By the time you read this, the deadline for the new trans fat and allergen labeling requirements may already be past.
January 1, 2006 is the cut-off date for implementing the new regulations for trans fat labeling and allergen declarations. Products containing one of the “big eight” allergens (shellfish, fish, eggs, milk, peanuts, tree nuts, soybeans or wheat) must be labeled in “plain English.” There are currently two acceptable ways to present allergens on a label. Either method requires that tree nuts, shellfish and fish must be listed by common or usual name. The manufacturer can choose to put a parenthetical clarification immediately after the ingredient containing an allergen. When allergens are labeled this way, they would appear on the product as, for example, “Casein (Milk).” When using this method of labeling, it is not necessary to provide a parenthetical clarification IF the name of the allergen is already apparent. For example, “Nonfat Milk” would be listed in an ingredient statement only as, “Nonfat Milk”; it would not be necessary to list it as “Nonfat Milk (Milk).”
Allergenic ingredients can also be listed in an “allergen disclosure statement,” a statement beginning with the word “contains” immediately after or adjacent to the ingredient statement. Again, using either method of allergen labeling, tree nuts, shellfish and fish must be listed by name.
The amount of trans fat in a product will appear on the Nutrition Facts panel directly below the listing for saturated fats. If the product contains less than 0.5 grams of total fat and no claims are made regarding fat, fatty acids or cholesterol content, trans fat does not have to be listed, but if trans fat is not listed, a footnote must be added that states the food is “not a significant source of trans fat.” At this time, the FDA has not set a daily recommended value (DVR) for amounts of trans fats, nor has it made a decision regarding nutritional claims specific to trans fats.
TRANS FAT FAQs. The new legislation requiring labeling of trans fat and allergens has raised several questions from industry professionals and consumers. Some of the most frequently asked questions are addressed on the following page.
Q When are the labeling changes required
to be present on new products?
A All products entering interstate com-
merce on/after Jan. 1, 2006, must include trans fat on the label. All products labeled on/after Jan. 1, 2006, must include allergens labeled in “plain English” on the label.
Q Is trans fat labeling required if the sim-
plified labeling format is being used?
A Not necessarily. When the simplified
format is used, the 5 core nutrients (Calories, Total Fat, Sodium, Total Carbohydrate and Protein) must always be declared. If the nutritional profile has eight insignificant nutrients, the insignificant nutrients (excluding the core nutrients) can be left off of the label. Insignificant is defined as “that amount that allows a declaration of zero in nutrition labeling, except that for total carbohydrate, dietary fiber and protein, it shall be an amount that allows a declaration of less than one gram.” If the trans fat in a product is zero grams, it could be one of the nutrients not included on the label. However, if any claims are made about fatty acids, then all information pertaining to nutrients from fat would have to be listed – even if they are zero grams. Further, declaration of voluntary nutrients, vitamins and minerals that are a part of a standard of identity or vitamins and minerals that are added as fortification will trigger the addition of a footnote to the simplified nutrition label which states, “Not a significant source of …” followed by a listing of any of the nutrients that were left off of the nutrition facts panel.
Q Has the FDA banned use of products
containing trans fat in food?
A No. The use of products containing
trans fats is not prohibited. The new legislation requires that trans fat levels be declared on food labels. It would be nearly impossible to eliminate trans fat completely, because foods such as meat and dairy products contain small amounts of naturally occurring trans fats.
Q New allergen labeling regulations require the labeling of tree nuts. Do coconuts fall into this category?
A A coconut is categorized as the seed of a
drupaceous fruit. Coconuts are not usually restricted in the diet of an individual allergic to tree nuts. FDA has not officially ruled on whether coconut will be labeled as an allergen. Because labeling law does not currently list coconut as an exemption, AIB does include coconut as an allergen on food labels.
Q Are there any exemptions to the food
allergen labeling requirements?
A As of October 2006, the only true
exemptions are 1.) any highly refined oils derived from milk, egg, fish (e.g., bass, flounder or cod), crustacean shellfish (e.g., crab, lobster or shrimp), tree nuts (e.g., almonds, pecans or walnuts), wheat, peanuts and soybeans and 2.) any ingredient derived from such highly refined oil. Any person may also petition the Secretary to exempt a food ingredient. Guidelines for this petition are available at http://www.fda.gov/opacom/laws/fdcact/fdcact4.htm.
Q What are the guidelines for requesting
an extension on the trans fat labeling deadline requirements?
A FDA has announced guidelines for
requesting an extension on the trans fat labeling deadline requirements. To request an extension to allow more time to use old labels, companies need to do the following:
1. Identify the types of product(s) (e.g., candy, canned vegetables, etc.) and whether the declared label value for trans fat is 0.5 g or less per serving.
2. Explain why the request is being made.
3. State the number of labels remaining for each type of product identified and the total amount the company desires to use.
4. State the dollar amount for each type of product identified and for the total amount of labels to be used up.
5. Estimate the amount of time needed to use up some or all of the old labels (not to exceed 12 months).
Companies may also consider using a sticker label to declare trans fat in the Nutrition Facts panel, as long as the sticker will remain in place on the package under storage conditions, and it does not obscure other required label information. The sticker label must contain the entire Nutrition Facts panel, and the sticker must entirely cover the Nutrition Facts panel printed on the package.
Letters submitted will not receive an “acknowledgment of receipt” from the FDA. The FDA will respond to the letter of request by either granting or denying permission for an extension. Until a company receives a letter granting permission for an extension, they should assume they will NOT be granted permission and should continue making preparations to meet the trans fat labeling deadline of Jan. 1, 2006.
Requests may be sent by either mail or e-mail to: Ms. Felicia B. Satchell, Food and Drug Administration, 5100 Paint Branch Pkwy., (HFS-820), College Park, MD 20740 USA, e-mail: Extension.Trans@fda.gov.
The Nutrition Labeling Program at the American Institute of Baking is available to assist companies with their labeling questions. AIB’s nutrition labeling program began in 1993 as a service to the baking and food processing industries.
All formulas and ingredients submitted to AIB remain confidential. Technical support is available to help you find answers to your questions about regulatory guidelines or to deal with specific questions regarding nutritional information, serving size, claims, formats, exemptions and other related areas. The labeling program at AIB is sanctioned by the FDA, allowing any label disputes to be solved through discussion between the FDA, AIB and the client. Both the FDA and AIB have conducted reviews of the system that have shown it to be as accurate as a more costly lab analysis.
AIB offers two different nutritional reports. The first report is based on unrounded nutrient values per 100 grams of product. The second report provides nutrient values that have been computed and rounded according to federal regulations per serving size. These reports are $85 each. The second report can be converted to a camera-ready format for an additional $25. AIB also offers compliance assurance services for food labels, package statements, format and ingredient declaration reviews for an actual time billing of $150 per hour. For more information, contact AIB at 785/537-4750, www.aibonline.org. AIB
The author is Technical Information Coordinator, AIB.