The Following information is provided as assistance for reviewing food labels for compliance with new requirements for nutrition labeling and nutrient claims. These new requirements are in addition to the previously established labeling requirements for statement of identity (21 CFR 101.3), net contents declaration (21 CFR 101.105), ingredient list (21 CFR 101.4) and name and place of manufacturer or distributor (21 CFR 101.5).
The Nutrition Labeling and Education Act of 1990 (NLEA) provides FDA with specific authority to require nutrition labeling of most foods regulated by the Agency; and to require that all nutrient content claims (i.e., ‘high fiber’, ‘low fat’, etc.) and health claims be consistent with agency regulations. Regulations implementing the NLEA labeling provisions issued on January 6, 1993, with technical amendments published on August 18, 1993.
The regulations became effective for health claims, ingredient declarations, and percent juice labeling on May 8, 1993 (percent juice labeling was subsequently exempted until May 8, 1994). The regulations for nutrition labeling and other provisions became effective on May 8, 1994. However, by an Act of Congress, these provisions do not apply to certain products until after August 8, 1994.
Compliance with the nutrition labeling regulations is based on the date the product was labeled, not the date the product is offered for entry into interstate commerce. Products labeled prior to effective dates referenced above must comply with the agency’s previous regulations (See chart Attachments # 33 for pre-NLEA requirements).
Exemptions from the nutrition labeling regulations are outlined in this guide. Two exemptions from the regulations address products manufactured by firms that meet the small business exemptions provided under the regulations. Firms that believe they meet the requirements for a small business exemption must file a Notice of Eligibility and provide the information necessary to verify their exempt status to FDA/CFSAN/Office of Food Labeling (OFL), (HFS-150), 200 C Street S.W., Washington, D.C., 20204.
Additionally when it is not technologically feasible, or some other circumstance makes it impracticable for firms to comply with required declaration of nutrients identified in section 101.9, then, per section 101.9(g)(9), firms seeking alternative approaches for compliance must submit a request to OFL. OFL will respond to each request.
Copies of Model Small Business Food Labeling Exemption Notices are attached (Attachment # 32). OFL will have no objections if a firm has submitted all required information, but in a different format than the model exemption notices.
If a firm is granted an exemption or special labeling provisions, a copy of the response will be sent to the home district. Exemption information for small businesses will also be available on Prime Connection. See Attachment #31-Information Registration Application for Prime Connection. To access the Prime Connection labeling menu from the main menu; at the prompt type B (space) FL (enter key).
If nutrition labeling does not appear on the label, determine if the product is exempt. If the product was labeled prior to May 8, 1994 or August 8, 1994 was applicable, it may comply with either the ‘old’ or ‘new regulations. If the product is not exempt, examine the label to determine if nutrition labeling is present; if it appears in a manner that is in compliance; and if present, defined terms or approved health claims are properly used.
