# Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling Regulations
**AGENCY:**
Food and Drug Administration, HHS.
**ACTION:**
Notice.
**SUMMARY:**
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
**DATES:**
Submit written comments (including recommendations) on the collection of information by June 19, 2020.
**ADDRESSES:**
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to *https://www.reginfo.gov/public/do/PRAMain* . Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. All comments should be identified with the OMB control number 0910-0381. Also include the FDA docket number found in brackets in the heading of this document.
**FOR FURTHER INFORMATION CONTACT:**
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, *[email protected]* .
**SUPPLEMENTARY INFORMATION:**
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
**Food Labeling Regulations**
**OMB Control Number 0910-0381—Revision**
This information collection supports our food labeling regulations and associated Agency guidance. Under the authority of sections 4, 5, and 6 of the Fair Packaging and Labeling Act (FPLA) (15 U.S.C. 1453, 1454, and 1455) and sections 201, 301, 402, 403, 409, 411, 701, and 721 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321, 331, 342, 343, 348, 350, 371, and 379e), we have issued regulations regarding the labeling of food. The regulations are codified in parts 101, 102, 104, and 105 (21 CFR parts 101, 102, 104, and 105) and implement statutory provisions that a food product shall be deemed to be misbranded if, among other things, its label or labeling fails to bear certain required information concerning the food product, is false or misleading in any particular, or bears certain types of unauthorized claims. While part 101 sets forth general food labeling provisions, requirements pertaining to the common or usual name for nonstandardized foods; guidelines for nutritional quality to prescribe the minimum level or range of nutrient composition appropriate for a given class of food; and requirements for foods for special dietary use are found in parts 102, 104, and 105, respectively.
The disclosure requirements, along with the reporting and recordkeeping provisions, are necessary to ensure the safety of food products produced or sold in the United States and enable consumers to be knowledgeable about the foods they purchase. Nutrition labeling provides information for use by consumers in selecting a nutritious diet. Other information enables consumers to comparison shop. Ingredient information also enables consumers to avoid substances to which they may be sensitive. Petitions or other requests submitted to us provide the basis for us to permit new labeling statements or to grant exemptions from certain labeling requirements. Recordkeeping requirements enable us to monitor the basis upon which certain label statements are made for food products and whether those statements are in compliance with the requirements of the FD&C Act or the FPLA.
Specifically, the regulations set forth the general content and format requirements for food packaging, including nutrition and ingredient information. Additional regulations provide for nutrient content claims. To assist respondents in this regard, we developed the document entitled “Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body.” The guidance is available from our website at: *https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-notification-health-claim-or-nutrient-content-claim-based-authoritative-statement* . The guidance communicates our recommendations regarding food labeling claims associated with regulations found in §§ 101.13, 101.14, 101.54, 101.69, and 101.70. It was developed to assist respondents in satisfying criteria found or discussed in these regulations regarding the submission of notifications for certain health claims and identifies information to include and information we will evaluate in determining compliance with statutory requirements ( *e.g.,* supporting literature; discussion of analytical methodology or methodologies used in support of a particular claim).
The regulations also include provisions applicable to the labeling of dietary supplements. To assist respondents in this regard and in understanding provisions under the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Pub. L. 109-462), we developed the guidance entitled “Questions and Answers: Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.” The guidance is available from our website at: *https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-labeling-dietary-supplements-required-dietary* . The guidance communicates the following information: (1) What “domestic address” means for purposes of the dietary supplement labeling requirements in section 403(y) of the FD&C Act; (2) FDA's recommendation for the use of an introductory statement before the domestic address or phone number that is required to appear on the product label under section 403(y); and (3) when FDA intends to begin enforcing the labeling requirements of section 403(y).
The guidance entitled “Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act” has also been developed to assist respondents to the information collection. The guidance is available from our website at: *https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-substantiation-dietary-supplement-claims-made-under-section-403r-6-federal-food* . The guidance discusses the requirement that a manufacturer of a dietary supplement making a nutritional deficiency, structure/function, or general well-being claim have substantiation that the claim is truthful and not misleading. The guidance is intended to describe the amount, type, and quality of evidence FDA recommends that a manufacturer have to substantiate a claim under section 403(r)(6) of the FD&C Act.
Finally, we are revising the information collection by consolidating elements associated with revised Nutrition Facts and Supplement Facts labels regulations. Requirements included among the food labeling regulations found in part 101 govern both format and content of the Nutrition Facts (§ 101.9) and Supplement Facts (§ 101.36) labels. Currently, the information collection associated with food labeling under §§ 101.9 (including petitions filed under 101.9(c)) and 101.36 (disclosures associated with serving size) is approved under OMB control number 0910-0813. These provisions were established by rulemaking (RIN 0910-AF22) and have now been incorporated into the regulations in part 101.
*Description of Respondents:* Respondents to this information collection are manufacturers, packers, and distributors of food products, as well as certain food retailers, such as supermarkets and restaurants.
In the *Federal Register* of February 5, 2020 (85 FR 6551), we published a notice inviting public comment on the proposed collection of information. One comment was received suggesting FDA consider including labeling requirements pertaining to folic acid, while a second comment was received that was not responsive to the information collection topics solicited. Neither comment suggested we revise our burden estimates, which are as follows:
| 21 CFR section; activity | Number of | Number of | Total annual | Average | Total hours |
| --- | --- | --- | --- | --- | --- |
| 101.9(c)(6)(i); dietary fiber | 28 | 1 | 28 | 1 | 28 |
| 101.9(j)(18) and 101.36(h)(2); procedure for small business nutrition labeling exemption notice using Form FDA 3570 | 10,000 | 1 | 10,000 | 8 | 80,000 |
| 101.12(h); petitions to establish or amend referenced amounts customarily consumed (RACC) | 5 | 1 | 5 | 80 | 400 |
| 101.69; petitions for nutrient content claims | 3 | 1 | 3 | 25 | 75 |
| 101.70; petitions for health claims | 5 | 1 | 5 | 80 | 400 |
| 101.108; written proposal for requesting temporary exemptions from certain regulations for the purpose of conducting food labeling experiments | 1 | 1 | 1 | 40 | 40 |
| Total | | | 10,042 | | 80,943 |
| 21 CFR section; activity | Number of | Number of | Total annual | Average | Total hours |
| --- | --- | --- | --- | --- | --- |
| 101.9(c)(6)(iii)
; added sugars | 31,283 | 1 | 31,283 | 1 | 31,283 |
| 101.9(c)(6)(i)
; dietary fiber | 31,283 | 1 | 31,283 | 1 | 31,283 |
| 101.9(c)(6)(i)(A)
; soluble fiber | 31,283 | 1 | 31,283 | 1 | 31,283 |
| 101.9(c)(6)(i)(B)
; insoluble fiber | 31,283 | 1 | 31,283 | 1 | 31,283 |
| 101.9(c)(8)
; vitamin E | 31,283 | 1 | 31,283 | 1 | 31,283 |
| 101.9(c)(8)
; folate/folic acid | 31,283 | 1 | 31,283 | 1 | 31,283 |
| New products | 216 | 1 | 216 | 1 | 216 |
| 101.12(e); recordkeeping to document the basis for density-adjusted RACC | 25 | 1 | 25 | 1 | 25 |
| 101.13(q)(5); recordkeeping to document the basis for nutrient content claims | 300,000 | 1.5 | 450,000 | 0.75 (45 minutes) | 337,500 |
| 101.14(d)(2); recordkeeping to document nutrition information related to health claims for food products | 300,000 | 1.5 | 450,000 | 0.75 (45 minutes) | 337,500 |
| 101.22(i)(4); recordkeeping to document supplier certifications for flavors designated as containing no artificial flavors | 25 | 1 | 25 | 1 | 25 |
| 101.100(d)(2); recordkeeping pertaining to agreements that form the basis for an exemption from the labeling requirements of section 403(c), (e), (g)-(i), (k), and (q) of the FD&C Act | 1,000 | 1 | 1,000 | 1 | 1,000 |
| 101.7(t); recordkeeping pertaining to disclosure requirements for food not accurately labeled for quality of contents | 100 | 1 | 100 | 1 | 100 |
| Total | | | 1,089,064 | | 864,064 |
| 21 CFR section; activity | Number of | Number of | Total annual | Average | Total hours |
| --- | --- | --- | --- | --- | --- |
| 101.3, 101.22, parts 102 and 104; statement of identity labeling requirements | 25,000 | 1.03 | 25,750 | 0.5 (30 minutes) | 12,875 |
| 101.4, 101.22, 101.100, parts 102, 104 and 105; ingredient labeling requirements | 25,000 | 1.03 | 25,750 | 1 | 25,750 |
| 101.5; requirement to specify the name and place of business of the manufacturer, packer, or distributor and, if the food producer is not the manufacturer of the food product, its connection with the food product | 25,000 | 1.03 | 25,750 | 0.25 (15 minutes) | 6,438 |
| 101.9, 101.13(n), 101.14(d)(3), 101.62, and part 104; labeling requirements for disclosure of nutrition information | 25,000 | 1.03 | 25,750 | 4 | 103,000 |
| 101.9(g)(9) and 101.36(f)(2); alternative means of compliance permitted | 12 | 1 | 12 | 4 | 48 |
| 101.10; requirements for nutrition labeling of restaurant foods | 300,000 | 1.5 | 450,000 | 0.25 (15 minutes) | 112,500 |
| 101.12(b); RACC for baking powder, baking soda, and pectin | 29 | 2.3 | 67 | 1 | 67 |
| 101.12(e); adjustment to the RACC of an aerated food permitted | 25 | 1 | 25 | 1 | 25 |
| 101.12(g); requirement to disclose the serving size that is the basis for a claim made for the product if the serving size on which the claim is based differs from the RACC | 5,000 | 1 | 5,000 | 1 | 5,000 |
| 101.13(d)(1) and 101.67; requirements to disclose nutrition information for any food product for which a nutrient content claim is made | 200 | 1 | 200 | 1 | 200 |
| 101.13(j)(2) and (k), 101.54, 101.56, 101.60, 101.61, and 101.62; additional disclosure required if the nutrient content claim compares the level of a nutrient in one food with the level of the same nutrient in another food | 5,000 | 1 | 5,000 | 1 | 5,000 |
| 101.13(q)(5); requirement that restaurants disclose the basis for nutrient content claims made for their food | 300,000 | 1.5 | 450,000 | 0.75 (45 minutes) | 337,500 |
| 101.14(d)(2); general requirements for disclosure of nutrition information related to health claims for food products | 300,000 | 1.5 | 450,000 | 0.75 (45 minutes) | 337,500 |
| 101.15; requirements pertaining to prominence of required statements and use of foreign language | 160 | 10 | 1,600 | 8 | 12,800 |
| 101.22(i)(4); supplier certifications for flavors designated as containing no artificial flavors | 25 | 1 | 25 | 1 | 25 |
| 101.30 and 102.33; labeling requirements for fruit or vegetable juice beverages | 1,500 | 5 | 7,500 | 1 | 7,500 |
| 101.36; nutrition labeling of dietary supplements | 300 | 40 | 12,000 | 4.025 | 48,300 |
| 101.42 and 101.45; nutrition labeling of raw fruits, vegetables, and fish | 1,000 | 1 | 1,000 | 0.5 (30 minutes) | 500 |
| 101.45(c); databases of nutrient values for raw fruits, vegetables, and fish | 5 | 4 | 20 | 4 | 80 |
| 101.79(c)(2)(i)(D); disclosure requirements for food labels that contain a folate/neural tube defect health claim | 1,000 | 1 | 1,000 | 0.25 (15 minutes) | 250 |
| 101.79(c)(2)(iv); disclosure of amount of folate for food labels that contain a folate/neural tube defect health claim | 100 | 1 | 100 | 0.25 (15 minutes) | 25 |
| 101.100(d); disclosure of agreements that form the basis for exemption from the labeling requirements of section 403(c), (e), (g)-(i), (k), and (q) of the FD&C Act | 1,000 | 1 | 1,000 | 1 | 1,000 |
| 101.7 and 101.100(h); disclosure requirements for food not accurately labeled for quantity of contents and for claiming certain labeling exemptions | 25,000 | 1.03 | 25,750 | 0.5 (30 minutes) | 12,875 |
| Nutritional labeling for new products | 500 | 1 | 500 | 2 | 1,000 |
| Total | | | 1,513,799 | | 1,030,258 |
Because of the consolidation of OMB control number 0910-0813, our estimate reflects an annual increase of 188,442 responses and 188,282 hours. These estimates are based on our experience with food labeling, related submissions of petitions, and informal communications with industry.
Dated: May 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.