The U.S. House of Representatives has voted 415-11 to pass the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act), a bill that will expand the definition of "major food allergen" to include sesame. The bipartisan bill, which passed the Senate in March 2021, will head to the White House for President Biden's signature. Upon enactment, sesame will become the ninth major food allergen, joining milk, egg, wheat, peanuts, shellfish, tree nuts, fish and soybeans.
Tag Archives FDA
The U.S. Food and Drug Administration (FDA) has released "Closer to Zero," its action plan for reducing infants' exposure to heavy metals following a Congressional report on toxic elements in baby foods. "Although the FDA’s testing shows that children are not at an immediate health risk from exposure to toxic elements at the levels found in foods, we are starting the plan’s work immediately, with both short- and long-term goals for achieving continued improvements in reducing levels of toxic elements in these foods over time," the agency states. Under the plan, FDA will (i) "evaluate the scientific basis for action levels," (ii) "propose action levels," (iii) "consult with stakeholders on proposed action levels," and then (iv) "finalize action levels." The agency will then "establish a timeframe for assessing industry’s progress toward meeting the action levels and recommence the cycle to determine if the scientific data support efforts to further adjust…
The U.S. Government Accountability Office (GAO) has issued "Imported Seafood Safety: FDA Should Improve Monitoring of Its Warning Letter Process and Better Assess Its Effectiveness," finding that the U.S. Food and Drug Administration (FDA) was inconsistent in following key procedures and meeting goals for monitoring the importation of seafood. The report's recommendation is that FDA "(1) establish a process to monitor whether the agency is following the procedures and meeting the goals established for its warning letter process for imported seafood, and (2) develop performance goals and measures to assess how effective warning letters are at ensuring the safety of imported seafood."
The U.S. Food and Drug Administration (FDA) has announced an investigation into Real Water alkaline water, which is allegedly the link between several cases of acute non-viral hepatitis. The investigation comes amid the filing of several lawsuits alleging harm to consumers of the water, including children. The agency announced that Real Water was not cooperating with the investigation because it failed to provide records or access to facilities. “The FDA is committed to protecting the health of Americans and is especially concerned when there is a food safety issue impacting our youngest, and some of the most vulnerable in the population – infants and young children," a press release stated. "Upon learning about reports of acute non-viral hepatitis in Nevada, impacting five young children, the FDA quickly activated a team to further investigate. We are working closely with the CDC, state and local partners to complete our investigation and monitor…
By Associate Anna El-Zein & Of Counsel John Johnson III Recent actions by the U.S. Food and Drug Administration (FDA) suggest that, in 2021, the Agency will sharpen its focus on enforcement efforts to ensure packaged foods appropriately declare the presence of major food allergens. In a series of high-profile warning letters and press releases, FDA confirmed that it is moving beyond expecting non-compliant food to be recalled and is concentrating on how companies are preventing the issue. Manufacturers and private labelers need to audit their practices and expect an FDA inspection, especially if they have had an allergen-related recall. What the Law Requires The Federal Food, Drug, and Cosmetic Act (FDCA) deems a packaged food misbranded if the label fails to declare the presence of a major allergen, either in the ingredient list or in a “contains” statement. This requirement and the list of major food allergens is found…
The U.S. Food and Drug Administration (FDA) has responded to the House report on levels of heavy metals in baby food with the promise of additional action. The FDA statement notes, "First, today we issued a letter to industry reminding manufacturers of these types of foods of their existing responsibilities related to these efforts. Secondly, the agency is announcing that we’ll soon be putting into action a plan aimed at reducing toxic elements in foods for babies and young children to levels as low as is reasonably achievable." The industry letter asserts that the agency will take action to remove foods from the market "when the levels of toxic elements or other chemicals in foods do pose a health risk," citing as an example a consent decree the agency obtained in January 2021 to stop Valley Processing Inc. from selling adulterated juice. The agency's plan includes finalizing an action level…
The U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA) have issued a joint statement stating that "there is no credible evidence of food or food packaging associated with or as a likely source of viral transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus causing COVID-19." The statement was issued one week after the World Health Organization reportedly stated that the virus could be transmitted on frozen food packaging. "The USDA and the FDA are sharing this update based upon the best available information from scientific bodies across the globe, including a continued international consensus that the risk is exceedingly low for transmission of SARS-CoV-2 to humans via food and food packaging. For example, a recent opinion from the International Commission on Microbiological Specifications for Foods (ICMSF), stated: 'Despite the billions of meals and food packages handled since the beginning of the COVID-19 pandemic, to…
The U.S. Food and Drug Administration (FDA) has issued a constituent update responding to the Senate's report on elevated levels of heavy metals in baby foods. "While the report released on February 4, 2021 by the U.S. House of Representatives Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy raises important questions on what more can be done to reduce toxic elements in baby foods, the FDA has been actively working on this issue using a risk-based approach to prioritize and target the agency’s efforts," the update states. "Firms and individuals who manufacture or sell food have a legal responsibility under the Federal Food, Drug, and Cosmetic Act to ensure the safety of their products. The FDA reviews information and takes action on a case-by-case basis. If the FDA finds that a product violates the law, the agency takes steps to stop the product from being imported, takes…
Shook Partner Jim Muehlberger and Of Counsel John Johnson III have authored an article for Law360 detailing litigation targeting honey producers. "Honey producers have sometimes been accused of diluting their product with syrup," they explain. "They have also faced many other accusations, including that their honey contains contaminants, that it lacks some key quality characteristic, or that its country of origin has been wrongly declared." The article discusses the relevant U.S. Food and Drug Administration regulations, noting that the agency "has not generally developed legally enforced quality parameters for honey," as well as litigation targeting the product. "In the 2010s, a wave of litigation focused on filtered honey, which has the pollen removed from it to meet consumer preferences for characteristics like increased clarity and slower crystallization. In these suits, the plaintiffs alleged that the filtered honey was not honey because, according to some definitions, '[no] pollen … may be removed except where this is unavoidable in…
The U.S. Food and Drug Administration (FDA) has announced the approval of GalSafe pigs, which have a "first-of-its-kind intentional genomic alteration (IGA)," for use in food. "This is the first IGA in an animal that the FDA has approved for both human food consumption and as a source for potential therapeutic uses," the announcement states. "The IGA in GalSafe pigs is intended to eliminate alpha-gal sugar on the surface of the pigs’ cells. People with Alpha-gal syndrome (AGS) may have mild to severe allergic reactions to alpha-gal sugar found in red meat (e.g., beef, pork, and lamb)." FDA reportedly found that "food from Galsafe pigs is safe for the general population to eat" and that the potential impact of the pigs is no greater than from conventional pigs.
