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.
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.
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:
You can hear more about menu labeling compliance on day 2 of our upcoming reCONNECT event, with National Restaurant Association Vice President, Patrick Guzzle.
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.
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.
Lastly, a few states have also enacted regulations that could have ripple effects across the industry.
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.
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.
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:
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.