Reports continue to emerge daily in the news of dogs that have become ill or died after consuming tainted jerky treats that remain on store shelves despite an avalanche of recent media coverage. Reports of problems began as far back as 2007 when the U.S. Food and Drug Administration (FDA) issues its first warning about the treats and since that time the agency has been unable to determine what is causing the problems and without definitive proof have been unable to issue a mandatory recall.

Manufacturers refuse voluntary or precautionary recalls based on the FDA’s inability to discover a specific contaminant. Multi-center testing in toxicology laboratories across the U.S. continue to scratch their heads as thus far all commonly known contaminants have tested negative.

In the meantime, responding to consumer pleas, U.S. Senator Brown and U.S. Representative Kucinich have made public appeals urging the FDA to speed up their investigation. Kucinich wrote to the FDA Commissioner Margaret Hamburg, demanding a recall of the pet food and requesting a briefing on their investigation. 

“The FDA has clearly established an association between consumption of the chicken jerky and illness and death.  It is simply not feasible to expect every dog owner to be aware of a modestly publicized warning from the FDA,” wrote Kucinich.

“The FDA must not wait to issue a voluntary recall until it is able to definitively identify a causal agent…I am requesting a detailed briefing on the status of FDA’s investigation and the information that is considered to be necessary to proceed to a voluntary recall.  The briefing should cover in considerable scientific detail the scope of potential biological and chemical contaminants for which testing has been conducted, the raw data from such testing with an accompanying summary, methodological protocols, and any other supporting qualitative and quantitative data.”

Both politicians have held news conferences, issued press releases, given interviews, spoken on the Senate floor and written letters to Dr. Margaret Hamburg Commissioner of the FDA. So far, the greatest accomplishment of their efforts was succeeded in increasing consumer awareness, which is a remarkable achievement considering the government has had five years to do what they accomplished in a matter of days that a serious problem exists.

The FDA continues to offer the same anemic assurance they have been offering since 2007. FDA spokesperson Tamara Ward reminded the public yet again that the, “FDA and several U.S. animal health diagnostic laboratories  are working to pinpoint the cause and contaminant involved in pet illnesses”. Even so, Ward couldn’t speak on what enforcement actions exactly the FDA might take, but that they would be “appropriate” once the tests come back.

Fed up with the lack of action, consumers have taken to the internet joining Facebook groups, posting videos on YouTube. Desperate for solutions some have suggested filing lawsuits in small claims court, others hold out hope for a positive test result so they can initiate a class action lawsuit.

But until then, victims frustrated by a sense of powerlessness have taken to leafleting stores, badgering store managers that carry the treats, posting “reviews” of the products on manufacturer’s websites, Facebook sites, e-tailer sites like Amazon and Walmart.

Victims complaints to manufacturers have left victims angry and disappointed. Insurance claims once offered, provided they agreed never to sue or bad-mouth them online, were pulled off the table. Letters of condolences from the manufacturers responsible for poisoning their pets, yet unwilling to take any responsibility for killing their pets have struck many as a slap in the face.

Most victims accustomed to navigating the web are at a loss as to how to file a complaints with government agencies; and those that do file complaints are given no reassurance that their report even matters, especially when some have been told by the FDA they don’t want or need to test samples of what they believe to be is a contaminated product.

There is another tool the FDA could employ to stop the import of the tainted treats and that is to excercise their authority to detain the product to prevent it from going to market. The FDA could use detention authority to keep imports of chicken jerky from entering the country until it can determine a cause of the sicknesses, like it did recently for orange juice.

“FDA will not hesitate to take immediate steps to protect the public’s health,” said Dara A. Corrigan, the FDA’s Associate Commissioner for Regulatory Affairs. “We will aggressively use our enforcement tools to prevent potentially adulterated food from reaching the public.”

The FDA may order the detention of food when an investigator has a “reason to believe” that the food is adulterated or misbranded. Food subject to an FDA detention order may not be moved, without agency permission, until the agency releases it or the detention order expires. A detention order may remain in place for up to 30 days.

In May, 2011 the U.S. Food and Drug Administration (FDA) issued a final rule that will allow the agency to detain on its own administrative authority food and feed products it believes are adulterated or misbranded. Previously, FDA’s ability to administratively detain food products for humans or animals applied only when the agency had credible evidence that the food or feed presented a threat of serious adverse health consequences or death to humans or animals. That was before – now the FDA doesn’t need proof of any kind.

With this expanded administrative detention authority, FDA will be able to detain food and feed products that it has reason to believe are adulterated or misbranded for up to 30 days, if needed, to ensure they are kept out of the marketplace while the agency determines whether an enforcement action may be required, such as seizure of products or federal injunction against a firm.

Yet why, despite hundreds of official reports and the likelihood of thousands of unreported illness and deaths associated with the suspected treats, has the FDA not exercised its authority? Could it be that, although the authority the FDA has applies to humans and animals, is in reality it has little practical use, unless the problem is with products such as orange juice or apple juice because those are products consumed by humans?

Besides the governments legal responsibility to protect its citizens, corporations have a similar responsibility. When corporations manufacture products that are marketed to consumers, those companies are responsible for ensuring that the merchandise meets all safety requirements; companies are expected to test their products before distributing them to the public, and when those products are unsafe and cause harm to customers, the corporation may be held legally responsible for the injuries caused. In this case, it is the responsibility of the companies who produced the jerky treats to ensure they are safe for pets to consume.

Another important concern is the concept that a person or business has a legal duty to use reasonable care to avoid causing emotional distress to another person. If a company’s negligent actions – such as failing to ensure that the dog treats were safe for pets – cause emotional distress to a person, the business may be made to pay damages to the injured person. For many Americans, dogs are considered an important part of the family, and their deaths, as a result of a corporation’s negligent may constitute a negligent or intentional wrongs that result in the injury or harm of another.

What criteria does the FDA use to order a detention?

An officer or qualified employee of FDA may order the detention of any article of food that is found during an inspection, examination, or investigation under the Act, if the officer or qualified employee has credible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals. That is the standard that must be met for administrative detention of all food, including pet food.

What reason does the FDA they need to give them for the detention?

Brief, general statement of the reasons for the detention.

Is pet food covered by the Food Safety Modernization Act (FSMA)?

Yes, but…the FDA is expressly authorized to modify the preventive controls requirements for facilities that are solely engaged in the production of animal foods or to exempt those facilities entirely from the preventive controls requirements. FDA would need to promulgate a regulation to accomplish such a modification or exemption.

How is a detention accomplished?

Accomplishing a detention can take one or more paths depending on the product/s involved and the actual statutes invoked. Some of the statutes under which detentions can be accomplished are under section 304 (Seizure) of the Federal Food Drug and Cosmetic Act (FD&C), including 304(g) and 304(h), which cover medical devices and foods, both human and animal. Other statutes which cover detention are those involving products under dual jurisdiction of the US Food and Drug Administration (FDA) and the US Department of Agriculture (USDA), specifically meat, poultry, and egg products.

How are foods detained?

Detention of foods (human or animal) can be accomplished under one of two statutory paths:

1. FD&C 304(h) – added to the FD&C Act as part of the Public Heath Security and Bioterrorism Preparedness and Response Act of 2002 (“Bioterrorism Act”) and covers any article of food that presents a threat of serious adverse health consequences or death to humans or animals. Although section 304(h) was added to the FD&C Act by the “Bioterrorism Act”, an act or threat of terrorism is not required to use the authority. Credible evidence or information indicating that the article presents a threat of serious health consequences or death is the primary evidentiary requirement for this authority. In addition, although the section 304(h) authority applies to food in import status, FDA does not expect to use this authority to control such food. Generally, FDA will use the authority of section 801(a) to detain articles of food in import status. See 21 CFR Part 1, subpart K and FD&C Act section 304(h).
2. Detention of dual jurisdiction meat, poultry, or egg products:  Such products that meet the jurisdictional requirements of section 304 of the FD&C may be adulterated or misbranded, and are covered under either sections 402 and 409(b) of the Federal Meat Inspection Act (FMIA, 21 U.S.C. 601 et seq.), sections 19 and 24(b) of the Poultry Products Inspection Act (PPIA, 21 U.S.C. 451 et seq.), or sections 19 and 23(d) of the Egg Products Inspection Act (EPIA, 21 U.S.C. 1031 et seq.

Section 304(h) of the FD&C Act provides FDA with the authority to order the detention of any article of food that is found during an inspection, examination, or investigation under the Act, if the officer or qualified employee has credible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals. See 21 CFR Part 1, subpart K.

What is the Federal Meat Inspection Act?

Federal Meat Inspection Act (FMIA) – Sections 402 and 409(b) provide the FDA with the authority to detain meat products subject to the FMIA, found outside an USDA inspected plant, if the FDA has reason to believe the products are adulterated or misbranded under the FD&C Act. The detention may not exceed twenty (20) days and the items detained shall not be moved by any person from the place of detention until released by the FDA representative.

What is the Poultry Products Inspection Act?

Poultry Products Inspection Act (PPIA) – Sections 19 and 24(b) provide the FDA with the authority to detain poultry products subject to the PPIA found outside an USDA inspected plant, if the FDA has reason to believe the products are adulterated or misbranded under the FD&C Act. Detention may not exceed twenty (20) days and the items detained shall not be moved from the place of detention until released by the FDA representative.

What is the definition of Food as it applies to the FD&C Act?

For the purpose of detention of food under section 304(h) of the FD&C Act, see section 201(f) of the FD&C Act, which defines food as follows: “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.”

Examples of food include, but are not limited to, fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities for use as food or components of food, animal feed, including pet food, food and feed ingredients and additives, including substances that migrate into food from food packaging and other articles that contact food, dietary supplements and dietary ingredients, infant formula, beverages, including alcoholic beverages and bottled water, live food animals, bakery goods, snack foods, candy, and canned foods.

See Rep. Kucinich’s full letter here.

References:

FDA Investigations Operations Manual/ Sub-chapter 2.7 Detention Activities
FDA Food Defense and Emergency Response; Administrative Detention of Food and Feed, Guide for Industry

Related articles on jerky treats on Poisoned Pets:

Congressional Leaders Demand FDA Action to Protect Dogs from Poisonous Jerky Treats
More dogs die as poisonous jerky treats remain on store shelves
With over 400 new reports of tainted treats, Senator Brown urges the FDA to speed it up…again
More dogs die as poisonous jerky treats remain on store shelves
Number one selling dog treat in US causing kidney failure, death in dogs
Nestle Purina pulls compensation offers “off the table” for Waggin’ Train deaths
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