Dietary Supplement Labeling Guide: Chapter IV. Nutrition Labeling. ![]() ![]() What nutrients am I required to list in the . A measurable amount is an amount that exceeds the amount that can be declared as . If present in a measurable amount, trans fat must be listed on a separate line underneath the listing of saturated fat by January 1, 2. Calories from saturated fat and the amount of polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble fiber, sugar alcohol, and other carbohydrate may be declared, but they must be declared when a claim is made about them. CFR 1. 01. 3. 6(b)(2)(i) (see 6. FR 4. 14. 34 at 4. July 1. 1, 3. 00. Must I declare vitamins and minerals (other than vitamin A, vitamin C, calcium, and iron) listed in 2. CFR 1. 01. 9(c)(8)(iv) and (c)(9)? No. You are only required to declare them when they are added to the product for purposes of supplementation, or if you make a claim about them. CFR 1. 01. 3. 6(b)(2)(i)Am I required to list any other nutrients if I make a claim about them? Yes. When you make a claim about calories from saturated fat, insoluble fiber, polyunsaturated fat, sugar alcohol, monounsaturated fat, other carbohydrate, and soluble fiber, you must list that nutrient. CFR 1. 01. 3. 6(b)(2)(i)May I declare dietary ingredients not having Daily Values (i. RDIs or DRVs)? Yes. Dietary ingredients for which no daily values have been established must be listed by their common or usual names when they are present in a dietary supplement. They must be identified as having no Daily Values by use of a symbol in the column for .
![]() Ingredients in dietary supplements that are not dietary ingredients, such as binders, excipients, fillers, must be included in the ingredient statement. CFR 1. 01. 4(g)Must I declare vitamin E when it occurs naturally in my product and I make no claim for it? No. Because Vitamin E is not one of the 1. CFR 1. 01. 3. 6(b)(2)(i)May I declare protein on the label if my product contains only individual amino acids? CFR 1. 01. 3. 6(b)(2)(i)Must I list the dietary ingredients in my products in a specified order? ![]() ![]() ![]() ![]() Yes. You must list the dietary ingredients that have Daily Values in the same order as for the labels of conventional foods, except that vitamins, minerals and electrolytes are grouped together. This results in the following order for vitamins and minerals: Vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B1. CFR 1. 01. 3. 6(b)(2)(i)(B)May I use synonyms for my dietary ingredients? Yes. You may use the following synonyms in parentheses after your dietary ingredients: Vitamin C (ascorbic acid), thiamin (vitamin B1), riboflavin (vitamin B2), folate (folacin or folic acid), and calories (energy). Alternatively, you may list . High protein, low-carb, sugarless diet helps rid young girl of depression, pain and anxiety 10/12/2016 - There is no doubt that food plays a crucial role in our well. Bernard Raising Cats Naturally 69 50 mg. CHAPTER 3: CALCULATION OF THE ENERGY CONTENT OF FOODS - ENERGY CONVERSION FACTORS. As stated in Chapter 1, the translation of human energy requirements into. You may place the amount of your dietary ingredient in a separate column or immediately following the name of your dietary ingredient. CFR 1. 01. 3. 6(b)(2)(ii)When I use a separate column for amounts, can the heading . Language consistent with the declaration of the serving size, such as . You may declare information on a . You may use additional columns when you have a product with different servings, such as one tablet in the morning and two at night. ![]() You must label the columns appropriately, e. For example, the amount of fat would be listed in terms of grams in both the . However, units of measurement for amounts of vitamins and minerals are not specified for use in the . You should use the units of measurement given in 2. CFR 1. 01. 9(c)(8)(iv) for the Daily Values of vitamins and minerals when listing these nutrients in . See Appendix B for the daily values to be used for adults and children 4 or more years of age and Appendix C for the daily values to be used for infants, children less than 4 years of age, or pregnant or lactating women. CFR 1. 01. 3. 6(b)(2)(iii)How do I calculate the % DV? You calculate the % DV by dividing the quantitative amount by weight by the established Daily Value for the specified dietary ingredient and multiplying by 1. DV for protein must be calculated in accordance with 2. CFR 1. 01. 9(c)(7)(iii)). In this calculation, you must use as the quantitative amount the unrounded amount, except that for total fat, saturated fat, cholesterol, sodium, potassium, total carbohydrate, and dietary fiber, you may use the quantitative amount by weight declared on the label (i. For example, the % DV for 6. C is 1. 00 (6. 0 mg divided by the Daily Value for vitamin C, multiplied by 1. CFR 1. 01. 3. 6(b)(2)(iii)(B) and 2. CFR 1. 01. 9(c)(7)(iii)What rounding rules must I use for expressing the % DV? You must express the percentages to the nearest whole percent, except that . ![]() For example, a product containing 1 gram of total carbohydrate would list the % DV as . For example, if a product contains 5 mg of potassium, the % DV calculates to 0. In this case, you would declare . You may show more than one column. FDA has established four sets of Daily Values for many nutrients. Appendix B shows the Daily Values to be used for adults and children 4 or more years of age and Appendix C has the Daily Values to be used for children under 4 years of age, for infants, and for pregnant and lactating women. When you show more than one column, you must clearly identify each column (e. Daily Value for Children Under 4 Years of Age). CFR 1. 01. 3. 6(b)(2)(iii)(E) and (e)(1. What are . RDIs or DRVs) such as phosphatidylserine. CFR 1. 01. 3. 6(b)(3)(i)Where must I list . FDA has not specified an order that you must follow. You must list the quantitative amount by weight per serving immediately following the name of the dietary ingredient or in a separate column. You must place a symbol in the column for . You may include information on the concentration of the dietary ingredient and the solvent used, e. You must identify the solvent in either the nutrition label or ingredient list. CFR 1. 01. 3. 6(b)(3)(ii)(B)How must I list dried extracts? For dietary ingredients that are extracts from which the solvent has been removed, you must list the weights of the dried extracts. CFR 1. 01. 3. 6(b)(3)(ii)(C)May I list constituents of a dietary ingredient? Yes. You may list constituents of a dietary ingredient indented under the dietary ingredient and followed by their quantitative amounts by weight per serving. You may declare the constituents in a column or in a linear display. CFR 1. 01. 3. 6(b)(3)(iii)How must I list proprietary blends? You must identify proprietary blends by use of the term . On the same line, you must list the total weight of all . Indented underneath the name of the blend, you must list the . These ingredients should be followed by a symbol referring to the footnote . The title, . The title and all headings must be bolded to distinguish them from other information. CFR 1. 01. 3. 6(e)How must I present the information in the . You also must use a type size larger than all other print size in the nutrition label for the title . See the section on . FDA has provided an exception for certain packages with space constraints. See the section on . Appendix B and its specifications are a model, which FDA has suggested in the interest of uniformity of presentation. For example, 2. 1 CFR 1. For two packets, this would consist of five columns. List all of the dietary ingredients in the first column. List the amounts and percents of the morning packet in the second and third columns and similar information for the evening packet in the fourth and fifth columns (see the illustration of aggregate nutrition labeling in 2. CFR 1. 01. 3. 6(e)(1. CFR 1. 01. 3. 6(e)(8)What kind of samples will FDA collect to determine compliance with 2. CFR 1. 01. 3. 6? FDA will collect a composite of 1. FDA will randomly select these packages. CFR 1. 01. 3. 6(f)(1)What if it is not technically feasible for me to comply with the nutrition labeling requirements? FDA may permit you to use an alternative means of compliance or additional exemptions in accordance with 2. CFR 1. 01. 9(g)(9). If your firm needs such special allowances, you must make your request in writing to the Office of Nutritional Products, Labeling, and Dietary Supplements (HFS- 8. Food and Drug Administration, 5. Paint Branch Parkway, College Park, Maryland 2. CFR 1. 01. 3. 6(f)(2)Must dietary ingredients that I have added to my products be present at 1. I declare? For dietary ingredients that are specifically added, your product must contain 1. Products that contain less than this amount of such a dietary ingredient would be misbranded and in violation of the law. Dietary ingredients that are naturally- occurring must be present at 8. For example, if you add vitamin C that was isolated from a natural source or made synthetically to your dietary supplement product, it would be subject to the 1. However, if you added rose hips to your product, the vitamin C in the rose hips is naturally- occurring and must be present at least 8. CFR 1. 01. 9(g)(3) and (g)(4)What are small packages? Small packages are those packages having less than 1. CFR 1. 01. 3. 6(i)(2) and 2. CFR 1. 01. 9(j)(1. What is the telephone provision for small packages? In lieu of a . You may use a telephone number or an address in place of the . You may use a tabular format on small packages. You also may present . Also, 4. 5 point type may be used on packages with less than 2. Furthermore, the type size used in the . You may use a linear format if the label will not accommodate a tabular format. You may use a row of dots connecting the columns containing the name of each dietary ingredient and the quantitative amount (by weight and as a percent of Daily Value) in the . On products for children less than 2 years of age, other than infant formula, you must not declare calories from fat, calories from saturated fat, saturated fat, polyunsaturated fat, monounsaturated fat, and cholesterol.
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