The FDA News You Should Know

by | February 15, 2023

The Food and Drug Administration (FDA) continuously changes its regulations and can introduce new ones at any time they deem it necessary. These regulatory changes aim to increase safety in the food and beverage manufacturing, processing, and handling industries.

There are a few FDA regulations and updates that stakeholders in the relevant industries should be aware of in 2023. 

Congressional funding updates

In January 2023, President Joe Biden signed into law a budget that earmarked $8.4 billion to the FDA. Lawmakers passed the substantial funding increase to boost food safety activities and invest more in infrastructure. In addition, Congress allocated $226 million in FDA funding to support existing programs and activities presented in the previous budget. 

Lawmakers assigned:

  • $41 million for food safety.
  • $8 million for emerging chemical and toxicology issues.
  • $20 million for the agency’s “New Era of Smarter Food Safety” initiative.
  • $10 million for maternal and infant health and nutrition.
  • $1 million for sodium reduction targets.
  • $1 million for machine learning. 

Legislators expect the funding to support activities noted in the previous budget and existing programs. Apart from allocating the finances to various programs, Congress shared their views and gave directives on critical issues, including: 

  • Farm-to-bottle assessment on infant formula. Given last year’s massive infant formula recall, which triggered national shortages, the Consumer Brands Association (CBA) and other relevant stakeholders stressed the need to elevate food safety and nutrition. In addition, legislators raised concerns about a third-party audit that exposed vulnerabilities in the infant formula supply chain and recent delays in food safety actions. They encouraged the FDA to strongly review the report’s recommendations and its proposed restructuring plan. Congress directed the FDA to continue monitoring the infant formula issue and asked the General Accounting Office (GAO) and the Health and Human Services Inspector General to investigate the issue. Finally, legislators insisted that the assessment should target the entire farm-to-bottle supply chain. This evaluation includes the production of ingredients, manufacturing, processing, and distribution, as well as inputs and regulatory approvals for each step. 
  • Concerns on domestic inspections. Given the concerns about the safety of infant formula, lawmakers also recommended a boost in the frequency of domestic human food inspections. They also advised the FDA to report on operational changes and the implications for inspecting non-high-risk domestic facilities every three years and high-risk domestic facilities every 18 months. Some specific inspection targets the bill mentions include embracing a risk-based approach to sampling imported food with higher pesticide violation rates than locally produced products. 
  • Increase in standards of identity. Lawmakers also directed the FDA to increase enforcement of identity standards for some foods, such as different grades of olive oil and yogurt. They also noted consumer concern over the labeling of added sugar on products such as maple syrup and honey and asked the FDA to ensure clear and appropriate labeling. 

New food poisoning standards

The FDA is also making regulatory changes to help identify food contaminants, including tracking food through the supply chain. This pivot means everyone who touches food, from the farmers to the processing plants to manufacturers to distributors to retailers. Also, restaurants must keep track of the food they handle.  

Every food will have a code, which also will identify risky and non-risky foods. This new regulation will make identifying potentially harmful food easier and mitigate consumer exposure to food poisoning. The new rule go live on Jan. 20, 2026. Since the USDA maintains jurisdiction over meat and poultry, the new rule doesn’t cover them.

Regulatory changes regarding CBD as a supplement

The FDA is working with Congress to develop a new strategy for handling CBD products. The FDA highlighted some concerns about the safety of these products and emphasized that CBD products must not be considered food additives or dietary supplements.

In a statement, FDA’s Principal Deputy Commissioner Dr. Janet Woodcock said they hadn’t found sufficient evidence to determine how long a person can consume CBD or how much they can consume before it risks harm. Consequently, they don’t intend to allow the use of CBD in conventional foods and dietary supplements. 

The FDA has only approved one drug containing CBD to manage rare and severe forms of epilepsy. They highlighted the potential risks and safety concerns and recommended new rules, including information on minimum purchase age, content limits, and labeling. Since people can be exposed to CBD through milk, eggs, and meat from animals consuming CBD, the FDA may oversee handling CBD products for animals under the new regulations.

Regulatory changes include an import crackdown

The FDA has enforced stricter controls on various imported products such as cheese, seafood, and avocados to increase safety on imports. 

These updates include the detention without physical examination of:

  • Seafood and seafood products from specific shippers or manufacturers because of the detection of histamines or decomposition.
  • Fish or fishery products from foreign processors not in compliance with seafood HACCP.
  • Seafood products due to nitrofurans.
  • Raw and cooked shrimp.
  • Cheese due to microbiological contamination.
  • Seafood and other food products because of the presence of salmonella.
  • Foods containing illegal and/or undeclared colors.
  • Cosmetics that are tainted and/or misbranded due to color additive violations.
  • Drugs coming from manufacturers or suppliers that haven’t met the drug GMPS.
  • Devices without approved PMAS or ideas and other devices not substantially equivalent or without a 510(k).
  • Raw agricultural products for pesticides.
  • Processed foods for pesticides.
  • Food products containing sulfites.
  • Foods due to heavy metal contamination.
  • Food products that are or contain unsafe food add.
  • Produce that appears to have been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.  

Additionally, FDA will detain frozen or refrigerated guacamole and processed avocado products due to listeria.

Stay ahead of shifting regulations

As the global economy welcomes new playersits increasingly crucial for brands to be able to rely on a single source of regulatory data from multiple countries and regions. With a dependable, current source of the latest global compliance information, brands can pursue international expansion with confidence.

TraceGains’ groundbreaking alliance with SGSDigicomply, the world’s leading intelligence data provider, provides access to an unmatched collection of global regulatory data that we’ve incorporated seamlessly into our solution suite.

Our unique Regulatory Global solution offers:

  • A strategic, process-driven approach to compliance built around complex, fully automated analysis of the global regulatory environment.
  • Consolidated tools for assembling and sharing global regulatory changes.
  • Combined market entry guides for nearly all the world’s growing economies. 

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