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Rules for Specific Foods

Issues (often serious issues) have arisen for several food products in the past.  As a consequence, Congress responded with unique laws to address specific food safety problems.  This page reviews several of these specific food laws.  FDA usually was given responsibility of administering these unique provisions.

FDA Requirements for ... Acidified & Low-Acid Canned Foods

The following paragraphs are excerpts from NSW Food Authority, "Shelf stable acid preserved foods -- Factors affecting the shelf stability of acid foods -- Condiments, sauces and salad dressings", NSW/FA/FI035/0811.  They provide some background information as to why low-acid canned foods have specific regulations.

"Thermally processed acid foods have a good record of food safety and shelf stability... Products that have the right combination of low pH, adequate levels of acetic acid, salt and sugars can be filled without a thermal process and still be safe and stable... However, if products are not properly formulated there can be risks to food safety or shelf stability. In particular poorly acidified foods can lead to botulism and cold filled products with inadequate acetic acid can spoil.

"Most foods on supermarket dry-grocery shelves are shelf stable products. Some foods such as dry pasta and rice are intrinsically shelf stable.

"Other foods rely on a range of technologies to ensure shelf stability. These include the elimination of microorganisms capable of growing in the food system by retorting or UHT processing or by adjusting the environment in the food so that it is not suitable for the growth of microorganisms. Control of water availability, pH reduction, the use of organic acids or preservatives and heat shocks are common methods to inhibit microbial growth.

"Acid and acidified foods are well represented on the supermarket shelf. The determinants of food safety and shelf stability are long established. However, the US Food and Drug Administration (FDA, undated) lists a history of botulism attributed to inadequately acidified foods and notes that products processed by 29 firms were found to be inadequately acidified. [Botulism is caused by the anaerobic, spore-forming microorganism Clostridium botulinum. Although outbreaks of botulism are extremely rare, the consequences can be lifethreatening.]"

End of excerpts

The following paragraph is an excerpt from FDA "Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods".

"Improperly processed low-acid canned foods or acidified foods present life-threatening hazards; therefore registration of those establishments which manufacture, process, or pack low-acid canned foods or acidified foods and filing of the processes they use are necessary to identify processors and to monitor compliance with the regulations, to provide for immediate application of emergency permit control should a potential public health hazard be identified."

• See 21 CFR Parts 108, 113 and 114
• Also see Process Filing for Aseptic Packaging Systems (Form FDA 2541C)

[edited] "The purpose of FDA's requirements for registration, manufacturing, and process filing of low-acid canned foods and acidified foods in hermetically sealed containers is to ensure safety from harmful bacteria or their toxins, especially the deadly Clostridium botulinum (C botulinum). [Ensuring the safety] can only be accomplished by adequate processing, controls, and appropriate processing methods, such as cooking the food at the proper temperature for sufficient times, adequately acidifying the food, or controlling water activity." Taken from FDA web site that is no longer available.

• "(n) Low-acid foods means any foods, other than alcoholic beverages, with a finished equilibrium pH greater than 4.6 and a water activity (aw) greater than 0.85. Tomatoes and tomato products having a finished equilibrium pH less than 4.7 are not classed as low-acid foods." see 21 CFR §113.3.
• "(b) Acidified foods means low-acid foods to which acid(s) or acid food(s) are added; these foods include, but are not limited to, beans, cucumbers, cabbage, artichokes, cauliflower, puddings, peppers, tropical fruits, and fish, singly or in any combination. They have a water activity (aw) greater than 0.85 and have a finished equilibrium pH of 4.6 or below. These foods may be called, or may purport to be, "pickles'' or "pickled" ..." see 21 CFR §114.3.

• Inspection guides
  • Low Acid Canned Food Manufacturers Part 1 - Adminstrative Procedures/Scheduled Processes
  • Low Acid Canned Food Manufacturers Part 2 - Processes/Procedures
  • Low Acid Canned Food Manufacturers Part 3 - Container/Closures (11/98)
  • Acidified Food Manufacturers
  • Aseptic Processing and Packaging for the Food Industry

• Some background information is available in Botulism in the United States, 1899-1996, Center for Disease Control and Prevention.  See pp. 8-10 of the pdf file.

... Infant Formula

• "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..."

  See 21 U.S.C. §350a

• "All manufacturers of infant formula must begin with safe food ingredients, which are either generally recognized as safe (GRAS) or approved as food additives for use in infant formula. Once an infant formula product is formulated, current laws require that the manufacturer must provide FDA assurance of the nutritional quality of that particular formulation before marketing the infant formula. FDA has provisions that include requirements for certain labeling, nutrient content, manufacturers quality control procedures (to assure the nutrient content of infant formulas), as well as company records and reports."

  See 21 CFR 107 (Infant Formula) and 21 CFR 106 (Infant Formula quality control procedures)

  FDA Guidance & Regulatory Information for infant formula

• Two unique features of the infant formula law:
  • Regulatory oversight includes nutrient content; not just safety concerns.  The focus on nutrient content reflects the international concern at that time that infant formula was not providing the nutrition needed by infants and that infants around the world were being malnourished.  This link provides some additional information.
  • FDA is authorized to mandate a recall of unsafe infant formula (21 CFR 107.200 et. seq.).

… Seafood

• "FDA operates a mandatory safety program for all fish and fishery products..." 

• "FDA's ... regulations (21 CFR 123) ... require processors of fish and fishery products to develop and implement Hazard Analysis Critical Control Point (HACCP) systems for their operations."

• See FDA's Fish and Fisheries Products Hazards and Controls Guidance; additional guides and background information is available at Seafood: Guidance for Industry and Seafood Regulations & Guidance.
• Also see National Marine Fisheries Service (NOAA Fisheries)

"The FDA operates an oversight compliance program for fishery products under which responsibility for the product's safety, wholesomeness, identity and economic integrity rests with the processor or importer, who must comply with regulations promulgated under the Federal Food, Drug and Cosmetic (FD&C) Act, as amended, and the Fair Packaging and Labeling Act (FPLA). In addition, FDA operates the Low-Acid Canned Food (LACF) program which is based on the Hazard Analysis Critical Control Point (HACCP) concept, and is focused on thermally processed, commercially sterile foods, including seafood such as canned tuna and salmon. Most FDA in-plant inspections consider product safety, plant/food hygiene and economic fraud issues..."  excerpt from a previous web page

... Juice

"All juice (as defined in 21 CFR 120.1(a)) sold as juice or for use as an ingredient in other beverages is subject to the requirements of the juice HACCP regulation, with the exception of juice produced at a retail establishment ..." excerpt from Guidance for Industry: Juice HACCP Hazards and Controls...

• See 21 CFR 120
• Also see Juice HACCP and Guidance Documents (e.g., 2001, 2003, 2004, 2005, 2007)
• For a summary of discussions that led to these regulations, see NACMCF Recommendations on Fresh Juice.

... Fresh-Cut Fruits and Vegetables

"The overarching goal of FDA's Action Plan is to minimize the incidence of foodborne illness associated with the consumption of fresh produce. To achieve this goal, the Action Plan has four general objectives: 1) Prevent Contamination of Fresh Produce with Pathogens; 2) Minimize the Public Health Impact When Contamination of Fresh Produce Occurs; 3) Improve Communication with Producers, Preparers, and Consumers about Fresh Produce; and 4) Facilitate and Support Research Relevant to Fresh Produce. For each objective, FDA's Action Plan identifies steps that could contribute to the achievement of the objective.

"FDA believes that the most effective strategy for reducing foodborne illness from fresh produce is one that approaches the problem from several different angles. For this reason, the Action Plan anticipates that FDA's food safety partners in both the public and private sectors will participate in the identified activities. By working both independently and cooperatively, these agencies or groups will ensure maximum progress toward the goal of reducing the incidence of foodborne illness associated with the consumption of fresh produce."

excerpt from Produce Safety From Production to Consumption: 2004 Action Plan to Minimize Foodborne Illness Associated with Fresh Produce Consumption

• FDA activities on produce safety (tomato, leafy greens, lettuce, coordinating with USDA, produce safety action plan, etc)
• Guidance documents for sprouts

… Dietary Supplements

• "FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products..."
• Overview of Dietary Supplements (an FDA web page with frequently asked questions about dietary supplements; appears to be a good place to start your reading on this topic)
• "A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders... [Dietary Supplement Health and Education Act of 1994 ] places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement."
• Congress defines dietary supplements as food and thus they are not regulated as a drug
• 21 USC 321(ff)
• 21 USC 342(f) and (g)
• 21 CFR Part 190
• "... the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading."
• Vitamins and minerals 21 U.S.C. §350; this section encompasses dietary supplements.

[edited] "A dietary supplement is a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or a concentrate, metabolite, constituent or extract."

[edited] "A new dietary ingredient is a dietary ingredient that was not sold in the U.S. in a dietary supplement before October 15, 1994. A manufacturer or distributor must notify FDA if the business intends to market a dietary supplement in the U.S. that contains a new dietary ingredient. The manufacturer (and distributor) must demonstrate to FDA why the ingredient is reasonably expected to be safe for use in a dietary supplement, unless it has been recognized as a food substance and is present in the food supply." "There is no authoritative list of dietary ingredients that were marketed before October 15, 1994. Therefore, manufacturers and distributors are responsible for determining if a dietary ingredient is "new", and if it is not, for documenting that the dietary supplements its sells, containing the dietary ingredient, were marketed before October 15, 1994."

• The Proxmire Amendment (Sec. 411 FDCA, codified at 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"
• "...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

• Labeling -- A Dietary Supplement Labeling Guide
  • Five statements are required on the package of a dietary supplement: 1) the statement of identity (name of the dietary supplement), 2) the net quantity of contents statement (amount of the dietary supplement), 3) the nutrition labeling, 4) the ingredient list, and 5) the name and place of business of the manufacturer, packer, or distributor.
  • The statement of identity and the net quantity of contents statement must appear on the principal display panel.
  • The information panel must contain the "Supplement Facts" panel, the ingredient list, and the name and place of business of the manufacturer, packer, or distributor if such information does not appear on the principal display panel.
  • The "Supplement Facts" panel is used on dietary supplements in place of the nutrient label that is required for food products.  The major differences between "Supplement Facts" panel and "Nutrition Facts" panel are
    • A supplement facts panel must list dietary ingredients without RDIs or DRVs.
    • A supplement facts panel may list the source of a dietary ingredient.
    • A dietary ingredient does not have to be listed in the ingredient statement for dietary supplements if it is listed in the supplement facts panel.
    • The part of the plant from which a dietary ingredient is derived must be listed in the supplement facts panel.
    • "Zero" amounts of nutrients are not allowed in the supplement facts panel for dietary supplements.

USDA Requirements for … Organic food

-- see organic commodities; discussed as part of commodity production and labeling.  Organic foods are generally addressed by USDA, rather than FDA.

Review USDA National Organic Program

See 7 CFR 205

The USDA accredits private businesses, organizations, and state agencies to certify producers and handlers of agricultural products according to the NOP regulations.

Certification is the process where a producer or handler is approved by an Accredited Certifying Agent as being in compliance with the NOP regulations and is then authorized to sell, label, or represent products as being “certified organic”.

Organic Labeling and Marketing Information: 

• Agricultural Products labeled as “100 percent organic” must contain (excluding water and salt) only organically produced ingredients and processing aids.  Agricultural Products labeled “organic” must consist of at least 95 percent organically produced ingredients (excluding water and salt).
• Processed products that contain at least 70 percent organic ingredients can use the phrase “made with organic ingredients” and list up to three of the organic ingredients or food groups on the principal display panel. Processed products that contain less than 70 percent organic ingredients cannot use the term organic anywhere on the principal display panel. However, they may identify the specific ingredients that are organically produced on the ingredients statement on the information panel.
• The information panel of any product labeled as organic must
  • identify each organically produced ingredient in the ingredient statement, and
  • provide the name and address of the certifying agent of the final product.

The National Organic Standards Board’s main mission is to make recommendations about whether a substance should be allowed or prohibited in organic production or handling, and to assist in the development of standards for substances to be used in organic production.

US regulation of biotechnology/GMO

"Responsibility for implementing the coordinated framework fell primarily to three agencies: USDA, the Environmental Protection Agency (EPA), and FDA. Within USDA, the Animal and Plant Health Inspection Service (APHIS) bears the main responsibility for assessing the environmental safety of GM crops. The primary focus of APHIS' review is to determine whether or not a plant produced through biotechnology has the potential to harm natural habitats or agriculture. Developers can petition APHIS to exempt a GM plant from regulation once sufficient and appropriate data have been collected regarding the potential environmental impact of a GM plant.

APHIS' Role in Biotechnology (USDA)

"APHIS regulates the introduction (importation, interstate movement, or environmental release) of certain genetically engineered (GE) organisms. All regulated introductions of GE organisms must be authorized by APHIS under either its permitting or notification procedures. 

"When a developer has collected enough evidence that a GE organism poses no more of a plant pest risk than an equivalent non-GE organism, the developer may petition APHIS to grant the GE organism non-regulated status. If the petition is approved by APHIS, the GE organism may then be introduced into the United States without any further APHIS regulatory oversight."  excerpt from Permits, Notifications, and Petitions

"To safeguard the environment and human health, EPA is responsible for regulating genetic modifications in plants that protect them from insects, bacteria, and viruses. These protectants are subject to the agency's regulations on the sale, distribution, and use of pesticides. EPA must review and grant a permit for field-testing plants with such protectants on more than 10 acres of land. Prior to commercialization of a GM plant with such a protectant, EPA reviews the application for approval of the protectant, solicits public comments, and may seek the counsel of external scientific experts.

Biotechnology (EPA)

Also see Microbial Products of Biotechnology: Final Regulations Under the Toxic Substances Control Act Summary

"FDA has primary authority for the safety of most of the food supply. The Federal Food, Drug, and Cosmetic Act establishes the standard for food safety as food being in an unadulterated condition. FDA established its basic policy regarding the review of GM foods in its 1992 Policy on Foods Derived from New Plant Varieties. According to this policy, FDA relies on companies developing GM foods to voluntarily notify the agency before marketing the foods. Notification leads to a two-part consultation process between the agency and the company that initially involves discussions of relevant safety issues and subsequently the company's submission of a safety assessment report containing test data on the food in question. At the end of the consultation, FDA evaluates the data and may send a letter to the company stating that the agency has no further questions, indicating in effect that it sees no reason to prevent the company from marketing the GM food. In 1997, FDA supplemented its 1992 Policy with the current Guidance on Consultation Procedures, clarifying procedures for the initial and final consultations.

Plant Biotechnology for Food and Feed (FDA)

"It is the responsibility of the producer of a new food to evaluate the safety of the food and assure that the safety requirement of section 402(a)(1) of the act is met."

"In regulating foods and their byproducts derived from new plant varieties, FDA intends to use its food additive authority to the extent necessary to protect public health. Specifically, consistent with the statutory definition of "food additive" and the overall design of FDA's current food safety regulatory program, FDA will use section 409 of the act to require food additive petitions in cases where safety questions exist sufficient to warrant formal premarket review by FDA to ensure public health protection."

"... the agency does not believe that the method of development of a new plant variety (including the use of new techniques including recombinant DNA techniques) is normally material information within the meaning of 21 U.S.C. 321(n) and would not usually be required to be disclosed in labeling for the food."

Guidance to Industry for Foods Derived from New Plant Varieties

"In January 2001, FDA issued a proposed rule in the Federal Register that provides further information on these procedures and, more importantly, would require pre-market notification by companies. Among the reasons that FDA cited for this change are concerns expressed by consumers and public interest groups about the limited transparency and voluntary nature of the current process. FDA also pointed to the growing power of biotechnology to create potentially more complex safety issues that could require more stringent regulatory evaluations. FDA, tentatively, expects to finalize this rule as early as fiscal year 2003."

Excerpt from GENETICALLY MODIFIED FOODS Experts View Regimen of Safety Tests as Adequate, but FDA's Evaluation Process Could Be Enhanced

International response to GMOs in food

• FAO/WHO Food Safety Assessments of Foods Derived from Biotechnology
• FAO Statement on Biotechnology
• EUROPA Genetically modified food and feed
• EUROPA GMOs in the EU - Labeling

Summary of Key Points

• U.S. food law has a long history of evolving as new issues and concerns lead to political reaction.  This has certainly been the trend for U.S. federal food law.  This page introduced several U.S. federal food laws that address specific foods. Each of these laws has a history of events that caught national or international attention in the past 50 years.  Persons involved in the food industry need to recognize the application of the general or encompassing food laws may be altered by additional or divergent legal requirements for specific foods.

Last updated April 24, 2010

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