The FDA Recall Policy

It’s important to understand how FDA recalls work.  These voluntary recalls are not exactly voluntary, which isn’t at all clear to most people.  There are two problems, first the recalls are called voluntary because the FDA has no power to demand a recall.  The FDA doesn’t actually require recalls, they request them.  If a company refuses, the FDA can seize product and shut down operations.*  So, technically all recalls are voluntary.  However, because of liability issues, companies pretty much have to conduct a recall or face litigation and a court ordered recall.  So not so voluntary.**  

And this is important because secondly, the term ‘voluntary’ implies the danger of the product may not be all that great, that the company had a choice about the recall, that the company is recalling the product out of the goodness of their heart.   

For more information, here is are:

*[“The FDA can order a recall only under unusual circumstances. These include, but are not limited to, infant formula recalls, medical tissue product recalls (such as skin graft cultures) and medical device recalls where there’s a significant risk to a patient if the device is not used in its mandated and recommended way.”]

**(The exception is if the company initiates the recall first and informs the FDA, which tends to happen when the company conducts their own internal testing.  This sort of recall IS voluntary in the true sense of the word.)

Recall: Advanced Cetyl M For Dogs

Response Products is recalling Advanced Cetyl M Joint Action Formula for Dogs due to possible Salmonella contamination.

The recall includes lot #1210903 & #0128010, which includes 120-count bottles shipped between Jan. 8 and April 2 and 360-count bottles shipped from Feb. 11 to April 2 of this year.

Salmonella can cause serious illness in cats and dogs and there can be cross-contamination to humans causing serious illness in humans.

EPA Evaluates Spot-On Flea & Tick Treatment

Reports of adverse reactions to spot-on pesticides increased 53% from 2007-2008.  That’s a big increase and the EPA launched a study.  Spot-on pesticides are those flea & tick treatments you apply between pet’s shoulder blades or down their spine like Defend ExSpot, Sergent’s Squeeze-On, Hartz Flea & Tick Drops, Bio Spot, Advantage, Frontline, etc.  Spot-on products fall under the purview of the EPA instead of the FDA because they are a pesticide, not a medication.  A scary ramification of EPA oversight instead of FDA oversight is that there’s been no post-market tracking of the products.  That means once they’re registered by their manufacturer, these spot-on pesticides haven’t been monitored.  Not good, but things are changing.

The EPA’s review of data on spot-on pesticides found most adverse reactions were minor, such as skin irritations that resolved quickly, however, they’re were disabilities & death.  In cats, the problem was usually inappropriate application of dog products, which contained ingredients dangerous for cats or were too large a dose.  In dogs, small & toy breeds had more adverse reactions than larger dogs probably due to too high a dose.  Here’s what the EPA plans to do:

Improving labeling as needed to insure product:

  • is very clearly identified as for cats or for dogs only
  • lists safety precautions, such as keeping dogs apart from cats immediately after product is applied
  • lists possible reactions

Safety changes:

  • changing dosage by narrowing weight ranges (a current weight range for one brand is 23-44lbs, which means a 23lbs. dog is getting almost twice as much of the active ingredient per pound as a 44lbs. dog at the high end of the weight range)
  • determining safety of inert ingredients which can enhance absorption through skin, cause skin sensitization, be toxic to cats
  • improving testing requirements to examine differences between dogs, long-term exposure, effects of exposure orally from grooming
  • appropriate testing–beagles are usually used in testing and this breed isn’t sensitive to spot-on pesticides
  • bring EPA’s data requirements inline with FDA’s data requirements (click on the chart below to see how they compare at this time)

EPA’s Safety Tips:

  • Consult your veterinarian about the best way to to protect your pets from fleas and ticks and whether pesticides are even needed.
  • Use extra care before use on weak, aged, medicated, sick, pregnant, or nursing pets, or on pets that have previously shown signs of  sensitivity to pesticide products.
  • If you use a spot-on product or any other pesticide on your pet, carefully read and follow the product label.
  • Use flea and tick control products only on the animal specified by the product label – for example, dog products for dogs only and cat products for cats only.
  • Follow any label prohibitions against use on weak, aged, medicated, sick, pregnant, or nursing pets, or on pets that have previously shown sensitivity to pesticide products. Apply only the amount indicated for the size of the animal being treated.
  • Do not apply to kittens or puppies unless the product label specifically allows this treatment. Pay attention to the age restrictions for puppies and kittens on the label.
  • Monitor your pet for side effects or signs of sensitivity after applying the product, particularly when using the product on your pet for the first time. Do not apply spot-ons to pets known to be sensitive to pesticide products.
  • Keep the package with the product container (such as individual applicator tubes).  Also keep the package after treatment in case adverse effects occur.
  • If your pet experiences an adverse reaction, immediately bathe the pet with mild soap and rinse with large amounts of water.

For more information check out:

How To Report Pet Food Complaint to FDA

If you suspect your pet has gotten sick from it’s food or you think there’s something wrong with the food, be sure to file a report with the FDA. The FDA has instructions on the information to include and where to file the report. It’s okay if you don’t have all the info. listed, just include as much as you can.

If you transfer your pet food to bins or other containers, it’s important that you keep the packaging until all the food is eaten so you can provide information on the variety, point of manufacture, lot numbers, best-by dates, etc.  I haven’t been good about this at all.

When you file a report, you’ll deal with your state’s Complaint Coordinator.  Check the FDA list for each State’s contact information.

I think it’s also a good idea:

  • to file a report with the manufacturer and let them know you’ve filed one with the FDA
  • to get your veterinarian to file a report
  • to be diligent about reporting concerns given how long it can take the FDA to respond