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  1. Compliance Actions and Activities

RESPONSE LETTER

Lystn LLC Supplemental Company 05/04/2016

Lystn LLC Supplemental Company - 485964 - 04/05/2016


Company:
Lystn LLC Supplemental Company

Lystn LLC

(Sent 4/5/2016 via. E-mail with hardcopy to follow in the mail or overnight delivery)

April 5, 2016

Robin M. Rivers
Compliance Officer
U.S. Food and Drug Administration
U.S. Customhouse, Room 900
2nd & Chestnut Street
Philadelphia, PA 19106

Anne E. Johnson
Acting District Director-Philadelphia District Office
U.S. Food and Drug Administration
U.S. Customhouse, Room 900
2nd & Chestnut Street
Philadelphia, PA 19106

Re: Supplemental Letter to Response to WARNING LETTER of Lystn's Complaint in the FDA's Handling of Investigation

Dear Ms. Rivers and Ms. Johnson:

This letter is intended to supplement our responses to the March 17, 2016 WARNING LETTER in an attempt to share with the FDA our ongoing complaint and position as to how the FDA has handled the investigation into Lystn's products and operations. We offer this letter for all parties to reflect upon actions taken to date, and assist the FDA in its decision if to terminate its present case with Lystn, LLC.

Lystn wishes to first reiterate what we communicated to the FDA in our first written response to the FDA back on September 28, 2015:

Lystn is a small, but competent family business and we would take immediate action on our own if we believed or have been provided any evidence-that any of our products presented a potential health risk to humans or their pets. We are one of the few (if not the only) raw pet food manufacturers whose Quality Control (QC) representative (as well as company owner) has a Masters' Degree in Food and Dairy Science and came out of the food consulting industry. Our other owner/management personnel also has significant experience in the science of microbiology. One of our recognized tag lines on our new product packaging is that we are "Integrating Raw Feeding & Science". We are not obstinate and do not wish to be combative with any state or federal regulatory agency. In fact, we invite such agencies to join us in researching and pursuing what innovative processes will improve food safety that may benefit various food related industries. We would be glad to further discuss with the FDA what future opportunities may exist to work together.


From actions of the FDA over the past 7 months, Lystn's frustration with the FDA has grown due to the following events.

The FDA's Ongoing Efforts to Link Lystn, LLC to some type of Federal Law Violation

As a result of Lystn questioning the FDA because of test result inconsistencies, Lystn raising concerns whether our actual product was being handled correctly and our questioning if the product being discussed is indeed a product of Lystn, the FDA would not address our concerns or correct the inconsistent reported test results but rather pursued continuing to test some of our other products in an effort to deflect the errors of the FDA making multiple attempts to find another alleged violation that might favor the FDA's position (essentially a "do over''). (See September 28, 2015 Lystn letter to Sean Duke)

When Lystn requested a proof of chain of custody for the samples tested by the FDA because of inconsistent and conflicting results, the FDA not only would not provide such proof but rather alleged our eggs were from a questionable source in (b)(4). Lystn does not buy its eggs from (b)(4) in (b)(4). Again we questioned if this was our product. (See September 28, 2015 Lystn letter to Sean Duke)

Even after exhaustive steps by Lystn proving our product fits into the exemption of not being considered Adulterated (including quantifying the Salmonella through our quantitative tests using (b)(4)), the FDA indicated it was the policy of zero tolerance of Salmonella (essentially regardless of what the federal law states). When we expressed our disagreement and that we were having difficulty understanding why the FDA was insisting Lystn "mitigate" a risk, when we received no reports of illness or problems and our tests support that outcome (no basis for illness or problems to exist), the FDA ignored the law and arbitrarily with no scientific evidence elevated the findings of their investigation from a potential health risk to the level of being a "public health risk".

• To date, we have never seen any paperwork, test results, or criteria required to be met by the FDA to unequivocally determine this matter as a concluded health risk nor a conclusion that our products present any wider public health concern. The fact that the FDA has prolonged this matter for more than 7 months and that neither the FDA, any state agency or Lystn has received any type of report of illnesses in humans or pets, nor reports of disease or injuries, only supports our findings, and yet even in the WARNING LETTER the FDA continues to state such health risk claims knowing there has been no evidence presented to Lystn of whether any existing conditions involving Lystn and its products could contribute to a clinical situation that could expose humans or animals to a health hazard which is to be supported by scientific documentation and/or statements; no assessment of the degree of seriousness of the health hazard to which the populations at risk would be exposed; no assessment of the likelihood of occurrence of the hazard; no assessment of the consequences or occurrence of the hazard.

• The federal legislation indicates the conclusion by the FDA of a health hazard and risk be supported by an ad hoc committee of Food and Drug Administration Scientists including statements and/or scientific documentation. When we respectfully and repeatedly requested the FDA please provide the required paperwork and name and credentials of the individual(s) that have conducted and concluded the investigation of Lystn and its products as a public health risk, not only did the FDA not provide Lystn with the required information or findings as to this conclusion, other than an e-mail, claiming a health risk, but the FDA is now introducing new alleged violations with inaccurate information for which we have not previously received any written notification.

When Lystn attended a face-to-face meeting at the Philadelphia District 3 offices of the FDA on November 3, 2015 in an attempt to seek clarification and discuss and resolve differing views, our team of 4 owners and our attorney were confronted with 25 representatives of the FDA or parties working with the FDA (see attached participation list) who attempted to intimidate us into a recall. Again when Lystn questioned why the FDA was not following the above language and provisions in the federal law, all the representatives of the FDA were silent refusing to address our question until an FDA representative said our product was not in violation of the FD&C Act (21 U.S. C. 342 (a)(1)) but rather Lystn was in violation of item {4} addressing a product being prepared, packed, or held under unsanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health. When Lystn responded that this was the first time we heard such a claim and was very concerned because we never received any such paperwork supporting such a claim, such as a 483 Report, and the fact that our pet food was produced at an USDA approved and inspected plant, after the FDA realized it could not support this claim, then another FDA representative claimed Lystn was in violation of using non-approved ingredients. Except for this brief comment, Lystn never received any paperwork making such claims until now, 7 months after the initial claims of the FDA. To compound this action, the FDA is now indicating Lystn has never expressed the intended corrective action for this alleged violation when Lystn never received any paperwork on such a claim until the March 17, 2016 WARNING LETTER.

• Regardless of our continued position that Lystn's pet food was not adulterated under the language of federal law, Lystn agreed that it would issue language addressing a recall based on negotiated language agreed upon by the FDA, when it came time to include the previously agreed upon negotiated language of a recall, the FDA reneged on the agreement with Lystn to allow the statement: "Lystn's decision to implement this recall should not be construed as an admission that its sale of these products was in violation of law and Lystn has undertaken this voluntary recall solely out of an abundance of caution and in deference to the FDA's stated concerns."

• Because of the FDA's intentional default in their agreement with Lystn and not knowing if the FDA intended to follow-up with a response to the interpretations and positions raised by Lystn to the FDA in our November 17, 2015 letter, at that time Lystn reported it was suspending our intention to initiate a Firm-initiated recall until the FDA responds in writing. Rather than the FDA addressing our concerns, the FDA now issued the subject WARNING LETTER containing more inaccurate statements and additional alleged violations.

While the FDA is trying to raise question on known healthy ingredients used by a small up and coming raw pet food company such as Lystn to protect pet food and the public, the FDA looks the other way on large pet food companies (represented by powerful trade associations) with significant egregious misbranding by having millions of tons of pet food on the market claiming use of "meat and bone meal", "soybean meal", "chicken-by-product meal" and much more. In addition, the FDA and State Departments of Agriculture overlook serious violations of law such as non-slaughtered/4-D animal ingredients in pet food. (See attached Publications).

While certainly the FDA has broad powers and authority, thankfully the United States constitution also provides recourse for U.S. citizens. Whether intended or not, from our perspective this concerted effort and continued pursuit by the FDA is an example of a federal government agency unfairly profiling and targeting groups that disagree with the philosophical position of an enforcement agency. It is assumed if the FDA believes a Lystn product warrants seizure or our operations warrant pursuing an injunction, then as previously and repeatedly stated Lystn requests such notification to consider appropriate action including seeking due process assured under federal law and the United States Constitution. Lystn will first attempt to resolve the matter with the FDA, but reserves any and all of its legal rights including to seek remedy for loss of monetary revenues, defamation of reputation and character damages, remedies for anti-trust violations by the government, class action suit and to seek criminal and abuse of power charges filed against individuals knowingly advancing such false statements, as well as petitioning the members of the Congress, testifying at congressional hearings, and filing a grievance with the U.S. Department of Justice. This is not in any way intended to be threatening, but rather Lystn is stating its intended position in response to the FDA's continual harassment and threatened regulatory actions.

Lystn was willing to conduct a firm initiated recall and submitted all the required paperwork until suspending our intention to initiate a Firm-initiated recall because of the FDA's reneging on the agreed upon language of the recall, as well as not knowing if the FDA intended to follow-up with a response to the interpretations and positions raised by Lystn in our November 17, 2015 letter. Lystn indicated the suspension of the Firm-initiated recall was in-place until the FDA responded in writing to our questions and concerns outlined in the previous correspondence including the November 20, 2015 letter to the FDA. To date, the FDA is unwilling to address our concerns and supply the supporting documentation requested and required under federal law.

Lystn is willing to continue to discuss and address any recommendations from the FDA that will improve our products and manufacturing processes without compromising our principals to satisfactorily resolve all concerns. Please feel free to contact me for further discussion, questions or concerns. Thank you for your time and consideration.

Sincerely,
Lystn, LLC
/S/
Keith A. Hill
President

Attachments: Attachment: FDA Representatives and Others that Participated in November 3, 2015 Meeting
(b)(4)