(2) the importance of that information in maintaining healthy dietary practices.

     (C) Within 24 months of the date of the enactment of this Act, the Secretary shall publish proposed revisions to the regulations found to be inadequate under subparagraph (B) and within 30 months of such date shall issue final revisions. Upon the effective date of such final revisions, no State or political subdivision may establish or continue in effect any requirement which is not identical to the requirement of the section which had its regulations revised in accordance with this subparagraph.

     (D)

     (i) If the Secretary does not issue a final list in accordance with subparagraph (B), the proposed list issued under subparagraph (A) shall be considered the final list and States and political subdivisions shall be preempted with respect to sections found to be adequate in such proposed list in accordance with subparagraph (B).
     (ii) If the Secretary does not issue final revisions of regulations in accordance with subparagraph (C), the proposed revisions issued under such subparagraph shall be considered the final revisions and States and political subdivisions shall be preempted with respect to sections the regulations of which are revised by the proposed revisions.

     (E) Subsection (b) of section 403A of the Federal Food, Drug, and Cosmetic Act shall apply with respect to the prohibition prescribed by subparagraphs (B) and (C).

(c) CONSTRUCTION.

     (1) The Nutrition Labeling and Education Act of 1990 shall not be construed to preempt any provision of state law, unless such provision is expressly preempted under section 403A of the Federal Food, Drug, and Cosmetic Act,
     (2) The amendment made by subsection (a) and the provisions of subsection (b) shall not be construed to apply to any requirement respecting a statement in the labeling of food that provides for a warning concerning the safety of the food or component of the food.
     (3) The amendment made by subsection (a), the provisions of subsection (b) and paragraphs (1) and (2) of this subsection shall not be construed to affect preemption, express or implied, of any such requirement of a State or political subdivision, which may arise under the Constitution, any provision of the Federal Food, Drug, and Cosmetic Act not amended by subsection (a), any other Federal law, or any Federal regulation, order, or other final agency action reviewable under chapter 7 of title 5, United States Code.

Section 403(i) (21 U.S. C. 343(i)) is amended(EDITORS NOTE: At this point the NL&EA of 1990 amends Federal Food, Drug, and Cosmetic Act §403(i) to provide for percentage labeling of juice products and the individual listing in ingredient statements of colors subject to certification (the FD&C colors). Section 403(i) can be found in the Labeling Section of this Almanac.)

Section 701(e) (21 U.S.C. 371(e)) is amended (EDITORS NOTE: Section 8 of the NL&EA of 1990 amends §701(e) of the FFD&CA to remove most food standards from the specialized rulemaking procedures of § 701(e), allowing them to be adopted, revised, and revoked through notice and comment rulemaking. Exceptions include: (1) dairy products, (2) cheese and related products, (3) frozen desserts, and (4) maple syrup which, for revision or revocation, are still subject to §701(e). Full text of FFD&CA §701(e) appears in "Section II - Food Law and Regulations" of this Almanac.)

The amendments made by this Act shall not be construed to alter the authority of the Secretary of Health and Human Services and the Secretary of Agriculture under the Federal Food, Drug, and Cosmetic Act, the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act

(a) IN GENERAL.

    (1) Except as provided in paragraph (2)-

    (A) the amendments made by section 2 shall take effect 6 months after

          (i) the date of the promulgation of all final regulations required to implement section 403(q) of the Federal Food, Drug, and Cosmetic Act, or
          (ii) if such regulations are not promulgated, the date proposed regulations are to be considered as such final regulations,except that section 403(q)(4) of such Act shall take effect as prescribed by such section,

     (B) the amendments made by section 3 shall take effect 6 months after

     (i) the date of the promulgation of final regulations to implement section 403(r) of the Federal Food, Drug, and Cosmetic Act, or
    (ii) if such regulations are not promulgated, the date proposed regulations are to be considered as such final regulations, except that any person marketing a food the brand name of which contains a term defined by the Secretary under section 403(r) (2)(A)(i) of the Federal Food, Drug, and Cosmetic Act shall be given an additional 6 months to comply with section 3,

     (C) the amendments made by section 4 shall take effect 24 months after the date of the enactment of this Act, and
     (D) the amendments made by section 5 shall take effect on the date the amendments made by section 3 take effect.

     (2) Section 403(q) of the Federal Food, Drug, and Cosmetic Act (as added by section 2) shall not apply with respect to food which was labeled before the effective date of the amendments made by section 2 and section 403(r) of the Federal Food Drug, and Cosmetic Act (as added by section 3) shall not apply with respect to food which was labeled before the effective date of the amendments made by section 3.

     (3)

     (A) If the Secretary finds that a person who is subject to section 403(q)(4) of such Act is unable to comply with the requirements of such section upon the effective date of final regulations to implement section 403(q) of such Act or of proposed regulations to be considered as such final regulations because the Secretary has not made available to such person the information required by such section, the Secretary shall delay the application of such section to such person for such time as the Secretary may require to provide such information.

     (B) If the Secretary finds that compliance with section 403(q) or 403(r)(2) of such Act would cause an undue economic hardship, the Secretary may delay the application of such sections for no more than one year.

(b) SECTION 6.

     (1) IN GENERAL.-Except as provided in paragraph (2), the amendments made by section -6 shall take effect

     (A) with respect to a requirement of a State or political subdivision described in paragraph (1) of section 403A(a) of the Federal Food, Drug, and Cosmetic Act, on the date of the enactment of this Act,

     (B) with respect to a requirement of a State or political subdivision described in paragraph (2) of section 403A(a) of the Federal Food Drug, and Cosmetic Act, one year after the date of the enactment of this Act,

     (C) with respect to a requirement of a State or political subdivision described in paragraph (3) of section 403A(a) of the Federal Food Drug, and Cosmetic Act, as prescribed by section 6(b) of the Nutrition Labeling and Education Act of 1990,

     (D) with respect to a requirement of a State or political subdivision described in paragraph (4) of section 403A(a) of the Federal Food, Drug, and Cosmetic Act, on the date regulations to implement section 403(q) of such Act take effect, and

     (E) with respect to a requirement of a State or political subdivision described in paragraph (5) of section 403A(a) of the Federal Food, Drug, and Cosmetic Act, on the date regulations to implement section 403(r) of such Act take effect.

     (2) EXCEPTION.-If a State or political subdivision submits a petition under section 403A(b) of the Federal Food, Drug, and Cosmetic Act for a requirement described in section 403 A(a) of such Act within 18 months of the date of the enactment of this Act, paragraphs (3) through (5) of such section 403A(a) shall not apply with respect to such State or political subdivision requirement until

     (1) 24 months after the date of the enactment of this Act, or
     (2) action on the petition, whichever occurs later.

(c) SECTION 7.-The amendments made by section 7 shall take effect one year after the date of the enactment of this Act.

     EDITORS NOTE: The Editor gratefully acknowledges the cooperation of Olsson, Frank and Weeda, P.C. in allowing reproduction of this summary as a.service to the food industry.

     In this summary Olsson, Frank and Weeda refer to FDA labeling proposals issued in 1990 prior to NL&EA. See proposal summaries prepared by Almanac Editor and inserted following §101.9 of the Regulations in this Almanac.

    The Nutrition Labeling and Education Act of 1990 (the Act) amends the Federal Food, Drug and Cosmetic Act (FDC Act). In summary, the most important changes to the FDC Act are a: follows:

• Mandatory nutrition labeling for almost all food products, including fresh products, including fresh produce and seafood.
• Federal regulation of nutrient content claims and health claims.
• National uniformity for most food labeling requirements.

These provisions are discussed in greater detail below.

     Except for fresh produce and seafood (discussed in Section ILB below), or exempted products (discussed in Section ILC below), the label or labeling of all food products must include the following information:

• Serving size;
• Number of servings per container;
• Amount of the following nutrients provided per serving:
  • Total calories;
  • Total calories from total fat;
  • Total fat;
  • Saturated fat;
  • Cholesterol;
  • Sodium;
  • Total carbohydrates;
  • Complex carbohydrates;
  • Sugars;
  • Dietary fiber; and
  • Total protein.

     FDA may by regulation revise the list of nutrients required to be declared on the label. FDA may also prescribe a simplified format for foods that contain "insignificant amounts" of more than one-half of the nutrients that are required to be declared. With respect to vitamins and minerals within the scope of Section 411 of the FDC Act, FDA is required to adopt regulations specifying the nutrition labeling format "in a manner which is appropriate for such food."

     REGULATORY TIMEFRAMES - FDA is required to issue proposed regulations to implement the new nutrition labeling requirements within 12 months after the Act's date of enactment, and issue final regulations within 24 months after the date of enactment. The final regulations must go into effect 6 months after publication If FDA fails to issue final regulations on schedule, the proposed regulations are deemed to be final regulations on the date the final regulations are due. These regulations must allow for "minor variations" in the nutritional value of a food of resulting from the normal course of production or from assortments of similar foods. Thus, except with respect to fresh produce and seafood (discussed in Section II. B below), the Act's nutrition labeling requirements would take effect no later than 30 months after enactment. If FDA finds that compliance with these requirements of the Act would cause undue economic hardship, it may delay application of the requirements for no more than one year.

     The Act establishes a two-tiered set of requirements for nutrition labeling of fresh produce and seafood (fish, shellfish, and other forms of aquatic animal life).

     1. VOLUNTARY GUIDELINES. Within 12 months after the date of enactment of the Act, FDA is required to obtain public comment and issue voluntary guidelines for food retailers on providing nutrition information for fresh produce and seafood. The guidelines may only encompass the 20 most frequently consumed vegetables, 20 most frequently consumed fruits, and 20 most frequently consumed varieties of seafood. However, the products included in the guidelines may vary by geographic region. At the time FDA issues the guidelines, it is also required to adopt a regulation defining what constitutes "substantial compliance" with the guidelines.

     2. POSSIBILITY OF MANDATORY REQUIREMENTS. If FDA finds that retailers of fresh produce and seafood have not substantially complied with the voluntary guidelines, FDA is required to propose mandatory regulations for nutrition labeling of fresh produce and seafood 30 months after the Act's enactment. FDA is required to issue final regulations within 6 months after issuing proposed regulations. If FDA fails to do so, the proposed regulations are deemed to be final regulations upon the expiration of the 6 month period If nutrition information for fresh produce and seafood becomes mandatory, FDA must provide the required nutrition information in a form readily usable by retailers. FDA is expressly prohibited from prosecuting any retailer who is in "substantial compliance" with these requirements.

     1. SMALL RETAILERS. Small retailers with annual gross sales of $500,000 or less, or annual gross food sales of $50,000 or less, are exempt from the Act's nutrition labeling requirements. The practical effect of this exemption is that small retailers do not have to provide nutrition labeling for bulk foods, fresh produce or seafood

     2.  MISCELLANEOUS EXEMPTIONS. The following food products are exempt from the Act's mandatory nutrition labeling requirements:

• Restaurant and carry-out foods;
• Infant formulas;
• Medical foods;
• Foods intended for further processing, labeling, or repacking;
• Foods in small packages if not labeled with any nutrition information;
• Foods that contain "insignificant amounts" of all nutrients required to be declared on the label (e.g., coffee), if no nutritional claims are made; and
• Foods distributed principally to restaurants and other foodservice institutions.

     FDA is required to provide consumer education concerning the availability and importance of nutrition information.

     The Act's mandatory nutrition labeling requirements represent a major expansion of current requirements. FDA regulations presently require nutrition labeling only if a food contains an added nutrient, or if a nutrition claim is made for the food on the label, on labeling, or in advertising. Although there are differences in a number of details, the Act's requirements are generally consistent with FDA's July 1990 proposed rule on mandatory nutrition labeling. That proposal would require mandatory nutrition labeling for all foods that are meaningful sources of nutrients, including fresh produce and seafood.

     A nutrient content claim is a claim that "characterizes the level of any nutrient" which is required to be declared on the label. These claims must be made using terms that have been defined by FDA; the use of other, undefined terms is not permitted. FDA is expressly required to define the following terms:

• "Free;"
• "Low;"
• "Light" or "lite;"
• "Reduced;"
• "Less;" and
• "High."

     All nutrient content claims must be accompanied, prominently and in immediate proximity to the claim, with the statement: "see _____ for nutrition information," with the panel where the nutrition information is located to be identified in the blank.

     The Act contains special, less stringent requirements with respect to nutrient content claims contained in the brand name of a food that was in use before October 25, 1989. FDA has adopted additional, more stringent requirements for claims concerning the absence of a nutrient, cholesterol content claims, saturated fat claims, and dietary fiber claims.

     1. CLAIMS CONCERNING THE ABSENCE OF A NUTRIENT. A claim about the absence of a nutrient cannot be made unless the nutrient is usually present in the food (or in a food for which the food is a substitute, as defined by FDA regulations). To use the examples cited in the legislative history, a "no cholesterol" claim could not be made for a soft drink, but might be appropriate for margarine. FDA can also, by regulation, permit such claims if they would be useful and the statement discloses that the nutrient is not usually present in the food, eg., "Brand X, a naturally sodium-free product."

     2. CHOLESTEROL CONTENT CLAIMS. The act limits cholesterol claims for foods that contain "fat or saturated fat in an amount which increases to persons in the general population the risk of disease or a health related condition," as determined by FDA by regulation. For these foods, a cholesterol content claim can be made only if: (a) FDA adopts a regulation that the level of cholesterol in the particular food is substantially less than the level usually present in the food (or the food for which it is a substitute), or (b) FDA adopts a regulation that cholesterol is not usually present in the food, that the cholesterol claim would be useful to consumers, and that the label statement discloses that cholesterol is notusually present in the food. If a food qualifies for a cholesterol content claim under either of these criteria, the food's fat or saturated fat content must be prominently disclosed in immediate proximity to the cholesterol content claim.

     FDA published a tentative final rule on cholesterol claims in July 1990. In some respects, the Act is less restrictive than FDA's tentative final rule, which would prohibit cholesterol content claims if the food's fat content is above a certain level In comparison, the Act calls for FDA to consider allowing cholesterol content claims to be made for some fatty foods, accompanied by the disclosure of the food's fat content.

     3. SATURATED FAT CLAIMS. Any claim concerning the level of saturated fat in a food must, if the food contains cholesterol, be accompanied by the prominent disclosure, in immediate proximity to the saturated fat claim, of the level of cholesterol in the food.

     FDA does not have any existing regulations on saturated fat claims.

     4. DIETARY FIBER CLAIMS. A food may not make a claim that it is high in dietary fiber unless: (a) the food is low in total fat, as defined by FDA, or (b) the level of total fat in the food is prominently disclosed in immediate proximity to the dietary fiber claim.

     FDA does not have any existing regulations on dietary fiber claims.

     A health claim is any claim that "characterizes the relationship of any nutrient" required to be declared on the label "to a disease or healthrelated condition." Health claims may only be made in accordance with claim-specific regulations adopted by FDA. In adopting regulations, FDA may take into account the contribution of a particular type of food to the total diet. According i to the example used in the legislative history, this provision might allow FDA to prohibit a health claim for a snack food product with a particular level of fat, while allowing a health claim for a frozen dinner with the same level of fat.

     FDA may adopt regulations authorizing specific health claims only if FDA finds, based on "the i totality of publicly available scientific evidence," that there is "significant scientific agreement" among qualified experts that the claim is supported by the evidence.

     In its implementing regulations, FDA must address the following areas:

• Calcium and osteoporosis;
• Dietary fiber and cancer;
• Lipids and cardiovascular disease;
• Lipids and cancer;
• Sodium and hypertension; and
• Dietary fiber and cardiovascular disease.

     FDA is only required to consider these six areas; it is not required to approve claims. FDA is expressly prohibited from requiring premarket approval for any health claims.

     In February 1990, FDA reproposed regulations on "health messages." The thrust of the Act and FDA's reproposal are very similar: Health claims would be at risk for regulatory action unless they are consistent with model claims approved by FDA. Both the Act and the reproposal adopt identical scientific standards for substantiating health claims, and both focus on the same six areas for permissible claims at the outset.

     The new requirements on nutrient content and health claims do not apply to infant formulas and medical foods. In addition, the limitations on cholesterol, fat, and fiber content claims do not apply to restaurant food.

     The Act expressly authorizes the submission of petitions to FDA with respect to new nutrient content claims and new health claims. FDA i. required to make a final decision (including the issuance of a proposed regulation if appropriate) within 100 days after submission. With respect to petitions for nutrient content claims using term. already defined by FDA, the agency is required to make a final decision within 90 days after submission. Finally, the Act authorizes the submission of petitions concerning the use of implied nutrient content claims in brand names for food products. FDA is required to act on these petitions within 100 days after submission. The petition will be considered granted if FDA does not act on it within 100 days.

REGULATORY TIMEFRAMES - FDA must propose implementing regulations within 12 months, and must adopt final regulations within 24 months after enactment If FDA fails to do so, the proposed regulations will be deemed to be final regulations after the expiration of 24 months after the date of enactment If FDA finds that compliance with the requirements of the Act would cause undue economic hardship, it may delay application of the requirements for no more than one year.

     Section 6 of the Act adds new Section 403A to the FDC Act concerning national uniformity in food labeling. National uniformity would be phased in over a period of time, depending on the particular provision of the FDC Act.

     Existing FDA standards of identity (FDC Act Sections401 and403(g)) are adopted as national uniform standards on the date of the Act's enactment.

     Federal requirements for the following food labeling requirements will be adopted as uniform national standards one year after the date of enactment:

• Imitation labeling requirements (FDC Act Section 403(c));
• Identification of the manufacturer, packer, or distributor (FDC Act Section 403(e)(1));
• Net contents declaration (FDC Act Section 403(e)(2)); and
• Listing of food ingredients (FDC Act Section 403(i)(2)).

     The new requirements added by the Act concerning mandatory nutrition labeling (FDC Act Section 403(q)), and nutrient content and health claims (FDC Act Section 403(r)) will become uniform national standards at the time those provisions become federal law, 30 months after the date of enactment.

     The Act requires FDA to commission a study of the following provisions of the FDC Act and FDA's implementing regulations, and related state and federal laws addressing the same subjects, to determine whether FDA is adequately implementing the FDC Act:

• Misrepresentation of food names (FDC Act Section 403(b));
• Deceptive packaging (FDC Act Section 403(d));
• Prominence of label statements (FDC Act Section 403(f));
• Standards of quality and standards of fill (FDC Act Section 403(h));
• Common or usual food names (FDC Act Section 403(i)(1)); and
• Declaration of artificial flavors, colors, and preservatives (FDC Act Section 403(k)).

     FDA must complete this study within 6 months after the date of enactment. FDA must publish within 9 months after the date of enactment its proposed conclusions concerning whether these provisions of the FDC Act are being adequately implemented; FDA's final conclusions must be published within 24 months after the date of enactment. If FDA fails to publish its final conclusions in timely fashion, the proposed conclusions will be treated as final conclusions. Those provisions that are finally listed as having been adequately implemented by FDA will become national uniform standards.

     If FDA concludes that one or more provisions are not being adequately implemented, it must publish proposed revisions to its regulations within 24 months of the date of the Act's enactment. FDA must adopt final revised regulations within 30 months after the date of enactment; upon adoption, these revised regulations become national uniform standards. If FDA fails to adopt final regulations in timely fashion, the proposed regulations will be deemed to be final regulations.