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Heading into 2024, the U.S. The Food and Drug Administration (FDA) remains vigilant in ensuring the safety and quality of our food supplies. This year, the company introduced important updates and guidance on emerging products, new technologies, and changing customer needs.
From updated labeling requirements to streamlined approval processes, this latest FDA food guidance aims to provide more transparency, encourage innovation, and strengthen consumer protection.
Stay up-to-date with our latest FDA reports, regulatory changes, and significant developments shaping the future of the food industry. Explore our blog for in-depth insights and expert analysis on the latest issues related to the latest FDA Food Guidelines for 2024.
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FDA Revises Top Food Guidance Areas for 2024
The U.S. Food and Drug Administration (FDA) updated several vital guidelines for the food industry. These changes aim to improve food safety, improve label transparency, and address emerging issues. Here are some of the top areas where the FDA has revised its guidance:
1. CFSAN Online Submission Module (COSM)
The FDA Center for Food Safety and Applied Nutrition (CFSAN) has launched the CFSAN Online Submission Module (COSM), a web-based tool to facilitate industry submission. COSM provides a seamless interface to guide companies in submitting documents electronically rather than printed forms.
COSM is accessible 24/7 by sending a variety of information to two central CFSAN offices for processing:
- Office of Food Additive Safety (OFAS) – For submissions related to food ingredients and packaging materials:
- Biotechnology Final Consultation (Form 3665)
- Color Additive Petition (Form 3503)
- Color Master File (Form 3503)
- Food Additive Petition (Form 3503)
- Food Contact Notification (Form 3480)
- Food Master File for Food Additives (Form 3503)
- Food Master File for a Food Contact Substance (Form 3480)
- Generally Recognized as Safe Notice (Form 3667)
- New Protein Consultation (Form 3666)
- Pre-Notification Consultation (Form 3480)
- Office of Dietary Supplement Programs (ODSP) – For dietary supplement submissions:
2. Determining the Regulatory Status of a Food Ingredient
The FDA requires pre-market approval for any substance expected to become a food component, unless it is generally recognized as safe (GRAS) by qualified experts or meets specific exclusions under the Federal Food, Drug, and Cosmetic Act. Food additives intended to have a technical effect are deemed unsafe without conforming to approved regulations or exemptions. Foods containing unsafe additives are considered adulterated.
Similarly, any substance added to impart color is a color additive requiring approval, with no GRAS exemption available. Foods with unapproved color additives are also adulterated.
Manufacturers must ensure all food ingredients used are food-grade and meet purity specs and limitations of applicable authorizations. Compliance requires considering the identity, specifications, and usage limitations for each ingredient’s authorization.
To assure customers an ingredient isn’t adulterated or misbranded, manufacturers can provide a letter of guarantee with shipments, following the suggested forms outlined in 21 CFR 7.13. This certifies the ingredient meets regulatory identity, purity, and approved usage requirements.
3. Food Additives and GRAS Ingredients – Consumer Information
Food additives and GRAS (generally recognized as safe) ingredients contribute to food safety, freshness, nutrition, taste, and appearance. Salt and spices are immaculate, and modern ingredients provide high-quality, affordable food all year round.
All supplements require FDA testing and approval for safe use unless otherwise exempt. Their safety must be scientifically supported for the intended use conditions. The FDA uses industry data to regulate and inspect foods.
Although the FDA ensures reasonable safety, some risks can never be eliminated due to scientific limitations. If new information shows that an approved supplement is unsafe, the FDA revokes its approval and warns consumers.
Food manufacturers must use only properly approved, advertised ingredients that meet all FDA regulations before selling them to the public.
4. FDA Updates Regulations on Food Contact Notifications (FCNs)
FDA issued a final rule that revises when a food contact notification (FCN) is no longer valid.
The significant changes are:
- FDA can now determine FCN is ineffective for reasons other than safety concerns, improving the response.
- Manufacturers/suppliers must provide input before the FDA considers FCN ineffective.
- FDA can revoke the FCN for safety concerns, even if the manufacturer stops using it.
- If the FCN is considered ineffective, food contact material is not allowed.
- FDA will publish information on ineffective FCNs and provide updated information on effective FCNs on its website.
This enhances FDA oversight by allowing unsafe information to be removed while safety concerns are addressed. Overall, it reduces dual licensing.
5. Color Additives in Foods – FDA Overview
The FDA regulates food additive colors to ensure safety and consumer benefits.
Highlights include:
- Colors serve various purposes, including compensating for color loss, enhancing natural colors, and coloring colorless/fresh foods.
- All paints require FDA approval based on safety issues such as composition, dosage, and health effects.
- Approved products have built-in safeguards that minimize any side effects.
List of items:
- Certified colors such as FD&C models.
- Colors that come from natural ingredients like annatto and beets.
- The approval process includes an FDA application with detailed information on the design, manufacturing, intended use, and safety assessment.
- The regulations specify the types of foods allowed, maximum serving sizes, and labeling requirements.
- FDA monitors the market and may take enforcement actions for violations such as unreported/rejected colors.
- While reasonably safe, the FDA cannot ensure no risk due to scientific limitations.
6. Generally Recognized as Safe (GRAS)
GRAS stands for ingredients that are Generally Recognized As Safe and are not food additives. Under the Federal Food, Drug, Cosmetic, and Cosmetic Act, any intentional dietary supplement requires FDA approval before marketing, except:
- Qualified experts generally agree that it is safe for its intended use.
- It complies with other exclusions in the definition of food supplements.
A product may be eligible for GRAS status:
- Scientific Process – Requires evidence consistent with FDA dietary supplement acceptance standards.
- Before 1958, experience was based on daily consumption of food.
FDA regulations provide criteria for establishing GRAS based on scientific methods or daily practice.
Even though they are exempt from premarket approval, GRAS products must meet FDA safety standards.
7. Irradiation of Food & Packaging – FDA Regulation
The FDA regulates the use of radiation in food and food packaging. This authority stems from the 1958 Food Additive Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Highlights:
- The 1958 amendments defined emissions as food additives under section 201(s) of the FD&C Act.
- Section 402(a)(7) states that food is considered contaminated and that if it has been irradiated, it cannot be legally marketed unless the irradiation is produced under specified approved conditions in the Land The Act FDA internally.
- Thus, the FDA regulates aerobic foods through the additives approach.
- Once this process is complete, FDA issues a rule published in the Federal Register that specifies the safe radiation conditions approved for that particular food or packaging material
8. Environmental Decisions by the FDA
The National Environmental Policy Act (NEPA) requires the FDA to consider potential environmental impacts when making critical decisions regarding its regulatory actions under the federal Food, Drug, and Cosmetic Act.
Actions requiring environmental review include approval of food/color additives, confirmation of GRAS, exemptions as food additives, and the GRAS reporting process.
Most practices require the submission of an Environmental Assessment (E.A.) unless a catastrophic exemption is warranted.
According to the FDA, E.A. data support Finding of No Significant Influence (FONSI). A written Environmental Impact Statement (EIS) is required if significant impacts are projected.
This NEPA compliance process ensures that FDA adequately considers potential environmental impacts when reviewing food additives, GRAS products, and related ingredient policies before making a decision.
9. FDA Guidance on Food from Genome-Edited Plants
On February 22, 2024, the FDA issued guidance for companies describing voluntary processes for producing foods from genome-derived plants and communicating with the agency before marketing.
Key Points:
- It also highlights the FDA’s risk-based approach to evaluating the safety of new plant foods, including those made with genome editing techniques such as CRISPR.
- It outlines two ways companies voluntarily notify the FDA of steps they have taken to ensure safety:
- Premarket consultations
- Premarket meetings
- These voluntary procedures can facilitate the introduction of genome-derived plant-derived foods to the market while maintaining FDA safety.
- The FDA regulates all human and animal foods of plant origin, whether or not they are derived from genetic engineering/gene modification processes.
- All foods are held to the same safety standards, as the FDA focuses on the quality of the food itself rather than the production method.
This approach is supported by more than 25 years of experience showing that, as a category, foods from genetically engineered plants present no different or more significant safety concerns than their non-engineered counterparts.
10. Human Food Made from Cultured Animal Cells
An emerging area of food science is taking a small amount of cells from live animals and growing them in controlled environments to make food made from cultured animal cells. Development can use livestock, poultry, marine cells in food, or other animals.
Key Points:
- No food products from cultured animal cells are commercially available in the U.S. marketplace.
- Producers work to increase production to marketable levels at competitive prices.
As these products approach the market, the FDA and the USDA Food Safety Inspection Service (FSIS) increasingly collaborate to ensure safety and accurate labeling. Both companies have control over certain animal-derived human foods.
- FDA continues to work with companies that manufacture cultured animal cell-based food products to ensure that they are legally and safely produced under the federal Food, Drug, and Cosmetic Act
- Although the FDA shares responsibility for food safety with the industry, manufacturers must ensure that their products meet all applicable FDA requirements before they are sold.
11. Food Chemical Safety
FDA protects the food supply chain by investigating the use of chemicals as food ingredients that may affect food safety through packaging, storage, or handling. This ensures safe use. The FDA also inspects foods for chemical contamination and acts if the levels present safety.
- Chemicals Intentionally Used in Foods
Some chemicals serve valuable purposes in foods or packaging, such as:
- Preserving quality
- Adding nutrition
- Improving texture/appearance
- Extending shelf life
- Protecting against pathogens
Before they go on the market, drugs must be approved by the FDA for use as food, coloring, or food additives. Companies must provide safety data demonstrating that the drug meets FDA safety standards for its intended use.
The FDA has policies for companies to obtain licenses:
- Food/Color Additive Petitions – Providing data for FDA approval
- Food Contact Notifications – Assessing migration levels into food
- GRAS (Generally Recognized as Safe) Notifications – For publicly recognized safe uses
- Environment Contaminants
Other chemicals can inadvertently enter foods through environmental pollution (soil, water, air) or as raw materials that cause contamination during manufacturing.
The food industry should implement preventive measures to minimize the risks associated with chemical contamination.
- Monitoring Activities
The FDA oversees licensing and conducts post-market inspections:
- Review of additional safety information for approved products
- Examination for contamination of the food supply
- Developing methods to detect/prevent contaminated manufacturing processes
- Establishment of limits by international standards
- When safety concerns arise, enforcement action is taken
FDA food labeling requirements for the US and Canadian market
There are notable differences between US and Canadian food packaging guidelines. Some of the main differences are as follows.
- Canadian law mandates bilingual registration and “best before” date marking, which is not mandatory in the United States.
- By January 1, 2022, the United States will have adopted a national organic food standard, a law that currently has no Canadian equivalent.
- American guidelines require traditional metric units for net volume declarations, while Canadian guidelines require only metric measurements.
- Canada imposes stricter noise standards than American requirements for production outside its borders.
- Due to differences in circumstances, nutrition fact sheets cannot simultaneously address the standards of both countries.
- By December 15, 2022, or later, Canada will introduce changes to ingredients, sweetener specifications, quotas, sleeping percentage of total sugar prices ahead of daily, and mandatory nutritional packaging labels.
- However, the accepted methods of labeling allergens remain similar in both markets.
The consultant emphasizes that these food packaging guidelines should only be used for informational purposes. Regulations are sometimes amended, and specific types of food may be more closely scrutinized.
The FDA’s continuous efforts to update and refine food guidelines reflect its commitment to promoting public health and fostering a safe, innovative, and transparent food industry.
As we progress, staying informed about the latest FDA announcements and regulatory changes will be crucial for food manufacturers, retailers, and consumers. We can collectively contribute to a more secure and sustainable food ecosystem by embracing these evolving guidelines.
