If you are in the dietary supplement and food industry, you may not know that there are new rules that are about to go effect in a very short while. In 2004, President George Bush signed into law the Food and Allergen Labeling and Consumer Protection Act of 2004 (hereafter referred to as FALCPA). In part, this is the result of a petition from the Center for Science and Public Interest (CSPI). On January 1, 2006 these mandatory laws go into effect and it is the first major overhaul of labels in a decade. We all know about label lead times (right?) and that means that you better start planning for this or you will be in violation of labeling laws at the beginning of the new year. Let's start off the new year right!
Many of you may be aware that the word -cis or-trans refers to a specific conformation of a molecule. It is merely a descriptor. You will see it on some label describing the conformation of natural products as well. But let's start with the most basic facts: the word "trans" is not synonymous with harmful. For example, our Coenzyme Q10 is the all-trans form, and that is very beneficial for you. Some molecules have both forms of bonds, such as the molecule cis-9, trans-11-CLA - - thus this is an example of a fat molecule that has a trans bond but is not harmful (but most oils are in the cis position). While discussing the example of CLA, I can confirm that CLA is not a âTransâ Fat.
A trans fat is shorthand for trans fatty acid, which is an unsaturated fatty acid that contains one or more isolated double bonds in a trans configuration. Trans fatty acids with conjugated bonds do not overlap with the FDA's definition of trans fats. Physically, trans fat is a liquid oil that has been made into a semi-solid or solid form, a process of adding hydrogens to the oil (hydrogenation). By pushing hydrogens into the double bonds of the oil, the hydrogenation saturates /reduces the double bonds thus imparting a harder consistency to the oil. Oil that is completely hydrogenated does not contain trans fat; oil that is partially hydrogenated does contain trans fats. The amount of trans fatty acids in the typical American diet has been estimated to be approximately 8.1 grams per person per day, largely through the consumption of spreads and margarines (reference #1). Governmental estimates are lower - - about 5.8 grams (2.6% of calories) trans fat/person/day. In 1980, the major brand salad and cooking oils contained 12-13% trans fats (reference #2). However, there are small amounts of naturally occurring trans fats present in the food supply through foods such as lamb, beef, cheese, milk, and butter.
The new required trans fat declaration is a subcomponent of Total Fat separated by a hairline expressed as grams per serving rounded to the nearest 0.5 gram increments. For trans fat concentrations of about 5 grams, the Trans Fat content is expressed to the nearest gram. The numbers are to be written under the saturated fat line, and remember, there is no Daily Value (%DV) for Trans Fat. The following is an example:
If the amount of trans fat is 2.7 grams per serving, it would be expressed at 2.5 grams Trans fat If the amount of trans fat is 6.7 grams per serving, it would be expressed as 7.0 grams Trans fat
Are Trans Fats mandatory on all Nutrition Facts labels?
No. If the total fat in a food is less than 0.5 grams per serving, then the trans fat does not have to be declared. And, that makes sense, right? If you have less than 0.5 grams of fat, then you are not declaring any total fat, saturated fat, or cholesterol.
What about Dietary Supplements and Trans Fats?
Some dietary supplements will contain a trans fat declaration, while others will not. Itâs really simple: if you have more than 0.5 grams trans fat in your dietary supplement, then you must declare it.
If the Trans Fats amount is low, can you use that fact for a nutritional claim?
No. You can not make a nutrient content claim on Trans Fat. So if your product contains 1 gram of Trans Fat, you can not state "low in Trans Fat". The FDA concluded that a reduced Trans Fat claim would detract from educational messages that emphasize lower intakes of saturated fat. You can not claim "Trans Fat Free".
Here is what you might encounter with a typical meal replacement powder. First, you will have to add in a line of Trans Fat underneath Saturated Fat (indented the same way). Put in the amount of Trans Fat, followed by a/an asterisk/ dagger symbol which will reference the fact "Daily Value not established".
The Big Eight: Allergens
Though the Big Eight sounds like a regional athletics division, I am referring to the impending requirement to label all dietary components that contain or are derived from the most common eight allergens. But before we get the Big Eight list, letâs take a quick review of the allergen story. How prevalent is this problem with allergies? The results of a six year period of skin testing performed on 10,508 subjects (Third National Health and Nutrition Examination Survey -NHANES III) showed that 54.3% had a positive test for one or more allergen (reference #3). About 150 people die every year because of allergic reactions to food. However, this problem is increasing and the numbers of those affected with food allergies is approximately 2% of the adult population in the US.
The Big 8 food allergens are milk, egg, fish (for example bass, flounder, etc.), crustacean shellfish (for example crab, lobster or shrimp), tree nuts (for example almonds, pecans or walnuts), wheat , peanuts and soybeans. If your product contains or is derived from any of the Big 8 allergens then it must be declared in an "Allergen Warning" statement or it must be a component of the ingredient statement, either written directly or as a parenthetical description. But you must state the Big Eight allergen warning in either the "parenthetical" format or "contains" format - - but you can't have it both ways.
The new labels will have to use the common names for the and not the general descriptor. For example, if the Vitamin D3 is from fish, then it must not state Vitamin D3 from fish, it must state Vitamin D3 from Menhaden fish. This is simply because allergies are very specific to a particular type of nut, or species of fish or shellfish, etc. The FDA will enforce this new labeling requirement and if the label does not comply, then it is deemed misbranded.
This article certainly covers very dry material but (a) it is a distillation of some 130 pages of an FDA petition review and (b) we all can rejoice that these types of label mandates are very infrequent (in this case, the first major change in a decade)!
Sid Shastri M.Sc. is the Vice President, Product Development for Jarrow Formulas. Sid received his degree In Exercise Physiologist from U.C. Berkeley and his Master's of Science in Human Nutrition from the University of Bridgeport in Connecticut. Access more information about Sid Shastri at www.shastris.com.
1. Groff, JL. Advanced Nutr and Human Metabolism. Third Edition. Wadsworth publishing. 1999, pages 124
2. Enig, M. Nutrition Reviews, Vol. 52, No.2, February 1994:69-71.
3. Are Allergies Becoming More Common?, Healthnotes Newswire, NewHope.com, August 18, 2005.