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    September 19, 2023

    Summer 2023 Regulatory Roundup: Allergens, Additives, and Alternatives

    The temperatures are cooling, kids are going back to school, and federal and state regulators are reconvening in Congress to round out the year. As we wrap up another eventful summer and begin the journey into fall and the holiday season, let’s take a review of all the regulatory updates that came out of the Food and Drug Administration (FDA), state departments, and the World Health Organization over the past several months.

    Top FDA Regulations for the Food and Beverage Industry

    It has not been a slow season for the FDA or U.S. lawmakers. As COVID-era Guidance documents are coming to an end, and new regulations are going into effect, the food and beverage industry faces significant changes and compliance challenges.

    Updates to COVID-Era Guidance Documents

    The COVID public health emergency (PHE) ended on May 11, 2023, which means the FDA, and other departments, are transitioning back to full regulatory enforcement. As a result, the FDA has announced that 22 COVID-era guidance documents will no longer be in effect after November 7, 2023.

    Among these documents, two pertain specifically to food and menu item labeling:

    • Temporary Policy Regarding Certain Food Labeling Requirements: Initially issued in May 2020, this FDA document provided temporary flexibility to food and beverage manufacturers during the pandemic to address supply chain disruptions. It allowed minor formula adjustments without requiring label changes and offered vending machine labeling flexibility.  
    • Temporary Policy Regarding Restaurant Menu Labeling: Originally released in April 2020, this guidance applied to chain restaurants and similar retail food establishments, offering flexibility in menu labeling provisions during the COVID-19 pandemic. However, this guidance is now concluding, and restaurant menu labeling regulations will soon return to full force. As a result, Restaurants with over 20 locations will need to review their menu labels for compliance with FDA menu labeling regulations. These regulations require restaurants to display caloric content on menu boards and provide additional nutritional information upon customer request.

    You can hear more about menu labeling compliance on day 2 of our upcoming reCONNECT event, with National Restaurant Association Vice President, Patrick Guzzle.

    Sesame Allergen Labeling Concerns

    In January 2023, the FDA added sesame as the ninth major food allergen as part of the Food Allergy, Safety, Treatment, Education, and Research (FASTER) Act. As an avenue to help consumers make safer, more informed choices about the products they’re consuming, the new ruling means that sesame is now required to be declared on any food labels as a major allergen when it’s an ingredient in a product.

    Since enacting this rule, however, the FDA has noticed many large-scale bakers intentionally adding sesame to products that previously did not contain sesame to avoid having to open a sesame-free production line. This keeps manufacturers in compliance with FDA regulations, but ultimately limits the number of safe, sesame-free options for consumers overall. You can read more about this development in our recent blog post: Avoid this Leading Cause of Recalls: Undeclared Allergens.

    Other FDA Regulations to Keep an Eye On

    • The FDA is working to finalize the restructuring of the Human Foods Program, which was initially announced in February. In August, the FDA named James “Jim” Jones as the first Deputy Commissioner of the department.
    • In May, the FDA released its Report on Occurrence of Foodborne Illness Risk Factors in Fast Food and Full-Service Restaurants (2017-2018), which summarizes findings from a 10-year study on “trends in the occurrence of foodborne illness risk factors and food safety behaviors and practices in food service facilities.” The report revealed that over half of foodborne illness outbreaks occur in restaurants, and two of the most common food safety issues were improper holding time and temperature and poor personal hygiene. More than likely, this report could lead to further food safety regulations impacting food service establishments and food service workers in the near future.
    • The FDA is cracking down on heavy metals and toxins in food intended for children or infants. The Closer to Zero plan, released in 2021, created specific action steps which are now being turned into draft actions. So far, the FDA is looking at lead, cadmium, mercury, arsenic, and other chemicals or toxins that may be present in foods and beverages, such as apple juice, and establishing lower limits for the presence of those chemicals. Companies will need to increase testing of products to ensure compliance as the FDA releases guidance on this topic.

    World Health Organization and the Future of Cell-Based Foods

    The World Health Organization (WHO) released resources on identifying and maintaining food safety with cell-based foods, which involves culturing cells isolated from animals. This means that various food end products might be produced using “muscle and fat tissues from cattle, pigs, poultry, fish, shrimp, crabs, lobsters, or even kangaroos.”

    While once seemingly a futuristic concept, cell-based food production – also known as “artificial, “lab-grown,” “cultured,” or “cultivated” – is now gaining popularity as an alleged sustainable alternative to the conventional livestock agricultural system. As production expands, the urgency to address consumer questions regarding cell-based food safety and production also grows.

    In April 2023, the Food and Agriculture Organization (FAO) and WHO issued a publication titled "Food safety aspects of cell-based food," which delves into the technologies employed in the production of cell-based foods, identifies possible food safety risks, and investigates regulatory structures across different nations. The FAO and WHO also continue to actively engage with food safety authorities, researchers, cell-based food developers, and non-governmental organizations to further the collective understanding of this emerging field and promote food safety in the realm of cell-based foods.

    State-Specific Regulatory Changes

    Lastly, a few states have also enacted regulations that could have ripple effects across the industry.

    California and New York are Banning Additives, Including Red Dye No. 3

    Editor's note: This blog has been updated to reflect the most recent changes, as of October 10, 2023.

    Some food and beverage manufacturers may find themselves in a bind, as California's governor recently approved, signed, and passed a bill that would ban certain additives found in food products. The Bill – Assembly Bill 418, or The California Food Safety Act – prohibits the “manufacture, sale or distribution of food products in California containing red dye No. 3, potassium bromate, brominated vegetable oil, or propylparaben.” Currently, many of these food additives are used in products due to the FDA’s Generally Recognized as Safe Rule – a portion of the Food, Drugs, and Cosmetic Act – meaning that certain additives aren’t subject to market preapproval if the additives meet certain criteria. 

    With the signing of the California Food Safety Act, food companies have until January 1, 2027 to adjust food product formulas and labels in adherence with the new law. Noncompliance will result in a fine of $10,000 for any violations. 

    New York is working on a similar bill, Senate Bill S6055A, but the bill is still sitting in the Committee stage as of September 2023.

    Both states are making this move in response to concerns about the potential health risks associated with these additives, particularly red dye No. 3, which a study by the California Office of Environmental Health Hazard Assessment linked to behavioral problems in children and suggested that current federal safety levels for food dyes might not adequately protect children's brain health. Although the FDA requires manufacturers list red dye No. 3 as an ingredient on food labels, the latest development demonstrates once again the growing emphasis on food safety and consumer health and well-being in the food industry.

    While the future of these particular additives remains uncertain, there are steps you can take now to prepare for action. If you’re manufacturing a product with red dye No. 3 or titanium dioxide as an ingredient, think about what you’d have to do if there was a ban on the ingredient.

    • What steps would you need to take to remove the ingredients from your product?
    • Would you be able to identify a replacement?
    • Would you be prepared to update your labeling and packaging to ensure compliance?

    Texas and Labeling Plant-Based Products

    A new law in Texas is establishing stricter guidelines for labeling plant-based meat and dairy products. The law seeks to address the issue of unclear labeling on products that taste or look similar to animal-derived products. The bill, signed into law and effective as of September 1, requires prominent labeling in close proximity to a product’s name that explains it’s an analog product (made through combining products to approximate animal meat) or made through cell-cultivation (artificial replication of animal cells in a laboratory).

    Many food companies are already voluntarily complying with the law by clearly labeling their products as plant-based, emphasizing the distinction from traditional animal-derived products. Additionally, the FDA has released draft guidance for the labeling of plant-based milk products that could further impact food companies in the space.

    If the FDA does establish guidelines for plant-based meat and milk products, federal regulations or requirements for labeling will take precedence over state regulations. At this time, the USDA and FDA, which are jointly responsible for regulating cell-cultivated meat, are actively working on establishing specific labeling guidelines for this emerging category. While the timeline for these regulations remains uncertain, they’re expected to be in place before cultivated meat products become widely accessible to consumers, ensuring consistent and clear labeling practices at the national level.

    Keeping an Eye of Regulatory Impacts

    No matter the regulation, make sure you’re taking steps to remain informed and up to date on the latest state and federal regulations to remain compliant. Trustwell’s podcast, Transparency Talk, offers a quarterly regulatory review episode, where our consulting experts discuss the latest topics to help you stay ahead of potential changes down the line. Here are some tips on how to stay in the know:

    • Sign up for as many industry newsletters as possible to keep an eye on regulations as they are announced.
    • Review your company’s history to determine how past regulations have been implemented at your organization and to get an idea of how you can move forward with upcoming regulations.

    As we continue to monitor and navigate the ever-evolving regulatory landscape, we encourage industry leaders and food safety professionals to be proactive. Take steps to stay informed and engaged, and if you’re feeling lost in the maze of regulations, reach out to regulatory experts for further guidance when necessary.


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