Tag: FDA

One more step forward in Hill’s class action lawsuits. Will DSM be next?

The Class Action suit against Hill’s Pet Nutrition, Inc., has taken another step forward in the legal process with the appointment on July 31st of Lead Counsels for the Plaintiffs and the Defendants.

Lead Counsels for the Plaintiffs are:

The Multidistrict Litigation consolidates approximately 20 individual Class Action suits initiated by grieving dog owners whose pets died as a result of vitamin D overdose.

During the first half of 2019, Hill’s Pet Nutrition recalled 33 varieties of canned, wet dog food due excessive levels of vitamin D in the products.

At present, Defendants named in the Class Action include Hill’s Pet Nutrition, Inc., Hill’s Pet Nutrition Sales, Inc., and Colgate-Palmolive Company.

Hill’s is a subsidiary of Colgate-Palmolive.

The toxic concentrations of vitamin D were found to have originated from a formulation error in the vitamin D premix supplied to Hill’s by the Fort Worth, Texas facility owned by DSM Nutritional Products, LLC. 

An employee at the Fort Worth plant added vitamin D to the premix instead of adding vitamin E, resulting in a 2900% excess of vitamin D in the premix.

FDA follow-up discussions with company management established that DSM did not have adequate systems in place to prevent this type of operator error. For example,

  • Although batch records were reviewed and signed off, the ingredient substitution was not caught either by the
  • The vitamin D and vitamin E ingredients were similar in color, and there was no color-code labelling system in place to differentiate the ingredients
  • DSM did not have a bar coding system in place to aid in identification and tracking of ingredients
  • DSM did not provide a Certificate of Analysis for each batch of premix supplied to Hill’s and does not test every finished batch

As of mid-April, DSM was preparing a revised food safety plan, which it promised to provide to FDA by the end of May.

DSM has not yet been named as a Defendant in the Class Action. It will be up to the Co-Lead Counsels to decide whether or not to do so.

The best last word in this saga belongs to Jessica Hensley of FDA, who told DSM representatives, “Your products killed life. Be sure that you have a process in place so that an employee can’t screw it up.“

 

 

 

Read before you feed: FDA reminds consumers of xylitol’s danger to pets

The US Food and Drug Administration (FDA) is reminding consumers that xylitol is highly toxic to dogs.

Xylitol is a naturally occuring alcohol found in plant materials. It is as sweet as suger, but contains 40% fewer calories.

In humans, xylitol does not raise blood sugar levels, nor does it trigger insulin production. It is used as an artificial sweetener in toothpastes, cough syrups, mouthwash, sugar-free gums, breath mints, sugar-free nut butters, and other sugar-free food products.

While safe for human consumption, xylitol is highly dangerous to dogs, whose metabolism is different from that of humans. The sweetener is absorbed rapidly into a dog’s bloodstream, triggering a potent release of insulin from the pancreas.

The insulin, in turn, causes a rapid and precipitous drop in blood sugar (hypoglycemia), producing symptoms of vomiting followed by decreased activity, weakness, staggering, incoordination, collapse and seizures.

While the effects of xylitol poisoning can begin to develop in as little as 10 to 60 minutes, symptoms may not develop until as long as 12 to 24 hours after ingestion of a product sweetened with xylitol.

Cats and other household pets are less at risk of xylitol poisoning than are dogs, according to FDA, although ferrets have been known to develop low blood sugar and seizures after eating products containing xylitol.

In 2016, the ASPCA’s Poison Control Center received more than 4300 calls relating to xylitol ingesttion.

FDA has received 31 formal reports of xylitol poisoning in dogs since 2010, according to a spokesperson for the agency. Many of the reports involved sugar-free chewing gum.

In addition to the formal reports, the agency has received numerous emails and phone calls from individuals who did not realize that products contained xylitol.

Take steps to safeguard your dog

  • Check the label for xylitol in the ingredients of products, especially ones that advertise as sugar-free or low sugar. If a product does contain xylitol, make sure your pet can’t get to it.
  • Keep products that contain xylitol (including those you don’t think of as food, such as toothpaste) well out of your dog’s reach. Remember that some dogs are adept at counter surfing.
  • Only use pet toothpaste for pets, never human toothpaste.
  • If you give your dog nut butter as a treat or as a vehicle for pills, check the label first to make sure it doesn’t contain xylitol.

Watch the video for more information

For additional information on safeguarding your pets from xylitol poisoning, follow the link to FDA’s video, “Xylitol and Dogs. A Deadly Combination”

Report safety issues to FDA

  • FDA wants to know if your pet encounters safety issues with a product, and/or unanticipated harmful effects that you believe are related to a product.
  • You can report problems related to both human and pet foods and treats at the Safety Reporting Portal.
  • Each report is evaluated to determine how serious the problem is and, if necessary, additional information may be requested from the person who filed the report.

 

Pig ear pet treats blamed for human Salmonella outbreak

Pig ear pet treats have been linked to an outbreak of multidrug-resistant Salmonella infections in 13 states, according to an investigation report released today by CDC.

Forty-five individuals in California (1), Illinois (3), Indiana (3), Iowa (12), Kansas (3), Massachusetts (2), Michigan (7), Missouri (3), New York (6), North Dakota (1), Pennsylvania (2), South Carolina (1) and Wisconsin (1) have been infected with the outbreak strain, identified as Salmonella I 4,[5],12:i:-.

Twelve outbreak victims were hospitalized.

According to CDC, epidemiological evidence points to pig ear pet treats as a likely source of the illnesses.

Of the outbreak victims interviewed, 89% reported contact with a dog before getting sick and 71% reported contact with pig ear dog treats or with dogs who were fed pig ear dog treats.

In comparison, only 61% of healthy individuals reported contact with a dog, and only 16% reported having handled dog treats such as pig ears in the week before the interview.

Pig ear pet treats obtained from bulk bins at two Michigan retailers have tested positive for a number of different Salmonella strains, according to a report from the Michigan Department of Agriculture and Rural Development (MDARD).

According to FDA, MDARD found four different strains – Salmonella London, Salmonella Typhimurium, Salmonella Newport, and Salmonella Infantis – in the pig ear samples.

FDA is working with CDC and state health partners to determine whether any human or animal cases of Salmonella illness may be linked to the strains found in the treats tested by MDARD.

Other brands of individually wrapped or bagged pig ears sold at multiple retail locations in the state tested negative for Salmonella.

Pet Supplies Plus (Livonia, MI) issued a voluntary recall after learning that MDARD found Salmonella in “…aging bulk pig ear product…” in one of the company’s stores.

The contaminated bulk pig ears were stocked in open bins in Pet Supplies Plus stores in AL, AR, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, VA, WI and WV. Prepackaged pig ears are unaffected by the recall.

The company has removed bulk pig ear treats from all of its stores and has stopped shipping these treats from its distribution center.

FDA is working to identify the source of the pig ear treats, how they became contaminated, and where they were distributed.

What consumers need to know

Salmonella can cause illness in both humans and animals. People infected with Salmonella can develop diarrhea, fever and abdominal cramps. Most individuals recover without treatment. However, in some cases, the diarrhea may be so severe that hospitalization is needed.

In severe cases, without antibiotic treatment the infection may spread from the intestines into the blood stream and from there to other parts of the body.

Pets do not always display symptoms when infected with Salmonella, but signs can include vomiting, diarrhea (which may be bloody), fever, loss of appetite and/or decreased activity level. Infected pets can shed the bacteria in their feces and saliva without showing signs of being sick.

If you or a household member is suffering from symptoms of Salmonella, consult a healthcare provider.

If you believe your pet may be infected with Salmonella, consult your veterinarian.

How to alert FDA to a problem

Veterinarians who wish to have pets tested for Salmonella may do so through the Veterinary Laboratory Investigation and Response Network (Vet-LIRN Network) if the pet is from a household with a person infected with Salmonella.

FDA encourages consumers to report complaints about pet food products electronically through the Safety Reporting Portal. This information helps FDA further protect human and animal health.