Summary. Food and beverage businesses answer to more agencies than almost any other consumer industry, and the boundaries between them are historical rather than logical. This article maps the framework: what makes a food adulterated or misbranded, how the label is constructed panel by panel, what the Food Safety Modernization Act requires of manufacturers and importers, when a claim converts a food into an unapproved drug, and how the USDA, TTB, state agriculture departments, and cottage food statutes divide what the FDA does not cover. It also addresses the two exposures that end companies rather than merely costing money: a recall handled badly, and the strict criminal liability the Park doctrine imposes on responsible corporate officers.

A beverage company launches a sparkling drink with a botanical extract, sold in grocery stores in eleven states. The can says "All Natural," "Supports Immunity," and "Only 20 Calories." The ingredient list is accurate. The company has a co-packer with a food safety plan and a certificate of insurance.

Within a year it faces four separate problems that arrived from four different directions.

The FDA sends a warning letter because "supports immunity," in the context of the product's marketing — which included testimonials about avoiding illness — is a claim to treat or prevent disease, making the beverage an unapproved new drug under the Food, Drug, and Cosmetic Act.

A class action is filed in California over "All Natural," alleging that a synthetically produced preservative and a citric acid derived by fermentation are inconsistent with the claim. The FDA has never defined "natural" for food. That absence has not stopped the litigation; it has fueled it.

A second class action alleges the botanical extract is not generally recognized as safe for use in a conventional beverage and has never been the subject of a food additive petition or a GRAS notification, making every can adulterated as a matter of law regardless of whether anyone was harmed.

And the co-packer issues a recall after an environmental swab finds Listeria on a filler line. The company has no written recall plan, cannot identify which lots went to which distributors within 24 hours, and learns that its "product liability" coverage excludes recall costs, which are a separate insuring agreement it did not buy.

Every one of these was preventable at low cost before launch and expensive afterward. That asymmetry is the core practical fact of food regulation.

Who regulates what

FDA — the great majority of the food supply: packaged foods, produce, seafood, dairy, dietary supplements, bottled water, and food additives, plus food contact substances and, importantly, the labels on all of it. Authority under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq.

USDA Food Safety and Inspection Service — meat, poultry, and processed egg products, under the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act. FSIS requires continuous inspection at slaughter and inspection at processing, and — critically — prior approval of labels in defined circumstances, which is a step FDA does not require. The boundary produces well-known oddities: an open-faced sandwich is FSIS, a closed one is FDA; a pizza with meat is FSIS, a cheese pizza is FDA.

USDA Agricultural Marketing Service — organic certification under the National Organic Program, grading standards, and the National Bioengineered Food Disclosure Standard.

Alcohol and Tobacco Tax and Trade Bureau (TTB) — labeling, formulation, and advertising for most alcohol beverages, with certificates of label approval required before sale. Note the split: most beer, wine, and distilled spirits are TTB; wines below 7 percent alcohol and beers not made from malted barley and hops are FDA-labeled, which surprises hard seltzer and cider producers regularly.

EPA — pesticide tolerances, which FDA then enforces on food.

FTC — advertising, as distinct from labeling, under Section 5 and the FTC's substantiation requirements.

State departments of agriculture and health — facility licensing and inspection (frequently under contract with FDA), retail food codes, weights and measures, milk and shellfish programs, and cottage food laws.

Customs and Border Protection, with FDA, at import.

Adulteration and misbranding

These two words carry the whole statutory scheme.

Adulterated — 21 U.S.C. § 342. A food is adulterated if it bears or contains a poisonous or deleterious substance that may render it injurious to health; if it consists in whole or in part of a filthy, putrid, or decomposed substance, or is otherwise unfit for food; if it was prepared, packed, or held under insanitary conditions whereby it may have become contaminated — note that no actual contamination is required; if it contains an unapproved food additive; if it contains an unsafe pesticide residue or color additive; or if a valuable constituent has been omitted or a substance substituted.

Misbranded — 21 U.S.C. § 343. A food is misbranded if its labeling is false or misleading in any particular; if it lacks the required statement of identity, net quantity, ingredient list, name and place of business, nutrition labeling, or allergen declaration; if required information is not prominent and conspicuous; if it purports to be a food for which a standard of identity exists and does not conform; or if it bears an unauthorized nutrient content or health claim.

Enforcement tools: warning letters; seizure of the goods; injunction; civil penalties in defined circumstances; mandatory recall authority under 21 U.S.C. § 350l; import alerts and detention without physical examination, which is functionally an import ban; suspension of facility registration, which prevents the facility from shipping at all; and criminal prosecution.

The Park doctrine deserves separate emphasis. Under 21 U.S.C. § 333(a), a first violation is a strict liability misdemeanor — no intent required. In United States v. Dotterweich, 320 U.S. 277 (1943), and United States v. Park, 421 U.S. 658 (1975), the Supreme Court held that a responsible corporate officer may be convicted for a corporate violation without personal participation or knowledge, where the officer had the authority and responsibility to prevent or correct it. A second offense, or a violation with intent to defraud or mislead, is a felony. Convictions also support exclusion from federal health care programs and debarment from the food industry.

The practical consequence is that food safety is a personal risk for executives in a way that most regulatory compliance is not, and that a documented system giving officers actual visibility and control is both a defense and a reason to build one.

The label

The label is where most companies first encounter regulation, and it is highly prescriptive. 21 C.F.R. Part 101 governs.

The principal display panel — the part of the label most likely to be displayed at retail — must bear:

  • The statement of identity: the common or usual name of the food, or the name required by a standard of identity if one exists. Standards of identity are real and binding — a product called "mayonnaise," "chocolate," "milk," or "peanut butter" must meet the compositional requirements or use a different name.
  • The net quantity of contents, in both metric and U.S. customary units, in a prescribed type size and placed within the bottom 30 percent of the panel.

The information panel — immediately to the right of the principal display panel — must bear, in order and without intervening material:

  • The ingredient statement, listing ingredients in descending order of predominance by weight, using common or usual names, with sub-ingredients of compound ingredients declared parenthetically or dispersed.
  • The allergen declaration.
  • The name and place of business of the manufacturer, packer, or distributor, with a qualifying phrase such as "Distributed by" if not the manufacturer.
  • Nutrition labeling.

The Nutrition Facts panel follows a mandated format. The current version requires: calories in large type; serving size based on the reference amount customarily consumed, not on what the manufacturer wishes people would eat; dual-column labeling for packages containing between one and two servings that could be consumed in one sitting; declaration of added sugars; vitamin D and potassium in place of vitamins A and C; and actual amounts in addition to percent daily value for vitamins and minerals. Small businesses have exemptions based on units sold and employee count, and low-volume products may qualify for exemption on request.

Allergen labeling — the Food Allergen Labeling and Consumer Protection Act, 21 U.S.C. § 343(w), requires declaration of the major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and — since the FASTER Act — sesame. Declaration is by a "Contains" statement following the ingredient list, or by parenthetical identification within it. The specific type of tree nut, fish, and shellfish must be named.

Allergen control is the single most common cause of Class I recalls. The dominant cause is not a formulation error but an undeclared allergen from a label mix-up or a supplier change. The controls that prevent it are mundane: label reconciliation at changeover, a specification and change-notification requirement in every supplier agreement, and verification that the label on the line matches the formula being run.

"Precautionary" or "may contain" statements are voluntary and unregulated. They do not excuse a failure to declare an intentional ingredient, and overusing them is both a marketing problem and, increasingly, a litigation target.

Bioengineered food disclosure — 7 C.F.R. Part 66 requires disclosure of bioengineered foods and ingredients by on-package text, symbol, electronic link, or text message option, with exemptions for very small manufacturers and threshold rules.

Country of origin labeling applies to certain commodities; juice and shell egg products have specific requirements; infant formula has an entirely separate regime; and food contact substances and packaging have their own approval pathway.

Claims

This is where good products get into trouble, because marketing writes the claims and regulatory sees them last.

Nutrient content claims — "low fat," "high fiber," "good source of," "reduced sodium," "light." Each has a regulatory definition in 21 C.F.R. Part 101 Subpart D, and using the term without meeting the definition is misbranding. Implied claims ("made with whole grain") are also regulated.

Health claims — statements characterizing the relationship between a substance and a disease or health-related condition. Three routes: authorized health claims approved by regulation after significant scientific agreement (a short list, including calcium and osteoporosis, sodium and hypertension, and folate and neural tube defects); qualified health claims permitted with disclaimers where evidence is weaker, following an FDA letter of enforcement discretion; and authoritative statement claims based on statements by other federal scientific bodies, with notification. Each authorized claim has required model language and conditions of use, including disqualifying nutrient levels.

Structure/function claims — statements that a nutrient or dietary ingredient affects the structure or function of the body. Permitted for conventional foods where the claim derives from the food's nutritive value, and for dietary supplements under 21 U.S.C. § 343(r)(6) with a disclaimer and notification to FDA within 30 days.

The line that matters. A claim that a product diagnoses, cures, mitigates, treats, or prevents disease makes it a drug under 21 U.S.C. § 321(g)(1)(B), regardless of what the product is. An unapproved new drug cannot be lawfully marketed. This is the theory behind the great majority of FDA warning letters in this space, and the evidence is not limited to the label — the agency looks at the website, social media, influencer content, customer testimonials the company amplifies, and product names. "Immunity," "detox," "anti-inflammatory," and "reduces anxiety" are the recurring problem words.

"Natural." FDA has no formal definition and has stated only a longstanding policy that it means nothing artificial or synthetic has been included that would not normally be expected. USDA has a separate policy for meat and poultry. The regulatory vacuum has produced sustained class action litigation, with theories directed at synthetic preservatives, citric and ascorbic acid produced by fermentation, high fructose corn syrup, bioengineered ingredients, and processing aids. If a product uses "natural," the company should have a written, defensible basis for it, and should recognize that the claim buys litigation risk in exchange for marketing value. Many companies have concluded the trade is not worth it.

"Organic" is different — it is defined and certified under the National Organic Program. Using it without certification is unlawful. The tiers are "100% organic," "organic" (95 percent), "made with organic ingredients" (70 percent), and ingredient-level identification below that, with only the first two eligible for the USDA seal.

Other claim categories requiring substantiation: "non-GMO" (a private certification, not a federal one), "gluten-free" (defined by regulation at less than 20 ppm), "healthy" (defined by regulation and recently revised), "fresh," "clean label," sustainability and animal welfare claims, and "made in USA," which the FTC enforces under an "all or virtually all" standard.

FTC substantiation. Advertising claims require competent and reliable scientific evidence at the time the claim is made. For health-related claims, the Commission's guidance contemplates well-controlled human clinical studies. A study conducted after the claim was launched does not cure the violation.

Food safety and the FSMA

The Food Safety Modernization Act shifted the regime from responding to contamination to preventing it. Its major rules:

Preventive Controls for Human Food — 21 C.F.R. Part 117. Registered facilities must implement:

  • Current Good Manufacturing Practices — personnel, plant and grounds, sanitary operations, equipment, processes and controls, warehousing.
  • A written food safety plan prepared or overseen by a preventive controls qualified individual, containing a hazard analysis identifying known or reasonably foreseeable biological, chemical (including radiological and allergen), and physical hazards; preventive controls for hazards requiring them (process, food allergen, sanitation, supply chain, and others); monitoring, corrective action, and verification procedures; a recall plan; and records.
  • Supply chain program for hazards controlled by a supplier, requiring approval of suppliers and verification activities.

Facility registration — under 21 U.S.C. § 350d, with biennial renewal. FDA may suspend registration, which halts shipment.

Produce Safety Rule — 21 C.F.R. Part 112 — for covered farms, addressing agricultural water, biological soil amendments, worker health and hygiene, domesticated and wild animals, and equipment and buildings, with exemptions for small farms selling primarily to qualified end users.

Foreign Supplier Verification Programs — 21 C.F.R. Part 1 Subpart L. Importers must verify that foreign suppliers produce food meeting U.S. standards: hazard analysis, evaluation of the supplier's performance and the food's risk, verification activities (with annual onsite audit required for hazards causing serious adverse health consequences unless another approach is justified), and records. The importer of record must have a DUNS number and be identified in the entry filing. FSVP violations are among the most common causes of import refusal, and the obligation falls on the importer regardless of what the supplier promised.

Food Traceability Rule — 21 C.F.R. Part 1 Subpart S. For foods on the Food Traceability List, persons who manufacture, process, pack, or hold them must maintain records of key data elements at critical tracking events — harvesting, cooling, initial packing, shipping, receiving, transformation — and produce a sortable electronic spreadsheet to FDA within 24 hours of request. Compliance dates have been extended; verify the current date.

Sanitary Transportation, Intentional Adulteration (food defense plans for certain facilities), and Accredited Third-Party Certification rules round out the framework.

HACCP remains mandatory for seafood (21 C.F.R. Part 123) and juice (Part 120), and USDA requires it for meat and poultry.

Reportable Food Registry — 21 U.S.C. § 350f requires a responsible party to report within 24 hours when there is a reasonable probability that use of a food will cause serious adverse health consequences or death. This is a fast clock that runs from the company's own knowledge.

Recalls

Most recalls are voluntary, conducted under FDA guidance with agency oversight, though FDA has mandatory recall authority. Classification: Class I (reasonable probability of serious adverse health consequences or death), Class II (temporary or medically reversible consequences), Class III (unlikely to cause adverse consequences).

What a recall requires, quickly:

  1. Decide and document — a recall decision team, a written hazard evaluation, and a decision within hours, not days.
  2. Determine scope — which lots, which dates, which distribution. This is where companies fail. If lot coding, production records, and distribution records cannot answer that question within 24 hours, the recall expands to everything.
  3. Notify FDA and file the reportable food report if applicable.
  4. Notify the trade — direct notice to every consignee, with instructions, a response mechanism, and a follow-up process.
  5. Public notification where the product reached consumers — press release and, for Class I, posting on FDA's site.
  6. Effectiveness checks — verifying that consignees received and acted on the notice, at a level FDA specifies.
  7. Disposition — return, destruction, or reconditioning, documented.
  8. Root cause analysis and corrective action, which is what FDA will focus on afterward.
  9. Termination — a written request to FDA after effectiveness checks are complete.

Insurance. Product liability coverage generally does not cover recall expense, business interruption from a recall, or lost profits. Product recall/contaminated product insurance is a separate line. Confirm it exists, read what triggers it (many policies require actual contamination rather than a precautionary recall), and understand the sublimits.

Contracts. Every co-packer, ingredient supplier, and distributor agreement should allocate recall costs, require notification of any issue affecting the product, require specifications and change notification, require insurance with the buyer as additional insured, and provide audit rights and record access. The company whose name is on the package bears the consumer-facing risk regardless of who caused the problem.

Dietary supplements, and the categories at the edges

Dietary supplements are regulated as a category of food under the Dietary Supplement Health and Education Act. Key features: no premarket approval, but a new dietary ingredient notification to FDA 75 days before marketing is required for ingredients not marketed before October 15, 1994; cGMP requirements at 21 C.F.R. Part 111, which are more demanding than food cGMPs and are the most common source of warning letters; Supplement Facts labeling rather than Nutrition Facts; structure/function claims with disclaimer and notification; and serious adverse event reporting within 15 business days.

Cottage food laws exist in every state and permit production of specified non-potentially-hazardous foods in a home kitchen for direct sale, with dollar limits, venue restrictions, labeling requirements, and prohibitions on interstate sale. They vary enormously — some require registration and inspection, some require only a food safety course, some permit online sales and shipping within the state and some do not. Exceeding the limits or the permitted food list moves the operation into full commercial regulation, including facility registration and preventive controls, which is a large step to take by accident.

Proposition 65 in California requires a clear and reasonable warning before knowingly exposing a person to a listed chemical, with a private right of action and a bounty structure that has produced a large volume of enforcement over lead and cadmium in foods, acrylamide in baked and fried products, and heavy metals in supplements. Reformulation, testing to establish that exposure is below the safe harbor level, and — where necessary — warning are the options. Note that acrylamide warnings have been the subject of First Amendment litigation.

State labeling and ingredient laws are proliferating: several states have enacted bans on specific additives with future effective dates, and states impose their own requirements on allergen disclosure in food service, menu labeling below the federal threshold, and sale of specified products. Preemption is uneven — the FDCA expressly preempts certain state labeling requirements that differ from federal requirements, but leaves substantial room, and POM Wonderful LLC v. Coca-Cola Co., 573 U.S. 102 (2014), held that FDCA compliance does not preclude a Lanham Act false advertising claim by a competitor.

What to do before launch

  1. Classify the product — food, dietary supplement, drug, or alcohol — and identify which agency labels it.
  2. Confirm every ingredient's regulatory status — approved food additive, GRAS with documentation, or subject to a notification. This is the analysis most often skipped and most expensive to skip.
  3. Build the label to the regulation, panel by panel, and have it reviewed by someone who has done it before. A label review is a few thousand dollars; a labeling recall is not.
  4. Write down the basis for every claim before it appears anywhere, including on social media, and put a claims-review gate in the marketing workflow.
  5. Register the facility, or confirm the co-packer's registration, and get a copy of the food safety plan and the last third-party audit.
  6. Build the recall plan and test it — a tabletop exercise that requires the team to identify affected lots within 24 hours will find the gaps.
  7. Get the right insurance, including recall coverage, and read the triggers.
  8. Paper the supply chain with specifications, change notification, allergen controls, insurance, indemnity, and audit rights.
  9. Check state overlays — Proposition 65, state ingredient bans, and cottage food limits if applicable.
  10. Give an officer real visibility and authority over food safety, and document it, because the Park doctrine makes that a personal matter.

Conclusion

Food regulation punishes assumptions. The three that cost the most are that a claim is fine because it is true, that an ingredient is fine because it is sold elsewhere, and that a co-packer's compliance is the company's compliance.

Claims are evaluated in context, across every channel, against a legal test that converts a health promise into a drug claim. Ingredient status is a formal question with a documented answer — GRAS, approved additive, or notified — and "widely used" is not one of the answers. And the name on the package bears the risk, which means supplier controls, audit rights, and recall cost allocation are the substance of the relationship rather than boilerplate.

The two exposures that end companies are a recall the company cannot scope and a criminal charge against an officer who had authority and no system. Both are addressed by the same investment: records good enough to identify what went where within a day, and a documented safety program that a responsible officer actually sees.

A worked example: from home kitchen to national brand

A baker sells at a farmers market under a state cottage food law. Five years later the product is in 2,400 stores. Here is what changes at each threshold, and what breaks when a step is skipped.

Stage one — cottage food. Production in a home kitchen, sale direct to consumers at markets and from the home, under a state exemption. Requirements are modest: an approved product on the state's non-potentially-hazardous list, a labeling statement identifying the product as home-produced, a food handler course, and a revenue cap. What is not permitted: wholesale to retailers, interstate shipment, and — in most states — anything requiring temperature control. The most common failure at this stage is accepting a wholesale order, which is outside the exemption everywhere and converts the operation into an unregistered commercial facility on the day the order ships.

Stage two — a commercial kitchen. The baker rents time in a licensed shared-use facility. The operation now needs facility registration with FDA (or coverage under the facility's registration, depending on structure), cGMP compliance, and — once it is no longer a qualified facility under the modified requirements — a full food safety plan with a hazard analysis prepared by a preventive controls qualified individual. Allergen controls become the central concern, because the kitchen is shared and the products contain wheat, milk, eggs, and tree nuts. The plan must address changeover sanitation and label control.

Stage three — retail packaging. Now the label matters. The product needs a statement of identity, net quantity in the bottom 30 percent of the principal display panel, an ingredient statement in descending order of predominance with sub-ingredients declared, a "Contains" allergen statement naming the specific tree nuts, the name and place of business, and a Nutrition Facts panel using the reference amount customarily consumed rather than the baker's preferred serving. The company qualifies initially for a small-business nutrition labeling exemption and loses it when unit volume crosses the threshold — a change that must be tracked, because it arrives silently.

Stage four — a co-packer. Volume moves production to a contract manufacturer. This is the point at which most brands mistakenly believe they have outsourced compliance. They have not. The brand owner is the responsible party for the label, remains liable for adulteration and misbranding, and is the name consumers and plaintiffs see. The contract must therefore carry specifications with tolerances, an allergen control program, a change-notification requirement covering ingredients and suppliers, the right to audit and to receive third-party audit reports and any FDA Form 483 observations, insurance with the brand as additional insured, an indemnity, and a recall cost allocation provision that does not simply say "each party bears its own costs."

Stage five — claims and expansion. Marketing proposes "clean," "no artificial anything," and "supports gut health." The first two are unregulated but litigable and require a written substantiation file. The third is a structure/function claim that will be read against the company's entire marketing record, including any testimonial about digestive conditions — and if that record implies treatment of a disease, the cookie has become an unapproved drug. Counsel puts a claims gate in the marketing workflow, which is the single cheapest control in this article.

Stage six — importing an ingredient. The company sources a specialty flour from abroad and becomes an importer subject to the Foreign Supplier Verification Program: hazard analysis of the ingredient, evaluation of the supplier, verification activities including an annual onsite audit where the hazard warrants it, a DUNS number, and records. FSVP failures are a leading cause of import refusal, and the obligation runs to the importer regardless of the supplier's assurances.

Frequently asked questions

Do I need FDA approval before selling a food? No. Foods are not approved. But every ingredient must be an approved food additive, GRAS, or otherwise lawful, the facility must be registered, and the label must comply. "No approval required" is not "no requirements."

Is my recipe protected? Not by copyright, which does not protect a list of ingredients or a functional process, though it may protect substantial expressive text accompanying it. Protect the formula as a trade secret and the brand as a trademark.

Can I say "no preservatives" if I use citric acid? Only if the citric acid is not functioning as a preservative in the product. If it is, the claim is false regardless of how consumers understand the ingredient — and this is precisely the fact pattern that generates class actions.

What is the fastest way to get a warning letter? Health claims in social media. The FDA reviews the whole marketing record, and companies routinely make on a podcast or in a reposted testimonial the claim they carefully avoided on the package.

Who is liable if the co-packer causes a recall? Practically, both. The brand faces the consumers, the retailers, and the agency. Whether the brand recovers from the co-packer depends entirely on the contract and the co-packer's insurance, which is why those provisions deserve real negotiation.

Do I need Proposition 65 warnings? Only if you sell into California and a listed chemical is present above the safe harbor level. Test first — many products are below the threshold, and an unnecessary warning carries its own marketing and litigation costs.

When does a supplement become a drug? When the claim crosses into treating, curing, mitigating, or preventing disease. The ingredient does not determine it; the claim does.

How much does a compliant launch actually cost? For a single packaged product: a label review and formulation status opinion in the low thousands, a claims substantiation file assembled by the marketing team with counsel review, a co-packer audit the brand pays for, and recall insurance priced against revenue. Together it is a small fraction of a first production run — and each item on the list corresponds to a failure mode that has cost other companies multiples of the entire launch budget.

Related articles

This article is provided for general informational purposes and does not constitute legal advice. Food regulation is detailed and changes frequently, compliance dates for several FSMA rules have been extended, and state ingredient and labeling laws vary. Consult qualified food and drug counsel before launching a product, making a claim, or responding to a contamination event.