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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA’s Recall Authority Is Important Arrow in Agency’s Enforcement Quiver

by Walt D. Osborne, M.S., J.D.
FDA Veterinarian Newsletter 2007 Volume XXII, No II

“Recall” is defined in the Food and Drug Administration’s regulations as a firm’s removal or correction of a marketed product that the agency considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure.1 There are a few specific exceptions (for products for human use), but for the most part, the enforcement tool of recall for animal products actually amounts to this voluntary action by the product-maker.

The teeth of a recall are revealed in the legal sanctions in place, should a firm not initiate a recall. In such instances, FDA can initiate a court action for removing or correcting violative, distributed products as part of its mandate to protect public health. Typically, these actions take the form of a seizure, which is a judicial civil action against an animal feed, drug, or device in violation of the adulteration and/or misbranding provisions of the FFDCA. The purpose of this action is to remove the offending product or products from the channels of commerce. However, the effect of a seizure can be somewhat limited, in that a separate action is needed for each place where the product is located. The product is in essence “arrested” by means of a Complaint filed in the appropriate U.S. District Court. The Court then orders the U.S. Marshal to seize the goods in question. Seizure, multiple seizure, or other court action is also indicated when FDA has reason to believe that a recall would not be effective, determines that a recall is ineffective, or discovers that a violation is continuing.2

On the other hand, with a recall, a firm can retrieve all of the dangerous or illegal products by means of just one action.

FDA has attributed three different categories to product recalls to indicate the relative degree of health hazard posed by the product being recalled:

  • Class I involves a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death;
  • Class II involves a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote; and
  • Class III involves a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.3

FDA determines the recall classification based on an evaluation of the health hazard presented by a product being recalled or considered for recall. This evaluation is carried out by an ad hoc committee of FDA scientists and takes into account the following factors: (1) whether any disease or injuries have already occurred from use of the products; (2) whether any existing conditions could contribute to a clinical situation that could expose humans or animals to a health hazard; and (3) assessment of the hazard to various segments of the population, the severity of the risk to that population, the likelihood or occurrence of the hazard, and the consequences (immediate or long-range) of occurrence of the hazard.4 If, based on this health hazard evaluation (HHE), the decision is made that the recall should be a Class I, the agency will advise the firm that a press release should be issued; the agency will work with the firm to devise this press release. If the firm refuses to issue one, FDA will prepare a press release for it. But it is always in the firm’s best interest to prepare its own release so that it can apply the preferred message about the story being announced. In contrast, Class II and Class III recalls rarely are the subject of a press release, but all recalls are listed in the weekly “FDA Enforcement Report.”5

Actual examples of Class I recall classifications of veterinary products during Fiscal Year 2006 included animal feeds that contained monensin, excessive salt in chicken feed, and aflatoxin in various pet foods. These recalls were classified as Class I because they all involved animal deaths. Examples of Class II recalls from the FDA Enforcement Report included excessive levels of Vitamin D3 in pet foods, possible metal tags in dog food, and enamel can lining flaking off into pet food. And lastly, examples of Class III recalls included such labeling violations as absent directions-for-use labeling on bulk animal feed, and animal food products in circulation beyond the expiration date.6

(Fiscal Year 2007 saw a huge recall of millions of individual servings of pet food manufactured by Menu Foods, Streetsville, Ontario, Canada. See the article, “Recent Pet Food Recall Extremely Complex,” on page 1.)

For both a firm-initiated recall and an agency one, a recall strategy must be put together.7 In addition to including the results of the HHE, the strategy must include the depth of the recall, i.e., the level in the distribution chain to which the recall is to extend: the consumer level, the retail level, or the wholesale level. In addition, the recall strategy plan may need to include a public warning (usually in the form of a press release), which is used to alert the public that a product being recalled presents a serious health hazard. These warnings are primarily reserved for urgent situations where other means for preventing use of the recalled product appear inadequate. Ordinarily, FDA issues these, following consultation with the recalling firm. In those situations where the firm decides to issue the warning, FDA will request the opportunity to review and comment on the warning.

Lastly, the recall strategy plan must specify the method or methods to be used and the level of effectiveness checks that are to be conducted by the firm in order to verify that all consignees at the recall depth specified by the strategy have received notification of the recall and have taken appropriate action. There are five levels of effectiveness and audit checks as - follows:

  • Level A = 100% of the total number of consignees to be contacted;
  • Level B = greater than 10% but less than 100% of the consignees;
  • Level C = 10% of the total number of consignees;
  • Level D = 2% of the total; and
  • Level E = no effectiveness checks needed.

An example of this last category would be a recalled food that is no longer on store shelves, such as bagged salad that is 2 weeks past its expiration date.

In Fiscal Year 2006, the Center for Veterinary Medicine was involved in a total of 136 recalls; 40 of these involved violations of the ruminant-to- ruminant feed ban to curtail the transmission of bovine spongiform encephalopathy. Since Fiscal year 1999, CVM has averaged 219 recalls per year.

Conclusion

FDA plays an important public health role by assessing the net benefits and risks of the products it regulates. FDA acts only for the public well-being. When the agency determines that a recall is necessary, it is acting in the best interests of the public. A company has a moral obligation to comply, and most act quickly to protect public and animal health, as well as the reputation of their product. While perhaps not 100 percent effective, product recall continues to play a pivotal role in the effective removal of products that pose a danger to public health or violate the laws that FDA administers. As we have seen, it is but one of FDA’s several arrows contained in its enforcement quiver to carry out its public health protection mandate.

Footnotes:

1 21 C.F.R. 7.3 (g).

2 21 C.F.R. 7.40 (c)

3 Investigations Operations Manual 2006, FDA.

4 21 C.F.R. 7.41 (a).

5 21 C.F.R. 7.50.

6 Fiscal Year 2006 Annual Report, Center for Veterinary Medicine.

7 21 C.F.R. 7.42 (b).