Insights

May 5, 2022 by Daniel Brooker

FDA declares sesame the 9th major food allergen.

The FDA has added sesame as the first new allergen required to be labeled since the original 8 major allergens were introduced in 2004. Under the FASTER Act of 2021, sesame is the 9th major food allergen required to be labeled effective January 1, 2023. This means food manufacturers will need to have sesame listed as a major food allergen on their packaging by this compliance date. In the meantime, the FDA has encouraged manufacturers to voluntarily list sesame as an allergen on food packaging now. If we have worked on ingredients and allergens for you recently we have already done this for you. We began doing this when FDA issued draft guidance in November of 2020 to encourage manufacturers to voluntarily declare sesame in the ingredient list when it is used as a “flavoring” or “spice” or when the common or usual name (such as tahini) does not specify sesame. Please reach out to us if you have any concerns or need updates on your food allergen labeling. We would love to help you update existing labels as needed.

While most people know what sesame seeds are, and can recognize them in or on foods, there are some ways that sesame may be “hidden” within the ingredient statement. One example is tahini, which is a ground sesame seed paste. Another way would be if sesame is used within a natural flavoring or simply listed as a “spice”. If there is any doubt about whether or not your ingredients may contain sesame (or any of the major allergens for that matter) we would highly recommend that you request updated allergen statements from your ingredient suppliers and let us know if you need assistance. We can also help you with food allergen testing of your products.

For more details, the U.S. Food and Drug Administration (FDA) released a new video that provides an overview of the 2021 Food Allergy Safety, Treatment, Education, and Research (FASTER) Act.

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March 1, 2021 by Daniel Brooker

How to get Nutrition Facts for my food label

This is a step-by-step guide to get the Nutrition Facts for your food labels.

Step 1: Decide how much food will be in your package

The amount of food in the package is called the “net contents”. If your food is solid, sort of solid, or very thick and slow flowing it should be labeled in terms of weight (e.g. grams, ounces). If your food is liquid and easily pourable it should be labeled in fluid measures (e.g. fluid ounces, milliliters). If you have different sized packages of food you will also need a different Nutrition Facts panel for each new size. The goal is that the serving size multiplied by the servings per package on the Nutrition Facts panel should add up to the net contents on the front of the food label.

Step 2: Measure the dimensions of your food package

Nutrition Facts come in many shapes and sizes but they are all regulated. The shape and size of the Nutrition Facts also called the format, is based on the area of your food package “available” for labeling. Measure the dimensions of this area in inches so you can determine the total square inches of your packaging that could be labeled. This does not mean the area of the small sticker label on the package. It means the area of the package that could be labeled. This excludes parts of the package that cannot be labeled and are not labeled, like the neck of a bottle or the bottom of a milk carton. The goal here is to select the compliant Nutrition Facts format for your size package.

Step 3: Determine the piece count or density of your food in the package

The piece count is an important part of your serving size when there are larger pieces of food. Examples of large pieces are tortilla chips, bagels, cookies, slices of bread. When the piece count in the package may vary it’s a good idea to do a count on several packages and then take an average. A density measurement is only needed when the food is liquid, scooped like peanut butter, or in small pieces (e.g. grains of rice, raisins, chocolate chips, table sugar). A simple way to estimate density is with a 1 cup measuring cup from your kitchen and a small digital postal scale. Fill the cup completely with the food and record the weight of only the food inside the cup. To do this you need to subtract out the weight of the measuring cup from the weight of the food. When you fill the cup fill it just like you would fill it with water, level with the top. Try to fill it in such a way that there are no air bubbles trapped inside. You may need to use a straight edge like a knife to make the food level with the top of the cup. Do this several times and get a good average weight of the food in grams. The goal here is to get a compliant serving size on the Nutrition Facts for your category of food which will be based on the piece count or density.

Step 4: Get a nutrition analysis

For most types of food, a recipe or database analysis is appropriate. This method is fast, economical, and allowed by the FDA. If you would like us to help you with a recipe analysis please click here to get started. Food Lab specializes in nutrition analysis of food products based on your recipe. However, a few types of foods require that you send samples to a chemistry lab for testing to determine their nutritional value. Examples of these types of foods are nut milk, beef jerky, pickles, and kombucha. Chemistry is the most expensive option for nutrition analysis and is a great method for all types of food, not just the ones we listed. We can also help you get a nutrition analysis of your product from chemistry if required. If you are not sure which option is best for your product please give us a call. We can help you determine which method is most appropriate for your type of food. The goal here is to obtain the nutrition values for your food that includes all of the mandatory nutrients required for a Nutrition Facts panel on your food label.

Step 5: Find your serving size

The last item that brings all these things together into a Nutrition Facts panel is your serving size. The quantity of all the nutrients and their corresponding percent daily values (%DV) are based on your serving size. Since they are regulated by the FDA you can’t just pick any serving size you want. The FDA requires that serving sizes be uniform between similar types of foods so that consumers can more easily compare the nutrition between them. The FDA has created a table called the Reference Amounts Customarily Consumed (or RACC table) that is used to determine serving sizes. The serving size is made up of two parts: a "household measure term" followed by its metric equivalent in grams (g). For liquids, the household measures may be declared in cups, tablespoons, teaspoons, or fluid ounces with the metric equivalent in milliliters (mL). In general, the serving size must be the closest number of pieces or fraction of a household measure to the reference amount. We have a step-by-step example of how to determine the serving size for a pizza here. The goal here is to select the FDA-compliant serving size for your category of food.

Step 6: Create the Nutrition Facts panel

Now that you have your net contents, count/density, package surface area, nutritional analysis, and serving size you are ready to create the Nutrition Facts. Each nutrient has its own set of rules for rounding the amounts labeled and for using the RDI’s and DRVs for calculating the percent daily values (%DV). These rules are found in the Code of Federal Regulations 21CFR101.9. There are three main formats for the Nutrition Facts called standard, tabular, or linear. The format of the Nutrition Facts is regulated by the FDA and is based on the area of the package available for labeling in square inches. You can find examples of different Nutrition Facts formats and helpful formatting guidelines on the FDA’s website. The FDA prefers that you use the largest format that your label will accommodate. However, most people want to use the smallest Nutrition Facts format allowed for their size package. This gives you the most label real-estate for the other more aesthetically pleasing artwork and the other important information you want to display on the label. The goal here is to be sure you have an FDA-compliant format for your Nutrition Facts that uses a reasonable amount of labeling area.

DIY Nutrition Facts or should you hire a pro?

Nutrition Facts formatting is fairly complicated and regulated by the FDA. We recommend hiring a professional to help you avoid common mistakes made on Nutrition Facts. Doing a nutrition analysis and making the Nutrition Facts panel is much like preparing taxes. Lots of people are comfortable doing their own taxes and receiving money-saving benefits. However, they also risk that they may do it incorrectly and have issues with the IRS in the future. If that is you there are many software programs and websites that offer these DIY services. Another option is to hire professionals like us to do the nutrition analysis and create the Nutrition Facts for you. Hiring us is like hiring a CPA to do your taxes with the same peace of mind that brings. If you are not sure which option is right for you give us a call or consider the following:

Always hire a professional to create your Nutrition Facts if…

You have a complicated food process and/or many ingredients.
Importing a food from another country
Making a significant investment in packaging
You have something new or unusual in the marketplace
Making claims on your food label

Please contact us if we can be helpful or if you have questions about creating Nutrition Facts for your food label Toll-Free 855-FOOD-LAB (366-3522).

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January 11, 2021 by Daniel Brooker

Should you disclose sesame as an allergen on your food label?

The simple answer is YES. FDA has recently issued draft guidance for the food industry to voluntarily disclose sesame as an allergen on food labels. They have also extended the comment period on this guidance. In plain language, if you have sesame in your food product you should disclose it clearly in the ingredients list. For example: When sesame is used in food as a “flavor” or “spice” there should be, in a parenthetical, following the spice or flavor, such as, “spice (sesame),” “spices (including sesame),” “flavor (sesame)” or “flavors (including sesame).” If a term is used for a food that is or contains sesame, such as tahini, they recommend that sesame be included in a parenthesis, e.g. “tahini (sesame)” in the ingredient list. This voluntary declaration of all sources of sesame in the ingredient list will help consumers, especially those allergic to sesame, avoid foods that could cause an allergic reaction.

The guidance can be found here:

Voluntary Disclosure of Sesame as an Allergen: Guidance for Industry

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December 23, 2020 by Daniel Brooker

How to Understand Nutritional Analysis

Foods are composed of a complicated matrix of compounds. Among these compounds are nutrients that are essential for life and growth. For human food, these nutrients have been defined and mandated by governments to be disclosed on food packaging in most countries around the world. These mandates are intended to help populations reduce nutrient deficiencies and preventable diseases caused by malnutrition. A nutritional analysis is the description of the method used to determine the amounts of these nutrients in a particular food. Nutrients are generally reported on a one hundred gram basis as a certificate of analysis (Fig 1.1).

Nutrient Analysis per 100g — Fig 1.1 Nutrition Analysis Report per 100g

After obtaining results, the nutrition analysis is used to prepare label nutrient disclosures on food packaging. In the United States, these disclosures are regulated by the FDA and titled “Nutrition Facts”. Nutrition labeling requirements for Nutrition Facts are contained in 21 C.F.R. § 101.9 and are required on most food products offered for sale. 21 U.S.C. § 343(q). The Nutrition Facts contain the amount of each nutrient in a serving of food and are characterized by a percent daily value (%DV) that is based on Daily Reference Values (DRVs in Fig 1.2) and Reference Daily Intakes (RDIs). The %DV helps consumers understand how the amount of a nutrient present in a food fits into their daily nutrition needs. In addition, there are both mandatory nutrients and voluntary nutrients that may appear on Nutrition Facts. Depending on how voluntary nutrients enter food products, and whether or not nutrients appear in other label statements outside of the Nutrition Facts, voluntary nutrients may become mandatory to disclose. This is an important consideration when designing Nutrition Facts for your food label to make sure that there is space on the label artwork to accommodate these additional nutrient disclosures.

Fig 1.2 Daily Reference Values (DRVs) - Adults

Fig 1.3 Reference Daily Intakes (RDIs) - Adults

In Nutrition Facts, nutrients are declared based on a food serving size. Serving sizes are regulated by the FDA and determined by a reference amount of food customarily consumed per eating occasion, or RACC table, for different food categories. Choosing the wrong serving size is a common mistake and can be a challenging exercise when food does not fit neatly into any one category. Servings must also be displayed in an appropriate common household measure like a teaspoon, tablespoon, or cups. 21 C.F.R. § 101.12(b). This allows consumers to compare the nutrition values between different options for the same categories of food. It empowers them to make healthy eating choices for themselves and their families.

The FDA is not so much concerned about the method food manufacturers use for nutritional analysis, and database calculations are an acceptable method in most cases. They are more concerned that the resulting Nutrition Facts be truthful and not misleading. Their role in regulating food labeling is more of an enforcement function rather than an approval function. The FDA does not approve food labels or the Nutrition Facts on them. However, they do regulate food labeling and enforce those regulations as resources allow and necessity guides them. If they do decide to decide about the truthfulness of the Nutrition Facts on a food label they will obtain samples and send them in for chemical analysis by an accredited laboratory. There is a protocol for this sampling and accepted methods of analysis that are used. This protocol and accepted methods of nutrition analysis are the gold standards for the food industry.

A chemical nutritional analysis is not necessary or required by the FDA in most cases. A recipe, or database, analysis is generally an appropriate, and accurate, method of nutritional analysis for most types of food. There are also the added benefits of speed and economy with this method. The main concern with database analysis is that the results be truthful and not misleading compared to what the FDA would find when performing chemical analysis on the food. For database nutrition analysis the results are only as good as the recipe information provided to the analyst and the quality of the nutrient data used. When the information is good a database analysis can be as accurate and reliable as a chemical analysis of the food.

There are times when only a chemical nutrition analysis is appropriate. For instance, nutrient content claim substantiation over the shelf life of a product can only be done through chemical analysis in the laboratory. Chemical analysis is also necessary when other methods of nutritional analysis are not appropriate for the type of food or for the processing techniques used to make the food. Beef jerky is a classic example of a food that should be analyzed chemically for nutrient content. Often the process to make beef jerky includes a marinade that is discarded followed by a drying process where juices fall off of the jerky. This complicated process makes recipe analysis from a nutrient database inappropriate. Other types of foods where chemical nutritional analysis is recommended include fermented and/or cultured foods like kombucha, cheese or kimchi, pickled foods, and nut milk.