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By Of Counsel John Johnson III The U.S. Food and Drug Administration’s (FDA) Warning Letter to Maribel’s Sweets, Inc., provides an important look into how FDA is implementing the Food Safety Modernization Act (FSMA)’s Preventive Control Rule. This is the requirement that a food facility must have and implement a written food safety plan to control known or reasonably foreseeable food safety hazards. Additionally, the warning reflects that FDA continues to prioritize seeking compliance with preventive controls and sanitation practices to avoid undeclared Major Food Allergens (which we discussed in A Taste of FDA’s 2021 Food Priorities: Undeclared Major Food Allergens. The list has been expanded to include sesame, which we discussed in Look Beyond the Label: How the FASTER Act Impacts Food Manufacturing). FDA has been relatively silent about the Preventive Control Rule in 2021, issuing only four Warning Letters directly on that topic. For context, FDA issued at…

The U.S. Food and Drug Administration (FDA) has released guidance on limiting sodium in processed and packaged foods. "Limiting certain nutrients, such as sodium, in our diets plays a crucial role in preventing diseases like hypertension and cardiovascular disease that disproportionately impact racial and ethnic minority groups; these diseases often result in hundreds of thousands of lives lost and billions in annual health care costs," the agency stated in a press release. The statement notes that "people consume 50% more sodium than recommended," and "about 70% of the sodium we eat comes from packaged, processed and restaurant foods." "[W]e recognize that most of the food consumption in the U.S. comes from a relatively small number of products and menu items in the marketplace that are produced by a limited number of food manufacturers," the guidance states. "It is possible that reformulation by these food manufacturers could lead to increased demand…

The U.S. Food and Drug Administration (FDA) has released two guidance documents on food contact substance notifications, pertaining to toxicology recommendations and administrative processes. The food contact substance notification process is "the primary means by which FDA regulates food additives that are food contact substances (FCSs)." The guidance documents define a food contact substance as "any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if the use is not intended to have any technical effect in the food," per the federal Food, Drug, and Cosmetic Act.

The U.S. Food and Drug Administration (FDA) announced the results of a study on the presence of per- and polyfluoroalkyl substances (PFAS) in processed foods, including baby foods. Out of 167 samples, three products had detectable levels of PFAS, the agency stated, and the amounts were not elevated to a level of concern. "Based on the best available current science, the FDA has no scientific evidence that the levels of PFAS found in the samples tested indicate a need to avoid any particular food in the food supply." “The FDA’s testing for certain PFAS in such a wide range of foods available, including those commonly eaten by babies and young children, is among the first study of its kind,” said Acting FDA Commissioner Janet Woodcock in a press release. “Although our studies to date, including these newly released results, do not suggest that there is any need to avoid particular…

By Anna El-Zein and John Johnson III Sesame is the ninth Major Food Allergen with the passage of the Food Allergy Safety, Treatment, Education, and Research Act (FASTER) Act on April 23, 2021. Starting on January 1, 2023, any food “introduced or delivered for introduction into interstate commerce” must appropriately declare the presence of “sesame” as a major food allergen. However, the FASTER Act is more than just updating food labels; it also implicates supplier controls, Food Safety or HACCP Plans, sanitation practices and other procedures. With the compliance deadline looming, companies must start thinking about how FASTER affects their procedures sooner rather than later. Under the Federal Food, Drug, and Cosmetic Act (FDCA), a packaged food is misbranded if the label fails to declare the presence of a major allergen, either in the ingredient list or in a “contains” statement. With the addition of sesame to the “Big 8,”…

The U.S. Food and Drug Administration (FDA) has "launched a challenge to spur the development of affordable, tech-enabled traceability tools to help protect people and animals from contaminated foods by enabling the rapid identification of their sources and helping remove them from the marketplace as quickly as possible." The agency has asked "food technology solution providers, public health advocates, entrepreneurs and innovators across the human and animal food supply chain to present food traceability solutions that utilize economic models that are affordable, with costs that are proportional to the benefits received and can scale to encourage widespread adoption." FDA will accept submissions until July 30, 2021, and will select up to 12 winners for the challenge. Winners "will have the opportunity to present their work publicly in a webinar planned for September and their videos will be posted for public viewing."

The U.S. Food and Drug Administration (FDA) has issued a compliance policy guide on aflatoxins in human food. "Aflatoxins may occur in food as a result of mold growth in susceptible raw agricultural commodities," the guide explains. "The growth of molds that produce aflatoxins is influenced by environmental factors such as temperature, humidity, and extent of rainfall during the pre-harvesting, harvesting, or post-harvesting periods. Foods most susceptible to molds that produce aflatoxins include: peanuts, corn, some tree nuts including Brazil nuts and pistachios, and some small grains such as rice. Because aflatoxins are known carcinogens to humans, the presence of aflatoxins in foods should be reduced to the lowest levels attainable using modern agricultural and processing techniques." FDA issued guides for aflatoxins in brazil nuts, peanuts and peanut products, and pistachio nuts.

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.

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."

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