A recent (1997) quote from a widely-recognized laboratory that analyzes food is $750 for the analysis of one composite sample for all required nutrients (see Nutrition Label on p. vi). We wish to acknowledge the assistance of Ellen Anderson, Ph.D., Carole Adler, M.A., R.D., and Virginia Wilkening, M.S., R.D., in the Office of Nutritional Products, Labeling, and Dietary Supplements, and Rene O'Neill and Jerome Schneidman, M.S., in the Office of Scientific Analysis and Support, in developing this manual. In-house quality control samples can be developed from large batches of well-characterized foods such as fortified cereals, specific oils, freeze-dried vegetables, chocolate chips, orange juice, or high-fiber cereals, to name several. For analyses of composites: In the broccoli example, the following calculations apply for protein, a class II nutrient: predicted value = (mean - t (0.95;df) (composite size/k + 1/n)1/2 (s)) (5/4)= (4.6003 - 1.796 (12/12 + 1/12) 1/2(.6165770)) (5/4)= (4.6003 - 1.796 (1.040833) (.6165770)) (5/4)= (4.6003 - 1.1525896)(5/4)= 3.4477104 (1.25)= 4.309638. (iv) If a manufacturer elects to use abbreviations for units, the following abbreviations shall be used: tbsp for tablespoon, tsp for teaspoon, g for gram, mL for milliliter, oz for ounce, and fl oz for fluid ounce. [The rounded predicted value would be 4 g; a discussion of rounding will follow in section 7.]    = 16230.76 / 223.891 This calculation method is described in A. L. Merrill and B. K. Watt, "Energy Value of Foods - Basis and Derivation," USDA Handbook 74 (slightly revised 1973) pp. Because selected nutrients in some foods may undergo changes due to various factors (e.g., time after harvest or catch, processing, manufacture, conditions of transport), the agency recommends that food products be sampled at the point that is closest to the consumer. The agency is aware of the possible impact of outliers on analyses with other data points in a data set. Data base developers may need to consult the scientific literature, and in some cases, a statistician or research analyst to obtain additional detailed information that is relevant to the data base(s) of interest, but that is not contained in this manual. The guidance document can be obtained from the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. For Federal Register citations affecting § 101.9, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov. One formula that may be used to estimate the standard deviation(s) for nutrient content is found in most basic statistics books and is: = the sum of squared differences between each nutrient value and the mean of the n After those two years, manufacturers will be expected to provide the agency with a summary update that reassesses the interim label values based upon completion of the planned laboratory analyses. When using multi-stage sampling, the data base developer should determine the stages and the number of sampling units to select within each stage. The FDA receives many questions from manufacturers, distributors, and importers about the proper labeling of their food products. Saturated fat content shall be indented and expressed as grams per serving to the nearest 0.5 gram ( At this point, for each of the 144 composite samples, representing 144 lots, 12 consumer units are to be systematically selected (from each of the 72 stores during 2 months) with equal probability. Over 25 years ago, the Food and Drug Administration (FDA) initiated regulatory activities directed toward the development of regulations for nutrition labeling of food products. FDA acknowledges that, in certain circumstances, a data base developer may want to sample products at other positions along the production chain, such as the producer level. Food and Drug Administration    = (3.8416) (4) / (.364 )2 Claims or other nutrition information, except as provided in § 101.8(c), subject the food to the provisions of this section. On this date, consumers will have access to calorie and nutrition information in certain chain establishments covered by the rule. In order to limit consumer confusion, however, the label includes a single term, i.e., Daily Value (DV), to designate both the DRVs and RDIs. Import and export, production and safety, medical documents, ethical conduct and advertising rules. On the other hand, if a firm or association submits a data base for one of the top 20 raw fruits, vegetables, or fish that provides data to support optional nutrients (e.g., folic acid), the firm may use those data upon submission for label and labeling purposes. Carpenter (AOAC International, Arlington, VA, 1993, 624 pages). When the sample sizes for various nutrients vary, the data base developer may conduct the number of analyses corresponding to the number that were calculated for each individual nutrient. (i) "Saturated fat," or "Saturated": A statement of the number of grams of saturated fat in a serving defined as the sum of all fatty acids containing no double bonds, except that label declaration of saturated fat content information is not required for products that contain less than 0.5 gram of total fat in a serving if no claims are made about fat, fatty acid, or cholesterol content, and if "calories from saturated fat" is not declared. This point is typically defined at the retail or wholesale level. FDA will then analyze the nutrient content of this 1 composite test sample. The information required in this paragraph shall be highlighted in bold or extra bold and be in a type size no smaller than 10 point, except the type size shall be no smaller than 9 point for this information in the tabular displays as shown in paragraphs (d)(11) and (e)(6)(ii) of this section, the tabular display for small packages as shown in paragraph (j)(13)(ii)(A)(1 ) of this section, and the linear display for small packages as shown in paragraph (j)(13)(ii)(A)(2 ) of this section. This formula also assumes that the sample was collected as a simple random sample (i.e., equal probability of selection for each unit). The individual shall also state that should the average number of full-time equivalent employees or the number of units of food products sold in the United States by the person exceed the applicable numbers for the time period for which exemption is claimed, the person will notify FDA of that fact and the date on which the number of employees or the number of products sold exceeded the standard. While food manufacturers have until January 1, 2020, to comply with the new label guidelines, many businesses are gearing up to make the switch sooner rather than later. FDA carefully examined and fully considered the thoughtful comments submitted in response to the request and discussed those comments in the final rule on voluntary nutrition labeling of raw produce and fish that published on August 16, 1996 (61 FR 42742). The following sample label illustrates an aggregate display. A summary of the example is delineated on the following table: The quality of the composite samples submitted for laboratory analysis can have a significant impact on the resultant data The best analytical capability available cannot restore the physical integrity (e.g., physical characteristics, nutrient content) of the laboratory sample if these or other qualities have been compromised during collection, handling, or shipping. In order for the sample to be representative of the population, the sampling plan must give consideration to the product descriptions, as specified earlier in this chapter.    = 77.0336 or 77, Potassium: FDA recommends that those choosing to use alternative procedures discuss the procedures further with the agency to prevent expenditure of resources and effort on activities that may later be determined to be unacceptable to FDA. The text also discusses the analysis of hazardous contaminants in foods. Jeon and W.G. Reproducibility (i.e., inter-laboratory precision) describes the agreement between individual results obtained with the same method on identical test material, but with different laboratories, instruments, analysts, reagents, and times. Former - Nutrition Labelling Compliance Test. When a nutrient content claim is made, the statement must express that the claim refers to the amount of the nutrient per serving (e.g., "good source of calcium per serving" or "per X [insert unit]_serving") or per reference amount (e.g., "good source of calcium per [insert reference amount (e.g., per 8 ounces)]), as required based on § 101.12(g). This abbreviation can also be used on dual-column displays as shown in paragraphs (e)(5), (e)(6)(i), and (e)(6)(ii) of this section. For each product that is included in a nutrition labeling data base submitted to FDA, the agency requests that the developer include a table identifying proposed analytical methods that were used in the analysis of each nutrient, with accompanying information containing validation of the method used by the onsite or commercial laboratory for the matrix of interest. 1/2) gram increment below 5 grams and to the nearest gram increment above 5 grams. Because each production line has associated with it a given number of degrees of freedom, it is necessary to compute the "effective degrees of freedom" (dfeff),  which depend on the within production line variance estimates. If such sampling practices are avoided, the selected sample will, for practical purposes, approximate a random sample and will be more representative of the population than a sample collected in a non-random manner. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal ... [Title 21, Volume 2] [Revised as of April 1, 2020] [CITE: 21CFR101.7] TITLE 21--FOOD AND DRUGS: CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES: SUBCHAPTER B - … FDA encourages each data base developer to provide the best data base(s) possible with available resources. Awareness of such nutrients and supporting documentation regarding their levels may help reduce the number of analyses needed. any auxiliary information that will be needed in the statistical evaluation (e.g., stratum size, cluster size, etc.). 1/4 cup mix" and "Per prepared portion"), the combinations of food, the units, or the RDI groups that are being declared as shown in paragraph (e)(5) of this section. The following is an example of the procedure needed to calculate the weighted mean and standard deviation for the amount of protein in the broccoli example cited under the current sampling scenario. Here are three examples of how to properly label your honey under the new guidelines. FDA requests that the results of any experimental study that is submitted to the agency be included in statistical tables to better describe the type(s) of statistical test used, the sample size, and the exact probability levels that were used in drawing conclusions based on these results. The sample sizes in the above examples were estimated under the assumption that a collective estimate (e.g., all apples), as opposed to subclass estimates (e.g., several varieties of apples), was needed. These nutrients are vitamins, minerals, protein, dietary fiber, or potassium. Once all units are collected, you will have 1728 consumer units (144 composite samples of 12 units each). (6) Dietary supplements, except that such foods shall be labeled in compliance with § 101.36. When such dual labeling is provided, equal prominence shall be given to both sets of values. Companies using ingredient composition data bases should have procedures in place to ensure that the nutrient values are used only for specific applications. (iv) The following RDIs, nomenclature, and units of measure are established for the following vitamins and minerals which are essential in human nutrition: 1 RDIs are based on dietary reference intake recommendations for infants through 12 months of age. (i) Nutrient information for vitamins and minerals shall be separated from information on other nutrients by a bar and shall be arrayed vertically in the following order: Vitamin D, calcium, iron, and potassium as shown in the following sample labels. The Nutrition Labeling and Education Act of 1990 specified, in part, that the serving size used on product labels must be "an amount customarily consumed ... expressed in a common household measure that is appropriate to the food." The new policy directly addresses concerns relevant to interim review and approval of data bases. How many warehouses, packers, shippers, and/or retail outlets will be sampled? On December 14, 2016, amendments to nutrition labelling, list of ingredients and food colour requirements of the Food and Drug Regulations came into force. Fluoride content shall be expressed as zero when the serving contains less than 0.1 milligrams of fluoride, to the nearest 0.1-milligram increment when the serving contains less than or equal to 0.8 milligrams of fluoride, and the nearest 0.2 milligram-increment when a serving contains more than 0.8 milligrams of fluoride. FDA recommends that a data base developer consider the manner in which the data were collected and carry out the following steps in calculating a label value based on laboratory data: [Please note that the number of digits included for decimal places varies in the text. At the same time, consumers have the right to expect, with a reasonable probability, that label values will honestly and reasonably represent the nutrient content of the products that they purchase.                                  (number of) analyses (4) Except as provided in § 101.11, foods that contain insignificant amounts of all of the nutrients and food components required to be included in the declaration of nutrition information under paragraph (c) of this section, Provided, That the food bears no nutrition claims or other nutrition information in any context on the label or in labeling or advertising. (2) 0 (iii) For random weight products, manufacturers may declare "varied" for the number of servings per container provided the nutrition information is based on the reference amount expressed in the appropriate household measure based on the hierarchy described in paragraph (b)(5) of this section. (ii) Aggregate displays shall comply with the format requirements of paragraph (d) of this section to the maximum extent possible, except that the identity of each food shall be specified immediately to the right of the "Nutrition Facts" heading, and both the quantitative amount by weight (i.e., g/mg/mcg amounts) and the percent Daily Value for each nutrient shall be listed in separate columns under the name of each food. Next you look at the third column (Upper Limit for 12-Unit Composites). This guidance represents the Agency's current thinking on the development and use of nutrition labeling data bases. (iv) Nutrition information may be provided per serving for individual foods in the package, or, alternatively, as a composite per serving for reasonable categories of foods in the package having similar dietary uses and similar significant nutritional characteristics. (i) "Official Methods of Analysis of the AOAC INTERNATIONAL," 19th Edition, Volumes 1 and 2, 2012. 1/8 pie, (i) A statement of the corrected amount of protein per serving, as determined in paragraph (c)(7)(ii) of this section, calculated as a percentage of the RDI or DRV for protein, as appropriate, and expressed as Percent of Daily Value, may be placed on the label, except that such a statement shall be given if a protein claim is made for the product, or if the product is represented or purported to be specifically for infants through 12 months or children 1 through 3 years of age. To obtain this minimum or maximum label value, a component of the calculation is subtracted from the mean for class I and class II nutrients and added to the mean for nutrients in the third group. If the serving contains less than 0.5 gram, the content shall be expressed as zero.