its products manufactured in the North Carolina facility, Believer Meats will have to navigate the regulatory hurdles necessary to obtain approval of its products for sale to consumers. Believer Meats has indicated that it has been working with the FDA, but the FDA has not yet issued any statement on Believer Meats’ processes or products. However, with the start of construction on the world’s largest cultured meat facility, Believer Meats will be well-positioned to begin commercial production when regulatory approvals are obtained. We will be following this emerging new market and the regulatory rubric designed to oversee these cutting-edge food products.

Article By L. Christine Lawson of Womble Bond Dickinson (US) LLP

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Copyright © 2022 Womble Bond Dickinson (US) LLP All Rights Reserved.

District of Columbia to Eliminate the Tip Credit: a Specter of the Future?

Currently, employers in the District of Columbia (like the majority of states) are permitted to count customer tips toward the minimum hourly wage they must pay to certain service employees. This practice is often referred to as taking a “tip credit.” Said differently, an employer is allowed to pay particular service employees a cash wage that is less than the minimum wage by relying on tips the employee receives from customers to make up the difference between the subminimum wage paid directly by the employer and the applicable federal or state minimum wage. In the District of Columbia, employers currently are allowed to pay their tipped workers a subminimum wage of $5.35 per hour, with the expectation that customers’ tips will cover the balance of the $16.10–per-hour minimum wage.

In early November 2022, nearly 74 percent of D.C. voters approved Initiative 82, the “District of Columbia Tip Credit Elimination Act of 2022,” which will gradually eliminate use of the tip credit in the District of Columbia by 2027. In 2027, the District will join the small group of states that currently prohibit use of the tip credit (Alaska, California, Minnesota, Montana, Nevada, and Oregon). In 2018, 55 percent of D.C. voters approved a different initiative, which would have phased out the tip credit, but the Council of the District of Columbia overturned the voter-approved initiative. Since then, the composition of the D.C. Council has changed, and the council is expected to implement Initiative 82.

Under Initiative 82, starting in January 2023, the District of Columbia’s minimum cash wage (i.e., the subminimum wage paid by the employer when an employer utilizes a tip credit) of $5.35 will increase by a dollar or two every year until it reaches minimum wage. Correspondingly, the maximum tip credit an employer can take in the District of Columbia will be reduced gradually until 2027 when the tip credit is eliminated. It is worth noting that the D.C. Council has not yet implemented Initiative 82, so employers may want to monitor what cash wage rates and tip credits are officially implemented to ensure compliance with the District of Columbia’s wage laws and tip credit notice requirements. As the end of the year approaches, employers may also want to review any changes to state minimum wage and minimum tip credit amounts that may become effective on December 31 or January 1.

The “DC Committee to Build a Better Restaurant Industry” was the campaign committee behind Initiative 82. The fact that voters approved the tip credit elimination initiative by nearly 20 percentage points more than the 2018 initiative shows that the campaign committee may indeed impact the fate of the tip credit. Other groups like “One Fair Wage” have also taken aggressive lobbying action to convince lawmakers and voters in other states to eliminate the tip credit. In early 2022, One Fair Wage announced a $25 million campaign to try to convince twenty-five states to remove the tip credit by 2026. According to One Fair Wage’s website, “One Fair Wage policy would require all employers to pay the full minimum wage with fair, non-discriminatory tips on top.” In addition to the District of Columbia, the group has campaigned in Illinois, Maine, Massachusetts, Michigan, and New York.

As we discussed in a June 2021 article, employers already are under siege with respect to the tip credit at the federal level. One of President Biden’s objectives has been to eliminate the tip credit on a nationwide basis, but because the tip credit exists in the statutory text of the Fair Labor Standards Act (FLSA), the U.S. Congress would need to amend the FLSA to accomplish that goal. However, through regulatory action that was finalized late last year, the U.S. Department of Labor (DOL) burdened the service industry with a harsh standard for maintaining compliance with tip credit regulations. In late 2021, the DOL released a rule that restored the pre-Trump-era 80/20 rule and added a new thirty-minute rule. Compliance with the new rule effectively created its own deterrent against continued use of the tip credit.

Ironically, a significant percentage of service industry employees actually oppose these initiatives to eliminate use of the tip credit because of the potential negative impact it will have on their total income. The U.S. Bureau of Labor Statistics indicates that, as of May 2021 (the most recent data available), individuals working as waiters and waitresses earned on average nearly $14 per hour. This is nearly twice the current federal minimum wage $7.25.

Many service industry employees advocate against elimination of the tip credit because they anticipate that employers may seek to offset the additional hourly labor costs by shrinking the workforce, decreasing hours, or recovering the added expense through higher menu prices or service charges, which may eat into the tips customers are willing to leave their servers. Many employers that have stopped utilizing the tip credit pay full minimum wage by automatically tacking a service fee onto customer bills. Unlike tips, employers can keep all, or portions of, an automatic charge, so long as the employer complies with local or state laws requiring adequate notice to customers about how the charge will be used.

Once the 118th Congress is sworn in this coming January, it is unlikely that employers will see much change regarding use of the tip credit at the federal level. Nevertheless, some state legislators may press forward with their efforts to eliminate use of the tip credit at the state level. For service industry employers that operate nationwide, there are mounting challenges to complying with federal and state tip regulations. Employers may want to continue to monitor states where legislation is targeting elimination of the tip credit and may wish to consider measures to address the additional labor costs that will follow.

© 2022, Ogletree, Deakins, Nash, Smoak & Stewart, P.C., All Rights Reserved.
For more Labor and Employment Law news, click here to visit the National Law Review.

Supply Chain Shortages in the Meat and Poultry Industries

With Thanksgiving fast approaching, you have probably heard that there is a turkey shortage1 – brought about by a combination of rising costs for feed and fuel, continued labor shortages, and – if that were not enough –a virulent strain of avian flu decimating turkey flocks across the U.S.

Although industries across the board have felt the effects of supply chain disruptions brought on by the COVID-19 pandemic, the meat and poultry industry has been particularly hard-hit. So much so that the Biden Administration, in concert with the United States Department of Agriculture (USDA), has moved forward with regulatory actions aimed at easing the supply bottleneck. Whether they will have the intended effect remains to be seen.

In July 2021, President Biden signed an Executive Order on Promoting Competition in the American Economy (the Executive Order).2 The Executive Order directs 72 different actions across the federal government, including several rulemaking directives to the USDA aimed at increasing competition within the meat and poultry industry. Among other things, the Executive Order directs the USDA to issue new rules defining when meat can bear “Product of USA” labels, to address perceived loopholes in the current rules, and to issue new rules under the Packers and Stockyards Act. Following the Executive Order, the USDA has made progress on these new rules, and recently announced new initiatives to ramp up antitrust enforcement in the meat industry.

(For more on this Executive Order and its implications across industries, see a prior article from our Foley colleagues, President Biden’s Executive Order on Competition Could Mean Broad Changes Across a Range of Industries.)

Modernizing the Packers and Stockyards Act

The Packers and Stockyards Act (PSA), enacted in 1921, is a federal law designed to combat labor abuses by meatpackers and processors. Specifically, the PSA makes it illegal for livestock and poultry producers to engage in any unfair, unjustly discriminatory, or deceptive practice,3 or to give any undue or unreasonable preference or advantage to any person or locality.4 Congress explicitly intended the protections in the PSA to be broader than those found in other federal statutes, such as the Sherman Antitrust Act.5 However, the USDA believes the force of the PSA has been reduced by a combination of regulatory narrowing, budget and administrative cuts, and under-enforcement in previous decades. For that reason, the USDA announced three rulemaking actions designed to address livestock and poultry markets as they exist today so the PSA fulfills Congress’s goal to protect livestock producers and poultry growers.

The first proposed rule, released in draft form on June 7, 2022,6 is intended to promote transparency in poultry production contracting by revising the list of disclosures and information live poultry dealers must furnish to poultry growers and sellers with whom the dealers contract. The proposed rule establishes additional disclosure requirements in connection with the use of poultry grower ranking systems by live poultry dealers to determine settlement payments for poultry growers.

The second proposed rule, released in draft form on October 3, 2022,7 identifies retaliatory practices taken by regulated entities – which the PSA defines as swine contractors, live poultry dealers, or packers – that interfere with lawful communications, assertions of rights, and participation in associations (among other protected activities), as “unjust discrimination.” The proposed rule also identifies unlawfully deceptive practices with respect to contract formation, performance, termination, and refusal. Specifically, USDA proposes to:

  • Prohibit, as “undue prejudices,” disadvantages and other adverse actions against “market vulnerable” individuals who are deemed to be at heightened risk of adversely differential treatment in relevant markets;

  • Prohibit, as “unjust discrimination,” retaliatory and adverse actions that interfere with lawful communications, assertions of rights, associational participation, and other protected activities;

  • Prohibit, as deceptive practices, regulated entities employing pretexts, false or misleading statements, or omissions of material facts, in contract formation, performance, termination, and refusal; and

  • Require recordkeeping to support USDA monitoring, evaluation, and enforcement of compliance with aspects of the rule.

The USDA is presently seeking comments on this proposed rule, with the rulemaking docket open for comment until December 2, 2022. Following the comment period, the third potential rule, which has not yet been released, will focus on certain unfair practices and undue preferences. In addition, the third rule will explain whether and when a showing of harm to competition is—or is not—required under sections 202(a) and (b) of the PSA.

Increased Focus on Antitrust Enforcement

A recurring theme underlying the USDA’s recent rulemaking efforts is a perception that existing federal laws aimed at protecting farmers, ranchers, and other agricultural producers have been under-enforced. Earlier in 2022, the USDA and the U.S. Department of Justice (DOJ) jointly expressed a shared commitment to enforcing “federal competition laws that protect farmers, ranchers, and other agricultural producers and growers from unfair and anticompetitive practices.”8 One notable component of this agency cooperation is a new USDA website, www.farmerfairness.gov, which allows anyone to report complaints of potential violations of antitrust laws and the PSA. In addition, the website incorporates existing PSA confidentiality and whistleblower protections against retaliation for those who report criminal antitrust concerns.

In September 2022, the USDA also announced the availability of $15 million in funding to encourage state Attorneys General (AGs) to partner with the USDA on competition issues in the food and agricultural space. The USDA expects to engage state AGs through a combination of renewable cooperation agreements and memoranda of understanding aimed at improving state AGs’ ability to conduct on-the-ground investigations of competition issues. The USDA says it will work directly with state AG offices to solicit applications for funding.

These recent agency efforts come on the heels of multiple civil lawsuits alleging price-fixing and other anticompetitive practices by producers across the beef, pork, and poultry industries.

Conclusion: Will the Turkey Shortage Affect Your Thanksgiving?

It is too early to say whether the USDA’s recent efforts to address competition in the meat and poultry industry will result in lower prices – in part because the effects of the COVID-19 pandemic (e.g., labor shortages, shipping disruptions, and higher prices for inputs like fuel and animal feed) still linger. However, as national and global supply chains begin to return to pre-pandemic operations, consumers can hope for a less expensive turkey on the dinner table by next Thanksgiving.

For more Biotech, Food & Drug Law news, click here to visit the National Law Review

© 2022 Foley & Lardner LLP

FOOTNOTES

1 https://www.nytimes.com/2022/10/21/dining/thanksgiving-turkeys-cost-infl…

2 Executive Order 14036, Promoting Competition in America’s Economy, 86 Fed Reg. 36987, July 9, 2021.

3 7 U.S.C. § 192(a).

4 7 U.S.C. § 192(b).

5 See, e.g., Wilson & Co. v. Benson, 286 F.2d 891, 895 (7th Cir. 1961).

6 Docket No. AMS-FTPP-21-0044.

7 Docket No. AMS-FTPP-21-0045.

8 https://www.usda.gov/media/press-releases/2022/01/03/agriculture-department-and-justice-department-issue-shared

Pair of Lawsuits Target Mint Flavored Products

  • Spencer Sheehan, a well-known class-action attorney, has filed a pair of class-action lawsuits in the U.S. District Court for the Northern District of Illinois, alleging that mint flavored products which do not contain mint are deceptively labeled.
  • The first lawsuit alleged that a “mint chocolate chip ice cream” statement of identity is misleading to consumers where the product’s flavor is derived from “natural flavor” and not any mint or mint-containing ingredient. The product also contains images of mint leaves on the front panel. As support for the allegation that the lack of mint is deceptive, the complaint cites to the ice cream flavoring regulation (21 CFR 135.110(f)(2)), which requires that the term “flavored” (e.g., mint flavored) be used where a product contains a natural flavor which predominates.
  • The second lawsuit alleged that consumers are misled by a gum product which is labeled as “original flavor” with a backdrop of what appears to be a blue mint leaf, but which only contains “natural and artificial flavor,” and no mint-based ingredients. Plaintiff, citing to the general flavoring regulation (21 CFR 101.22), alleged that the product should have been labeled as “naturally and artificially flavored mint” and that the failure to disclose the flavor or include the other qualifiers is misleading.
  • Although Plaintiffs have alleged technical violations of FDA’s labeling regulations, courts have consistently held that a reasonable consumer may not be aware of the intricacies of FDA’s labeling regulations and that therefore a technical labeling violation is not in itself sufficient to show that a reasonable consumer would be misled.

Article By Food and Drug Law Practice Group at Keller and Heckman LLP

For more biotech, food, and drug law legal news, click here to visit the National Law Review.

© 2022 Keller and Heckman LLP

FDA Updates Regulatory Definition of “Healthy” for the First Time Since 1994

The U.S. Food and Drug Administration (FDA) has issued a proposed rule (“Proposed Rule”)[1] that updates the definition of the “healthy” nutrient content claim under 21 C.F.R. § 101.65(d) for the first time since its issuance in 1994. The Proposed Rule, published on September 29, 2022, notes that “nutrition science has evolved since the 1990s” and that the proposed changes are intended to make the regulation “consistent with current nutrition science and Federal dietary guidance.”[2]

FDA is accepting comments until December 28, 2022.  Stakeholders should note that the proposed amendments may require companies to remove “healthy” claims from current labels and may make new products eligible to bear “healthy” claims. The comment period affords impacted companies the opportunity to provide FDA with input that could modify the current Proposed Rule. K&L Gates’ FDA team can assist clients with submitting comments and with assessing the impact of the Proposed Rule.

Highlights of the Proposed Rule

The changes in the Proposed Rule align with the FDA’s 2016 changes to the nutrition labeling regulation at 21 C.F.R. § 101.9,[3] primarily by refocusing the attention from limiting fat to limiting sugar intake.  The proposal also addresses several areas to make the regulation more consistent with current nutrition guidelines; for example, the Proposed Regulation would permit water, avocados, nuts, and seeds to bear the “healthy” claim, whereas products such as highly sweetened cereals would not be eligible for the claim.[4] 

Under the existing regulation,[5] a “healthy” food must meet certain criteria, including limits on total fat, saturated fat, cholesterol, and sodium, and minimum amounts (at least 10 percent of the Daily Value) of favorable nutrients (e.g., vitamin A, vitamin C, calcium, iron, protein, and dietary fiber).[6] In contrast, while continuing to place limits on the presence of certain nutrients (e.g., added sugar, sodium, saturated fat), the Proposed Rule’s updated “healthy” criteria take a very different approach to promoting the consumption of certain foods, consistent with the 2020-2025 Dietary Guidelines for Americans, through the new concept of “food group equivalents.” Specifically, to meet the proposed “healthy” claim criteria, a food would need to contain minimum amounts of one or more of the following food groups or subgroups: fruit, vegetables, grains, dairy, and protein foods. FDA’s proposed table of “food group equivalents” is reproduced below:

FDA Proposed Rule – Food Group Equivalents

Food Group Food Group Equivalent

 Examples
Vegetable 1/2 cup equivalent vegetable 1/2 cup cooked green beans; 1 cup raw spinach
Fruit 1/2 cup equivalent fruit 1/2 cup strawberries; 1/2 cup 100% orange juice; 1/4 cup raisins
Grains No less than 3/4 oz. equivalent whole grain 1 slide of bread; 1/2 cup cooked brown rice
Dairy 3/4 cup equivalent dairy 6 oz. fat free yogurt; 1 1/8 oz. nonfat cheese
Protein foods 1 1/2 equivalent game meat, 1 oz. equivalent seafood, 1 oz. equivalent egg, 1 oz. equivalent beans, peas, or soy products, or 1 oz. equivalent nuts and seeds 1 1/2 oz. venison; 1 oz. tuna; 1 large egg; 1/4 cup black beans; 1/2 oz. walnuts

In a change from the current “healthy” regulation, the Proposed Rule distinguishes between undesirable fat (i.e., saturated fat) and desirable fats (i.e., monounsaturated and polyunsaturated fats) in the diet. In this regard, the Proposed Rule reflects the impact of the 2015 citizen petition submitted by KIND LLC (Docket No. FDA-2015-P-4564[7]), a manufacturer of sweetened nut snack bars, which requested that FDA accommodate “healthy” claims for products containing monounsaturated and polyunsaturated fats but that are not “low fat” as defined under 21 C.F.R. § 101.62(b)(2).  KIND filed its petition after receiving a warning letter from FDA in 2015, requesting that they remove the “healthy” claim from products due to disqualifying levels of fat from nut ingredients (e.g., almonds, peanuts).  In a press release issued with submission of its petition, KIND highlighted that the current “healthy” regulation permits products like fat-free chocolate pudding, sweetened cereals, and toaster pastries to qualify as “healthy,” whereas foods like almonds, avocados, and salmon were ineligible due to their fat content.[8] In response to KIND’s petition, FDA had been exercising enforcement discretion since September 2016 for certain products not low in fat but that contain predominantly mono and polyunsaturated fats.[9]

Under the Proposed Rule, FDA has eliminated total fat and cholesterol from consideration for “healthy” claims.  Also, while a food product must adhere to limits for added sugars, saturated fat, and sodium, limits on unfavorable nutrients are no longer keyed to compliance with other nutrient content claim regulations (e.g., meeting the definition of “low saturated fat” under 21 C.F.R. § 101.62(c)(2)). The Proposed Rule expresses disqualifying levels for unfavorable nutrients as percentages of daily values under 21 C.F.R. § 101.9.

FDA summarizes the criteria for “healthy” claims by product type below.  Unlike the current regulation, the Proposed Rule would specifically allow all raw whole fruits and vegetables to qualify for the “healthy” claim because of their positive contribution to an overall healthy diet, as well as to allow water to bear the “healthy” claim:

FDA Proposed Rule – Eligible Products for “Healthy” Nutrient Content Claim

Product Criteria for bearing “healthy” claim
Raw, whole fruits and vegetables No additional criteria; all raw, whole fruits and vegetables may bear the claim.
Individual food products At least 1 food group equivalent per RACC from 1 food group, and Nutrients to limit.
Mixed products At least 1/2 food group equivalent each from at least 2 different food groups, and Nutrients to limit.
Main dish as defined at 21 CFR 101.13(m) At least 1 food group equivalent each from at least 2 different food groups, and Nutrients to limit.
Meal as defined at 21 CFR 101.13(l) At least 1 food group equivalent each from at least 3 different food groups, and Nutrients to limit.
Water Plain water and plain, carbonated water may bear the claim.

This proposed rule is likely the first of many that will bring FDA’s nutrient content claim regulations in line with its 2016 revisions to the nutrition labeling regulation.  The comment period for the Proposed Rule closes on December 28, 2022; comments can be submitted at https://www.federalregister.gov/documents/2022/09/29/2022-20975/food-labeling-nutrient-content-claims-definition-of-term-healthy#open-comment.

For more Food and Drug Legal News, click here to visit the National Law Review.

Copyright 2022 K & L Gates.

FOOTNOTES

[1] 87 Fed. Reg. 59168 (Sept. 29, 2022), https://www.federalregister.gov/d/2022-20975.

[2] Id. at 59174.

[3] For more information, see FDA, Changes to the Nutrition Facts Label, https://www.fda.gov/food/food-labeling-nutrition/changes-nutrition-facts-label.

[4] Id.

[5] 21 C.F.R. 101.65(d).

[6] 87 FR 59168, at pg. 59172, https://www.federalregister.gov/d/2022-20975/p-57.

[7] The petition is available at https://s3.amazonaws.com/kind-docs/citizen-petition.pdf.

[8] See KIND, Seven Years After KIND’s Citizen Petition, FDA Proposes New Definition of “Healthy,“ Press Release,  https://www.kindsnacks.com/media-center/press-releases/KIND+Citizen+Petition+FDA+proposes+new+definition+of+healthy.html

[9] FDA, Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-use-term-healthy-labeling-human-food-products

FDA Launches Study on the Role of Seafood Consumption in Child Development

  • On October 11, the FDA announced the launch of an independent study, “The Role of Seafood in Child Growth and Development,” by the National Academies of Science, Engineering, and Medicine (NASEM) on the state of scientific evidence in nutrition and toxicology associations between seafood consumption and child growth and development. The purpose of the study is to obtain the most up-to-date understanding of the science on fish consumption in a whole diet context, which will support the goals of the FDA’s Closer to Zero Action Plan for reducing the exposure of babies and young children to mercury, arsenic, lead, and cadmium from foods.

  • As part of the study, an ad hoc committee of the NASEM will:

    • Evaluate dietary intake and seafood composition data provided by the sponsors (i.e., Department of Commerce, HHS, EPA, and USDA’s Agricultural Research Service);

    • Conduct systematic reviews of the scientific literature covering the areas of seafood nutrition and toxicology associated with seafood consumption and child growth and development;

    • Review existing sources of evidence on maternal and child seafood consumption and child growth and development; and

    • Develop an approach to synthesize the scientific evidence, and utilize that strategy to develop its findings and conclusions (quantitative and/or qualitative) about associations between seafood consumption and child growth and development.

  • FDA intends for the study to help inform whether any updates are needed for the current Advice about Eating Fish for children and those who might become or are pregnant or breastfeeding, and also hopes to gain a better understanding of the science on mercury exposure from food.

  • The FDA is partnering with the National Oceanic and Atmospheric Administration, U.S. Department of Agriculture, and U.S. Environmental Protection Agency on the study, and NASEM will publish the committee’s report after the study is complete in approximately 18 months. The FDA intends to use the study findings to advance policies and programs that support healthy child growth and development.

For more Food and Drug Law News, click here to visit the National Law Review

© 2022 Keller and Heckman LLP

USDA Focused on Accurate “Made in the USA” Beef Labeling

  • In response to industry concerns for mislabeled beef products, U.S. Agriculture Secretary Tom Vilack recently said that the “Product of the USA” label on meat products should undergo a full-scale review. Vilack maintains that he is “committed to ensuring that the ‘Product of USA’ label reflects what a plain understanding of those terms means to U.S. consumers.” In March, we reported that the Tenth Circuit dismissed lawsuits based on meat producer’s use of allegedly deceptive and misleading “Product of the USA”  labels on their beef products that did not originate from cattle born and raised in the United States.
  • The issue of country-of-origin beef labeling (“COOL”) continues to be a source of debate. Earlier this week, the FTC finalized a rule that is intended to tighten the use of the Made in the USA standard. The FTC said that this update would benefit small businesses who lack the resources to defend their products from foreign imitators. However, the FTC rule does not require USDA action. In response, the beef industry is demanding Congress to act swiftly.
  • R-CALF, a group of USA-based cattle ranchers, has been pushing hard for reforms on COOL. On September 22, R-CALF released a poll that shows staggering support for mandatory COOL legislation by the American public. R-CALF reports that 86 percent of American voters support the American Beef Labeling Act that reinstates mandatory country of origin labeling for beef, and 90 percent of voters are concerned that foreign importers of beef can legally put a “Product of USA” sticker on a package containing beef that was born, raised, and harvested outside the United States.
  • Currently, Congress is working through prospective beef labeling legislation that would require USDA oversight of COOL. The American Beef Labeling Act (S.2716) is a bipartisan bill that was introduced in the Senate in 2021; however, the bill has languished without action in the U.S. Senate Agriculture Committee. In March 2022, a bipartisan companion bill was introduced in the U.S. House (H.R.7291), which has also seen little to no progress in the House Agriculture Committee. Keller and Heckman will continue to monitor these legislative developments and USDA action.

For more Food and Drug Law news, click here to visit the National Law Review.

© 2022 Keller and Heckman LLP

Ongoing Foodborne Illness Outbreaks Increasing

  • On September 14, 2022, Food and Drug Administration (FDA) officials reported a new outbreak of infections from Listeria monocytogenes. FDA has not yet identified a particular product linked to the pathogenic bacterial outbreak but has initiated traceback procedures. To date, FDA has confirmed 6 patients from this week’s Listeria outbreak, and the numbers appear to keep rising. It is still unclear what age group or geographic location has been afflicted by the outbreak.
  • FDA is currently actively investigating ten foodborne illness outbreaks with increasing patient numbers every week. The Center for Disease Control (CDC) continues to actively investigate a sizable E. coli outbreak suspected to have been caused by romaine lettuce served at Wendy’s restaurants in Indiana, Michigan, Ohio, and Pennsylvania starting in early September 2022. To date, 43 individuals have been hospitalized due to E. coli poisoning, and 13 new patients have been accounted for this week alone. Other current FDA investigations include a Salmonella Typhimurium outbreak that now affects 30 individuals, a Cyclospora outbreak whose patient count is now 81, and a Salmonella Mississippi outbreak that now afflicts 103 patients nationwide.
  • Notably, in March 2022, FDA opened a similar investigation into a Listeria outbreak caused by ice cream products originating from Big Olaf Creamery in Sarasota, Florida. This investigation is still ongoing, but has resulted in 24 patient hospitalizations, 1 death, and 1 miscarriage across 11 states. Keller and Heckman will continue to monitor these outbreaks as they impact the food industry.

For more Food Law news, click here to visit the National Law Review.

© 2022 Keller and Heckman LLP

Wendy’s E. Coli Outbreak Lawsuits

Health Department officials are investigating over one hundred cases of E. coli poisoning in Michigan, Ohio, Indiana and Pennsylvania. People have been diagnosed with food poisoning in Michigan, Ohio, Pennsylvania, and Indiana. The majority of these people claim that they ate sandwiches topped with lettuce at a Wendy’s Restaurant within the week before their food poisoning diagnosis.

Public health officials in Michigan have confirmed 43 cases of E. Coli that match the strain in a multi-state outbreak. A number of similar cases have been identified in Ohio. The specific source of the food poisoning has not been officially determined, but one possible source is romaine lettuce used to top hamburgers and sandwiches at Wendy’s restaurants.

The illness onset dates range from late July through early August 2022. The sickness and harm have ranged from mild to very severe. Many victims have required extensive hospitalization and medical care. Four cases of hemolytic uremic syndrome (HUS) have been diagnosed and suspected to be related to the contaminated lettuce at Wendy’s Restaurants.

  • E. Coli outbreak cases have been reported in the following counties: Allegan, Branch,Clinton, Genesee, Gratiot, Jackson, Kent, Macomb, Midland, Monroe, Muskegon, Oakland, Ogemaw, Ottawa, Saginaw, Washtenaw, and Wayne and the City of Detroit. Public health departments in those counties are closely monitoring patients and working hard to determine the source of the poisoning.

E. coli is a bacterium that lives in the digestive tracks of animals and humans. Most varieties are harmless, but some can cause severe illness. Common sources of E. coli include:

  • Raw milk or dairy products that are not pasteurized.
  • Raw fruits or vegetables, such as lettuce, that have come into contact with infected animal feces.

Symptoms of E. Coli poisoning are very serious. They include severe stomach cramps, diarrhea, and vomiting. Some people experience high fevers and many develop life-threatening conditions.

E. coli infections often require hospitalization and expensive medical care, the damages from this food poisoning can be extensive.

The Wendy’s food poisoning claims are just at their initial stages.  Very few lawsuits have been filed to date, but it is expected dozens will be filed in courthouses shortly.  At this time, there are no reported Wendy’s food poisoning settlements.

In general, food poisoning settlements include money payment for pain and suffering, mental anguish, and the physical injuries caused by the food contamination. In addition, claims for economic losses and damages are also demanded in a food poisoning lawsuit. These are financial losses and include payment of medical bills and expenses, as well as lost wages and income resulted from missed time at work.

If you ate food at a Wendy’s Restaurant that contained romaine lettuce in July or August and were diagnosed or hospitalized with E. coli poisoning, you may benefit from speaking to a food poisoning attorney.

Article By Lawrence J. Buckfire of Buckfire Law

For more personal injury legal news, click here to visit the National Law Review.

Buckfire & Buckfire, P.C. 2022

All Federal Research Agencies to Update Public Access Policies

On 25 August 2022, the Office of Science and Technology Policy (OSTP) released a guidance memorandum instructing federal agencies with research and development expenditures to update their public access policies. Notably, OSTP is retracting prior guidance that gave discretion to agencies to allow a 12-month embargo on the free and public release of peer-reviewed publications, so that federal funded research results will be timely and equitably available at no cost. The memo also directs affected agencies to develop policies that:

  1. Ensure public access to scientific data, even if not associated with peer-reviewed publications;
  2. Ensure scientific and research integrity in the agency’s public access by requiring publication of the metadata, including the unique digital persistent identifier; and
  3. Coordinate with OSTP to ensure equitable delivery of federally funded research results and data.

KEY COMPONENTS OF GUIDANCE:

Updating Public Access Policies

Federal agencies will need to develop new, or update existing, public access plans, and submit them to OSTP and the Office of Management and Budget (OMB). Deadlines for submission are within 180 days for federal agencies with more than US$100 million in annual research and development expenditures, and within 360 days for those with less than US$100 million in expenditures.

Agencies will need to ensure that any peer-reviewed scholarly publication is free and available by default in agency-designated repositories without any embargo or delay following publication. Similarly, OSTP expects the access polices to address publication of any other federally funded scientific data, even if not associated with peer-reviewed scholarly publications. As a concession, federal agencies are being asked to allow researchers to include the “reasonable publication costs and costs associated with submission, curation, management of data, and special handling instructions as allowable expenses in all research budgets.1”

Ensuring Scientific Integrity

To strengthen trust in governmentally funded research, the new or updated policies must transparently communicate information designed to promote OSTP’s research integrity goals. Accordingly, agencies are instructed to collect and make appropriate metadata available in their public access repositories, including (i) all author and co-author names, affiliations, and source of funding, referencing their digital persistent identifiers, as appropriate; (ii) date of publication; and (iii) a unique digital persistent identifier for research output. Agencies should submit to OSTP and OMB (by 31 December 2024) a second update to their policies specifying the approaches taken to implement this transparency, and publish such policy updates by 31 December 2026, with an effective date no later than one year after publication of the updated plan.

IMPLICATIONS FOR THE NATIONAL INSTITUTES OF HEALTH (NIH), OTHER FEDERAL AGENCIES, AND THEIR GRANTEES

The NIH is expected to update its Public Access Policy, potentially along with its Data Management and Sharing Policy to conform with the new OSTP guidance. Universities, academic medical centers, research institutes, and federally funded investigators should monitor agency publications of draft and revised policies in order to update their processes to ensure continued compliance.

In doing so, affected stakeholders may want to consider and comment to relevant federal agencies on the following issues in their respective public access policy development:

  • Federal agency security practices to prevent foreign misappropriation of research data;
  • Implications for research misconduct investigations and research integrity;
  • Any intellectual property considerations without a 12-month embargo, especially to the extent this captures scientific data not yet published in a peer-review journal; and
  • Costs allowable research budgets to support these data management and submission expectations.

1 Office of Science and Technology Policy, Memorandum for the Heads of Executive Departments and Agencies: Ensuring Free, Immediate, and Equitable Access to Federally Funded Research at p. 5 (25 August 2022) available at https://www.whitehouse.gov/wp-content/uploads/2022/08/08-2022-OSTP-Public-Access-Memo.pdf

Article By Cindy L. Ortega Ramos and Rebecca M. Schaefer of K&L Gates

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Copyright 2022 K & L Gates