Food and Drug Administration (FDA)

Under the Federal Food, Drug and Cosmetic Act, (FFDCA) the Food and Drug Administration
(FDA) protects consumers against impure, unsafe, and fraudulently labeled food. The FDA has
inspection authority over any food in interstate commerce except for products regulated by the
USDA Food Safety and Inspection Service (FSIS).

Products that are regulated by the USDA FSIS include meat, poultry, and egg products. Initially,
both FSIS and FDA were part of the US Department of Agriculture. However, in 1940 the FDA
was transferred out of the USDA. It is now part of the Department of Health and Human
Services.

The mission of both the FDA and the FSIS is to ensure national food safety. The FDA requires
that all food come from an “approved source and process.” The most common approved sources
include licensed food establishments, federally inspected meat plants, and state-inspected meat
plants.

The two agencies share statutory authority in a few instances. They both share authority in regard
to egg safety because FSIS is in charge of inspecting plants processing liquid, frozen, and dried
egg products, while FDA monitors fresh eggs. They both share authority for food additives used
in meat, poultry, and egg products. All new additives are initially evaluated for safety by the
FDA. However, the FSIS has the authority to enact different regulations than the FDA with
regard to the food additives allowed in the products under their jurisdiction. For example,
although the FDA considers ascorbic acid to be an approved food additive, the FSIS denied
permission to use it as an additive in meat salads because of fears that such usage would mask
meat spoilage by organisms causing food borne illnesses.

In addition, the 1958 Food Additives Amendment to the FFDCA permitted FSIS to continue to
permit use of nitrites and nitrates in amenable meat products even though the FDA does not
permit their use in other food products. The FDA does not allow the use of nitrite or nitrates in
food products; therefore, all meat food products must be manufactured under USDA FSIS
inspection. In March of 2006, FSIS issued notice 15-06 clarifying the use of nitrates in non
amenable meat products. (More on this in a later section.)

Meat products for use in pet foods fall under the jurisdiction of the FDA, which is also
responsible for ensuring the safety of medicines, cosmetics, animal feed, and drugs for pets and
farm animals.

The FDA also ensures that products are labeled truthfully with the information that people need
to use them properly.

The regulations require FDA inspection of the facilities and processes involved in slaughtering
of non-amenable species (if not already inspected by another party) and the processing of food,
including amenable and non-amenable meat and poultry products. According to the FDA the
source and process, not the animal itself, must be inspected and approved. FDA inspections are
usually done once a year. If a facility is involved only in processing, then the FDA requires that
all ingredients come from an “approved source and process.” Approved sources of meat and
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poultry are those that come from a licensed food establishment, a federally inspected meat plant,
or a state-inspected meat plant.

If a company is found violating any of the laws that FDA enforces, then the FDA can encourage
the firm to correct voluntarily the problem or to recall the product from the market. A recall is
generally the fastest and most effective way to protect the public from an unsafe product. When a
company can’t or won’t correct a public health problem voluntarily, FDA can enact legal
sanctions.

1. Food Safety Modernization Act

FDA’s approach to regulating companies in food safety matters was significantly altered by the
Food Safety Modernization Act (FSMA), which amended the FFDCA (Federal Food Drug and
Cosmetic Act) and was enacted in 2011. FSMA’s intent is to significantly increase the food
system’s focus on preventing contamination as opposed to responding to contamination. After
FSMA was enacted, the FDA published several rules in order to implement FSMA. These rules
were then codified as regulations.

FSMA and the regulations enacted under FSMA do not dramatically affect farmers
involved in direct marketing their meat and poultry, unless those same farmers are also
growing produce covered by the legislation. This resource guide will only discuss aspects of
FSMA that apply to businesses defined by the FDA as “small businesses” and “very small
businesses.” The FDA defines “small businesses” as “businesses employing fewer than 500 full
time equivalent employees,” and it defines a “very small business” as “business…that averages
less than $1 million per year during the three-year period preceding the applicable calendar year
in sales of human food plus the market value of human food manufactured, processed, packed or
held without sale.”58 Information on how FSMA and its regulations apply to small businesses
and very small businesses involved in direct marketing meat and poultry is found in the relevant
sections in this resource guide.

For more information on FSMA, see the FDA’s website on the Act. This website contains
numerous helpful links and resources. The website is Food Safety Modernization Act
(FSMA), FDA, https://www.fda.gov/food/guidance-regulation-food-and-dietary
supplements/food-safety-modernization-act-fsma. Note that the FDA’s website also
contains numerous guidances for industry about FSMA. These can be found at FSMA
Rules & Guidance for Industry, FDA, https://www.fda.gov/food/food-safety
modernization-act-fsma/fsma-rules-guidance-industry#Guidance.

For a helpful overview of FSMA and how it applies to meat processors, see Dr. Michele
Pfannenstiel, Dirigo Food Safety, Food Safety and Modernization Act: How Might It
Apply to Meat Processors? Fact Sheet Version 2.7.2017,
http://www.nichemeatprocessing.org/wp
content/uploads/2017/02/FSMASheetv2.7.17.docx1_.pdf

Although the Act was enacted in 2011, the Act established compliance dates in the future. The
dates by which small businesses and very small businesses need to comply with regulations
enacted under FSMA are generally between 2017 and 2020.

For more information on when businesses need to comply with FSMA regulations, see
FSMA Compliance Dates, FDA (last updated May 6, 2019),
https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-compliance-dates.