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FDA Refuses To Speak Via Phone To Veterinarians & Consumers Regarding Ongoing Regulatory Issues With Aflatoxin

Today, FDA confirmed they would not be granting phone call requests in relation to longstanding and ongoing regulatory issues with aflatoxin in dry pet foods, mainly dry pet foods produced with the ingredient corn. 

For years, Dr. Steven Solomon and other federal employees of FDA-CVM (Center for Veterinary Medicine) have continuously refused to speak to consumers, consumer groups, and members of the educational field regarding the myriad of issues surrounding various regulatory actions by FDA-CVM. Why wouldn't the FDA-CVM want to have open, honest, and continuous dialogue with the regulated consumers, or with the veterinary field? 

For years, FDA-CVM has been regulating the pet food industry by what they call their "opinion", instead of a properly passed rule. It has also been discovered that employees of FDA-CVM held secret meetings with the major grain and dry pet food lobbying group AFIA, where FDA-CVM actually worked with AFIA to stifle regulations that would have brought more quality assurance to pet food ingredients. Interestingly, FDA-CVM allows for dry pet foods to contain levels aflatoxin, a mold that can grow to become toxic and result in death of dogs and cats consuming the product. Look no further than the recent Midwestern Pet Food recall that led to many deaths and issues. FDA also exercises "enforcement discretion" when it comes to pentobarbital in pet food, essentially allowing for products in interstate commerce to contain this deadly drug. 

It has also come to light that FDA basically has "no" actual regulations for almost all ingredients allowed in the pet food stream. For decades, FDA-CVM has been engaged in helping "define" regulations in private meetings called "AAFCO" meetings, where consumers are charged $550 to attend each meeting. AAFCO is essentially public state and federal employees who come together under the umbrella of a "non profit" shield, where they perform regulatory work they should be doing in public. Although FDA-CVM performs a scientific review and even contributes to the writing of these animal feed ingredients, FDA-CVM allows the material to be "copyrighted" by these public officials performing their rulemaking work via this private "AAFCO" group. FDA-CVM then "recognizes" these official ingredients as acceptable to use in interstate commerce products which FDA regulates. But are these ingredients actual regulations? When asked that direct question, FDA-CVM has refused to provide a direct answer confirming yes, the AAFCO material is regulations or no, the AAFCO definitions are not actually regulations. It seems as though FDA-CVM is trying to operate through a loophole here, and not want the public to know that this AAFCO material isn't actually regulation. Or if the FDA considers the AAFCO material to be actual regulations, then the legal issue of why this material wasn't passed in accordance with federal law and the administrative procedures act comes into question. FDA has vaguely told some consumers that "CVM does not generally engage in rulemaking to 'codify' a food. The agency has limited resources and so cannot engage in frequent rulemaking." FDA has also stated "FDA does not have regulations that define all animal foods." Due to such vague answers, further attempts by consumers to receive for detail from the FDA on the matter of pet food regulations results in FDA responding: "The agency has limited resources and so cannot engage in frequent rulemaking. We have nothing further to add; you can consider this our final response to you." 

It sounds as if there are no actual federal regulations for any of the hundreds of ingredients allowed in pet food. FDA has been getting away with performing this work through in private, even though they could do this work publicly. As of now, no citizen can access any documents through AAFCO to review the science, who proposed which ingredient, and what comments were received when creating each ingredient allowable for use in pet food. If this were performed publicly by FDA and in compliance with the administrative procedures act, this information could be accessed by citizens looking into various pet food issues. 

The agency seems super comfortable with regularly meeting with special interest groups. FDA-CVM employees routinely fly to private AAFCO meetings, sometimes twice per year, where they converse with and have meetings with lobbying groups for the major dry pet food industry. Consumer groups and now veterinarian education groups, along with media groups, or consistently pushed to the side. When asked if FDA will be having a public meeting regarding pet food regulatory issues, the FDA confirmed it had no plans for any such meeting in the near future. FDA-CVM does plan to continue perform regulatory work in private at AAFCO meetings using public, federal funds. 

As a result of FDA's continuous action to not engage with consumers and veterinary groups, Pet Schooled submitted an official citizen petition regarding ongoing FDA regulatory issues with aflatoxin. Since FDA refuses to respond in good faith to a lot of inquiries made via email, a citizen petition is a legally binding document where FDA is required by law to respond within 180 days. 

The citizen petition asks FDA to take official action on the following issues: 

• Issue a consumer alert detailing the symptoms of aflatoxin poisoning;
• Issue a press release requesting veterinarians and pet owners to report any pet illness or death from the last 12 months to the FDA for pets fed any type of corn ingredient pet product – this includes corn, corn starch, corn gluten meal, yellow corn, etc;
• Identify the corn suppliers and trace all the suppliers’ customers, including pet food brands who purchased corn from them in the last 24 months;
• Implement a random mycotoxin testing program for all pet foods and treats that contain a corn ingredient. This program should at least be ongoing for the next 12 months; and
• Issue monthly updates to pet owners providing the number of aflatoxin/mycotoxin adverse events received (illnesses and death cases) and publicly provide testing results.

On April 28, 2021 FDA stated "we plan to respond to your Citizen Petition." No offense but, duh. You're required by law to respond to the citizen petition. If law didn't bind them to a response, they'd most likely ignore the petition as well. In regards to Dr. Solomon having a phone call to discuss these issues, FDA stated "we are not granting your request for an interview." There was no request for an interview though. The request was for a conversation that could lead to more education and understanding for consumers and veterinarians regarding these FDA regulatory issues. Since FDA has no plans for any type of public meeting regarding these issues, a phone call would be a nice gesture by the agency. Luckily, the citizen petition will force some type of answer from the agency, and it will be interesting to see what actual action FDA is willing to take on the above issues. 

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