The FDA's Authority to Recall Products

The FDA’s Authority to Recall Products
Updated September 16, 2008
Vanessa K. Burrows
Legislative Attorney
American Law Division



The FDA’s Authority to Recall Products
Summary
The Food and Drug Administration (FDA) has fielded increasing numbers of
questions regarding recalls of unsafe imports, including jalapeño peppers, pet food,
the blood thinner heparin, and toothpaste. Additionally, several domestic food
products, from peanut butter contaminated with Salmonella to spinach linked to E.
coli 0157:H7 to canned meat products such as chili sauce spoiled by Clostridium
botulinum (botulism), have been voluntarily recalled by businesses in the last year.
Recalls may decrease consumer confidence in the recalling company, food imports,
or food safety agencies such as the FDA; products later subject to a recall may have
sickened or killed people or pets. While the FDA only has the authority to order
recalls of infant formula, medical devices, and human tissue products, the agency
may request that a company recall other products, such as food, drugs, and cosmetics.
This report provides an overview of the FDA’s statutory authority with regard to the
three types of products that it can recall, as well as FDA regulations for designating
the particular class of recall, publicizing and monitoring the effectiveness of recalls,
and carrying out recalls. Additionally, this report reviews the recall provisions in
legislation proposed in the 110th Congress, which would give the FDA authority to
require recalls of additional products.
The 110th Congress has shown significant interest in the issue of food safety.
Congress passed H.R. 3580, P.L. 110-85, the FDA Amendments Act of 2007
(FDAAA), which contains provisions addressing communications and information
postings during a food recall similar to those the Senate previously approved, by a
vote of 94-0, in Senator Durbin’s amendment to the FDA Revitalization Act (S.
1082/H.R. 2900). Several bills would grant the FDA the ability to order recalls of
food and other products. The Food and Drug Import Safety Act of 2007, H.R. 3610,
would grant the Secretary of Health and Human Services (HHS) the authority to
require food recalls. Representative Dingell’s draft of the Food and Drug
Administration Globalization Act of 2008 — posted for comment on the House
Energy and Commerce Committee website — would also grant the Secretary the
authority to require food recalls and, in addition, would grant the Secretary the same
authority for recalling drugs as the Secretary has for recalling devices. The Family
Smoking Prevention and Tobacco Control Act, S. 625/H.R. 1108, would provide the
Secretary with the authority to require recalls of tobacco products. Other bills that
would provide the FDA with recall authority include the FDA Food Safety
Modernization Act, S. 3385; the Human and Pet Food Safety Act of 2007, S.
1274/H.R. 2108; the Safe Food Act of 2007, S. 654/H.R. 1148; the Protect
Consumers Act of 2007, H.R. 2099; the Safe And Fair Enforcement and Recall for
(SAFER) Meat, Poultry, and Food Act of 2007, H.R. 3484; the Food and Product
Responsibility Act of 2007, S. 2081; the Consumer Food Safety Act of 2007, H.R.

3624; and the Food Import Safety Act of 2007, H.R. 3937.



Contents
Background ..................................................1
Mandatory Recall Authority: Supporting and Opposing Views..........2
Current Statutory Authority for Mandatory Recalls....................5
Infant Formula............................................6
Medical Devices...........................................6
Biological Products........................................7
Current FDA Regulations Regarding Voluntary Recalls................8
Industry-Initiated Recalls....................................8
FDA-Requested Recalls.....................................9
Classification of Recalls...................................10
Communication Regarding a Recall..........................11
Monitoring and Termination of a Recall.......................12
The FDA’s Pilot Program......................................13
Food and Drug Administration Amendments Act of 2007 (FDAAA)....13
Legislative Proposals to Grant the FDA Recall Authority .............13
Human and Pet Food Safety Act of 2007......................14
Food and Drug Administration Revitalization Act...............15
Safe Food Act of 2007.....................................15
FDA Food Safety Modernization Act.........................16
Protect Consumers Act of 2007..............................16
Food and Drug Import Safety Act of 2007.....................16
Food and Product Responsibility Act of 2007...................17
SAFER Meat, Poultry, and Food Act of 2007...................17
Consumer Food Safety Act of 2007...........................18
Food Import Safety Act of 2007.............................18
Draft of the Food and Drug Administration Globalization Act
of 2008.............................................19
Family Smoking Prevention and Tobacco Control Act............19



The FDA’s Authority to Recall Products
Background
The Food and Drug Administration (FDA) has fielded increasing numbers of
questions regarding recalls of unsafe imports, including jalapeño peppers, pet food,
the blood thinner heparin, and toothpaste. Additionally, several domestic food
products, from peanut butter contaminated with Salmonella to spinach linked to E.
coli 0157:H7 to canned meat products such as chili sauce spoiled by Clostridium
botulinum (botulism), have been recalled in the last year. A recall is “a firm’s
removal or correction of a marketed product that the [FDA] considers to be in
violation of the laws it administers and against which the agency would initiate legal
action, e.g., seizure.”1
Recalls may decrease consumer confidence in the recalling company, food
imports, or food safety agencies such as the FDA; products later subject to a recall
may have sickened or killed people or pets.2 Recalls of tainted or defective products
can be costly to the recalling company in terms of the costs of the recall, injury to
reputation, and exposure to liability via class action lawsuits and punitive damages.3
For example, pet owners filed suit against Menu Foods seeking “compensation for
veterinary care, medical monitoring and other expenses, damages for negligence and
breach of express and implied warranty and attorney fees and costs,” which


1 21 C.F.R. § 7.3(g). The definition of a recall “does not include a market withdrawal or a
stock recovery.” Id. A market withdrawal is “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
[FDA] or which involves no violation, e.g., normal stock rotation practices, routine
equipment adjustments and repairs.” 21 C.F.R. § 7.3(j). A stock recovery is “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 C.F.R. § 7.3(k).
2 More than 1,250 people were sickened in an outbreak linked to jalapeño peppers; 246
deaths of patients receiving heparin were reported to the FDA (though “[i]n the majority of
reports with a death outcome, there was not enough clinical information to assess the
relationship between death and use of heparin”); and reportedly about “1,950 cats and 2,200
dogs died from kidney failure from eating melamine-contaminated pet food.” Annys Shin,
Salmonella-Tainted Jalapeño Found in Texas, WASH. POST, July 22, 2008, at A1; FDA,
Information on Adverse Event Reports and Heparin, [http://www.fda.gov/cder/drug/
infopage/heparin/adverse_events.htm]; John Pacenti, Animal Owners Seek Class Action
Status in Suit Over Pet Food Additives, Law.com, June 10, 2008.
3 Michael T. Roberts, Mandatory Recall Authority: A Sensible and Minimalist Approach to
Improving Food Safety, 59:4 FOOD & DRUG L. J. 563, 568 (2004).

reportedly may settle for $24 million.4 The company began testing its pet food on
animals at the end of February 2007, “one week after it began hearing from owners
who said the food had made their pets ill.”5 However, the company did not contact
the FDA or begin a recall of more than 60 million containers of pet food until March

2007.6


While the FDA only has the authority to order recalls of infant formula, medical
devices, and human tissue products, the agency may request that a company
voluntarily recall other products, such as food, drugs, and cosmetics. Companies
typically recall tainted products voluntarily but this may not always be the case.7 For
this reason and others discussed below, supporters of stronger food safety laws have
argued that the FDA should be given statutory authority to mandate recalls of food
and other products.
This report provides an overview of the FDA’s statutory authority with regard
to the three types of products for which the agency can require recalls, as well as
FDA regulations for designating the particular class of recall, publicizing and
monitoring the effectiveness of recalls, and carrying out recalls. Additionally, this
report reviews the recall provisions in legislation proposed in the 110th Congress,
which would give the FDA authority to require recalls of additional products.
Mandatory Recall Authority: Supporting and Opposing Views
Representative Rosa DeLauro and others have reportedly asserted that the
current food safety system, which “relies on voluntary recalls[,] implicitly protects
industry before it protects public health.”8 As a result, some argue that the discovery


4 Lisa Brennan, Judge Seethes Over Direct Contact of Represented Parties in Pet Food
Case, N.J. Law Journal, June 4, 2007; Geoff Mulvihill, Recalled Pet Food Settlement Gets
Initial Approval, Law.com, June 2, 2008.
5 Katie Zezima, Tests by Pet Food Maker Killed 7 Animals Before Recall, N.Y. TIMES,
March 20, 2007, at A12.
6 Chuck Neubauer, FDA Officials Will Face Senate Inquiry on Pet Food, LA TIMES, April
8, 2007, at A18; Hearing on Pet Food Safety Before the Senate Subcommittee on
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies,

110th Cong. 6 (April 12, 2007) (statement of Duane Ekedahl, President, Pet Food Institute),


[http://appropriations.senate.gov/ hearings.cfm].
7 Center for Science in the Public Interest, Support H.R. 1612 and S. 908 — The Consumer
Food Safety Act of 1999, [http://www.cspinet.org/foodsafety/hr1612.html]. According to
this advocacy organization, “[i]n August 1997, FDA tried to recall Royal Line smoked
salmon contaminated with Listeria, a bacteria that causes serious illnesses and deaths. The
salmon, sold in plastic packages, was imported from Denmark. However, the salmon’s U.S.
distributor refused to cooperate in the recall, leaving American consumers at risk of food
poisoning from the product.” Id.
8 Veggie Booty Recall Grows, Prompting Criticism of Weak FDA, Inside Health Policy, July

6, 2007.



of the source of contaminated products may not immediately be identified.9 The
FDA has also been accused of failing to aggressively pursue investigations of
products that were later recalled.10 For example, lawsuits have been brought against
ConAgra Foods, Inc. by individuals who allegedly became sick, sometimes more
than once, because they ate peanut butter tainted with Salmonella. According to the
plaintiffs, ConAgra did not recall contaminated peanut butter from one plant until
February 2007, though the FDA “suspected that peanut butter manufactured by
ConAgra Foods under different brand names might have been contaminated with
salmonella” as early as 2005.11
Consumer rights groups seek new statutory authority that would allow the FDA
to mandate recalls of food and other products.12 However, the FDA’s Center for
Food Safety and Applied Nutrition has argued that “cooperation between FDA and
its regulated industries has proven over the years to be the quickest and most reliable
method to remove potentially dangerous products from the market.”13 According to
the agency, both the FDA and industry share an interest in removing unsafe and/or
defective products from the marketplace.14 An industry representative involved in
the pet food recall has also argued against additional regulation, saying that industry
“could have been a more valuable partner” in the recall process if it received access
to the same information as the FDA.15 According to the head of the Pet Food
Institute, which represents U.S. pet food manufacturers, the communication of such
information would have allowed the organization to “cross-reference . . . lot numbers,
shipping information, and other data.”16
Some have argued that in situations where the manufacturer of a product cannot
be determined — such as the case of tainted toothpaste found in discount stores,
prisons, hospitals, and luxury hotels — granting the FDA the ability to recall such


9 See id.
10 “A similar lack of aggressiveness on the part of FDA may have contributed to the peanut
butter contamination deaths and illnesses.” Diminished Capacity: Can the FDA Assure the
Safety and Security of the Nation’s Food Supply — Part 2: Hearing Before the H. Comm.
on Energy and Commerce, Subcomm. on Oversight and Investigations, 110th Cong. (July

17, 2007) (Staff Statement at p. 16), [http://energycommerce.house.gov/cmte_mtgs/


110-oi-hrg.071707.Staff-testimony.pdf], (hereinafter “Subcommittee Staff Statement”).


11 Marian Burros, Who’s Watching What We Eat?, N.Y. Times, May 16, 2007, at D1; R.
Robin McDonald, ConAgra Faces 39 Suits Over Bad Peanut Butter, Fulton County Daily
Report, August 13, 2007. A Centers for Disease Control and Prevention network that
monitors food-borne diseases observed a “slowly rising increase” in cases of a certain type
of Salmonella that were connected to one peanut butter plant. Id.
12 See Caroline Smith DeWaal, Director of Food Safety, Center for Science in the Public
Interest, Statement at the National Food Policy Conference (May 9, 2003), [http://www.
cspinet.org/ foodsafet y/ new_bioact.html ].
13 FDA, Center for Food Safety and Applied Nutrition, Industry Affairs Staff Brochure, FDA
Recall Policies (June 2002), [http://vm.cfsan.fda.gov/~lrd/recall2.html]. The FDA’s recall
policies are described in detail in this document.
14 Id.
15 Ekedahl, supra note 6, at 8-9.
16 Id. at 9.

products would expedite the process of removing adulterated articles from store
shelves.17 Such authority would enable the agency to take actions beyond issuing a
warning about a particular product.18 A 2004 Government Accountability Office
(GAO) report found that:
FDA do[es] not know how promptly and completely the recalling companies and
their distributors and other customers are carrying out recalls, and neither [the
FDA nor the U.S. Department of Agriculture (USDA)] is using its data systems
to effectively track and manage its recall programs. For these and other reasons,19
most recalled food is not recovered and therefore may be consumed.
According to GAO, the FDA may not be using the regulations on voluntary recalls
that the agency currently has in place to their maximum effectiveness.20 The staff of
the House Energy and Commerce Committee’s Subcommittee on Oversight and
Investigations has also remarked that the “FDA’s current regulatory approach, which
relies upon voluntary guidelines for most domestic and imported foods, appears
inadequate in responding to the changing food industry.”21
In addition, advocates for a single food safety agency argue that a single contact
point could save time and lives in the event of a food recall.22 As demonstrated by
the chili products recall due to the potential for botulism, more than one agency may
have jurisdiction over adulterated or contaminated food.23 In that situation, the FDA
website listed all the recalled product numbers but only included photos of the labels
for chili products that did not contain meat and pet food products involved in the
same recall. (The FDA has jurisdiction over pet food.) Consumers were directed to
the USDA Meat and Poultry Hotline website for products containing meat, over


17 Press Release, Senator Charles Schumer, Schumer Reveals: Chinese Product Dangers Go
Far Beyond Tires, Seafood and Toothpaste (July 1, 2007), [http://schumer.senate.gov/
SchumerWebsite/pressroom/record.cfm?id=278328]; see also FDA, Imported Toothpaste,
[ h t t p : / / www.f d a . go v/ oc / opa c o m/ hot t opi c s / t oot hpa s t e .ht ml ] .
18 See Veggie Booty, supra note 8.
19 GAO, Food Safety: USDA and FDA Need to Better Ensure Prompt and Complete Recalls
of Potentially Unsafe Food (October 2004), [http://www.gao.gov/new.items/d0551.pdf].
20 See id. at 13-16, 21-22.
21 Subcommittee Staff Statement, supra note 10, at 2.
22 The U.S. Government does have a single website dedicated to product recalls,
[http://www.recalls.gov]. However, this website apparently does not address the concerns
of supporters of a single food safety agency, such as two agencies — FDA and USDA —
maintaining jurisdiction over eggs in shell, processed, and liquid forms.
23 In 2004, the FDA found contaminated animal feed but did not report the contamination
to the USDA, which inspects livestock that consume such feed, or the state involved, which
has authority to prevent such meat from entering the market. The state seized and destroyed
the animals before the FDA even sent a warning letter to the feed mill. Government
Accountability Office (GAO), Mad Cow Disease: FDA’s Management of the Feed Ban Has
Improved, but Oversight Weaknesses Continue to Limit Program Effectiveness, 24
(February 2005), [http://www.gao.gov/new.items/d05101.pdf].

which the USDA has jurisdiction.24 The linked USDA webpage provides general
information, but does not provide information about the meat products recalled due
to being potentially contaminated with botulism.25 Some have argued that the lack
of complete information regarding the recall, as well as links to webpages not
specifically associated with the chili product recall, could result in consumers
overlooking relevant information and potentially consuming tainted products. The
Food Marketing Institute — a nonprofit association of retailers and wholesalers that
account for the majority of U.S. grocery store sales — and others have contended that
the creation of a single food safety agency would help in a food crisis, because the
“public is faced with a lengthy delay while overlapping bureaucracies creak into
some attempt at a coordinated response. While the search for who knew what and
when goes on, the crisis worsens and public confidence erodes.”26
Those opposed to the idea of combining FDA and USDA into a single food
safety agency assert that such a measure would distract the agencies involved from
their mission while the reorganization process occurs.27 They argue that “food
security would be compromised” and that overlap between agencies “is not as
significant [an issue] as many assume.”28 Furthermore, critics of a single food safety
agency point out that coordination between federal, state, and local government
agencies would still be required to address threats to the food supply.29
Current Statutory Authority for Mandatory Recalls
The FDA possesses mandatory recall authority only with regard to three
products: infant formula,30 medical devices,31 and biologic products.32 This section
provides an overview of the statutory authorities that exist for recalling these three


24 FDA, Chili Products (Botulism) Recall (Includes Canned Chili, Stew, Hash, BBQ, Gravy,
and Pet Food Products), [http://www.fda.gov/oc/opacom/hottopics/castleberry.html#meat].
25 USDA, Food Safety Education, USDA Meat & Poultry Hotline, [http://www.fsis.usda.
gov/Food_Safety_Education/USDA_Meat_&_Poultry_Hotline/index.asp]. A press release
found after clicking on several links in the USDA website details the chili products with
meat that were recalled. Press Release, USDA, Georgia Firm Expands Recall of Canned
Meat Products that may Contain Clostridium botulinum, [http://www.fsis.usda.gov/
News_&_Eve nts/Recall _033_2007_expanded/index.asp].
26 Timothy M. Hammonds, It is Time to Designate a Single Food Safety Agency, 59:3 FOOD
& DRUG L. J. 427, 428 (2004); see, e.g., Richard J. Durbin, Food Safety Oversight for the
21st Century: The Creation of a Single, Independent Federal Food Safety Agency, 59:3
FOOD & DRUG L. J. 383 (2004); Sandra B. Eskin, Putting All Your Eggs in One Basket: Egg
Safety and the Case for a Single Food-Safety Agency, 59:3 FOOD & DRUG L. J. 441 (2004).
27 Stuart M. Pape, Paul D. Rubin, & Heili Kim, Food Security Would be Compromised by
Combining the Food and Drug Administration and the U.S. Department of Agriculture Into
a Single Food Agency, 59:3 FOOD & DRUG L. J. 405, 406 (2004).
28 Id. at 405-06.
29 Id. at 406.
30 Federal Food, Drug, and Cosmetic Act (FFDCA) § 412(f).
31 FFDCA § 518(e).
32 Public Health Service Act § 351; 42 U.S.C. § 262.

products. The FDA is one of several agencies that comprise HHS. Therefore, the
Federal Food, Drug, and Cosmetic Act (FFDCA) provisions refer to the Secretary of
HHS, who, in turn, delegates authority to the FDA.
Infant Formula. The HHS Secretary has prescribed regulations for recalls of
infant formula “begun by a manufacturer,”33 which address the mandatory scope and
extent of infant formula recalls “necessary and appropriate for the degree of risks to
human health presented by the formula subject to the recall.”34 The regulations for
infant formula recalls are available at 21 C.F.R. Part 107, Subpart E, Infant Formula
Recalls, and state, in part, the following:
When the Food and Drug Administration determines that an adulterated or
misbranded infant formula presents a risk to human health, a manufacturer shall
immediately take all actions necessary to recall that formula, extending to and
including the retail level, consistent with the requirements of [21 C.F.R. Part 107,35
Subpart E].
The FFDCA states that the regulations must require manufacturers that begin an
infant formula recall “because of a risk to human health to request each retail
establishment at which such formula is sold or available for sale to post at the point
of purchase . . . a notice of such recall at such establishment for such time that the
Secretary determines necessary to inform the public of such recall.”36 The FFDCA
also requires manufacturers of infant formula to create and keep “records respecting
the distribution of infant formula through any establishment owned or operated by37
such manufacturer as may be necessary to effect and monitor recalls.” The
manufacturer must retain such records for “at least one year after the expiration of the38
shelf life of the infant formula,” and the Secretary may promulgate regulations
regarding recordkeeping if the Secretary determines that the required records “are not39
being made or maintained.”
Medical Devices. The FFDCA’s medical device recall authority provisions
place requirements on device manufacturers, importers, distributors, retailers, and
other “appropriate persons.” If the HHS Secretary “finds that there is a reasonable
probability that a device intended for human use would cause serious, adverse health
consequences or death,” then the Secretary must issue an order requiring “the
appropriate person” to (1) immediately stop distributing the device, (2) immediately
notify health professionals and device user facilities of the Secretary’s order, and


33 FFDCA § 412(f)(1).
34 FFDCA § 412(f)(2).
35 21 C.F.R. § 107.200.
36 FFDCA § 412(f)(3); see 21 C.F.R. § 107.230(d); see also 21 C.F.R. § 107.250.
37 FFDCA § 412(g)(1).
38 Id.
39 FFDCA § 412(g)(2).

(3) instruct health professionals and device user facilities to stop use of the device.40
Thus, the first step of the statute does not require a mandatory recall of a device for
which the Secretary makes the above determination.
However, the order may be amended to mandate a recall of such device. The
Secretary’s order must “provide the person subject to the order with an opportunity
for an informal hearing, to be held not later than 10 days after the date of the issuance
of the order, on the actions required by the order and on whether the order should be
amended to require a recall.”41 If the Secretary determines, after the informal
hearing, that the order should be amended as such, the Secretary must amend the
order to require the recall, set a timetable for the recall, and require periodic reports
describing the recall’s progress.42 The Secretary’s amended order must not include
a recall of the device from individuals and must not include a recall from device user
facilities “if the Secretary determines that the risk of recalling such device from the
facilities presents a greater health risk than the health risk of not recalling the device
from use.”43
Additionally, the Secretary’s amended order must provide “notice to individuals
subject to the risks associated with the use of such device.”44 To notify individuals
regarding the device, the statute provides that “the Secretary may use the assistance
of health professionals who prescribed or used such a device.”45 However, if “a
significant number” of individuals cannot be identified, the Secretary must notify
them via FFDCA § 705(b). That provision gives the Secretary the broad authority
to “cause to be disseminated information . . . in situations involving, in the opinion
of the Secretary, imminent danger to health, or gross deception of the consumer.”46
Recalling a device is only one of the methods that the Secretary may use to address
the risk it presents to the public health. The Secretary may also notify health
professionals who prescribe or use the device; order the manufacturer, importer, or
any distributor to submit a plan for repairing or replacing the device, or refunding all
or part of the purchase cost of the device; and may require the manufacturer,
importer, distributor, or retailer to reimburse, for expenses incurred in carrying out
the Secretary’s order, “any other person who is a manufacturer, importer, distributor,
or retailer.”47
Biological Products. For biological products such as blood, blood
components, and human tissue, the Secretary must issue an order immediately
requiring a recall of “a batch, lot, or other quantity of a product licensed under [42


40 FFDCA § 518(e)(1).
41 Id.
42 FFDCA § 518(e)(2)(A).
43 FFDCA § 518(e)(2)(B)(i).
44 FFDCA § 518(e)(2)(B)(ii).
45 FFDCA § 518(e)(2)(B).
46 FFDCA § 705(b).
47 FFDCA § 518(a), (b), (c), (e)(3).

U.S.C. § 262, Regulation of Biological Products]” once a determination is made that
that quantity “presents an imminent or substantial hazard to the public health.”48 The
Secretary’s order must be issued in accordance with 5 U.S.C. § 554, which addresses
formal adjudications after an opportunity for an agency hearing. Violators of these
provisions may face inflation-adjustable civil penalties of up to $100,000 per day of
violation.49
Current FDA Regulations Regarding Voluntary Recalls
Part 7, Subpart C, of Title 21, Code of Federal Regulations gives “guidance for
manufacturers and distributors to follow with respect to their voluntary removal or
correction” of a FDA-regulated product on the market that violates the FFDCA or
other law that the FDA administers.50 Chapter Seven of the FDA’s Regulatory
Procedures Manual also serves as a reference for FDA employees and industry as to
recall procedures; the manual is not law and does not bind the FDA or industry.51 As
a result, only FDA regulatory authorities and not the manual are discussed in this
report.
The FDA views voluntary, industry-initiated recalls as an alternative to FDA
legal actions to remove or correct products that violate laws.52 For example, the FDA
has the power to seize adulterated and misbranded products under the FFDCA.53
However, the agency states that a company recall “is generally more appropriate and
affords better protection for consumers than seizure, when many lots of the product
have been widely distributed.”54 The FDA may turn to seizure as a remedy if “the
agency has reason to believe that a recall would not be effective, determines that a
recall is ineffective, or discovers that a violation is continuing.”55
Industry-Initiated Recalls. The FDA recommends that companies undertake
certain practices that may prepare them for a recall or assist them during a recall.
These include (1) creating a contingency plan, (2) using codes on FDA-regulated
products that will make it possible to identify and recall the defective products, and
(3) keeping records — even beyond the shelf or expected use life of a product — that


48 42 U.S.C. § 262(d)(1); FDA, FDA 101: Biological Products, [http://www.fda.gov/
consumer/updates/biologics062608.html ].
49 42 U.S.C. § 262(d)(2). The statute provides a formula for adjusting the maximum amount
of the civil penalty for violations of the recall statute. Id.
50 21 C.F.R. §§ 7.1, 7.40.
51 FDA, FDA REGULATORY PROCEDURES MANUAL, [http://www.fda.gov/ora/compliance_
ref/rpm].
52 See 21 C.F.R. § 7.40(a).
53 21 U.S.C. § 334; FFDCA § 304.
54 21 C.F.R. § 7.40(c).
55 Id.

can be used to find the tainted products.56 If a company initiates a recall, the FDA
regulations suggest that the firm immediately notify the closest FDA district office.
If the product being recalled would be subject to a court action, such as seizure for
being misbranded or adulterated, then the FDA deems the company’s action to be a
recall and will ask the business to provide the agency with information on the amount
and identity of the product, as well as communications about the recall and other
data. 57
FDA regulations also provide for instances in which a company decides to recall
a product after being informed by the agency that “the product in question violates
the law, but the agency has not specifically requested a recall.”58 In this case, the
company’s decision to recall the product is treated as an industry-initiated recall.
Furthermore, agency regulations provide procedures if a company begins to remove
or correct a product in a way that the company believes would constitute a market
withdrawal. A market withdrawal is “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 [FDA] or which involves no violation, e.g., normal stock rotation practices.”59
If the business is conducting a market withdrawal, but the reason for the need to
remove the product is not clear, the FDA is willing to help the company ascertain the
cause of the problem. For example, consumers may have experienced adverse
reactions to the product, but the source of the problem may not be “obvious or clearly
understood.”60
FDA-Requested Recalls. The FDA can request a business to voluntarily
recall a FDA-regulated product; however, such requests are “reserved for urgent
situations.”61 The FDA would make such a request to the company with “primary62
responsibility for the manufacture and marketing” of the defective product. The
FDA Commissioner can request a company to conduct a recall after these three
determinations have been made:


56 21 C.F.R. § 7.59.
57 21 C.F.R. § 7.46.
58 Id. One example of this may be Menu Foods’s expansion of its pet food recall to include
cat food varieties. The FDA “had confirmed test results it received from a laboratory . . .
[that] found that canned cat food which had not been included in Menu Foods’ earlier recalls
tested positive for melamine, a chemical used as a fertilizer and in the manufacture of
cutlery and kitchenware.” The FDA informed Menu Foods, Inc., and the company acted to
expand the recall. It is unclear whether the FDA requested the expanded recall or simply
informed Menu Foods that the cat food varieties violated the FFDCA. Press Release, FDA,
FDA Warns Consumers that Retailers May Still Have Recalled Pet Food on Shelves (April

12, 2007), [http://www.fda.gov/bbs/topics/NEWS/2007/NEW01605.html].


59 21 C.F.R. § 7.3(j); see supra note 1.
60 21 C.F.R. § 7.46(d).
61 21 C.F.R. § 7.40(b).
62 Id. The FDA’s Associate Commissioner for Regulatory Affairs, who leads the FDA’s
Office of Regulatory Affairs, “has direct responsibility for approval of all recalls requested
by FDA and Class I recalls.” Sandra Nowlin Whetstone, ORA’s Role at FDA Headquarters
and in the Field for Product Recalls, 53:3 FOOD & DRUG L. J. 513, 513 (1998).

(1) That a product that has been distributed presents a risk of illness or injury or
gross consumer deception.
(2) That the firm has not initiated a recall of the product.63
(3) That an agency action is necessary to protect public health and welfare.
If the company refuses to recall its products after the FDA makes its request, the64
agency may then turn to seizures or other court actions to protect the public health.
According to its regulations, if the FDA requests a recall, the agency should take into
account the factors listed in its recall strategy, such as “the degree to which the
product remains unused in the marketplace” and the “ease in identifying the65
product.”
Classification of Recalls. The FDA categorizes recalls in three classes.
Class I recalls involve “situation[s] 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.”66 According to the FDA, over 100 Class I recalls of food
products occurred in FY2006 and the average number of Class I food recalls for the
last five fiscal years is 188.67 Class II recalls involve “situation[s] 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,” while Class III recalls involve “situation[s] in which use
of, or exposure to, a violative product is not likely to cause adverse health
consequences.”68 The FDA posts information regarding all three classes of recalls
on its website in the agency’s weekly FDA Enforcement Report.69 Additionally, the
FDA’s webpage devoted to “Recalls, Market Withdrawals, and Safety Alerts”
contains press releases and information for mostly Class I recalls.70
In order to determine what classification to assign a recall, an ad hoc committee
of FDA scientists, perhaps at the closest FDA district office, will first examine the
factors below.
(1) Whether any disease or injuries have already occurred from the use of the
product.


63 21 C.F.R. § 7.45. When making its request, the FDA notice of the above determinations
will state the violation of the FDA-administered laws, the classification of the recall, the
recall strategy, and any agency instructions on carrying out the recall. Id.
64 21 C.F.R. § 7.40(c).
65 21 C.F.R. § 7.42(a).
66 21 C.F.R. § 7.3(m)(1).
67 FDA, FDA’s Pilot Program to Better Educate Consumers about Recalled Food Products,
[ h t t p : / / www.f d a . go v/ oc / po/ f i r mr e c a l l s / p i l o t .ht ml ] .
68 21 C.F.R. § 7.3(m)(2) and (3).
69 FDA, FDA Enforcement Report Index, [http://www.fda.gov/opacom/Enforce.html].
70 FDA, Recalls, Market Withdrawals and Safety Alerts, [http://www.fda.gov/opacom/

7alerts.html].



(2) Whether any existing conditions could contribute to a clinical situation that
could expose humans or animals to a health hazard. Any conclusion shall be
supported as completely as possible by scientific documentation and/or
statements that the conclusion is the opinion of the individual(s) making the
health hazard determination.
(3) Assessment of hazard to various segments of the population, e.g., children,
surgical patients, pets, livestock, etc., who are expected to be exposed to the
product being considered, with particular attention paid to the hazard to those
individuals who may be at greatest risk.
(4) Assessment of the degree of seriousness of the health hazard to which the
populations at risk would be exposed.
(5) Assessment of the likelihood of occurrence of the hazard.
(6) Assessment of the consequences (immediate or long-range) of occurrence of
the hazard.71
The committee is not limited to evaluating the health hazard posed by a product
based on these factors alone however.72 The FDA is to then use the committee’s
health hazard evaluation as the basis for assigning a classification.73
Communication Regarding a Recall. The company that recalls a product
“is responsible for promptly notifying each of its affected direct accounts about the
recall.”74 The FDA regulations set out what information should be specified in the
notification, such as the identity of the product, the need to stop distributing the
product, that the notified person should in turn notify its customers, and what other
steps to take with the recalled product. The agency also provides instructions about
the contents — or lack thereof, in the case of including promotional materials that
could distract from the recall information — and appearance of the communication
that will inform a customer of the recall. Those who purchased, received, or used the
product being recalled who are notified via a recall communication should also
promptly notify their customers or the individuals who may have received or used the75
product. As mentioned above, the FDA will place information regarding recalls in
its weekly FDA Enforcement Report, with two exceptions: (1) product removals or76
corrections that the FDA finds are market withdrawals or stock recoveries and
(2) “intentionally delay[ed] public notification of recalls of certain drugs and devices
where the agency determines that public notification may cause unnecessary and


71 21 C.F.R. § 7.41(a).
72 21 C.F.R. § 7.41.
73 Id. The FDA’s Office of Regulatory Affairs’ Associate Commissioner “may, and has,
delegated designation of certain Class I recalls to the agency’s Center directors,” such as the
Center for Food Safety and Applied Nutrition (CFSAN). Whetstone, supra note 62, at 513.
“CFSAN’s director has been delegated authority for certain routine Class I food recalls, e.g.,
listeria and undeclared allergen Class I recalls.” Id.
74 21 C.F.R. § 7.49.
75 21 C.F.R. § 7.49.
76 See supra note 1.

harmful anxiety in patients and that initial consultation between patients and their
physicians is essential.”77
Monitoring and Termination of a Recall. The FDA regulations request
that companies recalling products to send progress reports on the recall to the
appropriate FDA district or field office. The FDA is to inform the firm, based on the78
urgency of the recall, of how often it should submit recall status reports. The
recalling company should continue to send recall progress reports until the FDA
terminates the recall, and such reports should include information on the numbers of
individuals who were notified, who responded, or who failed to respond to the
company’s recall communication. The reports should also state the number of
products returned and accounted for, how many verification checks were conducted
to determine if the recall was effective and the results of such checks, and the firm’s
estimate of the time until the recall is completed.79 The FDA field office “is
responsible for determining whether the recall was effective and that disposition of
the product was completed properly.”80
Once the FDA “determines that all reasonable efforts have been made to remove
or correct the product in accordance with the recall strategy, and when it is reasonable
to assume that the product subject to the recall has been removed” and either
disposed of or corrected, the agency is to issue a written notice that the recall is
terminated.81 The FDA’s determination may depend on the degree of public health82
hazard associated with product being recalled. For Class I recalls, the FDA district
office is to prepare a recommendation for the appropriate FDA center, such as the
Center for Food Safety and Applied Nutrition, that the Class I recall be terminated.
However, Class II and III recalls do not need approval from an FDA Center.83
Alternately, the recalling company can request, in writing, that the FDA terminate the
recall. This request should include a statement in writing that the recall is effective,
in line with the type of determination that the FDA would make when terminating a
recall.84 The FDA’s Regulatory Procedures Manual states that the time from when
a company considers its recall complete to the time when the agency terminates the
recall should generally not exceed three months.85


77 21 C.F.R. § 7.50.
78 21 C.F.R. § 7.53. The regulations state that “generally the reporting interval will be
between 2 and 4 weeks.” Id.
79 21 C.F.R. § 7.53. For example, in the Menu Foods pet food recall, the FDA conducted
approximately 400 effectiveness checks in retail stores. See Press Release, supra note 58.
80 Whetstone, supra note 62, at 514.
81 21 C.F.R. § 7.55(a).
82 Id.
83 Whetstone, supra note 62, at 514.
84 21 C.F.R. § 7.55(b).
85 FDA, REGULATORY PROCEDURES MANUAL ch. 7, at 7-25, [http://www.fda.gov/ora/
compliance_ref/rpm/ pdf/ch7.pdf].

The FDA’s Pilot Program
From mid-February 2007 until August 12, 2007, the FDA ran a six-month pilot
program “to educate and assist consumers in identifying recalled food products that
may pose a significant health risk.”86 The program concentrated on posting photos
of Class I food product recalls, in the hope that pictures of the main label or display
panel would help consumers recognize and avoid using recalled products. Press
releases with these photos also contained other identifying information for the food
product, such as a lot number or flavor of a product, if only one flavor was affected.87
The FDA accepted comments from consumers and industry on the program, and the
agency’s website stated that the program would be “continuing for a short time after
the end date while it is being evaluated.”88
Food and Drug Administration Amendments Act
of 2007 (FDAAA)
Public Law 110-85 contains provisions addressing communications and
information postings during a food recall.89 To enhance communication during a
recall, the law requires the Secretary to post information regarding recalled human
or pet food products on the FDA website; work with industry, professional
organizations, and others to gather information relevant to the recall; and
communicate with the public.90 The law mandates that the HHS Secretary, by
September 27, 2008, “establish an early warning and surveillance system to identify
adulteration of the pet food supply and outbreaks of illness associated with pet91
food.” The law also requires the Secretary to work with notification networks
during a pet food recall “to inform veterinarians and relevant stakeholders.”92
Legislative Proposals to Grant the FDA Recall Authority
The 110th Congress has shown significant interest in the issue of food safety.
Several bills would grant the FDA the ability to order recalls of food products, drugs,
and tobacco products. The following summaries of proposed legislation address the
mandatory recall provisions in such legislation. S. 2418, the Ending Agricultural
Threats: Safeguarding America’s Food for Everyone (EAT SAFE) Act of 2007 also


86 FDA, FDA’s Pilot Program to Better Educate Consumers about Recalled Food Products,
[ h t t p : / / www.f d a . go v/ oc / po/ f i r mr e c a l l s / p i l o t .ht ml ] .
87 Id.
88 Id. As of July 18, 2007, the FDA received 188 comments. The website states that “[t]he
majority of consumers who commented on the pilot find the program beneficial.” Id.
89 These provisions were similar to those the Senate approved, by a vote of 94-0, in Senator
Durbin’s amendment to the FDA Revitalization Act (S. 1082).
90 P.L. 110-85, § 1003.
91 P.L. 110-85, § 1002.
92 P.L. 110-85, § 1002.

contains provisions regarding product recalls; however, it does not provide the FDA
with mandatory recall authority.
Human and Pet Food Safety Act of 2007. S. 1274 and H.R. 2108 propose
to amend the FFDCA to allow the HHS Secretary to handle recalls in a voluntary
manner at first. The bills would give the Secretary statutory authority for both
voluntary and mandatory recalls. If the Secretary determines that food in interstate
commerce violates the FFDCA and “that there is a reasonable probability that the
food, if consumed, would present a threat to public health,” the bills then require the
Secretary to “give the appropriate persons (including the manufacturers, importers,
distributors, or retailers of the food) an opportunity to” cease distributing the food;
notify individuals such as distributors, processors, handlers, consumers, and state and93
local public health officials; and recall the food. The bills also provide civil
penalties of up to $10,000 per violation per day.94
If a person, such as a manufacturer, refuses to or fails to adequately carry out the
above described actions “within the time period and in the manner prescribed by the
Secretary,” the bills would grant the Secretary the authority to “control and possess
the food, including ordering the shipment of the food from a food establishment . . .
to the Secretary” at either the establishment’s expense or, in an emergency, at the95
Secretary’s expense. The Secretary would be required to issue an order mandating
importers, retailers, or others to stop distributing the food and notify those involved
with the food product’s handling, transportation, sale, and other activities.
Furthermore, the Secretary must notify “consumers to whom the food was, or may96
have been distributed,” as well as state and local public health officials. Persons
such as distributors, processors, handlers, and sellers notified by either the Secretary
or an “appropriate person,” as described above, must also stop distributing the food
product and make available records regarding others who processed, distributed, and97
sold the food. After an informal hearing, the Secretary would also be able to
require a recall, set a timetable for the recall, mandate progress reports on the recall,98
and give notice of the recall to consumers.
The bills also contain provisions similar to those incorporated in FDAAA. To
enhance communication during a recall, the bills would require the Secretary to post
information regarding recalled human or pet food products on the FDA website;
work with industry, professional organizations, and others to gather information99
relevant to the recall; and communicate with the public. Finally, the HHS Secretary


93 S. 1274, § 2; H.R. 2108, § 2 (proposed FFDCA § 417(b)).
94 S. 1274, § 2; H.R. 2108, § 2 (proposed FFDCA § 417(c)).
95 S. 1274, § 2; H.R. 2108, § 2 (proposed FFDCA § 418(a)(1)).
96 S. 1274, § 2; H.R. 2108, § 2 (proposed FFDCA § 418(b)).
97 S. 1274, § 2; H.R. 2108, § 2 (proposed FFDCA § 418(c) and (d)).
98 S. 1274, § 2; H.R. 2108, § 2 (proposed FFDCA § 418(f)(1)).
99 S. 1274, § 3; H.R. 2108, § 3.

would have to work with notification networks during a pet food recall “to inform
veterinarians and relevant stakeholders.”100
Food and Drug Administration Revitalization Act. Senator Durbin’s
amendment to S. 1082, which passed 94-0, contains the same communication and
notification requirements during recalls as the Human and Pet Food Safety Act of
2007 (see above), which were similar to those incorporated in FDAAA. The
amendment would expand the FDA’s authority in other areas as well.
Safe Food Act of 2007. S. 654 and H.R. 1148 would create an independent
single food agency, headed by an Administrator of Food Safety. The bills’ voluntary
and mandatory recall provisions, in Section 403, are basically the same as those in
the Human and Pet Food Safety Act of 2007, except that the Administrator replaces
the Secretary of HHS; the term “food establishment” is defined in these bills;101 and
S. 654 and H.R. 1148 prohibit violations of food safety laws in general — from the
Egg Products Inspection Act to the Sanitary Food Transportation Act of 1990, as
amended — rather than solely the FFDCA.
The bills would institute additional recall provisions as well. Section 204 of the
bills would give the Administrator the power to order recalls from food
establishments if the Administrator determines that an establishment fails to meet a
performance standard for contaminants in food and does not take corrective actions
determined by the Administrator. These standards would be promulgated by the
Administrator. The frequency with which a food establishment conducts recalls of
its products would be taken into account in the bills’ provisions classifying food
establishments and how often the new agency would inspect such establishments.102
The bills also specify that any protections that the Administrator develops “to prevent
the unauthorized disclosure of any trade secret or confidential information obtained
by the Administrator” would not “limit the public disclosure of distribution records
or other records related to a food subject to a voluntary or mandatory recall.”103
Section 207 of the bills states that the new agency’s Administrator must support state
and local recall authorities. Like the current FFDCA, the bills create a section of
prohibited acts, one of which would be failing to comply with a recall or other
order.104 Additionally, the bills provide civil and criminal penalties.105


100 S. 1274, § 4; H.R. 2108, § 4.
101 The bills define “food establishment” as “a slaughterhouse, factory, warehouse, or facility
owned or operated by a person located in any State that processes food or a facility that
holds, stores, or transports food or food ingredients.” The terms “does not include a farm,
restaurant, other retail food establishment, nonprofit food establishment in which food is
prepared for or served directly to the consumer, or fishing vessel.” S. 654, § 3(13); H.R.

1148, § 3(13).


102 S. 654, § 205(d); H.R. 1148, § 205(d).
103 S. 654, § 205(i); H.R. 1148, § 205(i).
104 S. 654, § 401(11); H.R. 1148, § 401(11).
105 S. 654, § 405; H.R. 1148, § 405.

FDA Food Safety Modernization Act. Under S. 3385, the Secretary must
first provide the responsible party with an opportunity to voluntarily cease
distribution and recall the article of food if the Secretary makes a determination based
on information gathered through the FFDCA reportable food registry or through any
other means. The Secretary may determine that there is a reasonable probability that
an article of food is adulterated or misbranded, and the use of or exposure to such
article will cause serious adverse health consequences or death to humans or animals.
If a person refuses to comply or does not voluntarily comply with a request by the
Secretary to cease distribution or sale of, or to recall, an article of food, the Secretary
would be authorized to issue an order to cease distribution and to immediately notify
others to stop distribution of the article of food. After an opportunity for an informal
hearing, the Secretary could amend the order to cease distribution to include a
mandatory recall of the food involved, set a timetable for the recall, require reports
on its progress from the responsible party, and provide notice to consumers to whom
the food may have been distributed.
The Secretary would be required to work with state and local public health
officials, as appropriate, to carry out the recall provisions of the bill. In conducting
a recall, the Secretary would be required to issue a press release, and other notices as
appropriate, to provide consumers and retailers with information about the affected
articles of food, and the risks posed. The Secretary’s authority to issue or vacate
recall orders would not be able to be delegated to anyone other than the FDA
Commissioner, and the bill’s recall provisions would not affect the authority of the
Secretary to request or participate in a voluntary recall. Failure to comply with an
order by the Secretary would be a prohibited act under the FFDCA, and the person
who does not comply with such an order would be subject to a civil monetary
penalty.
Protect Consumers Act of 2007. H.R. 2099 would enable the HHS
Secretary to institute a mandatory recall of an FDA-regulated product. Under the bill,
if the Secretary makes a determination that a mandatory recall is necessary, the
Secretary must issue an order requiring distribution, manufacture, and sales of the
product to cease; giving “notice to individuals subject to the risks associated with the
use of such product”; and recalling the product immediately.106 The bill would
provide for an opportunity for an informal hearing after the order is issued.
Depending on whether the Secretary determines that there are adequate grounds to
support the order, the order could be vacated or could remain in effect until a future
decision by the Secretary. Noncompliance with an order would be treated as a
violation of the FFDCA. Section 3 of the bill would also provide for a study on
procedures for instituting voluntary and mandatory recalls and making them more
effective. The Secretary would also be required to promulgate regulations as a result
of the study on new recall procedures.
Food and Drug Import Safety Act of 2007. Section 10 of H.R. 3610
would grant the FDA mandatory authority to order manufacturers, importers,
distributors, retailers, and others to stop distributing food products if “the Secretary
finds that a food may cause serious, adverse health consequences or death.” After an


106 H.R. 2099, § 2.

opportunity for an informal hearing, the HHS Secretary could amend the order to
cease distribution to include a mandatory recall of the food involved, except from
individuals. The Secretary would also set a timetable for the recall and require
reports on its progress. This proposal has been endorsed by the consumer group
Food & Water Watch, which believes that “giving FDA such authority will speed up
the removal of adulterated food from commerce.”107
Food and Product Responsibility Act of 2007. S. 2081 would grant the
FDA authority, after the Secretary has provided an opportunity for an informal
hearing, to require a recall of an article of food if “the Secretary determines that there
is a reasonable probability that human consumption of the article . . . presents a threat
to public health.” After an opportunity for an informal hearing, the HHS Secretary
may also set a timetable for the recall, require reports on its progress, and “provide
notice of the recall to consumers to which the article was, or may have been,
distributed.” The bill would also require manufacturers of food, drugs, devices,
cosmetics, biologics, meat and poultry and their products, consumer products, eggs
and egg products, and certain replacement equipment to obtain a recall responsibility
certificate from U.S. Customs and Border Protection that indicates
a manufacturer possess[es] sufficient means (through insurance or otherwise) for
the 5-year period beginning on the date the manufacturer begins to distribute in
commerce [such a] product, to cover — (A) the entire cost of a recall of that
product . . . ; and (B) compensatory damages and costs (including reasonable
attorneys fees) of any product liability or other lawsuit filed for claims arising
out of, relating to, or resulting from any defect in that product.
SAFER Meat, Poultry, and Food Act of 2007. H.R. 3484 would grant the
FDA authority to mandate a recall of an article of food if the Secretary finds that it
is “adulterated or misbranded in a manner that, if consumed, may result in illness or
injury.” The Secretary must first provide an opportunity for a person to take voluntary
actions such as recalling the article of food or stopping distribution of the article.
Then, if the person “does not carry out the actions . . . within the time period and in
the manner prescribed by the Secretary,” the Secretary must require the immediate
ceasing of distribution of the article of food, including the immediate notification of
others to stop distribution of the article of food. The Secretary may also “take control
or possession of the article,” which would be in addition to the Secretary’s existing
seizure authority under FFDCA § 304, and notify consumers and state and local
health officials. The Secretary must provide an opportunity for a hearing on an order
issued by the Secretary, and, after such hearing, may amend the order to require a
recall of an article of food or other action, set a timetable for the recall, require
reports on the recall’s progress, and “provide notice of the recall to consumers to
which the article was, or may have been, distributed,” if the Secretary determines that
the article “is adulterated or misbranded in a manner that, if consumed, may result
in illness or injury.”


107 Letter from Wenonah Hauter, Executive Director, Food & Water Watch, to
Representative John Dingell, Chairman, House Committee on Energy and Commerce, at 3
(August 17, 2007).

The bill would also make it a prohibited act under the FFDCA to fail to comply
with certain orders or an amended order issued by the Secretary, such as those that
would require a person to cease distribution of an article of food or would require a
recall of the article of food. H.R. 3484 would also increase civil penalties for those
who commit prohibited acts “with respect to an article of food” and make “[e]ach
prohibited act and each day during which the act continues . . . a separate offense.”
Consumer Food Safety Act of 2007. H.R. 3624 contains provisions
similar to H.R. 3484. H.R. 3624 would grant the FDA authority to mandate a recall
of an article of food if the Secretary finds that it is “adulterated or misbranded” and
“there is a reasonable probability that such article, if consumed, would present a
threat to public health.” The Secretary must first provide an opportunity for a person
to take voluntary actions such as recalling the article of food or stopping distribution
of the article. Then, if the person “refuses to or does not voluntarily cease
distribution, make notification, recall such article, or provide notice to consumers,
as applicable, within the time and in the manner prescribed by the Secretary,” the
Secretary must require the immediate ceasing of distribution of the article of food,
or the immediate notification of others, such as those who process and transport the
article of food, or both actions. The Secretary also “shall, as the Secretary deems
necessary, provide notice to consumers to whom such article was, or may have been
distributed.” The Secretary must provide an opportunity for a hearing on an order
issued by the Secretary, and after such hearing, may amend the order to require a
recall of an article of food or other action, set a timetable for the recall, require
reports on the recall’s progress, and “provide notice of the recall to consumers to
which the article was, or may have been, distributed,” if the Secretary determines that
“there is a reasonable probability that the article . . . if consumed, presents a threat
to public health.”
The bill would make the failure to comply with certain orders or an amended
order issued by the Secretary, such as those that would require a person to cease
distribution of an article of food or would require a recall of the article of food, a
prohibited act under the FFDCA. H.R. 3624 would add civil penalties for those who
commit a violation of the FFDCA or the Consumer Food Safety Act of 2007 with
respect to food. H.R. 3624 would also enable any person to sue for a violation of a
recall order or “other action of the Secretary to ensure the safety of food products.”
Food Import Safety Act of 2007. Under H.R. 3937, the Secretary must first
provide an opportunity for a person to take voluntary actions such as recalling the
article of food or stopping distribution of the article, if the Secretary has determined
that the food violates the FFDCA and “that there is a reasonable probability that the
food, if consumed, would present a threat to public health.” Then, if the person
“refuses to or does not adequately carry out the action described . . . within the time
period and in the manner prescribed by the Secretary,” H.R. 3937 would grant the
FDA authority to “control and possess the food, including ordering the shipment of
the food from a food establishment,” or to require a person to immediately cease
distribution of the food and notify others with regard to the immediate ceasing of
distribution of the food. The Secretary also “shall, as the Secretary deems necessary,
provide notice . . . to consumers to whom the food was, or may have been,
distributed” and to state and local public health officials. The Secretary must provide
an opportunity for an informal hearing on an order issued by the Secretary, and after



such hearing, may amend the order to require a recall of an article of food or other
action, set a timetable for the recall, require reports on the recall’s progress, and
“provide notice of the recall to consumers to which the article was, or may have been,
distributed,” if the Secretary determines that “there is a reasonable probability that
the food . . . if consumed, would present a threat to public health.”
The bill would also add civil penalties for those who violate its notification and
recall standards. Each violative act and each day a violation continues would be
considered a separate offense, and the bill provides for a good faith exception to the
civil penalties.
Draft of the Food and Drug Administration Globalization Act of

2008. On the website of the House Energy and Commerce Committee,


Representative Dingell has posted a discussion draft of a bill that would be entitled108
the Food and Drug Administration Globalization Act of 2008. The bill would
grant the Secretary the authority to require food recalls and would grant the Secretary
the same authority for recalling drugs as the Secretary has for recalling devices.
Family Smoking Prevention and Tobacco Control Act. S. 625 and
H.R. 1108 would provide the HHS Secretary with the authority to require recalls of
tobacco products in a manner substantially similar to the Secretary’s authority to
recall medical devices. “If the Secretary finds that there is a reasonable probability
that a tobacco product contains a manufacturing or other defect not ordinarily
contained in tobacco products on the market that would cause serious, adverse health
consequences or death,” then the Secretary must issue an order requiring distribution
of such tobacco products to cease.109 The Secretary’s order would affect
manufacturers, importers, distributors, and/or retailers.110 Thus, similar to the
Secretary’s authority to recall medical devices, the first step of the statute does not
require a mandatory recall of the tobacco product for which the Secretary makes the
above determination.
As with medical devices, after providing an opportunity for an informal hearing
within 10 days of the date the order was issued, the Secretary would be able to amend
the order to require recalls of such tobacco products. The Secretary must set a
timeline “in which the tobacco product recall will occur.”111 The bills also specify
that the Secretary must require reports “describing the progress of the recall,” but
does not state from whom such reports would be required.112 Defective tobacco
products could not be recalled from individuals, however, an amended order from the


108 [http://energycommerce.house.gov/FDAGlobalAct-08/Dingel_60AXML.pdf].
109 S. 625, § 908(c); H.R. 1108, § 908(c).
110 The medical device recall provisions in the FFDCA call for notification “to health
professionals who prescribe or use the device and to any other person (including
manufacturers, importers, distributors, retailers, and device users) who should properly
receive such notification in order to eliminate such risk.” FFDCA § 518(a); 21 U.S.C. §

360h(a).


111 S. 625, § 908(c)(2)(A); H.R. 1108, § 908(c)(2)(A).
112 S. 625, § 908(c)(2)(A); H.R. 1108, § 908(c)(2)(A).

Secretary requiring a recall must give notice of the risks associated with using a
defective tobacco product. The Secretary could ask retailers and other distributors
to notify individuals about the defective tobacco products, which is arguably
comparable to the Secretary’s ability to use “the assistance of health professionals
who prescribed or used” a medical device subjected to a recall.113
Again, similar to the Secretary’s authority for recalling medical devices, if a
significant number of retailers and/or distributors of the defective products cannot be
identified,114 the Secretary must notify these persons by publicizing information
under FFDCA § 705(b).115 Unlike the medical device recall provisions, S. 625 and
H.R. 1108 do not provide for replacements, reimbursements, or refunds, however,
the bills specify that the value of remedies (potentially, a reimbursement of a
retailer’s costs associated with replacing the defective products) must be taken into
account in an award of damages for economic loss.116


113 FFDCA § 518(e)(2)(B).
114 S. 625, § 908(c)(2)(B); H.R. 1108, § 908(c)(2)(B).
115 However, S. 625 and H.R. 1108 do not amend FFDCA § 705(b) to include tobacco
products. Section 705(b) currently states that “The Secretary may also cause to be
disseminated information regarding food, drugs, devices, or cosmetics in situations
involving, in the opinion of the Secretary, imminent danger to health or gross deception of
the consumer. . . .” (emphasis added).
116 S. 625, § 908(b); H.R. 1108(b).