Questions We will ask FDA

Next week, Tony Corbo of Food & Water Watch, Mollie Morrissette of PoisonedPets.com and myself will have a phone conference meeting with the FDA regarding chicken jerky treats imported from China.  FDA was provided with our questions in advance, and petsumers should be provided with the same opportunity.

When a statement made by FDA (Dr. Dan McChesney) didn’t agree with a previous announcement made by the agency regarding the number of adverse event reports received by the agency related to the jerky treats imported from China, I sent a request to FDA for a meeting.  While I didn’t get exactly what I asked for (I asked for an FDA meeting with pet parents whose pets have suffered death or permanent kidney damage related to the Chinese treats and pet food safety advocates), the FDA (Dr. Bernadette Dunham, Director of CVM and Dr. Dan McChesney, Director Office of Surveillance and Compliance CVM) did agree to talk with myself, Mollie Morrissette and Tony Corbo.

Wanting this meeting to be productive, we have sent the FDA some questions in advance.

They are…

Any updates on illnesses/deaths associated with the pet treats imported from China since FDA’s September 2012 update.

Status of any protocols worked out between China and FDA on FDA’s ability to take samples in Chinese pet food manufacturing facilities.

Status of the research being conducted by NASA on the impact that irradiation could have on the safety of these imported pet treats.

Question:  Can the FDA elaborate on why the interim final rule (of the FSMA) does not provide any information regarding when FDA will have a “reasonable belief” or “reasonable probability” that a food is adulterated and/or will cause serious adverse health consequences to human and animals?

Question:  Current FDA guidance does not address how the agency intends its case-by-case approach to be implemented, therefore can the agency provide more detailed guidance concerning how the agency will employ its standards and procedures with regard to what constitutes a ‘reasonable belief’?

Question: Why have retailers and internet websites that have been selling reportable foods, and are continuing to do so, not been required by the agency to publish consumer notifications  in both conspicuous locations within grocery stores and by posting web notifications for consumers to see?

Question:  When FDA inspectors were denied access to samples for testing during the inspection of the food facilities in China, did the agency not ‘deny entry of food if the foreign facility inspection is denied’.  Why have the imported treats from China been allowed continuous entry, despite China’s refusal to allow the agency to complete a full inspection?

Question:  During inspection of the Chinese foreign food facilities, how was the FDA able to ascertain tests conducted on incoming raw materials, including results of these tests and acceptance criteria for filth, mold, chemical contaminants, pesticides, aflatoxin, bacterial load, deterioration, etc?

Question:  During inspection of the Chinese foreign food facilities, did the FDA examine food and color additives to determine if they are permitted and used at allowable levels?

Question:  During inspection of the Chinese foreign food facilities, how was the FDA able to ascertain what finished product tests are performed for filth, bacteria, aflatoxin, standards, nutrients, etc. and evaluate the results of these tests?

In Sec. 415(b) the FDA has the authority to suspend a registration of a facility if the agency concludes that the food carries, to a ‘reasonable probability’ the potential of causing ‘serious adverse health consequences or death’.  Further, food from a facility whose registration has been suspended cannot be introduced into interstate or intrastate commerce and cannot be imported or exported.
Question: With this in mind, can the agency tell us, on what authority the agency permitted the continuation of the pet treats imported from China, despite the agency’s ongoing knowledge that they had the potential of causing serious adverse health consequences and death to remain on the market?

SEC. 423.  MANDATORY RECALL AUTHORITY.
(a) VOLUNTARY PROCEDURES. If the Secretary determines, based on information gathered through the reportable food registry under section 417 or through any other means, that there is a reasonable probability that an article of food (other than infant formula) is adulterated under section 402 or misbranded under section 403(w) and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals, the Secretary shall provide the responsible party (as defined in section 417) with an opportunity to cease distribution and recall such article.
Question:  What is the practical and legal definition of  ‘reasonable probability’?

Question: Can the CVM justify allowing pet food to be labeled therapeutic when the food is allowed to contain unapproved food additives which would then be considered an adulterated food (within the meaning of section 402(a)(2)(c)(i)) to be labeled and sold as a food meant to diagnose, cure, mitigate, treat, or prevent disease in dogs and cats?  Further, can the agency explain why such a food would be unlikely to initiate enforcement action despite that food being adulterated?

Question:  Can you provide us with an accurate number of complaints received by FDA related to these jerky treats?

Regarding the recent announcement from FDA re Kasel Ind, the FDA stated “Don’t feed certain Nature’s Deli Chicken Jerky Dog treats.”
Question:  We ask FDA why they have not issued a similar statement and asked for retailers to pull the jerky treats imported from China?

Question:  Could you explain how FDA has authority to provide an industry with its permission to avoid federal food safety law?

Question:  Will FDA facilitate the position of consumer advocate for Mollie Morrissette and Susan Thixton (and/or their designated alternates) within FDA and AAFCO – with voting privileges at FDA (if appropriate) and AAFCO?

Yes, this is a lot of information to cover in an hour meeting.  We are hopeful the FDA will be prepared and will provide us with complete responses.  The outcome of this meeting will be shared as soon as possible.  Keep your fingers crossed!

Wishing you and your pet(s) the best,

Susan Thixton
Pet Food Safety Advocate
Author, Buyer Beware
Co-Author Dinner PAWsible
TruthaboutPetFood.com
PetsumerReport.com

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