Response from FDA, sort of
Weeks ago I sent some questions to the FDA; after being ignored (twice) by the Florida Public Affairs Specialist, I went higher up the FDA ladder. Finally, I’ve received answers; sort of.
All responses provided by Laura Alvey, Dep. Director, Communications Staff, CVM are in blue below my original questions…
1. I would like to understand completely how an FDA policy can allow pet foods to violate the Federal Food, Drug, and Cosmetic Act. Quoting FDA website…
Pet food consisting of material from diseased animals or animals which have died otherwise than by slaughter, which is in violation of 402(a)(5) will not ordinarily be actionable, if it is not otherwise in violation of the law. It will be considered fit for animal consumption.
The Center will consider regulatory action based on low acid canned food violations alone where the report indicates a probable hazard to pets. CVM will also consider regulatory action against canned pet food on the basis of use of decomposed animal tissues or use of tissues containing violative drug residues.
If Federal law clearly states a food (animal or human) is deemed adulterated if it contains a diseased animal or an animal that has died other than by slaughter…wouldn’t the above FDA policy be in violation of those Federal laws? I understand the CVM states they are unaware of health risks from pet foods containing a diseased animal or animal that has died other than by slaughter, however despite CVM findings…isn’t the law the law?
Please clarify how an FDA ‘policy’ can alter Federal Law.
Please see the Foreword http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm116271.htm and Introduction http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm116791.htm which explain what a Compliance Policy Guide is and how they are used.
2. Where on FDA website can a consumer find inspection reports for rendering facilities? The public deserves to have access to all food and or food ingredient inspection reports. If these reports are not available on your website, why?
Here’s a link to our on-line, searchable database: http://www.accessdata.fda.gov/BSEInspect/
This database holds a summary of the most recent inspection at every facility in our inventory, including renderers. So, you can look up a facility you’re interested in and see quite a bit of information, summarized from our last inspection. Anything beyond this will require an FOIA request
3. Recently the USDA provided a conditional use permit for a canine influenza drug. I could be mistaken, however I was under the impression that only FDA approves drugs and medical devices; and then ONLY after extensive testing. How can the USDA approve an animal drug? Is this practice common? Are veterinarians required to notify clients the drug was approved by USDA not FDA?
Vaccines are not drugs or devices – they fall under the category of vaccines. Vaccines for animals are regulated by the USDA. You’ll have to contact USDA with your questions.
As well, I would like to have the explanation of the difference between a pet food “Voluntary Withdrawal” and a “Voluntary Recall”. Is the public not required to be notified with a ‘voluntary withdrawal’?
FDA does not have statutory authority to require manufacturers to initiate pet food recalls. Therefore, the initiation of such recalls on the part of manufacturers or importers is voluntary.
Please see the following for additional information on recalls :
Recalls classified as Class I require a press release which is typically issued by the firm. FDA posts those releases at http://www.fda.gov/Safety/Recalls/default.htm.
Companies have conducted recalls that were not classified as Class I and issued press releases which is their prerogative but only Class I classified recalls require a press release.
To question number one, I replied to Laura Alvey of the FDA the follow (10/4/09)…
Thank you for your response. However…I’m still having a problem with FDA policy that allows diseased animals to be processed into pet food. I’ve read the Foreword and the Introduction to FDA CPG – and understand that. But to me, and to millions of pet owners, it seems impossible that an FDA policy could allow Federal Law to be violated – which is what is happening in this instance. I understand that FDA interprets the law and guides its officers how to enforce the laws, however to interpret a law by ignoring it? That doesn’t seem right. I guess at this point, I would like a statement from FDA regarding this specific issue; FDA CPG that allows (some) pet food to violate federal law. When I write on this issue, I would like a specific explanation to this particular FDA CPG.
After a second request (sent 10/7/09 AM) I received the following response…
The following information should help to further clarify our previous response:
The United States Food and Drug Administration (FDA) is the agency that is responsible for upholding the laws as specified in the Federal Food, Drug, and Cosmetic Act, (FFDCA) and the regulations promulgated on the basis of the FFDCA. The FDA, which is responsible for human as well as animal foods, and drugs, must also decide where it will place its regulatory priorities based on its available resources and the potential for harm caused by violations of the law and regulations (i.e., illegal activities).
Please see: http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074717.htm. The Background information is particularly helpful.
Besides the information in the above CPG and the Center for Veterinary Medicine’s Guidance Document 122 http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052662.pdf, there is also a Compliance Policy Guide (CPG) that instructs FDA inspectors and regulators in the field on the priority of animal food products containing animal tissues that are derived from animals that have died otherwise than by slaughter or that contain animal tissues declared inedible for people. The CPG, Number 7126.23 (Section 690.500) Uncooked Meat for Animal Food located at http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074712.htm specifies that,”Districts should conduct preliminary investigations only as follow-up to complaints or reports of injuries ….”
Thus, if FDA does not receive complaints of adverse events from such products, no action is taken, and pet food companies are allowed to use such meat and animal tissues under a policy of “enforcement discretion.”
When the CPG was last modified in 1989 the use of raw diets for dogs was limited almost exclusively to the dog racing industry. In 1989, most animal tissues used in pet foods that originated from animals that had died otherwise than by slaughter or that were declared inedible for people were processed by thermal methods. The Center for Veterinary Medicine recognized that these thermal processing methods were capable of killing pathogenic organisms.
The first link provided in the FDA response to question number one, the ‘Foreword’, tells us a great deal; it probably tells us the real reason the FDA allows Federal Laws to be violated with dog foods and cat foods. The last sentence of the first paragraph…”Compliance Policy Guides may derive from a request for an advisory opinion, from a petition from outside the Agency, or from a perceived need for a policy clarification by FDA personnel.” Specifically…’from a petition from outside the Agency’; I believe is the foundation of this problem.
My opinion is ‘a petition from outside the Agency’ means pet food industry lobbyists. The only opinion I can take from this is that industries that would benefit financially from an FDA policy that would allow diseased animals and animals that have died other than by slaughter to become pet food ingredients have been deemed more important to the FDA than our pets and more important than abiding by Federal law.
FDA response to question number 2…
Interestingly (again), upon searching the FDA database for inspection reports for Rendering Facilities, going over hundreds of Rendering Facility inspections over (at least) nine years…only two inspections required action by the Rendering company. That’s difficult to imagine…an industry that deals with so many high risk materials such as decomposing animals and diseased animals, processing these risk materials into human and animal food ingredients, are doing everything so perfectly that almost every FDA inspection of every facility over nine years is perfect? Hard to believe.
FDA response to question number 3…
I did try contacting the USDA for answers. I went through at least ten different people in ten different divisions of the USDA. Not one person had a clue what I was asking about; no one (that I spoke with) was aware the USDA approved a dog drug/vaccine.
FDA response to the final question…
Until the FDA requires all product withdrawals (human or animal) to be announced via a press release; many companies will continue to quietly pull food products from store shelves without notifying the public. In essence, consumers are left to do the ‘homework’ that the FDA is supposed to do for us.
Wishing you and your pet(s) the best,
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