target="_blank" rel="nofollow" href="#ulink_20d61999-f593-53aa-a9ae-cfd4e46ef136">55 The details of which vending machines are covered and how the requirements are to be implemented are provided in 21 C.F.R. section 101.8.56
4.6.3 State and Local Preemption
Regarding nutrition labeling, the Federal FD&C Act expressly preempts any state or local law that is not identical to the federal law.57 State and local governments cannot directly or indirectly impose any nutrition labeling requirements on chain retail food establishments that are not “identical to” requirements imposed by FD&C Act section 403(q). States and localities that have their own nutrition labeling requirements may petition FDA for an exemption from preemption.58
However, restaurants and similar retail food establishments that are not chains (i.e., with fewer than 20 locations) and vending machines operated by a person owning or operating fewer than 20 vending machines59 do not fall under the preemption provision because these establishments and vending machines are outside of the federal nutritional labeling requirements. That is, restaurants and vending machines that are exempt from the requirements of FD&C Act section 403(q)(5)(H) continue to be governed by state and local regulations, as applicable, unless those establishments elect to participate exclusively in the federal regulatory program (see below).
4.6.4 Voluntary Election Covered by the Law
A restaurant or similar retail food establishments and vending machines not covered by the federal nutrition labeling law may elect to become subject to the federal requirements by voluntarily registering every other year with the FDA.60 Those restaurants and vending machine operators that elect to participate in the federal program will not be subject to state or local nutrition labeling requirements unless these state or local requirements are identical to federal requirements.
NOTE
1 4.5. Congress Delays Implementation of Restaurant Nutritional Labeling Rule.The Fiscal Year 2016 Omnibus Appropriations Act covering the funding of the federal government, being Pub. L. No: 114‐113 (2015), section 747, delayed implementation of the nutritional labeling rule for restaurant items until after December 1, 2016.
4.7 NUTRIENT CONTENT CLAIMS (NUTRIENT LEVEL DESCRIPTORS)
FDA uses the terminology “nutrient content claims” and “nutrient descriptors,” but note that the FD&C Act identifies regulation for a claim that “characterizes the level of any nutrient” on the label or labeling of the food.61
The FD&C Act stipulates that a claim that characterizes the level of a nutrient may not be made unless the FDA has defined the claim in a regulation and the food meets the requirements of that regulation.62
However, the FDAMA amended the FD&C Act to create an exception to the requirement for explicit authorization of all nutrient content claims by regulation. Nutrient content claims not defined by FDA in regulation may be permitted if the claim was recognized by a scientific body of the U.S. government in a published authoritative statement63 (see Section 4.7.6).
4.7.1 Definition
FDA defines nutrient content claim in regulation to include the following64:
An expressed nutrient content claim, which is any direct statement about the level or range of a nutrient in the food (e.g., “low sodium” or “contains 100 calories”).
An implied claim that describes a food or an ingredient in a manner that suggests that a nutrient is absent or present in a certain amount (e.g., “high in oat bran”).
A claim that suggests that a food, because of its nutrient content, may be useful in maintaining healthy dietary practices when the claim is made with an explicit claim or statement about a nutrient (e.g., “healthy, contains 3 grams of fat”).
4.7.2 Express versus Implied Claims
“Expressed” claims directly characterize the nature of a food; for example, “low fat” and “fat free.” “Implied” claims indirectly characterize the nature of the food by inference or association, rather than by direct statement; for example, “baked, not fried” implies the food is lower in fat than an equivalent fried version. The context and the entire label are often necessary to determine if there is an implied claim.
Implied claims are prohibited when they wrongfully imply that a food contains or does not contain a meaningful level of a nutrient. For example, a product claiming to be made with an ingredient known to be a source of fiber (such as “made with oat bran”) is not allowed unless the product contains enough of that ingredient to meet the definition for “good source” of fiber. As another example, a claim that a product contains “no tropical oils” is allowed—but only on foods that are “low” in saturated fat because consumers have come to equate tropical oils with high saturated fat.
4.7.3 Core Nutrient Level Descriptors
The FDA regulations set conditions for the use of terms that characterize a food’s nutrient level. The general principles on nutrient level descriptors are established in 21 C.F.R. 101.13.65 A claim about the level of a nutrient in a food in relation to the DV is permitted only if the claim uses one of the terms defined by FDA and in accordance with the definition for that term and the general requirements for nutrient content claims.66
The FDA‐defined core nutrient level descriptors are the following:
Free
Good source
Healthy
High
Lean and extra lean
Less and fewer
Light
Low
More
Reduced
These terms are the core nutrient level descriptors. The accepted synonyms and summary definitions of these descriptors follow, but one should always consult the language in Code of Federal Regulations.
Free: Product contains no amount of, or only trivial or “physiologically inconsequential” amounts of, one or more of these components: fat, saturated fat, cholesterol, sodium, sugars, and calories. For example, “calorie‐free” means fewer than 5 calories per serving, and “sugar‐free” and “fat‐free” both mean less than 0.5 grams per serving. Accepted synonyms for “free” include “without,” “no,” and “zero.” A synonym for fat‐free milk is “skim.”
Good