Trans-fatty acids (TFAs) have been a focal point in food safety regulation due to their impact on public health. Trans fats are unsaturated fatty acids that have at least one double bond in the trans configuration. They can be either naturally occurring, found in small amounts in meat and dairy products, or artificially produced through the partial hydrogenation of vegetable oils, leading to what is commonly known as partially hydrogenated oils (PHOs).
The U.S. Food and Drug Administration (FDA) has played a crucial role in regulating the use of trans-fatty acids in the food industry, particularly concerning the artificial sources found in PHOs. The regulatory framework established by the FDA aims to mitigate the risks associated with trans fats and ensure the safety of the food supply.
In June 2015, the FDA made a landmark decision, determining that PHOs are no longer "Generally Recognized as Safe" (GRAS) for use in food. This determination marked a significant shift in food safety policy, reflecting growing scientific evidence linking artificial trans fats to adverse health effects, such as increased risk of coronary heart disease.
The FDA’s final determination required food manufacturers to remove PHOs from their products by January 1, 2021. This compliance date was set to allow manufacturers sufficient time to reformulate their products and ensure a smooth transition in the marketplace. The FDA’s decision was aimed at protecting public health while providing the food industry with a clear timeline for compliance.
To implement the removal of PHOs, the FDA issued a direct final rule that revised several key regulations:
Revised Standards of Identity: The FDA updated the standards of identity for certain food products, such as peanut butter and canned tuna, to no longer include PHOs as an optional ingredient. This revision reflects the broader effort to eliminate artificial trans fats from processed foods.
GRAS Affirmation Regulations: The FDA also revised its GRAS affirmation regulations, removing partially hydrogenated forms of specific oils, such as menhaden and rapeseed oils, from the list of substances recognized as safe. This action further solidifies the agency’s stance against the use of PHOs in the food supply.
Revocation of Pre-1958 Authorizations: Prior to the Food Additives Amendment of 1958, certain uses of PHOs in products like margarine, shortening, and bread had been authorized. The FDA’s direct final rule revoked these authorizations, effectively closing a regulatory loophole that allowed the continued use of PHOs in these products.
Labeling Requirements: The FDA’s regulations stipulate that trans fat content must be declared on food labels. However, if a product contains less than 0.5 grams of total fat per serving and makes no claims about fat content, the trans fat content declaration is not required. This nuance in labeling ensures that consumers are informed about trans fat levels in their food while recognizing that some products may contain trace amounts that are not significant.
While the FDA’s regulations have successfully targeted artificial trans fats, it is important to note that trans fats are not completely eliminated from the food supply. Naturally occurring trans fats are found in small quantities in meat and dairy products. Additionally, very low levels of trans fats may be present in certain edible oils that have not undergone hydrogenation.
The presence of naturally occurring trans fats does not pose the same level of health risk as artificial trans fats. Nonetheless, the FDA continues to monitor and regulate these substances to ensure that their levels remain within safe limits.
The FDA’s regulatory actions concerning trans-fatty acids represent a significant advancement in public health policy. By eliminating PHOs from the food supply, the FDA has reduced the population’s exposure to harmful artificial trans fats, contributing to the prevention of heart disease and other health issues associated with trans fat consumption.
Food manufacturers must remain vigilant in their compliance with these regulations, ensuring that their products meet the FDA’s standards. This ongoing commitment to food safety is essential in maintaining consumer trust and protecting public health in the United States.
For more detailed inquiries, stakeholders can reach out directly to the FDA or utilize the SGS Digicomply platform for comprehensive insights and updates. Feel free to get in touch now to learn about implementing the Regulatory Intelligence Hub for your company. Or explore the demo and try Regulatory Guides in action.
The SGS Digicomply Food Regulatory Guide for the United States of America includes:
To request access specifically to the United States of America Regulatory Guide, please contact us now:
SGS Digicomply offers over 250 Up-to-Date Regulatory Guides for countries worldwide. Explore the regulatory landscape using our guides, which provide a consistent and comprehensive format for understanding the regulatory framework specific to any market. These guides are designed to help you easily navigate complex compliance requirements, making it easier to conduct business across global markets. Explore our Regulatory Guides demo to see how it works.