In July 2003, the U.S. Food and Drug Administration (FDA) published a regulation modifying the “Nutrition Facts” label on packaged food products. As of January 1, 2006, food manufacturers must now list trans fat content on their nutrition labels.
Nevertheless, this Federal labeling rule allows manufacturers to list “zero” if the product includes less than half of a gram of trans fat per serving. Consequently, the product could still have small amounts of shortening or partially hydrogenated vegetable oil while showing “zero” trans fat. Also, no percentage of the daily value (%DV) is listed, as trans fat has no known nutritional value.
The issuance of this federal labeling rule is an example of how government agencies can issue rules and regulations that have the force of law, even though rules have neither been voted on by Congress nor signed into law by the President. However, the rule must be based on an existing statute or law over which the agency has been given command. Also, the public must be notified of the proposed rule so that people can oppose it before it is issued.
Furthermore, agencies like the FDA do not create these rules without analysis. Here, the FDA depended on investigations from the National Cholesterol Education Program, the Institute of Medicine, and the National Academies of Science to decide. The FDA also cooperates with other governmental entities like the DHHS and USDA to form the best rule benefiting people’s health.
Here, scientific reports showed that consumption of trans fat increases “bad” cholesterol levels and causes coronary heart disease. Trans fat can be seen in shortening, cookies, crackers, fried foods, snack foods, and other processed foods made with partially hydrogenated oils.
In response to the growing evidence for TFA as a dangerous substance, the U.S. Food and Drug Administration (FDA) began to require labeling trans fat content in processed food in 2006 (FDA 2013b). However, while labeling regulations have been primarily responsible for the decline in average TFA intake in the U.S. by 3.3g per day per person (pp/pd) from 2003 to 2009, from 4.6g pp/pd to 1.3g pp/pd (Doell et al. 2012), the risk of ingesting even small quantities of TFA has propelled FDA to take further action.
In 2013, the FDA determined that PHOs are not typically identified as safe (GRAS). If this decision is finalized, manufacturers would be restricted from selling foods containing PHOs, thereby eradicating the primary source of dietary TFAs. Despite the ostensibly concise nature of its health benefits, the potential ban has been the subject of much controversy and debate due to its coercive nature.
However, one critical aspect of trans fat regulation that both critics and proponents of the ban have failed to consider is that there is a lack of transparency in the reporting and labeling of trans fatty acid content in foods due to rounding errors and serving size variability. These issues cause labels to deceptively claim 0g trans fat in foods containing clinically significant amounts of trans fat, given that the recommended TFA intake is <2g pp/pd.
Therefore, these labels lie to consumers, preventing them from making knowledgeable judgments about their diet (the purpose of labeling in the first place) and causing them to think that they are on a trans-fat-free diet when they are far from it. Therefore, before FDA policy makers continue the discussion about a PHO ban, they must first learn that current labeling regulations of TFA content in processed foods are deficient and allow for deceptive labeling. They must transform existing TFA labeling regulations to allow for transparent and proper labeling of TFA in processed foods.
What can and cannot be reached through labeling regulations can only be seen once they are made evident enough to actually permit consumers to make informed choices about their TFA consumption. Only after this is it possible to specify the necessity of a ban.
The lack of transparency in the FDA’s TFA labeling regulations can best be compared to Canada’s TFA regulations. Although Canada’s labeling policies may not be faultless, their juxtaposition with those in the United States undoubtedly shows the flaws of the FDA’s TFA labeling rules.
The first significant difference between the U.S.’s and Canada’s TFA labeling regulations is that of rounding: in the U.S., foods with less than 0.5g of trans fat per serving can be labeled as having 0g of trans fat, whereas, in Canada, only foods with less than 0.2g of trans fat per serving can be marked as having 0g of trans fat. This allows more TFA-containing foods in the US to claim zero TFA content.
Rounding is required to some degree in all labeling conventions because it is impracticable and unfeasible to ascertain the exact amount of a given substance. For instance, a product may be experimentally determined to include 0.3456789g of trans fat per serving, but this number with many decimals will confuse the reader and take up too much space. Therefore, to improve clarity, rounding is required to some degree.
Nevertheless, the regulations for rounding this number are what decide whether this 0.3456789g amount is labeled, for instance, as 0.3g (rounded to the nearest 0.1g), 0.5g (rounded to the nearest 0.5g), or 0g (rounded to the nearest 1g). Based on the countries’ differing rounding practices, in the US, this 0.3456789g amount would be rounded to 0g since foods with less than 0.5g of TFA per serving can be labeled as 0g.
Yet, in Canada, it would be rounded to 0.3g since only foods with less than 0.2g of TFA per serving can be labeled as 0g. While this rounding mistake is seemingly insignificant, it is clinically significant in the case of TFAs since any amount of TFA consumption causes an increased risk of CVD.
Here, zero plus zero doesn’t always equal zero. Zero plus zero can add up to a non-zero, clinically significant amount. Expressions of rounding error falsifying a food’s actual content are, in fact, prevalent in the U.S.: 84% of U.S. products containing PHOs (the main dietary source of trans fats) are labeled as having 0g of trans fat, which can lead consumers to potentially “underestimate their trans fat consumption.”
Another problem behind trans fat labeling regulations in the United States is the inadequacy of the definition of “serving size,” which prevents consumers from accurately judging their TFA consumption. In the U.S., food can be labeled as having 0g trans fat if it has less than 0.5g TFA per serving. A “serving” is based on “reference amounts customarily consumed per eating occasion” (CFR 2014:1), which are provided by the Code of Federal Regulations Title 21.
Do I Need an Attorney for the Food Industry?
An experienced business lawyer can help you in several ways. If you are a consumer who wants to inquire about rules and regulations for the FDA or food items, you should consult with an experienced local business attorney or a local employment attorney.
Should I Hire a Lawyer for Help with a Food Injury Claim?
Hiring a food injury lawyer has many benefits, such as awareness of any current class action lawsuits you could join. You should consult with a skilled and knowledgeable defective products lawyer for assistance in filing a lawsuit due to a food injury.
An experienced attorney can advise you of your rights, provide legal advice throughout the proceedings, and represent you in court as needed.
In July 2003, the U.S. Food and Drug Administration (FDA) published a regulation modifying the “Nutrition Facts” label on packaged food products. As of January 1, 2006, food manufacturers must now list trans fat content on their nutrition labels.
Nevertheless, this Federal labeling rule allows manufacturers to list “zero” if the product includes less than half of a gram of trans fat per serving. Consequently, the product could still have small amounts of shortening or partially hydrogenated vegetable oil while showing “zero” trans fat. Also, no percentage of the daily value (%DV) is listed, as trans fat has no known nutritional value.
The issuance of this federal labeling rule is an example of how government agencies can issue rules and regulations that have the force of law, even though rules have neither been voted on by Congress nor signed into law by the President. However, the rule must be based on an existing statute or law over which the agency has been given command. Also, the public must be notified of the proposed rule so that people can oppose it before it is issued.
Furthermore, agencies like the FDA do not create these rules without analysis. Here, the FDA depended on investigations from the National Cholesterol Education Program, the Institute of Medicine, and the National Academies of Science to decide. The FDA also cooperates with other governmental entities like the DHHS and USDA to form the best rule benefiting people’s health.
Here, scientific reports showed that consumption of trans fat increases “bad” cholesterol levels and causes coronary heart disease. Trans fat can be seen in shortening, cookies, crackers, fried foods, snack foods, and other processed foods made with partially hydrogenated oils.
In response to the growing evidence for TFA as a dangerous substance, the U.S. Food and Drug Administration (FDA) began to require labeling trans fat content in processed food in 2006 (FDA 2013b). However, while labeling regulations have been primarily responsible for the decline in average TFA intake in the U.S. by 3.3g per day per person (pp/pd) from 2003 to 2009, from 4.6g pp/pd to 1.3g pp/pd (Doell et al. 2012), the risk of ingesting even small quantities of TFA has propelled FDA to take further action.
In 2013, the FDA determined that PHOs are not typically identified as safe (GRAS). If this decision is finalized, manufacturers would be restricted from selling foods containing PHOs, thereby eradicating the primary source of dietary TFAs. Despite the ostensibly concise nature of its health benefits, the potential ban has been the subject of much controversy and debate due to its coercive nature.
However, one critical aspect of trans fat regulation that both critics and proponents of the ban have failed to consider is that there is a lack of transparency in the reporting and labeling of trans fatty acid content in foods due to rounding errors and serving size variability. These issues cause labels to deceptively claim 0g trans fat in foods containing clinically significant amounts of trans fat, given that the recommended TFA intake is <2g pp/pd.
Therefore, these labels lie to consumers, preventing them from making knowledgeable judgments about their diet (the purpose of labeling in the first place) and causing them to think that they are on a trans-fat-free diet when they are far from it. Therefore, before FDA policy makers continue the discussion about a PHO ban, they must first learn that current labeling regulations of TFA content in processed foods are deficient and allow for deceptive labeling. They must transform existing TFA labeling regulations to allow for transparent and proper labeling of TFA in processed foods.
What can and cannot be reached through labeling regulations can only be seen once they are made evident enough to actually permit consumers to make informed choices about their TFA consumption. Only after this is it possible to specify the necessity of a ban.
The lack of transparency in the FDA’s TFA labeling regulations can best be compared to Canada’s TFA regulations. Although Canada’s labeling policies may not be faultless, their juxtaposition with those in the United States undoubtedly shows the flaws of the FDA’s TFA labeling rules.
The first significant difference between the U.S.’s and Canada’s TFA labeling regulations is that of rounding: in the U.S., foods with less than 0.5g of trans fat per serving can be labeled as having 0g of trans fat, whereas, in Canada, only foods with less than 0.2g of trans fat per serving can be marked as having 0g of trans fat. This allows more TFA-containing foods in the US to claim zero TFA content.
Rounding is required to some degree in all labeling conventions because it is impracticable and unfeasible to ascertain the exact amount of a given substance. For instance, a product may be experimentally determined to include 0.3456789g of trans fat per serving, but this number with many decimals will confuse the reader and take up too much space. Therefore, to improve clarity, rounding is required to some degree.
Nevertheless, the regulations for rounding this number are what decide whether this 0.3456789g amount is labeled, for instance, as 0.3g (rounded to the nearest 0.1g), 0.5g (rounded to the nearest 0.5g), or 0g (rounded to the nearest 1g). Based on the countries’ differing rounding practices, in the US, this 0.3456789g amount would be rounded to 0g since foods with less than 0.5g of TFA per serving can be labeled as 0g.
Yet, in Canada, it would be rounded to 0.3g since only foods with less than 0.2g of TFA per serving can be labeled as 0g. While this rounding mistake is seemingly insignificant, it is clinically significant in the case of TFAs since any amount of TFA consumption causes an increased risk of CVD.
Here, zero plus zero doesn’t always equal zero. Zero plus zero can add up to a non-zero, clinically significant amount. Expressions of rounding error falsifying a food’s actual content are, in fact, prevalent in the U.S.: 84% of U.S. products containing PHOs (the main dietary source of trans fats) are labeled as having 0g of trans fat, which can lead consumers to potentially “underestimate their trans fat consumption.”
Another problem behind trans fat labeling regulations in the United States is the inadequacy of the definition of “serving size,” which prevents consumers from accurately judging their TFA consumption. In the U.S., food can be labeled as having 0g trans fat if it has less than 0.5g TFA per serving. A “serving” is based on “reference amounts customarily consumed per eating occasion” (CFR 2014:1), which are provided by the Code of Federal Regulations Title 21.
Do I Need an Attorney for the Food Industry?
An experienced business lawyer can help you in several ways. If you are a consumer who wants to inquire about rules and regulations for the FDA or food items, you should consult with an experienced local business attorney or a local employment attorney.
Should I Hire a Lawyer for Help with a Food Injury Claim?
Hiring a food injury lawyer has many benefits, such as awareness of any current class action lawsuits you could join. You should consult with a skilled and knowledgeable defective products lawyer for assistance in filing a lawsuit due to a food injury.
An experienced attorney can advise you of your rights, provide legal advice throughout the proceedings, and represent you in court as needed.
