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Regulating the Food Processing Sector (sec 5)
The food processing sector (including, for example, food manufacturing, packaging, labeling, storage, and transportation) was the primary focus of the first U.S. federal food laws and continues to be subject to numerous regulations. This page presents an overview of various topics relating to the regulation of the food processing sector.
Much of the discussion addresses FDA regulations, but the role of state agencies also is introduced. USDA’s role in regulating meat, poultry and eggs is addressed, as well. Similarities and differences between the responsibilities of FDA and USDA for their respective products are discussed; likewise, the complementarities between these two agencies are noted.
The information on this page is arranged by topics such as additives, manufacturing practices, and labeling; specific rules for certain foods (such as meat, poultry and egg products) are incorporated into the discussion of these topics. These specific products have not be given a distinct section on this page.
The fundamental rule is that a food manufacturer may not market an adulterated or misbranded food (see 21 U.S.C. §331; also see 21 U.S.C. §610, 21 U.S.C. §458, and 21 U.S.C. §1037). This prohibition not only encompasses manufacturing practices, but also extends to other activities, such as the storage and transportation of food. For example, food will be considered adulterated if it is stored in filthy conditions even though the food is not contaminated or unsafe. Similarly, food will be considered misbranded if it is improperly labeled.
To operate a food business in the United States, the business must be registered with the FDA. This requirement was imposed following September 11, 2001. This requirement applies to all businesses (domestic and foreign) involved in the U.S. food industry.
In addition to the federal registration requirement, many states require food businesses to be licensed. For example in North Dakota, food processing plants and other food establishments are required to be licensed by the state Department of Health; see N.D.C.C. §23-09-01(6) (a state statute).
- The state requires the food processing plant to be licensed; e.g., N.D.C.C. §23-09-26.
- The license subjects the business to state requirements; e.g., N.D.C.C. §23-09-09.
- The business also is subject to inspection by a state agency; e.g., N.D.C.C. §23-09-11.
- The business is subject to state enforcement; e.g., N.D.C.C. §§23-09-18, -19, -21, and –22.
In Minnesota, the state Department of Agriculture has primary responsibility for regulating that state’s food industry.
- "The Dairy and Food Inspection Division [of the Minnesota Department of Agriculture] enforces state laws and regulations related to the production, processing and sale of milk and other dairy products, processed foods, meats, beverages, eggs, poultry and poultry products, and animal feed." Taken from http://www.mda.state.mn.us/about/divisions/dairyfood.htm.
For most states, either the state health department or agriculture department has the primary regulatory responsibility, as illustrated by the situations in North Dakota (Department of Health) and Minnesota (Department of Agriculture). Also see State Departments of Public Health (a USDA web page) for links to many of these state agencies. To continue the example, in Wisconsin, the responsibility is divided between the state’s departments of agriculture and health.
- “Whether you shop for groceries and prepare your family's meals, run a grocery store, process food in a home business or large plant, or warehouse foods, we can provide the how-to's -- of good practices and the law.” Wisconsin Department of Agriculture, Trade and Consumer Protection – Food Processing and Safety at http://datcp.state.wi.us/core/food/food.jsp.
- “The Food Safety and Recreational Licensing staff are responsible for managing programs that enforce applicable state administrative codes for the inspection and licensure of restaurants, … bed and breakfast establishments … in Wisconsin.” Wisconsin Department of Health and Family Services, Food Safety and Recreational Licensing at http://dhfs.wisconsin.gov/fsrl/.
Food Standards of Identity
One strategy for assuring consumers receive the type of food they believe they are purchasing is to define names and standards of identity for food products. Congress directed FDA to establish definitions and standards for food 21 U.S.C. §341 (statute). The purpose was to establish a common name to help consumers. The standard of identity specifies requirements for the food product, but does not address quality issues, such as, inadvertent adulteration or whether the item meets the consumer’s nutritional needs.
- The standards of identity are set forth in regulations (see 21 CFR parts 130 to 169); there are more than 300 standards in 20 categories of food.
Also see 9 CFR part 319, and 9 CFR §§381.155 to 381.167.
- Standards specify minimum and maximum requirements, optional ingredients and prohibited ingredients; e.g., sherbert 21 CFR 135.140. The product could be considered adulterated if it does not contain the required content.
- Note the differences among fruit butter (21 CFR 150.110), fruit jelly (21 CFR 150.140), and fruit jam (21 CFR 150.160). These products illustrate the level of detail set forth in the standards of identity. A product that does not have the correct standard of identity would be considered misbranded.
Ingredients and Additives
Federal law requires that substances used for food cannot be spoiled, diseased, or otherwise injurious to the consumer’s health. For example,
“A food shall be deemed to be adulterated … (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or … (5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter … ” Source: 21 U.S.C. §342.
Although this statute partially addressed the concern about what can be used for food, it does not fully explain the question of what can be added to food, for example, during the manufacturing process. Congress took a major step in 1958 to address this concern and thus that date has significance.
“Food additives includes all substances … the intended use of which results or may reasonably be expected to result, directly or indirectly, either in their becoming a component of food or otherwise affecting the characteristics of food.
“A material used in the production of containers and packages is subject to the definition [of food additive] if it may reasonably be expected to … affect the characteristics … of food packed in the container … If there is no migration of a packaging component from the package to the food, it does not become a component of the food and thus is not a food additive.
“A substance that does not become a component of food, but that is used, for example, in preparing an ingredient of the food to give a different flavor, texture, or other characteristic in the food, may be a food additive.”
Source: 21 CFR 170.3(e)(1).
Since 1958, FDA has categorized substances added to food as (1) a food additive, (2) generally recognized as safe (GRAS), (3) having prior approval, or (4) not a food additive under the conditions of intended use. See 21 CFR 170.6(b). This discussion focuses on GRAS and food additives.
Having GRAS status means the substance can be used in the food product as long as the substance is used for its intended purpose and in accordance with good manufacturing practices (GMP); for example, see 21 CFR 184(1)(b).
Note that GRAS status addresses both the substance and how the substance is being used; for example, a substance may be GRAS for one use but not for another use, or a substance may be GRAS for a particular use as long as it is used within the specified limit. For example, see acetic acid at 21 CFR 184.1005.
- GRAS status may be based only on (1) scientific procedures or (2) common use in food prior to January 1, 1958 (21 CFR 170.30).
- GRAS status based on scientific procedures is ordinarily based on published scientific studies
- Safe means that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use. (21 CFR 170.3(i)).
- GRAS status based on common use in food prior to 1958 is based solely on the food use of the substance prior to 1958 and generally available data and information. A food ingredient of natural biological origin that has been widely consumed for its nutrient properties in the United States prior to 1958, without known detrimental effects, which is subject only to conventional processing as practiced prior to 1958, and for which no known safety hazard exists, will ordinarily be regarded as GRAS.
- An ingredient not in common use in food prior to 1958 may achieve GRAS status only through scientific procedures.
- See 21 CFR part 182 for a list of GRAS substances. However, the large number of substances intended for use in food renders it impracticable to list all substances that are GRAS.
- Over time, substances on the GRAS list will be re-evaluated. Based on the outcome, the substance will be listed as 1) “affirmed as GRAS'' (see 21 CFR part 184 or 186) 2), “food additive regulation'' (see 21 CFR parts 170 through 180), 3) “interim food additive regulation'' (see 21 CFR part 180), or 4) “prohibited from use in food'' (see 21 CFR part 189) (21 CFR 182.1(d)).
- As these re-evaluation occur, the significance of the 1958 date will decline, and substances will be removed from "part 182" of the regulations to one of the other "parts," as described in the preceding point.
“A substance that will be added to food [that is, a food additive] is subject to pre-market approval by FDA unless its use is generally recognized as safe (GRAS) by qualified experts.” See GRAS Notification Program.
- A food business intending to use a new substance in its food product must petition for FDA approval (21 CFR part 171). The business is expected to submit data it has on the safety of using the substance as a food component. FDA will provide an opportunity for public and industry comment on the request. Based on the information and comments, FDA will determine a status for the substance, e.g., GRAS, a food additive, or prohibited. This determination will be incorporated into FDA’s regulations. The requesting business and other businesses can then use the substance according to FDA’s determination.
- A substance that is not GRAS, but can be used as a food additive, generally has limitations imposed on its use. For example, see dehydroacetic acid at 21 CFR 172.130. For a more complete listing of food additives, see 21 CFR parts 172 to 180.
- Note the distinction between direct and indirect food additives. For example, a direct food additive is intended to become a component of the food or affect the characteristic of the food (see 21 CFR 170.3(e)). An indirect additive includes "substances used in food-contact articles (e.g., food-packaging or food-processing equipment) that migrate, or that may be expected to migrate, into food at negligible levels..." (21 CFR 174.6).
- To simplify the process of receiving FDA approval to use a GRAS substance in another manner, FDA developed the GRAS Notifcation Program in the 1990s. See
About the GRAS Notification System; for a more complete discussion see
Federal Register: April 17, 1997 (this is an extensive document but the Background section provides a historical perspective on the role and implementation of GRAS).
Some substances are prohibited from being used in food; see 21 CFR part 189.
Also see Frequently Asked Questions About GRAS and What is a Food Additive?
Additional “Additive” Topics and References
- Color Additive 21 U.S.C. §379e
- "A color additive shall ... be deemed unsafe ... unless there is ... a regulation ... listing [that the] additive [may be safely used] for such use, ... and such additive either is from a batch certified..., or has, with respect to such use, been exempted by the Secretary from the requirement of certification..."
- 21 CFR parts 70 through 82
- 21 CFR 70, 71, 73, 74 – Color additives
- Color additives are treated similar to food additives; that is, "any interested person may propose the listing of a color additive for use in or on any food..." 21 CFR 71.1(a).
- Also see Color Additives and What is a Color Additive?
- Vitamins and minerals 21 U.S.C. §350
- "...the Secretary may not establish ... maximum limits on the potency of any synthetic or natural vitamin or mineral within a food; the Secretary may not classify any natural or synthetic vitamin or mineral (or combination thereof) as a drug solely because it exceeds the level of potency which the Secretary determines is nutritionally rational or useful; the Secretary may not limit... the combination or number of any synthetic or natural vitamin, mineral, or other ingredient of food ...
- "[This prohibition] shall not apply in the case of a vitamin, mineral, other ingredient of food, or food, which is represented for use by individuals in the treatment or management of specific diseases or disorders, by children, or by pregnant or lactating women."
- 21 CFR 190
- Tolerances for poisonous ingredients 21 U.S.C. §346
- "Any poisonous or deleterious substance added to any food, except where such substance is required in the production thereof or cannot be avoided by good manufacturing practice shall be deemed to be unsafe..."
- Tolerances for pesticide chemicals 21 U.S.C. §346a
- "...any pesticide chemical residue in or on a food shall be deemed unsafe ... unless a tolerance for such pesticide chemical residue ... in effect ... and the quantity of the residue is within the limits of the tolerance; or an exemption from the requirement of a tolerance is in effect ..."
- EPA is responsible for specifying pesticide residue tolerances for food products.
- 21 CFR 170.19
- A pesticide residue is not regulated as a food additive.
Good Manufacturing Practices
Food is considered adulterated, and thereby prohibited from being sold if it “has been manufactured under such conditions that it is unfit for food; or … has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” See 21 CFR 110.5. The question then becomes what conditions or practices must the business adopt to help assure the food will not be considered adulterated. FDA addressed this issue by defining good manufacturing practices (GMP); see 21 CFR part 110. Not following GMP means the food will be considered adulterated, however, following GMP will not guarantee that the food is not adulterated.
- Food produced by a business that is not following GMP will be considered adulterated because it had “been manufactured under such conditions that it is unfit for food; or … prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.”
GMP addresses personnel, plant and grounds, sanitary operations, sanitary facilities and controls, equipment and utensils, processes and controls, and warehousing and distribution. See 21 CFR part 110. A variety of issues are addressed within these broad topics, such as food-contact surfaces (21 CFR 110.40), cross-contamination (21 CFR 110.37), transportation, and storage (21 CFR 110.93). Also see
- A food-contact substance is defined as "any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have a technical effect in such food." See Food Contact Substance Notification Program and 21 CFR 170.3(e)(3).
GMP also includes plant/facility security against intentional attacks; a concern that has received more attention in the past several years. A concept that may emerge to help businesses address this concern is “CARVER plus Shock”. Also see "Food Security Preventative Measures Guidance".
Assuring Compliance with GMP -- Inspection of food processing plants by FDA, or more likely state agencies is one way the governmetn assures the businesses are complying with GMP. However, for meat, poultry, and eggs processing, the law requires continuous inspection by USDA; either by FSIS or a state agency designated by FSIS is conducting the inspections to assure operating conditions are acceptable. Inspections are discussed further in a subsequent paragraph.
Hazard Analysis and Critical Control Points
For some products, agencies have gone beyond GMP by adopting a process known as Hazardous Analysis and Critical Control Point (HACCP). The reason for this is that each plant and manufacturing process is different, and one set of standards may not fit all situations. HACCP imposes more requirements on the business to know its business, assess what could go wrong to render their product unsafe, and take steps to prevent the problem. This risk analysis and startegy to reduce the likelihood of a problem are compiled into a document or plan. The business is then required to adhere to its plan.
To what extent must the HACCP plan be approved by an agency?
"failure of an establishment to develop and implement a HACCP plan that complies with this section, or to operate in accordance with the requirements of this part, may render the products produced under those conditions adulterated." Excerpt from 9 CFR 417.2(e).
The HACCP plan does not need to be approved by the regulatory agency, but the business must develop and adhere to a plan, and be able to provide the plan and documentation that the business is adhering to the plan when required by government to provide such documentation.
FSIS (USDA) was an early adopter of HACCP for meat; USDA regulations help illustrate the concept of HACCP. See 9 CFR Part 417. Also see regulations of HACCP for juices (21 CFR part 120) and seafood (21 CFR part 123).
See descriptions of HACCP, for example, “HACCP: A State-of-the-Art Approach to Food Safety” – an FDA web page with background information about HACCP at http://www.cfsan.fda.gov/~lrd/bghaccp.html.
For an overview of HACCP by the National Agricultural Library, USDA, see A Focus on Hazard Analysis and Critical Control Point (HACCP).
A HACCP plan does not eliminate the requirement that USDA continuously inspect all meat and poultry processing plants, see “HACCP-Based Inspection Models Project” – an FSIS web page at http://www.fsis.usda.gov/Science/HIMP_History/index.asp. This piece describes FSIS efforts to refine its inspection processes to reflect the changes resulting from the adoption of HACCP requirements.
Brief discussions in other sections of these materials (section 8) illustrate HACCP’s impact on other sectors of the food industry, such as the preparation stage (e.g., the Food Code) and agricultural production. The concept of HACCP also is becoming more common among international organizations that consider food safety issues.
Product needs to be visible or name on the package – this relates back to the product’s standard of identity?
- Includes contact surfaces??
- Indirect additives
- Quality Standards
- Fill Standards: 21 CFR 130.12 and 130.14
- For example, see 9 CFR 381.144 for packaging regulations promulgated under the Poultry Product Inspection Act or 9 CFR 317.24 for packaging regulations promulgated under the Meat Inspection Act.
The primary goal for labeling food is to provide consumer accurate information on which they can base their decision. Labeling requirements have evolved over the years (e.g., expanded from focusing on product identity and quantity to also include more nutritional and health information). Improperly labeled food is considered misbranded.
This subsection introduces some basic requirements for food labeling. FDA’s "A Food Labeling Guide" is an excellent resource for additional information.
- 15 U.S.C. §§1451-1461 (federal statutes -- Fair Packaging and Labeling); administered by FDA and FTC
- 21 U.S.C. §343-1 (nutrition labeling) and §343-2 (dietary supplement labeling); administered by FDA
- 21 CFR part 101 food product labeling regulations; administered by FDA
- See 9 CFR 381.115 to 381.140 for labeling regulations promulgated under the Poultry Products Inspection Act (administered by FSIS)
- See 9 CFR part 317 for labeling regulations promulgated under the Meat Inspection Act (administered by FSIS)
Summary of Requirements:
A Food Labeling Guide -- FDA web site with numerous pages; developed in 1994 but with updates as recent as 2006. Site also includes links to relevant regulations.
Principal display panel (PDP) is the front or "portion of the package label that is most likely to be seen by the consumer at the time of purchase"
- Name of product or commodity
- Name and address of the manufacturer, packer or distributor
- Net quantity of contents, U.S. and metric terms in legible type and size, parallel to base of package
- No qualifying terms as big or large with contents statement
Information panel is the "label panel immediately to the right of the PDP"
- Nutrition label
- Serving size and number of servings in the package; serving size is not set by government; it is determined by processor; serving size will likely be acceptable to FDA as long as it is logical
- On a "per serving" basis, specify
- the quantity of calories and calories from fat,
- the quantify (in grams or milligrams) and percent daily value (%DV) of total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, dietary fiber, sugar, protein, and
- the percent daily value (%DV) of vitamin A, vitamin C, calcium, and iron.
- Other nutrition information is included voluntarily
- Formats are standardized and specific
- Nutrition label is required on most, but not on all, products; examples of exceptions:
- individual items such as candy bars from a box -- nutrition information is on box, individual items labeled as "not for sale as individual items;" individually selling items labeled in this manner violates the labeling law
- wholesale containers -- nutrition information must be provided to purchaser by another means such as a flyer
- container is too small to include all nutritional information (such as individual sugar packet) -- include as much information as possible
- Statement of ingredients
- Name and address of manufacturer, packer, or distributor
- Information on this panel cannot be interspersed with or separated by other information; the other information has to follow these three items. Exception may be to list/repeat certain ingredients (such as those that may cause allergic reaction) at end of ingredient list.
Advertisement panel(s) might include instructions/directions for product preparation, UPC label, warnings (such as hot when prepared or refrigerate after opening), quality guarantee statements, etc
Other Requirements for Labeling Food Products
- FDA does not pre-approve labels, however, FDA may offer suggestions if a processor inquires about a label the processor is developing. FDA will enforce the law after label is put in use. USDA requires a label to be pre-approved. Accordingly, the steps a processor will take in developing and beginning to use a label depends on whether the product is regulated by FDA or USDA.
The laws broad prohibition against misbranding not only encompasses the product label, but also the product's advertising. A misleading advertising claims would cause the product to be "misbranded." FDA and Federal Trade Commission (FTC) collaborate in regulating food advertising. Although FTC has primary responsible, it relies on FDA standards, especially FDA labeling standards to define food advertising standards. For example, "to prevent deceptive or misleading claims, food advertising will now be held to the same standards as food labeling..." (see Enforcement Policy Statement on
Food Advertising ).
Issues relating to food advetising appear to arise most frequently with respect to health claims.
- FTC regulates advertising of certain foods 21 U.S.C. §378
- Improper advertising can lead to "misbranding"
- FDA is required to notified Federal Trade Commission (FTC) of any enforcement action FDA is contemplating as a result of "misbranding due to advertising;" if FTC takes action against the alleged misbranding, FDA is prohibited from also taking action.
The regulatory scheme requires food businesses to maintain records; this allows regulatory agencies to review practices; it also allows the movement of food to be traced so the source and potential scope of a food-related problem can be identified and addressed.
- When a food related problem is recognized, the questions become what is the source of the problem, what other foods might be a problem, where are those foods and what can be done to prevent others from consuming food that may be a problem?
- Mandates certain records be kept and be accessible to FDA; see 21 U.S.C. §331(e) and 21 U.S.C. §350c(a).
- Records of interstate shipments 21 U.S.C. §373
- "carriers engaged in interstate commerce, and persons receiving food ... in interstate commerce or holding such articles ... [must maintain and provide, when requested,] ... records showing the movement ... of food ... or the holding thereof ... and the quantity, shipper, and consignee thereof;"
- Also "traceability records"
- The Bioterrorism Act of 2002 requires that persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import food maintain records for two years to identify the immediate previous sources and immediate subsequent recipients of food, including its packaging, in order to address credible threats of serious adverse health consequences or death to humans or animals. Based on
" Establishment and Maintenance of Records"; see 21 U.S.C §350c(b).
- Also, recall the records required for businesses implementing HACCp plans (see 21 CFR 120.12).
FDA is responsible for inspecting food processing business; however, but much of this responsibility has been shifted to state agencies. Frequently in those situations, FDA has entered into an agreement with the state agency whereby the agency conducts the inspections on behalf of FDA. This arrangement is convenient for FDA which would struggle to have enough inspectors to cover the entire nation. The states generally want to inspect the businesses within their jurisdiction, so one government inspection that meets both federal and state expectations appears logical. States are expected to adhere to standards comparable to FDA and this is often clarified in the interagency agreement. This collaborative arrangement is further accommodated by the state adopting statutes and regulations that reflect federal law (e.g., see North Dakota's law), and by FDA offering guidance to the states (see FDA Inspection Guide). FDA will probably conduct an inspection when a problem arises, but generally rely on the state agencies to conduct the periodic inspections.
Authority for inspecting the food businesses arises from federal statutory law, see 21 U.S.C §374.
- An inspection can be conducted during normal business hours.
- The inspector must identify him or herself.
- An inspection can involve walking through the plant, a review of the appropriate business records, and other activities needed for the inspector to complete the task.
- A written report of the inspection must be left at the end of the inspection.
- Any product samples taken must be documented with a reciept.
Meat, Poultry and Egg Products -- FDA is not responsible for inspecting meat, poultry and egg products. Instead, Congress has mandated that USDA (FSIS) continuously inspect the operation of these processing facilities; the processing plant cannot operate if the inspector is not in place. Any product produced while an inspector is not available is considered adulterated. USDA can force a plant to cease operation by withdrawing its inspectors if there is a problem that is not being resolved.
This federal mandate requires that each product be inspected; that is, USDA is required to inspect each animal before slaughter and the meat products after slaughter.
- To manage this task, USDA works with states that are willing to establish a state inspection program that implements the federal standards.
Dealing with an out-of-compliance food product
The first response when a problem with a food product is detected is to remove the product from the food system so it will not be consumed.
- If the food is still under the manufacturer’s control, such as in a warehouse, the strategy is referred to as a “stock recovery.”
- “Stock recovery means a firm's removal or correction of a product that has not been marketed or that has not left the direct control of the firm, i.e., the product is located on premises owned by, or under the control of, the firm and no portion of the lot has been released for sale or use.” 21 CFR 7.3(k)
- A “market withdrawal” is used for insignificant violation for food that is already distributed.
- “Market withdrawal means a firm's removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the Food and Drug Administration or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc.” 21 CFR 7.3(j)
- A “recall” is used to remove products from the market that may be hazardous to public health.
- Recall means a firm's removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery. 21 CFR 7.3(g)
- If a business determines that a recall is needed, the appropriate agency (FSIS, FDA, or in some states, a state agency) must be notified (see 21 CFR 7.46).
- The business initiates the recall; the agency monitors the recall and determines whether the recall has been effective. Only the federal agency (FDA or FSIS) can terminate a recall (see 21 CFR 7.55).
- Federal agencies cannot initiate a recall; thus recalls are described as voluntary (see FSIS Fact Sheet - Food Recalls and FDA Industry Guidance: Recalls).
- In some states, the state regulatory agency may have authority to mandate a recall.
- In the case of infant-formula, FDA has the authority to recall the product, but this is a limited exception (see 21 CFR 107.200).
- If a recall is initiated, the agency will assess the situation and classify the recall –
- Class I – use will cause serious adverse health consequences
- Class II – may cause temporary or medically reversible health effects
- Class III – not likely to cause any health problems, usually product quality issue
(1) Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
(2) Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
(3) Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 21 CFR 7.3(m)
- Consumers are notified of recall through media announcements (21 CFR 7.50).
- Inform the public that a product has been recalled. Again, the goal is to reduce the risk that an unsafe product is consumed. Informing the public is one way to assist consumers in understanding whether they are at risk of consuming an unsafe product. Public announcements via the mass media. Also see
Guidelines for Implementing a Recall
- FDA recall regulations are located at 21 CFR part 7; see 9 CFR §318.311 and 9 CFR §381.311 for FSIS recall regulations. Note, FDA regulations are the dominant rules for handling a recall.
- FDA prefers that firms recall their product rather than have FDA initiate legal actions, especially court actions. A firm can decide whether to recall a product; in urgent situations, FDA may request a recall, but will not mandate a recall. See 21 CFR 7.40
- After a recall is initiated, the agency will review the business’s recall strategy. “Recall strategy means a planned specific course of action to be taken in conducting a specific recall, which addresses the depth of recall, need for public warnings, and extent of effectiveness checks for the recall.” 21 CFR 7.42
- The firm also is required to report its progress with the recall to the agency 21 CFR 7.53
- Only FDA or USDA can terminate a recall (see 21 CFR 7.55).
General Industry Guidance
- Food businesses will want to develop a written recall plan because if a problem arises, there will be limited time in which to develop a plan, therefore the business should have a recall plan in place.
- Businesses are urged to have a product code system with to trace their products; such a system facilitates a recall.
- The system would track the date and time when product was manufactured, the line on which it was manufactured, where and how the product was distributed.
- The firms are required to maintain records of all products distributed and sold. This also is helpful if a recall is necessary.
- See Recalls and Market Withdrawals - Background and Definitions
If the problem is not resolved
- If a non-complying product is not recalled or the recall has not been effective, the agency will take its next step of enforcement.
- FDA enforcement authorities include injunctions, penalties, and seizures 21 U.S.C. §§332, 333, 334. FDA enforcement regulations are found at 21 CFR part 7. FSIS enforcement regulations are found at 9 CFR part 329 and §381.216.
- FDA can administratively detain the product.
- The FDA can initiate a court action in which the court will order that the product is seized, its distribution is enjoined, or the company is penalized.
Infant Formula 21 U.S.C. §350a
- Highly regulated food
- "An infant formula, including an infant formula powder, shall be deemed to be adulterated if such infant formula does not provide nutrients as required ..., such infant formula does not meet the quality factor requirements ..., or the processing of such infant formula is not in compliance with the good manufacturing practices and the quality control procedures..."
- 21 CFR 107 (Infant Formula) and 21 CFR 106 (Infant Formula quality control procedures)
- FDA's authority to recall infant formula (21 CFR 107.200 et. seq.)
Low-Acid Canned Foods and Acidified Foods
Oleomargarine 21 U.S.C. §347
- Product that led to some of the early food laws; arose over dairy industry concern about margarine and its competition with butter.
- "No person shall sell, or offer for sale, colored oleomargarine or colored margarine unless (1) such oleomargarine or margarine is packaged, (2) the net weight of the contents of any package sold in a retail establishment is one pound or less, (3) there appears on the label of the package (A) the word ''oleomargarine'' or ''margarine'' in type or lettering at least as large as any other type or lettering on such label, and (B) a full and accurate statement of all the ingredients contained in such oleomargarine or margarine, and (4) each part of the contents of the package is contained in a wrapper which bears the word ''oleomargarine'' or ''margarine'' in type or lettering not smaller than 20-point type."
Seafood inspection 21 U.S.C. §376
- "The Secretary, upon application of any packer of any sea food for shipment or sale within the jurisdiction of this chapter, may, at his discretion, designate inspectors to examine and inspect such food and the production, packing, and labeling thereof. If on such examination and inspection compliance is found with the provisions of this chapter and regulations promulgated thereunder, the applicant shall be authorized or required to mark the food as provided by regulation to show such compliance. Services under this section shall be rendered only upon payment by the applicant of fees fixed by regulation in such amounts as may be necessary to provide, equip, and maintain an adequate and efficient inspection service."
- 21 CFR 123
- Requires HACCP plan
- Organic food productin is regulated by USDA
- Agricultural products labeled as organic must originate from farms or handling operations certified by a state or private entity as organic. In order to be a certifying entity, it must be accredited by USDA. This approach prevents USDA from having to maintain a staff adeqaute to certify all organic production. Instead, USDA accredits entities that can then perform the certification process for producers.
- To be accredited, the certifying agency must
- have sufficient experience and training in organic production and handling to carry out certification activities.
- demonstrate an ability to certify organic producers and/or handlers; maintain proper records; adequately communicate with producers, handlers, and the public; and communicate with USDA about decisions made.
- prevent conflicts of interest and maintain strict confidentiality.
- conduct annual performance appraisals of their employees involved in the certification process, and have an annual program evaluation of their certification activities.
- To have a product certified as organic, the producer/handler must demonstrate that the production practices meet the national standards.
USDA’s National Organic Program -- Background Information
- In the US, the research and development of agricultural commodities containing a genetically modified organism (GMO) is the primary focus of the regulation; FDA, APHIS (USDA), and EPA are each involved in this regulatory scheme.
- Food produced from GMO ag commodity does not require special labeling in the US, but they do in Europe.
- Dietary Supplements (an FDA web page)
- Congress defines dietary supplements as food and thus they are not regulated as a drug
- The Proxmire Amendment (21 U.S.C. §350) prohibits FDA from specifying "maximum limits on the potency of any synthetic or natural vitamin or mineral within a food"
- Dietary Supplement Act of 1992 exempted dietary supplements from nutritional labeling requirements
- Dietary Supplement Health and Education Act of 1994
- A new set of rules
- Dietary ingredients in a supplement
- Safety of dietary ingredients
- Labeling and claims
- Expiration date
- Dietary supplements are not food additives (thus not subject to Delaney clause)
- “New dietary ingredients” – not chemically altered, used without prior FDA clearance
- Bottom line -- dietary supplements are not as regulated as a drug or as a food additive
- Limited regulation of food to be exported; the activity is primarily to certify to importer that the exporting business is subject to the US laws.
- Market incentives between the importer and the exporting business probably have the greater influence on the exporter’s activities.
Exporting Food Products from the United States
- Excerpts from FDA-Issued/Supported Export Certificates for Foods
FDA's long-established role in the U.S. government has been that of a domestic public health agency charged with protection of the health and economic interests of American consumers with regard to the safety and labeling of foods … Consequently, FDA has not participated actively in this "export trade" environment. However, foreign governments … are increasingly looking to FDA, as the "national competent authority" for FDA-regulated products, to ensure that products imported into their countries from the United States meet specific requirements. Thus, recently FDA has become increasingly and substantively involved in attesting to the safety and quality of U.S.-produced, FDA-regulated products exported to other countries.
Agencies of the Department of Agriculture (USDA) with responsibilities for food safety and quality and for other food-related issues are currently authorized, in some circumstances, to collect fees associated with issuance of export certificates for designated agricultural products, including foods. The Food Safety and Inspection Service (FSIS) has authority to … issue export certificates for foods under its authority -- meat, poultry, processed egg products -- when a foreign government's requirements are different than those covered by U.S. regulations. The Animal and Plant Health Inspection Service (APHIS) [issues] …food-related export certificates pertaining to plant and animal health issues. The Agricultural Marketing Service (AMS) has … authority for food export certificates for issues relevant to product quality and to certain food safety attributes. The Grain Inspection, Packers and Stockyard Administration (GIPSA) [issues] … export certificates for various aspects of grain safety and quality.
The National Marine Fisheries Service (NMFS) of the National Oceanic and Atmospheric Administration (NOAA), Department of Commerce is authorized to [issue] … export certificates for fish and fishery products under its Seafood Inspection Program (SIP). FDA, as the principal federal agency in the United States responsible for seafood safety, is also requested by the U.S. seafood industry and foreign governments to attest to the safety of U.S. harvested/produced seafood and to issue export certificates. FDA issues such certificates on a discretionary basis…
Certificates for Export [attest] … that the particular products are produced and marketed in the United States in general conformity with U.S. requirements.
… [A]ny FDA-issued export certificates for foods … will attest to compliance of the particular product and manufacturer with relevant U.S. regulations. FDA does not intend to provide export certificates for foods that attest to compliance with other countries' regulations.
The next section overviews
Directing Other Sectors of the Food Industry.
November 17, 2010