FDA Requires Trans Fatty Acid Labeling for Foods and Dietary Supplements

Date: Oct 01, 2003

The U.S. Food and Drug Administration (FDA) has issued a final rule requiring trans fatty acids content to be listed on the nutrition panel label of conventional food and dietary supplement products. Although the final rule is effective Jan. 1, 2006, the Agency is encouraging industry to modify labels as soon as possible - and expects many companies to do so soon.

This is the first significant change that FDA has mandated for the Nutrition Facts panel since it was required in 1993. The current Agency action responds to a petition filed by the Center for Science in the Public Interest in 1994 requesting that the Agency take steps to require trans fat to be listed on nutrition labels.

'Bad cholesterol'
Trans fatty acids, also known as trans fats, are made during partial hydrogenation of vegetable oils. Hydrogenation is a process by which hydrogen atoms are added to unsaturated sights on fatty acids, thereby eliminating double bonds. Partial hydrogenation relocates some double bonds and hydrogen atoms end up on different sides of the chain. This type of configuration is called trans.

The Agency has concluded that published human studies show intake of trans fatty acids increase low density lipoprotein-cholesterol or LDL-C (known as "bad" cholesterol) in the blood, as does the intake of saturated fatty acids. Elevated LDL-C increases the risk of developing coronary heart disease.

The Agency also concluded that listing trans fat under the total fat content line of the Nutrition Fact panel will help consumers realize that many popular food products contain significant amounts of trans fatty acids. U.S. consumers will learn to relate trans fatty acids with saturated fat and cholesterol and identify items to avoid in their diet.

Another line
FDA food labeling regulations currently require a line for total fat content on the Nutrition Facts panel, along with another line listing saturated fat content. This new regulation requires the addition of still another line, for trans fatty acid, which can be listed as either trans fat or trans. The trans fat content must be expressed as grams per serving to the nearest 0.5 gram increment if below 5 grams and to the nearest gram increment if above 5 grams. When a serving contains less than 0.5 gram, the content, when declared, must be expressed as "0 grams."

However, conventional food products need not declare "0 grams" of trans fatty acids if the product contains less than 0.5 gram of total fat in a serving, and if no health claims are made about fat, fatty acid or cholesterol content. In the absence of these claims, the statement "not a significant source of trans fat" may be placed at the bottom of the table of nutrient values in lieu of declaring 0 grams of trans fat.

For a dietary supplement, however, when the amount of trans fat is less than 0.5 grams per serving, trans fat must not be listed on the Supplement Facts panel at all. In addition, statements such as "0 grams" and "not a significant source &" are not allowed on the Supplement Facts panel.

Health claims deferred
The Agency has also decided to defer action on nutrition content claims and health claims. With respect to trans fatty acids, in its original proposal (64 Fed. Reg. 62746, Nov. 17, 1999), FDA suggested including a footnote after the Nutrition Fact panel indicating that "trans fat consumption should be as low as possible." This proposal was based on a National Academy of Sciences report recommending that trans fat consumption should be minimized within the context of maintaining a nutritionally balanced diet.

However, the Agency received so much negative criticism about the footnote wording that is has decided to conduct consumer studies to determine the appropriate manner of presenting such information.

The Agency also issued an advanced notice of proposed rulemaking (ANPR) to solicit data and information on the effectiveness of various nutrition content and claims, including those that address saturated fat and cholesterol in addition to trans fatty acids. In this ANPR, the Agency is requesting comment specifically on whether food products should be allowed to claim on their labels that they are "low in trans fat," information on whether current nutrient content claims for saturated fat and cholesterol appropriately reflect trans fat content as well and comment on whether health claims about cholesterol-raising fats should be permitted.

The final regulation and ANPR can be found on FDA's website at www.fda.gov/OHRMS/DOCKETS/98fr/03-17525.htm.

Used with permission. Copyright FOOD & DRUG PACKAGING, October, 2003.

For further information about this article, please contact George G. Misko at 202-434-4170 or by e-mail at misko@khlaw.com.