The National Uniformity for Food Act provides for national, uniform food safety standards and warning requirements. The legislation amends the Federal Food, Drug and Cosmetic Act to create a uniform, national system that not only recognizes the role of state and local governments in the regulation of food products, but also integrates them into the national system.

Under the current system, food regulation is composed of a variety of different, and sometimes inconsistent requirements. The bill seeks to harmonize those differences to achieve national uniformity.

National uniformity is not a new concept – Congress has repeatedly recognized the importance of uniformity in food regulation. The Nutrition Labeling and Education Act (1990), the Food Quality Protection Act (1996), the Poultry Products Inspection Act and the Meat Inspection Act all contain uniformity provisions.

The bill takes a measured approach to national uniformity for food by providing a mechanism for a thorough, orderly review of existing state regulations that may differ from a federal regulation. The bill allows for the states to petition the FDA to adopt theirs as a national requirement or exempt it from national uniformity. No existing state requirement that differs from a federal requirement would be preempted without the opportunity for petition, and state requirements would remain in effect while FDA considers the states’ petitions.

Uniformity would be achieved gradually as FDA acts on the states’ petitions, either adopting them as national requirements or concluding that they should not continue in effect. FDA’s decisions on state petitions would occur only after public input through a comment process.

The bill provides that where FDA has acted by setting a safety standard for a food ingredient or constituent, the states would adopt and enforce the same standard. If FDA has not set a safety standard for a particular substance in food, the states would remain free to set and enforce their own standard.

The bill would also provide for national uniformity in product warnings. States would not be permitted to require the regulated industry to communicate a warning in labeling, advertising, or any other form of public communication, if that warning differs from that imposed under Federal law. The authority of the states to issue warnings remains unhindered. States remain free to issue their own public warnings under state laws at any time and under any circumstance.

The authority of the states to act if presented with an imminent hazard is preserved. The bill does not affect state authority in several areas that are traditional local food enforcement matters: freshness dating, open date labeling, grade labeling, state inspection stamp, religious dietary labeling, organic or natural designation, returnable bottle labeling, unit pricing, and statement of geographic origin. Existing provisions related to food sanitation are not subject to national uniformity. Traditional federal/state/industry cooperative sanitation programs related to restaurants and retain stores would not be affected. Existing state requirements for shellfish warnings would also not be affected.

National uniformity does not apply to the federal or state enforcement powers (embargo, recall, or other enforcement powers).

Section-by-Section Analysis

The bill amends the Federal Food, Drug, and Cosmetic Act in two respects. First, it expands the existing national uniformity requirement for food labeling provisions in section 403A to include food adulteration provisions as well. Second, it adds a new section 403B that specifically requires uniformity in food safety warning notification requirements. Uniformity for Food Adulteration and Misbranding Other Than Food Safety Warnings

The legislation amends section 403A to add a new provision. National uniformity is extended to all aspects of food adulteration other than food sanitation. National uniformity is not applied to food sanitation because the states have traditionally provided a leadership role throughout the country in regulating sanitary food practices at the state and local levels. Uniformity for Food Warnings

New section 403B consists of eight subsections. They cover the following subjects:

(a) The national uniformity requirement.
(b) A procedure under which existing non-uniform state requirements will be reviewed.
(c) A procedure for granting exemptions from national uniformity and for adopting state requirements as national standards.
(d) Authority for states to take immediate action to address an imminent hazard to health.
(e) A determination that the legislation has no effect on product liability law.
(f) A determination that state and local governments may take whatever action is appropriate to enforce statutory requirements that are identical to the federal requirements.
(g) Exemptions for traditional local food enforcement activities.
(h) A definition of the term “requirement” that includes both mandatory action and any prohibition under the Federal Food, Drug, and Cosmetic Act or the Fair Packaging and Labeling Act.

Uniformity requirement: Under this provision, any and all forms of warnings imposed on the regulated industry related to food or to any constituent of food is required to be uniform throughout the nation. No state or political subdivision is permitted to require a warning relating to food, including any component or package of the food, unless the specific warning has been required by FDA and the state warning is identical to the FDA warning. The requirement of national uniformity in food warnings applies to the food label, labeling, advertising, posters, public notices, and any other means of communication. It covers warnings adopted by statute, regulation, or other administrative action. It includes any form of notification requirement, whether by a law specifically classified as a food statute, a consumer protection or unfair competition law, or a law that more generally applies to all chemicals present in consumer products or the environment. The requirement of national uniformity does not, however, apply to any requirement or prohibition that does not involve a notification requirement for the regulated industry. The intent is to insure that any direct or indirect form of warning imposed on the regulated industry about food will be identical throughout the country.
The term “warning” is defined broadly to include any statement, vignette, or other representation that indicates, directly or by implication, that the food presents or may present a hazard to health or safety. Thus, a requirement that information be disclosed about a food or any of its constituents, based upon public concern about safety, falls within the definition of a warning even though the provision is not specifically designated as a warning. The reason for the notification requirement will determine whether it falls within the definition of a warning.

State and federal authorities often take regulatory action relating to food safety that does not involve a notification requirement. Such activity is subject to the national uniformity provisions of section 403A but is not subject to section 403B.

Though a state may not require the regulated industry to comply with a notification requirement that provides for a warning that has not also been required by FDA, the state remains free to issue its own warning, under state statutory authority, whenever such a warning is justified. Similarly, any mandatory recall order or court injunction involving food adulteration under a state statutory requirement that is identical to a federal food adulteration statutory requirement is also exempt from national uniformity.

Review of existing state requirements: Numerous states presently have notification requirements for a food that provides for a warning that does not meet the uniformity requirement set forth in this legislation. The bill provides a mechanism for these requirements to remain in effect during the time that they are reviewed by FDA and a determination is made as to whether they will be exempted from the requirement of national uniformity or be adopted as a national standard that applies throughout the country.

To invoke this review, a state is required to petition FDA within 180 days after the date of enactment. A state law that is the subject of such a petition automatically remains in effect until such time as FDA takes full administrative action as provided under this provision. Within 270 days after the date of enactment, FDA is required to publish a notice of the petition in the Federal Register and to provide 180 days for public comment on it. The agency is then required to take final agency action on the petition, either granting or denying it, within one year after the time for comment expires. If FDA fails to meet the statutory deadlines, that failure constitutes final agency action that permits the aggrieved party to obtain a court order enforcing a reasonable timetable.

This provision assures that existing state requirements will not arbitrarily be superseded upon enactment of the new law. If a state can justify either an exemption from the requirement of national uniformity, or a national need to adopt the state requirement as a uniform standard applicable throughout the country, that state provision will remain in effect.

Exemptions and national standards: This provision allows both exemptions from national uniformity and the adoption of a state requirement as a uniform national standard.

Any state may petition FDA to obtain an exemption from the requirement of national uniformity for a requirement of either the state itself or a political subdivision of the state. FDA may grant the exemption if the state or local requirement protects an important public interest that would otherwise be unprotected, would not cause the food to be in violation of any federal law, and would not unduly burden interstate commerce.

This provision recognizes that special circumstances may justify a warning requirement in a particular state or locality even though that requirement should not apply throughout the country. Thus, the need for local protection is fully recognized under the legislation.

In circumstances where the need is national rather than local, however, the legislation provides that the state may petition FDA to establish by regulation a national standard that will apply to the entire country. Accordingly, this provision covers those situations both where the need is local and where it is national.

The legislation provides specific procedures to assure that FDA will give adequate attention to either an exemption petition or a national standard petition. Within thirty days after receipt of either type of petition, FDA is required to publish the petition in the Federal Register for public comment. FDA must then either take action on the petition or explain why it cannot act immediately, within sixty days after the end of the time for public comment. Under no circumstances may FDA take longer than 120 days for action. If FDA were to violate these statutory deadlines, the aggrieved party has a statutory right to judicial review in order to obtain a court order requiring FDA to comply within a reasonable period.

The states have been concerned about the lack of FDA action on similar petitions submitted under section 403A following enactment of this provision as part of the Nutrition Labeling and Education Act of 1990. Accordingly, the provisions in this legislation are also made applicable to the petitions under section 403A(b).

Imminent hazard authority: In some instances, an emergency may justify immediate state action to require industry to include a warning with regard to a food or a constituent. The legislation authorizes emergency state action in those situations where it is needed to address an imminent hazard to health that is likely to result in serious adverse health consequences or death. This standard for emergency action is used elsewhere for comparable matters in the Federal Food, Drug, and Cosmetic Act. When this occurs, the state must notify FDA about the matter to determine that FDA has not initiated enforcement action, and must submit a petition within thirty days either for an exemption from national uniformity or to establish a national standard. The state is required to institute enforcement action with respect to the matter within thirty days after it establishes the non-uniform emergency requirement.

For a petition submitted under the imminent hazard provision, FDA must take final agency action not later than seven days after it has received. Once again, the failure of FDA to comply with this deadline constitutes final agency action in order to obtain judicial review and a court order regarding FDA compliance. The imminent hazard requirement remains in effect until FDA takes final agency action on the petition.

No effect on product liability law: The legislation has no effect on the existing tort law that governs product liability in any state.

No effect on identical law: As long as a state statute imposes the same requirement as the federal law, a state or local government may enforce that state statute in the state courts. This is true even if FDA itself has taken no action either to bring enforcement proceedings in the courts or to publish a proposed regulation or to adopt an informal guidance. Accordingly, states remain free to enforce state provisions that are identical to federal law unless and until FDA acts to establish a national standard. Where FDA has particularized a statutory requirement through regulations, however, the state must then enforce the identical requirements that are imposed by the federal regulations. This provision therefore recognizes the legitimate need of state enforcement authorities to take enforcement action where FDA does not do so, as long as that action is taken under identical statutory provisions.

No effect on certain state law: There are a number of state and local laws that constitute traditional local food enforcement activities. This provision lists these activities and exempts them from the general rule of national uniformity: Freshness dating; Open date labeling; Grade labeling; State inspection stamp; Religious dietary labeling; Organic or natural designation; Returnable bottle labeling; Unit pricing; Statement of geographical origin.

The provision also exempts any consumer advisory relating to food sanitation that is imposed on a food establishment or is recommended by the Secretary under the FDA Food Code. This specific reference includes shellfish warnings that are required by several states and would thus remain in effect under this exemption.

Definition: Throughout both section 403A and section 403B, the term “requirement” is used to refer both to mandatory action and to any prohibition established under the Federal Food, Drug, and Cosmetic Act or the Fair Packaging and Labeling Act or by any regulation issued under, or by a court order relating to, those two statutes. The term “requirement” does not, however, extend to informal enforcement procedures such as action levels or guidance.

Conforming Amendment: The tighter requirements for FDA action on petitions for an exemption or a national standard under section 403B(c)(3) and (4), described above, are made applicable to the petition for an exemption established under section 403A(b) as it was added by the Nutrition Labeling and Education Act. This will bring all exemption and national uniformity petitions into conformity.

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