In June, 2010, after seeking FDA registration for my product and manufacturing facility, FDA investigators came to my establishment. They collected samples to send to the FDA laboratory in Jamaica, NY for testing. I feel it is important to note here,
FDA again visited our facility today,7/19/2010, and informed us that the turkey samples they took tested NEGATIVE for SALMONELLA, as did all of the CULTURE SWABS that were taken from our manufacturing facility! New samples of the Cornish Hen Formula had to be collected again, because the original samples that were picked up were mishandled during shipping to the Jamaica, NY testing facility and rendered useless.It is important to understand, at this juncture, that we produce a RAW poultry product. Our product should be handled with the same care as any other raw poultry product. Our product should be kept ON ICE at all times. This product should be kept frozen until it is ready for use. It is easy to determine this products freshness, where it is red in color and has virtually no odor.
Unfortunately, the method the investigators used in collecting and shipping the samples has been contested. We feel that they did not provide sufficient refrigeration to allow the samples to be properly shipped and maintained safely. On that basis alone, I requested an FDA hearing, and to this day I have not received any response, even after contacting the FDA Ombudsman, which still has not returned any emails or answered the phone calls left on an answering machine.
My concerns were realized when we received the report from the lab in Jamaica, NY. The report indicated the color of the samples they had received were brown in color, indicating exposure to heat which would contribute to deterioration and lead to positive testing for salmonella. Product received by our customers is not brown, but red in color, so long as it’s not allowed to sit out in the sun or experienced some other mishandling during shipping or delivery.
Sadly, there are many more issues that I cannot properly address. Significantly, there appear to be discrepancies within testing procedures that the FDA uses, questions regarding a common testing method (the ELISA method) and the ambiguous interpretation of FDA testing versus USDA testing. Simply put, USDA testing procedures ALLOWS small amounts of pathogens to pass to the American consumer in products the USDA certifies, but the FDA testing does not. And yet, FDA Guidance for Industry Article #122 directs that all raw food producers utilize USDA guidelines and certified materials in processing, but, by their own guidelines, are already contaminated with salmonella. It is well understood that all poultry is contaminated with salmonella, including the USDA certified source poultry we use to make our products.
This leaves us in the position that if we are to consistently and fervently follow USDA guidelines, we are assuring ourselves that we test positive for salmonella, specifically for following FDA standards. Incidentally, FDA #122 specifically indicates at the top of the article, “NON BINDING RECOMMENDATIONS”, which obviously leads to the question, how can the FDA force us to recall product, when their own recommendations, which are non-binding, guarantee that we can’t provide for the product that will meet the FDA’s standards?
The bottom line is that we have five years of integrity as a producer. No person was injured or sickened. No animal was injured or sickened.Interestingly, you would be hard pressed to find a barn cat who adhered to HACCP (Hazard Analysis and Critical Control Points), which is not to say we care not to adhere to them, but it’s ludicrous to take it out to its relevant conclusions as determined for people, because we are not manufacturing a product meant for human consumption. Our product is intended for cats, whose capability for handling certain environmental exposures are superior to humans, and may even constitute a critical function to their ability to synthesize nutrition. This animal’s necessity to ingest raw meat is inherent as a species. In consuming freshly killed animals, they are also ingesting that animal’s recent ingestion, and so on. Salmonella, as well as other pathogens, are most certainly a component of that cycle, and have served them well over the millennia. As it is, we as a company are producing a product in a facility which is proud to limit the amount of exposure to pathogens that already exist in our USDA graded source materials.
Our products have tested negative for salmonella in a veterinarian lab in Arlington, VA, negative from NY state sanctioned labs in Trenton, NJ, using the ELISA method, but did test positive in FDA labs in Jamaica, NY. Still, there is no accounting for the scientific collection and delivery of the samples prior to their testing. We were also refused copies of the laboratory results until our legal counsel intervened, at much cost to us.
We have received no answers, regardless of our attempts, with or without counsel from these governmental agencies. We are a small business, and without unlimited resources, and the FDA is aware of that. I have a right to protect my integrity, that of my company, and most assuredly, the integrity and jobs of my employees and distributors.
As a result of our concerns with contamination, our product has been tested by the New York State Department of Agriculture and Markets sponsored lab, the New Jersey Feed Labs in Trenton, NJ. Carl Schultz is the owner and president of that lab. Our samples are tested for pathogens and nutrient values. Our negative test results for pathogens, such as salmonella, had delivered my vision of founding a company making raw food for felines.
The extraordinarily clean facility we run, and techniques we use, has resulted in authorization by permit from the New York State Department of Agriculture and Markets (Est. # 142570). Our labeling for food is also deemed correct by the State of New York and the FDA Regional Office in Buffalo also indicates this, however, we have yet to receive this indication in writing from them.
The diet we manufacture was preened from a diet found on www.catnutrition.org, of which Anne Jablonski is the author. This diet is a relative re-creation of the nutritional value of a common field mouse, as basically outlined by Dr. Deborah Zoran’s nutritional breakdown of the common field mouse, published in the 2002 Vancouver Journal for American Veterinarian Medical Association. Cats are obligate carnivores, meaning that they must specifically consume meat. Indeed, we now know, based on much scientific investigation, that cats cannot properly digest carbohydrates, which dominate ingredients in virtually all commercial diets. Interestingly, prior to my efforts, no one had before expended the effort to see if this diet would be a positive, nutritional diet for cats. The species has been predicated on eating small mice and vermin, birds, etc. We have prepared a nutritionally correct raw diet for cats. Without a doubt, the most difficult part of developing, manufacturing and distributing a nutritionally complete and appropriate diet for cats is the extraordinary measures it takes to make a clean product, free of contaminants that could harm those very furry customers that I have striven to protect with this endeavor.
As a result of my efforts, Feline’s Pride produces an extraordinary product, and has been endorsed by several key professionals involved with pet nutrition. Some of our staunch supporters are as follows:
Dr. Elizabeth Hodgkins DVM, J.D.
Author of the popular book “Your cat, Simple New Secrets to a Longer, Stronger Life”, and key veterinarian adviser to Tracie Hotchner’s show on Cat Chat Channel (Martha Stuart Living) on Sirius Radio. She endorses our product as being one of the safest and most nutritionally correct diet for cats on the market.
Dr. Lisa Pierson
Founder of www.catinfo.org, and adviser to the Feline Diabetes Message Board (FDMB). Dr. Pierson is also a staunch advocate of the product we manufacture, and mentions it generously on her site.
Founder of www.catnutrition.org, and an educated advocate of appropriate cat nutrition. She is also honored as the 2007 Feline Outreach Paws for Education Award recipient, as a result of her advocacy and outreach, specifically towards the veterinary industry. Feline’s Pride is noted on her site, “one of my personal favorites is Feline’s Pride…”
I have an opportunity to grow and expand, and offer more jobs to an economy that is begging for littlie companies like mine, more commonly referred to as the backbone of this country, to succeed. It is little companies like mine that the current administration is asking to bail out the economy and provide new jobs and opportunities.
We need answers, and we’re not getting them. We see many discrepancies, and we believe that we may be on the forefront of seeing to it that policies, regulations, guidelines and even laws may need to be re-evaluated based on our case. We are in this for the long haul. Most importantly, we are in this for the cats who can’t speak for themselves, and would, simply put, prefer to eat a darned mouse without human intervention. One that hasn’t been cooked, irradiated and adulterated in any manner, thank you very much.
For your references, here a number of resources for anyone interested to peruse:
FDA Guidelines for Industry Article #122:
“The Carnivore Connection to Nutrition in Cats”, JAVMA Zoran, 2002: http://www.catinfo.org/docs/zorans_article.pdf
Thank you for your interest in our plight. I am happy to answer any questions you may have. Your attention to this story is greatly appreciated, and of great importance to us.
...and for all the kitties who cannot speak for themselves