Draft Guidance Pub. Notification and Warning

Public Warning and

Notification of Recalls Under

21 CFR Part 7, Subpart C

Guidance for Industry and FDA Staff

You may submit electronic or written comments regarding this guidance at any time. Submit

electronic comments to https://www.regulations.gov. Submit written comments to the Dockets

Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,

Rockville, MD 20852. All comments should be identified with the docket number FDA-2016-

D-3548.

For questions or information regarding this guidance, contact the Office of Regulatory Affairs

(ORA), Office of Strategic Planning and Operational Policy (OSPOP), Food and Drug

Administration at [email protected].

The draft of this guidance was issued in January 2018.

U.S. Department of Health and Human Services

Food and Drug Administration

Office of Regulatory Affairs

Center for Food Safety and Applied Nutrition

Center for Drug Evaluation and Research

Center for Biologics Evaluation and Research

Center for Devices and Radiological Health

Center for Veterinary Medicine

Center for Tobacco Products

FEBRUARY 2019

Contains Nonbinding Recommendations

Public Warning and

Notification of Recalls Under

21 CFR Part 7, Subpart C

Guidance for Industry and FDA Staff

Additional copies are available from:

Office of Strategic Planning and Operational Policy

Office of Regulatory Affairs,

Food and Drug Administration

12420 Parklawn Drive, Element Building,

Rockville, MD 20857

U.S. Department of Health and Human Services

Food and Drug Administration

Office of Regulatory Affairs

Center for Food Safety and Applied Nutrition

Center for Drug Evaluation and Research

Center for Biologics Evaluation and Research

Center for Devices and Radiological Health

Center for Veterinary Medicine

Center for Tobacco Products

FEBRUARY 2019

Recalls

 Contains Nonbinding Recommendations 
3 
 
Table of Contents 
 
I. INTRODUCTION ..................................................................................................................... 4 
II. TERMINOLOGY .................................................................................................................... 5 
III. DISCUSSION ......................................................................................................................... 6 
A.  Public Warnings ............................................................................................................. 6 
1.  Under what circumstances should firms issue public warnings?................................. 6 
2.  Who prepares public warnings? ................................................................................... 8 
3.  What information should be contained in a public warning? ...................................... 9 
4.  How are public warnings distributed and displayed? ................................................ 10 
B.  Public Notification of Recalls ...................................................................................... 11 
IV. REFERENCES ..................................................................................................................... 11

Contains Nonbinding Recommendations

Public Warning and Notification of

Recalls Under

21 CFR Part 7, Subpart C

Guidance for Industry and FDA Staff

This guidance represent the current thinking of the U.S. Food and Drug Administration (FDA,

we, or Agency) on this topic. It does not establish any rights for any person and is not binding

on the FDA or the public. You can use an alternative approach if it satisfies the requirements

of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA

staff responsible for this guidance as listed on the title page.

I. Introduction:

The purpose of this guidance is to assist and provide recommendations to industry and FDA staff

regarding the use, content, and circumstances for issuance of public warnings and public

notifications for firm-initiated or FDA-requested recalls under 21 CFR Part 7, Subpart C –

Recalls (Including Product Corrections) –Guidance on Policy, Procedures, and Industry

Responsibilities. The guidance also discusses what information should be included in a public

warning, as well as the parties responsible for issuing it. It represents FDA’s current thinking on

public warning and notification of recalls under 21 CFR Part 7.

This guidance applies to voluntary recalls of products subject to FDA’s jurisdiction, including

any food, drug, and device intended for human or animal use, any cosmetic and biologic

intended for human use, any tobacco product intended for human use, and any item subject to a

quarantine regulation under 21 CFR Part 1240. However, it does not apply to radiation emitting

electronic products which are governed only by 21 CFR Parts 1003 and 1004.

FDA's guidance documents do not establish legally enforceable responsibilities. Instead,

guidance describes the Agency's current thinking on a topic and should be viewed only as

recommendations, unless specific regulatory or statutory requirements are cited. The use of the

word should in Agency guidance means that something is suggested or recommended, but not

required.

Contains Nonbinding Recommendations

II. Terminology:

Recall

Recall means a firm’s removal or correction of a marketed product that FDA considers to be in

violation of the laws it administers and against which the Agency would initiate legal action,

e.g., seizure. Recall does not include a market withdrawal or a stock recovery.

(21 CFR

§7.3(g))

Recall Determination

A recall determination is the assessment the FDA makes in deciding that a firm’s ongoing or

completed removal or correction of a marketed violative product constitutes a recall as defined at

21 CFR § 7.3(g). A firm’s characterization of its action is not determinative of whether the FDA

would determine that the action is a recall. A firm’s action constitutes a recall when it meets the

definition of “recall” under 21 CFR § 7.3(g).

Recall Classification

Recall classification means the numerical designation, i.e., I, II, or III, assigned by the FDA to a

particular product recall to indicate the relative degree of health hazard presented by the product

being recalled or considered for recall. (21 CFR §§ 7.3(m), 7.41(b)). The determination is made

on the basis of the health hazard evaluation and in consideration of the factors provided at 21

CFR § 7.41.

Public Warning

The purpose of a public warning under 21 CFR Part 7 is to alert the public that a product being

recalled presents a serious health hazard. It is reserved for urgent situations where other means

of preventing use of the recalled product appear inadequate. (21 CFR § 7.42(b)(2)).

Public

warnings under 21 CFR Part 7 can be disseminated through general or specialized news media,

e.g., professional or trade press, and/or to specific segments of the population such as physicians,

hospitals, etc. The FDA may issue public warnings in a variety of forms, including, but not

limited to, press releases, emails, and web and social media postings.

Public Notification of Recalls

The FDA promptly makes available to the public in the weekly FDA Enforcement Report a

descriptive listing of each new recall according to its classification, whether it was FDA-

requested or firm-initiated, and the specific action being taken by the recalling firm. (21 CFR §

21 CFR § 7.3(j) defines market withdrawal to mean a firm's removal or correction of a distributed product which

involves a minor violation that would not be subject to legal action by the Food and Drug Administration or which

involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc. Stock

recovery means a firm's removal or correction of a product that has not been marketed or that has not left the direct

control of the firm, i.e., the product is located on premises owned by, or under the control of, the firm and no portion

of the lot has been released for sale or use. 21 CFR § 7.3(k).

In addition to the public warning authority described in 21 CFR Part 7, the Agency has other authorities to

disseminate information in an array of circumstances, for example, the Secretary’s authority in 21 U.S.C. 375(b) to

disseminate information about FDA regulated products in situations that the Secretary determines involve imminent

danger to health or gross deception of the consumer . Nothing in this guidance is meant to define, shape, or limit

those authorities in any way.

Contains Nonbinding Recommendations

7.50).

Confidential Commercial Information (CCI)

Commercial or financial information that is privileged or confidential means valuable data or

information which is used in one's business and is of a type customarily held in strict confidence

or regarded as privileged and not disclosed to any member of the public by the person to whom it

belongs. (21 CFR § 20.61(b)).

III. Discussion:

The FDA’s policy is to evaluate the particular circumstances of each individual recall in

determining whether a public warning is needed in accordance with 21 CFR § 7.42(b)(2) as part

of the recall strategy. The FDA may issue a public warning or notification before formally

classifying a recall under 21 CFR § 7.41(b). We note that due to the level of hazard associated

with Class I recalls, the FDA has generally issued, and/or sought issuance of, public warnings in

Class I or potential Class I recalls unless specific circumstances indicate that one would not be

beneficial to the public. The FDA also recommends and/or issues public warnings for some

urgent Class II recalls that, while not rising to Class I hazards, still present a serious hazard to

health.

Once the FDA makes a recall determination or classification, the recall will be listed in the

weekly FDA Enforcement Report in accordance with 21 CFR §7.50.

A. Public Warnings

1. Under what circumstances should firms issue public warnings?

Public warnings are for urgent situations and are issued to alert the public that a product being

recalled presents a serious hazard to health, and where other means for preventing the use of a

recalled product appear inadequate. For instance, public warnings may be appropriate for urgent

recalls of prescription drugs or medical devices when retail level consignees cannot identify

persons to whom the drug or device was dispensed. A public warning is also often needed when

a recalled product has been widely distributed.

On the other hand, when recalled products have only been distributed to direct accounts

, and the

recalling firm has records that show exactly where the products have gone, a prompt and

effective communication to such accounts informing them of the recall may be adequate to

FDA has recommended public warnings for Class II recalls involving, for example, foods with low levels of

undeclared allergens (e.g., wheat). While the adverse health consequences may be remote or temporary, FDA is

committed to acting immediately when necessary to protect the public health.

For internet purchases, the consumer level is considered a direct account. For some internet purchases, prompt and

effective communication may not be feasible, and thus distribution to the direct account in an internet transaction

may warrant a public warning. Where communication is feasible, the internet seller should attempt to confirm

receipt of the communication.

Contains Nonbinding Recommendations

prevent the use of a recalled product.

This could be an instance where the product has only

reached the wholesale level, such as a warehouse or distribution center, and has not been further

distributed to the retail or consumer level.

The FDA generally recommends public warning for recalls that are likely to be classified as, or

have been classified as Class I recalls, unless specific circumstances indicate that the warning

would not be beneficial to the public. Such circumstances could be where there is not adequate

information to convey risk and appropriate actions, or when the product is limited to a small

number of consignees that are easily identified and can be rapidly reached through targeted

contact. Furthermore, different products might dictate different communication considerations.

For instance, during a medical device recall, the FDA may consider how patients respond to a

public warning about a defective product without first having the benefit of consulting with their

physician. In these and similar situations, public warnings may be more confusing than helpful.

The FDA will continue to assess the need for public warnings for voluntary recalls of FDA-

regulated products based on the particular circumstances of the individual recall. The following

recalls generally present examples of serious hazards to health such that a public warning may be

warranted:

 Recalls of food products initiated by a firm after receipt of consumer reports of illness

or injury (including allergic reactions), for which there is an active outbreak

associated with the product or its ingredients, or for which the FDA has substantiated

reports of illness or injury.

 Recalls of food products that are intended for or would more likely be consumed by

vulnerable populations. Examples of vulnerable human populations include infants,

toddlers, the elderly, pregnant women, and medically-compromised individuals, who

may be more susceptible to foodborne hazards than healthy persons.

 Recalls of food products initiated because of manufacturing deviations where the

consequences of the manufacturing deviations could have significant health impacts;

e.g., under processed low-acid canned foods which could result in botulism if the

product is consumed.

 Recalls of food products initiated because of microbiological pathogen findings (e.g.,

Listeria monocytogenes, Salmonella, etc.) in environmental testing where direct food

manufacturing contact surfaces are found to be contaminated.

 Recalls of animal food products which may be contaminated with low levels of drugs

or unsafe food additives. Examples include pet jerky treats contaminated with

antibiotics, and cat food products containing propylene glycol.

 Recalls of home use medical devices which could malfunction and lead to incorrect

dosing of drugs or blood volumes.

To be adequate to prevent the use of the product, a recalling firm should be able to confirm that business accounts

received the communication and understood the instructions conveyed in the communication. FDA’s model recall

return response form, available in FDA’s Regulatory Procedures Manual, is one way a recalling firm can document

such confirmation from business accounts.

Contains Nonbinding Recommendations

 Recalls of sterile injectable drug products which may contain particulate matter.

 Recalls of implantable pacemakers or defibrillators where the device’s battery may

fail suddenly and without warning.

The FDA may issue or supplement a firm’s public warning, among other actions, in the

following situations: a firm refuses to issue its own public warning when recommended or

requested by the FDA, an ongoing recall or public warning is not prompt or effective, or the

FDA learns of a completed recall where new adverse events associated with the product are

reported after completion of the recall. The FDA will generally provide a timeframe for when the

firm should issue a public warning based on the circumstances of the individual recall. While

timeframes will vary depending on the recall and product, these firms should generally issue a

public warning within 24 hours of the FDA notifying the firm that it believes a public warning is

appropriate.

2. Who prepares public warnings?

The FDA generally gives firms the first opportunity to prepare and issue public warnings during

recalls. For instance, for firm-initiated recalls, recalling firms are expected to develop their own

recall strategy. The recall strategy addresses, among other things, whether a public warning is

needed and how it will be issued. In most cases, the FDA reviews and comments on the recall

strategies, including any public warnings developed by firms (see 21 CFR § 7.42(b)(2)). Firms

should include any drafted public warning as part of their submission of the recall strategy to the

extent that it does not delay strategy development or recall initiation.

In other situations that

warrant an immediate warning, firms may choose to issue public warnings without the FDA’s

review. The FDA may supplement that warning with its own public statement, if necessary.

When the FDA believes that a public warning is appropriate and the recalling firm does not

include one in its initial recall strategy, the FDA will generally request one from the recalling

firm.

In some situations, the FDA may prepare and issue public warnings on its own initiative and in

accordance with 21 CFR § 7.42(b)(2). This may occur, for instance, when the public needs

immediate warning concerning a product and the firm has not issued a public warning or a firm’s

public warning is deficient. The FDA will ordinarily work with the recalling firm to ensure the

factual accuracy of a public warning. However, the FDA is not required to contact the firm

before issuing a public warning or allow its review of the proposed statement.

If a firm issues a public warning that is deficient in any respect (see also section III.A.3 in this

document), the FDA may supplement or correct that warning with its own public warning. If a

firm’s public warning is not reasonably likely to be adequately received by the target audience,

the FDA may ask the firm to reissue its public warning and/or the FDA may issue its own public

warning. Additionally, the FDA may publicly issue information that may address outstanding

questions about the nature of the incident and/or the Agency’s actions.

Firms are reminded that, under 21 CFR § 7.42, they need not delay the initiation of a recall pending the FDA’s

review of their recall strategy.

Contains Nonbinding Recommendations

3. What information should be contained in a public warning?

The purpose of a public warning is to alert the public that a product being recalled presents a

serious hazard to health. As such, a public warning should include: a) information to help

identify the recalled product including images, numerical product information (e.g., lot number,

expiration date, serial number, unique device identification (UDI) number), packaging

information or brand names; b) the geographic areas and dates of distribution of the affected

product; c) a thorough description of the product defect, health hazard involved, and reason(s)

for recall (e.g., product testing, environmental sampling, etc.); d) the name and contact

information for the recalling firm; e) instructions to consumers or users; f) the number and nature

of any illnesses/injuries/complaints associated with the product, related to the product defect; and

g) a description of common symptoms of any illness of concern. The headline of the public

warning should include the brand name, type of product, and the hazard prompting the recall

(e.g., “XYZ chocolate chip cookies recalled for potential Salmonella contamination.”).

In some cases, it may also be necessary to include the recalling firm’s supply-chain relationships

in order to alert the public of the product being recalled. When possible, the FDA encourages

firms to provide specifics about firms it sold product to in order to help people better identify and

avoid recalled product.

What should not be included

Public warnings should not contain content that detracts from or defeats the purpose of the

warning. Brief and succinct warnings are generally better at informing consumers of a product

hazard and helping consumers understand the importance of avoiding the product. On the other

hand, messages that cloud or lengthen a warning may distract a consumer and should be avoided.

Generally, firms should not promote the qualities of the product being recalled, other products

sold by the firm, or the firm in general, as part of a public warning. Phrases such as “an

abundance of caution,” that can be seen as trying to minimize the hazard, should not be used, for

example, when illnesses or injury have resulted, or when there are positive results for pathogens

associated with the finished product or ingredients.

What might make a public warning deficient

A public warning may be considered deficient if, among other things, it does not adequately

identify the recalled product, describe the health hazard involved, or identify relevant

information about the product’s distribution. A public warning might also be considered

deficient if, on the basis of the FDA’s media monitoring, it is determined that the warning did

not sufficiently reach the target audience (e.g., the firm’s release was not disseminated

sufficiently by the news media; the firm’s warning for a nationally-distributed product was

issued only to a regional audience; no Spanish translation was made available for a product

largely used by Spanish-speaking populations). A factual statement in a firm’s public warning

that the FDA is unable to verify might also cause the FDA to issue a separate public warning.

FDA’s recall communications are intended to be as informative as possible within the scope of the Agency’s

authority for information disclosure. For example, depending on the circumstances, certain information such as

supply-chain relationships and product distribution data may be CCI, which is generally protected from public

disclosure. FDA’s regulations authorize the release of CCI, in relevant part, when necessary to effectuate a recall.

(21 CFR § 20.91).

Contains Nonbinding Recommendations

The FDA will take actions to correct or supplement deficient public warnings as described in this

guidance. The Agency encourages firms issuing public warnings to monitor media coverage and

take further action to raise public awareness if media coverage appears to be insufficient.

4. How are public warnings distributed and displayed?

Firms and the FDA can alert the public about a recall by various means, including issuing press

releases to the media, sending emails to a listserv or subscription service, and posting on the

FDA and company websites or social media. All of these methods could be used to issue a

public warning.

Issuing the Public Warning through a Press Release

It is critical that public warnings are distributed in a way that ensures that the information

conveyed in the warning actually reaches the public. To this end, the FDA is open to different

vehicles of dissemination that best convey the information of the particular recall. Historically,

the FDA and industry have used general news media, as well as specialized news media, e.g.,

professional or trade press, among other means. When warranted, the FDA recommends that

firms use press release distribution services or other mechanisms that ensurethe information in

the press release will be appropriately relayed to the public, e.g., through news media outlets.

Part of a firm’s responsibility to inform a consumer of a recalled product includes taking earnest

efforts to ensure that the information is actually distributed.

Firms issuing public warnings through press releases should also consider the area of distribution

of the recalled product. The distribution of the release should match the distribution of the

product: if the product is available online or is distributed nationally, the public warning should

also be available online and/or distributed nationwide. Similarly, if the product is only available

in a regional market, and the FDA and the firm are confident that no consumers from outside that

region may have received it, the distribution of the public notification may be similarly targeted.

If it is apparent that a significant percentage of consumers using the recalled product speak a

language other than English, firms should consider having the public warning translated into that

language and distributed via the appropriate distribution service.

Posting a Public Warning or Press Release on a firm or FDA Webpage

In many cases, a firm will announce a removal of an FDA regulated product from the market or

correction

through a press release or other public announcement prior to the FDA reviewing and

determining the action to be a recall. The FDA may post the information in or the text of the

announcement on FDA.gov/recalls

if the FDA believes the announcement is factually correct

and beneficial to consumers.

The FDA does not typically post a firm’s announcement of an action that the FDA believes will

A correction is a repair, modification, adjustment, relabeling, destruction or inspection (including patient

monitoring) of a product without its physical removal to some other location. 21 CFR § 7.3(h).

This webpage also provides links to various FDA Center webpages, where public warnings of recalls of products

specific to that Center are also posted.

Contains Nonbinding Recommendations

not be considered a recall. Further, not all recalls are posted on the FDA.gov/recalls page since

not all recalls warrant a public warning and not all firms will issue a press release, depending on

the circumstances. When the FDA posts removal or correction information that has been

publicized by a firm, we do so as a public service and it does not necessarily mean that the

situation is urgent or that the product presents a serious hazard to health, such that it would be

considered a “public warning” as the term is defined in this guidance document. Information on

major product recalls that the FDA believes merit expanded coverage due to the impact they

have on public health can be found at

https://www.fda.gov/Safety/Recalls/MajorProductRecalls/default.htm. When a firm posts its

public warning on its own webpage, it should ensure that the warning is prominently displayed

and accessible from both its home page and a web search. The posting should remain publicly

accessible until the product is no longer expected to be used or consumed.

B. Public Notification of Recalls

The FDA provides public access to information on recalls by posting a listing of recalls

according to their classification in the FDA Enforcement Report, whether they were requested by

FDA or firm-initiated, and the specific action taken by the recalling firm.

The FDA

Enforcement Report is designed to provide a public listing of products in the marketplace that

are being recalled. Unlike with public warnings, the recalls listed in the FDA Enforcement

Report are not limited to urgent situations that present serious hazards to health and are not

necessarily used to alert the public about the risk or hazard of a product under recall.

Information on all recalls will be provided in the FDA Enforcement Report, regardless of the

level of the hazard. The FDA will attempt to promptly post public notifications; however, delays

might occur due to the timeliness of a firm’s recall submission, the availability of facts, and other

factors outside the FDA’s control. The FDA may consider delaying public notification if it may

cause unnecessary and harmful anxiety in certain consumers (e.g., when a patient needs to hear

first from his doctor about a defective implanted medical device). The FDA is not required to

provide firms with an opportunity to review and comment on public notifications, but may

consult with a firm to ensure factual accuracy or when otherwise warranted.

Public notifications of recalls will only be posted in the FDA Enforcement Report after the FDA

makes a determination that the action is a recall under 21 CFR § 7.3(g). If the recall posted in

the FDA Enforcement Report has not yet been classified, the FDA will document the recall as

not yet classified.

IV. References

1. U.S. Food and Drug Administration. Guidance for Industry: Product Recalls, Including

Removals and Corrections. Last updated 08/22/2014.

https://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm

We note that, although they are not the subject of this guidance document, mandatory recalls are also listed in the

FDA Enforcement Report.

FDA has begun posting information relating to some voluntary recalls when this information is provided to the

agency, prior to the review and possible classification.

Contains Nonbinding Recommendations

2. U.S. Food and Drug Administration. “Recalls, Market Withdrawals, & Safety Alerts.”

Last updated 04/04/2017.

https://www.fda.gov/Safety/Recalls/default.htm

3. U.S. Food and Drug Administration. “Industry Guidance for Recalls. Information on

Recalls of FDA Regulated Products.” Last updated 08/15/2014.

http://www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm

4. U.S. Food and Drug Administration. Recalls, Corrections and Removals (Devices). Last

updated 01/03/2017.

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequire

ments/RecallsCorrectionsAndRemovals/default.htm