In late September 2021, the FDA hosted a virtual Listening Session giving pet owners, advocates, and industry an opportunity to voice their concerns about the regulation of pet food. Before everyone else could speak, the FDA spoke to us.
The Director of FDA’s Center for Veterinary Medicine Dr. Steven Solomon was the first FDA representative to speak. As expected, Dr. Solomon explained what FDA does to protect pet owners…
“Our response teams continue to encourage swift and complete recalls or market withdrawals when issues occur. These prevent further exposure to product and provide warning and other information to the public as soon as possible so that you can make informed decisions.”
Notice that Dr. Solomon stated the agency ‘encourages swift and complete recalls’. Shouldn’t the FDA make certain pet foods are recalled swiftly and completely? (Yes, they should.) So…how is FDA doing with that recall encouragement? The agency doesn’t have the best record…as example:
On January 31, 2019 Hill’s pet food announced a recall of canned pet foods for excess vitamin D. Two months later, Hill’s expanded the recall to include many other products. The FDA failed to properly trace the recall for two months.
In December 2019 Smucker’s issued a recall of canned cat food for excess levels of choline chloride. In July 2020 – twenty-nine weeks later – Smucker’s issued another recall of canned cat food for excess levels of choline chloride. The FDA failed to properly trace the recall for more than six months.
And as expected, Dr. Solomon gave the same old excuse to why the agency doesn’t always perform as they should…
“FDA simply doesn’t have enough resources to be everywhere at once, but we continue to do the very best we can to respond to food borne incidents, to conduct surveillance and inspections of the industry, to fill scientific gaps in our knowledge, and develop new guidance and regulations when needed to address emerging public health issues.”
But…then Dr. Solomon tells the audience that Congress did provide the agency with more funding. And what did Dr. Solomon say the agency did with that money? Was it spent to properly investigate recalls? Properly monitor known pet food contaminants? No, it wasn’t.
“Congress recently gave CVM some additional resources to increase our staffing levels. With additional staff members we’ve reduced the time it takes to complete our ingredient review and we hope to continue that trend into the future.”
FDA Center for Veterinary Medicine used the additional resources given to them by Congress to hire staff members that will review new ingredients for industry. Instead of hiring additional staff to properly investigate recalls or properly monitor known pet food risks – the FDA decided to spend that additional funding to make industry more money (approval of new pet food/animal feed ingredients).
The next FDA representative to speak was Tracey Forfa, JD – Deputy Director of FDA Center for Veterinary Medicine. Notice that Ms. Forfa is a lawyer, not a scientist or veterinarian. What does that tell us when the Deputy Director of Center for Veterinary Medicine is a lawyer?
Speaking after Tracey Forfa was Jenny Murphy Deputy Director for Foods CVM Office of Surveillance and Compliance. Both Ms. Forfa and Ms. Murphy made statements regarding FDA being a ‘science-based’ agency.
Tracey Forfa: “We are both a regulatory agency and because there is no CDC for animals, we are also a public health agency, and we keep science as our foundation.”
Jenny Murphy: “FDA again uses risk-based decision making and the best science available to consider how to enforce federal regulations.“
These claims of being science-based are absolutely not true when it comes to one very significant federal regulation that FDA allows pet food to violate. In response to our Citizen Petition, Dr. Steven Solomon stated “we do not believe that the use of diseased animals or animals that died otherwise than by slaughter to make animal food poses a safety concern and we intend to continue to exercise enforcement discretion.” We asked for the science FDA based this ‘belief’ that animal waste is safe for pets to consume through a Freedom of Information Act request. The FDA response was: “After searching our files, we did not find the requested records.”
Science as FDA foundation? Not always.
The FDA should be held accountable for their statements. In an attempt for accountability, we posted the following statement on the Regulations.gov website (comment to the Listening Session):
During the FDA Virtual Pet Food Listening Session held in September 2021, the FDA made several statements we challenge for accuracy and we ask for further explanation to.
Dr. Solomon stated “Our response teams continue to encourage swift and complete recalls or market withdrawals when issues occur.” When recall data is examined we found this statement to not be completely accurate. Two concerning examples are (1) Hill’s Pet Food recall in January 2019 and expanded two months later; and (2) Smucker’s excess choline chloride canned cat food recall in December 2019 and subsequent excess choline chloride canned cat food recall more than six months later in July 2020. A two month and six month delay cannot be considered “swift”.
And then Dr. Solomon informed listeners that FDA was provided more funding by Congress and instead of hiring investigators to properly investigate recalls, the agency decided to hire individuals that can speed up the ingredient approval process for industry. Considering the recent history of recall investigation failures, we ask was it appropriate for FDA to spend money from Congress to benefit industry instead of pet owners?
We would also like to point out that both Ms. Tracey Forfa and Ms. Jenny Murphy told the audience that FDA CVM is a science based agency. However, we remind FDA that you have not provided the science to prove animals that have died other than by slaughter or diseased animals allowed by the agency to be processed into pet food (with no disclosure to the consumer) is safe for pets to consume. We filed a FOIA request for the science, to which FDA responded “we could not find the requested records.” We ask FDA to stand behind your claim of being science based and provide pet owners the science to validate your belief this material is safe for pets to consume. Or, without the science, fully enforce the law and prohibit this material in pet food.
It’s unlikely FDA will respond, but if they do – it will be shared. To watch a recording of the event, Click Here. To post a comment to FDA regarding the regulation of pet food, Click Here.
Wishing you and your pet(s) the best,
Susan Thixton
Pet Food Safety Advocate
Author Buyer Beware, Co-Author Dinner PAWsible
TruthaboutPetFood.com
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T Allen
October 11, 2021 at 4:03 pm
Excellent Susan! Of course we won’t get a meaningful response from the FDA but once we have any response we can then take it to our Congressional delegation and others (including the media) to show that we’ve tried and the FDA is (and has been) refusing to deal with the safety issues surrounding pet food as well as their working with industry to avoid labeling pet feed. Thank you as always for laying out a clear roadmap towards the next steps!
Concerned
October 11, 2021 at 4:19 pm
Hills website:
Q: Why did you not recall all of your foods as soon as you knew there was an issue in January 2019?
A: Following the January 31, 2019 recall we did a detailed investigation and discovered that the vitamin premix that caused our January 31st recall also was used in additional canned dog food products. Which is why we expanded the recall further on March 20, 2019. We do not recall food unnecessarily, most of our products were not affected by this recall and are being fed to beloved pets safely and effectively.
Q: Why did your March 20, 2019 expanded recall take place so long after the January 31, 2019 recall?
A:A: Following a thorough investigation of our canned dog food, we recalled the additional production lots as soon as we confirmed there was an issue with those products.
Q: Does Hill’s test finished products?
A: Yes, we test finished products for protein, moisture, fat, ash, macrominerals. In addition, we test for salmonella in dry food and treats.. Finally, we screen for metal contamination across all products. Testing ingredients prior to manufacturing is a sound approach to help ensure food safety.
Looks like HILLS has a TESTING PROBLEM
Hill’s standard procedures required that raw materials such as the vitamin premix be analyzed and confirmed to be safe before being unloaded at the company’s manufacturing facility. However, the FDA investigation found that the vitamin premix had not been analyzed and that the final product had not been tested to determine that it met Hill’s specific formulation. Plus, Hill’s failed to obtain certificates of analysis from the supplier of the vitamin premix.
“As a result of your failure to follow your food safety plan, the hazard of vitamin D toxicity was not adequately managed at your receiving step,” the FDA wrote. “As a result of your failure to consistently implement your pre-requisite program, a systematic failure of your food safety plan occurred that resulted in the recall of canned dog food.”
The vitamin D levels in tested lots of recalled products were more than 33 times the recommended safe upper limit.
Hill’s response
In its letter, the FDA states that it cannot assess Hill’s corrective actions adequately since they don’t “address the root cause of this incident, which was accepting an ingredient without confirming that it contained vitamin levels that were within specification as required by your procedures.” The FDA says it will verify Hill’s proposed voluntary corrective actions—submitted in March, May, and August last year—during a future inspection.
Dr. Fern Slack
October 11, 2021 at 4:32 pm
I take exception to Tracey Forfa’s comment that “there is no CDC for animals.” That makes no sense (and not simply because humans are animals). The Center for Disease Control addressed diseases, epidemiology, treatment, and management measures, among many other things. This requires viewing the world as an interconnected ecosystem. The CDC cannot be, as this comment implies, just for humans, as humans do not exist in a vacuum. Zoonotic diseases are one area of overlap; antibiotic stewardship is another — there are many. The CDC provides clear guidance and leadership in all areas of medicine, non-human animals included. The FDA is indeed a public health agency, in effect if not in name, but not because the CDC is “not for animals.” The comment is an excellent demonstration of exactly why an attorney is not qualified be the Deputy Director of Center for Veterinary Medicine, however well she may be qualified to make arguments supporting actions and expenditures clearly aimed at improving the profitability of pet food.
Susan Thixton
October 11, 2021 at 4:46 pm
Excellent point! Thank you.
Debbie in CO
October 11, 2021 at 6:11 pm
Please people just keep making your own food for the pets. I feel sorry for all the animals that are getting these foods as if then their chronic problems are not related. Truly shameful!!!
Abby
October 11, 2021 at 8:06 pm
Disgusting.
Typical tactics, f-i-n-e-s-s-i-n-g the nair-ah-tive, too.
Stock values and asinine obsession with li-ah-bil-ity matters more than death and suffering in thousands of pets from krappy half-assed formulations.
While the idiots formulating them getting accolades for being “inn-oh-vative!”
Great “public health” and “regulatory” sector we have here (human and pet).
But the candy company that owns 80% of it probably had great returns though.
That’s what matters here.
Alexis
October 12, 2021 at 10:46 am
Susan, as always, great reporting. The FDA’s smarmy and irresponsible word “encourages” should have been the strong – and CARING – word “MANDATES.” To recall an old comedy routine cliche about the former market dominating communications giant (Ma Bell – remember Bell Tel?) “we don’t care – we don’t HAVE TO.” It is up to us caring and responsible and passionate pet parents to MAKE THE FDA ACTUALLY CARE ABOUT OUR PETS. For me that would also include companion livestock such as horses. Second: as consumers (oh law how I hate that word because WE ARE ACTUALLY FUNDING THIS FDA AND MEGA PET FOOD MFG BY OUR TAX DOLLARS AND OUR BUYING HABITS – IT IS OUR MONEY THAT IS BEING FRAUDULENTLY TAKEN FROM US WITH DISGUSTING FILTH PROVIDED IN RETURN!) we absolutely must refuse to sit back and be dictated to by such corrupt government agencies and corporations.
Adele Gaskin
October 15, 2021 at 5:31 pm
The FDA is a useless organization ever since Reagan made it business friendly and consumer unfriendly. That goes for human products too-um, Oxycontin?