21 U.S.C. § 343 — Misbranded food

This section lists the many ways a food's label, packaging, or advertising can make it "misbranded" — a legal problem even if the food itself is perfectly safe to eat. (a) False or misleading label. A food is misbranded if its labeling is false or misleading in any way. For a dietary supplement covered by section 350, its advertising also can't be false or misleading, and its label must follow the specific rule in section 350(b)(2). (b) Offer for sale under another name. It's misbranded if it's sold under the name of a different food. (c) Imitation of another food. It's misbranded if it copies another food, unless the label clearly says "imitation," in type just as noticeable as the rest of the label, right before the name of the food being imitated. (d) Misleading container. It's misbranded if the container is made, shaped, or filled in a way that misleads buyers — for example, a container built to look fuller than it really is. (e) Package form. A packaged food is misbranded unless the label states (1) the name and address of whoever made, packed, or distributed it, and (2) an accurate weight, measure, or count of what's inside. The Secretary can allow reasonable variation in that count and can exempt small packages by regulation. (f) Prominence of information on label. It's misbranded if any word or statement the law requires isn't displayed clearly enough — compared to the other words, designs, and pictures on the label, it has to stand out enough that an ordinary buyer would notice and understand it under normal shopping conditions. (g) Representation as to definition and standard of identity. If a food claims to be a type for which the Secretary has set an official "standard of identity" by regulation (under section 341), it's misbranded unless (1) it actually meets that standard, and (2) its label uses the official name and, where the regulations require it, lists the common names of any optional ingredients — other than spices, flavoring, and coloring. (h) Representation as to standards of quality and fill of container. It's misbranded in three situations: (1) if there's an official quality standard (under section 341) and the food falls short, unless the label says so in the way the regulations specify; (2) if there's an official "fill of container" standard and the food falls short, unless the label again says so as specified; and (3) if it's labeled "pasteurized" but wasn't actually treated by a process the regulations define as pasteurization for that food — unless it instead went through a different safe process that (A) reasonably destroys or removes the most dangerous, resistant germs likely present, is at least as protective, stays effective for at least the food's normal shelf life even under some abuse, and was reported to the Secretary with supporting data, and (B) at least 120 days have passed since that report without the Secretary ruling the process falls short. If the Secretary does rule it falls short, that ruling is a final agency action that can be appealed. (i) Label where no representation as to definition and standard of identity. If a food doesn't claim to meet an official standard, it's misbranded unless the label shows (1) its common name, if it has one, and (2) if it's made of two or more ingredients, the common name of each one. A juice beverage must also prominently state the total percentage of fruit or vegetable juice it contains. Spices, flavorings, and colors that don't need certification under section 379e(c) can just be called "spices," "flavorings," or "colorings" as a group without naming each — unless they're sold as spices, flavorings, or colors themselves. The Secretary can create exemptions by regulation where full ingredient listing is impractical or would mislead people or hurt fair competition. (j) Representation for special dietary use. It's misbranded if it's marketed for a special diet unless the label gives the vitamin, mineral, and other dietary information the Secretary decides, by regulation, buyers need to fully judge its value for that use. (k) Artificial flavoring, artificial coloring, or chemical preservatives. It's misbranded if it has artificial flavoring, artificial coloring, or chemical preservatives, unless the label says so — though the Secretary can exempt cases where that's impractical. This labeling rule for artificial coloring (and the same rule in (g) and (i)) doesn't apply to butter, cheese, or ice cream. And the chemical-preservative rule doesn't apply to a pesticide on a raw farm product straight from the soil. (l) Pesticide chemicals on raw agricultural commodities. A raw farm product is misbranded if it has a pesticide applied after harvest, unless the shipping container discloses the chemical, its common name, and its purpose. That disclosure isn't needed once the product is out of the shipping container and being sold or displayed loose, the way that product is normally sold at retail. (m) Color additives. A color additive is misbranded unless its packaging and labeling follow the rules for that additive under section 379e. (n) Packaging or labeling of drugs in violation of regulations. It's misbranded if its packaging or labeling breaks a regulation issued under section 1472 or 1473 of title 15. (o) and (p) have been repealed and no longer exist. (q) Nutrition information. Unless exceptions (3), (4), or (5) apply, a food meant for people to eat and offered for sale is misbranded unless its label gives: (1)(A) the serving size, in a common household measure fitting the food (or, if the food isn't usually measured by serving, the common unit that expresses its serving size); (B) servings or units per container; (C) total calories per serving, both from all sources and from total fat; (D) the amounts per serving of total fat, saturated fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, sugars, dietary fiber, and total protein; and (E) any vitamin, mineral, or other nutrient food labels already had to carry before October 1, 1990, if the Secretary decides that helps people eat healthy. The Secretary can require, by regulation, that this information — or the added-nutrient information described next — be highlighted with bigger type, bold type, or contrasting color if that would help consumers. (2)(A) If the Secretary decides some other nutrient should also be listed to help people eat healthily, the Secretary can add that requirement by regulation. (B) If the Secretary decides a currently required nutrient isn't actually necessary for that purpose, the Secretary can remove it by regulation. (3) For food that arrives at a store in bulk containers, the Secretary can allow the required information to be posted where the food is sold, by regulation. (4) Raw farm products and raw fish get a separate system: (A) the Secretary provides this information either through voluntary guidelines or, if needed, mandatory regulations. (B)(i) Within a year of November 8, 1990, and after taking comments, the Secretary had to issue voluntary guidelines for stores selling raw produce or raw fish, covering only the 20 most-consumed vegetables, 20 most-consumed fruits, and 20 most-consumed raw fish types each year (chosen by the Secretary by regulation, possibly region by region). (ii) The Secretary also had to define, by regulation, what counts as "substantial compliance" with those guidelines — there's no substantial compliance if a significant number of retailers aren't following them, weighing retailer size and market share. (C)(i) 30 months after November 8, 1990, the Secretary had to report on how well stores were following the guidelines, including whether there was substantial compliance. (ii) If there was, the Secretary had to keep issuing that report and finding every two years after. (D)(i) If the Secretary found there wasn't substantial compliance, the Secretary had to immediately propose mandatory regulations requiring the same information from anyone selling raw produce or raw fish, finalize them 6 months after proposing, effective 6 months after that. (ii) Those regulations could cover more than 20 varieties of each food type if more are commonly eaten, could let the information be posted in one place per selling area, could let it be shown as an average or range, and require the Secretary to prepare and supply that information to sellers. (iii) The regulations had to let the information be posted anywhere in the store selling these foods, shown through the Secretary's printed copies, a brochure or notebook, or a posted sign — and could allow it to be supplemented by video, live demonstration, or other Secretary-approved media. (E) "Fish" here means freshwater or ocean fin fish, crustaceans, and mollusks, including shellfish, amphibians, and other aquatic animals. (F) A seller of raw produce or raw fish can't be prosecuted for minor violations if they're substantially complying overall. (5) A set of exemptions from rules (1)-(4): (A) they don't apply to (i) restaurant food, or food sold for use in restaurants, meant for immediate eating — except as (H)(ii)(III) provides; (ii) food mostly made and prepared right in a retail store, ready to eat, sold only there and nowhere else — same exception; (iii) infant formula, covered instead by section 350a; (iv) medical food as defined in section 360ee(b); or (v) food described in section 345(2). (B) Rules (1) and (2) don't apply to a label if the Secretary decides by regulation the package is too small to fit the information, as long as the label carries no nutrition information at all. (C) If a food has only insignificant amounts (as the Secretary decides) of every required nutrient, the labeling rules don't apply — as long as nothing on the label, labeling, or ads makes a nutrition claim. If it has insignificant amounts of more than half the required nutrients, the Secretary must require those amounts shown in a simplified format the Secretary designs. (D) Small sellers are exempt: if someone's total yearly consumer sales are $500,000 or less, or their yearly food sales to consumers are $50,000 or less, rules (1)-(4) don't apply to their food — unless their label already gives nutrition information or makes a nutrition claim. (E) A temporary exemption existed for smaller manufacturers in the early 1990s, tied to filing an annual notice with the Secretary (stating average employee counts and units sold) and staying under specific employee and unit-sold thresholds that phased down over several years; anyone who exceeded a threshold mid-year kept the exemption for another 18 months, and the Secretary could later lower the thresholds by regulation for new products. A very small seller — not an importer, fewer than 10 full-time-equivalent employees, fewer than 10,000 units sold a year — didn't have to file the notice at all. (F) Dietary supplements (including foods covered by section 350) must follow rules (1) and (2) as adapted for supplements by the Secretary's regulations: list first the significant dietary ingredients that have a Secretary-set daily recommendation, then any other dietary ingredients present without one; show the quantity of each ingredient (or of a proprietary blend) per serving; may show an ingredient's source; and put the nutrition information right before the ingredient list, without repeating anything. (G) Rules (1)-(4) don't apply to food sold by a distributor whose main business is selling to restaurants, if the distributor doesn't manufacture, process, or repackage what it sells. (H) Restaurants, retail food establishments, and vending machines: (i) A standard menu item at a restaurant or similar place that's part of a chain of 20 or more locations under one name, selling substantially the same menu, must disclose the information below (except for food described in (vii)). (ii) They must clearly disclose (I) on the printed menu, next to each item, its calorie count as usually served, plus a short, prominent statement (set by regulation) about suggested daily calorie intake to give context; (II) the same two things on any menu board, including drive-through boards; (III) in writing, on-site and available on request, the fuller nutrient information from (1)(C) and (D); and (IV) on the menu or board, a clear statement that this written information is available. (iii) At a salad bar, buffet, cafeteria line, or similar self-serve setup, and for self-serve drinks or displayed food, they must post a sign next to each item listing calories per item or serving. (iv) A restaurant only needs a "reasonable basis" for its calorie claims — nutrient databases, cookbooks, lab tests, or similar reasonable methods described in FDA regulations or guidance. (v) The Secretary must set rules for menu items sold in varying flavors, sizes, or combos but listed as one item — like soft drinks, ice cream, pizza, doughnuts, or kids' combo meals — using ranges, averages, or similar methods. (vi) If the Secretary decides another nutrient should be disclosed to help consumers, it can be required in the written form from (ii)(III). (vii) None of this applies to items not listed on the menu (like table condiments), to daily specials or custom orders, to temporary items on the menu under 60 days a year, or to food in a market test on the menu under 90 days under Secretary-set conditions — though the insignificant-amounts rule in (5)(C) still applies to the written forms required here. (viii) For vending machines that don't show nutrition information at the point of sale, if the operator runs 20 or more machines, a sign near the food or selection button must clearly disclose its calorie count. (ix) Restaurants and vending operators not covered by this scheme can opt in voluntarily by registering with the Secretary every two years, as the Secretary specifies by regulation — a process that can't be turned into an application, review, or licensing requirement. (x) The Secretary had to propose implementing regulations within a year of March 23, 2010, addressing things like standardized recipes, reasonable serving-size variation, menu space, human error, staff training, and ingredient variation, and specifying the exact disclosure format — reporting progress to Congress quarterly. (xi) "Menu" or "menu board" means the primary document a customer uses to order. (r) Nutrition levels and health-related claims. Except as (5)(A)-(C) allow, if a food's label or labeling claims — directly or by implication — either (A) something about the level of a nutrient required under (q)(1) or (q)(2), or (B) how that nutrient relates to a disease or health condition, the claim is covered by this rule (a plain statement that's just part of the standard nutrition panel isn't a "claim" under this rule, and a level claim under (A) isn't treated the same as a disease-relationship claim under (B)). (2) Rules for level claims (like "low fat"), except as (4)(A)(ii)-(iii) and (5)(A)-(C) allow: (A) such a claim can only use terms the Secretary has defined by regulation; can't claim a nutrient is absent unless it's normally found in that food or a substitute food, or the Secretary allows the claim as helpful (with disclosure that the nutrient isn't normally present); can't claim a cholesterol level if the food's fat or saturated fat level (as the Secretary defines) raises disease risk, unless the Secretary finds the cholesterol level is genuinely much lower than typical (or allows a "no cholesterol" claim where it's not normally present) and the label discloses the fat or saturated-fat level right next to the claim, at least half its print size; can't claim a saturated-fat level if the food has cholesterol, unless the label discloses the cholesterol level the same way; can't call a food "high in dietary fiber" unless it's also low in total fat, or the label discloses the total fat level the same way; and can't be made at all if the Secretary decides by regulation it would mislead given some other nutrient's level. (B) If a level claim is made and the Secretary determines the food's level of some nutrient raises disease risk, the label must prominently state, right next to the claim: "See nutrition information for ___ content," naming that nutrient — considering how significant the food is in a typical diet. (C) The rules in (2)(A) don't apply to a level claim built into a brand name already in use before October 25, 1989, unless the brand name uses a term the Secretary has defined — such a claim still has to be truthful under (a). (D) Similarly, a pre-1989 "diet" claim in a soft drink's brand name that complied with the FDA's 1989 rule on "diet" is exempt from (2), but still covered by (a). (E) The detailed restrictions in (2)(A)(i)-(v) don't apply to a statement about a food's vitamin or mineral percentage compared to daily recommended amounts. (F) (2)(A)(i) doesn't apply to a supplement label statement about the percentage of an ingredient with no Secretary-set daily value. (G) Even without a Secretary regulation, a level claim is allowed if a U.S. government scientific body (like NIH or CDC) or the National Academy of Sciences has published a current, official statement identifying the relevant nutrient level; the claimant notifies the Secretary at least 120 days before first shipping the labeled food, with the exact claim wording, a copy of the relied-on statement, and a balanced science summary; the claim and food otherwise comply with (A), (B), the general misbranding rule (a), and section 321(n); and the claim accurately represents that official statement in an understandable way. (H) Such a claim can keep being used until the Secretary issues a regulation prohibiting or changing it, or finds the requirements weren't met, or a federal court rules in an enforcement case that they weren't met. (3) Rules for disease-relationship claims, except as (5) allows: (A) allowed only if it meets the Secretary's regulations under (B), and the food doesn't contain a nutrient amount the Secretary determines raises disease risk for the general population — unless the Secretary allows it anyway as helpful, with the disclosure required under (2)(B). (B)(i) The Secretary can only authorize such claims by regulation based on the full body of public scientific evidence, finding qualified experts significantly agree the claim is supported; (ii) the regulation must describe the nutrient-disease relationship and its significance; (iii) it must require the claim to accurately reflect that and be understandable in the context of a full diet. (C) Even without a Secretary regulation, a disease-relationship claim is allowed under essentially the same authoritative-statement, 120-day-notice, and accuracy process described for level claims in (2)(G). (D) Such a claim can keep being used under the same conditions described in (2)(H). (4) Anyone can petition the Secretary for a regulation authorizing a claim, to use specific terms in a claim, or to use an implied claim in a brand name — each petition type has its own deadline (100, 90, or 100 days) after which an unanswered petition is generally deemed denied (or, for the brand-name petition, deemed granted), and a full rulemaking on a claim petition must finish within 540 days of filing, with Congress notified if it doesn't. Petitions must explain the science backing the claim, and if a petition for a disease-claim regulation relies on a government scientific report, the Secretary must consider it and explain any rejection. (5) This paragraph doesn't apply to infant formula or medical food; the extra disclosure rules in (2)(A)(iii)-(v) and (2)(B) don't apply to restaurant food; a level claim required by an official standard of identity skips (2)(A)(i) and (2)(B); and a disease-relationship claim about a vitamin, mineral, herb, or similar dietary supplement isn't governed by (3) at all — instead the Secretary sets a separate procedure by regulation. (6) A dietary supplement can carry a statement about a nutrient's role in body structure or function, a classic deficiency disease, or general well-being, if the statement discloses the deficiency disease's prevalence where relevant, the manufacturer has evidence it's truthful, and the label prominently displays in bold: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." Such a statement can never claim to diagnose, treat, cure, or prevent a specific disease, and the manufacturer must notify the Secretary within 30 days of first using it. (7) The Secretary can make proposed regulations under this paragraph effective immediately, before final action, if needed to act quickly on petitions that help consumers eat healthily or get important new nutrition science, or to quickly ban or change a misleading claim — such proposed regulations count as final, appealable agency action. (s) Dietary supplements. A supplement is misbranded if its label fails to list each dietary ingredient (as section 321(ff) defines them) and either its quantity or, for a proprietary blend, the blend's total quantity; fails to identify the product as a "dietary supplement" (which can be modified with an ingredient name); contains a plant-based ingredient under section 321(ff)(1)(C) without saying what part of the plant it comes from; claims to meet an official compendium's specifications but doesn't; or, if not covered by a compendium, doesn't actually have the identity, strength, quality, purity, or composition it claims to have, based on validated testing. A supplement isn't misbranded just because its label includes directions, conditions of use, or warnings. (t) Catfish. It's misbranded if sold or presented as catfish unless it's actually a fish in the Ictaluridae family. (u) Ginseng. It's misbranded if sold or presented as ginseng unless it's an herb or herbal ingredient from a plant in the Panax genus. (v) Failure to label; health threat. It's misbranded if it lacks a label the Secretary required under section 381(n)(1) for food refused entry into the U.S., the Secretary finds it poses a serious risk of illness or death, and the Secretary — after telling the owner a label is required — also tells them about that serious threat. (w) Major food allergen labeling requirements. (1) A food that isn't a raw farm product is misbranded if it, or an ingredient in it, contains a major food allergen, unless either the word "Contains," followed by the allergen's food source, appears right after or next to the ingredient list in type at least as large as that list's type, or the allergen's common name in the ingredient list is followed in parentheses by its food source — except the source name isn't needed if the ingredient's common name already includes it, or if it appears elsewhere in the ingredient list (unless that other appearance is part of a non-allergen ingredient's name). (2) The "food source" name generally follows section 321(qq)(1), except for tree nuts, fish, or crustacean shellfish, where it means the specific nut type or species. (3) This information can appear in labeling instead of on the label itself only if the Secretary finds that's still enough to protect public health, announced by Federal Register notice. (4) Even flavorings, colorings, or minor additives that are or contain a major allergen must still follow this rule, regardless of what (g), (i), or (k) say. (5) The Secretary can modify or eliminate the (1)(A) or (1)(B) requirements by regulation if needed to protect public health. (6) Anyone can petition to exempt an ingredient from these rules by proving, with scientific evidence, that it doesn't cause a health-risking allergic reaction — the Secretary must decide within 180 days (or it's deemed denied), and must publicly post every petition and response within 14 days. (7) Instead of petitioning, a person can file a notification with scientific evidence the ingredient contains no allergenic protein, or point to a separate Secretary determination that it's not risky — the ingredient can then be used as a non-allergen 90 days after filing, unless the Secretary objects within that window; these notifications and objections must also be posted publicly within 14 days. (x) Nonmajor food allergen labeling requirements. Regardless of (g), (i), (k), or any other law, once the Secretary determines by regulation that a spice, flavoring, coloring, or minor additive is or contains a food allergen that isn't a "major" one, it must be disclosed the way the Secretary specifies by regulation. (y) Dietary supplements. A supplement sold in the U.S. is misbranded unless its label includes a U.S. address or phone number where the "responsible person" (as section 379aa–1 describes) can be reached to report a serious adverse event.