Issues: Consumption and Nutrition
PMA Trans Fat Labeling Requirement Overview
March 7, 2005
The following questions and answers about trans fat labeling requirements are intended to provide general information about the topics covered and are not intended to provide legal advice about specific situations or problems. PMA recommends that members who have an issue requiring attention or questions about their products or situation consult their legal counsel. This overview document is provided as a member service and prepared by PMA legal counsel, Keller & Heckman LLP.
What is trans fat?
Trans fat (also known as trans fatty acid) is defined as the sum of all unsaturated fatty acids that contain one or more isolated (nonconjugated) double bonds. Trans fat is formed when hydrogen is added to vegetable oil, a process known as hydrogenation. Hydrogenated oils can increase the shelf life and flavor stability of foods. In addition, a small amount of trans fat occurs naturally, primarily in animal-based foods such as beef and pork, chicken skin, butter, whole milk, and cheese. Trans fat is not expected to be present in raw produce.
What are the health concerns regarding trans fat?
Trans fat, like saturated fat and dietary cholesterol, increases low density lipoprotein (LDL or "bad" cholesterol). But trans fat also decreases high density lipoprotein (HDL or “good” cholesterol).
What will be required on labels?
As of January 1, 2006, the grams of trans fat per serving must be declared below saturated fat in the Nutrition Facts box for products subject to mandatory nutrition labeling. However, FDA concluded that there is insufficient information to set a Daily Value for trans fat, so only the quantity will be required (no %Daily Value).
Trans fat must be expressed to the nearest 0.5 gram increment below 5 grams, and to the nearest gram increment above 5 grams. If a serving contains less than 0.5 gram of trans fat, the content, when declared, is expressed as zero (even if partially hydrogenated oil is listed as an ingredient). However, trans fat does not have to be declared if the total fat in the product is less than 0.5 gram per serving and no claims are made about fat, fatty acids or cholesterol content. If a declaration of trans fat content is not required and it is not declared, the statement “Not a significant source of trans fat” must appear at the bottom of the table of nutrient values, unless the simplified format is used. The word “trans” may be italicized to indicate its Latin origin, but that is optional.
How is the trans fat labeling effective date defined?
Trans fat labeling requirements are effective as of January 1, 2006, based on “initial introduction into interstate commerce.” Allergen labeling requirements are also effective on January 1, 2006, but based on a different trigger -- the "date of labeling," as required in the allergen labeling statute. Given the uncertainties regarding the meaning of “initial introduction into interstate commerce,” as well as the potential burden created by different implementation criteria, industry is seeking clarification and relief from FDA. Recently, the Grocery Manufacturers of America (GMA) submitted a letter to FDA, on behalf of 14 trade associations, requesting that the two new labeling requirements be harmonized so that the effective dates are triggered the same way, based on the date of labeling. At this time, it is not known whether FDA will be providing a response to the GMA letter.
What does “initial introduction into interstate commerce” mean, for purposes of compliance with the trans fat labeling requirement?
FDA has indicated informally that the intrastate movement of finished product would probably be considered an “initial introduction into interstate commerce.”
Is trans fat labeling required under the voluntary nutrition labeling program for raw fruits, vegetables, and fish?
Under the voluntary nutrition labeling program for raw fruits, vegetables, and fish at 21 CFR §101.45(a)(2), the nutrient values set by FDA for the 20 most frequently consumed raw fruits, vegetables, and fish must be used to ensure uniformity. FDA is required by law to furnish the nutrition information for the voluntary program, and in 2002 proposed updating the produce list and nutrition labeling values, but has not yet issued a final rule. In the proposed rule, FDA tentatively concluded that the final rule on the voluntary nutrition labeling of raw fruits and vegetables should require a footnote such as: "Most fruits and vegetables provide negligible amounts of saturated fat, trans fat, and cholesterol; avocados provide 0.5 g of saturated fat per oz,” although the final rule could be different.
FDA stated in the trans fat final rule that trans fat labeling will not be applicable on January 1, 2006 to voluntary fruit, vegetable and fish nutrition labeling, but that trans fat labeling requirements will be included in the final rule updating the voluntary nutrition labeling program, and will be enforced after the effective date of that final rule.
Can nutrient content claims be made for trans fat?
FDA has concluded that there is insufficient scientific information to establish nutrient content claims for trans fat at this time. However, FDA regulations provide that a statement that does not expressly or implicitly characterize the level of a nutrient, and is not false or misleading in any respect, may be made on the label or labeling of food. Therefore, a statement such as “__ grams of trans fat” may be used outside the Nutrition Facts box. See 101.13(i.)(3). But qualifying language, such as “only __grams of trans fat,” would be considered as characterizing the level of trans fat, resulting in an unauthorized nutrient content claim.
Does FDA plan to authorize claims about trans fat in the future?
FDA issued an advance notice of proposed rulemaking (ANPRM), seeking information about trans fat to be used in considering nutrient content claims, health claims, footnotes or disclaimers.
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