88 FR 153 pgs. 54326-54329 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling Requirements
Type: NOTICEVolume: 88Number: 153Pages: 54326 - 54329
Pages: 54326, 54327, 54328, 54329Docket number: [Docket No. FDA-2023-N-0918]
FR document: [FR Doc. 2023-17145 Filed 8-9-23; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0918]
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling Requirements
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 September 11, 2023.
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. The OMB control number for this information collection is 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, 10 a.m.-12 p.m., 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, PRAStaff@fda.hhs.gov.
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 Requirements
OMB Control Number 0910-0381-Revision
This information collection supports statutory and regulatory requirements that govern food labeling, and information collection recommendations discussed in associated Agency guidance. 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), establish provisions under which 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. Implementing regulations are codified in parts 101, 102, 104, and 105 (21 CFR parts 101, 102, 104, and 105). While regulations in part 101 set 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 requirements are intended 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 and include corresponding information disclosure requirements, along with the reporting and recordkeeping provisions, subject to enforcement by FDA.
We provide information resources regarding food labeling under the FD&C Act and its amendments on our website at https://www.fda.gov/food/food-labeling-nutrition. Food labeling is required for most prepared foods, such as breads, cereals, canned and frozen foods, snacks, desserts, drinks, etc. Nutrition labeling for raw produce (fruits and vegetables) and fish is voluntary. We refer to these products as "conventional" foods. For detailed information on dietary supplement labeling requirements visit our website at https://www.fda.gov/food/dietary-supplements. 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. Requirements include general content and format for the labeling of food packaging, including nutrition and ingredient information. Additional regulations provide for specific nutrient content claims.
The information collection includes Form FDA 3570 entitled, "Small Business Nutrition Labeling Exemption Notice," for use as applicable and available for download from our website at https://www.fda.gov/food/labeling-nutrition-guidance-documents-regulatory-information/small-business-nutrition-labeling-exemption-notice-model-form. We have also developed the following guidance documents to assist respondents with various aspects of the information collection:
[top] • " Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body" (June 1998). The guidance document 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 document
• " Questions and Answers: Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act" (September 2009). The guidance document 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 document communicates content elements and FDA enforcement of labeling requirements in section 403(y) of the FD&C Act.
• "Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act" (January 2009). The guidance document 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 document discusses FDA recommendations regarding claims under section 403(r)(6) of the FD&C Act.
For operational efficiency, we are revising the information collection to account for burden that may result from activities associated with the labeling of certain beers, currently approved in OMB Control No. 0910-0728. The Tobacco Tax and Trade Bureau is responsible for the dissemination and enforcement of regulations with respect to the labeling of distilled spirits, certain wines, and malt beverages issued in the Federal Alcohol Administration Act. However, and as discussed in the guidance document "Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration" (December 2014), certain bottled or otherwise packaged beers are subject to section 403 of the FD&C Act. The guidance document is available for download from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-labeling-certain-beers-subject-labeling-jurisdiction-food-and-drug-administration and provides recommendations regarding applicable labeling requirements for products under FDA's jurisdiction.
We are also revising the information collection to include new requirements applicable to the gluten-free labeling of fermented or hydrolyzed foods established through rulemaking (RIN 0910-AH00) and approved in OMB Control No. 0910-0817.
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, subject to statutory and regulatory food labeling requirements.
In the Federal Register of April 12, 2023 (88 FR 22045), we published a 60-day notice soliciting comment on the proposed collection of information. No comments were received.
We estimate the burden of this collection of information as follows:
| 21 CFR section; activity | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | 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) | 1 | 1 | 1 | 80 | 80 |
| 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 | 10,038 | 80,623 | |||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
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| 21 CFR section; activity | Number of recordkeepers | Number of records per recordkeeper | Total annual records | Average burden per recordkeeping | Total hours |
|---|---|---|---|---|---|
| 101.9(c)(6)(iii); added sugars? 2 | 31,283 | 1 | 31,283 | 1 | 31,283 |
| 101.9(c)(6)(i); dietary fiber? 2 | 31,283 | 1 | 31,283 | 1 | 31,283 |
| 101.9(c)(6)(i)(A)? 2 ; soluble fiber | 31,283 | 1 | 31,283 | 1 | 31,283 |
| 101.9(c)(6)(i)(B); insoluble fiber? 2 | 31,283 | 1 | 31,283 | 1 | 31,283 |
| 101.9(c)(8); vitamin E? 3 | 31,283 | 1 | 31,283 | 1 | 31,283 |
| 101.9(c)(8); folate/folic acid? 3 | 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 |
| 101.91; Documentation necessary to verify compliance with gluten free labeling | 5,000 | 56 | 280,000 | 0.45 (~27 minutes) | 126,000 |
| Total | 1,369,064 | 990,064 | |||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
Our estimate reflects the cumulative average burden we attribute to the reporting and recordkeeping requirements found in the applicable regulations; individual collection activities may not be evenly distributed among respondents and/or the corresponding requirements.
| 21 CFR section; activity | Number of respondents | Number of disclosures per respondent | Total annual disclosures | Average burden per disclosure | 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), (h), (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 |
| "Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration" | 12 | 1 | 12 | 1 | 12 |
| Total | 1,030,270 | ||||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
These estimates reflect our continued experience with the information collection. We have made nominal adjustments to reflect the addition of burden associated with gluten and certain bottled or otherwise packaged beer; petition submissions received since our last evaluation of the information collection; and informal communications with industry regarding food product labeling.
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Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17145 Filed 8-9-23; 8:45 am]
BILLING CODE 4164-01-P